Vial Adapter Assembly

Abstract

The vial adapter assembly includes a housing, a first receptacle formed in the housing and configured to receive a first vial therein, and a second receptacle formed in the housing and configured to receive a second vial therein. The first receptacle opening and the second receptacle opening are in fluid communication with a top surface of the housing. The vial adapter assembly includes a cap coupled to the housing and movable relative to the housing from a closed configuration to an open configuration. In the closed configuration, the cap is configured to cover the first receptacle opening and the second receptacle opening on the top surface. In the open configuration, the cap is configured to expose the first receptacle opening and the second receptacle opening and expose the top surface.

Description

[Technical field]

[0001] Aspects of the present disclosure relate to devices and methods for assembling multiple containers for storing pharmaceutical agents and controlling access to their contents. More specifically, embodiments of the present disclosure relate to devices and methods for packaging together, storing, transporting, and / or facilitating access to multiple (two or more) vials that store different pharmaceutical substances or other fluids together in a single housing. [Background technology]

[0002] Pharmaceutical products that include fluid drug substances can be deliverable to patients in a variety of ways, including via injection. Often, the fluid drug substance is loaded and stored in a container, such as a vial. To preserve the fluid drug substance and prevent its contamination prior to use, the fluid drug substance can be stored in a separate vial. In some examples, a treatment may require administration of a solution that includes a combination of multiple fluid drug substances that cannot be formulated together in a single vial, e.g., one or more injections. In this example, each of the fluid drug substances is stored separately in a separate vial. For example, certain immunotherapies (e.g., cancer immunotherapy) may involve administration of compositions or formulations of different fluid substances that cannot be formulated in a single vial but must be administered together, e.g., in a single injection. Human error in separately maintaining, handling, controlling, or administering multiple vials that store different fluid substances can affect the efficacy of the injection in the patient and the subsequent clinical effect on the patient.

[0003] Additional aspects of fluid drug delivery can complicate the goal of accurately delivering the correct combination of different fluid substances via injection. For example, for a precise mixture of drug substances to be administered to a patient via a device (e.g., a syringe), the packaging, labeling, and / or storage of multiple loaded vials must be done error-free, either by human or otherwise. Summary of the Invention

[0004] Disclosed herein is a combination device, particularly a vial adapter, for attaching, packaging together, and controlling access to the contents of two or more vials. In one embodiment of the disclosure, the vial adapter assembly includes a housing and a first receptacle formed in the housing and configured to at least partially receive a first vial in the body of the housing. The opening of the first receptacle is in fluid communication with a top surface of the housing. The vial adapter assembly includes a second receptacle formed in the housing and configured to at least partially receive a second vial in the body of the housing. The opening of the second receptacle is in fluid communication with a top surface of the housing. The vial adapter assembly includes a cap coupled to the housing, the cap being movable from a closed configuration to an open configuration relative to the housing. In the closed configuration, the cap is configured to cover the opening of the first receptacle and the opening of the second receptacle on the top surface of the housing. In the open configuration, the cap is configured to expose the opening of the first receptacle and the opening of the second receptacle and to expose a top surface of the housing.

[0005] In some aspects of the disclosure, the housing includes at least one slot on a top surface of the housing, and the cap includes at least one corresponding protrusion extending outwardly from a surface of the cap configured to mate with the top surface of the housing. In the closed configuration, each of the at least one slot is configured to receive one of the at least one corresponding protrusion. In the open configuration, each of the at least one protrusion is configured to deform such that the cap is prevented from transitioning from the open configuration to the closed configuration. The first receptacle includes a second opening along a bottom portion of the housing, and the second receptacle includes a second opening along a bottom portion. The first openings of the first and second receptacles are smaller in size compared to the second openings of the first and second receptacles. The second openings of the first and second receptacles are sized to receive a first vial and a second vial, respectively. When the first and second vials are received in the first and second receptacles, the first openings of the first receptacle and the second receptacle are positioned to align with the first and second openings of the first and second vials, respectively.

[0006] In some embodiments of the present disclosure, the first receptacle is positioned adjacent to the second receptacle such that the first vial is maintained side-by-side with the second vial when received in the housing. The vial adapter assembly further includes a single hinge coupling the housing to the cap, the hinge configured to pivot the cap relative to the housing when moving from the closed configuration to the open configuration. The cap is configured to simultaneously cover the opening of the first receptacle and the opening of the second receptacle when in the closed configuration and simultaneously uncover the opening of the first receptacle and the opening of the second receptacle when in the open configuration. The housing is configured to at least partially surround the first vial and the second vial such that the first vial and the second vial are positioned adjacent to one another. The vial adapter assembly includes an actuator positioned over the opening of the first receptacle and the opening of the second receptacle. The actuator includes a first hollow piercing element extending toward the first receptacle and a second hollow piercing element extending toward the second receptacle, the actuator being configured to simultaneously move the first hollow piercing element relative to the first receptacle and the second hollow piercing element relative to the second receptacle.

[0007] According to another embodiment of the present disclosure, a vial adapter assembly includes a housing, a first receptacle formed in the housing and configured to at least partially receive a first vial, a second receptacle formed in the housing and configured to at least partially receive a second vial, and a first actuator coupled to the housing and positioned in longitudinal alignment with the first receptacle so as to be positioned over an opening of the first receptacle. The first actuator includes a hollow piercing element extending toward the first receptacle. The vial adapter assembly includes a second actuator coupled to the housing and positioned in longitudinal alignment with the second receptacle so as to be positioned over an opening of the second receptacle. The second actuator includes a hollow piercing element extending toward the second receptacle. Each of the first actuator and the second actuator are independently movable relative to the housing between an extended configuration and a compressed configuration. In the extended configuration, the piercing element of the first actuator and the piercing element of the second actuator are positioned outside the first receptacle and the second receptacle, respectively, such that the piercing element of the first actuator and the piercing element of the second actuator are not in fluid communication with the first receptacle and the second receptacle, respectively. In the compressed configuration, the piercing element of the first actuator and the piercing element of the second actuator are positioned at least partially within the first receptacle and the second receptacle, respectively, such that the piercing element of the first actuator and the piercing element of the second actuator are in fluid communication with the first receptacle and the second receptacle, respectively.

[0008] In some embodiments of the present disclosure, the vial adapter assembly further includes a first removable barrier coupled to the housing and positioned between the first actuator and the first receptacle, and a second removable barrier coupled to the housing and positioned between the second actuator and the second receptacle. The first removable barrier and the second removable barrier include adhesive liners. The housing includes a first slot and a second slot, the first slot and the second slot sized to receive at least one of the first removable barrier and the second removable barrier.

[0009] In some aspects of the present disclosure, the first removable barrier is configured to prevent movement of the first actuator from the extended configuration to the compressed configuration when the first removable barrier is received in the first slot. The second removable barrier is configured to prevent movement of the second actuator from the extended configuration to the compressed configuration when the second removable barrier is received in the second slot. The first removable barrier and the second removable barrier are configured to be independently removable with respect to the housing. Each of the first actuator and the second actuator includes a luer lock connector.

[0010] In a further embodiment of the present disclosure, a vial adapter assembly includes a housing, a first receptacle formed in the housing and configured to at least partially receive a first vial, and a first connector secured to the housing, a distal end of the first connector positioned at least partially within the first receptacle such that a distal end of the first connector extends into the first vial when received in the first receptacle and is in fluid communication with the first vial. The vial adapter assembly includes a second receptacle formed in the housing and configured to at least partially receive a second vial, and a second connector secured to the housing, a distal end of the second connector positioned at least partially within the second receptacle such that a distal end of the second connector extends into the second vial when received in the second receptacle and is in fluid communication with the second vial.

[0011] The vial adapter assembly includes a first actuator coupled to the housing and positioned in longitudinal alignment with the first receptacle, and a second actuator coupled to the housing and positioned in longitudinal alignment with the second receptacle. Each of the first actuator and the second actuator is independently movable relative to the housing between an extended configuration and a compressed configuration. When the first actuator and the second actuator are in the extended configuration, the first actuator and the second actuator conceal proximal regions of the first connector and the second connector, respectively. When the first actuator and the second actuator are in the compressed configuration, the first actuator and the second actuator expose proximal regions of the first connector and the second connector, respectively.

[0012] In some embodiments of the present disclosure, the vial adapter assembly further includes a first removable barrier coupled to the first actuator and a second removable barrier coupled to the second actuator when the first actuator and the second actuator are in the extended configuration. The first removable barrier and the second removable barrier include at least one of an adhesive liner or a cap. The first removable barrier is positioned over a proximal end of the first connector when coupled to the first actuator, and the second removable barrier is positioned over a proximal end of the second connector when coupled to the second actuator. The vial adapter assembly further includes a first lockout mechanism configured to prevent the first actuator from returning to the extended configuration from the compressed configuration, and a second lockout mechanism configured to prevent the second actuator from returning to the extended configuration from the compressed configuration.

[0013] In some aspects of the present disclosure, the proximal region of the first connector extends outwardly from the first actuator when the first actuator is in the compressed configuration, and the proximal region of the second connector extends outwardly from the second actuator when the second actuator is in the compressed configuration. The first removable barrier and the second removable barrier are configured to be independently movable relative to the housing. The proximal region of each of the first connector and the second connector includes a luer lock.

[0014] In a further embodiment of the present disclosure, a vial adapter assembly includes a housing and a first receptacle formed in the housing. The first receptacle is configured to receive a first vial therein. The vial adapter assembly includes a first connector movably coupled to the housing and positioned at least partially in the first receptacle, the first connector including a first channel defining a first flow path. The vial adapter assembly includes a second receptacle formed in the housing, the second receptacle configured to receive a second vial therein. The vial adapter assembly includes a second connector movably coupled to the housing and positioned at least partially in the second receptacle, the second connector including a second channel defining a second flow path. The first connector and the second connector are each configured to move independently relative to the housing between a first configuration and a second configuration. In the first configuration, the first flow path is blocked and the second flow path is blocked. In the second configuration, the first flow path is unblocked and the second flow path is unblocked.

[0015] In some aspects of the present disclosure, the vial adapter assembly further includes a first stopper extending around a distal region of the first connector in the first receptacle and a second stopper extending around a distal region of the second connector in the second receptacle. The first flow path extends through a sidewall of the distal region of the first connector and the second flow path extends through a sidewall of the distal region of the second connector. The vial adapter assembly further includes a first stopper extending around a distal region of the first connector in the first receptacle and a second stopper extending around a distal region of the second connector in the second receptacle. A portion of the first stopper is configured to block the first flow path when the first connector is in the first configuration and the second stopper is configured to block the second flow path when the second connector is in the first configuration.

[0016] In some aspects of the disclosure, the first connector is configured to rotate relative to the housing when transitioning from the first configuration to the second configuration. The second connector is configured to rotate relative to the housing when transitioning from the first configuration to the second configuration. The first connector and the second connector are each configured to independently rotate relative to the housing between the first and second configurations. Each of the first connector and the second connector includes a proximal region extending proximally from the housing and configured to be independently movable relative to the housing. Each of the first connector and the second connector includes a proximal region configured to couple to an external device. The proximal region configured to couple to an external device includes a luer lock.

[0017] In another embodiment of the present disclosure, a vial adapter assembly includes a housing; a first receptacle formed in the housing and configured to at least partially receive a first vial within a body of the housing, the opening of the first receptacle being in fluid communication with a top surface of the housing; a cap coupled to the housing, the cap including a hollow piercing element and movable relative to the housing from a closed configuration to an open configuration, the cap configured to cover the opening of the first receptacle on the top surface of the housing in the closed configuration and configured to uncover the opening of the first receptacle and expose the top surface of the housing in the open configuration; and an external device coupled to the housing.

[0018] In some embodiments of the present disclosure, the cap further includes a second receptacle formed in the housing and configured to at least partially receive a second vial in the body of the housing, the opening of the second receptacle being in fluid communication with the top surface of the housing. The hollow piercing element extends distally from the inner surface of the cap. The cap includes a proximal region configured to couple to an external device. The proximal region configured to couple to an external device includes a connector extending proximally from the outer surface of the cap. The connector is a luer lock. The external device is a syringe or an IV bag.

[0019] In a further embodiment of the present disclosure, a vial adapter assembly includes a housing, a first cartridge in the housing, the first cartridge containing a first substance, a second cartridge in the housing, the second cartridge containing a second substance, a first actuator coupled to the housing and positioned in longitudinal alignment with the first cartridge, and a second actuator coupled to the housing and positioned in longitudinal alignment with the second cartridge, each of the first actuator and the second actuator being independently movable relative to the housing between an extended configuration and a compressed configuration, wherein in the extended configuration a portion of the first actuator extends outwardly from the housing in a proximal direction and a portion of the second actuator extends outwardly from the housing in a proximal direction, and wherein in the compressed configuration a portion of the first actuator is concealed within the first cartridge and a portion of the second actuator is concealed within the second cartridge.

[0020] In some embodiments of the present disclosure, the vial adapter assembly includes a third cartridge in a housing, the third cartridge containing a third substance, and a third actuator coupled to the housing and longitudinally aligned with the third cartridge. In an extended configuration, a portion of the third actuator extends proximally outward from the housing, and in a compressed configuration, a portion of the third actuator is hidden within the third cartridge. The housing includes a proximal end and a distal tip. A first actuation translates the distal end of each cartridge toward the distal tip of the housing, and a second actuation delivers the substance stored within each cartridge. The first actuation translates the distal end of each cartridge outward from the housing through an opening in the distal tip. The distal tip of the housing is configured to connect to an external device. The distal tip includes a luer lock connection. The external device is a syringe or an IV bag. The housing includes a first receptacle containing a first cartridge and a second receptacle containing a second cartridge. The first cartridge is a first syringe and the second cartridge is a second syringe. The first syringe includes a first needle extending from a distal end of the first syringe and the second syringe includes a first needle extending from a distal end of the second syringe. [Brief description of the drawings]

[0021] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. The drawings illustrate various aspects of the present disclosure, and where appropriate, reference numerals that indicate similar structures, components, materials, and / or elements in different figures are similarly labeled. It is understood that various combinations of structures, components, and / or elements in the various embodiments other than those specifically shown are contemplated and are within the scope of the present disclosure.

[0022] Many embodiments are described and illustrated herein. The vial adapter and method are not limited to any single aspect or embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Moreover, each of the aspects of the described embodiments may be used alone or in combination with one or more of the other aspects of the described invention and / or embodiments thereof. For the sake of brevity, some permutations and combinations are not separately discussed and / or illustrated herein. [Figure 1] 1 illustrates an exemplary vial adapter according to some embodiments of the present disclosure. [Diagram 2] 1 illustrates another exemplary vial adapter and its components according to an additional embodiment of the present disclosure. [Diagram 3] 3 shows a cross-section of the vial adapter shown in FIG. 2. [Figure 4A] 3 illustrates a cross-section of the vial adapter shown in FIG. 2 in a partially actuated state, according to an embodiment of the present disclosure. [Figure 4B] 3 illustrates a cross-section of the vial adapter shown in FIG. 2 in a fully actuated state, according to an embodiment of the present disclosure. [Diagram 5] 13 illustrates a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 6] 6 illustrates a cross-section of the vial adapter shown in FIG. 5 in an unactuated state, according to an embodiment of the present disclosure. [Figure 7] 6 illustrates a cross-section of the vial adapter shown in FIG. 5 in a partially actuated state, according to an embodiment of the present disclosure. [Figure 8] 6 illustrates a cross-section of the vial adapter shown in FIG. 5 in an actuated state, according to an embodiment of the present disclosure. [Figure 9] 13 illustrates a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 10] 10 illustrates a cross-section of the vial adapter shown in FIG. 9 in a closed configuration according to an embodiment of the present disclosure. [Figure 11]10 illustrates a cross-section of the vial adapter shown in FIG. 9 in an open configuration, according to an embodiment of the present disclosure. [Figure 12] 13A-13C show side views of further exemplary vial adapters according to additional embodiments of the present disclosure. [Figure 13] 14 shows a top view of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 14] 1 illustrates a further exemplary vial adapter and components thereof according to additional embodiments of the present disclosure. [Figure 15] 1 illustrates a further exemplary vial adapter and components thereof according to additional embodiments of the present disclosure. [Figure 16] 13 illustrates a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 17] 17 illustrates a portion of the vial adapter shown in FIG. 16 attached to the neck of a vial according to an embodiment of the present disclosure. [Figure 18] 13 illustrates a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 19A] 13A-13C show further exemplary vial adapters in stages of assembly according to additional embodiments of the present disclosure. [Figure 19B] 13A-13C show further exemplary vial adapters in stages of assembly according to additional embodiments of the present disclosure. [Figure 20] FIG. 19B illustrates a top view of the exemplary vial adapter shown in FIGS. 19A-19B. [Figure 21] FIG. 13 shows a side view of an exemplary double vial according to an additional embodiment of the present disclosure. [Figure 22] FIG. 22 illustrates a top view of the exemplary double vial shown in FIG. 21. [Figure 23] 13 shows a side view of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 24] 13 shows a top view of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Diagram 25]1 illustrates a further exemplary vial adapter and components thereof according to additional embodiments of the present disclosure. [Figure 26] 1 illustrates a further exemplary vial adapter and components thereof according to additional embodiments of the present disclosure. [Figure 27] 1 illustrates a further exemplary vial adapter and components thereof according to additional embodiments of the present disclosure. [Figure 28] 1 illustrates a further exemplary vial adapter and components thereof according to additional embodiments of the present disclosure. [Figure 29] 13A-13C show side views of a further exemplary vial adapter and its components according to additional embodiments of the present disclosure. [Diagram 30] 13A-13C show cross sections of a further exemplary vial adapter and its components according to additional embodiments of the present disclosure. [Figure 31A] 29-30 in an unactuated state according to an embodiment of the present disclosure. [Figure 31B] 29-30 in an actuated state according to an embodiment of the present disclosure. [Figure 32A] 13 illustrates an unactuated state of a further exemplary vial adapter and a method of assembling the same according to an additional embodiment of the present disclosure. [Figure 32B] 13 illustrates an actuated state of a further exemplary vial adapter and a method of assembling the same according to an additional embodiment of the present disclosure. [Figure 33A] 13 illustrates an unaccessed state of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 33B] 13 illustrates an accessed state of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Diagram 34] 13 illustrates a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Figure 35A] 35A-35B show different cross-sections of the exemplary embodiment of the vial adapter shown in FIG. 34 in accordance with aspects of the present disclosure. [Figure 35B] 35A-35B show different cross-sections of the exemplary embodiment of the vial adapter shown in FIG. 34 in accordance with aspects of the present disclosure. [Figure 36A] 1 illustrates an exemplary adapter in an unassembled state according to an additional embodiment of the present disclosure. [Figure 36B] 1 illustrates an exemplary adapter in an assembled state according to an additional embodiment of the present disclosure. [Figure 37A] 13 illustrates a further exemplary adapter in an unassembled state according to an additional embodiment of the present disclosure. [Figure 37B] 13 illustrates a further exemplary adapter in an assembled state according to an additional embodiment of the present disclosure. [Figure 38] 13 illustrates a further exemplary adapter according to an additional embodiment of the present disclosure. [Figure 39] 13 illustrates a cross section of a further exemplary adapter according to an additional embodiment of the present disclosure. [Diagram 40] 1 illustrates an exemplary syringe according to an additional embodiment of the present disclosure. [Diagram 41] 13 illustrates a cross-section of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Diagram 42] 1 illustrates an exemplary syringe according to an additional embodiment of the present disclosure. [Diagram 43] 13 illustrates a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Diagram 44] 13A-13C illustrate a portion of a further exemplary vial adapter according to an additional embodiment of the present disclosure. [Diagram 45] 1 illustrates an exemplary crimp assembly according to an additional embodiment of the present disclosure. [Diagram 46] 13 illustrates a further exemplary crimp assembly according to an additional embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Many embodiments are described and illustrated herein. The present disclosure is not limited to any single aspect or embodiment thereof, nor to any combinations and / or permutations of such aspects and / or embodiments. Each of the aspects and / or embodiments of the present disclosure may be used alone or in combination with one or more of the other aspects and / or embodiments of the present disclosure. For the sake of brevity, many of these combinations and permutations are not discussed separately herein.

[0024] As used herein, the terms "comprises," "comprising," "include," "including," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." In particular, an embodiment or implementation described herein as "example" or "exemplary" should not be construed as being preferred or advantageous over other embodiments or implementations, for example, but rather is intended to reflect or indicate that the embodiment(s) is an "example" rather than an "ideal." In addition, terms such as "first," "second," and the like, in this specification do not denote any order, quantity, or importance, but rather are used to distinguish one element, structure, step, or process from another. Additionally, the terms "a" and "an" as used herein do not denote a limitation of quantity, but rather denote the presence of one or more of the referenced item. Additionally, the terms "about," "approximately," "substantially," and the like, when used in describing a numerical value, unless otherwise specified, indicate a + / - 10% variance of that value.

[0025] The embodiments of the present disclosure may be used with any type of fluid-containing product, such as liquid drug substance, liquid placebo, or other liquid that may be formulated in a dosage form. As used herein, the term "drug substance" may refer to a formulated substance that contains an active ingredient(s). In some embodiments, the devices and aspects of the present disclosure may be used with any therapy that uses the immune system to fight disease, such as immunotherapy, including vaccines, allergy treatments, cancer treatments, and the like. In particular, the devices and aspects of the present disclosure may be used for the treatment of patients with cancer (e.g., cancer immunotherapy). However, it is also envisioned that the embodiments of the present disclosure may be applicable to any therapy, liquid product, and / or any other situation in which different substances may be stored separately in multiple vials. Although medical indications are described herein, it is envisioned that non-medical liquids packaged together in different vials may be used in conjunction with the vial adapters described herein.

