Medicinal fluid delivery device

Abstract

To provide a medicinal fluid delivery device, such as a reconstitution device, and related methods of use.SOLUTION: In some embodiments, a reconstitution or medicinal fluid delivery device includes a transfer engine including two fluidly connected spikes, each configured to pierce a container. A check valve may be disposed between the two spikes to allow a unidirectional flow from one container to the other. Physical access to a fluid outlet may be obstructed by a housing until the reconstitution or medicinal fluid delivery device is actuated, and thereafter physical access to the fluid outlet is permitted. The reconstitution or medicinal fluid delivery device may be placed on a flat surface and actuated with force applied in a single direction toward the flat surface.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] Related Applications This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 985,797, filed March 5, 2020, which is incorporated herein by reference in its entirety.

[0002] The disclosed embodiments relate to drug delivery devices, such as reconstitution devices, and related methods of use. [Background technology]

[0003] Medications are administered to patients in a variety of ways. These conventional methods typically include injection with a syringe, ingestion, or delivery with an infusion pump and needle. Controlled amounts of medication are prescribed and delivered by one or more of these methods.

[0004] In some cases, formulations are manufactured in a dehydrated or otherwise unconstituted form, e.g., lyophilized. That is, the drug can be stored and packaged as a dry material that is combined and mixed with water or another reconstitution fluid prior to administration to a patient. In such cases, a predetermined amount of drug and, often, sterile water for injection, are provided for combination by the patient or other healthcare provider immediately prior to administration. Summary of the Invention [Means for solving the problem]

[0005] In some embodiments, systems and methods are provided for administering medicinal liquids to patients. Specifically, a reconstitution system is provided that allows for simplified reconstitution of dry (e.g., powder) formulations. In some embodiments, the system allows for simplified access of liquid pharmaceuticals. In some embodiments, the reconstitution device includes a first flow path including a first open end disposed within the first spike and an opposite end including an air inlet. In some embodiments, the device also includes a second flow path having a second open end disposed within the first spike and a third open end disposed within the second spike. In some embodiments, a valve is disposed within the second flow path between the second and third open ends. In some embodiments, the third flow path includes a fourth open end disposed within the second spike and an opposite end including a fluid outlet. Thus, in some embodiments, the device includes two interconnected dual-lumen spikes that allow fluid transmission from a first container (e.g., containing sterile water) to a second container (e.g., containing a drug for reconstitution). In some embodiments, the fluid outlet may include a luer lock valve, allowing a syringe to be fluidly connected to the fluid outlet and for the reconstituted drug solution to be withdrawn from the device. In some embodiments, the container containing the powdered drug may be configured to include a low or zero pressure vacuum, allowing sterile water or another fluid from another container to be forced into the drug-containing container without manually applying pressure or pumping. In some embodiments, the pressure differential between the drug-containing container and the fluid-containing container is sufficient to cause fluid from the fluid-containing container to be expelled into the drug-containing container, thereby agitating the drug and facilitating reconstitution.

[0006] In some embodiments, the reconstitution device may include a housing having an upper portion and a lower portion, the lower portion being slidably received in the upper portion. In some embodiments, the upper portion may be configured to hold at least two containers, and the lower portion may include at least one spike for each of the at least two containers. In some embodiments, the upper portion may be configured to at least partially surround the at least two containers and selectively hold them away from the spikes in the lower portion. In some embodiments, the upper portion may also be configured to apply a force to the at least two containers when the upper portion slides from a first, inactivated position to a second, activated position. In some embodiments, the at least two containers may be punctured by the spike(s) associated with the containers when the upper portion moves to the activated position. In some embodiments, the containers may be in fluid communication when punctured, thereby allowing fluid from one container to flow to the other container. In some embodiments, the first container may be under vacuum, thereby forcing fluid from the second container into the first container as a result of a pressure differential between the two containers.

[0007] In some embodiments, the reconstitution device includes a first flow path having a first open end and an inlet, a second flow path having a second open end and a third open end, the first and second open ends defining a first container receiving end, a valve disposed along the second flow path between the second and third open ends, and a third flow path having a fourth open end and an outlet, the third and fourth open ends defining the second container receiving end, wherein the first and second container receiving ends face in the same direction.

[0008] In some embodiments, the reconstitution device includes a housing having a lower portion and an upper portion slidably engaging the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position, and a transfer engine disposed within the lower portion of the housing, with a first container receiving end and a second container receiving end facing toward the upper portion of the housing. The reconstitution device also includes a fluid outlet in fluid communication with the second container receiving end of the transfer engine. The upper portion engages the first container and the second container such that the first container and the second container move toward the first container receiving end and the second container receiving end, respectively, when the upper portion moves from the inoperative position to the operative position. When the upper portion is in the inoperative position, physical access to the fluid outlet is at least partially blocked, and when the upper portion is in the operative position, physical access to the fluid outlet is permitted.

[0009] In some embodiments, the reconstitution device includes a housing having a lower portion and an upper portion slidably engaged with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position. The reconstitution device also includes a transfer engine disposed within the lower portion of the housing, with a first container receiving end and a second container receiving end facing toward the upper portion of the housing, the transfer engine and the lower portion being separate components. The reconstitution device also includes a fluid outlet in fluid communication with the second container receiving end of the transfer engine.

[0010] In some embodiments, the reconstitution device includes a housing having a first portion and a second portion movably engaged with the first portion, the first and second portions movable relative to one another between an unactuated configuration and an actuated configuration, a first spike coupled to the second portion of the housing, and a first ring coupled to the first portion of the housing and configured to at least partially surround a shoulder of the first container to hold the first container against the first spike.

[0011] In some embodiments, the drug solution delivery device includes a housing having a lower portion and an upper portion movably engaging the lower portion, the upper portion movable relative to the lower portion between an inactivated position and an activated position, a fluid outlet configured to deliver fluid from a container disposed within the housing when the upper portion is in the activated position, and a marker at least partially obstructed in the inactivated position of the upper portion, the marker being accessible in the activated position of the upper portion.

[0012] In some embodiments, the drug solution delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion, the upper portion movable relative to the lower portion between an inactive position and an active position, a fluid outlet configured to deliver fluid from a container disposed within the housing when the upper portion is in the active position, a communication module configured to transmit messages via at least one communication protocol, and a trigger configured to activate the communication module when the upper portion moves from the inactive position to the active position.

[0013] In some embodiments, a medicinal solution delivery device includes an inlet adapter having an inlet container containing the medicinal solution, an inlet spike configured to puncture the inlet container and receive the medicinal solution from the inlet container, an air inlet, an inlet adapter fluid channel fluidly connected to the inlet spike, and an inlet adapter coupling. The medicinal solution delivery device also includes an intermediate adapter having an intermediate container containing the medicinal solution or medicinal solid, the intermediate spike configured to puncture the intermediate container, a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel, a second intermediate fluid channel fluidly connected to the intermediate spike, a first intermediate adapter coupling configured to connect to the inlet adapter coupling to releasably attach the intermediate adapter to the inlet adapter, and a second intermediate adapter coupling. The medicinal solution delivery device also includes an outlet adapter having an outlet container containing a medicinal solid, an outlet spike configured to puncture the outlet container, an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to a second intermediate fluid channel, an outlet fluidly connected to the outlet spike, and an outlet adapter coupling configured to connect to a second intermediate adapter coupling for releasably attaching the outlet adapter to the intermediate adapter.

[0014] In some embodiments, the drug solution delivery device includes an inlet adapter having an inlet spike configured to puncture the inlet container, an air inlet, an inlet adapter fluid channel fluidly connected to the inlet spike, and an inlet adapter coupling spaced apart from the inlet adapter fluid channel. The drug solution delivery device also includes an intermediate adapter having an intermediate spike configured to puncture the intermediate container, a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel, a second intermediate fluid channel fluidly connected to the intermediate spike, and a first intermediate adapter coupling configured to be received in the inlet adapter coupling to releasably interlock the intermediate adapter with the inlet adapter, wherein the first intermediate adapter coupling and the second intermediate coupling are spaced apart from the first intermediate fluid channel and the second intermediate fluid channel. The drug solution delivery device also includes an outlet adapter having an outlet spike configured to puncture the outlet container, an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to the second intermediate fluid channel, an outlet fluidly connected to the outlet spike, and an outlet adapter coupling configured to be received in the second intermediate adapter coupling and spaced from the outlet adapter fluid channel to releasably interlock the outlet adapter to the intermediate adapter.

[0015] In some embodiments, the reconstitution device includes a housing having a lower portion and an upper portion slidably engaged with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position. The drug solution delivery device may include a transfer engine disposed within the lower portion of the housing, with a first container receiving end facing toward the upper portion of the housing, and a fluid outlet in fluid communication with the transfer engine. The upper portion may be configured to engage with the first container, such that the first container moves toward the first container receiving end when the upper portion moves from the inoperative position to the operative position. Physical access to the fluid outlet may be at least partially obstructed when the upper portion is in the inoperative position. Physical access to the fluid outlet may be permitted when the upper portion is in the operative position.

[0016] In some embodiments, the drug solution delivery device includes an inlet adapter having an inlet spike configured to puncture the inlet container, an air inlet, and an inlet adapter fluid channel fluidly connected to the inlet spike. The drug solution delivery device may also include an intermediate adapter having an intermediate spike configured to puncture the intermediate container, a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel, and a second intermediate fluid channel fluidly connected to the intermediate spike. The drug solution delivery device may also include an outlet adapter having an outlet spike configured to puncture the outlet container, an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to the second intermediate fluid channel, and an outlet fluidly connected to the outlet spike. The drug solution delivery device may also include an adapter plate. The inlet adapter, intermediate adapter, and outlet adapter may be configured to couple to the adapter plate.

[0017] It should be understood that the foregoing concepts, and additional concepts described below, may be arranged in any suitable combination, as the disclosure is not limited in this respect. Furthermore, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. The present invention provides, for example, the following items. (Item 1) a first flow channel having a first open end and an inlet; a second flow path having a second open end and a third open end, the first open end and the second open end defining a first container receiving end; a valve disposed along the second flow path between the second open end and the third open end; a third flow path having a fourth open end and an outlet, the third open end and the fourth open end defining a second container receiving end; the first container receiving end and the second container receiving end face in the same direction; Reconfiguration device. (Item 2) Item 1, wherein the inlet comprises an air filter. (Item 3) 3. The reconstitution device of item 2, wherein the air filter is a hydrophobic air filter. (Item 4) Item 1. The reconstitution device of any of the preceding items, wherein the valve is a one-way valve configured to allow fluid to flow from the second open end toward the third open end. (Item 5) Item 1 or any of the preceding items, wherein the outlet is a luer-activated valve. (Item 6) 5. The reconstitution device of item 1, 2, 3, or 4, wherein the outlet comprises a luer. (Item 7) Item 1 or any of the preceding items, wherein at least a portion of the first flow path extends parallel to at least a portion of the second flow path. (Item 8) Item 1 or any of the preceding items, wherein at least a portion of the second flow path extends parallel to at least a portion of the third flow path. (Item 9) Item 1 or any of the preceding items, further comprising a first spike, wherein a portion of the first flow path extending from the first open end forms a first lumen of the first spike, and a portion of the second flow path extending from the second open end forms a second lumen of the first spike. (Item 10) 10. The reconstitution device of claim 9, further comprising a second spike, wherein a portion of the second flow channel extending from the third open end forms a first lumen of the second spike, and a portion of the third flow channel extending from the fourth open end forms a second lumen of the second spike. (Item 11) Item 11. The reconstitution device of item 10, wherein the third open end is inclined at an angle relative to the puncture direction of the second spike. (Item 12) 12. The reconstruction device of claim 11, wherein the angle is about 90 degrees. (Item 13) Item 1 or any of the preceding items, wherein a portion of each of the first, second, and third flow paths is coplanar. (Item 14) Item 1 or any of the preceding items, further comprising a filter disposed in the third flow path. (Item 15) Item 1 or any of the preceding items, further comprising a first container fluidly connected to the first open end and the second open end, the first container containing a fluid. (Item 16) 16. The reconstitution device of item 15, wherein the fluid is sterile water for injection. (Item 17) Item 16. The reconstitution device of item 15, further comprising a second container fluidly connected to the third open end and the fourth open end, the second container containing a pharmaceutical agent. (Item 18) 18. The reconstitution device of claim 17, wherein the second container contains a vacuum such that the fluid in the first container is at a higher pressure than the pressure inside the second container, urging the fluid to flow from the first container to the second container. (Item 19) 2. The reconstitution device of claim 1, wherein the ratio of the overall length of the device to the overall width of the device is between 3 and 5. (Item 20) Item 1. The reconstitution device of any of the preceding items, wherein the first flow path includes a portion mirrored across the longitudinal axis to form a portion of the second flow path. (Item 21) 21. The reconstitution device of item 20, wherein the second flow path includes a portion mirrored across the longitudinal axis to form the third flow path. (Item 22) Item 1 or any of the preceding items, wherein the inlet is positioned adjacent to the outlet. (Item 23) Item 1 or any of the preceding items, wherein the third flow path is formed at least in part by flexible tubing. (Item 24) Item 1. The reconstitution device of any of the preceding items, wherein the outlet is movable relative to the first container receiving end and the second container receiving end. (Item 25) Item 1 or any of the preceding items, further comprising a filter chamber disposed in the third flow path, the first container receiving end and the second container receiving end being disposed on a first side of the first and second flow paths, and the filter chamber being disposed on an opposite second side of the first and second flow paths. (Item 26) Item 1. The reconstitution device of any of the preceding items, wherein the first flow path is disposed within a first housing, the third flow path is disposed within a second housing, and the second flow path is at least partially disposed within a tube extending between the first housing and the second housing. (Item 27) 27. The reconstitution device of claim 26, further comprising a filter chamber disposed in the third flow path, wherein the first container receiving end and second container receiving end are disposed on a first side of the first and second flow paths, and the filter chamber is disposed on an opposite second side of the first and second flow paths. (Item 28) 27. The reconstitution device of item 26, wherein the tube is flexible. (Item 29) 27. The reconstitution device of item 26, wherein the tube is curved. (Item 30) Item 27. The reconstitution device of item 26, wherein the first housing is attached to the second housing. (Item 31) Item 31. The reconstitution device of item 30, wherein the first housing and the second housing are attached via an interlocking arrangement comprising a protrusion received within a recess. (Item 32) Item 1. The reconstitution device of any of the preceding items, wherein the third flow path comprises a shaped channel. (Item 33) 32. The reconstitution device according to any one of items 1 to 31, wherein the third flow path comprises a hypotube. (Item 34) 10. The reconstitution device of item 9, further comprising a sheath covering at least a portion of the first spike. (Item 35) a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position; a transfer engine disposed within the lower portion of the housing, the transfer engine having a first container receiving end and a second container receiving end facing toward the upper portion of the housing; a fluid outlet in fluid communication with the second container receiving end of the transfer engine; the top is configured to engage a first container and a second container when the top moves from the inactivated position to the activated position, thereby moving the first container and the second container toward the first container receiving end and the second container receiving end, respectively; when the top is in the inoperative position, physical access to the fluid outlet is at least partially blocked, and when the top is in the operative position, physical access to the fluid outlet is permitted. Reconfiguration device. (Item 36) Item 37. The reconstitution device of item 35, wherein the top includes a cutout that at least partially surrounds the fluid outlet in the housing when the top is in the inactive position and exposes the fluid outlet when the top is in the active position. Item 37. The reconstitution device of item 36, wherein the lower portion has a fluid outlet receptacle, the fluid outlet is disposed within the fluid outlet receptacle, and when the upper portion is moved to the actuated position, the notch aligns with the fluid outlet receptacle and the fluid outlet is exposed. (Item 38) 38. The reconstitution device according to any one of items 35 to 37, further comprising a flexible leash connected to the fluid outlet. (Item 39) 38. The reconstitution device according to any one of items 35 to 37, wherein the fluid outlet is fixed relative to the lower part of the housing when the upper part is in the actuated position. (Item 40) 38. The reconstitution device according to any one of items 35 to 37, wherein the fluid outlet is movable relative to the lower part of the housing when the upper part is in the actuated position. (Item 41) Item 41. The reconstitution device of item 40, wherein the fluid outlet is connected to the second container receiving end by a flexible tube. (Item 42) Item 41. The reconstitution device of item 40, further comprising a clip attached to the fluid outlet and coupled to the lower part of the housing when the upper part is in the inactivated position to retain the fluid outlet to the housing. (Item 43) Item 43. The reconstitution device of item 42, wherein when the upper portion is in the activated position, the clip is removable from the lower portion of the housing to allow movement of the fluid outlet relative to the housing. (Item 44) Item 43. The reconstitution device of item 42, further comprising a cap covering at least a portion of the fluid outlet, wherein the holding force of the clip to the housing is less than the holding force of the cap to the fluid outlet. (Item 45) Item 43. The reconstitution device of item 42, wherein the lower portion of the housing includes a slot into which at least a portion of the clip is received to retain the fluid outlet to the housing when the upper portion is in the inactivated position. (Item 46) Item 43. The reconstitution device of item 42, further comprising a second clip. (Item 47) 47. The reconstitution device of any of items 35-38 or 40-46, wherein the fluid outlet is movable relative to the transfer engine. (Item 48) 48. The reconstruction device according to any one of items 35 to 47, wherein the upper portion includes a curved surface extending in a direction away from the lower portion. (Item 49) 49. The reconstitution device according to any one of items 35 to 48, wherein the lower portion comprises a flat surface opposite to the upper portion. (Item 50) 50. The reconstitution device of any of items 35 to 49, further comprising a warning module configured to warn a user when the top portion moves from the inactive position to the active position. (Item 51) Item 51. The reconfiguration device of item 50, wherein the alert module is configured to provide a visual alert, an audio alert, and / or a tactile alert. (Item 52) Item 51. The reconstruction device of item 50, wherein the warning module transmits a warning message via wireless communication. (Item 53) 53. The reconstitution device of any of items 35 to 52, wherein the top portion includes at least one window configured to allow a user to view at least one of the first container and the second container. (Item 54) Item 55: The reconstitution device according to any one of Items 35 to 53, wherein the first container receiving end is configured as a first spike and the second container receiving end is configured as a second spike. Item 55. The reconstitution device of item 54, wherein the first spike and the second spike are each dual-lumen spikes. (Item 56) Item 55. The reconstitution device of item 54, wherein the second spike comprises at least one open end of a channel inclined at an angle relative to the puncturing direction of the second spike. (Item 57) 57. The reconstruction device of item 56, wherein the angle is about 90 degrees. (Item 58) Item 55. The reconstitution device of item 54, wherein the transfer engine includes an inlet configured to admit air to the transfer engine. (Item 59) 59. The reconstitution device of item 58, wherein the inlet is configured as a hydrophobic filter. (Item 60) 60. The reconstitution device according to any of items 35 to 59, wherein the fluid outlet is a luer-actuated valve or luer. (Item 61) 61. The reconstitution device according to any one of items 35 to 60, wherein the first container receiving end is in unidirectional fluid communication with the second container receiving end. (Item 62) 61. The reconstitution device according to any one of items 35 to 60, wherein the upper portion is slidably engaged with the lower portion. (Item 63) Item 64: The reconstitution device according to any one of Items 35 to 62, wherein the upper portion includes at least one upper retention mechanism and the lower portion includes at least one lower retention mechanism, the upper retention mechanism and the lower retention mechanism being configured to engage with each other to hold the upper portion in the activated position. 63. The reconstitution device according to any of items 35 to 62, wherein the fluid outlet is releasably retained within the housing until a delivery device is coupled to the fluid outlet. (Item 65) Item 65. The reconstitution device of item 64, wherein the fluid outlet is rigidly attached to the housing until the delivery device is coupled to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is coupled to the fluid outlet. (Item 66) a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position; a transfer engine disposed within the lower portion of the housing, with a first container receiving end and a second container receiving end facing toward the upper portion of the housing, the transfer engine and the lower portion being separate components; a fluid outlet in fluid communication with the second container receiving end of the transfer engine; A reconfiguration device comprising: (Item 67) Item 67. The reconstitution device of item 66, wherein the transfer engine is held in the lower portion by a holding mechanism. (Item 68) Item 68. The reconstitution device of item 67, wherein the retention mechanism comprises at least one selected from the group consisting of a mechanical fastener, a snap-on tab, and an adhesive. (Item 69) Item 70. The reconstitution device according to any one of Items 66 to 68, wherein the first container receiving end is configured as a first spike and the second container receiving end is configured as a second spike. 70. The reconstitution device of item 69, wherein the first spike and the second spike are each dual-lumen spikes. (Item 71) 70. The reconstitution device of claim 69, wherein the transfer engine includes an inlet configured to admit air to the transfer engine. (Item 72) 72. The reconstitution device of claim 71, wherein the inlet is configured as a hydrophobic filter. (Item 73) 73. The reconstitution device according to any of items 66 to 72, wherein the fluid outlet is a luer-actuated valve or luer. (Item 74) 74. The reconstitution device of any of items 66 to 73, wherein the upper portion is slidably engaged with the lower portion. (Item 75) Item 76: The reconstitution device according to any one of items 66 to 74, wherein the upper portion includes at least one upper retention mechanism and the lower portion includes at least one lower retention mechanism, the upper retention mechanism and the lower retention mechanism being configured to engage with each other to hold the upper portion in the activated position. 76. The reconstitution device according to any of items 66 to 75, wherein the fluid outlet is releasably retained within the housing until a delivery device is coupled to the fluid outlet. (Item 77) 77. The reconstitution device of claim 76, wherein the fluid outlet is rigidly attached to the housing until the delivery device is coupled to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is coupled to the fluid outlet. (Item 78) a housing having a first portion and a second portion in movable engagement with the first portion, the first and second portions being movable relative to one another between an inactivated configuration and an activated configuration; a first spike coupled to the second portion of the housing; and a first ring coupled to the first portion of the housing and configured to at least partially surround a shoulder of a first container and hold the first container against the first spike; A reconfiguration device comprising: (Item 79) Item 79. The reconstitution device of item 78, wherein the first ring has an inner surface that transitions from a first diameter to a second, smaller diameter to accommodate the profile of the shoulder of the first container. (Item 80) 80. The reconstitution device of claim 78, further comprising an inner contact portion coupled to the first ring and configured to receive the shoulder of the first container, the first ring having a greater stiffness than the inner contact portion. (Item 81) Item 81. The reconstitution device of item 80, wherein the inner contact portion comprises a gasket. (Item 82) Item 82. The reconstitution device of item 81, wherein the ring includes an inner surface having a groove, the gasket seated within the groove. (Item 83) Item 81. The reconstitution device of item 80, wherein the inner contact portion comprises a shaped nub. (Item 84) 84. The reconstitution device of any of items 78 to 83, further comprising a second spike coupled to the second portion of the housing, the first and second spikes facing in the same direction. (Item 85) Item 83. The reconstitution device of item 82, further comprising a second ring coupled to the first portion of the housing and configured to at least partially surround a shoulder of a second container to hold the second container against the second spike. (Item 86) 86. The reconstitution device of any of items 78 to 85, further comprising a platform coupled to the first portion of the housing and configured to contact a bottom of the first container, wherein moving the first portion toward the second portion from the unactuated configuration to the actuated configuration presses the platform against the bottom of the first container to move the first container toward the first spike. (Item 87) 87. The reconstitution device of any one of items 78 to 86, further comprising a plurality of arms coupled to the first portion of the housing and extending toward the second portion of the housing, the plurality of arms configured to at least partially surround a bottom of the first container. (Item 88) Item 88. The reconstitution device of item 87, further comprising a gasket coupled to and at least partially surrounded by the plurality of arms. (Item 89) Item 79. The reconstruction device of item 78, wherein the first ring is fixed to the first portion such that the first ring moves with movement of the first portion. (Item 90) a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position; a fluid outlet configured to deliver fluid from a container disposed within the housing when the top is in the actuated position; a marker that is at least partially obstructed in the inactivated position of the upper portion, the marker being accessible in the activated position of the upper portion; and A drug solution delivery device comprising: (Item 91) Item 91. The drug delivery device of item 90, wherein the marker is a QR code (registered trademark). (Item 92) Item 92. The medication delivery device of item 91, wherein the QR code includes information readable by a remote device. (Item 93) Item 93. The medication delivery device of item 92, wherein the information includes at least one selected from the group consisting of dosage and medication identification. (Item 94) Item 93. The drug delivery device of item 92, wherein the remote device is a smartphone. (Item 95) Item 91. The drug delivery device of item 90, wherein the marker is a near-field communication tag. (Item 96) Item 96. The drug delivery device of item 95, wherein the marker is a radio frequency identification tag. (Item 97) 97. The drug solution delivery device of any of items 90 to 96, wherein the upper portion includes a marker window, the upper portion in the inactive position encloses the marker within the housing, and the marker window exposes the marker when the upper portion is in the active position. (Item 98) 97. The drug solution delivery device of any of items 90 to 96, wherein the upper portion in the inactive position covers at least a portion of the marker, and the upper portion in the active position exposes the marker. (Item 99) 97. The drug delivery device of any of items 90 to 96, wherein the upper opaque portion conceals at least a portion of the marker and at least partially obstructs the marker. (Item 100) 100. The medication delivery device of claim 99, wherein the transparent portion of the top is aligned with the marker when the top is in the actuated position. (Item 101) a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position; a fluid outlet configured to deliver fluid from a container disposed within the housing when the top is in the actuated position; a communication module configured to transmit messages via at least one communication protocol; a trigger configured to activate the communications module when the top is moved from the inactivated position to the activated position; A drug solution delivery device comprising: (Item 102) Item 102. The medication delivery device of item 101, wherein the trigger is a switch configured to be moved by the upper portion from a first switch position to a second switch position. (Item 103) Item 102. The medication delivery device of item 101, wherein the trigger includes a Hall effect sensor disposed in the lower portion and the trigger includes a magnet disposed in the upper portion. (Item 104) Item 102. The drug solution delivery device of item 101, wherein the trigger includes a pressure sensor configured to detect pressure applied to the upper portion to move the upper portion to the actuated position, and the trigger is configured to activate the communication module when a threshold pressure applied to the upper portion is detected by the pressure sensor. (Item 105) Item 102. The drug solution delivery device of item 101, wherein the trigger includes a light beam transmitter and a light beam receiver disposed in the lower portion, the light beam transmitter configured to emit a light beam that is received by the light beam receiver, and the upper portion configured to physically block the light beam in the actuated position. (Item 106) 106. A drug solution delivery device according to any one of items 101 to 105, wherein the at least one communication protocol includes Bluetooth (registered trademark). (Item 107) 107. The drug delivery device of any of items 101 to 106, further comprising a sensor configured to provide information to the communication module. (Item 108) Item 108. The drug solution delivery device of item 107, wherein the sensor is a temperature sensor configured to provide temperature information to the communication module. (Item 109) Item 108. The medication delivery device of item 107, wherein the sensor is an accelerometer configured to provide movement information to the communication module. (Item 110) 109. A drug delivery device according to any one of items 101 to 109, wherein the trigger is configured to connect the communication module to a power source. (Item 111) A drug solution delivery device described in any of items 101 to 110, wherein the communication module is configured to transmit a message including at least one selected from the group consisting of a dosage and a drug identification. (Item 112) Item 90 or 101, wherein the upper portion in the inactivated position is configured to at least partially block physical access to the fluid outlet, and the upper portion in the activated position is configured to allow physical access to the fluid outlet. (Item 113) Item 113. The drug solution delivery device of item 112, wherein the upper portion includes a cutout, the upper portion at least partially enclosing the fluid outlet in the housing in the inactive position, and the cutout exposing the fluid outlet when the upper portion is in the active position. (Item 114) The container; a top portion fluidly connected to the fluid outlet and configured to puncture the container when the top portion moves from the inactivated position to the activated position; a first spike configured as follows: Item 90 or 101, the drug solution delivery device further comprising: (Item 115) the container is a first container, and the drug delivery device comprises: a second container; and a spike fluidly connected to the first spike and configured to puncture the second container when the top moves from the inactivated position to the activated position; Item 115. The drug delivery device of item 114, further comprising a second spike configured to: (Item 116) Item 116. The drug solution delivery device of item 115, wherein the first container contains a freeze-dried solid, the second container contains a drug solution, and the upper portion is configured to allow the drug solution to dissolve the freeze-dried solid in the actuated position. (Item 117) an inlet vessel containing a chemical solution; an inlet spike configured to puncture the inlet container, the inlet spike configured to receive the medical solution from the inlet container; An air inlet; an inlet adapter fluid channel fluidly connected to the inlet spike; an inlet adaptor including an inlet adaptor coupling; an intermediate container containing a medicinal liquid or solid; an intermediate spike configured to puncture the intermediate container; a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel; a second intermediate fluid channel fluidly connected to the intermediate spike; a first intermediate adapter coupling configured to connect to the inlet adapter coupling to releasably attach the intermediate adapter to the inlet adapter; an intermediate adapter including a second intermediate adapter coupling; an outlet container containing a medicated solid; an outlet spike configured to puncture the outlet receptacle; an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to the second intermediate fluid channel; an outlet fluidly connected to the outlet spike; an outlet adapter coupling configured to connect to the second intermediate adapter coupling to releasably attach the outlet adapter to the intermediate adapter; A drug solution delivery device comprising: (Item 118) Item 118. The medication delivery device of item 117, wherein the outlet adapter coupling is configured to connect to the inlet adapter coupling to releasably attach the outlet adapter to the inlet adapter. (Item 119) the intermediate adapter is a first intermediate adapter, the intermediate container is a first intermediate container, and the drug solution delivery device is a second intermediate container containing a medicinal liquid or solid; a second intermediate spike configured to puncture the second intermediate container; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the second intermediate fluid channel; a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; a third intermediate adapter coupling configured to connect to the second intermediate adapter coupling to releasably attach the first intermediate adapter to the second intermediate adapter in an in-line configuration; and a fourth intermediate adapter coupling configured to connect to the outlet adapter coupling and releasably attach the second intermediate adapter to the outlet adapter in an in-line configuration. the intermediate adapter is a first intermediate adapter, the intermediate container is a first intermediate container, the inlet adapter includes a second inlet adapter coupling, the outlet adapter includes a second outlet adapter coupling, and the drug solution delivery device comprises: a second intermediate container containing a medicinal liquid or solid; a second intermediate spike configured to puncture the second intermediate container; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the inlet adapter fluid channel; a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; a third intermediate adapter coupling configured to connect to the second intermediate adapter coupling to releasably attach the inlet adapter to the second intermediate adapter in a parallel configuration; Item 118. The drug solution delivery device of item 117, further comprising a second intermediate adapter, and a fourth intermediate adapter coupling configured to connect to the second outlet adapter coupling and releasably attach the second intermediate adapter to the outlet adapter in a parallel configuration. (Item 121) the intermediate adapter is a first intermediate adapter, the intermediate container is a first intermediate container, and the drug solution delivery device is a second intermediate container containing a medicinal liquid or solid; a second intermediate spike configured to puncture the second intermediate container; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the inlet adapter fluid channel; a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; a third intermediate adapter coupling configured to connect to the inlet adapter coupling to releasably attach the inlet adapter to the second intermediate adapter in a parallel configuration, the inlet adapter coupling configured to simultaneously connect to both the first intermediate adapter coupling and the third intermediate adapter coupling; and Item 118. The drug solution delivery device of item 117, further comprising a second intermediate adapter, and a fourth intermediate adapter coupling configured to connect to the outlet adapter coupling and releasably attach the second intermediate adapter to the outlet adapter in a parallel configuration, wherein the outlet adapter coupling is configured to simultaneously connect to both the second intermediate adapter coupling and the fourth intermediate adapter coupling. (Item 122) an inlet spike configured to puncture the inlet receptacle; An air inlet; an inlet adapter fluid channel fluidly connected to the inlet spike; an inlet adapter comprising: an inlet adapter coupling spaced from the inlet adapter fluid channel; an intermediate spike configured to puncture the intermediate container; a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel; a second intermediate fluid channel fluidly connected to the intermediate spike; a first intermediate adapter coupling adapted to connect to the inlet adapter coupling for releasably interlocking the intermediate adapter to the inlet adapter; a second intermediate adapter coupling, wherein the first intermediate adapter coupling and the second intermediate coupling are spaced apart from the first intermediate fluid channel and the second intermediate fluid channel; an outlet spike configured to puncture the outlet receptacle; an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to the second intermediate fluid channel; an outlet fluidly connected to the outlet spike; an outlet adapter comprising: an outlet adapter coupling configured to couple with the second intermediate adapter coupling to releasably interlock the outlet adapter with the intermediate adapter, the outlet adapter coupling being spaced from the outlet adapter fluid channel; A drug delivery device comprising: (Item 123) Item 123. The medication delivery device of item 122, wherein the outlet adapter coupling is configured to connect to the inlet adapter coupling to releasably interlock the outlet adapter to the inlet adapter. (Item 124) Item 123. The drug solution delivery device of item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are positioned on opposite sides of the intermediate adapter. (Item 125) Item 123. The medication delivery device of item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an oblique angle relative to each other. (Item 126) Item 127. The drug delivery device of item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an acute angle relative to each other. a first tube configured to fluidly connect the inlet adapter fluid channel and the first intermediate fluid channel; Item 123. The drug solution delivery device of item 117 or 122, further comprising a second tube configured to fluidly connect the second intermediate fluid channel and the outlet adapter fluid channel. (Item 128) the intermediate adapter is a first intermediate adapter, and the medication delivery device comprises: a second intermediate spike configured to puncture a second intermediate container containing a medicinal liquid or solid; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the second intermediate fluid channel; a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; a third intermediate adapter coupling configured to be received in the second intermediate adapter coupling to releasably interlock the first intermediate adapter to the second intermediate adapter in an in-line configuration; Item 123. The medication solution delivery device of item 122, further comprising a second intermediate adapter, and a fourth intermediate adapter coupling configured to receive the outlet adapter coupling and releasably interlock the second intermediate adapter to the outlet adapter in an in-line configuration. (Item 129) the intermediate adapter is a first intermediate adapter, the inlet adapter includes a second inlet adapter coupling, the outlet adapter includes a second outlet adapter coupling, and the drug solution delivery device comprises: a second intermediate spike configured to puncture a second intermediate container containing a medicinal liquid or solid; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the inlet fluid channel; a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; a third intermediate adapter coupling configured to be received in the second intermediate adapter coupling to releasably interlock the first intermediate adapter to the second intermediate adapter in a parallel configuration; Item 123. The medication solution delivery device of item 122, further comprising a second intermediate adapter, and a fourth intermediate adapter coupling configured to receive the second outlet adapter coupling and releasably interlock the second intermediate adapter to the outlet adapter in a parallel configuration. (Item 130) the intermediate adapter is a first intermediate adapter, and the medication delivery device comprises: a second intermediate spike configured to puncture a second intermediate container containing a medicinal liquid or solid; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the inlet fluid channel; a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; a third intermediate adapter coupling configured to be received in the inlet adapter coupling and to releasably interlock the inlet adapter to the second intermediate adapter in a parallel configuration, the inlet adapter coupling configured to simultaneously receive both the first intermediate adapter coupling and the third intermediate adapter coupling; Item 123. The drug solution delivery device of item 122, further comprising a second intermediate adapter including: a fourth intermediate adapter coupling configured to receive the outlet adapter coupling and releasably interlock the second intermediate adapter with the outlet adapter in a parallel configuration, the fourth intermediate adapter coupling being configured to be simultaneously received in both the second intermediate adapter coupling and the fourth intermediate adapter coupling. (Item 131) a first tube configured to fluidly connect the inlet adapter fluid channel and the first intermediate fluid channel; a second tube configured to fluidly connect the second intermediate fluid channel and the third intermediate fluid channel; Item 129. The drug solution delivery device of item 119 or 128, further comprising a third tube configured to fluidly connect the fourth intermediate fluid channel and the outlet adapter fluid channel. (Item 132) a first tube configured to fluidly connect the inlet adapter fluid channel, the first intermediate fluid channel, and the third intermediate fluid channel; Item 129. The drug solution delivery device of item 119 or 128, further comprising a second tube configured to fluidly connect the second intermediate fluid channel, the fourth intermediate fluid channel, and the outlet adapter fluid channel. (Item 133) Item 117 or 122. The drug solution delivery device of item 117 or 122, wherein the first intermediate adapter coupling includes a neck and a tab, the tab having a tab width, the neck having a neck width, and the tab width being greater than the neck width; and the inlet adapter coupling includes a collar and a pocket, the collar having a collar width, the pocket having a pocket width, and the pocket width being greater than the collar width. (Item 134) Item 123. The drug solution delivery device of item 122, wherein when the intermediate adapter and the inlet adapter are interlocked, the inlet adapter coupling and the first intermediate adapter coupling are configured to resist relative movement of the inlet adapter and the intermediate adapter in a first direction and allow relative movement of the inlet adapter and the intermediate adapter in a second direction transverse to the first direction. (Item 135) Item 135. The drug delivery device of item 134, wherein the first direction and the second direction are perpendicular to each other. (Item 136) a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion between an inoperative position and an operative position; a transfer engine disposed within the lower portion of the housing, the transfer engine having a first container receiving end facing toward the upper portion of the housing; a fluid outlet in fluid communication with the transfer engine; the top is configured to engage a first container such that the first container moves toward the first container receiving end when the top moves from the inactivated position to the activated position; A drug solution delivery device, wherein physical access to the fluid outlet is at least partially blocked when the top is in the inactivated position, and physical access to the fluid outlet is permitted when the top is in the activated position. (Item 137) Item 137. The medication delivery device of item 136, wherein the upper portion includes a cutout that at least partially surrounds the fluid outlet in the housing when the upper portion is in the inactive position and exposes the fluid outlet when the upper portion is in the active position. (Item 138) Item 138. The drug delivery device of item 137, wherein the lower portion has a fluid outlet receptacle, the fluid outlet is positioned within the fluid outlet receptacle, and when the upper portion is moved to the operating position, the notch aligns with the fluid outlet receptacle and the fluid outlet is exposed. (Item 139) 139. The drug delivery device of any one of items 136 to 138, further comprising a flexible leash connected to the fluid outlet. (Item 140) Item 139. A drug delivery device according to any one of items 136 to 138, wherein the fluid outlet is fixed relative to the lower part of the housing when the upper part is in the actuated position. (Item 141) Item 139. A drug delivery device according to any one of items 136 to 138, wherein the fluid outlet is movable relative to the lower part of the housing when the upper part is in the actuated position. (Item 142) Item 142. The drug delivery device of item 141, further comprising a clip attached to the fluid outlet and coupled to the lower part of the housing when the upper part is in the inactivated position to hold the fluid outlet to the housing. (Item 143) Item 143. The medication delivery device of item 142, wherein when the upper portion is in the actuated position, the clip is removable from the lower portion of the housing to allow movement of the fluid outlet relative to the housing. (Item 144) Item 143. The drug delivery device of item 142, further comprising a cap covering at least a portion of the fluid outlet, wherein the holding force of the clip to the housing is less than the holding force of the cap to the fluid outlet. (Item 145) Item 143. The drug delivery device of item 142, wherein the lower portion of the housing includes a slot into which at least a portion of the clip is received to retain the fluid outlet to the housing when the upper portion is in the inactivated position. (Item 146) Item 143. The drug delivery device of item 142, further comprising a second clip. (Item 147) The drug delivery device of any of items 136-139 or 141-146, wherein the fluid outlet is movable relative to the transfer engine. (Item 148) Item 148. The drug delivery device of any one of items 136 to 147, wherein the upper portion includes a curved surface extending away from the lower portion. (Item 149) 149. The drug delivery device of any of items 136 to 148, wherein the lower portion includes a flat surface opposite the upper portion. (Item 150) 150. The drug delivery device of any of items 136 to 149, further comprising a warning module configured to warn a user when the upper portion moves from the inactive position to the active position. (Item 151) Item 151. The medication delivery device of item 150, wherein the warning module is configured to provide a visual warning, an audio warning, and / or a tactile warning. (Item 152) Item 151. The medication delivery device of item 150, wherein the warning module transmits a warning message via wireless communication. (Item 153) 153. The drug solution delivery device of any of items 136 to 152, wherein the top portion includes at least one window configured to allow a user to view the first container. (Item 154) 154. The drug solution delivery device of any of items 136 to 153, wherein the first container receiving end is configured as a first spike. (Item 155) Item 155. The drug delivery device of item 154, wherein the first spike is a dual lumen spike. (Item 156) Item 155. The drug solution delivery device of item 154, wherein the first spike includes at least one open end of a flow path inclined at an angle relative to the puncture direction of the first spike. (Item 157) Item 157. The drug delivery device of item 156, wherein the angle is about 90 degrees. (Item 158) Item 155. The drug solution delivery device of item 154, wherein the transfer engine includes an inlet configured to admit air into the transfer engine. (Item 159) Item 160. The drug delivery device of item 158, wherein the inlet is configured as a hydrophobic filter. 159. The drug solution delivery device according to any one of items 136 to 159, wherein the fluid outlet is a luer-actuated valve or luer. (Item 161) 161. The drug delivery device of any of items 136 to 160, wherein the upper portion is slidably engaged with the lower portion. (Item 162) 162. The drug solution delivery device of any of items 136 to 161, wherein the upper portion includes at least one upper retention mechanism, the lower portion includes at least one lower retention mechanism, and the upper retention mechanism and the lower retention mechanism are configured to engage with each other to hold the upper portion in the actuated position. (Item 163) 162. A drug delivery device according to any one of items 136 to 161, wherein the fluid outlet is releasably retained within the housing until a delivery device is coupled to the fluid outlet. (Item 164) Item 164. The drug solution delivery device of item 163, wherein the fluid outlet is rigidly attached to the housing until the delivery device is coupled to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is coupled to the fluid outlet. (Item 165) Item 137. The medication delivery device of item 136, wherein the top portion is configured to engage with only a single container. (Item 166) an inlet spike configured to puncture the inlet receptacle; An air inlet; an inlet adapter fluid channel fluidly connected to the inlet spike; an intermediate spike configured to puncture the intermediate container; a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel; an intermediate adapter including a second intermediate fluid channel fluidly connected to the intermediate spike; an outlet spike configured to puncture the outlet receptacle; an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to the second intermediate fluid channel; an outlet adapter including an outlet fluidly connected to the outlet spike; an adapter plate; The inlet adaptor, the intermediate adaptor, and the outlet adaptor are configured to couple to the adaptor plate. (Item 167) Item 167. The medication delivery device of item 166, wherein the inlet adapter, the intermediate adapter, and the outlet adapter are configured to couple to the adapter plate by an interference fit. (Item 168) Item 167. The medication delivery device of item 166, wherein the adapter plate includes studs configured to engage with the inlet adapter, the intermediate adapter, and the outlet adapter. (Item 169) Item 170: The drug solution delivery device according to items 166 to 168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are disposed on opposite sides of the intermediate adapter. 169. The drug solution delivery device of items 166-168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an oblique angle relative to each other. (Item 171) 169. The drug solution delivery device of items 166-168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an acute angle relative to each other. (Item 172) a first tube configured to fluidly connect the inlet adapter fluid channel and the first intermediate fluid channel; 172. The drug solution delivery device of items 166-171, further comprising a second tube configured to fluidly connect the second intermediate fluid channel and the outlet adapter fluid channel. (Item 173) the intermediate adapter is a first intermediate adapter, and the medication delivery device comprises: a second intermediate spike configured to puncture the second intermediate container; a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the second intermediate fluid channel; a second intermediate adapter including a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel configured to fluidly connect to the outlet adapter fluid channel; 173. The drug solution delivery device according to items 166 to 172, wherein the second intermediate adapter is configured to couple to the adapter plate.

