Drug 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 on Mar. 5, 2020, the entire disclosure of which is incorporated herein by reference.

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

Background Art

[0003] Drug solutions are administered to patients in a variety of ways. These conventional methods typically include injection by syringe, ingestion, or delivery by infusion pumps and needles. A controlled amount of the drug solution is prescribed and delivered by one or more of these methods.

[0004] In some cases, the formulation is manufactured in a dehydrated or otherwise unconfigured form, such as a lyophilized form. That is, the drug can be stored and packaged as a dry material that is combined with water or another reconstitution fluid and mixed prior to administration to the patient. In such cases, a predetermined amount of the drug and, in many cases, sterile water for injection are provided for the patient or other healthcare provider to combine immediately prior to administration.

Summary of the Invention

Means for Solving the Problems

[0005] In some embodiments, a system and method for administering a medicament solution to a patient are provided. Specifically, a reconstitution system is provided that enables simplified reconstitution of a dry (e.g., powder) formulation. In some embodiments, the system enables simplified access to liquid pharmaceuticals. In some embodiments, the reconstitution device includes a first flow path having a first open end disposed within a 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 a second spike. In some embodiments, a valve is disposed within the second flow path between the second open end and the third open end. 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 enable fluid transfer from a first container (e.g., containing sterile water) to a second container (e.g., containing a medicament for reconstitution). In some embodiments, the fluid outlet may include a luer lock valve, whereby a syringe can be fluidly connected to the fluid outlet and the reconstituted medicament solution can be withdrawn from the device. In some embodiments, the container containing the powder medicament may be configured to include a low pressure or zero pressure vacuum, whereby sterile water or another fluid from another container can be pushed into the container containing the medicament without manually applying pressure or pumping. In some embodiments, the pressure difference between the medicament-containing container and the fluid-containing container is large enough for the fluid from the fluid-containing container to be discharged into the medicament-containing container, thereby agitating the medicament and facilitating reconstitution.

[0006] In some embodiments, the reconfiguration device may include a housing having an upper portion and a lower portion, where the lower portion is slidably received within 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 of 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 non-operating position to a second operating position. In some embodiments, when the upper portion moves to the operating position, the at least two containers may be punctured by the spike(s) associated with the container(s). In some embodiments, the containers may be in fluid communication when punctured, such that fluid from one container can flow to the other container. In some embodiments, the first container may be under vacuum, such that as a result of the pressure difference between the two containers, fluid from the second container is pushed into the first container.

[0007] In some embodiments, the reconfiguration 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, a first open end and a 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, and a third flow path having a fourth open end and an outlet, where the third open end and the fourth open end define a second container receiving end. The first container receiving end and the second container receiving end face in the same direction.

[0008] In some embodiments, the reconfiguration device includes a housing having a lower portion and an upper portion that slidably engages the lower portion, an upper portion that is movable relative to the lower portion between a non-operating position and an operating position, and a transfer engine disposed within the lower portion of the housing, the first container receiving end and the second container receiving end facing towards the upper portion of the housing. The reconfiguration 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 when the upper portion moves from the non-operating position to the operating position, the first container and the second container move towards the first container receiving end and the second container receiving end, respectively. When the upper portion is in the non-operating position, physical access to the fluid outlet is at least partially blocked, and when the upper portion is in the operating position, physical access to the fluid outlet is permitted.

[0009] In some embodiments, the reconfiguration device includes a housing having a lower portion and an upper portion that slidably engages the lower portion, the upper portion being movable relative to the lower portion between a non-operating position and an operating position. The reconfiguration device also includes a transfer engine disposed within the lower portion of the housing, the first container receiving end and the second container receiving end facing towards the upper portion of the housing, and the transfer engine and the lower portion being separate components. The reconfiguration device also includes a fluid outlet in fluid communication with the second container receiving end of the transfer engine.

[0010] In some embodiments, the reconfiguration device includes a housing having a first portion and a second portion that movably engages the first portion, a first and a second portion that are movable relative to each other between a non-operating configuration and an operating 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 and hold the first container against the first spike.

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

[0012] In some embodiments, the medicament delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion, an upper portion movable relative to the lower portion between a non-operating position and an operating position, a fluid outlet configured to deliver fluid from a container disposed within the housing when the upper portion is in the operating 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 non-operating position to the operating position.

[0013] In some embodiments, the drug delivery device includes an inlet adapter having an inlet container containing a drug solution, an inlet spike configured to pierce the inlet container and configured to receive the drug 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 drug delivery device also includes an intermediate adapter having an intermediate container containing a drug solution or a pharmaceutical solid, an intermediate spike configured to pierce 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 for releasably attaching the intermediate adapter to the inlet adapter, and a second intermediate adapter coupling. The drug delivery device further includes an outlet adapter having an outlet container containing a pharmaceutical solid, an outlet spike configured to pierce 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 connect to the second intermediate adapter coupling for releasably attaching the outlet adapter to the intermediate adapter.

[0014] In some embodiments, the drug delivery device includes an inlet adapter having an inlet spike configured to pierce an inlet container, an air inlet, an inlet adapter fluid channel fluidly connected to the inlet spike, and an inlet adapter coupling spaced from the inlet adapter fluid channel. The drug delivery device also includes an intermediate adapter having an intermediate spike configured to pierce an 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 by 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 from the first intermediate fluid channel and the second intermediate fluid channel. The drug delivery device further includes an outlet adapter having an outlet spike configured to pierce an 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 by a second intermediate adapter coupling to releasably interlock the outlet adapter with the intermediate adapter and spaced from the outlet adapter fluid channel.

[0015] In some embodiments, the reconfiguration 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 a non-operating position and an operating position. The drug delivery device may include a transfer engine disposed within the lower portion of the housing and having a first container receiving end facing towards 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 a first container such that the first container moves towards the first container receiving end when the upper portion moves from the non-operating position to the operating position. Physical access to the fluid outlet may be at least partially obstructed when the upper portion is in the non-operating position. Physical access to the fluid outlet may be permitted when the upper portion is in the operating position.