[0026] As used herein, the terms "proximal" and "proximally" refer to a location (or portion of a device) relatively closer to or in the direction of the access point, and the terms "distal" and "distally" refer to a location (or portion of a device) relatively closer to or in the direction of the user end opposite the proximal location / portion of the device.

[0027] As used herein, the term "body," when used in reference to a portion of a device, may refer to a component of a device suitable for containing a volume of drug substance. The body may include, for example, a barrel (such as a syringe barrel), a tube, a cylinder, or other containing portion of a device. In some embodiments, the body may also include a distal end portion having a nozzle, a needle, a needle attachment site, and / or a distal cap.

[0028] In some embodiments, vial adapters according to the present disclosure may be manufactured, packaged, assembled with a vial, and / or otherwise prepared according to a process associated with the product (e.g., pharmaceutical product) of which they may be a part. For example, in some embodiments, vial adapters according to the present disclosure may be packaged, e.g., in a blister package, or assembled with a pre-filled vial and packaged, e.g., in a blister package.

[0029] Described herein are various embodiments of vial adapters, particularly for packaging together two or more vials and / or cartridges storing different contents. In some examples, the embodiments or aspects of the embodiments disclosed herein may be used in conjunction with existing vials, cartridges, and / or syringe body components to modify off-the-shelf products. In other examples, the embodiments or aspects of the embodiments disclosed herein may be included in devices during their manufacture. Such components may be intended to reduce human error and / or increase accuracy of administering a treatment or composition formed by a mixture of multiple fluidic substances stored in separate vials prior to administration, e.g., injection, into a patient.

[0030] 1, an exemplary vial adapter assembly 100 is shown. The vial adapter assembly 100 may be configured and operable to hold and facilitate simultaneous access (fluid communication) to two or more vials housed together in separate receptacles upon removal of a moveable cap sealing each receptacle. The vial adapter assembly 100 may include a housing 102 having a distal end 104 and a proximal end 106. The vial adapter assembly 100 may include a plurality of receptacles formed in the housing 102 and extending between the distal end 104 and the proximal end 106. Each of the plurality of receptacles may be configured to at least partially receive a vial within the housing 102. In this example, vial adapter assembly 100 includes a pair of receptacles, such as a first receptacle for receiving a first vial 10a within the body of housing 102, and a second receptacle for receiving a second vial 10b within the body of housing 102. Although vial adapter assembly 100 is shown and described herein as including a pair of receptacles for receiving the pair of vials 10a, 10b, housing 102 may include additional receptacles for simultaneously storing additional vials adjacent to one another.

[0031] The first receptacle may include at least one opening along a bottom of the housing 102, such as proximate or flush with the distal end 104, sized and shaped to receive the first vial 10a therein. The second receptacle may include at least one opening along a bottom of the housing 102, such as proximate or flush with the distal end 104, to receive the second vial 10b therein. In some embodiments, the openings along the bottom of the housing 102 may be sized, shaped, and configured to form a friction fit with each of the vials, thereby securely coupling the first vial 10a and the second vial 10b to the housing 102. In some embodiments, portions of the first receptacle and the second receptacle may interact with the neck of the first vial 10a and the neck of the second vial 10b, respectively, to maintain the first vial 10a and the second vial 10b in the first receptacle and the second receptacle.

[0032] The first receptacle may be disposed adjacent to the second receptacle such that the first vial 10a is maintained side-by-side with the second vial 10b when received within the housing 102. It should be understood that the first and second receptacles may be sized and shaped relatively similarly to one another such that a pair (or more) of receptacles may be configured to receive vials of similar cross-sectional dimensions. In other embodiments, the first and second receptacles may have different cross-sectional dimensions relative to one another.

[0033] The pair of receptacles may be sized and shaped to at least partially receive the pair of vials such that at least a portion of the first vial 10a and at least a portion of the second vial 10b may extend beyond the housing 102. For example, the tops of the vials 10a, 10b adjacent the vial openings may be disposed within the housing 102 when the vials 10a, 10b are received by the receptacles. In this case, the distal ends of the vials 10a, 10b may extend from the distal end 104 of the housing 102 for easy access by a user of the vial adapter assembly 100 to allow visual inspection of the vial contents. Each of the pair of receptacles may include corresponding openings 110a, 110b that are recessed from or flush with the proximal end 106 such that each of the openings 110a, 110b may be in fluid communication with the top surface 108 of the housing 102.

[0034] The first opening 110a of the first receptacle and the second opening 110b of the second receptacle are positioned along the top surface 108 to align with the openings of the first and second vials 10a, 10b when the pair of vials 10a, 10b are received in the corresponding receptacles. Thus, the openings 110a, 110b may allow access to the first and second vials 10a, 10b, respectively, when received in the housing 102. In some embodiments, the openings 110a, 110b of the first and second receptacles along the top surface 108 are sized relatively smaller than the openings of the first and second receptacles along the bottom of the housing 102.

[0035] 1, vial adapter assembly 100 may include a cap 120 releasably coupled to housing 102 such that cap 120 may be movable relative to housing 102 from a closed configuration to an open configuration, as shown. Cap 120 may be coupled to housing 102 via a single hinge 114 configured to pivot cap 120 relative to housing 102 to transition vial adapter assembly 100 between the closed and open configurations. When in the closed configuration, cap 120 may be configured to simultaneously cover a pair of openings 110a, 110b along top surface 108 for each of the receptacles formed in housing 102 to seal and prevent access to openings 110a, 110b.

[0036] Each of the housing 102 and the cap 120 may include corresponding engagement features for fastening the components together when the vial adapter assembly 100 is in the closed configuration. For example, the housing 102 may include at least one slot along the top surface 108 formed therein, such as a first slot 112a for a first receptacle and a second slot 112b for a second receptacle. The cap 120 may include at least one protrusion 128a, 128b extending outwardly from the bottom surface 122 of the cap 120 for each slot 112a, 112b on the housing 102. The protrusions 128a, 128b may be configured to mate with the corresponding slots 112a, 112b to facilitate connection between the cap 120 and the housing 102 when the vial adapter assembly 100 is in the closed configuration. Stated another way, when in the closed configuration, each of the slots 112a, 112b can be configured to receive a corresponding protrusion 128a, 128b to couple the cap 120 to the housing 102. Although one slot and protrusion for each receptacle is shown in FIG. 1, there may be any number of slot and receptacle pairs, e.g., more than one or two. Additionally, although the slots are described as being located on the top surface 108 and the protrusions extend from the bottom surface 122 of the cap 120, the locations of these structures may be swapped.

[0037] The configuration of the slots and protrusions may enable the cap 120 to perform a tamper-evident function to prevent tampering or reuse of the pair of vials 10a, 10b after the cap 120 has been transitioned from a closed to an open configuration. For example, the slots and protrusions may be configured to prevent a user from closing the cap 120 once it has been opened, thereby maintaining the cap 120 in a locked-out state. In another example, the cap 120 may be weakly bonded (e.g., by a plastic-to-plastic weld or adhesive) to the housing 102, such as by an adhesive positioned along the proximal end 106. The cap 120 may be configured to disengage the proximal end 106 upon application of a proximal force to the cap 120 that exceeds the bond strength of the adhesive, thereby moving the cap 120 proximally relative to the housing 102. Upon disengaging the cap 120 from the housing 102, the adhesive located along the proximal end 106 may be permanently deformed and / or damaged such that the bond strength and / or properties of the adhesive may be reduced, thereby preventing the cap 120 from returning to an engaged state with the housing 102. Preventing the cap 120 from resealing to the housing 102 may provide tamper protection.

[0038] In the example of FIG. 1, the cap 120 may include a pair of protrusions 128a, 128b configured to interact with each slot 112a, 112b. The cross-sectional profile of the pair of protrusions 128a, 128b may be larger than the cross-sectional profile of the slots 112a, 112b, and the pair of protrusions 128a, 128b may be at least partially flexible. The pair of protrusions 128a, 128b may be biased toward each other when received within each of the slots 112a, 112b, and may be configured to expand to prevent a user from closing the cap 120 when removed from the slots 112a, 112b when the cap 120 is opened. Protrusions 128a, 128b may form a snap-fit ​​connection with slots 112a, 112b to maintain vial adapter assembly 100 in a closed configuration until a minimal opening force is applied against cap 120 to withdraw protrusions 128a, 128b from slots 112a, 112b. In other embodiments, other tamper-proof mechanisms may be incorporated in addition to or in place of the slot and protrusion arrangements described herein to prevent closure of cap 120 once opened.

[0039] When in the closed configuration, cap 120 is configured to cover top surface 108 of housing 102. Cap 120 may include a lid 124a, 124b on bottom surface 122 for each of openings 110a, 110b on top surface 108 of housing 102. Each lid 124a, 124b may be sized and shaped to correspond to a cross-sectional dimension (e.g., diameter) of the corresponding opening 110a, 110b. Further, each lid 124a, 124b may be positioned relative to bottom surface 122 to align with the position of the corresponding opening 110a, 110b on top surface 108 when cap 120 is coupled to housing 102 in the closed configuration. Lids 124a, 124b may be configured to seal openings 110a, 110b in the closed configuration, thereby preventing contamination of the contents of each vial 10a, 10b when vial adapter assembly 100 is in the closed configuration.

[0040] 1, when cap 120 of vial adapter assembly 100 is opened, cap 120 may be configured to simultaneously expose first and second receptacle openings 110a, 110b as well as expose top surface 108 of housing 102. As described above, each of protrusions 128a, 128b may be configured to deform, for example, radially outwardly, when removed from slots 112a, 112b such that protrusions 128a, 128b return to a cross-sectional profile that is larger than the cross-sectional profile of slots 112a, 112b. In this case, cap 120 may be prevented from transitioning from an open configuration to a closed configuration.

[0041] In use, a first vial 10a may be inserted into a first receptacle of vial adapter assembly 100, and a second vial 10b may be inserted into the second receptacle. Cap 120 may be coupled to housing 102, thereby maintaining sterility of the contents stored in first vial 10a and second vial 10b by concealing openings 110a, 110b. Vial adapter assembly 100 may then be packaged, shipped, stored, or otherwise handled while maintaining first vial 10a and second vial 10b together. When a user is ready to access the contents of the first vial 10a and the second vial 10b, the cap 120 may be transitioned from a closed configuration to an open configuration in response to pulling the cap 120 proximally against the top surface 108, thereby disengaging the pair of protrusions 128a, 128b from the corresponding slots 112a, 112a and allowing the cap 120 to pivot about the single hinge 114.

[0042] In the open configuration, the lower surface 122 of the cap 120 is separated from the upper surface 108 of the housing 102, thereby exposing the openings 110a, 110b and the proximal ends of the vials 10a, 10b received therein to facilitate simultaneous access to the contents stored therein. Thus, the vial adapter assembly 100 may be operable to maintain the first vial 10a and the second vial 10b together for ease of handling, storage, and control prior to and during use. The housing 102 defines a sleeve positioned about the first vial 10a and the second vial 10b such that a user of the vial adapter assembly 100 may be able to simultaneously move the pair of vials 10a, 10b in response to selectively manipulating the housing 102 and to simultaneously access the contents of the vials 10a, 10b upon transitioning the vial adapter assembly 100 from the closed configuration to the open configuration. By maintaining the first and second vials 10a, 10b in close proximity to one another prior to and during use, the likelihood that the vials will become separated prior to administration or that the contents of the vials will not be administered together to a patient may be reduced. The vial adapter assembly 100 may be configured to provide a closed system for transferring fluid from each of the vials 10a, 10b to a corresponding external device received in a respective receptacle.

[0043] 2, another exemplary vial adapter assembly 200 is shown. Vial adapter assembly 200 may be configured and operable to maintain and facilitate independent access (fluid communication) to two or more vials housed together in separate receptacles upon removal of a respective barrier sealing each receptacle. Vial adapter assembly 200 may include a housing 202 having a distal end 204 and a proximal end 206. Vial adapter assembly 200 may include a plurality of receptacles formed within housing 202 and extending between distal end 204 and proximal end 206. Each of the plurality of receptacles may be configured to at least partially receive one vial within housing 202. In this example, as best seen in FIG. 3, the vial adapter assembly 200 includes a pair of receptacles, such as a first receptacle 201a for receiving a first vial 10a within the body of the housing 202, and a second receptacle 201b for receiving a second vial 10b within the body of the housing 202.

[0044] Vial adapter assembly 200 may include one or more actuators coupled to housing 202 for each of the receptacles formed therein. In this example, vial adapter assembly 200 may include a first actuator 212a movably coupled to housing 202 and positioned in longitudinal alignment with opening 210a of first receptacle 201a. Vial adapter assembly 200 may include a second actuator 212b movably coupled to housing 202 and positioned in longitudinal alignment with opening 210b of second receptacle 201b.

[0045] Each of the first actuator 212a and the second actuator 212b may be independently movable relative to one another and relative to the housing 202, such as between an extended configuration and a compressed configuration. As described further below, each of the first actuator 212a and the second actuator 212b may be configured to establish fluid communication with a corresponding vial 10a, 10b received in the first and second receptacles 201a, 201b upon actuation (e.g., depression) of the respective actuator 212a, 212b.

[0046] 2, the first actuator 212a may include a first connector 214a, and the second actuator 212b may include a second connector 214b, each of which may be configured to couple the respective actuator 212a, 212b to an external device, such as a syringe. As described in detail herein, the first actuator 212a may be configured to fluidly couple the first vial 10a to an external device (e.g., a syringe) via the first connector 214a, and the second actuator 212b may be configured to fluidly couple the second vial 10b to an external device (e.g., a syringe) via the second connector 214b. In some embodiments, the external device coupled to the first actuator 212a may be the same as or different from the external device coupled to the second actuator 212b. In this example, the first connector 214a and the second connector 214b may include luer lock connectors.

[0047] The vial adapter assembly 200 may include a first removable barrier 220a removably coupled to the housing 202. In this example, the housing 202 may include a first slot 217a positioned between the distal end 204 and the proximal end 206 of the housing 202. The first slot 217a is sized, shaped, and configured to receive at least a portion of the first removable barrier 220a therein. The vial adapter assembly 200 may further include a second removable barrier 220b removably coupled to the housing 202. The housing 202 may include a second slot 217b positioned between the distal end 204 and the proximal end 206 along an opposite side of the housing 202 from the first slot 217a, the second slot 217b being sized, shaped, and configured to receive at least a portion of the second removable barrier 220b therein. In some examples, one or more of the first removable barrier 220a and / or the second removable barrier 220b may include an adhesive liner.

[0048] 3, in an initial default state of the vial adapter assembly 200, the first removable barrier 220a may be received in the first slot 217a and positioned between the distal end of the first actuator 212a and the first receptacle 201a, and the second removable barrier 220b may be received in the second slot 217b and positioned between the distal end of the second actuator 212b and the second receptacle 201b. During packaging, storage, shipping, etc. of the vials 10a, 10b in the vial adapter assembly 200, the first removable barrier 220a may be configured to maintain the sterility of the first vial 10a received in the first receptacle 201a, and the second removable barrier 220b may be configured to maintain the sterility of the second vial 10b received in the second receptacle 201b. Additionally, the first removable barrier 220a, when received in the slot 217a, extends across and covers the opening 210a of the first receptacle 201a. This can prevent the first actuator 212a from being depressed and moved to the compressed configuration. Similarly, the second removable barrier 220b, when received in the slot 217b, extends across and covers the opening 210b of the second receptacle 201b. This can prevent the second actuator 212b from being depressed and moved to the compressed configuration. The removable barriers 220a, 220b may serve a tamper-evident function to prevent reuse of the pair of vials 10a, 10b, as the presence of the removable barriers 220a, 220b prevents premature activation of the first and second actuators 212a, 212b and the absence of the removable barriers 220a, 220b may indicate to a user that the first and second actuators may have been previously activated and / or that the first and second vials 10a, 10b may not be sterile.

[0049] The first actuator 212a may include a first hollow piercing element 216a having a distal tip 219a that is aligned with and extends toward the first receptacle 201a when the vial adapter assembly 200 is in the initial, unactivated, default state. The second actuator 212b may include a second hollow piercing element 216b having a distal tip 219b that is aligned with the second receptacle 201b when the vial adapter assembly 200 is in the initial, unactivated, default state. A channel extending through the first hollow piercing element 216a may be in fluid communication with the distal tip 219a at a distal end and the first connector 214a at a proximal end, and a channel extending through the second hollow piercing element 216b may be in fluid communication with the distal tip 219b at a distal end and the second connector 214b at a proximal end. Each hollow piercing element 216a, 216b is configured to move relative to the housing 202 in response to actuation of a corresponding actuator 212a, 212b. The hollow piercing element 216a may be coupled to the actuator 212a such that when the actuator 212a is depressed, the hollow piercing element 216a is pushed downward toward the opening 210a of the first receptacle 201a. The hollow piercing element 216b may be coupled to the actuator 212b such that when the actuator 212b is depressed, the hollow piercing element 216b is forced downward toward the opening 210b of the second receptacle 201b.

[0050] The vial adapter assembly 200 may include a first stopper 218a disposed in a first receptacle 201a and a second stopper 218b disposed in a second receptacle 201b. Each of the stoppers 218a, 218b may be coupled to and / or at least partially received within a corresponding vial 10a, 10b received in the respective receptacle 201a, 201b. The first stopper 218a may be configured to control access to and / or maintain sterility of the contents 30a stored in the first vial 10a received in the first receptacle 201a, and the second stopper 218b may be configured to control access to and / or maintain sterility of the contents 30b stored in the second vial 10b. The contents 30a, 30b may include a variety of substances, such as drugs, fluid drug substances, or other liquid formulations. Also, as mentioned above, the contents 30a, 30b may be different liquids.

[0051] 3, when the first vial 10a is received in the first receptacle 201a and the first removable barrier 220a is received in the first slot 217a, with the first slot 217a positioned above (i.e., proximal to) the receptacle opening 210a and the first stopper 218a, the first removable barrier 220a is configured to prevent depression of the first actuator 212a, thus isolating the first hollow piercing element 216a from the first vial 10a. Thus, the first removable barrier 220a may be configured to block fluid communication between the channel of the first hollow piercing element 216a and the first vial 10a by obstructing the path of the distal tip 219a toward the first stopper 218a.

[0052] Stated another way, the first removable barrier 220a may be configured to prevent the first actuator 212a from moving from the extended configuration to the compressed configuration when the first removable barrier 220a is received in the first slot 217a. In this example, when the first vial 10a is received in the first receptacle 201a, fluid communication between the first actuator 212a and the first vial 10a is prevented by the first removable barrier 220a.

[0053] Furthermore, when the second vial 10b is received in the second receptacle 201b and the second removable barrier 220b is received in the second slot 217b, with the second slot 217b positioned above (i.e., proximal to) the receptacle opening 210b and the second stopper 218b, the second removable barrier 220b is configured to prevent depression of the second actuator 212b, thus isolating the second hollow piercing element 216b from the second vial 10b. Thus, the second removable barrier 220b may be configured to block fluid communication between the channel of the second hollow piercing element 216b and the second vial 10b by obstructing the path of the distal tip 219b toward the second stopper 218b. The first and second removable barriers 220a, 220b can prevent accidental or premature depression of the first and second actuators 212a, 212b. Additionally, the first and second removable barriers 220a, 220b can act as tamper-evident indicators such that if either the first or second removable barriers 220a, 220b are missing, the user may know to discard the contents of the corresponding vial since they may have been tampered with.

[0054] In other words, the second removable barrier 220b may be configured to prevent movement of the second actuator 212b from the extended configuration to the compressed configuration when the second removable barrier 220b is received in the second slot 217b. In this case, when the second vial 10b is received in the second receptacle 201b, fluid communication between the second actuator 212b and the second vial 10b is prevented by the second removable barrier 220b.

[0055] In an exemplary use, the first actuator 212a and the second actuator 212b may be positioned above (i.e., proximal to) the first receptacle 201a and the second receptacle 201b, respectively, when in the extended configuration. In this case, the first and second actuators 212a, 212b may not be in fluid communication with the first and second receptacles 201a, 201b, respectively. Each of the first actuator 212a and the second actuator 212b may be prevented from being actuated (e.g., depressed) by the position of the first removable barrier 220a and the second removable barrier 220b in a corresponding slot of the housing 202.