[0018] The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component shown in various figures may be represented by a like numeral. For clarity, not every component may be labeled in every drawing. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a schematic diagram of one embodiment of a transfer engine for a reconstruction device.

[0020] [Figure 2] FIG. 1 is a perspective view of one embodiment of a reconstitution device.

[0021] [Figure 3] FIG. 1 is a schematic diagram of an embodiment of a transfer engine for a reconstitution device during a first stage of an embodiment of a reconstitution and drug delivery process.

[0022] [Figure 4] FIG. 4 is a schematic diagram of the transfer engine of FIG. 3 during a second stage of the reconstitution and drug delivery process.

[0023] [Figure 5] FIG. 4 is a schematic diagram of the transfer engine of FIG. 3 during a third stage of the reconstitution and drug delivery process.

[0024] [Figure 6] FIG. 4 is a schematic diagram of the transfer engine of FIG. 3 during an optional fourth stage of the reconstitution and drug delivery process.

[0025] [Figure 7] FIG. 1 illustrates a perspective view of one embodiment of a reconstitution device in an unactuated state.

[0026] [Figure 8] FIG. 8 is a perspective view of the reconstitution device of FIG. 7 in an actuated state.

[0027] [Figure 9] FIG. 8 is a side elevational view of the reconstitution device of FIG. 7.

[0028] [Figure 10A] FIG. 9 is a side elevational view of the reconstitution device of FIG. 8.

[0029] [Figure 10B] FIG. 10B is a perspective view of the reconstitution device of FIG. 10A.

[0030] [Figure 11] 11 is a cross-sectional view of the reconfiguration device of FIG. 7 taken along line 11-11.

[0031] [Figure 12] 12 is a cross-sectional view of the reconfiguration device of FIG. 8 taken along line 12-12.

[0032] [Figure 13] FIG. 1B is a side elevation view of one embodiment of a transfer engine of a reconstitution device.

[0033] [Figure 14] FIG. 14 is a top cross-sectional view of the transfer engine of FIG. 13 taken along 14-14.

[0034] [Figure 15] 1 is a flow chart of one embodiment of a reconstitution and drug delivery process.

[0035] [Figure 16] 10 is a flow chart of another embodiment of a reconstitution and drug delivery process.

[0036] [Figure 17] 1 is a flow chart of one embodiment of a reconstitution and drug delivery process.

[0037] [Figure 18] FIG. 1 is a schematic diagram of an embodiment of a reconstruction device in communication with one or more remote devices.

[0038] [Figure 19A] FIG. 10 is a schematic diagram of another embodiment of a reconstitution device in a first state.

[0039] [Figure 19B] FIG. 19B is a schematic diagram of the reconstitution device of FIG. 19A in a second state.

[0040] [Figure 20A] FIG. 10 is a schematic diagram of yet another embodiment of a reconstitution device in a first state.

[0041] [Figure 20B] FIG. 20B is a schematic diagram of the reconfiguration device of FIG. 20A in a second state.

[0042] [Figure 21A] FIG. 10 is a schematic diagram of another embodiment of a reconstitution device in a first state.

[0043] [Figure 21B] FIG. 21B is a schematic diagram of the reconstitution device of FIG. 21A in a second state.

[0044] [Figure 22] FIG. 10 is a perspective view of another embodiment of a transfer engine.

[0045] [Figure 23] FIG. 23 is a side cross-sectional view of the transfer engine of FIG. 22 taken along line 23-23.

[0046] [Figure 24] 24 is a top cross-sectional view of the transfer engine of FIG. 22 taken along line 24-24.

[0047] [Figure 25] 25 is a top cross-sectional view of the transfer engine of FIG. 22 taken along line 25-25.

[0048] [Figure 26] FIG. 10 is a perspective view of another embodiment of a transfer engine.

[0049] [Figure 27] FIG. 27 is a side cross-sectional view of the transfer engine of FIG. 26 taken along line 27-27.

[0050] [Figure 28] FIG. 28 is a top cross-sectional view of the transfer engine of FIG. 26 taken along line 28-28.

[0051] [Figure 29] 1 is a cross-sectional schematic view of one embodiment of a spike.

[0052] [Figure 30] 10 is a cross-sectional schematic view of another embodiment of a spike.

[0053] [Figure 31] 10 is a cross-sectional schematic view of another embodiment of a spike.

[0054] [Figure 32A] FIG. 10 is a schematic diagram of another embodiment of a reconstitution device in a first state.

[0055] [Figure 32B] FIG. 32B is a schematic diagram of the reconfiguration device of FIG. 32A in a second state;

[0056] [Figure 32C] FIG. 32B is a schematic diagram of the reconstitution device of FIG. 32A in a third state.

[0057] [Figure 32D] FIG. 32B is a schematic diagram of the reconfiguration device of FIG. 32A in a fourth state.

[0058] [Figure 33] FIG. 10 illustrates a top perspective view of another embodiment of a transfer engine.

[0059] [Figure 34] FIG. 34 is a top view of the transfer engine of FIG.

[0060] [Figure 35] FIG. 34 is a bottom perspective view of the transfer engine of FIG.

[0061] [Figure 36] FIG. 10 is an exploded perspective view of another embodiment of a reconstitution device.

[0062] [Figure 37A] 37 shows the reconfiguration device of FIG. 36 in a first state.

[0063] [Figure 37B] 37B is the reconfiguration device of FIG. 37A in a second state.

[0064] [Figure 37C] 37B is the reconfiguration device of FIG. 37A in a third state.

[0065] [Figure 38] FIG. 10 is an exploded perspective view of another embodiment of a reconstitution device.

[0066] [Figure 39] FIG. 39 is another exploded perspective view of the reconstitution device of FIG. 38.

[0067] [Figure 40A] 39 shows the reconfiguration device of FIG. 38 in a first state.

[0068] [Figure 40B] 40B is the reconfiguration device of FIG. 40A in a second state.

[0069] [Figure 40C] 40B is the reconfiguration device of FIG. 40A in a third state.

[0070] [Figure 40D] 40B is the reconfiguration device of FIG. 40A in a fourth state.

[0071] [Figure 41] FIG. 10 is an exploded perspective view of another embodiment of a reconstitution device.

[0072] [Figure 42] FIG. 42 is another exploded perspective view of the reconstitution device of FIG. 41.

[0073] [Figure 43A] 42 is the reconfiguration device of FIG. 41 in a first state.

[0074] [Figure 43B] 43B is the reconfiguration device of FIG. 43A in a second state.

[0075] [Figure 43C] 43B is the reconfiguration device of FIG. 43A in a third state.

[0076] [Figure 44] FIG. 44 is a cross-sectional view of the reconstitution device of FIG. 40B taken along line 44-44.

[0077] [Figure 45]FIG. 45 is a perspective cross-sectional view of the reconstitution device of FIG. 44.

[0078] [Figure 46] FIG. 2 is a perspective view of a container retaining ring.

[0079] [Figure 47] FIG. 40C is a bottom view of the top of the reconstitution device of FIG. 40B.

[0080] [Figure 48] FIG. 48 is a bottom perspective view of the top portion of FIG. 47.

[0081] [Figure 49] FIG. 49 is a perspective cutaway view of the reconstitution device of FIG. 40B taken along line 49-49.

[0082] [Figure 50A] FIG. 10 is an exploded top view of another embodiment of a transfer engine.

[0083] [Figure 50B] FIG. 50B is a plan view of the transfer engine of FIG. 50A.

[0084] [Figure 51] FIG. 1 is a schematic diagram of an embodiment of a transfer engine adapter coupling.

[0085] [Figure 52] FIG. 10 is a plan view of another embodiment of a transfer engine.

[0086] [Figure 53] FIG. 10 is a plan view of another embodiment of a transfer engine.

[0087] [Figure 54] FIG. 10 is a plan view of another embodiment of a transfer engine.

[0088] [Figure 55] FIG. 10 is a side view of another embodiment of a drug delivery device.

[0089] [Figure 56] FIG. 10 is a side view of another embodiment of a drug delivery device.

[0090] [Figure 57] FIG. 10 is a top schematic view of another embodiment of a transfer engine.

[0091] [Figure 58] FIG. 10 is a top schematic view of another embodiment of a transfer engine.

[0092] [Figure 59] FIG. 10 is a top schematic view of another embodiment of a transfer engine.

[0093] [Figure 60] FIG. 10 is a top schematic view of another embodiment of a transfer engine.

[0094] [Figure 61A] 1 is a front schematic view of another embodiment of a drug solution delivery device in a first state. FIG.

[0095] [Figure 61B] FIG. 61B is a front schematic view of the drug delivery device of FIG. 61A in a second state.

[0096] [Figure 62A] 1 is a front schematic view of another embodiment of a drug solution delivery device in a first state. FIG.

[0097] [Figure 62B] FIG. 62B is a front schematic view of the drug delivery device of FIG. 62A in a second state.

[0098] [Figure 63] 10 is a flow chart of another embodiment of a drug delivery process.

[0099] [Figure 64A]1 is a front schematic view of another embodiment of a drug solution delivery device in a first state. FIG.

[0100] [Figure 64B] FIG. 64B is a front schematic view of the drug delivery device of FIG. 64A in a second state.

[0101] [Figure 65] FIG. 2 is a schematic diagram of one embodiment of a communication module.

[0102] [Figure 66] 10 is a flow chart of another embodiment of a drug delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0103] During a typical reconstitution and administration process, a syringe can be used to mix a liquid diluent (e.g., sterile water for injection) with a liquid, dry, or unconstituted drug product, such as a drug product in lyophilized form. At each step, a nurse or other healthcare professional takes care to avoid contamination as the reconstitution fluid is removed from the packaging and dispensed into a mixing container or drug product container. Such a process typically involves handling multiple containers and syringes. Therefore, traditional reconstitution methods performed by nurses or other healthcare professionals can be time-consuming and complicated.

[0104] In some cases, patient-performed reconstitution and administration may be the preferred option from a convenience and cost perspective. When performed by a healthcare professional, the already time-consuming and difficult procedure may be challenging for patients who practice self-administration. Reducing the time and complexity of reconstitution and administration of medications may be desirable for self-administering patients as well as healthcare providers.

[0105] In view of the above, the inventors have recognized the advantages of a reconstitution device that allows a patient or healthcare provider to reconstitute and administer a medication contained in one container with a reconstitution fluid in another container. Compared to conventional reconstitution and administration processes, the present reconstitution device can enable the use of a simpler reconstitution and administration process having fewer steps. The reconstitution device can also enable reconstitution and administration with reduced handling of the container. Furthermore, the reconstitution device can enable less pressure to be applied to actuate the device than conventional devices, promoting an easier actuation sensation for the user. Furthermore, the reconstitution device can improve agitation and mixing of the medication and reconstitution fluid.