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

[0017] It should be understood that, since the present disclosure is not limited in this respect, the foregoing concepts, as well as additional concepts described below, may be combined in any suitable combination. Further, 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 path having a first open end and an inlet; A second flow path having a second open end and a third open end, wherein the first open end And the second open end define a first container receiving end, the second flow path; 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, wherein the third open end and the fourth open end define a second container receiving end, the third flow path, comprising: The first container receiving end and the second container receiving end face the same direction. Reconfiguration device. (Item 2) The reconfiguration device according to item 1, wherein the inlet includes an air filter. (Item 3) The reconfiguration device according to item 2, wherein the air filter is a hydrophobic air filter. (Item 4) The reconfiguration device according to item 1 or any of the preceding items, wherein the valve is a one-way valve configured to allow fluid to flow from the second open end to the third open end. (Item 5) The reconfiguration device according to item 1 or any of the preceding items, wherein the outlet is a luer-activated valve. (Item 6) The reconfiguration device according to item 1, 2, 3, or 4, wherein the outlet includes a luer. (Item 7) The reconfiguration device according to 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) The reconfiguration device according to 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) The reconfiguration device according to 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 inner cavity of the first spike, and a portion of the second flow path extending from the second open end forms a second inner cavity of the first spike. (Item 10) The reconfiguration device according to item 9, further comprising a second spike, wherein a portion of the second flow path extending from the third open end forms a first inner cavity of the second spike, and a portion of the third flow path extending from the fourth open end forms a second inner cavity of the second spike. (Item 11) The reconfiguration device according to item 10, wherein the third open end is inclined at an angle with respect to the piercing direction of the second spike. (Item 12) The reconfiguration device according to item 11, wherein the angle is about 90 degrees. (Item 13) The reconfiguration device according to any one of item 1 or the preceding items, wherein a part of each of the first, second, and third flow paths is on the same plane. (Item 14) The reconfiguration device according to any one of item 1 or the preceding items, further comprising a filter disposed in the third flow path. (Item 15) The reconfiguration device according to any one of item 1 or the preceding items, further comprising a first container fluidly connected to the first open end and the second open end, the first container containing fluid. devices. (Item 16) The reconfiguration device according to item 15, wherein the fluid is sterile water for injection. (Item 17) The reconfiguration device according to 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 product. (Item 18) The reconfiguration device according to item 17, wherein the second container contains a vacuum, whereby the fluid in the first container is at a higher pressure than the pressure inside the second container, and the fluid is urged to flow from the first container to the second container. (Item 19) The reconfiguration device according to any one of item 1 or the preceding items, wherein the ratio of the overall length of the device to the overall width of the device is between 3 and 5. (Item 20) The reconfiguration device according to any one of item 1 or the preceding items, wherein the first flow path includes a portion that is mirrored across a longitudinal axis to form a portion of the second flow path. (Item 21) The reconstruction device according to item 20, wherein the second flow path includes a portion that is mirror-imaged across the longitudinal axis to form the third flow path. (Item 22) The reconstruction device according to item 1 or any of the preceding items, wherein the inlet is disposed adjacent to the outlet. (Item 23) The reconstruction device according to item 1 or any of the preceding items, wherein the third flow path is at least partially formed of a flexible tube. (Item 24) The reconstruction device according to item 1 or 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) The reconstruction device according to item 1 or any of the preceding items, further comprising a filter chamber disposed in the third flow path, wherein the first container receiving end and the second container receiving end are disposed on a first side of the first and second flow paths, and the filter chamber is disposed on a second side opposite to the first and second flow paths. (Item 26) The reconstruction device according to item 1 or any of the preceding items, wherein the first flow path is disposed in a first housing, the third flow path is disposed in a second housing, and the second flow path is at least partially disposed in a tube extending between the first housing and the second housing. (Item 27) The reconstruction device according to item 26, further comprising a filter chamber disposed in the third flow path, wherein the first container receiving end and the second container receiving end are disposed on a first side of the first and second flow paths, and the filter chamber is disposed on a second side opposite to the first and second flow paths. (Item 28) The reconstruction device according to item 26, wherein the tube is flexible. (Item 29) The reconstruction device according to item 26, wherein the tube is curved. (Item 30) The reconfiguration device according to item 26, wherein the first housing is attached to the second housing. (Item 31) The reconfiguration device according to item 30, wherein the first housing and the second housing are attached via an interlock arrangement including protrusions received within recesses. (Item 32) The reconfiguration device according to item 1 or any of the preceding items, wherein the third flow path comprises a shaping channel. (Item 33) The reconfiguration device according to any of items 1 to 31, wherein the third flow path includes a hypodermic tube. (Item 34) The reconfiguration device according to item 9, further comprising a sheath covering at least a portion of the first spike. (Item 35) A housing having a lower part and an upper part that movably engages with the lower part, the upper part being movable relative to the lower part between a non-operating position and an operating position, the housing, A transfer engine disposed within the lower part of the housing, the first container receiving end and the second container receiving end facing towards the upper part of the housing, A fluid outlet in fluid communication with the second container receiving end of the transfer engine, The upper part is configured to engage the first container and the second container when the upper part moves from the non-operating position to the operating position, whereby the first container and the second container move towards the first container receiving end and the second container receiving end, respectively, When the upper part is in the non-operating position, physical access to the fluid outlet is at least partially obstructed, and when the upper part is in the operating position, physical access to the fluid outlet is permitted. Reconfiguration device. (Item 36) The reconfiguration device according to item 35, wherein the upper part includes a notch, and when the upper part is in the non-operating position, the upper part at least partially surrounds the fluid outlet in the housing, and when the upper part is in the operating position, the notch exposes the fluid outlet. (Item 37) The reconfiguration device according to item 36, wherein the lower part has a fluid outlet receptacle, the fluid outlet is disposed within the fluid outlet receptacle, and when the upper part is moved to the operating position, the notch is aligned with the fluid outlet receptacle and the fluid outlet is exposed. (Item 38) The reconfiguration device according to any one of items 35 to 37, further comprising a flexible leash connected to the fluid outlet. (Item 39) The reconfiguration device according to any one of items 35 to 37, wherein when the upper part is in the operating position, the fluid outlet is fixed relative to the lower part of the housing. (Item 40) The reconfiguration device according to any one of items 35 to 37, wherein when the upper part is in the operating position, the fluid outlet is movable relative to the lower part of the housing. (Item 41) The reconfiguration device according to item 40, wherein the fluid outlet is connected to the second container receiving end by a flexible tube. (Item 42) The reconfiguration device according to item 40, further comprising a clip attached to the fluid outlet and connected to the lower part of the housing when the upper part is in the non-operating position to hold the fluid outlet in the housing. (Item 43) The reconfiguration device according to item 42, wherein when the upper part is in the operating position, the clip is removable from the lower part of the housing to enable