[0056] Thus, first actuator 212a is maintained in the extended configuration by first removable barrier 220a, and second actuator 212b is maintained in the extended configuration by second removable barrier 220b. First removable barrier 220a and second removable barrier 220b are configured to be independently removable from housing 202. Additionally, first actuator 212a and second actuator 212b may be independently movable relative to one another, such that a user of vial adapter assembly 200 can selectively and independently establish fluid communication between each of the external devices coupled to the pair of vials 10a, 10b via vial adapter assembly 200. In some embodiments, when the first and second actuators 212a, 212b are actuated, a portion of the first and second actuators 212a, 212b, or a portion of the first and second receptacles 201a, 201b, may be deformed or otherwise engaged to lock the first and second actuators 212a, 212b in the actuated configuration. This may prevent reuse and / or tampering of the vial adapter assembly 200, thus promoting sterility of the contents of the first and second vials 10a, 10b. As seen in FIG. 4A, the first removable barrier 220a may be removed from within the first slot 217a to allow actuation of the first actuator 212a, thereby transitioning the first actuator 212a from the extended configuration to the compressed compressed configuration. Removal of the first removable barrier 220a from the first slot 217a allows fluid communication between the first actuator 212a and the first vial 10a. For example, depressing the first actuator 212a translates the first hollow piercing element 216a distally (e.g., downwardly) through an opening in the first stopper 218a toward the first receptacle 201a and into fluid communication with the first vial 10a. In the compressed configuration, at least a portion of the first actuator 212a is positioned at least partially inside the first receptacle 201a.

[0057] Specifically, the distal tip 219a may be configured to pierce the first stopper 218a and extend into the first vial 10a, thereby establishing fluid communication between the first connector 214a and the first vial 10a. An external device (e.g., a syringe) may be coupled to the first connector 214a, e.g., a Luer lock, to access the first fluid 30a through the channel of the first hollow piercing element 216a.

[0058] As seen in FIG. 4B, the second removable barrier 220b may be removed from within the second slot 217b to allow actuation of the second actuator 212b, thereby transitioning the second actuator 212b from the extended configuration to the compressed configuration. Removal of the second removable barrier 220b from the second slot 217b allows fluid communication between the second actuator 212b and the second vial 10b. For example, depressing the second actuator 212b causes the second hollow piercing element 216b to translate distally (e.g., downwardly) through an opening in the second stopper 218b toward the second receptacle 201b and into fluid communication with the second vial 10b. In the compressed configuration, at least a portion of the second actuator 212b is at least partially positioned inside the second receptacle 201b.

[0059] Specifically, the distal tip 219b may be configured to pierce the second stopper 218b and extend into the second vial 10b, thereby establishing fluid communication between the second connector 214b and the second vial 10a. An external device (e.g., a syringe) may be coupled to the second connector 214b, e.g., a Luer lock, to access the second fluid 30b through the channel of the second hollow piercing element 216b.

[0060] In some embodiments, the first fluid 30a stored in the first vial 10a may be different from the second fluid 30b stored in the second vial 10b. In other embodiments, the first fluid 30a may be the same as the second fluid 30b. Furthermore, the external device coupled to the first actuator 212a via the first connector 214a may be a different first device than the second device coupled to the second actuator 212b via the second connector 214b. In some embodiments, the same external device may be coupled to the first actuator 212a and the second actuator 212b, such as in series and / or simultaneously.

[0061] Thus, the vial adapter assembly 200 may be operable to maintain the first vial 10a and the second vial 10b together for ease of handling, storage, and control before and during use. The housing 202 may define a sleeve positioned about the first vial 10a and the second vial 10b such that a user of the vial adapter assembly 200 may be able to simultaneously move the pair of vials 10a, 10b in response to selectively manipulating the housing 202, and independently access the contents of the vials 10a, 10b upon transitioning the first and second actuators 212a, 212b of the vial adapter assembly 200 between different states. By maintaining the first vial 10a and the second vial 10b in close proximity to one another before and during use, the likelihood of the vials becoming separated prior to administration or the contents of the vials not being administered together to a patient may be reduced.

[0062] The vial adapter assembly 200 may be configured to provide a closed system for transferring fluid from each of the vials 10a, 10b to a corresponding external device coupled to the respective connector 214a, 214b. In some embodiments, one or more of the first actuator 212a and / or the second actuator 212b may include a visual indicator (e.g., color, marking, etc.) that may enable a user to distinguish between the two vials in the two respective receptacles. In some aspects, the visual indicator of the first actuator 212a and / or the second actuator 212b may be associated with a corresponding indicia on the first vial 10a and / or the second vial 10b, respectively. The visual indicators on the actuators 212a, 212b can facilitate visual identification of the contents (e.g., medication) stored in each vial 10a, 10b, thereby providing a user of the vial adapter assembly 200 with a visual reference of the contents being delivered from each receptacle 201a, 201b during use.

[0063] 5, another exemplary vial adapter assembly 300 is shown. The vial adapter assembly 300 may be configured and operable to maintain and facilitate independent access (fluid communication) to two or more vials housed together in separate receptacles upon removal of respective barriers sealing each access point. In the vial adapter assembly 200, transitioning the first and second actuators 212a, 212b to a compressed configuration causes the first and second hollow piercing elements 216a, 216b to extend through the first and second stoppers 218a, 218b to establish fluid communication with the first and second vials 10a, 10b. On the other hand, the vial adapter assembly 300 includes first and second hollow piercing elements 316a, 316b that are in constant fluid communication with the first and second vials 10a, 10b, and the first and second actuators 312a, 312b alternately prevent or allow access to the contents of the vials, as described further below.

[0064] The vial adapter assembly 300 may include a housing 302 having a distal end 304, a proximal end 308, and a sidewall 306 extending between the distal end 304 and the proximal end 308. The vial adapter assembly 300 may include a plurality of receptacles formed in the housing 302 and extending between the distal end 304 and the proximal end 308. Each of the plurality of receptacles may be configured to at least partially receive one vial within the housing 302. In this example, as best seen in FIG. 6 , the vial adapter assembly 300 includes a pair of receptacles, such as a first receptacle 301 a for receiving a first vial 10 a within the body of the housing 302, and a second receptacle 301 b for receiving a second vial 10 b within the body of the housing 302.

[0065] Vial adapter assembly 300 may include an actuator coupled to housing 302 for each of the receptacles formed therein. In this example, vial adapter assembly 300 may include a first actuator 312a movably coupled to housing 302 and positioned in longitudinal alignment with first receptacle 301a. Vial adapter assembly 300 may include a second actuator 312b movably coupled to housing 302 and positioned in longitudinal alignment with second receptacle 301b.

[0066] Each of the first actuator 312a and the second actuator 312b may be independently movable relative to one another and relative to the housing 302, such as between an extended configuration and a compressed configuration. As described further below, each of the first actuator 312a and the second actuator 312b may be configured such that actuating (e.g., depressing) the respective actuator 312a, 312b allows access to the corresponding vial 10a, 10b received in the first and second receptacles 301a, 301b.

[0067] 5 and 6, the first actuator 312a may include a first connector 314a, and the second actuator 312b may include a second connector 314b, each of which may be configured to couple the respective first and second connectors 314a, 314b to an external device, such as a syringe. As described in detail herein, the first connector 314a may be configured to fluidly couple the first vial 10a to an external device (e.g., a syringe), and the second connector 314b may be configured to fluidly couple the second vial 10b to an external device (e.g., a syringe). In some embodiments, the external device coupled to the first connector 314a may be the same as or different from the external device coupled to the second connector 314b. In this example, the first connector 314a and the second connector 314b may include luer lock connectors.

[0068] In this example, the first connector 314a may be fixed relative to the housing 302 and positioned at least partially within the first receptacle 301a. When received in the first receptacle 301a, the first connector 314a may extend into and establish fluid communication with the first vial 10a. As described in further detail below, the first actuator 312a may be configured to move relative to the first connector 314a such that the position of the first connector 314a remains fixed when the first actuator 312a moves from the extended configuration to the compressed configuration. As described further herein, when the first actuator 312a is in the extended configuration, the first actuator 312a may surround the first connector 314a and prevent external devices from coupling to the first connector 314a. When the first actuator 312a is depressed, the first actuator 312a may move distally downward to expose the first connector 314a, which may then extend upwardly beyond the first actuator 312a in the compressed configuration.

[0069] Similarly, the second connector 314b may be fixed relative to the housing 302 and positioned at least partially within the second receptacle 301b. When received in the second receptacle 301b, the second connector 314b may extend into and establish fluid communication with the second vial 10b. The second actuator 312b may be configured to move relative to the second connector 314b such that the position of the second connector 314b remains fixed when the second actuator 312a moves from the extended configuration to the compressed configuration. As described further herein, when the second actuator 312b is in the extended configuration, the second actuator 312b may surround the second connector 314b and prevent external devices from coupling to the second connector 314b. When the second actuator 312b is depressed, it may move distally downward to expose the second connector 314b, which may then extend upwardly past the second actuator 312b in the compressed configuration. It should be understood that for illustrative purposes, Figure 5 shows the first actuator 312a in a compressed configuration and the second actuator 312b in an extended configuration (with a removable barrier coupled thereto).

[0070] As best seen in FIG. 6, the first removable barrier 320a may be removably coupled to the vial adapter assembly 300. The first removable barrier 320a may be positioned to cover a proximal surface of the first actuator 312a and to cover a proximal end of the first connector 314a that is surrounded by the first actuator 312a in the extended configuration. A portion of the first removable barrier 320a may extend out from the proximal surface of the first actuator 312a to facilitate grasping the first removable barrier 320a and removing it from the first actuator 312a. A pulling or peeling force, for example, may be applied to remove the first removable barrier 320a from the first actuator 312a.

[0071] Similarly, vial adapter assembly 300 may further include a second removable barrier 320b that is removably coupled to second actuator 312b and covers a proximal end of second connector 314b that is surrounded by second actuator 312b in the extended configuration, as described with respect to first removable barrier 320a for first actuator 312a. In some examples, one or more of first removable barrier 320a and / or second removable barrier 320b may include an adhesive liner, cap, and / or other suitable device for covering the actuator.

[0072] 6, in an initial default state of the vial adapter assembly 300, the first actuator 312a and the second actuator 312b are positioned in an extended configuration. The first actuator 312a is configured to conceal the first connector 314a when in the extended configuration, and the second actuator 312b is configured to conceal the second connector 314b when in the second configuration. In addition, the first removable barrier 320a may be coupled to the first actuator 312a, thereby at least partially concealing the first connector 314a when the first actuator 312a is in the extended configuration. The second removable barrier 320b may be coupled to the second actuator 312b, thereby at least partially concealing the second connector 314b when the second actuator 312b is in the extended configuration.

[0073] The first removable barrier 320a may be configured to maintain sterility between the first connector 314a and the first vial 10a received in the first receptacle 301a by covering the first actuator 312a and the first connector 314a, and the second removable barrier 320b may be configured to maintain sterility between the second connector 314b and the second vial 10b received in the second receptacle 301b by covering the second actuator 312b and the second connector 314b. The first removable barrier 320a and the second removable barrier 320b may further prevent depression of the first actuator 312a and the second actuator 312b when coupled to the first actuator 312a and the second actuator 312b, respectively. In order to depress the first and second actuators 312a, 312b, the first and second removable barriers 320a, 320b must first be removed. As described in detail herein, when the first and second actuators 312a, 312b are each in a compressed configuration, the first and second connectors 314a, 314b may be exposed and accessible to an external device.

[0074] The first connector 314a may be fluidly coupled to a first hollow piercing element 316a having a distal tip 319a that is aligned with and extends into the first receptacle 301a when the vial adapter assembly 300 is in the initial extended state. The second connector 314b may be fluidly coupled to a second hollow piercing element 316b having a distal tip 319b that is aligned with and extends into the second receptacle 301b when the vial adapter assembly 300 is in the initial extended state. The channel of the first hollow piercing element 316a may be in fluid communication with the distal tip 319a at a distal end and the first connector 314a at a proximal end, and the channel of the second hollow piercing element 316b may be in fluid communication with the distal tip 319b at a distal end and the second connector 314b at a proximal end. Each connector 314a, 314b and hollow piercing element 316a, 316b is fixed relative to the housing 302 such that a corresponding actuator 312a, 312b is configured to move relative to the connector 314a, 314b and hollow piercing element 316a, 316b in response to actuation of the actuator 312a, 312b.

[0075] The vial adapter assembly 300, or the vials 10a, 10b positioned in the first and second receptacles 301a, 301b, may include a first stopper 318a and a second stopper 318b. Each of the stoppers 318a, 318b may be coupled to and / or at least partially received within an opening of a corresponding vial 10a, 10b received in the respective receptacle 301a, 301b. The first stopper 318a may be configured to maintain sterility of a first content 30a stored in a first vial 10a received in the first receptacle 301a, and the second stopper 318b may be configured to maintain sterility of a second content 30b stored in a second vial 10b. The first contents 30a and the second contents 30b may contain various substances, such as drugs, fluid drug substances, or other liquid formulations, which may be the same or different from one another.

[0076] 6, the first removable barrier 320a disposed over the first actuator 312a is configured to prevent the first actuator 312a from moving from the extended configuration to the compressed configuration. In this example, the first connector 314a may be disposed within the body of the first actuator 312a when the first actuator 312a is in the extended configuration, thereby preventing the first connector 314a from coupling with an external device. Thus, the first removable barrier 320a is configured to prevent an external device (e.g., a syringe) from connecting to the first connector 314a and establishing fluid communication with the first vial 10a received in the first receptacle 301a.

[0077] Further, the second removable barrier 320b disposed over the second actuator 312b is configured to prevent the second actuator 312b from moving from the extended configuration to the compressed configuration. In this example, the second connector 314b may be disposed within the body of the second actuator 312b when the second actuator 312b is in the extended configuration, thereby preventing the second connector 314b from coupling with an external device. Thus, the second removable barrier 320b is configured to prevent an external device (e.g., a syringe) from connecting to the second connector 314b and establishing fluid communication with the second vial 10b received in the second receptacle 301b. The first and second connectors 314a, 314b may be in fluid communication with the first and second vials 10a, 10b, respectively, in both the extended and compressed configurations, but an external device may not be able to fluidly connect with the first and second connectors 314a, 314b in the extended configuration because the first and second actuators 312a, 312b block access to the connectors. The first and second actuators 312a, 312b must be moved out of the way (e.g., pressed down) to access the first and second connectors 314a, 314b.

[0078] In an exemplary use, the first actuator 312a and the second actuator 312b may be positioned in an extended configuration with the first removable barrier 320a attached to an outer surface of the first actuator 312a and the second removable barrier 320b attached to an outer surface of the second actuator 312b. In this case, the first and second connectors 314a, 314b may be disposed within the first and second actuators 312a, 312b, respectively. Thus, the first and second connectors 314a, 314b may be prevented from connecting with an external device, and each of the first and second actuators 312a, 312b may be prevented from being actuated (e.g., depressed) due to the position of the first and second removable barriers 320a, 320b, respectively.

[0079] In some embodiments, the housing 302 may include one or more tamper-evident mechanisms to prevent reuse of the vial adapter assembly 300 and / or to prevent the first and second actuators 312a, 312b from inadvertently moving from the extended configuration to the compressed configuration. For example, the first and second removable barriers 320a, 320b may each include an adhesive liner positioned along an inner surface of the respective removable barrier, which may contact the corresponding actuator and connector when the vial adapter assembly 300 is in an initial default state (see FIG. 6). The first removable barrier 320a may be configured to mate with the first actuator 312a and the first connector 314a, thereby preventing actuation (e.g., depression) of the first actuator 312a from the extended configuration to the compressed configuration (see FIG. 7) until the first removable barrier 320a is detached from the first actuator 312a and the first connector 314a. The second removable barrier 320b may be configured to mate with the second actuator 312b and the second connector 314b, thereby preventing actuation (e.g., depression) of the second actuator 312b from the extended configuration to the compressed configuration (see FIG. 8) until the second removable barrier 320b is detached from the second actuator 312b and the second connector 314b. Once detached, the removable barriers 320a, 320b may not be able to be reapplied.

[0080] In another example, each of the first actuator 312a and the second actuator 312b may be configured to rotate relative to the housing 302 and the corresponding connector. Upon removal of the first removable barrier 320a, the first actuator 312a may be prevented from moving from the expanded configuration to the compressed configuration. First, the first actuator 312a may need to be rotated (e.g., clockwise, counterclockwise) relative to the housing 302 to align with the housing 302 and allow the first actuator 312a to move to the compressed configuration. Similarly, upon removal of the second removable barrier 320b, the second actuator may be prevented from moving to the compressed configuration and may need to be rotated relative to the housing 302 to align with the housing 302 before moving to the compressed configuration. Thus, the housing 302 may be configured to prevent actuation of each actuator 312a, 312b until each respective actuator 312a, 312b is independently rotated to align with the corresponding channel.

[0081] Thus, the first actuator 312a is maintained in the extended configuration until the first removable barrier 320a is removed from the first actuator 312a, and the second actuator 312b is maintained in the extended configuration until the second removable barrier 320b is removed from the second actuator 312b. The first removable barrier 320a and the second removable barrier 320b are configured to be independently removable with respect to each other. Fluid communication between an external device and the first vial 10a is enabled when the first removable barrier 320a is removed from the first actuator 312a and the first actuator 312a is pressed, and fluid communication between an external device and the second vial 10b is enabled when the second removable barrier 320b is removed from the second actuator 312b and the first actuator 312b is pressed. Additionally, first actuator 312a and second actuator 312b may be independently movable relative to one another such that a user of vial adapter assembly 300 can selectively establish fluid communication between each of the external devices coupled to the pair of vials 10a, 10b via vial adapter assembly 300.

[0082] As seen in FIG. 7, the first removable barrier 320a may be removed from an outer surface of the first actuator 312a to allow actuation of the first actuator 312a. When transitioning the first actuator 312a from the extended to the compressed configuration, the first connector 314a may extend outwardly from the first actuator 312a, thereby exposing the first connector 314a and allowing connection of an external device to the vial adapter assembly 300. Thus, fluid communication between the external device and the first vial 10a is enabled when the first removable barrier 320a is removed and the first actuator 312a is actuated. In this example, the first hollow piercing element 316a is in fluid communication with the first receptacle 301a with the distal tip 319a positioned at least partially inside the first vial 10a when the first actuator 312a is in the extended and compressed configurations. With the first connector 314a exposed, an external device (e.g., a syringe) coupled to the first connector 314a can access the first fluid 30a through the channel of the first hollow piercing element 316a.

[0083] As seen in FIG. 8, the second removable barrier 320b may be removed from an outer surface of the second actuator 312b to allow actuation of the second actuator 312b. When transitioning the second actuator 312b from the extended to the compressed configuration, the second connector 314b may extend outwardly from the second actuator 312b, thereby exposing the second connector 314b and allowing connection of an external device to the vial adapter assembly 300. Thus, fluid communication between an external device and the second vial 10b is possible when the second removable barrier 320b is removed and the second actuator 312b is actuated. In this example, the second hollow piercing element 316b is in fluid communication with the second receptacle 301b with the distal tip 319b positioned at least partially inside the second vial 10b when the second actuator 312b is in the extended and compressed configurations. With the second connector 314b exposed, an external device (e.g., a syringe) coupled to the second connector 314b can access the second fluid 30b through the channel of the second hollow piercing element 316b.

[0084] In some embodiments, the housing 302 may include one or more lockout mechanisms to prevent the first and second actuators 312a, 312b from returning to the extended configuration once the actuators have been moved to the compressed configuration. For example, the lockout mechanisms may include one or more tabs, protrusions, fasteners, etc. that can prevent movement of the first and second actuators 312a, 312b after they have been moved to the compressed configuration. In some aspects, one or more portions of the housing 302 and / or corresponding receptacles 301a, 301b of the first and second actuators 312a, 312b may be configured to deform to lock the respective actuators 312a, 312b in the compressed configuration. In this example, the housing 302 may include a first lockout mechanism for independently securing the first actuator 312a in a compressed configuration relative to the first receptacle 301a, and a second lockout mechanism for independently securing the second actuator 312b in a compressed configuration relative to the second receptacle 301b. The first and second lockout mechanisms may provide a tamper-evident function and prevent reuse of the pair of vials 10a, 10b after each of the actuators 312a, 312b is transitioned from the extended configuration to the compressed configuration, respectively.

[0085] Thus, the vial adapter assembly 300 may be operable to maintain the first vial 10a and the second vial 10b together for ease of handling, storage, and control before and during use. The housing 302 may define a sleeve positioned about the first vial 10a and the second vial 10b such that a user of the vial adapter assembly 300 may be able to simultaneously move the pair of vials 10a, 10b in response to selectively manipulating the housing 302, and independently access the contents of the vials 10a, 10b upon transitioning the vial adapter assembly 300 between different states. By maintaining the first vial 10a and the second vial 10b in close proximity to one another before and during use, the likelihood of the vials becoming separated prior to administration or the contents of the vials not being administered together to a patient may be reduced.

[0086] The vial adapter assembly 300 may be configured to provide a closed system for transferring fluid from each of the vials 10a, 10b to a corresponding external device coupled to the respective connectors 314a, 314b. In some embodiments, one or more of the first actuator 312a and / or the second actuator 312b may include a visual indicator (e.g., color, marking, etc.) that may enable a user to distinguish between the two vials associated with the respective connectors. In some aspects, the visual indicators of the first actuator 312a and / or the second actuator 312b may be associated with corresponding indicia on the first vial 10a and / or the second vial 10b, respectively. The visual indicators of the actuators 312a, 312b may facilitate visual identification of the contents (e.g., medication) stored in each vial 10a, 10b, thereby providing a user of the vial adapter assembly 300 with a visual reference of the contents being delivered from each receptacle 301a, 301b during use.

[0087] 9, an exemplary vial adapter assembly 400 is shown. The vial adapter assembly 400 may be configured and operable to hold and facilitate independent access (fluid communication) to two or more vials housed together in separate receptacles upon actuation (e.g., rotation) of a respective actuator coupled to each vial. The vial adapter assembly 400 may include a housing 402 having a distal end 404 and a proximal end 406. The vial adapter assembly 400 may include a plurality of receptacles formed in the housing 402 and extending between the distal end 404 and the proximal end 406. Each of the plurality of receptacles may be configured to at least partially receive a vial within the housing 402.