[0106] In some embodiments, the transfer engine may include multiple flow paths in a compact arrangement, for example, to facilitate the transfer of fluid from a first container to a second container to reconstitute a drug in the second container. In some embodiments, the reconstitution device includes a first flow path including a first open end and an air inlet. The reconstitution device also includes a second flow path having a second open end and a third open end. The first and second open ends may be parallel to each other and together define a first container receiving end. The reconstitution device also includes a valve disposed along the second flow path between the second open end and the third open end. The third flow path includes a fourth open end and a fluid outlet. The third open end and the fourth open end may be parallel to each other and together define a second container receiving end. In some embodiments, the container receiving end may include a spike configured to spike into the container. According to this embodiment, the device includes two interconnected dual-lumen spikes, allowing fluid transfer from a first container (e.g., containing sterile water) to a second container (e.g., containing an agent for reconstitution). In some embodiments, a first open end of the first flow path and a second open end of the second flow path are disposed within the first spike. In some embodiments, a third open end of the second flow path and a fourth open end of the third flow path are disposed within the second spike. A portion of the first flow path and a portion of the second flow path can form the lumen of the first spike. A portion of the second flow path and a portion of the third flow path can form the lumen of the second spike. In some embodiments, the transfer engine can be used with fluid delivery devices other than reconstitution devices, such as devices for pools or devices used to access a single container. Thus, it should be understood that in some embodiments, the transfer engine can include only a single container receiving end rather than multiple container receiving ends.

[0107] In some embodiments, the fluid outlet may include a Luer lock valve, allowing a syringe or other delivery device to be fluidly connected to the fluid outlet and withdraw the reconstituted drug solution from the device. However, in other embodiments, other suitable fluid outlets may be used in the reconstitution device, including, but not limited to, a Luer activation device, a simple Luer or other threaded connector, a slip-fit ​​connector, and a pierceable septum. In some embodiments, the container containing the powdered drug may be configured to include a low- or zero-pressure vacuum, allowing sterile water or another fluid from another container to be forced into the drug-containing container without manually applying pressure or pumping. In some embodiments, the pressure differential between the drug-containing container and the fluid-containing container may be large enough to expel fluid from the fluid-containing container into the drug-containing container at a rate that may help agitate the drug to facilitate reconstitution.

[0108] The inventors also recognized the advantage of a self-contained reconstitution device that can perform the reconstitution process by applying a force in a single direction. A first container may be pre-placed within the reconstitution device containing a reconstitution fluid along with a second container containing a pharmaceutical product. The reconstitution device can apply a force to the housing to fluidly couple the first container to the second container, allowing fluid to flow from the first container to the second container and reconstitute the pharmaceutical product.

[0109] In some embodiments, the reconstitution device may include a housing having an upper portion and a lower portion, the lower portion being slidably received within the upper portion, or vice versa. The upper portion may be configured to hold at least two containers, and the lower portion may include at least one spike for each of the at least two containers. In some embodiments, the upper portion may be configured to at least partially surround the at least two containers and selectively hold them away from the spikes on the lower portion. The upper portion may be configured to apply a force to the at least two containers when the upper portion slides from a first, inactivated position to a second, activated position in which the upper portion approaches the lower portion. Specifically, the bottom-most surface of the upper portion is closer to the base of the lower portion. When the upper portion moves to the activated position, the at least two containers may be punctured by the spike(s) associated with the containers. When punctured, the containers may be in fluid communication, allowing fluid from one container to flow to the other container. In some embodiments, the first container may be under vacuum, causing fluid from the second container to be forced into the first container as a result of a pressure differential between the two containers. The lower part of the housing can be formed as a base that can be placed on a flat surface (e.g., a table, a countertop, etc.). The base can support the reconstitution device and provide a platform against which a user can apply force. In some embodiments, the upper surface of the upper part of the housing can be curved, which can cause the reconstitution device to be unstable if a user attempts to use the upper surface of the upper part on a flat surface as a base. The instability can help alert the user that the device is improperly oriented for use. Such an arrangement can also promote a single orientation for use of the reconstitution device. Such an arrangement can also improve ergonomics compared to conventional reconstitution devices. The curved surface can provide a natural place to rest the hand and has a shape that corresponds to other objects and surfaces commonly received by a user's palm. In this regard, the curved upper surface can provide positive movement, thereby promoting preferred handling and operation of the reconstitution device.

[0110] The inventors have also recognized the benefit of providing feedback to the user for complete actuation of the reconstitution device. Additionally, the inventors have recognized the benefit of one or more retention mechanisms that hold the reconstitution device in an actuated state to discourage repeated activation or retrieval of used containers from the reconstitution device. Furthermore, such an arrangement can mitigate movement of the upper portion of the housing away from the lower portion of the housing as a result of the resilience of the punctured septum of the container biasing the upper portion away from the lower portion.

[0111] In some embodiments, the reconstitution device may include a housing having a lower portion and an upper portion, where the lower portion is slidably received within the upper portion, or vice versa. The upper portion may be configured to hold at least two containers, and the lower portion may include at least one spike for each of the at least two containers. In some embodiments, the upper portion may be configured to at least partially surround the at least two containers and selectively hold them away from the spikes on the lower portion. The upper portion may also be configured to apply a force to the at least two containers when the upper portion slides from a first, inactivated position to a second, activated position in which the upper portion approaches the lower portion. The upper portion of the housing may have at least one upper stop, and the lower portion may have at least one lower stop. The at least one upper stop may be configured to engage with the at least one lower stop when the upper housing moves to the activated position to puncture each of the at least two containers. In some embodiments, the upper and lower stops may be corresponding shelves or ledges on the housing that abut against each other to prevent further movement of the upper portion of the housing toward the lower portion of the housing. In some embodiments, the container can function as an upper stop that abuts (e.g., bottoms out) against the lower part of the housing when the upper housing is moved to the activated position. The upper and lower stops can be located in any suitable portions of the upper and lower housings that can contact each other, as the disclosure is not so limited. In some embodiments, the upper and lower housings can include one or more retention mechanisms to enable unidirectional capture of the reconstitution device in the activated position. The retention mechanisms can include flexible tabs, ratchets and pawls, hooks, hook-and-loop fasteners, adhesive, or another suitable arrangement for securing the two parts of the reconstitution device housing together upon activation. For example, in one embodiment, flexible tabs located on the lower part of the housing can engage corresponding detents or recesses in the upper part of the housing when the upper part is moved to the activated position.

[0112] The inventors also recognized the advantages of physically preventing user access to the fluid outlet before device activation and allowing user access to the fluid outlet in response to activation of the reconstitution device housing. Specifically, the inventors recognized the advantages of physically preventing access to the fluid outlet before reconstitution of a medication. The reconstitution device housing can be arranged to allow access to the fluid outlet only after the two containers are fluidly joined, thereby allowing fluid from the first container to flow to the second container containing the medication for reconstitution. Such an arrangement can simplify the reconstitution and administration process and further ensure that the medication is reconstituted before the user attempts to connect a delivery device (e.g., a syringe, an infusion pump, etc.) to the reconstitution device. This can help prevent the user from prematurely removing the medication before reconstitution is complete. Furthermore, if a vacuum is used to transfer fluid between the first and second containers, such an arrangement can ensure that the vacuum within the containers is maintained until pressure equalizes between the first and second containers. Specifically, such an arrangement can avoid air being drawn into the flow path through the fluid outlet.

[0113] In some embodiments, the reconstitution device includes a housing having an upper portion and a lower portion, the lower portion being slidably received within the upper portion. The upper portion can be configured to hold at least two containers, and the lower portion can include at least one spike for each of the at least two containers. The upper portion can be configured to at least partially surround the at least two containers and selectively hold them at a distance from the spikes disposed within the lower portion prior to activation of the device. The upper portion can be configured to apply a force to the at least two containers when the upper portion slides from a first, inactivated position to a second, activated position in which the upper portion approaches the lower portion. Specifically, the bottommost surface of the upper portion can be closer to the base of the lower portion. When the upper portion moves to the activated position, the at least two containers can be punctured by one or more associated spikes. When punctured, the containers can be placed in fluid communication, thereby allowing fluid from one container to flow from the first container to the second container, and allowing the medicinal product in the second container to be reconstituted with the fluid from the first container. The spike can be fluidly connected to a fluid outlet, which can be held in the lower portion of the housing. The upper part of the housing is configured to cover or otherwise prevent physical user access to the fluid outlet when the upper part is in the inactivated position. Activation of the reconstitution device allows physical access to the fluid outlet. For example, in one embodiment, a cutout in the upper part is configured to expose the fluid outlet when the upper part is moved to the activated position. In some embodiments, the fluid outlet can be connected to one or more spikes via flexible tubing, thereby allowing the fluid outlet to move relative to the spikes. According to this embodiment, the fluid outlet can be accessed and removed from the lower housing through the cutout when the upper part is in the activated position. Once removed, a delivery device (e.g., a syringe) can be coupled to the fluid outlet and used to withdraw the reconstituted medication. In some embodiments, the fluid outlet can include a port cap configured to seal the fluid outlet and prevent air from entering the flow path between the spike and the fluid outlet until it is removed. According to this embodiment, the port cap cannot be accessed and removed from the fluid outlet until the upper part is in the activated position.

[0114] Although some embodiments described herein use flexible tubing that allows a user to move the fluid outlet relative to the reconstitution device housing, other configurations can be used in which the fluid outlet is physically blocked until the reconstitution device is actuated. For example, in some embodiments, the fluid outlet can be rigidly attached to the reconstitution device housing. In some embodiments, the fluid outlet can be fixed relative to a lower portion of the housing. In some embodiments, the fluid outlet can be movably fixed to the reconstitution device housing. For example, in some embodiments, the fluid outlet can be coupled to the reconstitution device housing with a pin, thereby allowing the fluid outlet to rotate relative to the housing. In such embodiments, actuation of the reconstitution device can rotate the fluid outlet from a first rotational position to a second rotational position. In another embodiment, the fluid outlet can be positioned on a ball that is positioned within a socket formed on the reconstitution device housing. In such an arrangement, the angle of the fluid outlet relative to the housing can be adjusted, but the fluid outlet may not be removable from the housing. Of course, the fluid outlet can have any suitable arrangement and can be associated with any suitable portion of the reconstitution device housing, and the disclosure is not so limited. For example, the fluid outlet can be located in the lower, middle, or upper portion of the reconstitution device housing (e.g., the upper third, middle third, or lower third). The fluid outlet can be flexibly connected to the reconstitution device housing, can be movable about a hinge or pivot, or can be fixed relative to the housing.

[0115] In some embodiments, the reconstitution device can include a fluid outlet releasably attached to the reconstitution device outlet. The fluid outlet can also be coupled to a flexible tube disposed inside the reconstitution device housing when the fluid outlet is releasably attached to the housing. The fluid outlet can be securely held in the lower, middle, or upper third of the reconstitution device housing and can be physically accessible to the user only after the reconstitution device housing is actuated. Once the fluid outlet is physically accessible, a delivery device can be coupled to the fluid outlet. For example, a delivery device (e.g., a syringe) can be coupled to the fluid outlet with a twisting motion. Of course, any suitable motion can be used to couple the delivery device to the fluid outlet, as the disclosure is not so limited. Once the delivery device is coupled, a user can use the delivery device to pull or apply force to the fluid outlet to detach it from the reconstitution device housing. Once detached, the fluid outlet can move relative to the reconstitution device housing, thereby extending the flexible tube.

[0116] The inventors have recognized the benefits of facilitating directional flow to ensure proper dosing and reconstitution. Specifically, the inventors have recognized the benefits of a check valve or other one-way valve in facilitating one-way flow from a first container to a second container. In some embodiments, a check valve or other one-way valve can be disposed in the flow path between the first container and the second container. During the reconstitution process, the reconstitution fluid can flow from the first container to the second container and be retained within the second container by the check valve. Such an arrangement can help prevent backflow and loss of fluid or reconstituted medicinal product from the second container.

[0117] In some embodiments, a transfer engine for a reconstitution device includes a first flow path extending between an inlet and a first spike, a second flow path extending between the first spike and a second spike, and a third flow path extending between the second spike and a fluid outlet. In some embodiments, a check valve is disposed along the second flow path. The check valve is configured to allow flow from the first spike to the second spike but prevent flow in the opposite direction. Thus, when a first container containing reconstitution fluid is punctured and fluidly connected by the first spike, fluid can flow from the first container through the second flow path to the second container. When a second container containing a pharmaceutical product for reconstitution is punctured and fluidly connected by the second spike, fluid from the first container can flow into the second container but may not flow back into the first container due to the presence of the check valve. In some embodiments, the second container can contain at least a partial vacuum, while the internal pressure of the first container can be atmospheric or greater, such that a pressure differential between the first and second containers urges fluid in the first container to flow to the second container. The pressure differential can be configured to allow all of the fluid from the first container to flow through the check valve toward the second container and mix with and reconstitute the pharmaceutical agent. The check valve prevents backflow of the reconstituted pharmaceutical agent, ensuring that the correct dose of the reconstituted pharmaceutical agent is retained in the second container and accessible to a delivery device (e.g., a syringe) via the fluid outlet.

[0118] The inventors have recognized the advantage of improving stirring and mixing during the reconstitution process without requiring the user to handle one or more containers. Specifically, the inventors have recognized the advantage of a check valve positioned between a first container and a second container, retaining fluid in the second container and preventing backflow into the first container. When a reconstituted or partially reconstituted pharmaceutical product is withdrawn and placed into the second container using a delivery device (e.g., a syringe), the fluid can be stirred to facilitate mixing, while remaining accessible to the delivery device in the second container. The delivery device can then be used to effectively stir and mix the pharmaceutical product to ensure it is completely dissolved or rehydrated before administration.

[0119] In some embodiments, the reconstitution device includes a first container and a second container disposed within an upper portion of a housing, the upper portion of the housing at least partially enclosing the first and second containers. In some embodiments, a method of performing a reconstitution process includes applying a force to the upper portion to move the upper portion from a first inactive position to a second active position. The first container can be punctured with a first spike disposed in the lower portion of the housing, and the second container can be punctured with a second spike disposed in the lower portion of the housing, and the upper portion moves to the second active position. Upon puncturing, fluid can flow from the first container to the second container, creating a vacuum or low-pressure volume within the second container. As the fluid flows from the first container to the second container, the fluid can flow through a check valve configured to prevent flow in the opposite direction (i.e., back toward the first container). The method also includes withdrawing at least a portion of the fluid from the second container using a syringe via the fluid outlet. Once at least a portion of the fluid has been withdrawn, the fluid can be redeposited into the second container using the syringe. The syringe can be used to withdraw and reconstitute fluid from the second container until the medication in the second container is sufficiently mixed and reconstituted. While fluid is being transferred to and from the second container, a check valve can ensure that the fluid or medication does not return to the first container. Once reconstituted, the medication can be withdrawn completely by the syringe and then self-administered by the user or administered to a patient.

[0120] While some embodiments described herein are directed to reconstitution devices, it should be understood that the various mechanisms and methods described herein can be used with drug solution delivery devices that are not necessarily used for reconstitution. For example, in some embodiments, the drug solution delivery device can be used with only a single container (e.g., to access the contents of a single container for delivery to a patient). In another example, the drug solution delivery device can be used to pool contents from multiple containers without reconstitution. However, in other embodiments, the drug solution delivery device can both reconstitute and pool (e.g., access the contents of two or more containers containing fluids and one or more containers containing solids). Thus, the various mechanisms and methods described herein are applicable to drug solution delivery devices having any number of containers, as the disclosure is not so limited.

[0121] The inventors have also recognized the benefit of a reconstitution or medication delivery device that provides cues to a user practicing self-administration, either via one or more alerts on the reconstitution device itself or via a complementary device. The reconstitution or medication delivery device can provide visual, audible, and / or tactile alerts to the user about the status of the reconstitution process; such an arrangement can simplify the reconstitution or medication delivery process for the user.

[0122] In some embodiments, the reconstitution or drug solution delivery device can include a first container having a fluid (e.g., a reconstitution fluid) and a second container having a pharmaceutical agent (e.g., a lyophilized pharmaceutical agent). The reconstitution or drug solution delivery device can also include a power source (e.g., a battery), a processor, and at least one indicator (e.g., an alert module). The at least one indicator can include a visual indicator (e.g., an LED, a display screen, etc.), an audible indicator (e.g., a speaker), and / or a tactile indicator (e.g., an eccentric rotating mass actuator, a linear resonant actuator, a piezoelectric actuator, etc.). The at least one indicator can indicate one or more states of the reconstitution or drug solution delivery device during the reconstitution or drug solution delivery process. For example, in one embodiment, the at least one indicator can indicate when the reconstitution device is actuated and the reconstitution fluid is flowing and mixing with the pharmaceutical agent. In another example, the at least one indicator can indicate when the reconstitution fluid has had an appropriate time to mix with the pharmaceutical agent, thereby indicating when the pharmaceutical agent is appropriate for withdrawal from the reconstitution device using a delivery device (e.g., a syringe). In yet another example, the reconstitution or medication delivery device can include an orientation sensor (e.g., an accelerometer, a gyroscope, etc.), and the indicator can indicate when the reconstitution or medication delivery device is in a predetermined orientation, or conversely, when the reconstitution or medication delivery device is in an orientation different from the predetermined orientation. In some embodiments, the reconstitution or medication delivery device can include a communication device (e.g., a wireless transceiver that transmits and receives wireless signals using one or more of Bluetooth, Bluetooth Low-Energy, Wi-Fi, 802.15.4, ZigBee, GSM, HSPA, CDMA, and / or any other suitable protocol). The communication device can be used to communicate and send one or more alerts to a remote device (e.g., a smartphone, a pager, a personal computer, a tablet, etc.). The remote device then provides the alert to the user via a visual, audible, and / or tactile indicator.

[0123] The inventors have also recognized the advantages of a medical fluid delivery device configured to communicate with one or more remote devices. The medical fluid delivery device can be configured to communicate information to one or more remote devices. For example, in some embodiments, dosage, time, and / or one or more sensor values ​​(e.g., temperature, orientation, etc.) can be communicated to a remote device, thereby allowing the one or more remote devices to track a treatment schedule or otherwise record information regarding the use of the medical fluid delivery device. In some embodiments, the medical fluid delivery device can include a marker that is revealed or otherwise accessible (e.g., physically accessible, visually accessible, or wirelessly accessible) when the medical fluid delivery device is activated. In other embodiments, a communication module of the medical fluid delivery device can be activated by a trigger when the medical fluid delivery device is activated.

[0124] In some embodiments, the medical fluid delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion. Similar to the previous embodiment, the upper portion may be movable relative to the lower portion between an inactive position (e.g., an upper position) and an active position (e.g., a lower position). The medical fluid delivery device may also include a fluid outlet configured to deliver fluid from a container disposed within the housing when the upper portion is in the active position. In some embodiments, the fluid outlet may be inaccessible to a user when the upper portion is in the inactive position. According to such embodiments, physical access to the fluid outlet and / or the fluid outlet may be revealed by moving the upper portion to the active position. The medical fluid delivery device may also include a marker configured to be readable by a remote device (e.g., a smartphone) when accessible. For example, the marker may be a QR code, a barcode, a radio frequency identification (RFID) tag, a near field communication (NFC) tag, or another suitable marker. The marker may be unpowered, such that the medical fluid delivery device does not include an on-board power source. In some embodiments, the markers may be partially obscured when the top is in the inactivated position and accessible to a user when the top is in the activated position. For example, in some embodiments, the top may enclose the markers in the inactivated position and expose the markers (e.g., via a cutout) in the activated position. The markers can be used by a remote device to obtain information about the medication delivery device, such as dosage, date of manufacture, etc.

[0125] In some embodiments, the medication delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion. Similar to the previous embodiment, the upper portion is movable relative to the lower portion between an inactive position (e.g., an upper position) and an active position (e.g., a lower position). The medication delivery device can also include a fluid outlet configured to deliver fluid from a container disposed within the housing when the upper portion is in the active position. In some embodiments, the fluid outlet may be inaccessible to a user when the upper portion is in the inactive position. According to such embodiments, moving the upper portion to the active position can allow physical access to the fluid outlet and / or reveal the fluid outlet. The medication delivery device can also include a communications module configured to transmit messages via at least one communications protocol (e.g., Bluetooth, Bluetooth Low-Energy, Wi-Fi, 802.15.4, ZigBee, GSM, HSPA, CDMA, and / or any other suitable protocol). The communications module may be configured to transmit a message containing information about the medication delivery device (e.g., dosage, medication identification, time, and / or one or more sensor values, such as temperature, orientation, etc.) to a remote device (e.g., a smartphone). The medication delivery device may also include a trigger configured to activate the communications module when the top is moved to the activated position. Such an arrangement can ensure that the communications module consumes little or no power before activation, such that the power source of the medication delivery device has sufficient power for the communications module for a desired shelf life. In some embodiments, the trigger may be a switch, a Hall effect sensor, a strain gauge, or other suitable sensor configured to detect the top moving to the activated position.

[0126] The inventors have recognized the benefits of a reconstitution device that provides a mechanical advantage and / or electromechanical assistance to the user to reduce the force used to actuate the reconstitution device compared to conventional reconstitution devices. Such an arrangement may allow for easier and more consistent actuation of the reconstitution device by the user.

[0127] In some embodiments, the upper and lower housing portions are operably coupled via a screw mechanism, such that a rotational force applied to the screw mechanism applies a linear force, moving the upper portion toward the lower portion, providing a mechanical advantage over direct application of the linear force. As another example, in some embodiments, a lever is coupled to the lower housing portion, such that a linear force applied to the lever magnifies the force applied to the upper portion of the housing, causing the upper portion of the housing to move toward the lower portion. In yet another embodiment, the upper housing portion can include a ramp squeeze mechanism, such that squeezing at least one wedge including a ramp in a direction parallel to the surface on which the reconstitution device is placed can push the upper housing portion toward the lower housing portion (or the two containers toward corresponding spikes). Of course, the present disclosure is not so limited; any suitable arrangement, with or without a mechanical advantage, can be used for the reconstitution device. Some embodiments of reconstitution devices that include a mechanical advantage are further described with reference to FIGS. 19A-21B.

[0128] In some embodiments, the housing of the reconfiguration device may include a mechanical or electromechanical actuator that reduces the actuation force of the reconfiguration device. For example, the reconfiguration device may include one or more of a spring (e.g., compression, tension, torsion, air), a servo, a motor, and a linear actuator. According to some embodiments, the reconfiguration device may include a power source (e.g., a battery) that may power the electromechanical actuator. The actuator may be actuated by a user to correspondingly actuate the reconfiguration device. Various user input devices, including but not limited to, a button or switch, may be used for such actuation. In embodiments in which a mechanical assist element (e.g., a spring) is used, the user may operate a release to actuate the reconfiguration device. That is, the spring or other mechanical assist element may be pre-biased (i.e., store potential energy), which may be used to actuate the device when released. Of course, any mechanical or electromechanical assist configuration, or combination thereof, may be used in the reconfiguration device, as the disclosure is not so limited.

[0129] The inventors have also recognized the advantages of a modular drug delivery device that can be used to deliver a wide range of drug solutions in different amounts. Specifically, the inventors have recognized the advantages of a modular transfer engine that includes multiple adapters that can be replaced or expanded depending on a given fluid delivery application. The adapter can include at least one fluid channel configured to connect to at least one second fluid channel of another adapter. Additionally, the adapter can include a coupling spaced apart from the at least one fluid channel that can be used to physically interlock the adapter with another adapter. In this manner, the transfer engine can include any number of adapters in any desired configuration to deliver drug solutions. The modular transfer engine can be used to reconstitute lyophilized solids, pool multiple drug solutions, or access a single container.

[0130] In some embodiments, the drug delivery device may be modular. A modular drug delivery device may include an inlet adapter, an intermediate adapter, and an outlet adapter. The drug delivery device may be configured to use any number of intermediate adapters in a modular manner to accommodate a particular delivery volume. In some embodiments, the inlet adapter, the intermediate adapter, and the outlet adapter may all be configured to fluidly connect to the container. For example, the inlet adapter, the intermediate adapter, and the outlet adapter may all include a spike configured to puncture the container and fluidly connect the container to the respective adapter. The inlet adapter may include an inlet adapter fluid channel and an inlet adapter coupling. The intermediate adapter may include a first intermediate fluid channel, a second intermediate fluid channel, a first intermediate adapter coupling, and a second intermediate adapter coupling. The outlet adapter may include an outlet adapter fluid channel and an outlet adapter coupling. The first intermediate adapter coupling is configured to connect with the inlet adapter coupling, and the second intermediate adapter coupling is configured to connect with the outlet adapter coupling. Similarly, the inlet adapter fluid channel is configured to fluidly connect to the first intermediate fluid channel, and the outlet adapter fluid channel is configured to fluidly connect to the second intermediate fluid channel. The fluidic channels may be separate from and spaced apart from the couplings, such that the adapters may be physically connected to one another (e.g., via fluidic channels) separately from the fluidic connections (e.g., via the couplings). If additional intermediate adapters are desired, the additional intermediate adapters may be identical to the first intermediate adapter and may be configured to fluidly and physically attach to the first intermediate adapter and the inlet adapter, or the first intermediate adapter and the outlet adapter. In some embodiments, the additional intermediate adapters may not be identical to the first intermediate adapter, but may nevertheless be configured to fluidly and physically attach to the first intermediate adapter and the inlet adapter, or the first intermediate adapter and the outlet adapter.Of course, any suitable number of intermediate adapters may be used as the disclosure is not so limited. Further, it should be noted that the modular liquid medication delivery device may be used to reconstitute solid medications stored in one or more containers, to pool liquid medications from one or more containers or any combination of reconstitution and pooling, or to access the contents of just one container.

[0131] For purposes of this disclosure, the term "coupled" (in all its forms, coupled, connecting, coupled, etc.) generally means joining two components to one another directly or indirectly. Such a connection may be static in nature or movable in nature, may be achieved by the two components and any additional intermediate members being integrally formed with each other or with the two components as a single unit, and may be permanent in nature or removable or releasable in nature, unless otherwise specified.

[0132] While specific embodiments of the device are further described herein, other alternative embodiments of all components associated with the reconstitution device are interchangeable to suit different applications. With reference to the drawings, specific, non-limiting embodiments of the reconstitution device and corresponding methods are described in further detail. It should be understood that the present disclosure is not limited to only the specific embodiments described herein, and that the various systems, components, mechanisms, and methods described with respect to these embodiments may be used individually and / or in any desired combination.

[0133] FIG. 1 is a schematic diagram of one embodiment of a transfer engine 100 that can be used in a reconstitution device or other mixing device. As shown in FIG. 1, the transfer engine includes a first spike 102 and a second spike 105, each configured to pierce a rubber stopper, septum, or any other suitable seal of a container. The first spike 102 is associated with a first flow path 103 and a second flow path 104. Specifically, a first open end of the first flow path is disposed within the first spike, as is a second open end of the second flow path. The portions of the first and second flow paths disposed within the first spike are parallel to each other and together define a first container-receiving end. According to the embodiment of FIG. 1, the first flow path is associated with an inlet 108. In the illustrated embodiment, the inlet is configured as an air inlet and includes a hydrophobic filter configured to allow air to enter the first flow path, while preventing any liquid from crossing the hydrophobic filter. Of course, any suitable inlet or vent that allows air to enter the transfer engine can be used, as the disclosure is not so limited. In some embodiments, the air inlet may be configured as a check valve configured to allow air into the first flow path while preventing air or fluid from exiting the first flow path. The second flow path extends between the first spike and the second spike 105. A check valve 109 is disposed along the second flow path 104. The check valve 109 is configured to allow fluid and air to flow through the second flow path in a direction from the first spike toward the second spike, but not vice versa. The third flow path 107 also has a fourth open end that is also disposed within the second spike and extends from the fourth open end to the outlet 111. The portions of the second flow path and the third flow path disposed within the second spike are parallel to each other and together define a second container-receiving end. The outlet in the illustrated embodiment is configured as a Luer-activated valve. Of course, any suitable valve or fluid outlet connection may be used with transfer engine 100, as the disclosure is not so limited.For example, in other embodiments, other suitable fluid outlets may be used with the transfer engine, including, but not limited to, luer activation devices, simple luer or other threaded connectors, slip-fit ​​connectors, and puncturable septa. According to the embodiment of Figure 1, the transfer engine also includes a drug filter 110 disposed in the third flow path and configured to filter drug precipitates or undissolved drug from the fluid flowing to the outlet.