movement of the fluid outlet relative to the housing. (Item 44) The reconfiguration device according to item 42, further comprising a cap covering at least a portion of the fluid outlet, wherein the holding force of the clip with respect to the housing is smaller than the holding force of the cap with respect to the fluid outlet. (Item 45) The reconfiguration device according to item 42, wherein the lower portion of the housing includes a slot in which at least a portion of the clip is received to hold the fluid outlet in the housing when the upper portion is in the non-operating position. (Item 46) The reconfiguration device according to item 42, further comprising a second clip. (Item 47) The reconfiguration device according to any one of items 35 - 38 or 40 - 46, wherein the fluid outlet is movable relative to the transfer engine. (Item 48) The reconfiguration device according to any one of items 35 - 47, wherein the upper portion includes a curved surface extending in a direction away from the lower portion. (Item 49) The reconfiguration device according to any one of items 35 - 48, wherein the lower portion includes a flat surface opposite to the upper portion. (Item 50) The reconfiguration device according to any one of items 35 - 49, further comprising a warning module configured to warn a user when the upper portion moves from the non-operating position to the operating position. (Item 51) The reconfiguration device according to item 50, wherein the warning module is configured to provide a visual warning, an audible warning, and / or a tactile warning. (Item 52) The reconfiguration device according to item 50, wherein the warning module transmits a warning message by wireless communication. (Item 53) The reconfiguration device according to any one of items 35 - 52, wherein the upper portion includes at least one window configured such that a user can see at least one of the first container and the second container. (Item 54) The reconstruction device according to any one of items 35 to 53, wherein the first container receiving end portion is configured as a first spike, and the second container receiving end portion is configured as a second spike. (Item 55) The reconstruction device according to item 54, wherein the first spike and the second spike are each a dual lumen spike. (Item 56) The reconstruction device according to item 54, wherein the second spike includes at least one open end of a flow path inclined at an angle with respect to the piercing direction of the second spike. (Item 57) The reconstruction device according to item 56, wherein the angle is about 90 degrees. (Item 58) The reconstruction device according to item 54, wherein the transfer engine includes an inlet configured to introduce air into the transfer engine. (Item 59) The reconstruction device according to item 58, wherein the inlet is configured as a hydrophobic filter. (Item 60) The reconstruction device according to any one of items 35 to 59, wherein the fluid outlet is a Luer actuated valve or a Luer. (Item 61) The reconstruction device according to any one of items 35 to 60, wherein the first container receiving end portion is in fluid communication with the second container receiving end portion in one direction. (Item 62) The reconstruction device according to any one of items 35 to 60, wherein the upper part is slidably engaged with the lower part. (Item 63) The reconstruction device according to any one of items 35 to 62, wherein the upper part includes at least one upper holding mechanism, the lower part includes at least one lower holding mechanism, and the upper holding mechanism and the lower holding mechanism are engaged with each other to hold the upper part in the operating position. (Item 64) The reconstruction device according to any one of items 35 to 62, wherein the fluid outlet is releasably held in the housing until the delivery device is connected to the fluid outlet. (Item 65) The reconfiguration device according to item 64, wherein the fluid outlet is firmly attached to the housing until the delivery device is connected to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is connected to the fluid outlet. (Item 66) A housing having a lower part and an upper part that movably engages with the lower part, the upper part being movable relative to the lower part between a non-operating position and an operating position, the housing, and A transfer engine disposed within the lower part of the housing, the first container receiving end and the second container receiving end facing the upper part of the housing, the transfer engine and the lower part being separate components, the transfer engine, and A fluid outlet in fluid communication with the second container receiving end of the transfer engine, and A reconfiguration device comprising. (Item 67) The reconfiguration device according to item 66, wherein the transfer engine is held in the lower part by a holding mechanism. (Item 68) The reconfiguration device according to item 67, wherein the holding mechanism includes at least one selected from the group consisting of a mechanical fastener, a snap tab, and an adhesive. (Item 69) The reconfiguration 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. (Item 70) The reconfiguration device according to item 69, wherein the first spike and the second spike are each a dual lumen spike. (Item 71) The reconfiguration device according to item 69, wherein the transfer engine includes an inlet configured to admit air into the transfer engine. (Item 72) The reconfiguration device according to item 71, wherein the inlet is configured as a hydrophobic filter. (Item 73) The reconfiguration device according to any one of items 66 to 72, wherein the fluid outlet is a Luer actuating valve or a Luer. (Item 74) The reconfiguration device according to any one of items 66 to 73, wherein the upper part is slidably engaged with the lower part. (Item 75) The reconfiguration device according to any one of items 66 to 74, wherein the upper part includes at least one upper holding mechanism, the lower part includes at least one lower holding mechanism, and the upper holding mechanism and the lower holding mechanism are engaged with each other to hold the upper part in the operating position. (Item 76) The reconfiguration device according to any one of items 66 to 75, wherein the fluid outlet is releasably held in the housing until the delivery device is connected to the fluid outlet. (Item 77) The reconfiguration device according to item 76, wherein the fluid outlet is firmly attached to the housing until the delivery device is connected to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is connected to the fluid outlet. (Item 78) A housing having a first part and a second part movably engaged with the first part, wherein the first and second parts are movable relative to each other between a non-operating configuration and an operating configuration, the housing, A first spike connected to the second part of the housing, A first ring connected to the first part of the housing and configured to at least partially surround the shoulder of the first container and hold the first container against the first spike, Comprising a reconfiguration device. (Item 79) The reconfiguration device according to 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) The reconfiguration device according to item 78, further comprising an inner contact portion connected to the first ring and configured to receive the shoulder of the first container, wherein the first ring has a greater rigidity than the inner contact portion. (Item 81) The reconfiguration device according to item 80, wherein the inner contact portion comprises a gasket. (Item 82) The reconfiguration device according to item 81, wherein the ring includes an inner surface having a groove, and the gasket is seated in the groove. (Item 83) The reconfiguration device according to item 80, wherein the inner contact portion includes a formed knob. (Item 84) The reconfiguration device according to any one of items 78 to 83, further comprising a second spike connected to the second portion of the housing, wherein the first and second spikes are oriented in the same direction. (Item 85) The reconfiguration device according to item 82, further comprising a second ring connected to the first portion of the housing and configured to at least partially surround the shoulder of the second container and hold the second container against the second spike. (Item 86) The reconfiguration device according to any one of items 78 to 85, further comprising a platform connected to the first portion of the housing and configured to contact the bottom of the first container, and moving the first portion toward the second portion from the non-operating configuration to the operating configuration presses the platform against the bottom of the first container to move the first container toward the first spike. (Item 87) The reconfiguration device according to any one of items 78 to 86, further comprising a plurality of arms connected to the first portion of the housing and extending toward the second portion of the housing, the plurality of arms being configured to at least partially surround the bottom of the first container. (Item 88) The reconstruction device according to item 87, further comprising a gasket connected to the plurality of arms and at least partially surrounded by the plurality of arms. (Item 89) The reconstruction device according to item 78, wherein the