[0088] 10, vial adapter assembly 400 includes a pair of receptacles, such as a first receptacle 401a for receiving a first vial 10a within the body of housing 402, and a second receptacle 401b for receiving a second vial 10b within the body of housing 402. Although vial adapter assembly 400 is shown and described herein as including a pair of receptacles for receiving the pair of vials 10a, 10b, housing 402 may include additional receptacles for simultaneously storing additional vials adjacent to one another.

[0089] The first receptacle 401a may include at least one opening along a bottom of the housing 402, such as proximate the distal end 404 or flush with the distal end 104, that is sized and shaped to receive a first vial 10a therein. The second receptacle 401b may include at least one opening along a bottom of the housing 402, such as proximate the distal end 404 or flush with the distal end 104, for receiving a second vial 10b therein. As described herein, each of the first receptacle 401a and the second receptacle 401b may include an engagement interface for securing a corresponding vial 10a, 10b to the housing 402.

[0090] 10, the first receptacle 401a may be positioned adjacent to the second receptacle 401b such that the first vial 10a is maintained side-by-side with the second vial 10b when received in the housing 402. The pair of receptacles 401a, 401b may be sized and shaped to at least partially receive the pair of vials, such that at least a portion (e.g., a distal end) of the first vial 10a and at least a portion (e.g., a distal end) of the second vial 10b may extend outwardly from the housing 402 for ease of access or visual inspection of the contents. Each of the pair of receptacles 401a, 401a may include a corresponding opening 410a, 410b near the proximal end 406, such that each of the openings 410a, 410b may be in fluid communication with the top surface 408 of the housing 102.

[0091] The first opening 410a of the first receptacle 401a and the second opening 410b of the second receptacle 401b are positioned along the top surface 408 to align with the openings of the vials when the pair of vials 10a, 10b are received in the corresponding receptacles 401a, 401b. The vial adapter assembly 400 may further include a first connector 412a and a second connector 412b that extend outwardly (e.g., proximally) from the housing 402 through the first opening 410a and the second opening 410b, respectively.

[0092] 9-10, the first connector 412a may include a first engagement mechanism 414a for coupling the first connector 412a to an external device, and the second connector 412b may include a second engagement mechanism 414b for coupling the second connector 412b to an external device. In this example, the first and second engagement mechanisms 414a, 414b may include threaded portions positioned along the outer surfaces of the first and second connectors 412a, 412b, respectively. In other embodiments, the connectors 412a, 412b may include a variety of other suitable engagement mechanisms to facilitate connection to an external device, such as, for example, a clasp, a luer lock, a snap-fit ​​connection, etc.

[0093] The first connector 412a may be rotatably coupled to the housing 402 and may extend at least partially into the first receptacle 401a, and the second connector 412b may be rotatably coupled to the housing 402 and may extend at least partially into the second receptacle 401b. As described herein, each of the first connector 412a and the second connector 412b may be configured to move (e.g., rotate) between a first (unconnected) configuration and a second (connected) configuration with respect to the housing 402. Additionally, the first connector 412a and the second connector 412b may be independently movable with respect to one another such that a user of the vial adapter assembly 400 may selectively establish fluid communication between an external device coupled to the pair of vials 10a, 10b via the respective connectors 412a, 412b.

[0094] As best seen in FIG. 10, the first connector 412a may be coupled to a first bracket 420a, and the second connector 412b may be coupled to a second bracket 420b. The first bracket 420a may include a first pair of clips 422a configured to engage a proximal end of the first vial 10a, and the second bracket 420b may include a second pair of clips 422b configured to engage a proximal end of the second vial 10b. The first stopper 418a may be sized and shaped to extend into the first vial 10a when the first bracket 420a is coupled to the first vial 10a. The first stopper 418a may be configured to receive at least a portion of the first hollow shaft 416a of the first connector 412a therein.

[0095] As described herein, the first hollow shaft 416a may be configured to move (e.g., rotate) relative to the first stopper 418a in response to a corresponding movement (e.g., rotation) of the first connector 412a. For example, a user may rotate the first connector 412a using a finger or by connecting and rotating an external device (e.g., a syringe) coupled to the first connector 412a. The second stopper 418b may be sized and shaped to extend into the second vial 10b when the second bracket 420b is coupled to the second vial 10b. The second stopper 418b may be configured to receive at least a portion of the second hollow shaft 416b of the second connector 412b therein. As further described herein, the second hollow shaft 416b may be configured to move (e.g., rotate) relative to the second stopper 418b in response to a corresponding movement (e.g., rotation) by the second connector 412b. For example, a user may rotate the second connector 412b using their fingers or by connecting and rotating an external device (eg, a syringe) coupled to the second connector 412b.

[0096] The first connector 412a and the first hollow shaft 416a may be rotatable relative to the first bracket 420a, the first stopper 418a, the first vial 10a, and the housing 402. The second connector 412b and the second hollow shaft 416b may be rotatable relative to the second bracket 420b, the second stopper 418b, the second vial 10b, and / or the housing 402.

[0097] 10, the first hollow shaft 416a may include a closed distal end 419a that extends into the first vial 10a when the first vial 10a is received in the housing 402. The first hollow shaft 416a may also include one or more openings 415a that extend through a sidewall of the first hollow shaft 416a near the closed distal end 419a. In the first (unconnected) configuration, the one or more openings 415a may be positioned against an inner surface of the first stopper 418a, specifically, a first portion of the first stopper 418a. In this case, the first portion of the first stopper 418a may form a closed seal with the opening 415a.

[0098] When the opening 415a is aligned with the first portion of the first stopper 418a, the first connector 412a is not in fluid communication with the first vial 10a. Thus, the contents of the vial 10a received in the first receptacle 401a may not be accessible through the first connector 412a when the opening 415a is blocked by the inner surface of the first stopper 418a. In this manner, the first connector 412a may be configured to maintain the sterility of the first vial 10a or prevent access to the contents of the first vial 10a when in the first (unconnected) configuration.

[0099] As described further herein and seen in FIG. 11, rotation of the first connector 412a and the first hollow shaft 416a from a first (unconnected) configuration to a second (connected) configuration may cause one or more openings 415a to be oriented toward a different inner surface of the first stopper 418a, specifically, toward the second portion of the first stopper 418a. The second portion of the first stopper 418a includes a recessed portion, opening, or channel such that the second portion of the stopper 418a is spaced from the first hollow shaft 416a. Thus, the openings of the first stopper 418a may be wider in the second portion than in the first portion.

[0100] In this case, the second portion of the first stopper 418a may be spaced from the opening 415a such that the second portion does not obstruct the opening 415a. With the first connector 412a in the second (connected) configuration, the opening 415a may be unobstructed such that the first connector 412a may be in fluid communication with the first vial 10a. In other words, the opening 415a may be aligned with a channel / opening / recess in the first stopper 418a such that the first connector 412a is in fluid communication with the first vial 10a.

[0101] 10, the second connector 412b may include a structure similar to the first connector 412a illustrated and described above, such that the second connector 412b may be configured and operable like the first connector 412a. For example, the second connector 412b may include one or more openings 415b extending through a sidewall of the second hollow shaft 416b near the closed distal end 419b. Additionally, the second connector 412b and the second hollow shaft 416b may be configured to transition from a first (unconnected) configuration to a second (connected) configuration to orient the one or more openings 415b from a first position where they are blocked by an inner surface of the second stopper 418b to a second position where the inner surface of the second stopper 418b does not block the one or more openings 415b.

[0102] In an exemplary use, each of the vials 10a, 10b may be coupled to a corresponding bracket 420a, 420b via engagement between a proximal neck portion of the vial 10a, 10b and a clip 422a, 422b of the bracket 420a, 420b. The brackets 420a, 420b and clips 422a, 422b are described with reference to Figures 10 and 11, although any suitable mechanism for maintaining the first and second vials 10a, 10b may be used. In use, the first connector 412a may be coupled to an external device (e.g., a syringe), such as by mating the first engagement mechanism 414a (e.g., a luer lock) with a corresponding engagement feature (e.g., a threaded portion) of the external device. The second connector 412b may be coupled to an external device (e.g., a syringe), such as by mating the second engagement mechanism 414b (e.g., a luer lock) with a corresponding engagement feature (e.g., a threaded portion) of the external device.

[0103] 10-11, the opening 415a on the first hollow shaft 416a may be positioned within the first vial 10a and sealed by a first stopper 418a such that the first connector 412a is not in fluid communication with the first vial 10a when in the first (disconnected) configuration. Thus, the first hollow shaft 416a is fluidically isolated from the first vial 10a, thereby preventing fluid flow between the first vial 10a and an external device coupled to the first connector 412a. The opening 415b on the second hollow shaft 416b may be positioned within the second vial 10b and sealed by a second stopper 418b such that the second connector 412b is not in fluid communication with the second vial 10b when in the first (disconnected) configuration. The second hollow shaft 416b is thus fluidly isolated from the second vial 10b, thereby preventing fluid flow between an external device coupled to the second connector 412b and the second vial 10b.

[0104] 11, each of the first actuator 412a and the second actuator 412b may be independently rotated (e.g., by about 90 degrees) relative to the housing 402 to transition from a first (unconnected) configuration to a second (connected) configuration. For example, rotation of an external device coupled to the first actuator 412a may cause a corresponding rotation of the first actuator 412a and the first hollow shaft 416a relative to a first stopper 418a disposed in the first vial 10a. Additionally, rotation of an external device coupled to the second actuator 412b may cause a corresponding rotation of the second actuator 412b and the second hollow shaft 416b relative to a second stopper 418b disposed in the second vial 10b.

[0105] Alternatively, rotation of the housing 402 relative to the first actuator 412a and / or the second actuator 412b (e.g., by about 90 degrees) may similarly transition the actuators 412a, 412b from the first (disconnected) configuration to the second (connected) configuration. In this case, the opening 415a extending through the sidewall of the first hollow shaft 416a may be realigned with respect to the first stopper 418a to allow fluid communication between the first connector 412a and the first vial 10a. The opening 416b extending through the sidewall of the second hollow shaft 416b may be realigned with respect to the second stopper 418b to allow fluid communication between the second connector 412b and the second vial 10b.

[0106] Thus, the vial adapter assembly 400 may be operable to maintain the first vial 10a and the second vial 10b together for ease of handling, storage, and control before and during use. The housing 402 defines a sleeve positioned about the first vial 10a and the second vial 10b such that a user of the vial adapter assembly 400 may be able to simultaneously move the pair of vials 10a, 10b in response to selectively manipulating the housing 402, and independently access the contents of the vials 10a, 10b upon transitioning the vial adapter assembly 400 from a first (unconnected) configuration to a second (connected) configuration. By maintaining the first vial 10a and the second vial 10b in close proximity to one another before and during use, the likelihood of the vials becoming separated prior to administration or the contents of the vials not being administered together to a patient may be reduced.

[0107] The vial adapter assembly 400 may be configured to provide a closed system for transferring fluid from each of the vials 10a, 10b to a corresponding external device coupled to the respective connector 412a, 412b. In some embodiments, one or more of the first connector 412a and / or the second connector 412b may include a visual indicator (e.g., color, marking, etc.) that may enable a user to distinguish between the two vials associated with the respective connector. In some aspects, the visual indicator of the first connector 412a and / or the second connector 412b may be associated with a corresponding indicia on the first vial 10a and / or the second vial 10b, respectively. The visual indicator of the actuators 412a, 412b may facilitate visual identification of the contents (e.g., medication) stored in each vial 10a, 10b, thereby providing a user of the vial adapter assembly 400 with a visual reference of the contents being delivered from each receptacle 401a, 401b during use.

[0108] 12, an exemplary vial adapter assembly 500 is shown. The vial adapter assembly 500 may be configured and operable to maintain and facilitate independent access (fluid communication) to two or more vials housed together in separate receptacles upon removal of the respective caps enclosing each vial. The vial adapter assembly 500 may include a housing 502 having an at least partially closed distal end 504 and an at least partially open proximal end 506. The vial adapter assembly 500 may include a plurality of receptacles formed within the housing 502 and extending between the closed distal end 504 and the open proximal end 506. Each of the plurality of receptacles may be configured to at least partially receive a vial within the housing 502. In this example, the vial adapter assembly 500 includes a pair of receptacles, such as a first receptacle 501a for receiving a first vial 10a within the body of the housing 502, and a second receptacle 501b for receiving a second vial 10b within the body of the housing 502.

[0109] The first and second receptacles 501a, 501b may each be configured to receive and hold a body of a vial therein, for example, downward from a shoulder of the vial. The first receptacle 501a may be sized to allow the first vial 10a to extend outwardly (e.g., proximally) from the open proximal end 506 such that at least the mouth 19a of the first vial 10a is positioned above the top surface 508 of the housing 502 when the vial adapter assembly 500 is in the first configuration. The second receptacle 501b may be sized to allow the second vial 10b to extend outwardly (e.g., proximally) from the open proximal end 506 such that at least the mouth 19b of the second vial 10b is positioned above the top surface 508 when the vial adapter assembly 500 is in the first configuration. Although vial adapter assembly 500 is shown and described herein as including a pair of receptacles 501a, 501b for receiving a pair of vials 10a, 10b, housing 502 may include additional receptacles for simultaneously storing additional vials adjacent to one another.

[0110] 12, the vial adapter assembly 500 may include a first cap 510a and a second cap 510b. The first cap 510a may be configured to engage the mouth 19a of the first vial 10a when the first vial 10a is received in the first receptacle 501a. In this example, the first cap 510a may include a rim 512a configured to form a snap-fit ​​connection with an underside of the mouth 19a, thereby securely coupling the first vial 10a to the housing 502. The first cap 510a may be sized, shaped, and configured to surround an opening of the first vial 10a at the mouth 19a such that the first vial 10a is maintained in a closed state when the first cap 510a is coupled to the mouth 19a. As described herein, the first cap 510a may be configured to move independently of the second cap 510b to disengage from the port 19a, thereby transitioning the first vial 10a to an open state.

[0111] The second cap 510b may be configured to engage the mouth 19b of the second vial 10b when the second vial 10b is received in the second receptacle 501b. In this example, the second cap 510b may include a rim 512b configured to form a snap-fit ​​connection with the underside of the mouth 19b, thereby securely coupling the second vial 10b to the housing 502. The second cap 510b may be sized, shaped, and configured to surround the opening of the second vial 10a at the mouth 19b such that the second vial 10b is maintained in a closed state when the second cap 510b is coupled to the mouth 19b. As described herein, the second cap 510b may be configured to move independently of the first cap 510a to disengage from the mouth 19b, thereby transitioning the second vial 10b to an open state.

[0112] 13, vial adapter assembly 500 may include a first hinge 514a coupling first cap 510a to housing 502 such that first cap 514a may be configured to move (e.g., pivot) relative to housing 502 between a coupled state and a separated state with first vial 10a. Vial adapter assembly 500 may include a second hinge 514b coupling second cap 510b to housing 502 such that second cap 514b may be configured to move (e.g., pivot) relative to housing 502 between a coupled state and a separated state with second vial 10b.

[0113] 14 illustrates cap 510 of vial adapter assembly 500 removed from mouth 19 of vial 10 received in housing 502 in response to rim 512 disengaging from mouth 19 and cap 510 pivoting away from open proximal end 506 via single hinge 514. It should be understood that cap 510, rim 512, and single hinge 514 illustrated in FIG. 14 may represent caps 510a, 510b, rims 512a, 512b, and hinges 514a, 514b illustrated and described in detail above.

[0114] The housing 502 may be formed from two or more separate sections that may be assembled to cooperatively surround the vial 10. In some embodiments, the housing 502 may include at least one sidewall 505 that is selectively removable from the remainder of the housing 502 to facilitate receipt of the vial 10 into a corresponding receptacle. In this example, the at least one sidewall 505 may include one or more openings and / or grooves 509 sized, shaped, and configured to mate with one or more protrusions and / or guides 503 on the housing 502 to securely attach the at least one sidewall 505 to the remainder of the housing 502 to surround the vial 10. Although the openings and / or grooves 509 and the protrusions and / or guides 503 are shown in FIG. 14, it should be understood that any suitable fastening mechanism may be used to secure the at least one sidewall 505 to the remainder of the housing 502. Additionally, separate side walls 505 may be separately attachable / detachable to the remaining housing 502 to allow for independent removal and insertion of vials 10 into and out of vial adapter assembly 500, or a single side wall 505 may be attached / detachable to the remaining housing 502 to allow access to or enclose both vials 10 simultaneously. When inserting vial 10 into vial adapter assembly 500, the standard vial cap that comes with the vial may be removed from vial 10 and replaced with caps 510a, 510b, or caps 510a, 510b may fit over and cooperate with a vial cap that may come standard with the vial being inserted.

[0115] 15 , at least one side wall 505 may include a window 507 configured to allow for visual inspection of a vial 10 within the housing 502 when the at least one wall 505 is secured to the housing 502. For example, a user of the vial adapter assembly 500 may be enabled to visually inspect the contents of one or more vials 10 received within corresponding receptacles of the housing 502.

[0116] 16, an exemplary vial adapter assembly 600 is shown. The vial adapter assembly 600 may be configured and operable to hold and facilitate independent access (fluid communication) to two or more vials housed together in separate receptacles. The vial adapter assembly 600 may include a housing 602 having an at least partially closed distal end 604 and an at least partially open proximal end 606. The vial adapter assembly 600 may include a plurality of receptacles formed in the housing 602 and extending between the closed distal end 604 and the open proximal end 606. Each of the plurality of receptacles may be configured to at least partially receive a vial within the housing 602. In this example, the vial adapter assembly 600 includes a pair of receptacles. The housing 602 of the vial adapter assembly 600 may be similar to the housing 502 of the vial adapter assembly 500 described above.

[0117] The vial adapter assembly 600 may include a cap 610 for each of the pair of receptacles of the housing 602. The cap 610 may be configured to engage the mouth 19 of the vial 10 when the vial 10 is received in the receptacle. In this example, the cap 610 may include a periphery 612 configured to form a snap-fit ​​connection with the underside of the mouth 19, thereby securely coupling the cap 610 to the mouth 19. The cap 610 may be sized, shaped, and configured to surround the opening of the vial 10 at the mouth 19 such that when the cap 610 is coupled to the mouth 19, the vial 10 is maintained in a closed state. As described herein, the cap 610 may be configured to move and disengage from the mouth 19 independently of the other caps on the housing 602, thereby transitioning the vial 10 to an open state.

[0118] 16 , the cap 610 may include a connector 618 extending proximally from an outer surface of the cap 610 and a needle 616 extending distally from an inner surface of the cap 610. The connector 618 may be configured to facilitate access to the vial 10 and / or movement of the cap 610 between various positions relative to the housing 602. In some embodiments, the connector 618 may include a luer lock or other connection mechanism to enable needleless extraction of the contents of the vial 10.

[0119] Needle 616 may have a sharp distal tip configured to pierce a lid cover 620 coupled to port 19. Alternatively, lid cover 620, which may come standard with vial 10, may be removed and replaced with cap 610 when vial 10 is inserted into vial adapter assembly 600 and cap 610 is attached.

[0120] 16, vial adapter assembly 600 may include a hinge 614 coupling cap 610 to housing 602 such that cap 610 may be configured to move (e.g., pivot) between a coupled state and a disengaged state with vial 10 relative to housing 602. In the coupled state, needle 616 may extend into vial 10 to facilitate access to the contents of the vial by, for example, an external device (e.g., a syringe) or the like.

[0121] 16 illustrates the cap 610 removed from the mouth 19 of a vial 10 housed within the housing 602. It should be understood that the cap 610, rim 612, and hinge 614 may be configured and operable similarly to the analogous components of the vial adapter assembly 500 shown and described above, except for the differences expressly noted herein. In some embodiments, the housing 602 may include at least one sidewall selectively removable from the remainder of the housing 602 to facilitate receipt of the vial 10 into a corresponding receptacle. The at least one sidewall may be configured to mate with one or more protrusions and / or guides 603 on the housing 602 to securely attach the at least one sidewall to the remainder of the housing 602 in a manner similar to the vial adapter assembly 500.

[0122] 17, when the cap 610 is coupled to the mouth 19 of the vial 10, the needle 616 may extend into the vial 10. With the cap 610 in place, an external device may be coupled to the connector 618 to access the contents of the vial 10. For example, if the connector 618 is a luer lock, a syringe body may be connected to the connector 618 to fill the body of the syringe with the contents of the vial 10 or to establish a connection to an IV bag.

[0123] Alternatively, cap 610 may be separated from port 19 to allow an external device to extend into vial 10 and access the contents stored therein via port 19. For example, as seen in FIG. 18 , the external device may include a syringe 50 having a barrel 52, a needle 54 extending distally from barrel 52, and a plunger extending proximally from barrel 52. A needle 616 may be inserted through the opening of vial 10 to withdraw the contents of vial 10.