[0134] According to the transfer engine of FIG. 1 , the first container receiving end and the second container receiving end are each configured to receive a first container and a second container, respectively. The first container may be configured to contain a reconstitution fluid (e.g., sterile water for injection), and the second container may contain a pharmaceutical product (e.g., a dry formulation) for reconstitution. When the first container is punctured by the first spike 102 and the second container is punctured by the second spike 105, fluid from the first container can flow into the second container and mix with the pharmaceutical product to form a pharmaceutical product solution. The check valve 109 can retain the pharmaceutical product solution in the second container and prevent backflow of the pharmaceutical product solution from the second container to the first container. Once the pharmaceutical product solution is placed in the second container, the pharmaceutical product solution can be withdrawn via the outlet 111 using a delivery device such as a syringe. One embodiment of the reconstitution process is further described with reference to FIGS. 3-6.

[0135] FIG. 2 is a perspective view of one embodiment of a reconstitution device 200. The reconstitution device shown in FIG. 2 can include a transfer device (e.g., a transfer device similar to that of FIG. 1) configured to reconstitute a drug solution using two containers. That is, the reconstitution device of FIG. 2 is configured to accommodate two containers and to reconstitute and deliver a drug. As shown in FIG. 2, the reconstitution device includes a housing 201 having an upper portion 202 and a lower portion 204. According to the embodiment shown in FIG. 2, the upper portion 202 is slidable relative to the lower portion 204 between an activated position and an inactivated position. Examples of this sliding motion and associated mechanisms are further described with reference to the embodiments of FIGS. 7-12. The lower portion 204 is formed as a flat base capable of supporting the reconstitution device in a stable orientation on a flat surface, such as a table, desk, or countertop. In contrast, the upper portion 202 includes a rounded upper surface 203, such that the reconstitution device is not supported in a stable orientation by the rounded upper portion when placed on a flat surface. 2 is configured to have a primary orientation that provides stability when the housing is placed on a flat surface. In this primary orientation, force can also be applied to the upper portion 202 while the lower portion 204 prevents rotation of the housing. Additionally, the rounded upper surface 203 is configured to provide a handle for a user to grasp, facilitating correct use of the reconstitution device.

[0136] According to the embodiment of FIG. 2, the reconstitution device is configured to accommodate two containers. As mentioned above, the two containers may be joined by a transfer engine disposed in the reconstitution device, exemplary embodiments of which are described herein. Each container may contain a specific dose of a medication and / or reconstitution fluid. Before reconstituting and administering a medication solution, a patient may want to verify that the correct size and dosage of container is placed in the reconstitution device, especially if the container is enclosed and non-removable by the upper portion 202 of the housing 201. Accordingly, in the embodiment of FIG. 2, the upper portion 202 includes windows 206A, 206B configured to allow a user to view the interior of the upper portion. Specifically, the windows 206A, 206B can be aligned with a label on the container disposed inside the housing, allowing the user to obtain information about the medication in the container, such as the medication type, volume, dosage, etc. The windows 206A, 206B have covers that prevent a user from inserting their fingers into the reconstitution device. According to the embodiment of FIG. 2, the upper portion also includes a window 210 that further improves visibility of the label. In some embodiments, the window 210 allows a user to touch and rotate the container adjacent to the window to better view the container label. Such windows can be located on both sides of the top, allowing both containers located within the housing to be visible and / or conveniently rotated to view the label. In some embodiments, the window of the reconstitution device housing may include a magnifying lens to allow a user to more easily read text on the containers located within the reconstitution device housing. In some embodiments, an LED or other suitable lighting element can be located inside the top to illuminate any labels on the containers and / or provide one or more visual alerts to the user. Illumination of the container may be beneficial for medications for which patient visualization is desirable. In some embodiments, the lighting element can emit light at a wavelength that is less susceptible to degradation of the medication located within the container. Such an arrangement may be beneficial for some photosensitive medications. In some embodiments, the reconstitution device may not have a window, but may be positioned to conceal the containers inside the housing.As an example, such an arrangement may be suitable for photosensitive pharmaceuticals that are susceptible to photodegradation.

[0137] According to the embodiment of FIG. 2, reconfiguration device 200 is configured to block access to a fluid outlet of a transport engine disposed within housing 201 prior to device actuation, and subsequently allow access to the fluid outlet after device actuation. That is, sliding of upper portion 202 relative to lower portion 204 selectively exposes or covers the fluid outlet depending on the position of the upper portion relative to the lower portion. In some embodiments, the reconfiguration device blocks access to the fluid outlet by both hiding the fluid outlet from a user and physically blocking access to the fluid outlet. In other embodiments, the fluid outlet is visible to a user prior to device actuation, but access to the fluid outlet is blocked, for example, by a physical obstruction.

[0138] In the embodiment of Figure 2, as shown in Figures 9-10B, the top includes a slot 208 that forms part of a larger cutout that exposes the fluid outlet when the top is in the actuated position as shown in Figures 10A, 10B, allowing it to be physically accessed and removed from the housing.

[0139] FIG. 3 is a schematic diagram of one embodiment of a transfer engine 100 for a reconstitution device during a first stage of one embodiment of a reconstitution and drug delivery process. According to the embodiment of FIGS. 3-6, the transfer engine is similar to the embodiment described in FIG. 1. A first flow path 103 extends between an inlet 108 and a first open end disposed on a first spike 102. A second flow path 104 extends between a second open end disposed on the first spike 102 and a third open end disposed on a second spike 105. A third flow path 107 extends between a fourth open end disposed on the second spike and an outlet 111. The first spike defines a first container-receiving end, and the second spike defines a second container-receiving end. The inlet 108 is configured as an air vent and includes a hydrophobic filter to allow air to enter the transfer engine but prevent fluid from exiting the transfer engine through the inlet. A check valve 109 may be included along the second flow path 104. The check valve 109 is configured to allow unidirectional fluid flow through the second flow path from the first spike to the second spike. The outlet 111 is configured as a Luer-activated valve that can accept a delivery device (e.g., a syringe) that can withdraw reconstituted medical fluid from the transfer engine. According to the embodiment of FIGS. 3-6, the transfer engine also includes a drug filter 110 disposed in the third flow path and configured to filter drug precipitates or undissolved pharmaceutical agent from the fluid flowing to the outlet. The drug filter may be positioned anywhere within the flow path between the outlet 111 and the fourth open end of the third flow path 107.

[0140] As shown in the embodiment of Figures 3-6, two containers are used with the transfer engine 100. Specifically, the first container 300 is configured to be punctured by the first spike 102. The first container contains a reconstitution fluid 302 sealed by a stopper 304. The reconstitution fluid may be sterile water for injection or another suitable fluid. The stopper 304 is configured as a stopper having a septum that can be punctured by the first spike 102. The stopper can be made of rubber, silicone, or other suitable materials. Of course, any suitable stopper or seal can be used, as the present disclosure is not so limited. The second container 350 is configured to be punctured by the second spike 105. The second container contains a pharmaceutical agent 352 disposed at the bottom of the second container opposite the stopper 354. Such an arrangement can ensure that the pharmaceutical agent does not block or otherwise impede fluid flow through either the second flow path 104 or the third flow path 107 via the third and fourth open ends, respectively. Of course, in other embodiments, the pharmaceutical agent may be disposed in another portion of the second container, and the disclosure is not so limited. For example, the pharmaceutical agent may be disposed adjacent to and abutting the stopper 354. In some embodiments, when the stopper 354 is punctured, even if the pharmaceutical agent abuts the second spike 105, fluid flow therethrough can disintegrate the pharmaceutical agent so that the flow path remains free. In some embodiments, the piercing tip of the spike can lift the pharmaceutical agent, keeping it away from the open end of the flow path. Like the stopper of the first container, the stopper 354 of the second container is configured as a stopper having a septum that can be punctured by the second spike 105. The pharmaceutical agent may be a lyophilized formulation that may be in powder form to facilitate dissolution in the reconstitution fluid. Of course, the pharmaceutical agent may take any suitable form, as the disclosure is not so limited. As shown in the embodiment of Figures 3-6, the first and second containers are inverted to allow gravity to urge the fluid in the containers toward the outlet 111 or otherwise toward a lower height portion of the transfer engine.Stated another way, in some embodiments, the first and second containers are positioned such that air within the containers is disposed within the containers at the end opposite the spike. Such an arrangement can ensure that fluid is drawn through the spike before air within the containers. Additionally, in accordance with the embodiment of Figures 3-6, a 10 mL container is shown. However, any suitable size container can be used, including, but not limited to, containers having volumes of 0.1 mL, 0.3 mL, 0.5 mL, 1 mL, 1.25 mL, 2 mL, 2.5 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 40 mL, 50 mL, 75 mL, 100 mL, 200 mL, and 300 mL or greater.

[0141] As shown in FIG. 3 , the first container 300 is inverted and placed on the first spike 102. Similarly, the second container 350 is inverted and placed on the second spike 105. The stopper 304 of the first container and the stopper 354 of the second container are spaced apart from the first spike and the second spike, respectively, so that the first and second containers remain sealed and are not in fluid communication with the transfer engine 100. Thus, the state shown in FIG. 3 may be the state of the reconstitution device immediately prior to commencing the reconstitution process. The first and second containers may be held in a spaced apart relationship relative to the spikes 102, 105 such that the fluid 302 in the first container and the pharmaceutical agent 352 in the second container remain sterile and ready to use during transportation, storage, and delivery to an end user or patient. In some embodiments, the transfer engine 100 can be disposed in a first housing portion, and the first and second containers 300, 350 can be disposed in a second housing portion. The second housing portion can be selectively movable relative to the first housing portion at the start of a reconstitution process. When a reconstitution process has not been initiated, the second housing portion can ensure that the first and second containers remain sealed until the process is initiated. For example, in some embodiments, a pin or safety can be removed or otherwise activated by a user to allow the spike to puncture the containers. In another example, a threshold force applied to the second housing portion may be required before the first and second containers are punctured.

[0142] Figure 4 is a schematic diagram of the transfer engine 100 of Figure 3 during a second stage of the reconstitution and drug delivery process. According to the stage of Figure 4, the first container 300 and the second container 350 have been punctured by the first spike 102 and the second spike 105, respectively. According to the embodiment of Figure 4, the second container 350 is under at least a partial vacuum, such that the pressure inside the second container 350 is lower than the pressure inside the first container 300 and / or the atmospheric pressure surrounding the transfer engine. Thus, as shown in Figure 4, when the first container and the second container are punctured simultaneously, the pressure difference between the first container 300 and the second container 350 urges the reconstitution fluid 302 into the second container 350. In fact, as shown in FIG. 4 , the pressure difference may be so great that fluid 302 may be ejected from the third open end of second flow channel 104 and impinge upon pharmaceutical agent 352 disposed at the end of second container 350 opposite second spike 105. As the fluid is forced into second container 350, it mixes with the pharmaceutical agent to form a medicinal solution. The placement of the pharmaceutical agent at the bottom, away from second spike 105, is configured so that a jet of fluid 353 impinges upon and disperses the pharmaceutical agent, facilitating mixing of the pharmaceutical agent with the reconstitution fluid. In some embodiments, pharmaceutical agent 352 dissolves in the reconstitution fluid. In other embodiments, the pharmaceutical agent rehydrates the pharmaceutical agent.

[0143] In some embodiments, at least one spike of the reconstitution device can include an open end for an internal lumen (i.e., a flow path) that directs fluid flow into the container at an angle. For example, in some embodiments, the spike's internal lumen can terminate in an open end disposed on a side of the spike. That is, the open end can be formed on a substantially vertical face of the spike, such that fluid flow through the spike is transverse to the spike's puncture direction. In some embodiments, the spike can include multiple open ends for the lumen so that flow is directed out multiple sides of the spike. In some embodiments, the open ends can be angled relative to the spike's puncture or insertion direction, so that fluid flow is directed at that angle. In some embodiments, the open end of the spike's internal lumen can be angled between 1 and 90 degrees relative to the spike's puncture direction. Depending on the angle of the open end and the particular spike's configuration, various types of fluid flow may be generated as fluid flows from the spike into the container. For example, flow at an angle relative to the spike's puncture direction can generate vortices inside the container. In some embodiments, the spike can include a flow nozzle that produces a gentle or otherwise slow atomized spray. Without wishing to be bound by theory, different medications can be more easily reconstituted depending on the flow. Furthermore, some medications may be damaged by particularly harsh or powerful flows. Thus, the exemplary embodiments described herein can use any suitable spike arrangement to produce a desired fluid flow inside the container.

[0144] As mentioned above, in some cases, certain harsh or powerful flows can damage or degrade different pharmaceuticals. Furthermore, some reconstituted pharmaceuticals may be susceptible to degradation under high fluid shear. Therefore, in some embodiments, one or more flow paths of the transfer engine can include a flow restrictor or otherwise be configured to limit the flow rate between the first container, the second container, and the outlet. For example, in some embodiments, the diameter of the flow path between the first container and the second container can have a smaller cross-sectional area than the cross-sectional area of ​​the flow paths elsewhere in the transfer engine. In some embodiments, the flow path between the second container and the fluid outlet can have a smaller cross-sectional area than the cross-sectional area of ​​the flow paths elsewhere in the transfer engine. In some embodiments, the flow path can include a flow check valve configured to close if the fluid flow rate is too high. Such a configuration can ensure that the fluid flows at the correct rate and that the pharmaceutical is not accidentally damaged as it is drawn into the delivery device.

[0145] Of course, the reconstitution fluid and pharmaceutical agent can take any initial form to ultimately form the drug solution, as the disclosure is not so limited. Furthermore, the exemplary transfer engine and process shown in Figure 4 can be used to mix two fluids, which may be the same or different fluids, as the disclosure is not so limited.

[0146] According to the embodiment of FIG. 4 , when the reconstitution fluid 302 flows into the second container 350, the fluid 302 is prevented from flowing back into the first container 300 by the check valve 109. The pressure differential between the first container 300 and the second container 350 can be configured to allow substantially all of the reconstitution fluid to flow through the check valve 109. As fluid is expelled from the first container 300, air enters the inlet 108 to replace the flowing fluid. Thus, when the pressures are equalized between the first container, the second container, and the atmosphere, the first container contains air, and the second container contains both the reconstitution fluid and the pharmaceutical agent. Such an arrangement can help prevent some of the reconstitution fluid from flowing back into the first container 300. In some cases, fluid flowing back into the first container 300 can be difficult to extract from the transfer engine. Additionally, the check valve may help ensure that the entire dose of medicinal product remains in the second container 350 to be mixed and reconstituted, so that the entire dose or appropriate concentration can be withdrawn via the outlet 111.

[0147] In some embodiments, when pressure equalizes between first container 300, second container 350, and atmospheric pressure, the pharmaceutical agent has not yet fully combined with the reconstitution fluid. Thus, in some embodiments, a user can swirl or shake transfer engine 100 or a device including a transfer engine to ensure proper mixing of reconstitution fluid 302 and pharmaceutical agent 352. In some embodiments, a delivery device can be used to agitate and mix the reconstitution fluid and pharmaceutical agent, as further described with reference to FIG. 6 .

[0148] FIG. 5 is a schematic diagram of the transfer engine 100 of FIG. 3 during a third stage of the reconstitution and drug solution delivery process. As shown in FIG. 5, a delivery device is connected to the outlet 111. The delivery device in FIG. 5 is a syringe 400 including a handle 402 connected to a plunger 404. The syringe may be connected to the outlet using a Luer lock connector or any other suitable fluid and mechanical connection. In the state of FIG. 5, the handle is pulled away from the transfer engine 100, filling the syringe with the drug solution 356 formed by the reconstituted drug solution shown in FIGS. 3-4. As shown in FIG. 5, the check valve 109 prevents the drug solution from flowing back into the first container 300. The drug solution is drawn from the second container 350 and replaced with air through the inlet 108, as indicated by the dashed arrow. According to the embodiment of FIG. 5, the filter 110 filters out any drug precipitate or undissolved drug being transferred to the syringe. Thus, when the medical solution 356 is fully reconstituted, the fluid can be drawn into the syringe 400 and then administered to the patient using an appropriate administration process.

[0149] In some embodiments, a further mixing step may be applied to facilitate reconstitution or other mixing of the contents of the containers. This mixing step may be optional in some embodiments. FIG. 6 is a schematic diagram of the transfer engine of FIG. 3 during a fourth stage of reconstitution of the reconstitution and drug solution delivery process. Specifically, in the state shown in FIG. 6, a syringe 400 is used to facilitate mixing of the drug solution 356, complementing or replacing other mixing methods, such as swirling and shaking, of the transfer engine 100. From the state shown in FIG. 5, in which the drug solution is at least partially drawn into the syringe, the syringe handle 402 can be pushed toward the transfer engine 100, correspondingly moving the plunger 404 and driving the drug solution back into the second container 350. Such action can facilitate combination of the medicinal product and the reconstitution fluid. As shown in FIG. 6, the drug solution is prevented from flowing back into the first container 300 by a check valve. Therefore, backflow of the drug solution into the second container can compress the air in the second container and increase the pressure of the drug solution. The process of withdrawing and depositing portions of the drug solution from the second container can be repeated until the drug solution is sufficiently combined for administration.

[0150] In some embodiments, the third flow path 107 can include an air outlet that allows the second container 350 to be depressurized. In one embodiment, the air outlet can be arranged as a one-way vent, allowing air to escape from the second container 350 via the third flow path 107, but preventing air from entering the second container. According to this embodiment, an air source located within the second container 350 can originate from the air inlet 108, such that the reconstitution fluid is drawn from the first container into the second container. However, when the syringe 400 is used to mix the medicinal solution 356 by transferring portions of the medicinal solution back and forth from the second container 350, the air outlet can effectively keep the pressure of the fluid constant, thereby reducing the force that would cause the fluid to return to and deposit in the second container. Of course, the air outlet can take any suitable form of a valve or filter and may be located in any suitable portion of the transfer engine 100 and / or the second container 350. For example, the air outlet may be located on the second container side of the check valve 109 in the second flow path 104. As another example, the air outlet may be located in the second container (e.g., at the bottom of the second container) to allow pressurized air above the medicinal solution 356 to escape.

[0151] FIG. 7 is a perspective view of one embodiment of the reconstitution device 200 in an inoperative state, while FIG. 8 illustrates the reconstitution device in an operative state. As shown in FIGS. 7-8, the reconstitution device includes a housing 201 including an upper portion 202 and a lower portion 204 arranged similarly to the housing described with reference to FIG. 2. The lower portion 204 includes an inner guide 205 that supports the upper portion 202 and allows the upper portion to slide relative to the lower portion 204. That is, the inner guide allows the upper portion to move linearly relative to the lower portion between the inoperative position shown in FIG. 7 and the operative position shown in FIG. 8. When the upper portion is in the inoperative position, a container disposed within the upper portion can be spaced apart from a transfer engine disposed in the lower portion 204. That is, the container may remain sealed and fluidly decoupled from the transfer engine. When the upper portion moves to the operative position shown in FIG. 8, the container moves toward the transfer engine, and the container area is each punctured by a spike, placing the container in fluid communication with the transfer engine, thereby initiating the reconstitution process, as shown in FIG. 8. Such an arrangement is further described with reference to FIGS. 11-12.

[0152] In some embodiments, the inner guide may include one or more engagement features that slidably engage with feature(s) on the top portion 202. For example, the inner guide may have grooves molded into it that receive fins on the top portion, with the fins slidable along the grooves. The components may be reversed so that the grooves are on the top portion and the fins are on the inner guide. Other sliding engagement arrangements may be used, such as other rails, elongated members extending through enclosed channels, or any other suitable sliding engagement arrangement.

[0153] According to the embodiment of FIGS. 7-8, the reconstitution device 200 includes an upper stop 207 formed on the upper portion 202 of the housing 201 and a lower stop 209 formed on the lower portion 204 of the housing. The upper and lower stops are formed as ledges configured to abut one another and prevent further movement of the upper portion 202 toward the lower portion 204 when the reconstitution device is subsequently actuated. That is, the upper and lower stops define an actuation position in which the upper and lower stops contact one another. In the embodiment of FIGS. 7-8, the upper and lower stops extend along the perimeters of the upper and lower portions of the housing, respectively. Of course, in other embodiments, the stops may have any suitable arrangement, and the disclosure is not so limited.

[0154] FIG. 9 is a side elevation view of the reconstitution device 200 of FIG. 7 in an unactuated state, and FIG. 10A is a side elevation view of the reconstitution device in an actuated state. FIGS. 9-10B specifically illustrate how physical access to the fluid outlet 111 of the reconstitution device is prevented prior to actuation. According to certain embodiments of FIGS. 9-10B, the fluid outlet 111 may be at least partially concealed or enclosed within the housing 201 prior to actuation. Upon actuation, the fluid outlet 111 may be exposed so that it can be accessed by a delivery device once the medicinal solution is reconstituted. As shown in FIG. 9 , the top 202 of the housing includes a slot 208 and a notch 212 that form an opening in the top of the housing. However, in the position shown in FIG. 9 , nothing is accessible through the notch 212 or the slot 208, except for a portion of the inner guide 205 in the bottom 204 of the housing 201. However, when the upper portion is moved toward the lower portion, the notch 212 aligns with the fluid outlet 111, thereby allowing physical access and removal of the fluid outlet. As shown in FIG. 9 , the fluid outlet 111 is disposed in a fluid outlet receptacle 213 formed in the lower portion 204. Thus, when the notch 212 aligns with the fluid outlet receptacle 213, the fluid outlet 111 is accessible and removable from the fluid outlet receptacle through the notch 212. To facilitate removal, the fluid outlet includes a flexible leash 112. User access to the flexible leash 112 is permitted upon aligning the notch 212 with the fluid outlet receptacle 213. In some embodiments, the leash can at least partially deploy when the notch is aligned with the fluid outlet receptacle. The leash allows a user to pull the fluid outlet 111 from outside the housing 201, thereby facilitating its removal. 10A-10B, the fluid outlet is connected to an associated transport engine via flexible tubing 114, allowing the fluid outlet to be removed and manipulated while housing 201 remains stationary. Flexible tubing 114 aligns with slot 208, allowing a portion of the flexible tubing to be released through the slot, allowing the fluid outlet to be manipulated.10A-10B, when the multiple containers are punctured, the fluid outlets 111 are exposed and accessible to the user for connecting a delivery device. Such an arrangement can ensure that the medical fluid is at least partially reconstituted before the delivery device is connected.

[0155] As shown in FIG. 10B , the fluid outlet 111 is disposed within a fluid outlet receptacle 213 and is physically accessible to a user when the reconstitution device is activated. According to the embodiment of FIG. 10B , the fluid outlet 111 is a luer-activated device including external threads 113 configured to receive corresponding threads on a syringe or other delivery device. The fluid outlet 111 includes a flexible leash 112 configured to fold within the reconstitution device housing and unfold when the device is activated. The leash 112 may be formed of any suitable flexible material, including plastic film, rubber, or the like. A user can pull on the leash to remove the fluid outlet 111, which may otherwise be difficult to grasp and remove from the fluid outlet receptacle 213. In some embodiments, the leash 112 may be disposed on a flexible tube 114 in place of the fluid outlet 111 so that the fluid outlet can be removed from the fluid outlet receptacle using the flexible tube. In some embodiments, the leash may be a molded sleeve that fits over at least a portion of the fluid outlet 111 and provides an area where a user can grasp the leash and use it to remove the fluid outlet from the fluid outlet receptacle.

[0156] Of course, while one embodiment of a housing that selectively allows physical access to the fluid outlet is shown and described with reference to FIGS. 9-10B , other suitable configurations are contemplated. For example, in one embodiment, the upper housing may not include a cutout, but instead, a wall of the upper housing may be moved out of alignment with the fluid outlet receptacle. In another embodiment, a movable component (e.g., a cam, a door, etc.) may move simultaneously with actuation of the reconstitution device housing, thereby providing physical access to the fluid outlet only after actuation. In some embodiments, the fluid outlet may be visible to a user prior to actuation of the reconstitution device, but may be at least partially blocked so that the fluid outlet is not physically accessible. In one such embodiment, the fluid outlet receptacle may have an opening that is partially open when the reconstitution device is not actuated. When the reconstitution device is actuated, the opening of the receptacle may be widened or otherwise further opened so that the fluid outlet is physically accessible through the opening. Of course, the fluid outlet may be retained in any appropriate portion of the reconstitution device housing, including the lower portion of the housing or the upper portion of the housing, prior to actuation of the device, as the disclosure is not so limited. In some embodiments, the top of the housing is molded as shown in the embodiment of Figures 9-10B, but the housing is transparent, so that the fluid outlet is visible but not physically accessible prior to device activation.

[0157] FIG. 11 is a cross-sectional view of the reconstitution device of FIG. 7 taken along line 11-11 showing the reconstitution device with the container in an inactive state, while FIG. 12 is a cross-sectional view of the reconstitution device of FIG. 8 taken along line 12-12 showing the reconstitution device with the container in an active state. As shown in FIG. 11 and described above, the reconstitution device includes a housing 201 having an upper portion 202 and a lower portion 204. The lower portion is slidably disposed within the upper portion, and an inner guide 205 provides a sliding interface with the upper portion. As shown in FIGS. 11-12, a first container 300 and a second container 350 are disposed within the upper portion 202. In FIG. 11, the first and second containers are spaced apart from the first and second spikes 102 and 105 of the transfer engine, respectively, thereby maintaining the first and second containers sealed. In FIG. 12 , the first and second containers are moved toward the spikes 102, 105, causing the spikes to simultaneously puncture the stopper 304 of the first container and the stopper 354 of the second container. When moving from the inactive position to the active position, the user can place the lower portion 204 of the housing 201 on a flat surface to act as a base. The user can then apply force to the curved upper surface 203 of the housing to move the upper portion 202 toward the lower portion 204, thereby moving the first and second containers 300, 350 into contact with the spikes. Once the first and second containers are punctured, the reconstitution process can begin, exemplary embodiments of which were previously described with reference to FIGS. 3-6.

[0158] While a specific embodiment of the housing 201 is shown in FIGS. 11-12 , it should be noted that the housing can take any suitable shape to allow the two containers to selectively move toward one or more container-receiving ends of the fluid transfer engine. For example, in one embodiment, the upper portion of the housing can be nested inside the lower portion. In another embodiment, the upper surface 203 of the housing may be non-curved or may be curved to a lesser extent. Additionally, the upper housing can include one or more retention mechanisms to secure the first container 300 and the second container 350 therein. For example, tabs, protrusions, and / or shelves corresponding to the shape of the containers can be used to maintain spacing between the containers and the transfer engine. Additionally, in some embodiments, one or more biasing members can be used to bias the reconstitution device toward a non-actuated position, thereby requiring a threshold force on the upper portion to activate the reconstitution device.