first ring is fixed to the first part, whereby the first ring moves with the movement of the first part. (Item 90) A housing having a lower part and an upper part that movably engages with the lower part, the upper part being movable relative to the lower part between a non-operating position and an operating position, the housing, A fluid outlet configured to deliver fluid from a container disposed within the housing when the upper part is in the operating position, A marker that is at least partially obstructed in the non-operating position of the upper part, the marker being accessible in the operating position of the upper part, the marker, A medicament delivery device comprising: (Item 91) The medicament delivery device according to item 90, wherein the marker is a QR code (registered trademark). (Item 92) The medicament delivery device according to item 91, wherein the QR code (registered trademark) contains information readable by a remote device. (Item 93) The medicament delivery device according to item 92, wherein the information includes at least one selected from the group of dosage and drug identification. (Item 94) The medicament delivery device according to item 92, wherein the remote device is a smartphone. (Item 95) The medicament delivery device according to item 90, wherein the marker is a near field communication tag. (Item 96) The medicament delivery device according to item 95, wherein the marker is a radio frequency identification tag. (Item 97) The chemical solution delivery device according to any one of items 90 to 96, wherein the upper part includes a marker window, the upper part in the non-operating position surrounds the marker in the housing, and the marker window exposes the marker when the upper part is in the operating position. (Item 98) The chemical solution delivery device according to any one of items 90 to 96, wherein the upper part in the non-operating position covers at least a part of the marker, and the upper part in the operating position exposes the marker. (Item 99) The chemical solution delivery device according to any one of items 90 to 96, wherein an opaque part of the upper part hides at least a part of the marker and at least partially obstructs the marker. (Item 100) The chemical solution delivery device according to item 99, wherein a transparent part of the upper part is aligned with the marker when the upper part is in the operating position. (Item 101) A housing having a lower part and an upper part that movably engages with the lower part, the upper part being movable relative to the lower part between a non-operating position and an operating position, the housing, A fluid outlet configured to deliver fluid from a container disposed within the housing when the upper part is in the operating position, A communication module configured to transmit messages via at least one communication protocol, A trigger configured to activate the communication module when the upper part is moved from the non-operating position to the operating position, A chemical solution delivery device comprising: (Item 102) The chemical solution delivery device according to item 101, wherein the trigger is a switch configured to be moved by the upper part from a first switch position to a second switch position. (Item 103) The chemical solution delivery device according to item 101, wherein the trigger includes a Hall effect sensor disposed in the lower part, and the trigger includes a magnet disposed in the upper part. (Item 104) The trigger includes a pressure sensor configured to detect the pressure applied to the upper part to move the upper part to the operating position, and the trigger is configured to activate the communication module when the threshold pressure applied to the upper part is detected by the pressure sensor, the chemical solution delivery device according to item 101. (Item 105) The trigger includes a light beam transmitter and a light beam receiver disposed in the lower part, the light beam transmitter is configured to emit a light beam received by the light beam receiver, and the upper part is configured to physically block the light beam in the operating position, the chemical solution delivery device according to item 101. (Item 106) The chemical 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) The chemical solution delivery device according to any one of items 101 to 106, further comprising a sensor configured to provide information to the communication module. (Item 108) The chemical solution delivery device according to item 107, wherein the sensor is a temperature sensor configured to provide temperature information to the communication module. (Item 109) The chemical solution delivery device according to item 107, wherein the sensor is an accelerometer configured to provide motion information to the communication module. (Item 110) The chemical solution 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) The chemical solution delivery device according to any one of items 101 to 110, wherein the communication module is configured to transmit a message including at least one selected from the group of dosage and drug identification. (Item 112) The upper part in the non-operating position at least partially obstructs physical access to the fluid outlet, and the upper part in the operating position is configured to allow physical access to the fluid outlet, the chemical solution delivery device according to item 90 or 101. (Item 113) The upper part includes a notch, and the upper part in the non-operating position at least partially surrounds the fluid outlet in the housing, and in a state where the upper part is in the operating position, the notch exposes the fluid outlet, the chemical solution delivery device according to item 112. (Item 114) The container, fluidly connected to the fluid outlet and configured to puncture the container when the upper part moves from the non-operating position to the operating position, configured as such, a first spike, further comprising the chemical solution delivery device according to item 90 or 101. (Item 115) The container is a first container, and the chemical solution delivery device a second container, fluidly connected to the first spike and configured to puncture the second container when the upper part moves from the non-operating position to the operating position, configured as such, a second spike, further comprising the chemical solution delivery device according to item 114. (Item 116) The first container contains a lyophilized solid, the second container contains a chemical solution, and the upper part is configured such that the chemical solution can dissolve the lyophilized solid in the operating position, the chemical solution delivery device according to item 115. (Item 117) An inlet container containing a chemical solution, an inlet spike configured to puncture the inlet container, the inlet spike being configured to receive the chemical solution from the inlet container, the inlet spike, an air inlet, an inlet adapter fluid channel fluidly connected to the inlet spike, An inlet adapter including an inlet adapter coupling, and An intermediate container containing a chemical solution or a medicinal solid, and An intermediate spike configured to pierce the intermediate container, and 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, and A first intermediate adapter coupling configured to connect to the inlet adapter coupling to removably attach the intermediate adapter to the inlet adapter, and An intermediate adapter including a second intermediate adapter coupling, and An outlet container containing a medicinal solid, and An outlet spike configured to pierce the outlet container, and 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, and An outlet adapter including an outlet adapter coupling configured to connect to the second intermediate adapter coupling to removably attach the outlet adapter to the intermediate adapter, and A chemical solution delivery device comprising. (Item 118) The chemical solution delivery device according to item 117, wherein the outlet adapter coupling is configured to connect to the inlet adapter coupling to removably 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 chemical solution delivery device A second intermediate container containing a chemical solution or a medicinal solid, and A second intermediate spike configured to pierce the second intermediate container, and A third intermediate fluid channel fluidly connected to the second intermediate spike and configured to fluidly connect to the second intermediate fluid channel, and A fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel being configured to fluidly connect to the outlet adapter fluid channel, and the fourth intermediate fluid channel; A third intermediate adapter coupling connected to the second intermediate adapter coupling and configured to releasably attach the first intermediate adapter to the second intermediate adapter in a series configuration; A fourth intermediate adapter coupling connected to the outlet adapter coupling and configured to releasably attach the second intermediate adapter to the outlet adapter in a series configuration, the chemical solution delivery device according to item 117 further comprising a second intermediate adapter. (Item 120) 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 chemical solution delivery device is, A second intermediate container containing a chemical solution or a medicinal solid; A