[0124] 19A, an exemplary vial adapter assembly 700 is shown. The vial adapter assembly 700 may be configured and operable to hold two or more vials together when a portion of the vial adapter assembly 700 is attached over each vial. The vial adapter assembly 700 may be crimped over the openings of a plurality of vials. The vial adapter assembly 700 may include a body 702 having a first outer portion 704 and a second outer portion 706 positioned opposite the first outer portion 704. The body 702 may be formed from a flexible material and configured to deform into a plurality of positions, shapes, and / or configurations between the first outer portion 704 and the second outer portion 706. For example, the body 702 may be formed from aluminum or various other malleable metals. In one embodiment, the body 702 may be formed from a stamped piece of aluminum.

[0125] It should be understood that the body 702 may have a variety of suitable lengths defined between the first outer portion 704 and the second outer portion 706 such that the body 702 may include one or more intermediate portions between the outer portions 704, 706. The body 702 may be positioned over a pair of vials 10a, 10b with the first outer portion 704 aligned with the first vial 10a and the second outer portion 706 aligned with the second vial 10b. The outer end 708 of the first outer portion 704 may be positioned adjacent the mouth 19a of the first vial 10a and the outer end 710 of the second outer portion 706 may be positioned adjacent the mouth 19b of the second vial 10b.

[0126] 19B, the body 702 may be deformed according to the size, shape, and / or cross-sectional profile of the first and second vials 10a, 10b to securely couple the vial adapter assembly 700 to the pair of vials 10a, 10b. Specifically, the first outer portion 704 may be molded around the mouth 19a, such as one or more surfaces and / or edges defining the mouth 19a, to securely engage the first vial 10a. In other words, the first outer portion 704 may be crimped onto the mouth 19a. An outer end 708 of the first outer portion 704 may be crimped to engage the underside of the mouth 19a to hold the vial adapter 700 onto the first vial 10a.

[0127] The second outer portion 706 may be molded around the mouth 19b, such as one or more surfaces and / or edges that define the mouth 19b, and may securely engage the second vial 10b. The outer end 708 may conform to and engage with a surface and / or edge of the shoulder 19a to securely couple the first outer portion 704 to the first vial 10a, and the outer end 710 may conform to and engage with a surface and / or edge of the mouth 19b to securely couple the second outer portion 706 to the second vial 10b. In other words, the second outer portion 706 may be crimped onto the mouth 19b. The outer end 710 of the second outer portion 706 may be crimped to engage the underside of the mouth 19b to hold the vial adapter 700 onto the second vial 10b. To crimp the vial adapter assembly 700 onto the openings of the first and second vials 10a, 10b, the body 702 may be deformed in response to the application of a force to the body 702, e.g., manually by a user's hand or tool, stamped by an automated machine, etc.

[0128] 20, vial adapter assembly 700 may be configured to enclose only a portion of the pair of vials 10a, 10b, such that the remaining portions of the first vial 10a and second vial 10b are not covered by body 702. In other embodiments, vial adapter assembly 700 may be configured to enclose additional and / or fewer portions of the first vial 10a and / or second vial 10b, such as the proximal end, the body, and the distal end.

[0129] The embodiment of FIG. 21 illustrates an alternative to the use of a separate vial adapter assembly. Rather than using a vial adapter into which multiple vials can be inserted and held together, the embodiment of FIG. 21 illustrates a double vial 10c formed together as a single monolithic unit. For example, the double vial 10c may include two vial portions that share a common wall and cannot be separated from one another. FIG. 22 illustrates a cross-sectional view through a central region of the double vial 10c, showing portions 804, 806 of the body 802 that have a shared wall. The double vial 10c may be formed, for example, from molded plastic or glass.

[0130] 23 and 24, rather than specifically forming a double vial container as a single unit, vial adapter assembly 800 can function to hold two separate vials together as well. Vial adapter assembly 800 can include a body 812 having a first portion 814 and a second portion 816 positioned opposite first portion 814. First portion 814 can be sized, shaped, and configured to receive at least a portion of a first vial 10a, e.g., a central region of first vial 10a. Second portion 816 can be sized, shaped, and configured to receive at least a portion of a second vial 10b, e.g., a central region of second vial 10b.

[0131] The body 812 may be formed from a rigid material (e.g., plastic or metal) and, in some embodiments, may be molded over the first and second vials 10a, 10b. Additionally, the body 812 may include a single moldable body. For example, the body 812 may be formed from glass, plastic, metal, and / or a variety of other materials. Although the body 812 is shown and described as having two portions 814, 816 for receiving the first and second vials 10a, 10b, respectively, the body 812 may have additional portions for receiving more than two vials.

[0132] As best seen in FIG. 24, the body 812 may be molded according to the size, shape, and / or cross-sectional profile of the first and second vials 10a, 10b to securely couple the vial adapter assembly 800 to the pair of first and second vials 10a, 10b. In particular, the first portion 814 may be molded around a central region of the first vial 10a to securely engage the first vial 10a. The second portion 816 may be molded around a central region of the second vial 10b to securely engage the second vial 10b. In some embodiments, an adhesive layer or glue may be used to help retain the first and second vials 10a, 10b within the first and second portions 814, 816. In this example, the vial adapter assembly 800 may be configured to surround only a portion of the pair of vials 10a, 10b. In other embodiments, the vial adapter assembly 800 may be configured to enclose additional and / or fewer portions of the first vial 10a and / or second vial 10b, such as the proximal end, the body, and the distal end.

[0133] 25, an exemplary vial adapter assembly 900 is shown. The vial adapter assembly 900 may be configured and operable to hold and facilitate access (fluid communication) to two or more vials secured together upon attachment of a portion of the vial to the vial adapter assembly 900. The vial adapter assembly 900 may include a cap 902 and a sleeve 910. Each of the cap 902 and the sleeve 910 may be configured to couple multiple vials together along a respective portion of the vial. In this example, the cap 902 and the sleeve 910 may be cooperatively configured to couple a first vial 10a to a second vial 10b, although in other embodiments, the vial adapter assembly 900 may couple additional vials together. As seen in FIG. 26, the cap 902 may include a first lid cover 904 and a second lid cover 906, which are integrated with each other to form a single body. The first lid cover 904 may be sized, shaped, and configured to receive at least a portion of the first vial 10a, such as the mouth 19a. The second lid cover 906 may be sized, shaped, and configured to receive at least a portion of the second vial 10b, such as the mouth 19b. The cap 902 may be configured to couple the first vial 10a to the second vial 10b and simultaneously expose or enclose the openings of the first vial 10a and the second vial 10b with the first lid cover 904 and the second lid cover 906, respectively. In this example, the cap 902 may be formed from any suitable material, such as, for example, plastic or metal.

[0134] The cap 902 may be a double flip-off cap configured to simultaneously disengage from the first vial 10a and the second vial 10b in response to application of a proximal (pull or push) force to the cap 902 relative to the vials 10a, 10b, thereby separating the first lid cover 904 from the port 19a and separating the second lid cover 906 from the port 19b. Thus, the vial adapter assembly 900 may be configured to simultaneously block fluid communication to the pair of vials 10a, 10b from an external device or the like when the cap 902 is coupled to the first vial 10a and the second vial 10b. The vial adapter assembly 900 may further be configured to simultaneously allow fluid communication to the pair of vials 10a, 10b in response to separating the cap 902 from the first vial 10a and the second vial 10b.

[0135] The cap 902 may be used in conjunction with a sleeve 910. The sleeve 910 may share some similarities with the body 812 described above. The sleeve 910 may be overmolded around the first and second vials 10a, 10b, or an adhesive layer (e.g., a pressure sensitive adhesive) or glue may be used to hold the first and second vials 10a, 10b in the sleeve 910. The sleeve 910 may be a single unit or may be formed from more than one piece. For example, the sleeve 910 may consist of two halves that fit together to surround the first and second vials 10a, 10b. Forming the sleeve 910 from two or more pieces may aid in fitting the sleeve 910 onto the first and second vials 10a, 10b if an adhesive or glue is used. In other embodiments, the sleeve 910 may hold the first and second vials 10a, 10b using an adhesive or glue and may not encircle the complete circumference of the first and second vials, as described further below. The sleeve 910 may be formed from any suitable material, such as plastic or metal.

[0136] 27-28, the sleeve 910 may include a first portion 912 and a second portion 914 positioned opposite the first portion 912. The first portion 912 may define a first receptacle 920a sized, shaped, and configured to receive at least a portion of the first vial 10a, and the second portion 914 may define a second receptacle 920b sized, shaped, and configured to receive at least a portion of the second vial 10b (see FIG. 25). In this example, the first portion 912 may be configured to receive a portion of the body of the first vial 10a, and the second portion 914 may be configured to receive a portion of the body of the second vial 10b.

[0137] As best seen in FIG. 28, the first portion 912 and the second portion 914 may each have a cross-sectional profile that matches the profile of the body of the vial 10a, 10b, respectively. In this example, the first portion 912 may have a semicircular shape such that the sleeve 910 is configured to surround a portion of the body when the first vial 10a is received in the first receptacle 220a. Additionally, the second portion 914 may have a semicircular shape such that the sleeve 910 is configured to surround a portion of the body when the second vial 10b is received in the second receptacle 920b. In other embodiments, the first portion 912 and / or the second portion 914 may have a variety of other suitable cross-sectional profiles other than those shown and described herein. In further embodiments, the first portion 912 and the second portion 914 may have different cross-sectional profiles relative to one another.

[0138] The sleeve 910 may include a first engaging element 916 in the first receptacle 920a for securing the first vial 10a to the first portion 912 and a second engaging element 918 in the second receptacle 920b for securing the second vial 10b to the second portion 914. In this example, one or more of the first engaging element 916 and / or the second engaging element 918 may include an adhesive liner (e.g., a pressure sensitive adhesive, glue, etc.) and / or other suitable bonding material for securing the vials to the sleeve 910. The sleeve 910 may be configured to store each of the first vial 10a and the second vial 10b in the respective receptacle 916, 918, independent of the other. Additionally, the sleeve 910 may be configured to maintain the first and second vials 10a, 10b connected to one another after the caps 902 are separated from the corresponding ports 19a, 19b. Additionally, the sleeve 910 shown in FIG. 28 may constitute an entire sleeve that may encircle approximately half of the circumference of each of the first and second vials 10a, 10b. Alternatively, the sleeve 910 shown in FIG. 28 may be half of the sleeve 910 and may be used in conjunction with a second half (not shown) to more completely encircle the circumference of the first and second vials 10a, 10b.

[0139] 29, an exemplary vial adapter assembly 1000 is shown. The vial adapter assembly 1000 may be configured and operable to hold and facilitate access (fluid communication) to two or more vials secured together from the attachment of a respective lid cover on each vial. The vial adapter assembly 1000 may include a tear-off double flip-off cap. The vial adapter assembly 1000 may include a body 1002 configured to couple multiple vials together. In this example, the body 1002 may be configured to couple a first vial 10a to a second vial 10b, although in other embodiments, the vial adapter assembly 1000 may couple additional vials together. The body 1002 may include a first lid cover 1004 and a second lid cover 1006. The first lid cover 1004 may be sized, shaped, and configured to receive at least a portion of the first vial 10a, such as the mouth 19a. The second lid cover 1006 may be sized, shaped, and configured to receive at least a portion of the second vial 10b, such as the mouth 19b. The body 1002 may be configured to couple the first vial 10a to the second vial 10b and simultaneously surround or expose the openings of the first vial 10a and the second vial 10b with the first lid cover 1004 and the second lid cover 1006, respectively. The body 1002 and the first and second lid covers 1004, 1006 may be formed from two halves extending parallel to one another. One half of the first and second lid covers 1004, 1006 may be configured to engage with a first side of the mouths 19a, 19b of the first and second vials 10a, 10b, and the other half of the first and second lid covers 1004, 1006 may be configured to engage with a second side of the mouths of the first and second vials 10a, 10b.

[0140] The vial adapter assembly 1000 may further include at least one of a first pull tab 1008 extending laterally outward from the first lid cover 1004 and a second pull tab 1010 extending laterally outward from the second lid cover 1006. Each of the first pull tab 1008 and the second pull tab 1010 may be sized, shaped, and configured to define a handle for manually manipulating the body 1002, such as to deform one or more of the first lid cover 1004 and / or the second lid cover 1006. As further described herein, the vial adapter assembly 1000 may be configured to transition from a first (assembled) state to a second (disassembled) state in response to actuating one or more of the first pull tab 1008 and / or the second pull tab 1010.

[0141] 30, the vial adapter assembly 1000 may include a first pair of clips 1012a and a second pair of clips 1012b for securing each of the first vial 10a and the second vial 10b, respectively, to the body 1002. In this example, the first pair of clips 1012a may extend distally (e.g., downwardly) from the first lid cover 1004 and the second pair of clips 1012b may extend distally from the second lid cover 1006. The first pair of clips 1012a may be at least partially flexible and configured to form a snap-fit ​​connection with the mouth 19a of the first vial 10a received in the first lid cover 1004. The second pair of clips 1012b may be at least partially flexible and configured to form a snap-fit ​​connection with the mouth 19b of the second vial 10b received in the second lid cover 1006. In other embodiments, the vial adapter assembly 1000 may include various other engagement mechanisms for selectively coupling the first vial 10a and the second vial 10b to the body 1002 without departing from the scope of the present disclosure.

[0142] 31A, the vial adapter assembly 1000 is shown in a first (assembled) configuration with the body 1002 fully assembled. In this case, a first central portion 1003 of a first lid cover 1004 may be positioned over and coupled to the mouth 19a of the first vial 10a, thereby surrounding the opening of the first vial 10a and coupling the first vial 10a to the body 1002. A second central portion 1005 of a second lid cover 1006 may be positioned over and coupled to the mouth 19b of a second vial 10b, thereby surrounding the opening of the second vial 10b and coupling the second vial 10b to the body 1002.

[0143] In this example, the first central portion 1003 may be coupled to a first pull tab 1008, and the first lid cover 1004 may be coupled to the first central portion 1003 by one or more frangible prongs 1007. The second central portion 1005 may be coupled to a second pull tab 1010, and the second lid cover 1006 may be coupled to the second central portion 1005 by one or more frangible prongs 1007. As described further herein, the frangible prongs 1007 may be at least partially deformable to separate each of the first central portion 1003 from the first lid cover 1004 and the second central portion 1005 from the second lid cover 1006 upon transitioning the vial adapter assembly 1000 to the second (disassembled) state.

[0144] With continued reference to FIG. 31A , the first pull tab 1008 may be coupled to the second pull tab 1010 by an intermediate strip 1009 positioned between the first pull tab 1008 and the second pull tab 1010. In some embodiments, the vial adapter assembly 1000 may be configured such that actuation of the first pull tab 1008 is independent of actuation of the second pull tab 1010, and vice versa. Stated another way, application of a force (e.g., either a pulling force or a peeling force) to either the first pull tab 1008 and / or the second pull tab 1010 may not cause a corresponding movement of the opposite tab across the intermediate strip 1009. In this case, the intermediate strip 1009 may be configured to deform upon actuation of either the first pull tab 1008 and / or the second pull tab 1010, such that the body 1002 can sever along the intermediate strip 1009.

[0145] In other embodiments, vial adapter assembly 1000 may be configured such that actuation of first pull tab 1008 may provide a corresponding actuation of second pull tab 1010 via intermediate strip 1009, or vice versa. In this case, application of a force (e.g., either a pulling force or a peeling force) to either first pull tab 1008 and / or second pull tab 1010 may cause a corresponding movement of the opposing tab and intermediate strip 1009. In this example, body 1002 may be formed from a flexible material, such as, for example, plastic.

[0146] 31B, the body 1002 may be at least partially deformable in response to application of force, such as at the first pull tab 1008 and / or the second pull tab 1010. In this example, at least a portion of the first lid cover 1004, particularly the first central portion 1003, may be removable from the remainder of the first lid cover 1004 (e.g., the periphery) in response to pulling the first pull tab 1008. Specifically, actuation of the first pull tab 1008 may sever one or more frangible prongs 1007, thereby removing the first central portion 1003 and exposing the mouth 19a of the first vial 10a (e.g., a stopper within the mouth 19a).

[0147] At least a portion of the second lid cover 1006, particularly the second central portion 1005, may be removable from the remainder of the second lid cover 1006 (e.g., the periphery) in response to pulling the second pull tab 1010. Actuation of the second pull tab 1010 may sever one or more frangible prongs 1007, thereby removing the second central portion 1005 and exposing the mouth 19b (e.g., a stopper in the mouth 19a) of the second vial 10b. The openings of the first vial 10a and the second vial 10b may be exposed upon selectively removing each of the central portions 1003, 1005 by independently actuating each of the first pull tab 1008 and the second pull tab 1010, respectively. Alternatively, however, only one pull tab may be included and force may be applied to the single pull tab to remove the first and second central portions 1003, 1005, and intermediate strip 1009 all at once by breaking the frangible branch 1007.

[0148] As shown in FIG. 31B, the body 1002 may be configured to maintain engagement with the ports 19a, 19b when the first central portion 1003 and the second central portion 1005 are removed. In other words, the vial adapter assembly 1000 may maintain the first vial 10a connected to the second vial 10b when in the second (disassembled) state. In this example, with at least a portion of the first lid cover 1004 maintained on the first vial 10a and a portion of the second lid cover 1006 maintained on the second vial 10b, the vial adapter assembly 1000 may be configured to prevent an ancillary cap from covering the first vial 10a and / or the second vial 10b. Thus, the vial adapter assembly 1000 may prevent reuse of the first vial 10a and the second vial 10b when facilitating access to the vial contents. In other words, the remaining portions of the first lid cover 1004 and second lid cover 1006 may provide a tamper-evident indicator to prevent reuse.

[0149] 32A, an exemplary vial adapter assembly 1100 is shown. The vial adapter assembly 1100 may be configured and operable to hold and facilitate simultaneous access (fluid communication) to two or more vials housed together in a blister pack sealed by a blister pack seal. The vial adapter assembly 1100 may include a housing 1102 configured to couple multiple vials together. In this example, the housing 1102 may be configured to couple a first vial 10a to a second vial 10b, although in other embodiments, the vial adapter assembly 1100 may couple additional vials together. The housing 1102 may include a fixed bottom wall 1104, at least one side wall 1105, and a removable top wall 1106 that collectively define an enclosure for housing the first vial 10a and the second vial 10b. In this example, the housing 1102 may be a blister pack and the removable top wall 1106 may be a blister pack seal configured to move in response to application of a proximal (e.g., pulling or peeling) force thereto.

[0150] The housing 1102 may be sized and shaped to completely enclose the first vial 10a and the second vial 10b between a fixed bottom wall 1104 and a removable top wall 1106. The vial adapter assembly 1100 may include a seal 1108 extending around the periphery of the housing 1102 adjacent the removable top wall 1106. The seal 1108 may be configured to prevent fluid communication between the first vial 10a and the second vial 10b, and in particular the contents stored therein, and a space outside the housing 1102 to maintain sterility of the contents. The seal 1108 may be broken upon removal of the removable top wall 1106. In some embodiments, the vial adapter assembly 1100 may include separate receptacles for each of the first vial 10a and the second vial 10b in the housing 1102 to prevent fluid communication between the first vial 10a and the second vial 10b. The removable top wall 1106 may be configured to simultaneously enclose or expose the openings of the first vial 10a and the second vial 10b when the vial adapter assembly 1100 is in the first (closed) configuration. Alternatively, the blister pack housing 1102 may include the first vial 10a and the second vial 10b, which may need to be opened individually once the removable top wall 1106 is at least partially removed.

[0151] As seen in FIG. 32B, the vial adapter assembly 1100 may be transitioned from a first (closed) configuration to a second (open) configuration upon removal of the removable top wall 1106. In this example, the removable top wall 1106 may be configured to move relative to the fixed bottom wall 1104 and / or at least one side wall 1105 to facilitate access into the housing 1102. In this case, the openings of the first vial 10a and the second vial 10b may be simultaneously exposed by the removable top wall 1106, thereby facilitating access to the contents stored therein. In other embodiments, each of the receptacles defined in the housing 1102 may include a separate removable top wall. The vial adapter assembly 1100 is configured to prevent reassembly of the removable top wall 1106 upon removal of the removable top wall 1106. Thus, the vial adapter assembly 1100 may be configured to prevent reuse of the first vial 10a and the second vial 10b while facilitating access to the vial contents. In other words, the removable top wall 1106 can provide a tamper-evident indicator to discourage reuse.

[0152] 33A, an exemplary vial adapter system 1200 is shown. The vial adapter system 1200 may be configured and operable to facilitate access (fluid communication) to a vial through a corresponding connector to which an external device (e.g., a syringe) can be coupled. The vial adapter system 1200 may include at least one adapter for each of a plurality of vials. In this example, the vial adapter system 1200 may include at least a first adapter 1202a configured to couple to a port 19a of a first vial 10a and at least a second adapter 1202b configured to couple to a port 19b of a second vial 10b. The first adapter 1202a and the second adapter 1202b are independent of each other, such that the vial adapter system 1200 allows individual access to each of the first vial 10a and the second vial 10b. As described in detail herein, each of the first vial 10a and the second vial 10b may include a respective visual indicator (e.g., a colored label) that corresponds to a matching visual indicator (e.g., color) on the first adapter 1202a and the second adapter 1202b, respectively.

[0153] The first adapter 1202a may include a pair of first clips 1204a at a distal (bottom) end and a first connector 1206a at a proximal (top) end. The pair of first clips 1204a may be configured to engage the port 19a, thereby coupling the first adapter 1202a to the first vial 10a. The second adapter 1202b may include a pair of second clips 1204b at a distal (bottom) end and a second connector 1206b at a proximal (top) end. The pair of second clips 1204b may be configured to engage the port 19b, thereby coupling the second adapter 1202b to the second vial 10b.