[0159] In some embodiments, the transfer engine may be a separate component from the lower portion of the housing. That is, the transfer engine and housing of the reconstitution device may be formed separately. The lower portion of the housing may include a slot or transfer engine receiving portion configured to receive the transfer engine. The transfer engine may be secured to the lower portion with any suitable configuration, including, but not limited to, mechanical fasteners (e.g., screws, bolts, etc.), snap-fit ​​tabs, and adhesives (e.g., glue, epoxy, etc.). Such an arrangement may allow the transfer engine flow path to be sterilized before assembly with the reconstitution device housing. In some embodiments, the reconstitution device includes other components, such as pharmaceutical or electronic device containers, that may be sensitive to certain sterilization processes. In some embodiments, having a transfer engine that can be sterilized separately before assembly with the device housing eliminates the need to sterilize the entire reconstitution device and, therefore, avoids exposing components sensitive to certain sterilization processes.

[0160] In some embodiments, the reconstitution device can be stored and transported in a packaging container. The packaging container can be formed as a clamshell or blister pack having a shape corresponding to the shape of the housing of the reconstitution device. The packaging container can also include one or more protrusions or tabs that prevent the upper part of the housing from moving relative to the lower part of the housing, or vice versa. That is, one or more protrusions or tabs can engage with the upper part to hold the upper part in an inactivated position. Such an arrangement can ensure that the reconstitution device will not be accidentally activated during transportation and storage.

[0161] In some embodiments, a reconstitution device having a housing with an upper and lower portion movable relative to one another between an activated position and a non-activated position may include one or more locking latches that permanently lock the housing in the activated position after activation of the device. For example, in one embodiment, a latch located on the lower portion of the housing can capture and permanently hold the upper portion of the housing when the upper housing is moved to the activated position. The latch can be located inside the housing so that it is inaccessible to the user. Thus, the housing can be effectively locked in the activated position, and the upper portion cannot be non-destructively returned to the non-activated position. Such a location can prevent a user from disassembling the reconstitution device or discourage attempts to remove a used container from the reconstitution device.

[0162] FIG. 13 is a side elevation view of one embodiment of a transfer engine 100 of a reconstitution device. As shown in FIG. 13, the transfer engine includes a first spike 102 and a second spike. Similar to the schematic diagram described with reference to FIG. 1, the first spike 102 is associated with an air inlet 108 and a first flow channel 103. The air inlet includes a hydrophobic filter that allows air to enter the first flow channel 103 and prevents fluid from escaping the first flow channel. The second spike 105 is associated with a third flow channel 107 that extends to a fluid outlet connector 115. The second flow channel extends between the first spike 102 and the second spike 105, as will be further described with reference to FIG. 14. According to the embodiment of FIG. 13, a fluid outlet 111 is connected to the third flow channel 107 via a flexible tube 114, allowing the fluid outlet to move relative to the first and second spikes. Fluid outlet 111 is configured as a Luer-activated valve and includes a leash 112 configured to assist a user in removing the fluid outlet from the reconstitution device housing. According to the embodiment of Figure 13, fluid outlet 111 is adjacent to air inlet 108, thereby causing the transfer engine to effectively form a geometric circuit. Furthermore, in some embodiments shown in Figure 13, all of the flow path portions are flush with each other within the transfer engine.

[0163] In some embodiments, each of the spikes 102, 105 of the transfer engine 100 may have a corresponding sheath configured to seal and / or protect a fluid path disposed within the transfer engine. The sheath may be configured to be compressible and be broken by the spikes 102, 105 when the container is punctured by the spike. Such an arrangement may help the sterile fluid path of the transfer engine maintain sterility during storage and transport of the reconstitution device. Additionally, the sheath may provide a fluid seal for the spikes that prevents loss of any reconstitution fluid or pharmaceutical agent if one container is punctured and fluidly connected to the transfer engine before the other container.

[0164] FIG. 14 is a top cross-sectional view of the transfer engine 100 of FIG. 13 taken along line 14-14, illustrating the geometry of the various fluid paths. As shown in FIG. 14, the first fluid path 103 extends between the air inlet 108 and the location of the first spike 102. The first fluid path 103 defines a first lumen 120 within the first spike. The second fluid path 104 defines a second lumen 122 within the first spike and a third lumen 124 within the second spike 105. A check valve 109 is disposed along the second fluid path 104. Finally, the third fluid path 107 defines a fourth lumen 126 within the second spike and extends to the fluid outlet connector 115. As previously described, the fluid outlet connector can receive a flexible tube that creates a continuous fluid path to a movable fluid outlet.

[0165] According to the embodiment of FIG. 14 , the transport engine 100 is arranged in a compact rectangular shape. The parallel circuit arrangement of the channels and first and second spikes 102, 105 allows for a reduced size of the reconstitution device including the transport engine for ease of transportation and handling. That is, at least a portion of the channels curves upon itself rather than extending in a single straight path. As shown in FIG. 14 , portions of the first channel 103, second channel 104, and third channel 107 are all parallel to one another. In fact, each channel has a portion parallel to the longitudinal axis X-X of the transport engine. Furthermore, according to some embodiments shown in FIG. 14 , at least a portion of the first channel 103 can be mirrored across the longitudinal axis X-X to form at least a portion of the second channel 104. Similarly, at least a portion of the second channel 104 can be mirrored across the longitudinal axis X-X to form the third channel 107. Thus, the flow path is at least partially symmetrical across the longitudinal axis, reducing the overall size of the transfer engine. Note that although the first, second, and third flow paths in Figure 14 include curved portions where the flow path changes direction, any suitable arrangement for changing the direction of the flow path may be used. For example, in some embodiments, the flow path may include one or more angled portions that transition the direction of the flow path.

[0166] 14 shows a rectangular transfer engine, in other embodiments, the transfer engine may take any suitable shape. For example, the transfer engine may be circular, oval, square, or another suitable shape, and the disclosure is not limited in this respect.

[0167] According to the embodiment of FIG. 14, the transfer engine 100 can have a rectangular size well suited for placement in a compact reconstitution device. That is, the overall width W of the transfer device is less than the overall length L of the transfer device. Specifically, according to the embodiment of FIG. 14, the ratio between the length L and the width W can be 3 to 5. Thus, the length of the transfer engine can be 3 to 5 times longer than the width of the transfer engine, making it well suited for accommodating linearly arranged containers. Because the transfer engine can include movable fluid outlets connected via flexible tubing (see FIG. 13), the flow paths extending between the spikes 102, 105, the inlet 108, and the fluid outlet connector 115 can be arranged in parallel to reduce the overall size of a reconstitution device employing the transfer engine. In other words, the first flow path 103 and the third flow path 107 are wound around to extend parallel to the second flow path 104, thereby reducing the overall length of the transfer engine without substantially increasing its width. Of course, the present disclosure is not so limited; any suitable length-to-width ratio can be used in other embodiments.

[0168] FIG. 15 is a flowchart of one embodiment of a reconstitution and drug delivery process. In step 500, first and second containers are provided within a housing, with an upper portion of the housing at least partially enclosing the first and second containers. The first and second containers may contain a reconstitution fluid and a drug for reconstitution, respectively. In some embodiments, step 500 may be omitted, and the process may begin with step 502. In step 502, a force is applied to the upper portion of the housing, moving the upper portion from a first, inactive position to a second, active position. Applying the force to the upper portion may include applying the force to the upper portion in a linear direction toward a plane on which the housing is disposed. In step 504, the first container is punctured with the first spike, and the second container is punctured with the second spike as the upper portion moves to the active position. In step 506, fluid is allowed to flow from the first container to the second container, creating a vacuum within the second container. Allowing the fluid to flow to the second container may include discharging the fluid into the second container at a rate that may help move the fluid through a check valve disposed between the first spike and the second spike and facilitate reconstitution. In step 508, the fluid is mixed with a formulation or pharmaceutical agent in the second container to produce a medicinal solution. In step 510, a syringe (or other delivery device) is coupled to the fluid outlet to draw the medicinal solution from the second container.

[0169] FIG. 16 is a flowchart of another embodiment of a reconstitution and drug delivery process. In step 600, first and second containers are provided in a housing, with an upper portion of the housing at least partially enclosing the first and second containers. The first and second containers can contain a reconstitution fluid and a drug for reconstitution, respectively. In some embodiments, step 600 can be omitted, and the process can begin with step 602. In step 602, a force is applied to the upper portion of the housing, moving the upper portion from a first, inactive position to a second, active position. Applying the force to the upper portion can include applying the force to the upper portion in a linear direction toward a plane on which the housing is disposed. In step 604, the first container is punctured with the first spike, and the second container is punctured with the second spike as the upper portion moves to the active position. In step 606, fluid is allowed to flow from the first container to the second container, occupying a vacuum in the second container. Allowing the fluid to flow into the second container may include discharging the fluid into the second container at a rate that may help move the fluid through a check valve disposed between the first spike and the second spike and facilitate reconstitution. In step 608, a syringe is coupled to the fluid outlet to withdraw at least a portion of the medicinal solution from the second container. For example, in one embodiment, the syringe handle may be moved away from the fluid outlet. In step 610, the withdrawn portion of the medicinal solution is deposited back into the second container using the syringe. For example, step 610 may be accomplished by pushing the syringe handle toward the fluid outlet to increase the pressure of the medicinal solution.

[0170] 16 can be used in processes where there is no vacuum in the second container or where there is insufficient vacuum to draw the reconstitution fluid from the first container into the second container. In such embodiments, a syringe can be used to draw the fluid from the first container into the second container and ultimately into the syringe. Once the fluid is at least partially disposed in the syringe, the drawn portion of the fluid can be deposited back into the second container to mix the contents of the first and second containers with each other, and the process can be repeated until the contents of the first and second containers are sufficiently mixed.

[0171] FIG. 17 is a flowchart of another embodiment of a reconstitution and drug delivery process. In step 650, first and second containers are provided within a housing, with an upper portion of the housing at least partially enclosing the first and second containers. The first and second containers may contain a reconstitution fluid and a liquid drug for reconstitution, respectively. In some embodiments, step 650 may be omitted, and the process may begin with step 652. In step 652, a force is applied to the upper portion of the housing, moving the upper portion from a first, inactive position to a second, active position. Applying the force to the upper portion may include applying a force to the upper portion in a linear direction toward a plane on which the housing is disposed. In step 654, as the upper portion moves to the active position, the first container is punctured with the first spike, and the second container is punctured with the second spike. In step 656, fluid is allowed to flow from the first container to the second container. According to the embodiment of FIG. 17, fluid may not automatically flow from the first container to the second container. Nevertheless, the reconstitution fluid and the liquid medicinal product may at least partially mix when the container is punctured. In step 658, a syringe is coupled to the fluid outlet to withdraw at least a portion of the medicinal product from the second container. For example, in one embodiment, the syringe handle can be moved away from the fluid outlet. In step 658, all of the liquid medicinal product and reconstitution fluid may be withdrawn into the syringe in one withdrawal. In step 660, the withdrawn portion of the medicinal product is deposited back into the second container using the syringe. For example, step 660 can be accomplished by pushing the syringe handle toward the fluid outlet. Step 660 can be used if the medicinal product and reconstitution fluid are not sufficiently mixed. In some cases, steps 658 and 660 can be repeated to more thoroughly mix the reconstitution fluid and medicinal product.

[0172] FIG. 18 is a schematic diagram of one embodiment of a reconstruction device 700 that communicates with one or more remote devices. As shown in FIG. 18, the reconstruction device is similar in shape and size to the reconstruction device described with reference to FIG. 2. The reconstruction device includes a housing 701 including an upper portion 702 and a lower portion 704. The upper portion is configured to slide relative to the lower portion, and an inner guide 705 is received in the upper portion to support and guide the upper portion as it slides between an inactive position and an active position. According to the embodiment of FIG. 18, the reconstruction device 700 includes a processor 708 (e.g., a programmable logic controller) located in the lower portion 704, along with an internal power source configured as a communication device 710 and a battery 712. The processor is configured to execute a set of one or more computer-readable instructions stored in a volatile or non-volatile memory located in the lower portion 704. The communication device is configured to transmit signals via at least one of a wired and a wireless protocol. For example, the communications module may be configured as a wireless transceiver configured to communicate with one or more remote devices using one or more of Bluetooth, Bluetooth Low-Energy, Wi-Fi, 802.15.4, ZigBee, GSM, HSPA, CDMA, and / or any other suitable protocols. Battery 712 may be any suitable battery, such as a NiMH, Li-ion, or alkaline battery, as the disclosure is not so limited.

[0173] In some embodiments, the reconstitution device may include a marker, such as a QR code or other identification label (e.g., a barcode). Such a marker may be used to link the reconstitution device to an application (e.g., a smartphone application) or otherwise allow it to be tracked by a complementary remote device (e.g., a smartphone). In some embodiments, scanning the QR code with an appropriate reader or camera may populate the complementary remote device with information regarding medication dosage, medication identification, and / or the amount of medication placed in the reconstitution device for display to the user. The complementary device may also track timing, dosage, frequency, medication lot information, and other medically relevant parameters to allow a user or physician to monitor the extended treatment process. In some embodiments, the QR code or other marker may be hidden from view inside the reconstitution device housing or otherwise prevented from being accessed prior to device activation. Once the device is activated, the QR code is displayed or otherwise accessible for the user to scan.

[0174] According to some embodiments, and as shown in FIG. 18 , the electronics of the reconfiguration device can only operate when the reconfiguration device is activated. That is, when the upper portion 702 is in the inactive position, the processor 708 and communication device 710 may be in a hibernation state, a sleep state, or electrically disconnected from a power source. When the upper portion 702 moves to the active position (e.g., moving closer to the lower portion 704, e.g., so that the bottom-most surface of the upper portion moves closer to the base of the lower portion), one or more switches are triggered to wake up or connect the processor and communication devices to a power source. Thus, the on-board power supply may not be depleted during transportation and storage and may hold a sufficient charge to power the reconfiguration device when the device is activated. According to the embodiment of FIG. 18 , the reconfiguration device includes a first Hall effect sensor 716 and a second Hall effect sensor 718 disposed on the lower portion 704 of the housing. The Hall effect sensors are configured to sense the adjacent presence of a magnet 714 disposed on the upper housing. That is, a first Hall effect sensor is configured to sense when the top 702 is in the unactuated position, and a second Hall effect sensor is configured to sense when the top 702 is in the actuated position. When the magnet 714 moves adjacent to the second Hall effect sensor 718, the processor 708 and the communication device 710 may be activated. Of course, while Hall effect sensors are shown in FIG. 18, any suitable switch or sensor may be used to determine the position of the top, including, but not limited to, a linear potentiometer or a microswitch.

[0175] In some embodiments, and as shown in FIG. 18 , the reconstitution device 700 can include one or more visual indicators 720 configured as LEDs that indicate one or more states of the reconstitution device to a user. The visual indicators can be controlled by the processor 708 and activated by movement of the top portion 702 to the activated position. The visual indicators can indicate one or more states of the reconstitution device when the reconstitution process is in progress. For example, in one embodiment, at least one indicator can indicate when the reconstitution device is activated and the reconstitution fluid is flowing and mixing with the medicinal product. In another example, the at least one indicator can indicate when the reconstitution fluid has had an appropriate amount of time to mix with the medicinal product based on input from a real-time clock module, thereby indicating when the medicinal product is suitable for withdrawal from the reconstitution device using a delivery device (e.g., a syringe). According to one such example, the one or more visual indicators 720 can display a first color when the reconstitution fluid is mixing with the medicinal product and a second color when the reconstitution fluid has had a predetermined amount of time to mix with the medicinal product. In another such example, the one or more visual indicators 720 may flash in a first pattern when the reconstitution fluid is mixing with the medicinal product, and flash in a second pattern or display a solid color once the reconstitution fluid has had a predetermined time to mix with the medicinal product. In yet another example, the reconstitution or medicinal product delivery device may include an orientation sensor (e.g., an accelerometer, a gyroscope, etc.), and the indicator may indicate when the reconstitution or medicinal product delivery device is in a predetermined orientation, or conversely, when the reconstitution or medicinal product delivery device is in an orientation different from the predetermined orientation. Of course, the disclosure is not so limited, and any of the above examples may be used alone or in any combination with each other to relay desired information to the user.

[0176] The indication of the status by the visual indicator may be coordinated by a processor 708, which may receive and process information from one or more sensors. In some embodiments, the visual indicator may be color-coded to relay the general status of the reconstitution device during the reconstitution process. For example, the visual indicator may illuminate red for an error condition, yellow when the reconstitution fluid has mixed with the medication in the device, and green when the medication is ready to be withdrawn from the device. Of course, any suitable color or flashing pattern may be used to indicate any desired status, as the disclosure is not so limited. In some embodiments, the communication device 710 may also communicate the status of the reconstitution device to a remote device, as described further below. In some embodiments, the reconstitution device may include one or more light sources configured to illuminate containers disposed within the reconstitution device.

[0177] According to the embodiment of FIG. 18 , the reconfiguration device 700 is configured to communicate with one or more remote devices, including, but not limited to, a personal computer 721, a mobile device 722, and a remote server 724. Information relayed through such communications may be shared with one or more parties, who may use the information in different ways. Communications may be one-way or two-way in either direction. Communications may utilize any suitable number of local or external networks, including the Internet, to communicate with remote devices. For example, in some embodiments, the reconfiguration device may use short-range communication protocols to communicate with base stations or local relays, such as Bluetooth®, ZigBee®, infrared transmission, and radio frequency (RF) communications. Thus, even if the reconfiguration device lacks longer-range communication capabilities, such as Wi-Fi or cellular network technologies, or if the user has not activated these communication features, the reconfiguration device can communicate wirelessly with the local relay. In some embodiments, the reconfiguration device may also use short-range communication protocols to wirelessly communicate with nearby external devices, such as mobile devices. In some embodiments, the reconstitution device can communicate wirelessly over longer distances with other external devices, such as with a remote server 724 or directly with a personal computer 721. In some embodiments, the reconstitution device can send messages containing information to one or more remote devices. This information may include time information, dosage, drug lot information, and other medically related parameters. In some embodiments, the reconstitution device can include a global positioning system (GPS) sensor configured to provide location information to the processor 708. In such embodiments, the information may include location information from the GPS sensor. In some embodiments, the reconstitution device can include an accelerometer configured to detect movement and / or orientation of the reconstitution device. In such embodiments, the information may include orientation, average acceleration, etc. from the accelerometer.In some embodiments, the reconstitution device may include a temperature sensor configured to detect the temperature of the reconstitution device, in such embodiments, the information may include the current temperature, the average temperature, the peak maximum temperature, the peak minimum temperature, etc. from the temperature sensor.

[0178] In some embodiments, the reconstitution device 700 may directly and / or indirectly interact with a number of different parties that may utilize information from the reconstitution device and / or send commands or other information to the reconstitution device. As a first example, information from the reconstitution device may be sent directly or indirectly to the patient. The patient may obtain information from a visual indicator 720 on the reconstitution device, from a mobile device 722 that may be running a companion application to the reconstitution device, or from a remote server 724. As an example, the patient may use the mobile device to obtain information from the remote server 724 via an internet website or other program. In some embodiments, the user may have access to a “patient services” mechanism that serves as a type of customer service for the user. The user may connect to this service via phone, text, website, live chat, or other suitable form of communication for assistance related to the reconstitution device and / or medication. As an example, in some embodiments, the patient may use the patient services feature to receive training on how to use the reconstitution device and / or any accessories associated with the reconstitution device, how to troubleshoot any problems that may arise, or any questions related to the reconstitution device or medication. In some embodiments, the patient may use the patient services feature to receive assistance with payment and / or insurance issues. Patient services may need to access information from the patient's reconstruction device to assist the patient with some of these issues. In some embodiments, the information can be obtained from a remote server 724.

[0179] In some embodiments, the reconstitution device 700 can communicate directly or indirectly with a healthcare provider, such as a hospital, clinic, or other healthcare provider, and personnel, such as nurses or doctors. The healthcare provider can obtain information from a remote server 724 or other external device, such as a mobile device 722, which receives information from the reconstitution device 700. Alternatively, the healthcare provider may be in direct communication with the reconstitution device 700. Information that may be transmitted to the healthcare provider includes, but is not limited to, the time of administration, dosage, patient symptoms, etc. The healthcare provider can use the information to monitor patient compliance and / or determine the effectiveness of the patient's medication and / or dosage regimen. From the information, the healthcare provider can, for example, choose to provide patient education and / or encouragement and / or adjust the patient's treatment. Communication between the reconstitution device and the healthcare provider can be one-way or two-way communication. For example, in some embodiments, the healthcare provider may be able to send messages to the patient, such as reminders or alerts, on the reconstitution device itself or on a mobile device that the patient uses in conjunction with the reconstitution device, e.g., via an application running on the mobile device that may be specific to the reconstitution device and / or combination with the particular treatment for which the reconstitution device is being used. Through the application on the mobile device or the reconstitution device itself, the patient can send questions or concerns directly to the healthcare provider, and the healthcare provider can provide a reply to the patient.

[0180] In some embodiments, the information communicated from the reconstitution device 700 can be integrated with the patient's electronic health record, which can include information such as time of administration, dosage, patient symptoms, etc.

[0181] In some embodiments, the reconfiguration device 700 can communicate directly or indirectly with a payer, also known as an insurance company. The payer can use information from the reconfiguration device to monitor aspects such as patient adherence, medication effectiveness, and treatment plan effectiveness. In some embodiments, the payer may seek to encourage or reward certain behaviors. For example, the payer can reward patients with good adherence by lowering fees or offering discounts. The payer can also encourage adherence by sending treatment reminders or alerts to the patient and / or healthcare provider.

[0182] In some embodiments, information relayed through communications to and / or from the reconstitution device 700 may be used for data analysis, which can be used by various parties. For example, a provider (e.g., a pharmaceutical and / or reconstitution device manufacturer) may use information from the reconstitution device to determine which features are most used by users and when, what errors or problems are occurring, etc. The information may be filterable into different categories, such as age, gender, income, experience level, etc. In some embodiments, the information collected for data analysis may be anonymous and may not include PHI (Patient Health Information). However, in other embodiments, the information may include PHI.

[0183] In some embodiments, information collected from the reconstitution device 700 can help provide information about the performance of a pharmaceutical product. The inventors recognize that, outside of clinical trials, it can be difficult to evaluate a drug's performance when it is widely distributed to the public. Communications from the reconstitution device and other sources, such as a mobile device and / or healthcare provider, can help provide information about the performance of the pharmaceutical product and / or reconstitution device. Information about a patient's symptoms and treatment progress can be collected from the patient, for example, via an electronic symptom diary embedded in a companion app running on a mobile device, and / or from healthcare provider notes taken during the patient's clinic visits. The collected information can help inform future formulation and / or reconstitution device designs for providers, and positive performance can be used to help promote the use of the pharmaceutical product.

[0184] In some embodiments, information relayed through communications to and from the reconstitution device 700 can be used to assist in supply chain management. The information may include identification of which medications were used and when (e.g., by transmitting lot / batch numbers or other identifiers associated with the medications). The information may also include the geographic region of medication use. Such information may help a medication supplier understand the supply and demand for a medication in various regions of the world, for example, as reflected by the medication's actual use (as compared to being limited to prescription fill information). This may help the supplier understand whether they should stock more or less medication in a particular region, whether they should increase marketing efforts in a particular region, and / or whether past marketing efforts have been effective in increasing demand.

[0185] In some embodiments, the reconfiguration device 700 may include a near field communication (NFC) module that allows a remote device, such as a smartphone, to pair with the communication device 710. That is, the NFC module may allow pairing information to be relayed to a device that has a corresponding NFC module, avoiding the typical pairing process. Such a configuration may be beneficial for enabling reconfiguration device communication without pre-pairing the devices or otherwise preparing the remote device for specific use with the reconfiguration device.

[0186] It should be noted that while the embodiment of Figure 18 illustrates a reconstitution device, in other embodiments, a device such as that of Figure 18 may be a drug delivery device configured to pool a drug solution as opposed to reconstituting a solid pharmaceutical product. Accordingly, the various mechanisms and methods described with reference to Figure 18 are also applicable to drug delivery devices configured to pool a fluid, as the disclosure is not so limited.

[0187] In addition to the above, it should be noted that while the device of FIG. 18 is configured to access and deliver the contents of two containers, any suitable number of containers may be used. For example, in some embodiments, a drug solution delivery device such as that described with reference to FIG. 18 may include a single container, two containers, three containers, four containers, five containers, or any suitable number of containers. Accordingly, the various mechanisms and methods described with reference to FIG. 18 are also applicable to drug solution delivery or reconstitution devices having any number of containers, as the disclosure is not so limited.

[0188] 19A-19B are schematic diagrams of another embodiment of a reconstitution device 800 in an unactuated state and an actuated state, respectively. According to the depicted embodiment, the reconstitution device includes a housing 802 that houses a first container 300 and a second container 350. The device also includes a first actuator 806A and a second actuator 806B arranged as a ramp. The first and second actuators are configured to move within the housing 802 to actuate the reconstitution device. Specifically, the actuators are configured to move corresponding first wedges 808A and second wedges 808B. The first and second wedges are configured to move the first and second containers toward a base 804 of the housing 802 to be punctured by the first and second spikes, respectively. That is, as shown in Figures 19A-19B, the first and second actuators can be squeezed or otherwise forced into the housing 802 to drive the first and second wedges downward toward the base 804 of the housing. When the angled surfaces of the actuators and wedges engage one another, lateral movement of the actuators is translated into downward movement of the wedges, driving them to puncture the container. Such a configuration can provide a mechanical advantage for puncturing the container.

[0189] 20A-20B are schematic diagrams of another embodiment of a reconstitution device 900 in an inactivated state and an activated state, respectively. As shown in FIGS. 20A-20B, the reconstitution device includes a housing having an upper portion 902 and a lower portion 904. The upper portion is movable (e.g., slidable) relative to the lower portion, and the upper portion moves toward the lower portion from the inactivated position to the activated position. The reconstitution device includes a bolt 906 secured to the lower portion. A nut 908 and a handle 910 are threadably coupled to the bolt and secured to the upper portion. Thus, a user can turn the handle 910 to move the upper portion toward the lower portion and activate the reconstitution device. In doing so, the first spike 102 can puncture the first container 300 and the second spike 105 can puncture the second container 350.

[0190] 21A-21B are schematic diagrams of another embodiment of a reconstitution device 1000 in an unactuated state and an actuated state, respectively. As shown in FIGS. 21A-21B, the reconstitution device includes a housing having an upper portion 1002 and a lower portion 1004. The upper portion is movable (e.g., slidable) relative to the lower portion, such that the upper portion moves toward the lower portion from an unactuated position to an actuated position. The reconstitution device includes a lever 1008 rotatably coupled to the lower portion 1004. The lever 1008 protrudes from a slot 1006 in the upper portion 1002 such that the lever can apply a force to the upper portion. Thus, to actuate the reconstitution device, the lever can be moved toward the lower portion from the upper position shown in FIG. 21A, correspondingly moving the upper portion toward the lower portion. In doing so, the first spike 102 can puncture the first container 300 and the second spike 105 can puncture the second container 350.

[0191] FIG. 22 is a perspective view of another embodiment of a transfer engine 1100. As shown in FIG. 22, the transfer engine includes a first spike 1111 and a second spike 1114 formed as part of a first plate 1102. The transfer engine also includes a second plate 1104 that forms a flow path with the first plate and a filter chamber 1117 with a third plate 1106. The transfer engine includes an inlet 1109 (e.g., an air inlet) that, in some embodiments, may include a hydrophobic filter. The inlet is connected to a first flow path 1110 that is curved and extends to the first spike 1111. A second flow path 1112 extends from the first spike 1111 to the second spike 1114. A check valve 1119 is disposed in the second flow path to allow one-way flow from the first spike to the second spike. A third flow path 1115 extends from the second spike 1114 and includes a filter inlet 1116. The filter inlet allows fluid to flow from the third flow path between the first plate 1102 and the second plate 1104 to a filter chamber 1117 disposed between the second plate 1104 and the third plate 1106. A filter can be disposed within the filter chamber to effectively filter the medicinal fluid passing through to the fluid outlet. The location of the filter chamber may allow for the use of a filter with a larger surface area. The filter chamber terminates in an outlet 1118, which may be formed as or coupled to any suitable fluid connector, as described with reference to previous embodiments described herein.