second intermediate spike configured to pierce 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 being configured to fluidly connect to the outlet adapter fluid channel, and the fourth intermediate fluid channel; A third intermediate adapter coupling connected to the second intermediate adapter coupling and configured to releasably attach the inlet adapter to the second intermediate adapter in a parallel configuration; A fourth intermediate adapter coupling connected to the second outlet adapter coupling and configured to releasably attach the second intermediate adapter to the outlet adapter in a parallel configuration, the chemical solution delivery device according to item 117 further comprising a second intermediate adapter. (Item 121) The intermediate adapter is a first intermediate adapter, the intermediate container is a first intermediate container, and the chemical solution delivery device a second intermediate container containing a chemical solution or a medicinal solid, a second intermediate spike configured to pierce the second intermediate container, a third intermediate fluid channel fluidly connected to the second intermediate spike and configured to be fluidly connected to the inlet adapter fluid channel, a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel being configured to be fluidly connected to the outlet adapter fluid channel, a third intermediate adapter coupling connected to the inlet adapter coupling and configured to releasably attach the inlet adapter to the second intermediate adapter in a parallel configuration, the inlet adapter coupling being configured to be simultaneously connected to both the first intermediate adapter coupling and the third intermediate adapter coupling, a fourth intermediate adapter coupling connected to the outlet adapter coupling and configured to releasably attach the second intermediate adapter to the outlet adapter in a parallel configuration, the outlet adapter coupling being configured to be simultaneously connected to both the second intermediate adapter coupling and the fourth intermediate adapter coupling, The chemical solution delivery device according to item 117, further comprising a second intermediate adapter including the fourth intermediate adapter coupling. (Item 122) an inlet spike configured to pierce an inlet container, an air inlet, an inlet adapter fluid channel fluidly connected to the inlet spike, an inlet adapter coupling spaced from the inlet adapter fluid channel, including an inlet adapter, an intermediate spike configured to pierce an 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 couple to the inlet adapter coupling to releasably interlock the intermediate adapter to the inlet adapter; A second intermediate adapter coupling, the intermediate adapter including the first intermediate adapter coupling and the second intermediate coupling, the first intermediate adapter coupling and the second intermediate coupling being spaced apart from the first intermediate fluid channel and the second intermediate fluid channel; An outlet spike configured to pierce an 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; An outlet adapter coupling configured to couple to the second intermediate adapter coupling to releasably interlock the outlet adapter to the intermediate adapter, the outlet adapter coupling being spaced apart from the outlet adapter fluid channel, the outlet adapter including the outlet adapter coupling; A medicament delivery device comprising the above. (Item 123) The medicament delivery device according to 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) The medicament delivery device according to item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are disposed on opposite sides of the intermediate adapter. (Item 125) The medicament delivery device according to item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an oblique angle to each other. (Item 126) The chemical solution delivery device according to item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an acute angle with respect to each other. (Item 127) A first tube configured to fluidly connect the inlet adapter fluid channel and the first intermediate fluid channel, The chemical solution delivery device according to 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) Wherein the intermediate adapter is a first intermediate adapter, and the chemical solution delivery device is A second intermediate spike configured to puncture a second intermediate container containing a chemical solution or a medicinal solid And, 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, wherein the fourth intermediate fluid channel is configured to fluidly connect to the outlet adapter fluid channel, the fourth intermediate fluid channel, A third intermediate adapter coupling received in the second intermediate adapter coupling and configured to releasably interlock the first intermediate adapter with the second intermediate adapter in a series configuration, The chemical solution delivery device according to 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 series configuration. (Item 129) Wherein 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 chemical solution delivery device is A second intermediate spike configured to pierce a second intermediate container containing a chemical solution or a medicinal solid, A third intermediate fluid channel fluidly connected to the second intermediate spike and configured to be fluidly connected to the inlet fluid channel, A fourth intermediate fluid channel fluidly connected to the second intermediate spike, wherein the fourth intermediate fluid channel is configured to be fluidly connected to the outlet adapter fluid channel, the fourth intermediate fluid channel, A third intermediate adapter coupling received in the second intermediate adapter coupling and configured to releasably interlock the first intermediate adapter with the second intermediate adapter in a parallel configuration, A fourth intermediate adapter coupling that receives the second outlet adapter coupling and is configured to releasably interlock the second intermediate adapter with the outlet adapter in a parallel configuration, the chemical solution delivery device according to item 122, further comprising a second intermediate adapter including the fourth intermediate adapter coupling. (Item 130) The intermediate adapter is the first intermediate adapter, and the chemical solution delivery device A second intermediate spike configured to pierce a second intermediate container containing a chemical solution or a medicinal solid, A third intermediate fluid channel fluidly connected to the second intermediate spike and configured to be fluidly connected to the inlet fluid channel, A fourth intermediate fluid channel fluidly connected to the second intermediate spike, wherein the fourth intermediate fluid channel is configured to be fluidly connected to the outlet adapter fluid channel, the fourth intermediate fluid channel, A third intermediate adapter coupling received in the inlet adapter coupling and configured to releasably interlock the inlet adapter with the second intermediate adapter in a parallel configuration, the inlet adapter coupling being configured to simultaneously receive both the first intermediate adapter coupling and the third intermediate adapter coupling, the third intermediate adapter coupling, 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, wherein the outlet adapter coupling is configured to be received simultaneously by both the second intermediate adapter coupling and the fourth intermediate adapter coupling, the fourth intermediate adapter coupling, and further comprising a second intermediate adapter. The chemical solution delivery device according to item 122. (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. A third tube configured to fluidly connect the fourth intermediate fluid channel and the outlet adapter fluid channel, and further comprising the chemical solution delivery device according to item 119 or 128. (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. A second tube configured to fluidly connect the second intermediate fluid channel, the fourth intermediate fluid channel, and the outlet adapter fluid channel, and further comprising the chemical solution delivery device according to item 119 or 128. (Item 133) The chemical solution delivery device according to item 117 or 122, wherein the first intermediate adapter coupling includes a neck and a tab, the tab has a tab width, the neck has a neck width, the tab width is greater than the neck width, the inlet adapter coupling includes a collar and a pocket, the collar has a collar width, the pocket has a pocket width, and the pocket width is greater than the collar width. (Item 134) When the intermediate adapter and the inlet adapter are interlocked, the inlet adapter coupling and the first intermediate adapter coupling resist relative movement of the inlet adapter and the intermediate adapter in a first direction, and are configured to allow relative movement of the inlet adapter and the intermediate adapter in a second direction transverse to the first direction. The chemical solution delivery device according to item 122. (Item 135) The chemical solution delivery device according to item 134, wherein the first direction and the second direction are perpendicular to each other. (Item 136) A housing having a lower part and an upper part that movably engages with the lower part, wherein