[0154] As seen in FIG. 33B, the first connector 1206a may be configured to couple the first adapter 1202a to an external device, such as, for example, a first syringe 50a having a barrel 52a, a needle 54a, and a locking mechanism 55a. In this example, the first connector 1206a may include a luer lock configured to mate with the locking mechanism 55a of the first syringe 50a. The first adapter 1202a may further include a first actuator 1208a configured to selectively establish fluid communication between the first vial 10a and the first syringe 50a. In particular, actuation of the first actuator 1208a may fluidly couple the first syringe 50a to the first vial 10a by translating the needle 54a of the first syringe 10a into the first vial 10a. In some embodiments, the first actuator 1208a may include a push button having a visual indicator (e.g., color) that matches a corresponding color on the first vial 10a to indicate the contents stored in the first vial 10a.

[0155] The second connector 1206b may be configured to couple the second adapter 1202b to an external device, such as, for example, a second syringe 50b having a barrel 52b, a needle 54b, and a locking mechanism 55b. In this example, the second connector 1206b may include a luer lock configured to mate with the locking mechanism 55b of the second syringe 50b. The second adapter 1202b may further include a second actuator 1208b configured to selectively establish fluid communication between the second vial 10b and the second syringe 50b. In particular, actuation of the second actuator 1208b may fluidly couple the second syringe 50b to the second vial 10b by translating the needle 54b of the second syringe 10b into the second vial 10b. In some embodiments, the second actuator 1208b may include a push button having a visual indicator (e.g., color) that matches a corresponding color on the second vial 10b to indicate the contents stored therein. It should be appreciated that the color of the second actuator 1208b is different from the color of the first actuator 1208a to facilitate identification of the corresponding adapter connected to each respective vial.

[0156] Referring now to FIG. 34, an exemplary adapter 1300 is shown. The adapter 1300 may be configured and operable to facilitate access (fluid communication) and delivery of contents stored in a vial using each end of the vial adapter assembly 1300. The adapter 1300 may be configured to open and facilitate delivery of a fluidic substance stored in a vial or a cartridge, such as the cartridge 20 shown in FIGS. 35A-35B. It should be understood that at least one adapter 1300 may be coupled to each of the multiple cartridges 20 or may be separate from each of the multiple cartridges 20. The adapter 1300 may include a housing 1302 having a needle 1304 at a first end and an opening 1306 at a second end opposite the first end. The housing 1302 may define a receptacle 1308 for receiving at least a portion of the cartridge 20 to couple the adapter 1300 to the cartridge 20 (see FIG. 35B).

[0157] The housing 1302 may include a pair of clips 1310 positioned adjacent the opening 1306 at the second end. The pair of clips 1310 may be configured to engage a portion of the cartridge 20 to securely couple the adapter 1300 to the cartridge 20 (see FIG. 35B). Although clips 1310 are shown, it should be understood that the adapter 1300 may be attached to the cartridge 20 in any suitable manner, e.g., a snap fit, a threaded fit, a friction fit, etc. The needle 1304 may include a hollow channel in fluid communication with the receptacle 1308 such that fluid received in the adapter 1300 at the receptacle 1308 (e.g., via the opening 1306) may be communicated to the needle 1304 through the hollow channel.

[0158] In an exemplary use, as seen in FIG. 35A , the adapter 1300 may be positioned and / or oriented in a first configuration to facilitate access into the body 22 of the cartridge 20. For example, the adapter 1300 may be positioned to align the needle 1304 with the mouth 29 of the cartridge 20. The needle 1304 may be configured to pierce a seal of the cartridge 20 located at the mouth 29 to facilitate access into the cavity 28 of the body 22. Upon piercing the seal of the cartridge 20, the adapter 1300 may be transitioned from the first configuration to the second configuration by reorienting the adapter 1300 to position the opening 1306 in alignment with an opening formed in the mouth 29a.

[0159] 35B, the adapter 1300 may be coupled to the cartridge 20 by attaching the housing 1302 to the shoulder 29 when the adapter 1300 is in the second configuration. In particular, a pair of clips 1310 may be configured to engage an edge of the mouth 29 to securely couple the housing 1302 to the cartridge 20. The opening 1306 and / or the receptacle 1308 may be sized, shaped, and configured to receive at least a portion of the cartridge 20, such as the mouth 29. In this case, the adapter 1300 may be in fluid communication with the cartridge 20 such that contents stored in the cavity 28 may be received through the opening 1306, the receptacle 1308, and into the hollow channel of the needle 1304.

[0160] For example, plunger 27 of cartridge 20 disposed within body 22 may be actuated to release contents stored in cavity 28 into housing 1302. Needle 1304 may be positioned at a target treatment site to deliver contents from cartridge 20 to the target treatment site. Thus, needle 1304 may be configured to facilitate access to cartridge 20 when adapter 1300 is in a first configuration and to deliver contents stored in cartridge 20 when adapter 1300 is in a second configuration.

[0161] 36A, an exemplary adapter 1400 is shown. The adapter 1400 may be configured and operable to hold and facilitate independent delivery of contents stored in two or more cartridges housed together in separate barrels via respective plungers positioned in each barrel. The adapter 1400 may include a handle 1402, a pair of barrels 1404, each having a proximal end 1406 and a distal end 1408, and at least one plunger 1412 movably coupled to each of the pair of barrels 1404. In this example, the adapter 1400 may include at least two barrels 1404 positioned adjacent to one another, and each barrel 1404 may be configured to receive at least one cartridge 20. In other embodiments, the adapter 1400 may include additional barrels 1404 for receiving additional cartridges 20. Although a single barrel 1404 and cartridge 20 is shown and described herein with respect to the adapter 1400, it should be understood that the adapter 1400 may include at least one pair of barrels 1404 for receiving at least one pair of cartridges 20. Thus, the following description may be applicable to each cartridge 20 received within the adapter 1400.

[0162] The plunger 1412 may extend through the proximal end 1406 and into the barrel 1404. For example, the plunger 1412 may include a proximal end 1414 positioned outside the barrel 1404 and proximal to the proximal end 1406, and a distal end 1416 positioned inside the barrel 1404 and distal to the proximal end 1406. The adapter 1400 may further include an actuator 1418 coupled to the plunger 1412 and configured to move the plunger 1412 relative to the barrel 1404 in response to actuation of the actuator 1418.

[0163] With continued reference to FIG. 36A , the adapter 1400 may include an opening 1410 at the distal end 1408 configured to receive the cartridge 20. The barrel 1404 may be sized and shaped to at least partially receive the cartridge 20 into the adapter 1400 via the opening 1410. The barrel 1404 may be configured to securely engage the cartridge 20, thereby fixing the axial position of the cartridge 20 relative to the proximal end 1406 and / or the distal end 1408. When disposed within the barrel 1404, the distal end 1416 of the plunger 1412 may be received within the cartridge 20 and positioned relative to the plunger 27 of the cartridge 20. Alternatively, the plunger 27 or the cartridge 20 may form the proximal (bottom) surface of the cartridge 20 and may be movable toward the mouth of the cartridge 20 upon application of force. In such an embodiment, the plunger 1412 may be aligned with the bottom of the cartridge 20 (i.e., the plunger 27). Thus, plunger 1412 is configured to move plunger 27 when cartridge 20 is received within barrel 1404 .

[0164] As seen in FIG. 36B , the cartridge 20 may be disposed within the barrel 1404 with the proximal (bottom) end of the cartridge 20 positioned adjacent the proximal end 1406 and the port 29 positioned adjacent the opening 1410. The distal end 1416 of the plunger 1412 may be received within or in contact with a portion of the cartridge 20 and may abut the plunger 27 of the cartridge 20. The port 29 may be coupled to a flexible tube 1422 (not shown) to facilitate fluid communication between the cartridge 20 and a distal end of the flexible tube 1422 (not shown) positioned, for example, in a container (e.g., an intravenous (IV) bag). In an exemplary use, the actuator 1418 may be actuated to move the plunger 1412 distally relative to the barrel 1404, thereby abutting the distal end 1416 of the plunger 1412 against the plunger 27. In this case, contents stored within the cartridge 20 may be expelled through the flexible tube 1422 towards the container when the plunger 27 is urged distally within the cartridge 20 .

[0165] In this example, actuation of the actuator 1418 can simultaneously move each plunger 1412 disposed in a pair of barrels 1404, each of which can be coupled to at least one cartridge 20. Thus, the actuator 1418 can be configured to simultaneously expel the contents of each cartridge 20 coupled to the adapter 1400. In other embodiments, the actuator 1418 can be configured to independently actuate each plunger 1412, thereby delivering the contents of each cartridge 20 to the receptacle separately from one another.

[0166] In one embodiment, the adapter 1400 may be configured to actuate the actuator 1418 to move the plunger 1412 to a predetermined position to set a predetermined volume of contents to be dispensed prior to delivery to the container. For example, prior to coupling the flexible tube 1422 to the port 29, the actuator 1418 may be first actuated to translate the plunger 1412 distally relative to the barrel 1404 until it stops at a predetermined position indicating the set volume. In this case, the flexible tube 1422 may be coupled to the port 29, and the actuator 1418 may be actuated to further translate the plunger 1412 to deliver the set volume of contents to the container via the flexible tube 1422. In some aspects, before or after coupling the flexible tube 1422 to the port 29, the adapter assembly 1400 may be configured to stop the plunger 1412 after moving a set amount distally, which may correspond to a set amount of contents to be dispensed from the container. Thus, vial adapter assembly 1400 may allow for control of the dose of contents expelled from cartridge 20.

[0167] 37A, an exemplary adapter 1500 is shown. The adapter 1500 may be configured and operable to hold and facilitate independent delivery of contents stored in two or more vials housed together in separate barrels via respective plungers positioned in each barrel. The adapter 1500 may include a handle 1502, a pair of barrels 1504, each having a proximal end 1506 and a distal end 1508, and at least one plunger 1512 movably coupled to each of the pair of barrels 1504. In this example, the adapter 1500 may include at least two barrels 1504 positioned adjacent to one another, and each barrel 1504 may be configured to receive at least one vial 10. In other embodiments, the adapter 1500 may include additional barrels 1504 for receiving additional vials 10. Although a single barrel 1504 and vial 10 is shown and described herein with respect to the adapter 1500, it should be understood that the adapter 1500 includes at least a pair of barrels 1504 for receiving at least a pair of vials 10. Thus, the following description may be applicable to each vial 10 received within the adapter 1500.

[0168] The plunger 1512 may extend through the proximal end 1506 into the barrel 1504. For example, the plunger 1512 may include a proximal end 1514 positioned outside the barrel 1504 and proximal to the proximal end 1506 and a connector 1516 positioned inside the barrel 1504 and distal to the proximal end 1506. In some embodiments, the connector 1516 may have a sharp distal tip. The adapter 1500 may further include an actuator 1518 coupled to the plunger 1512 and configured to move the plunger 1512 relative to the barrel 1504 in response to actuation of the actuator 1518.

[0169] 37A , the adapter 1500 may further include an opening 1510 at the distal end 1508 configured to receive the vial 10. The barrel 1504 may be sized and shaped to at least partially receive the vial 10 into the adapter 1500 via the opening 1510. The barrel 1504 may be configured to securely engage the vial 10, thereby fixing an axial position of the vial 10 relative to the proximal end 1506 and / or the distal end 1508. The connector 1516 of the plunger 1512 may include a channel 1517 extending between a first open end positioned on the distal tip of the connector 1516 and a second open end along a sidewall of the connector 1516. A second open end of the channel 1517 may be fluidly coupled to a flexible tube 1522 (not shown) to facilitate fluid communication between the connector 1516 and, for example, a distal end of the flexible tube 1522 positioned in a container (e.g., an IV bag). The connector 1516 may further include another channel, not shown, extending longitudinally through the plunger 1512 from a first open end positioned on a distal tip of the distal end 1516.

[0170] 37B, the vial 10 may be placed into the barrel 1504 with the port 19 positioned adjacent to the connector 1516 of the plunger 1512. When placed into the barrel 1504, the connector 1516 of the plunger 1512 may be received into the vial 10 through the port 19. In an exemplary use, the actuator 1518 may be actuated to move the plunger 1512 distally relative to the barrel 1504, thereby forcing air present in the plunger 1512 out of the connector 1516 and into the vial 10. This increases the pressure within the vial 10, thereby forcing contents (e.g., fluidic material) stored in the vial 10 out of the port 19 via the channel 1517 and out of the vial 10.

[0171] Thus, the plunger 1512 is configured to push contents outward from within the vial 10 as the plunger 1512 moves further distally toward the connector 1516. As a result, the contents may be received along the connector 1516, through a first open end of the channel 1517, through the channel 1517, and into a flexible tube 1522 coupled to the channel 1517 at a second open end. In this example, actuation of the actuator 1518 may simultaneously move each plunger 1512 disposed within a pair of barrels 1504, each of which may be coupled to at least one vial 10. Thus, the actuator 1518 may be configured to simultaneously eject the contents of each vial 10 coupled to the adapter 1500. In other embodiments, the actuator 1518 may be configured to independently actuate each plunger 1512, thereby delivering the contents of each vial 10 to the container separately from one another.

[0172] 38, an exemplary adapter 1600 is shown. The adapter 1600 may be configured and operable to hold and facilitate independent delivery of contents stored in two or more cartridges positioned together via respective plungers coupled to each vial. The adapter 1600 may include a handle 1602 having a longitudinal length defined between a proximal end 1604 and a distal end 1606. The adapter 1600 may include a receptacle 1605 along the handle 1602 for receiving at least a pair of cartridges 20a, 20b. In this example, the first cartridge 20a and the second cartridge 20b are coupled to the handle 1602 in the receptacle 1605. The receptacle 1605 may be at least partially exposed to an exterior surface of the handle 1602 to facilitate selective attachment of the cartridges 20a, 20b to the handle 1602. Additionally, the receptacle 1605 may allow for visual inspection of the first body 22a of the first cartridge 20a and the second body 22b of the second cartridge 20b.

[0173] The handle 1602 may include a first pair of clips 1614a or other suitable connection mechanism in the receptacle 1605 for coupling the port 29a of the first cartridge 20a to the handle 1602, and a second pair of clips 1614b or other suitable connection mechanism for coupling the port 29b of the second cartridge 20b to the handle 1602. The actuator 1600 may further include a first plunger 1610a and a second plunger 1610b coupled to the first cartridge 20a and the second cartridge 20b, respectively. In this example, the first plunger 1610a may be configured to extend into the first body 22a and urge contents stored in the first cartridge 20a outward upon actuation of the first plunger 1610a. The second plunger 1610b may extend into the second body 22b and be configured to urge contents stored in the second cartridge 20b outwardly upon actuation of the second plunger 1610b.

[0174] 38, each of the plungers 1610a, 1610b may include an actuator 1608a, 1608b positioned adjacent the proximal end 1604 of the handle 1602 for selectively actuating the plungers 1610a, 1610b, respectively. Thus, the vial adapter 1600 may be configured such that contents stored in each of the cartridges 20a, 20b may be accessed independently of one another upon actuation of the corresponding actuator 1608a, 1608b. In this example, the first actuator 1608a and the second actuator 1608b may include levers and / or depressors, each of which may be configured to translate the first plunger 1610a and the second plunger 1610 through the corresponding cartridge 20a, 20b, respectively.

[0175] The adapter 1600 may further include a first pipette 1612a and a second pipette 1612b coupled to the handle 1602 and extending distally from the distal end 1606. The first pipette 1612a may be in fluid communication with the first cartridge 20a, and the second pipette 1612b may be in fluid communication with the second cartridge 20b. In some embodiments, one or more of the first pipette 1612a and / or the second pipette 1612b may be connected to an external device, such as via a luer lock connection, for example. In some aspects, the adapter 1600 may allow the cartridges 20a, 20b to be individually actuated, or may allow a user to actuate either or both cartridges using one hand.

[0176] 39, an exemplary adapter 1700 is shown. The adapter 1700 may be configured and operable to hold and facilitate independent delivery of contents stored within multiple co-housed cartridges via respective actuators coupled to each cartridge. The adapter 1700 may include a housing 1702 having a longitudinal length defined between a proximal end 1704 and a distal end 1706. The distal end 1706 may terminate at a distal tip 1708 including an opening. As further described herein, the size, shape, and / or configuration of the distal end 1706 may be configured to guide one or more cartridges disposed within the housing 1702 toward the distal tip 1708, such as a tapered shape.

[0177] The adapter 1700 may include multiple cartridges disposed within the housing 1702. In this example, the adapter 1700 includes at least a first cartridge 1710a, a second cartridge 1710b, and a third cartridge 1710c. Each of the cartridges 1710a, 1710b, 1710c may store a different substance. The first cartridge 1710a may include, for example, a proximal actuator 1712a extending outwardly from the housing 1702 at the proximal end 1704, and a distal end 1714a having an opening for delivering a first substance stored in the first cartridge 1710a. The second cartridge 1710b may include, for example, a proximal actuator 1712b extending outwardly from the housing 1702 at the proximal end 1704, and a distal end 1714b having an opening for delivering a second substance stored in the second cartridge 1710b. The third cartridge 1710c may include, for example, a proximal actuator 1712c extending outward from the housing 1702 at the proximal end 1704 and a distal end 1714c having an opening for delivering a third substance stored in the third cartridge 1710c.

[0178] 39, the adapter 1700 may be configured such that each of the actuators 1712a, 1712b, 1712c may be actuated independently of the others, such that substances stored in each cartridge 1710a, 1710b, 1710c may be delivered from the adapter 1700 separately from one another. In some embodiments, each of the actuators 1712a, 1712b, 1712c may be configured to require a first actuation to translate the corresponding distal end 1714a, 1714b, 1714c toward the distal tip 1708 or outward from the housing 1702 through an opening in the distal tip 1708, and a second actuation to deliver the substance stored in the respective cartridge 1710a, 1710b, 1710c.

[0179] Thus, it should be understood that each of the cartridges 1710a, 1710b, 1710c may extend outwardly from the housing 1702 through the same opening at the distal tip 1708. In some embodiments, the housing 1702 may be connected to an external device, such as, for example, via a luer lock connection at the distal tip 1708. The vial adapter assembly 1700 may allow for multiple fluid paths in a smaller footprint.

[0180] 40, an exemplary syringe 1800 is shown. The syringe 1800 may be configured and operable to hold and facilitate independent delivery of two or more volumes of a fluidic substance stored therein via movement (e.g., rotation) of an actuator in different directions. The syringe 1800 may include a barrel 1802, an actuator 1804 coupled to the barrel 1802 at a proximal end of the barrel 1802, and a needle 1806 extending distally from a distal end of the barrel 1802. The barrel 1802 may be configured to store a fluidic substance (e.g., a medication) within a cavity of the barrel 1802. The actuator 1804 may include a plunger disposed within the cavity of the barrel 1802 to expel the fluidic substance in response to movement of the actuator 1804 relative to the barrel 1802. The needle 1806 may be in fluid communication with the cavity of the barrel 1802 and configured to deliver a fluidic substance from the barrel 1804 upon actuation of the actuator 1804.

[0181] The actuator 1804 may be rotatably coupled to an exterior surface of the barrel 1802. In some embodiments, the actuator 1804 may include a rotatable knob and / or dial. The actuator 1804 may be configured to release a first volume of a fluidic material stored within the barrel 1802 when rotated in a first direction relative to the barrel 1802 and release a second volume of a fluidic material stored within the barrel 1802 when rotated in a second direction relative to the barrel 1802. The barrel 1804 may include a first threaded portion 1810 extending along a longitudinal length of the barrel 1804 from a proximal portion to a mid-portion of the barrel 1804 and a second threaded portion 1820 extending along a longitudinal length of the barrel 1804 from a mid-portion to a distal portion of the barrel 1804.

[0182] 40 , the first threaded portion 1810 may be oriented in a first direction and the second threaded portion 1820 may be oriented in a second direction different from the first direction. The actuator 1804 may include a threaded portion along an inner surface of the actuator 1804 such that the threaded portion of the actuator 1804 may be configured to mate with the first threaded portion 1810 and the second threaded portion 1820 when the actuator 1804 is coupled to an outer surface of the barrel 1802. Thus, the actuator 1804 may be configured to rotate in a first direction when received along the first threaded portion 1810 and rotate in a second direction when received along the second threaded portion 1820.

[0183] A longitudinal length of the first threaded portion 1810 relative to the barrel 1804 may correspond to a first volume of the fluidic material, and a longitudinal length of the second threaded portion 1820 relative to the barrel 1804 may correspond to a second volume of the fluidic material. The actuator 1804 may be configured to translate along the longitudinal lengths of the first threaded portion 1810 and the second threaded portion 1820 while rotating about the barrel 1802 to dispense the first and second volumes of the fluidic material via the needle 1806. It should be appreciated that a plunger disposed within a cavity of the barrel 1802 and coupled to the actuator 1804 may translate through the interior of the barrel 1802 as the actuator 1804 rotates along the exterior of the barrel 1802.