[0192] FIG. 23 is a side cross-sectional view of the transfer engine of FIG. 22 taken along line 23-23. As shown in FIG. 23, the transfer engine is formed of three separate plates. First plate 1102 includes first spike 1111 and second spike 1114. Second plate 1104 forms a flow path with the first plate, and filter chamber 1117 forms a flow path with third plate 1106. The third plate forms a filter chamber with second plate 1104. Note that while the transfer engine of FIG. 22 is formed by three separate plates, the transfer engine may be formed by a single, integral part or any suitable number of components forming various flow paths. For example, in some embodiments, the transfer engine may be formed by two separate plates joined together to form multiple flow paths.

[0193] 23, the flow channels extend within the lumens of the first and second spikes. That is, the first flow channel 1110 extends within a first lumen 1120 disposed within the first spike 1111. The third flow channel 1115 extends within a fourth lumen 1126 disposed within the second spike 1114.

[0194] FIG. 24 is a top cross-sectional view of the transfer engine of FIG. 22 taken along line 24-24, and FIG. 25 is a top cross-sectional view of the transfer engine of FIG. 22 taken along line 25-25. As shown in FIG. 24, the flow paths are arranged in a circuit configuration similar to the embodiment previously described herein. That is, the first flow path 1110 and the third flow path 1115 are arranged in a mirror-parallel configuration relative to the second flow path 1112. However, instead of the outlet 1118 being located adjacent to the inlet 1109, the outlet 1118 is located on the opposite side of the transfer engine, across from the filter inlet 1116. As shown in FIG. 24, the first flow path 1110 extends into the first lumen 1120. The second flow path 1112 extends from the second lumen 1122 into the third lumen 1124. The third flow path 1115 extends from the fourth lumen 1126 to the filter inlet 1116. FIG. 25 shows a filter chamber 1117 extending in a racetrack or square rectangular shape. The filter chamber is configured to receive and retain a planar filter (e.g., a 1-micron filter) that filters fluid passing through the filter chamber. According to the embodiment of FIG. 25, the outlet 1118 is configured so that fluid flows down the filter inlet 1116 before being drawn back through the outlet and delivered to the patient. Such an arrangement ensures that the fluid passes through the filter before being delivered. FIG. 26 is a perspective view of another embodiment of a transfer engine 1200. As shown in FIG. 26, the transfer engine includes two spike housings separated by a tube. That is, a first spike housing 1202 includes a first spike 1203 and an inlet 1204. A second spike housing 1210 includes a second spike 1211. Connecting the spike housings is a tube 1220. The tube 1220 may be flexible or rigid. Such an arrangement allows the center-to-center spacing of spikes 1203, 1211 to be varied for different container sizes using the same spike housing, i.e., tube 1220 can be interchanged to have a variety of different lengths to accommodate different sized reconstitution device embodiments.

[0195] FIG. 27 is a side cross-sectional view of the transfer engine 1200 of FIG. 26 taken along line 27-27, and FIG. 28 is a top cross-sectional view of the transfer engine taken along line 28-28. As shown in FIGS. 27-28, the transfer engine 1200 has a linear layout. The first spike housing 1202 includes an inlet connected to a first flow path 1205. The first flow path extends from the inlet to a first lumen 1206 disposed in the first spike 1203. In some embodiments, the air inlet 1204 can include a hydrophobic filter that allows air to enter the transfer engine while preventing fluid loss from the transfer engine. The first spike housing also includes a second flow path 1208 connected to a second lumen 1207 disposed within the first spike. The second flow path is connected to a tube 1220, specifically a tube flow path 1221. The second spike housing 1210 includes a third flow path 1212 connected to the tube flow path 1221 and extending to a third lumen 1214 disposed within the second spike 1211. Thus, the second flow path 1208, the tube flow path 1221, and the third flow path 1212 form a continuous flow path from the second lumen 1207 to the third lumen 1214. A check valve 1213 is disposed within the third flow path 1212 and allows unidirectional flow from the second lumen 1207 to the third lumen 1214. The second spike housing also includes a fourth lumen 1215 disposed within the second spike 1211. A fourth flow path 1216 extends between the fourth lumen 1215 and a filter chamber 1217. The filter chamber is then connected to an outlet 1218 through which fluid can be withdrawn from the transfer engine. A filter may be disposed within the filter chamber to filter fluid drawn from the transfer engine.

[0196] FIG. 29 is a cross-sectional schematic diagram of one embodiment of a spike 1300. As shown in FIG. 29, the spike includes a first flow channel 1302 terminating in a first open end 1304. According to the embodiment of FIG. 29, the first open end is angled at an angle α relative to the spike insertion direction S. Specifically, the first open end is perpendicular to the spike puncture or insertion direction, with α equal to 90 degrees. Thus, when fluid exits the first open end 1304 at high velocity, the fluid can generate vortices within the container, promoting mixing of the reconstitution fluid and the pharmaceutical agent. As shown in FIG. 29, the spike includes a second flow channel 1306 terminating in a second open end 1308. In contrast to the first open end, the second open end is parallel to the spike insertion direction. Of course, in other embodiments, the first and second open ends may be symmetrical or have any combination of angles relative to the spike insertion direction, as the disclosure is not so limited.

[0197] FIG. 30 is a cross-sectional schematic diagram of another embodiment of a spike 1400. As shown in FIG. 30, the spike includes a first flow channel 1402 terminating in a first open end 1404. According to the embodiment of FIG. 30, the first open end is angled at an angle α with respect to the spike insertion direction S. Specifically, the first open end is inclined with respect to the spike insertion direction at a non-perpendicular angle β equal to approximately 45 degrees. Therefore, when fluid exits the first open end 1404 at high velocity, the fluid can generate vortices within the container, promoting mixing of the reconstitution fluid and the pharmaceutical agent. As shown in FIG. 30, the spike includes a second flow channel 1406 terminating in a second open end 1408. In contrast to the first open end, the second open end is parallel to the spike insertion direction. Of course, in other embodiments, the first open end or the second open end may be inclined at any suitable angle with respect to the spike insertion direction. In some embodiments, the angle of the open end relative to the spike insertion direction may be 15 degrees, 30 degrees, 60 degrees, 75 degrees, or any other angle between 1 and 90 degrees.

[0198] FIG. 31 is a cross-sectional schematic diagram of another embodiment of a spike 1500. As shown in FIG. 31, the spike includes a first flow channel 1502 terminating in multiple first open ends 1504A, 1504B, 1504C. According to the embodiment of FIG. 31, the first open ends are angled relative to the spike insertion direction S. Arranging the first flow channel with multiple open ends can modify the flow characteristics of fluid passing through the first flow channel at high speeds. For example, multiple open ends can reduce the overall force and velocity of fluid exiting the first fluid flow channel compared to an arrangement with a single first open end. As shown in FIG. 31, the spike includes a second flow channel 1506 terminating in a second open end 1508. In contrast to the first open end, the second open end is parallel to the spike insertion or puncture direction.

[0199] In some embodiments, the reconstitution device can include a fluid outlet that is releasably retained within the reconstitution device housing until a delivery device is coupled. FIGS. 32A-32D depict schematic views of another embodiment of one such reconstitution device 1600. As shown in FIGS. 32A-32D , the reconstitution device includes a housing having an upper portion 1602 and a lower portion 1604. The upper portion is movable (e.g., slidable) relative to the lower portion, and the upper portion moves toward the lower portion from a non-activated position to an activated position. The upper portion 1602 of the housing includes a notch 1606 configured to selectively provide physical access to a fluid outlet 1610 disposed within the reconstitution device housing. That is, the fluid outlet 1610 is physically inaccessible when the housing is in the non-activated position, but is physically accessible through the notch 1606 when the reconstitution device is activated. The fluid outlet 1610 is releasably retained within the reconstitution device housing by a retainer 1608 configured to abut a protrusion 1612 disposed on the fluid outlet 1610. The retainer and protrusion are positioned such that connection of a delivery device (e.g., a syringe) to the fluid outlet 1610 releases the fluid outlet from the reconstitution device housing, which can then be removed from the housing and moved, since the fluid outlet 1610 is connected to the transfer engine of the reconstitution device by flexible tubing 1616.

[0200] In the state shown in FIG. 32A , the reconstitution device is in an unactivated state. That is, the upper portion 1602 has not moved toward the lower portion 1604. Therefore, the notch 1606 is not aligned with the fluid outlet 1610, thereby preventing the fluid outlet 1610 from being physically accessible to the user. According to the embodiment of FIG. 32A , the fluid outlet is retained entirely within the housing when the device is not activated, although other configurations are contemplated. For example, the fluid outlet may be partially disposed within the housing and blocked until the reconstitution device is activated. In some embodiments, the fluid outlet may be visible to the user prior to activation of the reconstitution device but may be at least partially obstructed such that the fluid outlet is physically inaccessible. The fluid outlet 1610 is shown shaded with dashed diagonal lines in FIG. 32A for clarity.

[0201] In the state shown in FIG. 32B , the reconstitution device is actuated. That is, the upper part 1602 of the housing is moved toward the lower part 1604 of the housing. As described with reference to other exemplary embodiments described herein, actuation of the reconstitution device can puncture a fluid container within the reconstitution device housing. As shown in FIG. 32B , the notch 1606 is aligned with the fluid outlet 1610, thereby making the fluid outlet 1610 physically accessible by a user outside the reconstitution device housing. As shown in FIG. 32B , the protrusion 1612 of the fluid outlet 1610 is positioned inside the retainer 1608 (i.e., inside the retainer relative to the reconstitution device housing). Thus, while the fluid outlet 1610 is physically accessible, the retainer 1608 releasably retains the fluid outlet inside the reconstitution device housing. Furthermore, the retainer 1608 can provide frictional resistance to rotation of the fluid outlet 1610 within the reconstitution device housing. In the embodiment of FIG. 32B , the retainer and fluid outlet are configured to fully couple the delivery device to the fluid outlet and release the fluid outlet from the reconstitution device housing. That is, in some embodiments, the fluid outlet can be retained within the reconstitution device housing until an appropriate delivery device is fully coupled to the reconstitution device. In the embodiment of FIG. 32B , the retainer is configured to allow a rotational force to be applied to the fluid outlet 1610 by the delivery device to release the protrusion 1612 from the retainer, as further described with reference to FIG. 32C . According to the embodiment of FIG. 32B , the cutout 1606 can be sized and shaped such that the top 1602 of the housing can prevent a user from physically accessing the fluid outlet 1610 with anything other than an appropriate delivery device. For example, the cutout can be sized and shaped such that multiple fingers cannot be inserted through the cutout to grasp the fluid outlet 1610, but a delivery device such as a syringe can be inserted through the cutout to interact with the fluid outlet. In this manner, the cutout 1606 can facilitate proper use of the delivery device to couple the fluid outlet to the delivery device.

[0202] In the state shown in FIG. 32C , a delivery device (e.g., a syringe) 1614 is coupled to a fluid outlet 1610 disposed inside the reconstitution device. In the embodiment of FIGS. 32A-32D , the fluid outlet 1610 includes external threads and is configured as a luer actuation device. Accordingly, the delivery device 1614 includes corresponding threads configured to engage with the threads of the fluid outlet. When the reconstitution device is in the state shown in FIG. 32B , the delivery device 1614 can be threadably coupled to the fluid outlet (e.g., by rotating the delivery device clockwise), with the retainer 1608 providing frictional resistance to maintain the rotational position of the fluid outlet. Because the delivery device is threadably coupled, the fluid outlet 1610 can be retained within the reconstitution device housing until the delivery device is fully coupled to the fluid outlet. Once the delivery device is fully coupled, further rotation of the delivery device overcomes the frictional resistance of the retainer 1608 and can rotate the fluid outlet 1610 to the state shown in FIG. 32C , where the protrusion 1612 is no longer aligned with the retainer 1608. This rotation of the fluid outlet can indicate to the user that the delivery device is fully coupled to the fluid outlet and that the fluid outlet can be released from the reconstitution device housing.

[0203] 32D , the fluid outlet 1610 has been released from the reconstitution device housing and removed through the notch 1606. As previously described, when the delivery device 1614 is threadably coupled to the fluid outlet 1610, the protrusion 1612 can pass through the retainer 1608. Thus, pulling on the delivery device 1614 can remove the fluid outlet 1610 through the notch 1606. As shown in FIG. 32D , the fluid outlet is connected to the reconstitution device through a flexible tube 1616 so that the fluid outlet 1610 can be moved to a desired position. When the fluid outlet 1610 is removed from the reconstitution device housing, the flexible tube 1616 can extend or unwind from inside the reconstitution device housing.

[0204] Although one embodiment of a reconstitution device housing including a fluid outlet that is releasably retained within the housing until a delivery device is coupled is described with reference to FIGS. 32A-32D , other configurations are contemplated, and the disclosure is not so limited in this respect. For example, in some embodiments, the fluid outlet may be coupled to the reconstitution device housing using a frangible connection that can be broken by coupling the delivery device to the fluid outlet. In some embodiments, coupling the delivery device to the fluid outlet can release a latch that holds the fluid outlet within the reconstitution device housing. In some embodiments, the fluid outlet may have a friction fit with the reconstitution device housing, and coupling the delivery device to the fluid outlet releases the friction fit. A user can release the fluid outlet from the reconstitution device housing using any suitable action or combination of actions of the delivery device, including pushing, pulling, turning, twisting, etc.

[0205] Another exemplary embodiment of a transfer engine 2100 is shown in FIGS. 33-35. As shown in FIG. 33, the transfer engine includes a first spike 11 and a second spike 14. As shown in FIG. 35, in some embodiments, the transfer engine includes an inlet 136 (e.g., an air inlet) that can include a hydrophobic filter. The transfer engine, in some embodiments, can include a filter chamber 137 that receives the inlet hydrophobic filter. The inlet 136 is connected to a first flow path 291 that forms a first lumen through the first spike 11. A second flow path, including a second lumen 282, a tube 290, and a third lumen 293, connects the first spike 11 to the second spike 14. The third lumen 293 extends through the second spike 14. A check valve 271 is disposed in the second flow path to allow one-way flow from the first spike to the second spike. A third flow path comprising a fourth lumen 286 and a pathway 135 through the second spike 14 fluidly connects the second spike 14 to an outlet 298. In some embodiments, tubing can be coupled to the outlet 298 to direct the fluid to a fluid outlet (e.g., a luer connector or other connector) for administration to a user.

[0206] The first spike 11 may be formed as part of or otherwise attached to the first plate 262, and the second spike 14 may be formed as part of or otherwise attached to the second plate 264. The first and second plates may mate with one another via an interlock 280. In some embodiments, the interlock 280 may be formed by a protrusion 284 on the second plate 264 that is received within a recess 283 on the first plate 262. It should be understood that the positions of the protrusion and recess may be reversed. Additionally, other interlock shapes may be used, such as multiple protrusions / recesses, other jigsaw shapes, or any other suitable shape.

[0207] 33-35, the pathway 135 is a molded channel that may be molded as part of or otherwise attached to the second plate 264. However, it should be understood that other implementations of the pathway 135 are possible. In other embodiments, the pathway 135 may be a tube, a hypotube, or any other suitable arrangement, and this aspect is not so limited.

[0208] 33-35, a tube 290 connects the first spike 11 to the second spike 14. In some embodiments, the plates 262, 264 may include recesses 78, 79, respectively, to accommodate the tube 290. However, it should be understood that in other embodiments, a molded channel or other suitable arrangement may be used in place of the tube to connect the first and second spikes.

[0209] 33, in some embodiments, the transfer engine can include spike sheaths 85, 87 that cover the spikes 11, 14 prior to actuation of the reconstitution device. When a container is pressed down onto the spike during actuation, the spike may pass through the spike sheath and puncture into the container. In some embodiments, the spike sheaths help prevent foreign objects from entering the fluid path by covering the lumen of the spike prior to use and / or help prevent inadvertent premature puncture of the container.

[0210] The spike sheath may be made from silicone, plastic, elastomer, or other suitable material.

[0211] As mentioned above, in some embodiments, the reconstitution device may be configured so that physical access to the fluid outlet is prevented prior to activation. As previously mentioned, in some embodiments, a flexible leash may be coupled to the fluid outlet. User access to the flexible leash may be permitted by aligning a notch in the top of the housing with the fluid outlet receptacle. According to one aspect, in some embodiments, the flexible leash, e.g., a pull tab, may be part of or otherwise attached to a cap covering the fluid outlet. Pulling the leash can remove the cap from the fluid outlet and expose the fluid outlet for connection to another component, such as a syringe or other delivery device. In some embodiments, the fluid outlet is movable relative to the housing, such that pulling the leash can remove the fluid outlet from the housing. In some embodiments, the retention force between the fluid outlet and the housing may be less than the retention force between the cap and the fluid outlet, such that pulling the pull tab first removes the fluid outlet from the housing and then removes the cap from the fluid outlet. However, in other embodiments, the fluid outlet is fixed relative to the housing and is not configured to be pulled from the housing during use.

[0212] One exemplary embodiment of a reconstitution device 3200 is shown in FIG. 36 , where the device has a housing 420 having an upper portion 421 and a lower portion 422. The device includes a fluid outlet 430 secured to the lower portion 422 of the housing. In the exemplary embodiment of FIG. 36 , the fluid outlet 430 may be formed with or attached to a flange 440, which may be attached to an extension 250 on the lower portion 422 of the housing. In some embodiments, an additional flange may be positioned behind the extension 250 and may be attached to a tab to provide further retention reinforcement. However, it should be understood that the fluid outlet may be secured to the lower portion of the housing by any suitable attachment arrangement, as this aspect is not so limited.

[0213] A cap 432 having a pull tab 434 covers the fluid outlet 430. The pull tab 434 may be flexible such that when the housing top 421 is in an inactivated state, the inner surface of the top 421 presses against the pull tab 434, causing the pull tab to assume a folded or otherwise compressed state. When the top 421 is depressed, the notch 424 in the top 421 moves into alignment with the fluid outlet 430 and the cap 432, so that the pull tab 434 can unfold and extend out of the notch 424 for access by the user.

[0214] 37A-37C depict various stages of operation of the reconstitution device 3200. In FIG. 37A, the device is in an unactuated state. The notch 424 in the housing top 421 is spaced from the fluid outlet, and the pull tab may be in a folded state, e.g., abutting the inner surface of the top 421. Thus, physical access to the pull tab and fluid outlet is blocked by the housing top. In some embodiments, the pull tab may not be visible. In other embodiments, the pull tab may be visible, for example, if the top is made of a transparent material, but the pull tab may remain inaccessible to the user.

[0215] 37B, a user can push downward on the housing upper portion 421 and slide the upper portion 421 downward toward the housing lower portion 422. The downward movement of the upper portion 421 aligns the notch 424 with the fluid outlet 430 and the cap 432, allowing the pull tab 434 to unfold and extend from the notch 424.

[0216] The user can then pull the pull tab 434 to remove the cap 432, thereby exposing the fluid outlet 430, as shown in Figure 37C. With the fluid outlet 430 exposed, the user can proceed to attach a syringe or other delivery device to the fluid outlet 430.

[0217] Another exemplary embodiment of a reconstruction device 3300 is shown in FIGS. 38-40D. The device includes a housing 820 having an upper portion 821 and a lower portion 822. The device includes a fluid outlet 830 that is movable relative to the lower portion 822 of the housing. As shown in the exploded views of FIGS. 38 and 39, the fluid outlet 830 may be formed with or otherwise attached to the clip 310. The clip 310 may have a first leg 317 and a second leg 319. Prior to activation, the clip is removably coupled to the lower portion 822 of the housing. After activation, a user can separate the clip from the lower housing by pulling the fluid outlet from the housing. As seen in FIG. 39, an inner guide 823 in the lower portion 822 of the housing may include a slot 306 sized to receive the second leg 319 of the clip 310. The clip is shown fully engaged with the slot 306 in FIG. 38. 38, clip 310 and slot 306 may be positioned vertically below fluid outlet 830, with clip 310 fully engaged with slot 306. However, in other embodiments, clip and / or slot may be positioned in a different location relative to the fluid outlet, such as vertically above, to the left, or to the right of the fluid outlet.

[0218] In this exemplary embodiment, a cap 840 with a pull tab 842 can cover the fluid outlet 430 before the device is activated. When a user pulls the pull tab 842 after the device is activated, the second leg 319 slides through and emerges from the slot 306, decoupling the clip and fluid outlet 830 from the lower part 822 of the housing. The pull tab 842 can thus function as a leash that a user can pull to remove the fluid outlet from the housing. In some embodiments, the holding force of the cap 840 to the fluid outlet 830 can be greater than the holding force of the clip 310 to the lower part 822 of the housing. Thus, pulling the pull tab 842 can first cause the clip 310 to emerge from the slot 306 and separate before the cap 840 separates from the fluid outlet 830.

[0219] In some embodiments, the notch 824 in the top portion 821 can include an enlarged opening 825 to accommodate movement of the clip 310 therethrough.

[0220] 40A-40D depict various stages of operation of the reconstitution device 3300. In FIG. 40A, the device is in an unactuated state. The notch 824 in the housing top 821 is spaced from the fluid outlet 830, and the pull tab may be in a folded state abutting the inner surface of the top 821. Thus, physical access to the pull tab and the fluid outlet is blocked by the housing top.

[0221] 40B, a user can push downward on the housing upper portion 821 and slide the upper portion 821 downward toward the housing lower portion 822. The downward movement of the upper portion 821 aligns the notch 824 with the fluid outlet and cap 840, allowing the pull tab 842 to unfold and extend from the notch 824.

[0222] The user can then pull on the pull tab 842. With the holding force of the cap 840 against the fluid outlet greater than the holding force of the clip 310 against the lower part 822 of the housing, pulling on the pull tab 842 causes the clip to move out of the slot 306 in the lower part 822. As a result, as shown in FIG. 40C , both the cap 840 and the fluid outlet 830 attached to the cap can be pulled out of the housing when the user pulls on the pull tab 842. After the fluid outlet 830 is disconnected from the lower part 822 of the housing, the user can continue to pull on the pull tab 842 to remove the cap 840 from the fluid outlet 830, thereby exposing the fluid outlet 830, as shown in FIG. 40D . In some embodiments, the user can pull on the pull tab 842 with one hand while holding the fluid outlet 830, the clip 310, and / or a portion of the tubing 313 with the other hand to pull the cap 840 away from the fluid outlet 830.

[0223] Another exemplary embodiment of a reconstitution device 3350 is shown in FIGS. 41-43C, where the device has a housing 920 having an upper portion 921 and a lower portion 922. Similar to the exemplary embodiment of FIG. 38, the reconstitution device 3300 includes a fluid outlet 940 that is movable relative to the lower portion 922 of the housing. However, in this embodiment, as shown in FIGS. 41 and 42, the fluid outlet 940 is formed of or otherwise attached to two clips, a first clip 320 and a second clip 322. Prior to actuation, the first clip 320 and the second clip 322 are removably coupled to the lower portion 922 of the housing. In some embodiments, the inner guide 928 can include two extending tabs 360, each having a slot 55. In some embodiments, the slot can be defined by two opposing arms 51, 53. In other embodiments, the slot can be a through-hole through the tab. Prior to actuation of the reconstitution device, clips 320, 322 of fluid outlet 940 can be received in slots 55 to couple the fluid outlet to the lower portion 922 of the housing. As shown in FIG. 41 , with clips 320, 322 received in slots 55, slot 55 and clips 320, 322 may be adjacent to the left and right sides of the fluid outlet. However, in other embodiments, the clips and / or slots may be positioned in different locations relative to the fluid outlet, for example, vertically above and below the fluid outlet.

[0224] In some embodiments, the notch 924 can include enlarged openings 925, 926 to accommodate movement of the clip through the notch.

[0225] In this exemplary embodiment, a cap 930 with a pull tab 932 can cover the fluid outlet 940 before the device is activated. When a user pulls the pull tab 932 after the device is activated, the clips 320, 322 slide out through the slots 55, thus decoupling the clip and fluid outlet 940 from the lower part 922 of the housing. The pull tab 932 can thus function as a leash that a user can pull to remove the fluid outlet from the housing. In some embodiments, the holding force of the cap 930 to the fluid outlet 940 can be greater than the holding force of the clips 320, 322 to the lower part 822 of the housing. Thus, pulling the pull tab 932 can first cause the clips 320, 322 to move out of the slots 55 and separate before the cap 930 separates from the fluid outlet 940.

[0226] 43A-43C depict various stages of operation of the reconstitution device 3350. In FIG. 43A, the device is in an unactuated state. The cutout 924 in the housing top 921 is spaced from the fluid outlet 940, and the pull tab may be in a folded state abutting the inner surface of the top 921. Thus, physical access to the pull tab and the fluid outlet is blocked by the housing top 921.

[0227] 43B, a user can press downward on the housing upper portion 921 and slide the upper portion 921 downward toward the housing lower portion 922. The downward movement of the upper portion 921 aligns the notch 924 with the fluid outlet and cap 930, allowing the pull tab 932 to unfold and extend from the notch 924.

[0228] A user can then pull on the pull tab 932. With the holding force of the cap 930 against the fluid outlet greater than the holding force of the clips 320, 322 against the lower part 922 of the housing, pulling on the pull tab 932 will cause the clips to move out of the slots 55 in the lower part 922. As a result, as shown in FIG. 43C , both the cap 930 and the fluid outlet 940 attached to the cap can be withdrawn from the housing when the user pulls on the pull tab 932. After the fluid outlet 940 is disconnected from the lower part 922 of the housing, the user can continue to pull on the pull tab 932 to remove the cap 930 from the fluid outlet 940, thereby exposing the fluid outlet 940.

[0229] Although the embodiment of Figure 38 uses a single clip and the embodiment of Figure 41 uses two clips, it should be understood that any number of clips may be used.

[0230] According to one aspect, the reconstitution device can include one or more mechanisms to help retain the container. Such a retention mechanism can help position the container, for example, to help prevent premature puncture of the container and / or to assist in puncturing the container by facilitating alignment of the spike with the container during spiking. In some embodiments, the container retention mechanism can be coupled to a portion of the housing that moves during actuation. For example, in embodiments in which the top of the housing is pressed downward by the user to actuate the reconstitution device, one or more container retention mechanisms can be coupled to the top of the housing.

[0231] In some embodiments, the container retention mechanism includes a ring that surrounds a portion of the container to retain the container. In some embodiments, the ring can be configured to surround a shoulder portion of the container. An inner surface of the ring can be contoured to match the shape of the shoulder portion of the container.

[0232] 38-40D and 44-48, the reconstitution device includes a first ring 740 surrounding the first container 300 and a second ring 750 surrounding the second container 350. As described in more detail below, the rings can be attached to the top 821 of the housing. By surrounding the containers, the rings can act to limit side-to-side movement of the containers.