the upper part is movable relative to the lower part between a non-operating position and an operating position. A transfer engine disposed within the lower part of the housing, with a first container receiving end facing towards the upper part of the housing. A fluid outlet in fluid communication with the transfer engine. The upper part is configured to engage with a first container, such that when the upper part moves from the non-operating position to the operating position, the first container moves towards the first container receiving end. When the upper part is in the non-operating position, physical access to the fluid outlet is at least partially blocked, and when the upper part is in the operating position, physical access to the fluid outlet is allowed. The chemical solution delivery device. (Item 137) The upper part includes a notch, and when the upper part is in the non-operating position, the upper part at least partially surrounds the fluid outlet within the housing, and when the upper part is in the operating position, the notch exposes the fluid outlet. The chemical solution delivery device according to item 136. (Item 138) The lower part has a fluid outlet receptacle, the fluid outlet is disposed within the fluid outlet receptacle, and when the upper part is moved to the operating position, the notch aligns with the fluid outlet receptacle and the fluid outlet is exposed. The chemical solution delivery device according to item 137. The chemical solution delivery device according to item 137, wherein the fluid outlet is exposed when the notch aligns with the fluid outlet receptacle when the upper part is moved to the operating position. (Item 139) The chemical solution delivery device according to any one of Items 136 to 138, further comprising a flexible leash connected to the fluid outlet. (Item 140) The chemical solution delivery device according to any one of Items 136 to 138, wherein when the upper part is in the operating position, the fluid outlet is fixed relative to the lower part of the housing. (Item 141) The chemical solution delivery device according to any one of Items 136 to 138, wherein when the upper part is in the operating position, the fluid outlet is movable relative to the lower part of the housing. (Item 142) The chemical solution delivery device according to Item 141, further comprising a clip attached to the fluid outlet and connected to the lower part of the housing when the upper part is in the non-operating position to hold the fluid outlet to the housing. (Item 143) The chemical solution delivery device according to Item 142, wherein when the upper part is in the operating position, the clip is removable from the lower part of the housing, allowing movement of the fluid outlet relative to the housing. (Item 144) The chemical solution delivery device according to Item 142, further comprising a cap covering at least a part of the fluid outlet, and the holding force of the clip on the housing is smaller than the holding force of the cap on the fluid outlet. (Item 145) The chemical solution delivery device according to Item 142, wherein the lower part of the housing includes a slot for receiving at least a part of the clip to hold the fluid outlet to the housing when the upper part is in the non-operating position. (Item 146) The chemical solution delivery device according to Item 142, further comprising a second clip. (Item 147) The chemical solution delivery device according to any one of Items 136 to 139 or 141 to 146, wherein the fluid outlet is movable relative to the transfer engine. (Item 148) The chemical solution delivery device according to any one of Items 136 to 147, including a curved surface where the upper part extends in a direction away from the lower part. (Item 149) The chemical solution delivery device according to any one of Items 136 to 148, where the lower part includes a flat surface on the opposite side of the upper part. (Item 150) The chemical solution delivery device according to any one of Items 136 to 149, further comprising a warning module configured to warn the user when the upper part moves from the non-operating position to the operating position. (Item 151) The chemical solution delivery device according to Item 150, where the warning module is configured to provide a visual warning, an audible warning, and / or a tactile warning. (Item 152) The chemical solution delivery device according to Item 150, where the warning module transmits a warning message by wireless communication. (Item 153) The chemical solution delivery device according to any one of Items 136 to 152, where the upper part includes at least one window configured such that the user can see the first container. (Item 154) The chemical solution delivery device according to any one of Items 136 to 153, where the first container receiving end is configured as a first spike. (Item 155) The chemical solution delivery device according to Item 154, where the first spike is a dual-lumen spike. (Item 156) The chemical solution delivery device according to Item 154, where the first spike includes at least one open end of a flow path inclined at an angle with respect to the piercing direction of the first spike. (Item 157) The chemical solution delivery device according to Item 156, where the angle is about 90 degrees. (Item 158) The chemical solution delivery device according to Item 154, where the transfer engine includes an inlet configured to admit air into the transfer engine. (Item 159) The chemical solution delivery device according to item 158, wherein the inlet is configured as a hydrophobic filter. (Item 160) The chemical solution delivery device according to any one of items 136 to 159, wherein the fluid outlet is a Luer-activated valve or a Luer. (Item 161) The chemical solution delivery device according to any one of items 136 to 160, wherein the upper part is slidably engaged with the lower part. (Item 162) The chemical solution delivery device according to any one of items 136 to 161, wherein the upper part includes at least one upper holding mechanism, the lower part includes at least one lower holding mechanism, and the upper holding mechanism and the lower holding mechanism are engaged with each other to hold the upper part in the operating position. (Item 163) The chemical solution delivery device according to any one of items 136 to 161, wherein the fluid outlet is releasably held in the housing until the delivery device is connected to the fluid outlet. (Item 164) The chemical solution delivery device according to item 163, wherein the fluid outlet is firmly attached to the housing until the delivery device is connected to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is connected to the fluid outlet. (Item 165) The chemical solution delivery device according to item 136, wherein the upper part is configured to engage with only a single container. (Item 166) An inlet spike configured to puncture an inlet container, An air inlet, An inlet adapter including an inlet adapter fluid channel fluidly connected to the inlet spike, An intermediate spike configured to puncture an intermediate container, A first intermediate fluid channel fluidly connected to the intermediate spike and configured to be fluidly connected to the inlet adapter fluid channel, An intermediate adapter including a second intermediate fluid channel fluidly connected to the intermediate spike, An exit spike configured to pierce an exit container, An exit adapter fluid channel fluidly connected to the exit spike and configured to fluidly connect to the second intermediate fluid channel, An exit adapter including an exit fluidly connected to the exit spike, An adapter plate, A medicament delivery device, wherein the inlet adapter, the intermediate adapter, and the exit adapter are configured to be connected to the adapter plate. (Item 167) The medicament delivery device according to Item 166, wherein the inlet adapter, the intermediate adapter, and the exit adapter are configured to be connected to the adapter plate by interference fit. (Item 168) The medicament delivery device according to Item 166, wherein the adapter plate includes studs configured to engage with the inlet adapter, the intermediate adapter, and the exit adapter. (Item 169) The medicament 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. (Item 170) The medicament delivery device according to Items 166 to 168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an oblique angle to each other. (Item 171) The medicament delivery device according to Items 166 to 168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an acute angle to each other. (Item 172) 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 exit adapter fluid channel, and the medicament delivery device according to Items 166 to 171. (Item 173) wherein the intermediate adapter is a first intermediate adapter, and the chemical solution delivery device comprises a second intermediate spike configured to puncture a 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, and a fourth intermediate fluid channel fluidly connected to the second intermediate spike, the fourth intermediate fluid channel being configured to fluidly connect to the outlet adapter fluid channel, and further comprising a second intermediate adapter including the fourth intermediate fluid channel, wherein the second intermediate adapter is configured to be connected to the adapter plate. The chemical solution delivery device according to Items 166 to 172.