[0184] 41, an exemplary vial adapter assembly 1900 is shown. The vial adapter assembly 1900 may be configured and operable to hold and facilitate simultaneous access (fluid communication) to two or more vials housed together via respective connectors that may extend into each vial in response to actuating a single actuator. The vial adapter assembly 1900 may include a housing 1902 having a distal end 1904 and a proximal end 1906. The vial adapter assembly 1900 may further include a pair of first clips 1908a and a pair of second clips 1908b extending distally (e.g., downwardly) from the distal end 1904. The pair of first clips 1908a may be configured to couple a first vial 10a to the housing 1902 along the distal end 1904, and the pair of second clips 1908b may be configured to couple a second vial 10b to the housing 1902 along the distal end 1904. In this example, a first pair of clips 1908a may be configured to engage with the mouth 19a and form a snap-fit ​​connection between the housing 1902 and the first vial 10a, and a second pair of clips 1908b may be configured to engage with the mouth 19b and form a snap-fit ​​connection between the housing 1902 and the second vial 10b.

[0185] A first cavity defined between the pair of first clips 1908a may correspond to a first receptacle in the housing 1902 for receiving at least a portion of a first vial 10a, such as port 19a. A second cavity defined between the pair of second clips 1908b may correspond to a second receptacle in the housing 1902 for receiving at least a portion of a second vial 10b, such as port 19b. The vial adapter assembly 1900 may further include a first connector 1910a and a second connector 1910b positioned proximate the proximal end 1906 and a first needle 1912a and a second needle 1912b disposed within the cavity of the housing 1902. In some embodiments, the first connector 1910a and the second connector 1910b may include luer lock connectors.

[0186] 41, the first connector 1910a may be fluidly coupled to the first needle 1912a, and the second connector 1910b may be fluidly coupled to the second needle 1912b. In this example, the first connector 1910a and the first needle 1912a may be aligned with a first receptacle (defined between the pair of first clips 1908a) for receiving the first vial 10a, and the second connector 1910b and the second needle 1912b may be aligned with a second receptacle (defined between the pair of second clips 1908b) for receiving the second vial 10b. The vial adapter assembly 1900 may include an actuator 1914 positioned along the housing 1902, and the actuator 1914 may be coupled to the needles 1912a, 1912b.

[0187] In an exemplary use, the actuator 1914 may be configured to simultaneously move the first needle 1912a and the second needle 1912b relative to a cavity of the housing 1902 in response to actuating the actuator 1914. In this case, the needles 1912a, 1912b may translate distally (e.g., downwardly) toward the first and second receptacles, respectively. The first needle 1912a may be configured to extend into the first vial 10a, thereby establishing fluid communication between the first vial 10a and the first connector 1910a. The second needle 1912b may be configured to extend into the second vial 10b, thereby establishing fluid communication between the second vial 10b and the second connector 1910b. Thus, an external device coupled to each of the first connector 1910a and the second connector 1910b can be fluidly coupled to the first vial 10a and the second vial 10b, respectively.

[0188] 42, an exemplary adapter 2000 is shown. The adapter 2000 may be configured and operable to hold and facilitate independent delivery of contents stored in two or more co-housed syringes via respective actuators coupled to each syringe. The adapter 2000 includes a housing 2002 having a longitudinal length defined between a distal end 2004 and a proximal end 2006. The housing 2002 may be sized and shaped to define a first receptacle 2001a for receiving a first syringe 50a and a second receptacle 2001b for receiving a second syringe 50b. The first and second syringes 50a, 50b may be pre-filled syringes. In this example, the housing 2002 is configured to position the first and second syringes 50a and 50b adjacent to and parallel to one another when received in the first and second receptacles 2001 and 2001b, respectively.

[0189] In this example, at least a portion of the first syringe 50a and the second syringe 50b may extend outwardly from the housing 2002. For example, the distal end 51a and / or needle 52a of the first syringe 50a may be positioned outside the first receptacle 2001a, such as to facilitate delivery of a first substance stored in the first syringe 50a outwardly from the adapter 2000. Additionally, the distal end 51b and / or needle 52b of the second syringe 50b may be positioned outside the second receptacle 2001b, such as to facilitate delivery of a second substance stored in the second syringe 50b outwardly from the adapter 2000. The housing 2002 may be configured to receive at least a portion of the first syringe 50a and the second syringe 50b, such as the plunger rods 56a, 56b and plungers 59a, 59b, respectively, therein.

[0190] 42, the adapter 2000 may include a first actuator 2008a and a second actuator 2008b positioned proximate the proximal end 2006. The first actuator 2008a may be coupled to the plunger rod 56a of the first syringe 50a and configured to translate the plunger rod 56a and plunger 59a relative to the housing 2002 to dispense a fluidic substance (e.g., a medicament) stored in the first syringe 50a.

[0191] The second actuator 2008b may be coupled to the plunger rod 56b of the second syringe 50b and configured to translate the plunger rod 56b and plunger 59b relative to the housing 2002 to dispense a fluidic substance (e.g., a medication) stored in the second syringe 50b. Thus, the adapter 2000 may be configured to enable delivery of the fluidic substances stored in each syringe 50a, 50b independently of one another via selective actuation of the respective actuators 2008a, 2008b.

[0192] 43, an exemplary vial adapter assembly 2100 is shown. The vial adapter assembly 2100 may be configured and operable to hold and facilitate independent access (fluid communication) to two or more vials housed together via actuation of a single actuator. The vial adapter assembly 2100 may include a housing 2102 having a distal end 2104 and a proximal end 2106. The housing 2102 may define a cavity that encloses a first valve assembly 2111a and a second valve assembly 2111b, each of which may be coupled to an actuator 2110 positioned along an exterior of the housing 2102. The first valve assembly 2111a and the second valve assembly 2111b may be, for example, a stopcock valve. As described further below, the actuator 2110 may be configured to transition the valve assemblies 2111a, 2111b from a first configuration to a second configuration.

[0193] The valve adapter assembly 2100 may include a first connector 2108a and a second connector 2108b extending outwardly from the housing 2102 proximate the proximal end 2106. In this example, the first connector 2108a may be in fluid communication with the first valve assembly 2111a and the second connector 2108b may be in fluid communication with the second valve assembly 2111b. In some embodiments, the first connector 2108a and the second connector 2108b may include luer lock connectors configured to couple an external device to the vial adapter assembly 2100, and in particular to the corresponding valve assemblies 2111a, 2111b.

[0194] 43, the first valve assembly 2111a may include a first lever 2112a movably coupled to the actuator 2110, a first channel 2114a fluidly coupled to the first connector 2108a, and a second channel 2116a. The vial adapter assembly 2100 may further include a pair of first clips 2118a disposed within the housing 2102 and configured to engage at least a portion of the first vial 10a, such as the port 19a, to secure the first vial 10a to the first valve assembly 2111a. As described in further detail herein, the first vial 10a may be in fluid communication with at least one of the first channel 2114a and / or the second channel 2116a based on the relative position of the actuator 2110.

[0195] The second valve assembly 2111b may include a second lever 2112b movably coupled to the actuator 2110, a second channel 2114b fluidly coupled to the second connector 2108b, and a second channel 2116b. The vial adapter assembly 2100 may further include a pair of second clips 2118b disposed within the housing 2102 and configured to engage at least a portion of the second vial 10b, such as the port 19b, to secure the second vial 10b to the second valve assembly 2111b. The second vial 10b may be in fluid communication with at least one of the first channel 2114b and / or the second channel 2116b based on the relative position of the actuator 2110.

[0196] 43, the actuator 2110 may be configured to simultaneously adjust the fluid pathways of the first vial 10a and the second vial 10b to the respective channels of each valve assembly 2111a, 2111b. For example, the actuator 2110 may be configured to cause the first vial assembly 2111a to fluidly couple the first vial 10a to one of the first channel 2114a or the second channel 2116a. At the same time, the actuator 2110 may be configured to cause the second vial assembly 2111a to fluidly couple the second vial 10b to one of the first channel 2114b or the second channel 2116b. Thus, rotation of the actuator 2110 may provide simultaneous actuation of the first vial assembly 2111a and the second vial assembly 2111b.

[0197] In some embodiments, the first valve assembly 2111a may be configured to divert a fluidic material from the first vial 10a to an external device coupled to the first connector 2108a when in fluid communication with the first channel 2114a. Additionally, the first valve assembly 2111a may be configured to divert a fluidic material away from the first vial 10a, for example to a closed end of the second channel 2116a. The second valve assembly 2111b may be configured to divert a fluidic material from the second vial 10b to an external device coupled to the second connector 2108b when in fluid communication with the second channel 2114b. Additionally, the second valve assembly 2111b may be configured to divert a fluidic material away from the second vial 10b, for example to a closed end of the second channel 2116b. Each of the first valve assembly 2111a and the second valve assembly 2111b may be further configured to simultaneously seal fluid communication between both corresponding channels. For example, rotation of the actuator 2110 to a predetermined position may prevent each of the first vial 10a and the second vial 10b from fluid communication with either of the channels 2114, 2116.

[0198] In one embodiment, the actuator 2110 may be configured to simultaneously close the first valve assembly 2111a and the second valve assembly 2111b when the actuator 2110 is in a first rotational position, open the first valve assembly 2111a and close the second valve assembly 2111b when the actuator 2110 is in a second rotational position, and close the first valve assembly 2111a and open the second valve assembly 2111b when the actuator 2110 is in a third rotational position. It should be understood that each of the first, second, and third rotational positions are relative to the housing 2102 and may each be different from one another. In some embodiments, the actuator 2110 may be configured to open both the first valve assembly 2111a and the second valve assembly 2111b when the actuator 2110 is in a fourth rotational position.

[0199] 44, an exemplary vial adapter assembly 2200 is shown. The vial adapter assembly 2200 may be configured and operable to facilitate access (fluid communication) to vials of different sizes. The vial adapter assembly 2200 may include a body 2202 having a first pair of clips 2204 and a second pair of clips 2206 positioned distally relative to the first pair of clips 2204. The first pair of clips 2204 may be configured to engage at least a portion of the sleeve 40, and the second pair of clips 2206 may be configured to engage at least a portion of the vial 10, such as a neck portion below the mouth 19.

[0200] The vial adapter assembly 2200 may be configured and operable to couple the sleeve 40 to a vial 10 having a particular size and / or shape. The vial adapter assembly 2200 may include multiple bodies having pairs of second clips of different sizes, shapes, and / or configurations than those shown and described herein for coupling the sleeve 40 to different vials having various cross-sectional dimensions. Thus, the vial adapter assembly 2200 may be configured to couple vials of various sizes.

[0201] 44, the first pair of clips 2204 may define a universal fastening pattern that may be attached to a variety of sleeves 40. The second pair of clips 2206 may be formed of plastic and operable to form a snap-fit ​​connection with the shoulder 19 to secure the first vial 10 to the sleeve 40. In some embodiments, the sleeve 40 may include a portion of a syringe, cartridge, vial, and / or various other devices.

[0202] 45, an exemplary crimp assembly 2300 is shown. The crimp assembly 2300 may be configured and operable to facilitate access (fluid communication) to a vial through a crimp and a stopper coupled to the crimp. The crimp assembly 2300 may include a crimp 2302 and a stopper 2306. The stopper 2306 may fit within an opening of the vial 10 to control access to the vial 10. The stopper 2306 may include one or more proximal arms 2305 extending proximally from a body of the stopper 2306 to secure the stopper 2306 within the vial 10, and one or more distal arms 2308 extending distally from a body of the stopper 2306. The one or more distal arms 2308 may be configured to mate with the vial 10, particularly the mouth 19, to couple the stopper 2306 to the vial 10. For example, one or more distal arms 2308 may extend through the opening of the mouth 19 into the vial 10, thereby forming a seal against the opening of the vial 10. The stopper 2306 may be a flexible material, such as rubber. An additional crimp (not shown) may also extend over the stopper 2306 to further secure it to the vial 10. The additional crimp may be metal or plastic.

[0203] The crimp assembly 2300 may further include a crimp 2302 having a body and one or more arms 2304 extending distally from the body of the crimp 2302. The crimp 2302 may be configured to cover and seal the stopper 2306 when attached to the stopper 2306. In this example, the crimp 2302 may be at least partially flexible and formed of plastic. The one or more proximal arms 2305 of the stopper 2306 may be configured to mate with the one or more arms 2304 of the crimp 2302 to couple the stopper 2306 to the crimp 2302.

[0204] 45, the stopper 2306 may be configured to allow access into the vial 10, such as, for example, via a channel 2309 extending through the body of the stopper 2306. With the crimp 2302 coupled to the stopper 2306, the crimp 2302 may be configured to close the channel 2309, thereby maintaining the sterility of the vial 10. The crimp 2302 may be selectively removable from the stopper 2306, for example, to facilitate access to the vial 10 by an external device (e.g., a syringe), etc. The crimp assembly 2300 may eliminate the need for terminal sterilization prior to use with an external device.

[0205] 46, an exemplary crimp assembly 2400 is shown. The crimp assembly 2400 may be configured and operable to facilitate access (fluid communication) to a vial through a connector capable of coupling an external device (e.g., a syringe). The crimp assembly 2400 may include a crimp 2402, a stopper 2406, and a peel tab 2410. The crimp 2402 may include a body having a connector 2403 at a proximal end and a plurality of openings 2404, 2405 at a distal end. In this example, the crimp 2402 may include at least a first opening 2404 and a second opening 2405. The location of the first opening 2404 relative to the body of the crimp 2402 may be offset laterally and / or longitudinally from the location of the second opening 2406 on the body of the crimp 2402. In other embodiments, the crimp 2402 may include additional openings along its distal end other than those shown and described herein, or may only include one opening.

[0206] The body of the crimp 2402 may further define a channel 2401 extending along a proximal end of the crimp 2402, with each of the plurality of openings 2404, 2405 in fluid communication with the channel 2401. The opening of the channel 2401 at the proximal end of the crimp 2402 may be covered by a peel-off tab 2410 coupled thereto. The peel-off tab 2410 may be configured to form a seal against the crimp 2402 and close the opening of the channel 2401, thereby maintaining the sterility of the crimp 2402. As described herein, the channel 2401 and openings 2404, 2405 may be configured to facilitate fluid communication between an external device and the vial 10.

[0207] 46, the connector 2403 may include a luer lock connector configured to couple the crimp 2402 to an external device, such as a syringe, upon removal of the peel tab 2410 from the proximal end of the crimp 2402. The stopper 2406 may include a body 2408 configured to extend into the vial 10, such as through an opening in the port 19. In this example, the stopper 2406 may be configured to form a seal against the port 19, thereby maintaining the sterility of the vial 10. The body 2408 may be sized and shaped to receive at least a portion of the crimp 2402, such as the distal end of the crimp 2402. In this case, the multiple openings 2404, 2405 may be at least partially disposed in the body 2408.

[0208] In the first configuration, the crimp 2402 may be positioned relative to the stopper 2406 such that one or more of the first opening 2404 and the second opening 2405 may be sealed relative to the body 2408 such that the channel 2401 is not in fluid communication with the vial 10. The crimp 2402 may be configured to move (e.g., rotate) relative to the stopper 2406 from the first configuration to the second configuration in response to, for example, simultaneous movement of an external device coupled to the crimp 2402 via the connector 2403.

[0209] In the second configuration, the first opening 2404 and the second opening 2405 may be repositioned relative to the stopper 2406 such that the body 2408 does not abut one or more of the first opening 2404 and / or the second opening 2405. In this case, the crimp 2402 may be configured to facilitate fluid communication between an external device and the vial 10 via the openings 2404, 2405 and the channel 2401.

[0210] The features listed above are described within the context of specific embodiments, however, as one of ordinary skill in the art will appreciate, the features and aspects of each embodiment may be combined, added to other embodiments, removed from embodiments, etc., in any manner suitable to aid in the controlled preparation and / or delivery of a drug.

[0211] Aspects of the embodiments disclosed herein are described with respect to assembling together multiple vials and / or cartridges storing different fluidic substances (e.g., medicaments), and some embodiments disclosed herein are described as specific types of drug delivery devices (e.g., syringes, pipettes, crimps). Aspects of the present disclosure may also be employed and / or used with other types of devices.

[0212] While several embodiments are presented herein, it is contemplated that multiple variations on such embodiments, and combinations of elements from one or more embodiments, are possible and are within the scope of the present disclosure. Moreover, those skilled in the art will appreciate that the conception on which the present disclosure is based may be readily used as a basis for the designing of other devices, methods, and systems for carrying out the several purposes of the present disclosure.

[0213] Implementations of the present disclosure may include the following features. Item 1. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial within a body of the housing, an opening of the first receptacle in fluid communication with a top surface of the housing; a second receptacle formed within the housing and configured to at least partially receive a second vial within the body of the housing, an opening of the second receptacle in fluid communication with the top surface of the housing; a cap coupled to the housing, the cap being movable relative to the housing from a closed configuration to an open configuration, in the closed configuration, the cap is configured to cover the opening of the first receptacle and the opening of the second receptacle on the top surface of the housing; A vial adapter assembly, wherein in the open configuration, the cap is configured to expose the opening of the first receptacle and the opening of the second receptacle and to expose the top surface of the housing.

[0214] Item 2. The vial adapter assembly of item 1, wherein the housing includes at least one slot in the top surface of the housing and the cap includes at least one corresponding protrusion extending outwardly from a surface of the cap configured to mate with the top surface of the housing.

[0215] Item 3. The vial adapter assembly of item 2, wherein in the closed configuration, each of the at least one slot is configured to receive one of the at least one corresponding protrusion.

[0216] Item 4. The vial adapter assembly of item 2, wherein in the open configuration, each of the at least one protrusion is configured to deform such that the cap is prevented from transitioning from the open configuration to the closed configuration.

[0217] Item 5. The first receptacle includes a second opening along a bottom portion of the housing, and the second receptacle includes a second opening along the bottom portion; 2. The vial adapter assembly of claim 1, wherein the first openings of the first and second receptacles are smaller in size than the second openings of the first and second receptacles.

[0218] Item 6. The second openings of the first receptacle and the second receptacle are sized to receive the first vial and the second vial, respectively; 6. The vial adapter assembly of claim 5, wherein the first openings of the first receptacle and the second receptacle are positioned to align with first and second openings of the first and second vials, respectively, when the first and second vials are received in the first and second receptacles.

[0219] Item 7. The vial adapter assembly of item 1, wherein the first receptacle is positioned adjacent to the second receptacle such that the first vial is maintained side-by-side with the second vial when the first vial is received within the housing.

[0220] Item 8. The vial adapter assembly of item 1, further comprising a single hinge connecting the housing to the cap, the hinge configured to pivot the cap relative to the housing upon movement from the closed configuration to the open configuration.

[0221] Item 9. The vial adapter assembly of item 1, wherein the cap is configured to simultaneously cover the opening of the first receptacle and the opening of the second receptacle when in the closed configuration and to simultaneously expose the opening of the first receptacle and the opening of the second receptacle when in the open configuration.

[0222] Item 10. The vial adapter assembly of item 1, wherein the housing is configured to at least partially surround the first vial and the second vial such that the first vial and the second vial are positioned adjacent to one another.

[0223] Item 11. The vial adapter assembly of item 1, further comprising an actuator positioned over an opening of the first receptacle and an opening of the second receptacle.

[0224] Item 12. The vial adapter assembly of item 11, wherein the actuator includes a first hollow piercing element extending toward the first receptacle and a second hollow piercing element extending toward the second receptacle.

[0225] Item 13. The vial adapter assembly of item 12, wherein the actuator is configured to simultaneously move the first hollow piercing element relative to the first receptacle and the second hollow piercing element relative to the second receptacle.

[0226] Item 14. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial; a second receptacle formed within the housing and configured to at least partially receive a second vial; a first actuator coupled to the housing and positioned in longitudinal alignment with the first receptacle, the first actuator adapted to be positioned over an opening of the first receptacle and including a hollow piercing element extending toward the first receptacle; a second actuator coupled to the housing and positioned in longitudinal alignment with the second receptacle, the second actuator adapted to be positioned over an opening of the second receptacle and including a hollow piercing element extending toward the second receptacle, each of the first actuator and the second actuator is independently movable relative to the housing between an extended configuration and a compressed configuration; in the extended configuration, the piercing element of the first actuator and the piercing element of the second actuator are positioned outside the first receptacle and the second receptacle, respectively, such that the piercing element of the first actuator and the piercing element of the second actuator are not in fluid communication with the first receptacle and the second receptacle; a vial adapter assembly, wherein in the compressed configuration, the piercing element of the first actuator and the piercing element of the second actuator are at least partially positioned within the first receptacle and the second receptacle, respectively, such that the piercing element of the first actuator and the piercing element of the second actuator are in fluid communication with the first receptacle and the second receptacle, respectively.

[0227] Item 15. A first removable barrier coupled to the housing and positioned between the first actuator and the first receptacle; Item 15. The vial adapter assembly of item 14, further comprising: a second removable barrier coupled to the housing and positioned between the second actuator and the second receptacle.

[0228] Item 16. The vial adapter assembly of item 15, wherein the first removable barrier and the second removable barrier comprise adhesive liners. Item 17. The vial adapter assembly of item 12, wherein the housing includes a first slot and a second slot, the first slot and the second slot sized to receive at least one of the first removable barrier and the second removable barrier.

[0229] Item 18. The first removable barrier is configured to prevent movement of the first actuator from the extended configuration to the compressed configuration when the first removable barrier is received in the first slot; Item 18. The vial adapter assembly of item 17, wherein the second removable barrier is configured to prevent movement of the second actuator from the extended configuration to the compressed configuration when the second removable barrier is received in the second slot.