[0233] In some embodiments, the container can rest on a portion of the ring. As seen in FIG. 44 , the rings 740, 750 are contoured to fit the shape of the shoulder 35 of the container. For example, the ring 750 has an inner surface 744 that varies in diameter, forming a contoured surface. The inner surface 744 transitions from a first diameter to a second, smaller diameter to accommodate the contour of the shoulder 35 of the container 350. In some embodiments, the cross section of the inner surface can form an S-shape.

[0234] With the shoulder of the container abutting the molded inner surface of the ring, the ring can act to restrict movement of the container toward the spike. When the upper housing portion 821 moves toward the lower housing portion 822 during actuation of the device, the ring attached to the upper housing portion 821 moves toward the spike, thus allowing the container to move toward the spike for puncture.

[0235] In some embodiments, the inner contact portion can be coupled to the inner surface of the ring. The inner surface of the ring may be stiffer than the inner contact portion. The inner contact portion can function as a finer sizing member that can help reduce clearance with the container. The inner contact portion can be a gasket, a molded nub, a radially inwardly extending finger, or any other suitable contact portion. For example, in one exemplary embodiment, the inner surface of the ring can include a circumferential groove into which the gasket fits.

[0236] It should be appreciated that the container retention feature can engage different portions of the container, for example, in some embodiments, the container retention feature can engage a sidewall of the body, a shoulder, a neck, a crimp, and / or any other suitable portion of the container.

[0237] Attachment of the ring to the housing will now be described. As seen in FIG. 46, the ring 740 may include multiple radially extending extensions 742, each of which may include a recess 743. As seen in FIGS. 45, 47, and 48, the housing's top 821 includes multiple protrusions 745 shaped to match the shape of the recesses in the ring. In the illustrated exemplary embodiment, the recesses and protrusions are semi-elliptical. The ring is attached to the housing's top by mating the protrusions on the top 821 with the recesses in the ring. In some embodiments, additional retention reinforcement, such as adhesive or fasteners, can be used to reinforce the attachment. However, in other embodiments, the ring is held to the housing's top by simply a snap-fit ​​engagement between the protrusions and recesses. It should be understood that the protrusions and recesses may be reversed, such that the recesses are located on the housing's top and the protrusions are located on the ring. Furthermore, although the protrusions and recesses shown in the figures are semi-elliptical, it should be understood that they may be hemispherical, prismatic, conical, truncated conical, truncated cylindrical, or any other suitable shape.

[0238] In some embodiments, attachment of the ring to the housing may be achieved by adhesives, fasteners, and / or other attachment arrangements as an alternative to, or in addition to, the mating protrusion and recess arrangement described above.

[0239] It should be understood that in some embodiments the ring may be omitted. In some embodiments, adhesives, fasteners, or other attachment arrangements may be used to hold the container(s) relative to the housing.

[0240] In some embodiments, the container retention mechanism includes a plurality of arms that at least partially surround a portion of the container to restrict movement of the container.

[0241] 47-49, the reconstitution device includes a plurality of arms 456 extending from a housing top 821. As shown in FIG. 49, a perspective cross-sectional view showing a portion of a container 300, 350 received in the housing top 821, the plurality of arms 456 surround the container 300, 350. The plurality of arms 456 are positioned radially outward of the container and receive the bottom end of the container.

[0242] In some embodiments, the reconstitution device may include a platform that abuts the bottom end of the container, which may serve to fill the gap between the housing and the container to prevent the container from shifting within the housing prior to actuation, e.g., during transport.

[0243] In the exemplary embodiment shown in Figures 47-48, the reconstitution device includes platforms 450, 451 configured to abut the bottom end of the container. In the exemplary embodiment, the platforms are arcuate. However, in other embodiments, the platforms may be circular, oval, square, dome-shaped, or any other suitable shape. The platforms may be made of foam, elastomer, silicone, or other suitable material.

[0244] In some embodiments, the reconstitution device may have a modular design that may allow for different container sizes to be accommodated in the same housing. For example, platforms 450, 451 can be replaced with platforms of other heights and / or radii of curvature to accommodate various container sizes. For example, by using a platform with a higher height, shorter containers can still be used in the same housing. Similarly, multiple arms 456 can be replaced with other arms, for example, arms positioned at different distances to accommodate containers of different diameters. In some embodiments, multiple arms and / or platforms may be pre-molded or otherwise pre-attached to plates that can be attached to the inside of the top 821 of the housing. Plates with different combinations of arms and / or platforms can be manufactured to accommodate various container sizes and shapes. The top of the housing can be configured to attach to any of these plates, thus allowing the housing to have a modular design that can accommodate different sized containers using the same housing. Furthermore, rings 740, 750 can also be replaced with rings of different inner diameters to accommodate different container sizes.

[0245] As described above, in some embodiments, the reconstitution device can include one or more engagement mechanisms that allow the upper and lower portions of the housing to slidably engage with one another. In some embodiments, the inner guide can include one or more engagement mechanisms that slidably engage with a mechanism or mechanisms on the upper portion. For example, the inner guide can have grooves shaped to receive fins on the upper portion, with the fins slidable along the grooves. The components can be reversed, so that the grooves are on the upper portion and the fins are on the inner guide. Other sliding engagement arrangements can be used, such as other rails, elongated members extending through enclosed channels, or any other suitable sliding engagement arrangement.

[0246] In the exemplary embodiment of FIG. 45, the inner guide 823 can include grooves 760 that receive fins 314 that slide within the grooves 760 to allow the upper portion 821 to slidably move relative to the lower portion 822.

[0247] FIG. 50A is an exploded plan view of another embodiment of a transfer engine 3400. According to the embodiment of FIG. 50A, the transfer engine is modular, allowing for a desired number of vessels to be attached, with an increased or decreased number of fluid connections on the transfer engine. In the configuration shown in FIG. 50A, the transfer engine is configured to accommodate three vessels. As shown in FIG. 50A, the transfer engine includes an inlet adapter 3402. The inlet adapter includes an inlet spike 3404 having a first inlet spike channel 3406 and a second inlet spike channel 3408. The first inlet spike channel 3406 may be fluidly connected to an air inlet, which in some embodiments may include a hydrophobic filter or check valve. The second inlet spike channel is connected to an inlet adapter fluid channel 3410, allowing fluid to flow from the connected vessel out of the inlet adapter. In the particular embodiment of FIG. 50A, the inlet adapter fluid channel 3410 terminates in an inlet fluid connector 3412, which in the illustrated embodiment is configured to receive tubing. Of course, in other embodiments, other fluid connectors can be used as the disclosure is not so limited. The fluid arrangement of the inlet adapter 3402 allows air to be introduced into the container via the first inlet spike channel 3406 when the inlet spike punctures the inlet container and fluid flows out of the inlet adapter fluid channel 3410. In some embodiments, the inlet adapter 3402 may include a check valve configured to allow one-way flow from the spike out through the inlet adapter fluid channel 3410. Such an arrangement can ensure that fluid does not flow through the first inlet spike channel 3406 toward the air inlet.

[0248] According to the embodiment of FIG. 50A , the inlet adapter 3402 includes an inlet adapter coupling 3414 configured to allow the inlet adapter to be releasably attached to another adapter (e.g., an intermediate adapter 3420). Specifically, in the embodiment of FIG. 50A , the inlet adapter coupling is configured to releasably attach (e.g., interlock) the inlet adapter to the intermediate adapter 3420. The intermediate adapter coupling of FIG. 50A includes a collar 3416 and a pocket 3418, which is configured to receive a first intermediate adapter coupling 3435 having a corresponding shape. As will be further described with reference to FIG. 50B , when the first intermediate adapter coupling 3435 and the inlet adapter coupling 3414 are engaged and interlocked, the intermediate adapter 3420 and the inlet adapter may not be able to move relative to one another in a first direction. In the particular example of FIG. 50A , when releasably coupled, the intermediate adapter and the inlet adapter can resist relative movement of one another in a plane (e.g., the x-y plane). However, when releasably coupled, the inlet adapter coupling and the intermediate adapter coupling may allow relative movement in a second direction (e.g., the z-direction) to allow the adapters to disengage from one another. According to the embodiment of FIG. 50A , the inlet adapter coupling is symmetrical. In other embodiments, the inlet adapter may be irregularly shaped or have any suitable shape to allow the adapters to interlock, as the disclosure is not so limited. In the embodiment of FIG. 50A , the inlet adapter coupling is configured to receive a corresponding coupling. In other embodiments, the inlet adapter coupling may be configured to be received in a corresponding coupling. In the embodiment of FIG. 50A , the inlet adapter coupling is separate and spaced from the inlet adapter fluid channel 3410, thereby separating the physical interconnection and the fluid connection. Such an arrangement may be beneficial for simplicity of manufacturing and reliability of the connection.

[0249] As shown in FIG. 50A , the intermediate adapter 3420 includes a first intermediate adapter coupling 3435. The first intermediate adapter coupling includes a neck 3436 and a tab 3437. The neck 3436 is configured to engage with the collar 3416 of the inlet adapter coupling 3414. Similarly, the tab is configured to engage with the pocket 3418 of the inlet adapter coupling. As further described with reference to FIG. 51 , the arrangement of the neck, pocket, collar, and tab allows the adapters to securely interlock with one another. As shown in FIG. 50A , the intermediate adapter also includes a second intermediate adapter coupling 3438. The second intermediate adapter coupling is configured to receive a correspondingly shaped coupling (e.g., the outlet adapter coupling 3456). In the embodiment of FIG. 50A , the first and second intermediate adapter couplings are disposed on opposite sides of the intermediate adapter, although other configurations are contemplated, as further described with reference to FIG. 54 . In some embodiments shown in FIG. 50A , the second intermediate adapter coupling can share the same shape and size as the inlet adapter coupling 3414. In such an arrangement, the intermediate adapter 3420 can be replaced or extended with another copy of the intermediate adapter. That is, another intermediate adapter may be replaced with the intermediate adapter 3420, or another intermediate adapter may be used to extend the transfer engine 3400 (see, e.g., the exemplary embodiment of FIG. 52 ). A first intermediate adapter coupling (e.g., such as the first intermediate adapter coupling 3435) may be received into the second intermediate adapter coupling 3438. Thus, desired intermediate adapters can be added to expand the number of spikes to accommodate the desired number of containers that can ultimately deliver medicinal fluids to a patient.

[0250] As shown in FIG. 50A , the intermediate adapter 3420 includes an intermediate spike 3422 configured to puncture the intermediate container. The intermediate spike includes a first intermediate spike channel 3424 fluidly connected to a first intermediate fluid channel 3428. Similar to the inlet adapter, the first intermediate fluid channel terminates in an intermediate fluid connector 3430 (e.g., a tubing connector). The intermediate spike also includes a second intermediate spike channel 3426 fluidly connected to a second intermediate fluid channel 3432. Similar to the first intermediate fluid channel, the second intermediate fluid channel also terminates in an intermediate fluid connector 3434 (e.g., a tubing connector). According to the embodiment of FIG. 50A , and as further described with reference to FIG. 50B , the first intermediate fluid channel is configured to be fluidly connected (e.g., via tubing) to the inlet adapter fluid channel 3410. The second intermediate fluid channel is configured to connect to the outlet adapter fluid channel 3448. Thus, the intermediate adapter is configured to form a fluid path from the inlet adapter to the outlet adapter. Similar to the inlet adapter 3402 , the fluid channels of the intermediate adapter are separated from the first intermediate adapter coupling 3435 and the second intermediate adapter coupling 3438 .

[0251] According to the embodiment of FIG. 50A , the transfer engine 3400 includes an outlet adapter 3440. The outlet adapter includes an outlet spike 3442 including a first outlet spike channel 3444 fluidly connected to an outlet adapter fluid channel 3448. Similar to the inlet adapter 3402 and the intermediate adapter 3420, the outlet adapter fluid channel terminates in an outlet fluid connector 3450 (e.g., a tubing connector). The outlet spike also includes a second outlet spike channel 3446 fluidly connected to an outlet 3452. The outlet 3452 is connected to an infusion set coupling 3454, which may allow fluid from the transfer engine 3400 to ultimately flow to the patient. In other embodiments, an infusion set or other delivery device may be connected directly to the outlet 3452, as the disclosure is not so limited.

[0252] As shown in FIG. 50A , the outlet adapter 3440 includes an outlet adapter coupling 3456. In the embodiment of FIG. 50A , the outlet adapter coupling is configured to be received into the second intermediate adapter coupling 3438. The outlet adapter coupling has a size and shape that matches that of the first intermediate adapter coupling 3435. Thus, if desired, the outlet adapter coupling can also be received within the inlet adapter coupling 3414, allowing the outlet adapter to be removably attached to the inlet adapter. Such an arrangement is beneficial when only two vessels are connected to the transfer engine, so that the intermediate adapter 3420 can be omitted.

[0253] FIG. 50B is a plan view of the transfer engine of FIG. 50A in an assembled configuration. As shown in FIG. 50B, the first intermediate adapter coupling 3435 is received into the inlet adapter coupling 3414. Thus, the collar 3416 engages with the neck 3436 and the pocket 3418 engages with the tab 3437. Thus, the inlet adapter 3402 is releasably interlocked with the intermediate adapter 3420. Similarly, as shown in FIG. 50B, the outlet adapter coupling 3456 is received into the second intermediate adapter coupling 3438, thereby releasably coupling the intermediate adapter and the outlet adapter 3440. Thus, the inlet adapter, intermediate adapter, and outlet adapter are all physically connected to one another via the couplings.

[0254] Aside from the physical connection of the couplings, the adapters are fluidly connected to form a continuous flow path between the inlet spike 3404, the intermediate spike 3422, the outlet spike 3442, and ultimately the outlet 3452 so that fluid can be delivered to a patient via an infusion set or other delivery device (e.g., a syringe). As shown in FIG. 50B , the inlet adapter fluid channel 3410 is fluidly connected to the first intermediate fluid channel 3428 using a first tubing 3460. The first tubing is coupled to the inlet fluid connector 3412 and the first intermediate fluid connector 3430. The outlet adapter fluid channel 3448 is coupled to the second intermediate fluid channel 3432 using a second tubing 3462. The second tubing is coupled to the outlet fluid connector 3450 and the second intermediate fluid connector 3434. Thus, the inlet adapter, intermediate adapter, and outlet adapter are fluidly connected in a serial configuration. In some embodiments, the fluid connectors may be quick-connect tubing connectors. In some embodiments, adapters may include integral tubing configured to interconnect tubing of other adapters. In such embodiments, quick connect fittings or other fittings may be used. In other embodiments, any suitable connector may be used to fluidly connect the adapters, as the disclosure is not so limited.

[0255] It should be noted that although tubing and tubing connectors are used in the embodiment of Figure 50B, any suitable fluid flow path can be used to fluidly interconnect the various adapters. For example, the tubing interconnecting the adapters can be rigid or flexible tubing. Furthermore, in some embodiments, the adapters can include integrated fluid connectors and pathways separate from the couplings to enable fluid connections without additional components such as tubing.

[0256] In some embodiments, the transfer engine of Figures 50A-50B may be used for reconstitution or pooling. In some embodiments, the intermediate adapter and / or outlet adapter may be configured to receive and connect to a container containing a solid pharmaceutical agent (e.g., a lyophilized solid). In other embodiments, the intermediate adapter and / or outlet adapter may be configured to receive and connect to a container containing a pharmaceutical agent liquid. Any number of containers containing solid pharmaceutical agents or pharmaceutical agents liquids may be used with the transfer engine according to the embodiments described herein, as the disclosure is not so limited.

[0257] It should be noted that while the spike channels and fluid channels are illustrated and labeled separately in the embodiment of Figures 50A-50B, in other embodiments the spike channels and fluid channels may be considered a single component. For example, the adapter may be molded such that the fluid channels form the spike channels.

[0258] As previously mentioned, the modular transfer engine of Figures 50A-50B can be configured in a wide array of different shapes to accommodate a desired number of containers. For example, in some embodiments, an inlet adapter and an outlet adapter may be used together to deliver fluid from two containers (e.g., an inlet container and an outlet container). As another example, in some embodiments, an inlet adapter and an outlet adapter may be used with two intermediate adapters to deliver fluid from four containers (e.g., an inlet container, a first intermediate container, a second intermediate container, and an outlet container). In this manner, the number of adapters may be expanded or contracted as desired for any number of containers, including, but not limited to, two containers, three containers, four containers, five containers, six containers, seven containers, and eight containers.

[0259] While in the embodiments of FIGS. 50A-50B, the inlet adapter coupling is configured to receive the intermediate adapter coupling or the outlet adapter coupling as a socket, in other embodiments, the arrangement can be reversed. That is, in some embodiments, the intermediate adapter coupling or the outlet adapter coupling may be configured to receive the inlet adapter coupling. Alternatively, the intermediate adapter coupling or the outlet adapter coupling may be configured as a socket configured to receive the protruding inlet adapter coupling. In some embodiments, the adapter coupling may include a socket portion and a protruding portion, whereby the coupling receives a corresponding protruding portion of another coupling and is also received in a corresponding socket portion of the other coupling. Accordingly, any suitable coupling capable of physically connecting the adapters to one another for any of the embodiments described herein may be used, as the disclosure is not so limited.

[0260] FIG. 51 is a schematic diagram of one embodiment of a transport engine adapter coupling showing an exemplary mating engagement for securing the adapters of the transport engine together. As shown in FIG. 51 , a first coupling 3500 is configured as a socket and includes a collar 3502 and a pocket 3504. A second coupling 3550 is configured to be received into the first coupling 3500 and includes a neck 3552 and a tab 3554. As shown in FIG. 51 , the shape and size of the first coupling matches the shape and size of the second coupling. The tab 3554 is configured to be received in the pocket 3504, and the collar 3502 is configured to engage the neck 3552. As shown in FIG. 51 , the collar 3502 and the neck 3552 have widths that are smaller than the widths of the pocket 3504 and the tab 3554. Specifically, the pocket 3504 has a pocket width A, the collar 3502 has a collar width B, the tab 3554 has a tab width C, and the neck 3552 has a neck width D. The pocket width A is approximately equal to the tab width C, and the tab width is slightly smaller than the pocket width (e.g., within 1% of the pocket width) so that the tab can fit within the pocket. Similarly, the collar width B is approximately equal to the neck width D, and the neck width is slightly smaller than the collar width (e.g., within 1% of the collar width) so that the neck can fit within the collar. The pocket width A is larger than the collar width B (i.e., collar width B is smaller than pocket width A). Similarly, the tab width C is larger than the neck width D (i.e., neck width D is smaller than the tab width C). Thus, when the second coupling is received in the first coupling, the couplings cannot move relative to each other in a plane (e.g., the xy plane). However, the couplings can move relative to each other in a second direction (e.g., the z direction) that is perpendicular to the plane in the illustrated embodiment. In other embodiments, the couplings can be prevented from moving relative to each other in the first direction and can move relative to each other in the second direction. In some embodiments, the second direction can be transverse (e.g., perpendicular) to the first direction.

[0261] It should be noted that one embodiment of a coupling is shown in FIG. 51 , and that in other embodiments, other couplings may be used. For example, the coupling pair used to physically connect the multiple adapters may be a mortise-and-tenon, a T-slot-and-T-slot adapter, or any other suitable coupling. In some embodiments, the coupling may include a poka-yoke tab configured to assist a user in aligning and connecting the multiple adapters. In some embodiments, the coupling may have a shape configured to control the orientation of the transfer engine formed by the multiple adapters. For example, in some embodiments, the adapter coupling may be capable of connecting in a single direction.

[0262] FIG. 52 is a plan view of another embodiment of a transfer engine 3600. According to the embodiment of FIG. 52, the transfer engine is similar to that of FIGS. 50A-50B except that a second intermediate adapter 3602 has been added to allow the transfer engine to connect to four vessels. That is, the transfer engine includes an inlet adapter 3402, a first intermediate adapter 3420, and an outlet adapter 3440 having a configuration similar to that of FIGS. 50A-50B. In the embodiment of FIG. 52, the second intermediate adapter 3602 is identical to the first intermediate adapter. That is, the second intermediate adapter includes a second intermediate spike 3604 having a third intermediate spike channel 3606 connected to a third intermediate fluid channel 3610 and a fourth intermediate spike channel 3608 connected to a fourth intermediate fluid channel 3614. The third intermediate fluid channel 3610 and the fourth intermediate fluid channel 3614 terminate in intermediate fluid connectors 3612, 3616 (e.g., tubing connectors). The second intermediate adapter includes a third intermediate adapter coupling 3618 and a fourth intermediate adapter coupling 3620. The third intermediate adapter coupling 3618 is received in the second intermediate adapter coupling 3438. The fourth intermediate adapter coupling receives the outlet adapter coupling 3456. Thus, the second intermediate adapter coupling can releasably attach and / or interlock the second intermediate adapter coupling and the outlet adapter coupling in a series configuration. According to the embodiment of FIG. 52, the second intermediate adapter coupling is interchangeable with the first intermediate adapter coupling. Thus, if desired, the third intermediate adapter coupling may be received in the inlet adapter coupling 3414. Correspondingly, in some embodiments, the fourth intermediate adapter coupling can receive the first intermediate adapter coupling 3435.

[0263] As shown in Figure 52, fluid connections between the adapters are made using tubing, similar to Figure 50B. Specifically, a first tube 3460 fluidly connects the inlet adapter fluid channel 3410 to the first intermediate fluid channel 3428. A second tube 3462 fluidly connects the second intermediate fluid channel 3432 to the third intermediate fluid channel 3610. Finally, a third tube 3464 fluidly connects the fourth intermediate fluid channel 3614 to the outlet adapter fluid channel 3448. As discussed above with reference to Figures 50A-50B, in Figure 52 the physical connections between the adapters via couplings are separate and / or spaced apart from the fluid connections between the adapters.

[0264] In the embodiment of FIG. 52, the various adapters are fluidly connected and physically connected in a serial configuration. In other embodiments, the adapters may be fluidly connected or physically connected in a parallel configuration. For example, in some embodiments, the inlet adapter, the first intermediate adapter, and the second intermediate adapter may all be fluidly connected to the outlet adapter. For example, tubing from each of the inlet adapter, the first intermediate adapter, and the second intermediate adapter can join to the outlet adapter fluid channel 3448 at a Y-junction. In such embodiments, the first intermediate fluid channel 3428 and the third intermediate fluid channel 3610 can function as air inlets. In embodiments in which one or more fluid channels are configured as inlets, the fluid channels may include check valves configured to allow the entry of air into the respective fluid channels but prevent fluid from escaping through the respective fluid channels. In some other embodiments, the fluid channels may include hydrophobic filters configured to allow the entry of air into the respective fluid channels but prevent fluid from escaping through the respective fluid channels. In the embodiment of FIG. 52 , the first intermediate fluid channel 3428 and the third intermediate fluid channel 3610 may include check valves that allow air to enter the channels but not allow fluid to exit the channels. Of course, any suitable parallel, series, or combination of parallel and series fluid configurations can be used to deliver the medicinal fluid from the transfer engine, as the disclosure is not so limited. Additional examples of fluid configurations having combinations of parallel and series flow paths are described with reference to the exemplary embodiment of FIG. 53 .

[0265] According to exemplary embodiments described herein, any suitable number of check valves can be used in one or more fluid channels of an adapter, as the disclosure is not so limited. The check valves can ensure one-way flow of fluid from the adapter regardless of whether the fluid channel is used as an air inlet. If the fluid channel is an air inlet, the check valve can prevent fluid from escaping through the air inlet while allowing air to be evacuated from an attached container. However, in the alternative case where the fluid channel is a fluid inlet, the check valve can enforce one-way flow. Thus, in some embodiments, the adapter can include at least one check valve in a fluid channel, thereby allowing the adapter to be modularly used in configurations with air inlets or configurations with fluid inlets. Of course, any suitable arrangement or number of check valves can be used in the adapter, as the disclosure is not so limited.

[0266] FIG. 53 is a plan view of another embodiment of a transfer engine 3700 including multiple intermediate couplings configured to expand the vessel volume of the transfer engine while maintaining a physically compact footprint. According to the embodiment of FIG. 53, the transfer engine includes an inlet adapter 3402 and an outlet adapter 3440 having the configuration described with reference to the embodiment of FIGS. 50A-50B. As shown in FIG. 53, the transfer engine includes a first intermediate adapter 3702 and a second intermediate adapter 3720. In the embodiment of FIG. 53, the first and second intermediate adapters are mirror images of each other (e.g., across the y-axis) and are generally configured to provide two spikes in space in a single intermediate adapter as shown and described with reference to FIGS. 50A-50B. The first and second intermediate adapters are configured to simultaneously releasably attach to the inlet and outlet adapters.

[0267] As shown in FIG. 53 , the first intermediate adapter 3702 includes a first intermediate spike 3704 having a first intermediate spike channel 3706 and a second intermediate spike channel 3708. The first intermediate spike channel is fluidly connected to a first intermediate fluid channel 3710. The second intermediate spike channel is fluidly connected to a second intermediate fluid channel 3714. The first intermediate spike channel and the second intermediate spike channel terminate in intermediate fluid connectors 3712, 3716, respectively. Finally, the first intermediate adapter includes a first intermediate adapter coupling 3718 and a second intermediate adapter coupling 3719. According to the embodiment of FIG. 53 , the first intermediate adapter coupling is received in the inlet adapter coupling 3414. The first intermediate adapter coupling is configured to be received on a first side of the inlet adapter coupling, such that the first intermediate adapter coupling occupies at least a portion of the inlet adapter coupling (e.g., half of the inlet adapter coupling). The second intermediate adapter coupling 3719 receives the outlet adapter coupling 3456. Like the first intermediate adapter coupling, the second intermediate adapter coupling is configured to receive a first portion of the outlet adapter coupling. Specifically, in the embodiment of FIG. 53, the second intermediate adapter is configured to receive at least a portion of the outlet adapter coupling (e.g., half of the outlet adapter coupling). Of course, in other embodiments, the first intermediate adapter coupling and the second intermediate adapter coupling can engage any portion of the corresponding coupling, as the disclosure is not so limited.

[0268] As shown in FIG. 53 , the second intermediate adapter 3720 is a mirror image (e.g., across the y-axis) of the first intermediate adapter 3702. Thus, the second intermediate adapter includes the same components as the first intermediate adapter. The second intermediate adapter 3720 includes a second intermediate spike 3724 having a third intermediate spike channel 3726 and a fourth intermediate spike channel 3728. The third intermediate spike channel is fluidly connected to a third intermediate fluid channel 3730. The fourth intermediate spike channel is fluidly connected to a fourth intermediate fluid channel 3734. The third intermediate spike channel and the fourth intermediate spike channel each terminate in an intermediate fluid connector 3732, 3736 (e.g., a tubing connector). Finally, the second intermediate adapter includes a third intermediate adapter coupling 3738 and a second intermediate adapter coupling 3739. The third intermediate adapter coupling is received within the inlet adapter coupling 3414 and, in the specific embodiment of Figure 53, engages at least a portion of the inlet adapter coupling (e.g., half of the inlet adapter coupling). The fourth intermediate adapter coupling receives the outlet adapter coupling 3456 and, in the specific embodiment of Figure 53, receives at least a portion of the outlet adapter coupling (e.g., half of the outlet adapter coupling). Thus, both the first intermediate adapter and the second intermediate adapter simultaneously connect and releasably interlock with the inlet and outlet adapters.