[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 the same numerals. For clarity, not all components are necessarily labeled in all the figures.

Brief Description of the Drawings

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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 pharmaceutical, such as a freeze-dried form of a pharmaceutical. At each step, the nurse or other healthcare professional takes care to avoid contamination as the reconstitution fluid is removed from the package and discharged into the mixing container or the container of the pharmaceutical. Such a process typically involves the handling of multiple containers and syringes. Therefore, the conventional reconstitution methods performed by nurses and other healthcare professionals can be time-consuming and complex.

[0104] In some cases, reconstitution and administration performed by the patient may be a preferred option from the perspectives of convenience and cost. Difficult procedures that are already time-consuming when performed by healthcare professionals can be difficult for patients practicing self-administration. Reducing the time and complexity involved in reconstituting and administering the medicament may be desirable not only for self-administering patients but also for healthcare providers.

[0105] From the above perspective, the inventors recognized the advantages of a reconstitution device that enables a patient or healthcare provider to reconstitute and administer a pharmaceutical product 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 with fewer steps. The reconstitution device can also reduce the handling of containers to perform reconstitution and administration. Further, the reconstitution device can enable reducing the pressure applied to operate the device compared to conventional devices, promoting an easier operating feel for the user. Additionally, the reconstitution device can improve the agitation and mixing of the pharmaceutical product and the reconstitution fluid.

[0106] In some embodiments, the transfer engine may include a plurality of fluid conduits in a compact arrangement that facilitate the transfer of fluid, for example, from a first container to a second container and reconstitute a medicament within the second container. In some embodiments, the reconstitution device includes a first fluid conduit that includes a first open end and an air inlet. The reconstitution device also includes a second fluid conduit having a second open end and a third open end. The first and second open ends are parallel to each other and together can define a first container receiving end. The reconstitution device also includes a valve disposed along the second fluid conduit between the second open end and the third open end. The third fluid conduit includes a fourth open end and a fluid outlet. The third open end and the fourth open end are parallel to each other and together can 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 that enable fluid transmission from a first container (e.g., containing sterile water) to a second container (e.g., containing a medicament for reconstitution). In some embodiments, the first open end of the first fluid conduit and the second open end of the second fluid conduit are disposed within the first spike. In some embodiments, the third open end of the second fluid conduit and the fourth open end of the third fluid conduit are disposed within the second spike. A portion of the first fluid conduit and a portion of the second fluid conduit can form the lumen of the first spike. A portion of the second fluid conduit and a portion of the third fluid conduit can form the lumen of the second spike. In some embodiments, the transfer engine can be used with a fluid delivery device other than the reconstitution device, such as a device used for a pool or a device 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 a plurality of container receiving ends.