[0230] Item 19. The vial adapter assembly of item 18, wherein the first removable barrier and the second removable barrier are configured to be independently removable with respect to the housing.

[0231] Item 20. The vial adapter assembly of item 14, wherein the first actuator and the second actuator each include a luer lock connector. Item 21. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial; a first connector secured to the housing, a distal end of the first connector positioned at least partially within the first receptacle such that a distal end of the first connector extends into and is in fluid communication with the first vial when received in the first receptacle; a second receptacle formed within the housing and configured to at least partially receive a second vial; a second connector secured to the housing, a distal end of the second connector positioned at least partially within the second receptacle such that a distal end of the second connector extends into and is in fluid communication with the second vial when received in the second receptacle; a first actuator coupled to the housing and positioned in longitudinal alignment with the first receptacle; a second actuator coupled to the housing and positioned in longitudinal alignment with the second receptacle, each of the first actuator and the second actuator being independently movable relative to the housing between an extended configuration and a compressed configuration; when the first actuator and the second actuator are in the extended configuration, the first actuator and the second actuator conceal proximal regions of the first connector and the second connector, respectively; a vial adapter assembly, wherein the first actuator and the second actuator expose the proximal regions of the first connector and the second connector, respectively, when the first actuator and the second actuator are in the compressed configuration;

[0232] Item 22. The vial adapter assembly of item 21, further comprising a first removable barrier coupled to the first actuator and a second removable barrier coupled to the second actuator when the first actuator and the second actuator are in the extended configuration.

[0233] Item 23. The vial adapter assembly of item 22, wherein the first removable barrier and the second removable barrier comprise at least one of an adhesive liner or a cap.

[0234] Item 24. The vial adapter assembly of item 22, wherein the first removable barrier is positioned over a proximal end of the first connector when coupled to the first actuator, and the second removable barrier is positioned over a proximal end of the second connector when coupled to the second actuator.

[0235] Item 25. The vial adapter assembly of item 22, further comprising a first lockout mechanism configured to prevent the first actuator from returning to the extended configuration from the compressed configuration, and a second lockout mechanism configured to prevent the second actuator from returning to the extended configuration from the compressed configuration.

[0236] Item 26. The vial adapter assembly of item 21, wherein the proximal region of the first connector extends outwardly from the first actuator when the first actuator is in the compressed configuration, and the proximal region of the second connector extends outwardly from the second actuator when the second actuator is in the compressed configuration.

[0237] Item 27. The vial adapter assembly of item 26, wherein the first removable barrier and the second removable barrier are configured to be independently movable relative to the housing.

[0238] Item 28. The vial adapter assembly of item 21, wherein a proximal region of each of the first connector and the second connector includes a luer lock. Item 29. Housing and a first receptacle formed in the housing, the first receptacle configured to receive a first vial therein; a first connector movably coupled to the housing and positioned at least partially within the first receptacle, the first connector including a first channel defining a first flow path; a second receptacle formed in the housing, the second receptacle configured to receive a second vial therein; a second connector movably coupled to the housing and positioned at least partially within the second receptacle, the second connector including a second channel defining a second flow path; the first connector and the second connector are each configured to move independently relative to the housing between a first configuration and a second configuration; In the first embodiment, the first flow path is blocked and the second flow path is blocked, In the second configuration, the first flow path is unobstructed and the second flow path is unobstructed.

[0239] Item 30. The vial adapter assembly of item 29, further including a first stopper extending around a distal region of the first connector in the first receptacle and a second stopper extending around a distal region of the second connector in the second receptacle.

[0240] Item 31. The vial adapter assembly of item 29, wherein the first flow path extends through a side wall of a distal region of the first connector and the second flow path extends through a side wall of a distal region of the second connector.

[0241] Item 32. The vial adapter assembly of item 31, further comprising a first stopper extending around a distal region of the first connector in the first receptacle and a second stopper extending around a distal region of the second connector in the second receptacle, a portion of the first stopper configured to block the first flow path when the first connector is in the first configuration, and a second stopper configured to block a second flow path when the second connector is in the first configuration.

[0242] Item 33. The first connector is configured to rotate relative to the housing when transitioning from the first configuration to the second configuration; Item 33. The vial adapter assembly of item 32, wherein the second connector is configured to rotate relative to the housing when transitioning from the first configuration to the second configuration.

[0243] Item 34. The vial adapter assembly of item 29, wherein the first connector and the second connector are each configured to independently rotate relative to the housing between the first configuration and the second configuration.

[0244] Item 35. The vial adapter assembly of item 29, wherein each of the first connector and the second connector includes a proximal region extending proximally from the housing and is configured to be independently movable relative to the housing.

[0245] Item 36. The vial adapter assembly of item 29, wherein the first connector and the second connector each include a proximal region configured to couple to an external device.

[0246] Item 37. The vial adapter assembly of item 36, wherein the proximal region configured to couple to the external device comprises a luer lock. Item 38. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial within a body of the housing, an opening of the first receptacle in fluid communication with a top surface of the housing; a cap coupled to the housing, the cap including a hollow piercing element and movable relative to the housing from a closed configuration to an open configuration, the cap configured to cover the opening of the first receptacle on the top surface of the housing in the closed configuration, and the cap configured to uncover the opening of the first receptacle and expose the top surface of the housing in the open configuration; and an external device coupled to the housing.

[0247] Item 39. The vial adapter assembly of item 38, further comprising a second receptacle formed within the housing and configured to at least partially receive a second vial within the body of the housing, an opening of the second receptacle in fluid communication with the top surface of the housing.

[0248] Item 40. The vial adapter assembly of item 38, wherein the hollow piercing element extends distally from an inner surface of the cap. Item 41. The vial adapter assembly of item 38, wherein the cap includes a proximal region configured to couple to the external device.

[0249] Item 42. The vial adapter assembly of item 40, wherein the proximal region configured to couple to the external device includes a connector extending proximally from an outer surface of the cap.

[0250] Item 43. The vial adapter assembly of item 42, wherein the connector is a luer lock. Item 44. The vial adapter assembly of item 38, wherein the external device is a syringe or an IV bag.

[0251] Item 45. Housing and a first cartridge in the housing, the first cartridge containing a first substance; a second cartridge in the housing, the second cartridge containing a second substance; and a first actuator coupled to the housing and positioned in longitudinal alignment with the first cartridge; a second actuator coupled to the housing and positioned in longitudinal alignment with the second cartridge, each of the first actuator and the second actuator being independently movable relative to the housing between an extended configuration and a compressed configuration; In the extended configuration, a portion of the first actuator extends outwardly from the housing in a proximal direction and a portion of the second actuator extends outwardly from the housing in a proximal direction; A vial adapter assembly, wherein in the compressed configuration, a portion of the first actuator is concealed within the first cartridge and a portion of the second actuator is concealed within the second cartridge.

[0252] Item 46. The vial adapter assembly of item 45, comprising a third cartridge in the housing, the third cartridge containing a third substance, and a third actuator coupled to the housing and in longitudinal alignment with the third cartridge.

[0253] Item 47. The vial adapter assembly of item 46, wherein in the extended configuration, a portion of the third actuator extends proximally outward from the housing, and in the compressed configuration, a portion of the third actuator is hidden within the third cartridge.

[0254] Item 48. The vial adapter assembly of item 47, wherein the housing includes a proximal end and a distal tip. Item 49. The vial adapter assembly of item 48, wherein a first actuation translates a distal end of each cartridge toward the distal tip of the housing and a second actuation delivers a substance stored in each cartridge.

[0255] Item 50. The vial adapter assembly of item 49, wherein the first actuation causes the distal end of the respective cartridge to translate outwardly from the housing through an opening in the distal tip.

[0256] Item 51. The vial adapter assembly of item 45, wherein the distal tip of the housing is configured to connect to an external device. Item 52. The vial adapter assembly of item 51, wherein the distal tip includes a luer lock connection.

[0257] Item 53. The vial adapter assembly of item 51, wherein the external device is a syringe or an IV bag. Item 54. The vial adapter assembly of item 45, wherein the housing includes a first receptacle that contains the first cartridge and a second receptacle that contains the second cartridge.

[0258] Item 55. The vial adapter assembly of item 54, wherein the first cartridge is a first syringe and the second cartridge is a second syringe. Item 56. The vial adapter assembly of item 55, wherein the first syringe includes a first needle extending from a distal end of the first syringe and the second syringe includes a first needle extending from a distal end of the second syringe.

Claims

1. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial within a body of the housing, an opening of the first receptacle in fluid communication with a top surface of the housing; a second receptacle formed within the housing and configured to at least partially receive a second vial within the body of the housing, an opening of the second receptacle in fluid communication with the top surface of the housing; a cap coupled to the housing, the cap being movable relative to the housing from a closed configuration to an open configuration, in the closed configuration, the cap is configured to cover the opening of the first receptacle and the opening of the second receptacle on the top surface of the housing; A vial adapter assembly, wherein in the open configuration, the cap is configured to uncover the opening of the first receptacle and the opening of the second receptacle and expose the top surface of the housing.

2. 2. The vial adapter assembly of claim 1, wherein the housing includes at least one slot in the top surface of the housing and the cap includes at least one corresponding protrusion extending outwardly from a surface of the cap configured to mate with the top surface of the housing.

3. 3. The vial adapter assembly of claim 2, wherein in the closed configuration, each of the at least one slot is configured to receive one of the at least one corresponding protrusion.

4. 3. The vial adapter assembly of claim 2, wherein in the open configuration, each of the at least one projection is configured to deform such that the cap is prevented from transitioning from the open configuration to the closed configuration.

5. the first receptacle includes a second opening along a bottom portion of the housing, and the second receptacle includes a second opening along the bottom portion; 2. The vial adapter assembly of claim 1, wherein said first openings of said first and second receptacles are smaller in size than said second openings of said first and second receptacles.

6. the second openings of the first and second receptacles being sized to receive the first and second vials, respectively; 6. The vial adapter assembly of claim 5, wherein the first openings of the first receptacle and the second receptacle are positioned to align with first and second openings of the first and second vials, respectively, when the first and second vials are received in the first and second receptacles.

7. 2. The vial adapter assembly of claim 1, wherein the first receptacle is positioned adjacent to the second receptacle such that the first vial is maintained side-by-side with the second vial when the first vial is received in the housing.

8. 10. The vial adapter assembly of claim 1, further comprising a single hinge coupling said housing to said cap, said hinge configured to pivot said cap relative to said housing upon movement from said closed configuration to said open configuration.

9. 2. The vial adapter assembly of claim 1, wherein the cap is configured to simultaneously cover the opening of the first receptacle and the opening of the second receptacle when in the closed configuration and to simultaneously expose the opening of the first receptacle and the opening of the second receptacle when in the open configuration.

10. 2. The vial adapter assembly of claim 1, wherein the housing is configured to at least partially surround the first vial and the second vial such that the first vial and the second vial are positioned adjacent to one another.

11. 10. The vial adapter assembly of claim 1, further comprising an actuator positioned over an opening of said first receptacle and an opening of said second receptacle.

12. 12. The vial adapter assembly of claim 11, wherein the actuator includes a first hollow piercing element extending toward the first receptacle and a second hollow piercing element extending toward the second receptacle.

13. 13. The vial adapter assembly of claim 12, wherein the actuator is configured to simultaneously move the first hollow piercing element relative to the first receptacle and the second hollow piercing element relative to the second receptacle.

14. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial; a second receptacle formed within the housing and configured to at least partially receive a second vial; and a first actuator coupled to the housing and positioned in longitudinal alignment with the first receptacle, the first actuator adapted to be positioned over an opening of the first receptacle and including a hollow piercing element extending toward the first receptacle; a second actuator coupled to the housing and positioned in longitudinal alignment with the second receptacle, the second actuator adapted to be positioned over an opening of the second receptacle and including a hollow piercing element extending toward the second receptacle, each of the first actuator and the second actuator is independently movable relative to the housing between an extended configuration and a compressed configuration; in the extended configuration, the piercing element of the first actuator and the piercing element of the second actuator are positioned outside the first receptacle and the second receptacle, respectively, such that the piercing element of the first actuator and the piercing element of the second actuator are not in fluid communication with the first receptacle and the second receptacle; a vial adapter assembly, wherein in the compressed configuration, the piercing element of the first actuator and the piercing element of the second actuator are at least partially positioned within the first receptacle and the second receptacle, respectively, such that the piercing element of the first actuator and the piercing element of the second actuator are in fluid communication with the first receptacle and the second receptacle, respectively.

15. a first removable barrier coupled to the housing and positioned between the first actuator and the first receptacle; 15. The vial adapter assembly of claim 14, further comprising: a second removable barrier coupled to said housing and positioned between said second actuator and said second receptacle.

16. 16. The vial adapter assembly of claim 15, wherein the first removable barrier and the second removable barrier comprise adhesive liners.

17. 13. The vial adapter assembly of claim 12, wherein the housing includes a first slot and a second slot, the first slot and the second slot sized to receive at least one of the first removable barrier and the second removable barrier.

18. the first removable barrier configured to prevent movement of the first actuator from the extended configuration to the compressed configuration when the first removable barrier is received in the first slot; 18. The vial adapter assembly of claim 17, wherein the second removable barrier is configured to prevent movement of the second actuator from the extended configuration to the compressed configuration when the second removable barrier is received in the second slot.

19. 20. The vial adapter assembly of claim 18, wherein the first removable barrier and the second removable barrier are configured to be independently removable relative to the housing.

20. 15. The vial adapter assembly of claim 14, wherein the first actuator and the second actuator each include a luer lock connector.

21. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial; a first connector secured to the housing, a distal end of the first connector positioned at least partially within the first receptacle such that a distal end of the first connector extends into and is in fluid communication with the first vial when received in the first receptacle; a second receptacle formed within the housing and configured to at least partially receive a second vial; and a second connector secured to the housing, a distal end of the second connector positioned at least partially within the second receptacle such that a distal end of the second connector extends into the second vial when received in the second receptacle and is in fluid communication with the second vial; a first actuator coupled to the housing and positioned in longitudinal alignment with the first receptacle; a second actuator coupled to the housing and positioned in longitudinal alignment with the second receptacle, each of the first actuator and the second actuator being independently movable relative to the housing between an extended configuration and a compressed configuration; when the first actuator and the second actuator are in the extended configuration, the first actuator and the second actuator conceal proximal regions of the first connector and the second connector, respectively; a vial adapter assembly, wherein the first actuator and the second actuator expose the proximal regions of the first connector and the second connector, respectively, when the first actuator and the second actuator are in the compressed configuration.

22. 22. The vial adapter assembly of claim 21, further comprising a first removable barrier coupled to the first actuator and a second removable barrier coupled to the second actuator when the first actuator and the second actuator are in the extended configuration.

23. 23. The vial adapter assembly of claim 22, wherein the first removable barrier and the second removable barrier comprise at least one of an adhesive liner or a cap.

24. 23. The vial adapter assembly of claim 22, wherein the first removable barrier is positioned over a proximal end of the first connector when coupled to the first actuator, and the second removable barrier is positioned over a proximal end of the second connector when coupled to the second actuator.

25. 23. The vial adapter assembly of claim 22, further comprising a first lockout mechanism configured to prevent the first actuator from returning to the extended configuration from the compressed configuration, and a second lockout mechanism configured to prevent the second actuator from returning to the extended configuration from the compressed configuration.

26. 22. The vial adapter assembly of claim 21, wherein the proximal region of the first connector extends outwardly from the first actuator when the first actuator is in the compressed configuration and the proximal region of the second connector extends outwardly from the second actuator when the second actuator is in the compressed configuration.

27. 27. The vial adapter assembly of claim 26, wherein the first removable barrier and the second removable barrier are configured to be independently movable relative to the housing.

28. 22. The vial adapter assembly of claim 21, wherein the proximal region of each of the first connector and the second connector includes a luer lock.

29. Housing and a first receptacle formed in the housing, the first receptacle configured to receive a first vial therein; a first connector movably coupled to the housing and positioned at least partially within the first receptacle, the first connector including a first channel defining a first flow path; a second receptacle formed in the housing, the second receptacle configured to receive a second vial therein; a second connector movably coupled to the housing and positioned at least partially within the second receptacle, the second connector including a second channel defining a second flow path; the first connector and the second connector are each configured to move independently relative to the housing between a first configuration and a second configuration; In the first mode, the first flow path is blocked and the second flow path is blocked, In the second configuration, the first flow path is unobstructed and the second flow path is unobstructed.

30. 30. The vial adapter assembly of claim 29, further comprising a first stopper extending around a distal region of the first connector in the first receptacle and a second stopper extending around a distal region of the second connector in the second receptacle.

31. 30. The vial adapter assembly of claim 29, wherein the first flow path extends through a sidewall of a distal region of the first connector and the second flow path extends through a sidewall of a distal region of the second connector.

32. 32. The vial adapter assembly of claim 31, further comprising a first stopper extending around the distal region of the first connector in the first receptacle and a second stopper extending around the distal region of the second connector in the second receptacle, a portion of the first stopper configured to block the first fluid path when the first connector is in the first configuration and a second stopper configured to block a second fluid path when the second connector is in the first configuration.

33. the first connector is configured to rotate relative to the housing when transitioning from the first configuration to the second configuration; 33. The vial adapter assembly of claim 32, wherein the second connector is configured to rotate relative to the housing when transitioning from the first configuration to the second configuration.

34. 30. The vial adapter assembly of claim 29, wherein the first connector and the second connector are each configured to independently rotate relative to the housing between the first configuration and the second configuration.

35. 30. The vial adapter assembly of claim 29, wherein the first connector and the second connector each include a proximal region extending proximally from the housing and are configured to be independently movable relative to the housing.

36. 30. The vial adapter assembly of claim 29, wherein the first connector and the second connector each include a proximal region configured to couple to an external device.

37. 37. The vial adapter assembly of claim 36, wherein the proximal region configured to couple to the external device comprises a luer lock.

38. Housing and a first receptacle formed within the housing and configured to at least partially receive a first vial within a body of the housing, an opening of the first receptacle in fluid communication with a top surface of the housing; a cap coupled to the housing, the cap including a hollow piercing element and movable relative to the housing from a closed configuration to an open configuration, the cap configured to cover the opening of the first receptacle on the top surface of the housing in the closed configuration, and the cap configured to uncover the opening of the first receptacle and expose the top surface of the housing in the open configuration; and an external device coupled to the housing.

39. 40. The vial adapter assembly of claim 38, further comprising a second receptacle formed within the housing and configured to at least partially receive a second vial within the body of the housing, an opening of the second receptacle in fluid communication with the top surface of the housing.

40. 40. The vial adapter assembly of claim 38, wherein the hollow piercing element extends distally from an inner surface of the cap.

41. 40. The vial adapter assembly of claim 38, wherein the cap includes a proximal region configured to couple to the external device.

42. 41. The vial adapter assembly of claim 40, wherein the proximal region configured to couple to the external device includes a connector extending proximally from an exterior surface of the cap.

43. 43. The vial adapter assembly of claim 42, wherein said connector is a luer lock.

44. 40. The vial adapter assembly of claim 38, wherein the external device is a syringe or an IV bag.

45. Housing and a first cartridge in the housing, the first cartridge containing a first substance; a second cartridge in the housing, the second cartridge containing a second substance; and a first actuator coupled to the housing and positioned in longitudinal alignment with the first cartridge; a second actuator coupled to the housing and positioned in longitudinal alignment with the second cartridge, each of the first actuator and the second actuator being independently movable relative to the housing between an extended configuration and a compressed configuration; In the extended configuration, a portion of the first actuator extends outwardly from the housing in a proximal direction and a portion of the second actuator extends outwardly from the housing in a proximal direction; a vial adapter assembly, wherein in the compressed configuration, a portion of the first actuator is concealed within the first cartridge and a portion of the second actuator is concealed within the second cartridge.

46. 46. ​​The vial adapter assembly of claim 45 comprising a third cartridge in the housing, the third cartridge containing a third substance, and a third actuator coupled to the housing and in longitudinal alignment with the third cartridge.

47. 47. The vial adapter assembly of claim 46, wherein in the extended configuration, a portion of the third actuator extends proximally outward from the housing and, in the compressed configuration, a portion of the third actuator is concealed within the third cartridge.

48. 48. The vial adapter assembly of claim 47, wherein the housing includes a proximal end and a distal tip.

49. 49. The vial adapter assembly of claim 48, wherein a first actuation translates a distal end of each cartridge toward the distal tip of the housing and a second actuation delivers a substance stored in each cartridge.

50. 50. The vial adapter assembly of claim 49, wherein said first actuation causes said distal end of said respective cartridge to translate outwardly from said housing through an opening in said distal tip.

51. 46. ​​The vial adapter assembly of claim 45, wherein the distal tip of the housing is configured to connect to an external device.

52. 52. The vial adapter assembly of claim 51, wherein said distal tip comprises a luer lock connection.

53. 52. The vial adapter assembly of claim 51, wherein the external device is a syringe or an IV bag.

54. 46. ​​The vial adapter assembly of claim 45, wherein the housing includes a first receptacle containing the first cartridge and a second receptacle containing the second cartridge.

55. 55. The vial adapter assembly of claim 54, wherein said first cartridge is a first syringe and said second cartridge is a second syringe.

56. 56. The vial adapter assembly of claim 55, wherein the first syringe includes a first needle extending from a distal end of the first syringe and the second syringe includes a first needle extending from a distal end of the second syringe.

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