[0269] As shown in FIG. 53 , the transfer engine 3700 is arranged in a partially serial and partially parallel fluidic configuration. The inlet adapter is fluidly connected to both the first and second intermediate adapters via a first tube 3460 and a second tube 3462. The first and second tubes are connected at a Y-junction 3461 and fluidly connected to the inlet adapter fluid channel 3410. The outlet adapter is also fluidly connected to both the first and second intermediate adapters via a third tube 3464 and a fourth tube 3466. The third and fourth tubes are connected at a second Y-junction 3465 and fluidly connected to the outlet adapter fluid channel 3448. Thus, the intermediate adapters are not fluidly connected to each other in series, but instead are connected in parallel between the inlet and outlet adapters. However, fluid flow from the inlet adapter passes through two intermediate adapters before reaching the outlet adapter; in this way, the transfer engine has a serial fluidic configuration between the inlet adapter, the intermediate adapter, and the outlet adapter.

[0270] While the embodiment of FIG. 53 uses a Y-junction to interconnect the various adapters, in other embodiments, the adapters can include multiple fluid channels or integrated fluid junctions to facilitate parallel connection of multiple intermediate adapters. For example, the inlet adapter includes multiple fluid connectors (e.g., two tubing connectors) so that the inlet adapter can accommodate multiple tubing, with both fluid connectors fluidly connected to the inlet adapter fluid channel. Thus, the inlet adapter includes an internal Y-junction, thereby allowing the inlet adapter to be interconnected to two intermediate adapters using direct tubing without a Y-junction. Similarly, the outlet adapter also includes multiple fluid connectors (e.g., two tubing connectors) so that the outlet adapter can accommodate multiple tubing, with both fluid connectors fluidly connected to the outlet adapter fluid channel. The inlet and outlet adapters can include any suitable number of fluid channels and corresponding fluid connectors so that any number of intermediate adapters can be connected in parallel, as the disclosure is not so limited.

[0271] FIG. 54 is a plan view of another embodiment of a transfer engine 3800 showing an alternative adapter layout. In some cases, it may be desirable to reduce the adapter footprint for a given number of containers or otherwise reduce a particular dimension of the transfer engine. For example, in the embodiment of FIG. 54 discussed above, the transfer engine is arranged in a straight line, which reduces the overall width of the transfer engine by having a longer length. However, to reduce the overall maximum dimension (e.g., width or length), the adapters can be arranged in a zigzag pattern as shown in FIG. 54. In the embodiment of FIG. 4, the fluid arrangement is similar to that of FIG. 52. That is, the transfer engine includes an inlet adapter 3402, a first intermediate adapter 3802, a second intermediate adapter 3810, and an outlet adapter 3440. The inlet and outlet adapters are arranged similarly to FIGS. 50A-50B. Similarly, the fluid arrangement of the first and second intermediate adapters is similar to that of FIG. 52. However, in contrast to the embodiment of FIG. 52, the intermediate adapter couplings are angled relative to one another, as will be further explained below.

[0272] As shown in FIG. 54 , the first intermediate adapter 3802 includes a first intermediate adapter coupling 3804 and a second intermediate adapter coupling 3806. The second intermediate adapter includes a third intermediate adapter coupling 3812 and a fourth intermediate adapter coupling 3814. The first intermediate adapter coupling 3804 is received in the inlet adapter coupling 3414. The second intermediate adapter coupling receives the third intermediate adapter coupling. Finally, the fourth intermediate adapter coupling receives the outlet adapter coupling 3456. As shown in FIG. 54 , the first intermediate adapter coupling 3804 and the second intermediate adapter coupling 3806 are angled relative to each other. The first intermediate adapter coupling is aligned with a first axis EE, and the second intermediate adapter coupling is aligned with a second axis FF. The axes EE and FF are inclined at an angle α relative to each other. In the embodiment of FIG. 54 , the angle between the first and second intermediate adapter couplings is 90 degrees (e.g., α = 90 degrees), such that the couplings are orthogonal to one another. In other embodiments, the intermediate couplings may be angled at an acute angle relative to one another (e.g., α < 90 degrees). In yet other embodiments, the intermediate couplings may be angled at an oblique angle relative to one another (e.g., α > 90 degrees). In the embodiment of FIG. 54 , the third and fourth intermediate adapter couplings are angled relative to one another at an angle equal to the angle between the first and second intermediate adapter couplings. In some embodiments, the angle between the first and second intermediate adapter couplings may be different from the third and fourth intermediate adapter couplings.

[0273] FIG. 55 is a side view of another embodiment of a drug solution delivery device 4400. As shown in FIG. 55, the device includes a first adapter 4410 (e.g., an inlet adapter), a second adapter 4412 (e.g., an intermediate adapter), and a third adapter 4414 (e.g., an outlet adapter) connected in a serial fluid arrangement via a first tube 4416 and a second tube 4418. All of the adapters are disposed in a lower portion 4402 of the housing. According to the embodiment of FIG. 55, the lower portion of the housing includes an adapter plate 4404 configured to physically couple the modular adapters together. The adapter plate 4404 may be formed integrally with the lower portion 4402 or may be formed as a separate component. As shown in FIG. 55, the adapter plate 4404 includes a plurality of recesses 4406 formed by studs 4408. Together, the recesses and studs are sized and shaped to receive the adapters and prevent relative movement therebetween. The stud 4408 is configured to engage (e.g., by an interference fit) with the first adapter base 4411, the second adapter base 4413, and the third adapter base 4415 to prevent relative movement between the adapters. In some embodiments shown in FIG. 55 , the stud is configured to engage with a side of the adapter base. In this manner, the adapter bases releasably connect to one another via the adapter plate 4404, a coupling that cannot move relative to one another in a first direction (e.g., in the x-y plane). Of course, while in the embodiment of FIG. 55 the stud 4408 engages with a side of the adapter base, in other embodiments the stud may engage with any suitable portion of the adapter. For example, in some embodiments, the adapter base may include an adapter recess (e.g., a tenon) configured to receive the stud. In some embodiments, the adapter base may include a stud configured to be received in a recess in the adapter plate. Of course, the disclosure is not so limited; any suitable number of studs and recesses may be used in the adapter base and adapter plate as a coupling to enable multiple adapters to be releasably connected to one another.Additionally, although the embodiment of Figure 55 includes three adapters, any suitable number of adapters can be used in an arrangement similar to that of Figure 55. Similarly, although the embodiment of Figure 55 includes adapters in a series arrangement, any suitable fluidic or physical arrangement can be used (e.g., matrix, zigzag, etc.) as the disclosure is not so limited.

[0274] FIG. 56 is a side view of another embodiment of a medication solution delivery device 4500. As shown in FIG. 56, the device includes a first adapter 4510 (e.g., an inlet adapter), a second adapter 4512 (e.g., an intermediate adapter), and a third adapter 4514 (e.g., an outlet adapter). Although the fluid connections of the adapters are not shown in FIG. 56, the adapters may be fluidly connected in a series arrangement, a parallel arrangement, or any other suitable configuration to deliver the contents of the three containers. All of the adapters are disposed in the lower part 4502 of the housing. According to the embodiment of FIG. 56, the lower part of the housing is configured to form an interference fit with the adapters. In the illustrated embodiment, the lower part of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. The first adapter base 4515, in turn, is configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, second adapter base 4513, and third adapter base 4515 prevents relative movement between the adapters through interference and friction. When configured as shown in FIG. 56 , the adapters may be unable to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force may be overcome, causing the adapters to move in the second direction relative to the other adapters. Thus, in the embodiment of FIG. 56 , the adapter bases 4511, 4513, 4515 cooperate with the lower housing portion 4502 to function as couplings between the adapters. In some embodiments shown in FIG. 56 , the lower portion 4502 includes a lead-in 4504 configured to guide the adapters into position and facilitate the formation of an interference fit between the lower portion and the adapters 4510, 4512, 4514. Of course, any suitable configuration having an interference fit can be used at the bottom, including embodiments without a lead-in, as the disclosure is not so limited. Additionally, although the embodiment of FIG. 56 includes three adapters, any suitable number of adapters can be used in an arrangement similar to that of FIG.Similarly, although the embodiment of FIG. 55 includes adapters in a serial physical arrangement, any suitable physical arrangement may be used (e.g., matrix, staggered, etc.) as the disclosure is not so limited.

[0275] FIG. 57 is a top schematic view of another embodiment of a transfer engine 4600. In the embodiment of FIG. 57, "I" is an inlet adapter, "M" is an intermediate adapter, and "O" is an outlet adapter, as described in accordance with exemplary embodiments described herein. Arrows indicate the flow path between the adapters. The relative placement of the adapters indicates the physical arrangement of the transfer engine. In some embodiments, the adapters can include various couplings and / or cooperate with the lower part of the housing to hold the adapters in the physical position shown in FIG. 57. In the embodiment of FIG. 57, the physical arrangement is staggered, similar to that shown in FIG. 54. Additionally, the adapters are fluidly connected in a serial fluidic arrangement, where fluid flows sequentially from the inlet adapter, through two intermediate adapters, and to the outlet adapter, and the medicinal solution can be delivered to a user via an appropriate delivery device.

[0276] FIG. 58 is a top schematic view of another embodiment of a transfer engine 4700. In the embodiment of FIG. 58, "I" is an inlet adapter, "M" is an intermediate adapter, and "O" is an outlet adapter, as described in accordance with exemplary embodiments described herein. Arrows indicate the flow paths between the adapters. The relative placement of the adapters indicates the physical arrangement of the transfer engine. In some embodiments, the adapters can include various couplings and / or cooperate with the lower part of the housing to hold the adapters in the physical position shown in FIG. 58. In the embodiment of FIG. 58, the physical arrangement is a diamond matrix. Furthermore, the adapters are fluidically connected in a parallel fluidic arrangement, with fluid flowing individually from the inlet adapter and two intermediate adapters to the outlet adapter. The resulting medicinal solution can be delivered from the outlet adapter to a user via an appropriate delivery device.

[0277] FIG. 59 is a top schematic view of another embodiment of a transfer engine 4800. In the embodiment of FIG. 59, "I" is an inlet adapter, "M" is an intermediate adapter, and "O" is an outlet adapter, as described in accordance with exemplary embodiments described herein. Arrows indicate the flow paths between the adapters. The relative placement of the adapters indicates the physical arrangement of the transfer engine. In some embodiments, the adapters can include various couplings and / or cooperate with the lower part of the housing to hold the adapters in the physical position shown in FIG. 59. In the embodiment of FIG. 59, the physical arrangement is a diamond matrix. Furthermore, the adapters are fluidly connected in a partially parallel, partially serial fluidic arrangement. In particular, fluid flows from two inlet adapters individually to one intermediate adapter. The fluid then flows from the intermediate adapter to the outlet adapter. The resulting medicinal solution can be delivered from the outlet adapter to a user via an appropriate delivery device.

[0278] FIG. 60 is a top schematic view of another embodiment of a transfer engine 4900. In the embodiment of FIG. 60, "I" is an inlet adapter, "M" is an intermediate adapter, and "O" is an outlet adapter, as described in accordance with exemplary embodiments described herein. Arrows indicate the flow paths between the adapters. The relative placement of the adapters represents the physical arrangement of the transfer engine. In some embodiments, the adapters can include various couplings and / or cooperate with the lower part of the housing to hold the adapters in the physical position shown in FIG. 60. In the embodiment of FIG. 60, the physical arrangement is a square matrix. Furthermore, the adapters are fluidically connected in a serial fluidic arrangement, as in FIG. 57. Specifically, fluid flows sequentially from the inlet adapter through two intermediate adapters to the outlet adapter. The resulting medicinal solution can be delivered from the outlet adapter to a user via an appropriate delivery device.

[0279] While the exemplary embodiments described herein are arranged in linear, angled, and matrix patterns, in other embodiments, the transfer engines may be arranged in a square matrix, a hexagonal pattern, or any other suitable geometric pattern, as the disclosure is not so limited. In some embodiments, the adapter may include any number of couplings such that multiple transfer engines may be arranged in a desired matrix. For example, the adapter may include one coupling, two couplings, three couplings, four couplings, or any other suitable number of couplings. In some embodiments, the inlet adapter may include a first inlet adapter coupling and a second inlet adapter coupling, each configured to connect to a separate intermediate adapter coupling in a parallel configuration. Such an arrangement can provide a fluidic arrangement similar to the embodiment of FIG. 53, although other fluidic configurations are contemplated. In some embodiments, the outlet adapter may include a first outlet adapter coupling and a second outlet adapter coupling, each configured to connect to a separate intermediate adapter coupling in a parallel configuration.

[0280] FIG. 61A is a front schematic view of another embodiment of a drug delivery device 3900 in a first state, and FIG. 61B illustrates the drug delivery device in a second state. According to the embodiment of FIGS. 61A-61B, the device includes a housing having an upper portion 3902 and a lower portion 3910. The housing is configured to receive a single container, although in other embodiments, any suitable number of containers may be disposed within the housing. The upper portion is configured to move between an inactive position shown in FIG. 61A and an active position shown in FIG. 61B. As in some embodiments described above, the upper portion is configured to slide along an inner guide 3912. The upper portion includes a fluid outlet cutout 3904 configured to expose and provide physical access to the fluid outlet when the upper portion is moved to the active position. In the embodiment of FIGS. 61A-61B, the cutout 3904 is configured to align with the fluid outlet 3914 when the upper portion is in the active position. Of course, any arrangement for selectively providing access to the fluid outlet may be used in accordance with other exemplary embodiments described herein. In some alternative embodiments, the fluid outlet may be physically accessible regardless of the state of the upper portion 3902, as the disclosure is not so limited.

[0281] The embodiments of FIGS. 61A-61B include a marker configured to selectively communicate information to a remote device (e.g., a user device such as a smartphone). In the embodiment of FIGS. 61A-61B, the marker is a QR code 3916 disposed on the lower portion 3910 of the housing. In some embodiments, as shown in FIGS. 61A-61B, the QR code is at least partially obstructed by the upper portion when the upper portion is in the inactivated position. Specifically, the opaque portion of the upper portion obscures the marker, so that the QR code is hidden and invisible when the upper portion is in the inactivated position. However, in the activated position, a marker window 3906 formed in the upper portion aligns with the QR code, exposing the QR code to the user and making it accessible. Thus, when the medication delivery device is activated, the user can scan the QR code using the remote device. When scanned, the QR code can relay information such as dosage, medication lot information, etc. to the remote device. That is, the QR code can contain information readable by a remote device. In some embodiments, the marker window 3906 can be formed as a hole in the top. In some embodiments, the marker window 3906 can be a transparent portion of the top configured to align with the marker when the top is in the activated position. Of course, the QR code can be made accessible to a user in any suitable configuration, as the disclosure is not so limited. For example, in some embodiments, the top can cover at least a portion of the marker in the non-activated position and expose the marker without a window in the activated position. The configuration of FIGS. 61A-61B can allow information to be transferred to a remote device without pairing or a power source onboard the medication solution delivery device.

[0282] FIG. 62A is a front schematic view of another embodiment of a drug solution delivery device 4000 in a first state, and FIG. 62B shows the drug solution delivery device in a second state. According to the embodiment of FIGS. 62A-62B, the device includes a housing having an upper portion 4002 and a lower portion 4010. The housing is configured to receive a single container, although in other embodiments, any suitable number of containers may be disposed within the housing. The upper portion is configured to move between an inactive position shown in FIG. 62A and an active position shown in FIG. 62B. As in the previous embodiment, the upper portion is configured to slide along an inner guide 4012. The upper portion includes a fluid outlet cutout 4004 configured to expose and provide physical access to the fluid outlet when the upper portion is moved to the active position. In the embodiment of FIGS. 62A-62B, the cutout 4004 is configured to align with the fluid outlet 4014 when the upper portion is in the active position. Of course, any configuration for selectively providing access to the fluid outlet may be used in accordance with other exemplary embodiments described herein.

[0283] The embodiment of FIGS. 62A-62B includes a marker configured to selectively communicate information to a remote device. In the embodiment of FIGS. 62A-62B, the marker is an NFC tag 4016 disposed in the lower portion 4010 of the housing. As shown in FIGS. 62A-62B, the NFC tag is surrounded by the upper portion in the inactive position. However, in the active position, a marker window 4006 formed in the upper portion aligns with the NFC tag, revealing and making the NFC tag accessible to a user. In some embodiments, the upper portion may be formed with an NFC signal impeder or other radio frequency (RF) shield such that the NFC tag is at least partially obstructed by the upper portion when the upper portion is in the inactive position. According to such embodiments, the NFC tag may not be activated by a remote device until the NFC tag is aligned with the window, which may be radio-transparent. In other embodiments, a visual indicator of where a user can read the NFC tag may be at least partially obstructed by the upper portion in the inactive position. According to such embodiments, the window may reveal a visual indicator of where a user can read the NFC tag. Thus, when the medication delivery device is activated, a user can scan the NFC tag with a remote device. The NFC tag can relay information such as dosage, medication lot information, etc. to the remote device. In some embodiments, the marker window 4006 can be formed as a hole in the top. In some embodiments, the marker window 4006 can be a wirelessly transparent portion of the top 4002. Of course, the NFC tag can be made accessible to a user in any suitable arrangement, as the disclosure is not so limited. The arrangement of FIGS. 62A-62B can allow information to be transferred to a remote device without a power source onboard the medication delivery device, as the NFC tag can be wirelessly powered by the remote device.

[0284] FIG. 63 is a flowchart of another embodiment of a drug solution delivery process. As shown in step 4100, a first container is provided within a housing, with an upper portion of the housing at least partially enclosing the first container. In step 4102, a force is applied to the upper portion to move the upper portion from a non-activated position to an activated position. In some embodiments, moving the upper portion to the activated position can puncture the first container. In step 4104, a marker is exposed when the upper portion is moved to a second activated position. For example, a window formed in the upper portion can be aligned with the marker. In some embodiments, moving the upper portion to the activated position can also physically make a fluid outlet accessible, as further described in accordance with other exemplary embodiments herein. In step 4106, fluid is allowed to flow from the first container to the fluid outlet. For example, as described above, moving the upper portion to the activated position can fluidly connect the first container to the fluid outlet (e.g., via a spike).

[0285] FIG. 64A is a front schematic view of another embodiment of a medical fluid delivery device 4200 including a communications module in a first state, and FIG. 64B shows the medical fluid delivery device of FIG. 64A in a second state. According to the embodiment of FIGS. 64A-64B, and similar to the previously described embodiments, the device includes a housing having an upper portion 4202 and a lower portion 4210. The housing is configured to receive a single container, although in other embodiments, any suitable number of containers may be disposed within the housing. The upper portion is configured to move between an inactive position shown in FIG. 64A and an active position shown in FIG. 64B. As in the previously described embodiments, the upper portion is configured to slide along an inner guide 4212. The upper portion includes a fluid outlet cutout 4204 configured to reveal and allow physical access to the fluid outlet when the upper portion is moved to the active position. In the embodiment of FIGS. 64A-64B, the cutout 4204 is configured to align with the fluid outlet 4214 when the upper portion is in the active position. Of course, any arrangement for selectively allowing access to the fluid outlet may be used in accordance with other exemplary embodiments described herein.

[0286] The embodiment of Figures 64A-64B includes a communications module 4230 configured to communicate with one or more remote devices (e.g., user devices). The communications and related functionality are similar to those described with reference to the embodiment of Figure 18. The communications module is further described with reference to Figure 65. According to the embodiment of Figures 64A-64B, the communications module can be easily attached to the lower portion 4210. The communications module can be self-contained, such that the medication delivery device can easily communicate with the remote devices when paired with the trigger.

[0287] According to the embodiment of FIGS. 64A-64B, the medication delivery device 4200 includes a trigger configured to activate the communication module 4230. Two examples of triggers are shown in the embodiment of FIGS. 64A-64B, which may be used alone in other embodiments. First, the device includes a switch 4224 (e.g., a microswitch) configured to engage with an engagement portion 4203 of the housing's upper portion 4202. While the engagement portion 4203 in FIGS. 64A-64B is a lip, in other embodiments, the engagement portion may be a housing wall, an internal protrusion or feature, or any other suitable feature of the housing's upper portion 4202. The switch is configured to be activated (e.g., depressed) when the upper portion is moved to an actuated position. That is, the switch is configured to be moved from a first switch position to a second switch position by the upper portion. Second, the device includes a light beam sensor 4226 disposed in the lower portion 4210 that emits a light beam 4227. Specifically, the light beam sensor includes a light beam transmitter and a light beam receiver, where the light beam transmitter is configured to emit a light beam that is received by the light beam receiver. The upper portion 4202 includes a protrusion 4206 configured to physically block the light beam when the upper portion is in the activated position. The light beam sensor is configured to detect when the light beam is blocked, thereby determining that the upper portion is activated. In some embodiments, triggers on the medication delivery device can connect the communication module 4230 to a power source. When the communication module is activated by one or both triggers, the communication module can transmit one or more messages containing information to a remote device. While two example triggers are shown in FIGS. 64A-64B , any suitable sensor can be used to activate the communication module, as the disclosure is not so limited. For example, a strain gauge or other pressure sensor can be positioned on the upper portion and configured to detect force or pressure applied to the upper portion by a user. When the detected force or pressure exceeds a threshold force or pressure, the communication module can be activated.As another example, a Hall effect sensor can be used to detect movement of the top to an activated position and activate the communications module, as described above with reference to other exemplary embodiments herein. As yet another example, a proximity sensor can be used to detect movement of the top to an activated position and activate the communications module.

[0288] FIG. 65 is a schematic diagram of one embodiment of a communications module 4230. As shown in FIG. 65, the communications module includes a processor 4232 that can be configured to execute computer-readable instructions stored in non-transitory memory. The communications module also includes a power source 4234 (e.g., a battery) configured to power various components of the communications module. The communications module also includes a communications device 4236, which may be a wireless transceiver using any suitable radio frequency communications protocol (e.g., Bluetooth, Bluetooth Low-Energy, Wi-Fi, 802.15.4, ZigBee, GSM, HSPA, CDMA, etc.). In some embodiments shown in FIG. 65, the communications module can optionally include one or more sensors 4238 configured to provide information to the communications module. The sensors may include an accelerometer configured to provide motion information to the communications module and a temperature sensor (e.g., a thermocouple) configured to provide temperature information to the communications module. Information from these sensors may be included in messages transmitted by the communications module to one or more remote devices. Of course, any suitable sensor may be used as part of the communications module, as the present disclosure is not so limited.

[0289] In some embodiments, the communications module may include additional components that can provide additional functionality to facilitate use of the medical delivery device. For example, in some embodiments, the communications module may include a vibration motor configured to agitate the device. In some embodiments, the vibration motor can be used to assist in mixing various fluids and solids in the medical fluid delivery device. In some embodiments, the vibration motor may be configured to provide a tactile alert to the user, as described with reference to other embodiments described herein. As another example, in some embodiments, the communications module may include a speaker. In some embodiments, the speaker may be configured to provide an audio alert to the user, as described with reference to other embodiments described herein.

[0290] FIG. 66 is a flowchart of another embodiment of a drug solution delivery process. As shown in step 4300, a first container is provided within a housing, with an upper portion of the housing at least partially enclosing the first container. In step 4302, a force is applied to the upper portion to move the upper portion from an inactivated position to an activated position. In some embodiments, moving the upper portion to the activated position can puncture the first container. In step 4304, the communication module is triggered when the upper portion moves to the activated position. For example, a switch may be depressed by the upper portion when the upper portion moves to the activated position. In some embodiments, moving the upper portion to the activated position can also physically make a fluid outlet accessible, as further described in accordance with other exemplary embodiments herein. In step 4306, fluid is allowed to flow from the first container to the fluid outlet. For example, as described above, moving the upper portion to the activated position can fluidly connect the first container to the fluid outlet (e.g., via a spike).

[0291] It should be noted that while some of the above embodiments illustrate reconstitution devices, in other embodiments, devices similar to these embodiments may be drug solution delivery devices configured to pool drug solutions or to access the contents of only a single container, as opposed to reconstituting solid pharmaceuticals. Accordingly, the various mechanisms and methods described with reference to these embodiments are also applicable to drug solution delivery devices configured to pool fluids or to access the contents of only a single container, as the disclosure is not so limited.

[0292] In addition to the above, it should be noted that while some of the devices described above are configured to access and deliver the contents of two containers, any suitable number of containers may be used. For example, in some embodiments, a drug solution delivery device such as those described above may include a single container, two containers, three containers, four containers, five containers, or any suitable number of containers. Accordingly, the various mechanisms and methods described above are applicable to drug solution delivery or reconstitution devices having any number of containers, as the present disclosure is not so limited.

[0293] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those skilled in the art. Accordingly, the foregoing description and drawings are by way of example only.

Claims

1. A reconfiguration device, comprising: a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion from an inoperative position and an operative position; a first spike coupled to the first plate; a second spike coupled to a second plate, the first and second plates being coupled via an interlock; an inlet in fluid communication with the first spike; an outlet in fluid communication with the second spike; A reconfiguration device comprising:

2. The reconstitution device of claim 1, wherein the inlet comprises an air inlet.

3. The reconstitution device of claim 1, further comprising a hydrophobic filter at the inlet.

4. The reconstruction device of claim 1, wherein the interlock comprises a protrusion and a recess.

5. The reconstruction device of claim 1, wherein the interlock has a jigsaw shape.

6. The reconstitution device of claim 1, further comprising a first container aligned with the first spike and a second container aligned with the second spike, wherein when the upper portion of the housing is moved to the operating position, the first spike is configured to spike the first container and the second spike is configured to spike the second container.

7. The reconstitution device of claim 6, wherein the second container contains a vacuum, whereby the fluid in the first container is at a pressure higher than the pressure inside the second container.

8. The reconstruction device of claim 1, wherein the outlet is movable relative to the housing.

9. A first sheath covering at least a portion of the first spike; a second sheath covering at least a portion of the second spike; The reconstitution device of claim 1 , further comprising:

10. The reconstitution device of claim 1, further comprising a first tube fluidly connecting the inlet to the second spike.

11. The reconstitution device of claim 1, further comprising a first pathway fluidly connecting the second spike to the outlet.

12. A reconfiguration device, comprising: a housing having a lower portion and an upper portion in movable engagement with the lower portion, the upper portion being movable relative to the lower portion from an inoperative position and an operative position; a first spike coupled to the first base piece; a second spike coupled to a second base piece, the first and second base pieces being coupled through an interlocking arrangement; an inlet in fluid communication with the first spike; an outlet in fluid communication with the second spike; A reconfiguration device comprising:

13. The reconstruction device of claim 12, wherein the interlocking arrangement comprises at least one intermediate component, the at least one intermediate component connecting the first base component to the second base component.

14. The reconstruction device described in claim 13, further comprising a third spike connected to the at least one intermediate component.

15. The reconstruction device of claim 12, wherein the first base part and the second base part are directly attached to each other.

16. The reconstitution device of claim 12, wherein the inlet is an air inlet.

17. The reconstitution device of claim 12, further comprising a hydrophobic filter at the inlet.

18. The reconstruction device of claim 12, wherein the interlocking element comprises a protrusion and a recess.

19. The reconstruction device of claim 12, wherein the interlocking arrangement has a jigsaw shape.

20. The reconstitution device of claim 12, further comprising a first container aligned with the first spike and a second container aligned with the second spike, wherein when the upper portion of the housing is moved to the operating position, the first spike is configured to spike the first container and the second spike is configured to spike the second container.

21. The reconstitution device of claim 20, wherein the second container contains a vacuum, whereby the fluid in the first container is at a pressure higher than the pressure inside the second container.

22. The reconstitution device of claim 12, wherein the outlet is movable relative to the housing.

23. The reconstruction device of claim 12, further comprising a first sheath covering at least a portion of the first spike and a second sheath covering at least a portion of the second spike.

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