[0107] In some embodiments, the fluid outlet may include a luer lock valve, whereby a syringe or other delivery device can be fluidly connected to the fluid outlet and draw the reconstituted pharmaceutical solution out of the device. However, in other embodiments, other suitable fluid outlets may be used with the reconstitution device, including, but not limited to, luer actuated devices, simple luer or other threaded connectors, slip fit connectors, and pierceable septa. In some embodiments, the container containing the powder drug may be configured to contain a low pressure or zero pressure vacuum, whereby sterile water or another fluid from another container can be pushed into the container containing the drug 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 discharge the fluid from the fluid-containing container into the drug-containing container at a rate that can help agitate the drug to facilitate reconstitution.

[0108] The inventors have also recognized the advantages of a self-contained reconstitution device that can perform the reconstitution process by applying force in a single direction. The first container may be pre-positioned within a reconstitution device that contains a reconstitution fluid, along with a second container that houses the pharmaceutical. The reconstitution device can apply force to the housing to fluidly join the first container to the second container, allowing fluid to flow from the first container to the second container and enabling the reconstitution of the pharmaceutical.

[0109] In some embodiments, the reconfiguration device may include a housing having an upper portion and a lower portion, where the lower portion is slidably received in the upper portion or vice versa. 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. In some embodiments, the upper portion can be configured to at least partially surround the at least two containers and selectively hold them away from the spikes of 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 non-operating position to a second operating position where the upper portion approaches the lower portion. Specifically, the bottommost surface of the upper portion is closer to the base of the lower portion. When the upper portion moves to the operating position, the at least two containers can be punctured by the spike(s) associated with that container. When punctured, the containers can be in fluid communication, such that fluid from one container can flow to the other container. In some embodiments, the first container may be under vacuum, such that as a result of the pressure difference between the two containers, fluid from the second container is pushed into the first container. The lower portion 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 reconfiguration device and provide a platform on which the user can apply force. In some embodiments, the upper surface of the upper portion of the housing may be curved, such that if the user attempts to place the upper surface on a flat surface and use it as a base, the reconfiguration device may be unstable. The instability can serve to inform the user that the device is placed in an inappropriate orientation for use. Such an arrangement can also facilitate a single direction for the use of the reconfiguration device. Such an arrangement can also improve ergonomics compared to conventional reconfiguration devices. The curved surface can provide a natural place to rest the hand, and the shape can correspond to other objects and surfaces that are generally accepted in the palm of the user's hand. In this regard, the curved upper surface can result in positive movement, thereby facilitating the preferred handling and operation of the reconfiguration device.

[0110] The inventors have also recognized the advantages of providing feedback to the user for the complete operation of the reconfiguration device. Further, the inventors have recognized the advantages of one or more retention mechanisms that keep the reconfiguration device in an operative state and prevent repeated activation or retrieval of the used container from the reconfiguration device. Further, such an arrangement can reduce the movement of the upper part of the housing away from the lower part of the housing as a result of the elasticity of the punctured septum of the container that biases the upper part away from the lower part.

[0111] In some embodiments, the reconfiguration device may include a housing having a lower portion and an upper portion, where the lower portion is slidably received in the upper portion or vice versa. 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. In some embodiments, the upper portion can be configured to at least partially surround the at least two containers and selectively hold them away from the spikes of 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 non-operating position to a second operating position where the upper portion moves closer to the lower portion. The upper portion of the housing can have at least one upper stop, and the lower portion can have at least one lower stop. The at least one upper stop can be configured to engage the at least one lower stop when the upper housing moves to the operating position and pierces each of the at least two containers. In some embodiments, the upper and lower stops can be corresponding shelves or protrusions of the housing that abut each other to prevent the upper portion of the housing from moving further towards the lower portion of the housing. In some embodiments, the container can function as an upper stop that abuts (e.g., reaches the bottom of) the lower portion of the housing when the upper housing moves to the operating position. Since the present disclosure is not so limited, the upper and lower stops can be disposed at any suitable portions of the upper and lower housings that can contact each other. In some embodiments, the upper and lower portions of the housing can include one or more retention mechanisms to capture the reconfiguration device in one direction in the operating position. The retention mechanism can include a flexible tab, ratchet and pawl, hook, hook-and-loop fastener, adhesive, or another suitable arrangement for securing the two parts of the reconfiguration device housing together during operation. For example, in one embodiment, a flexible tab disposed on the lower portion of the housing can engage a corresponding detent or recess in the upper portion of the housing when the upper portion moves to the operating position.

[0112] The inventors have also recognized the advantages of preventing physical user access to the fluid outlet prior to device operation and permitting user access to the fluid outlet in response to the operation of a reconfiguration device housing. Specifically, the inventors have recognized the advantage of physically preventing access to the fluid outlet prior to reconstitution of a pharmaceutical. The reconfiguration device housing can be arranged to permit access to the fluid outlet only after two containers are fluidly joined, whereby fluid from a first container can flow to a second container containing a pharmaceutical for reconstitution. Such an arrangement can simplify the reconstitution and administration process and can further ensure that the pharmaceutical is reconstituted before a user attempts to connect a delivery device (e.g., a syringe, infusion pump, etc.) to the reconfiguration device. This can help prevent the user from prematurely removing the pharmaceutical before reconstitution is complete. Further, if a vacuum is used to transfer fluid between the first and second containers, such an arrangement can ensure that the vacuum inside the containers is maintained until the 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 spikes disposed within the lower portion prior to operation 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 non-operative position to a second operative position where the upper portion approaches the lower portion. Specifically, the bottommost surface of the upper portion may become closer to the base of the lower portion. When the upper portion moves to the operative position, the at least two containers can be punctured by one or more associated spikes. When punctured, the containers can be in fluid communication, whereby fluid from one container can flow from the first container to the second container and the pharmaceutical within the second container can be reconstituted by the fluid from the first container. The spikes can be fluidly connected to a fluid outlet held within the lower portion of the housing. The upper portion of the housing is configured to cover or otherwise prevent physical user access to the fluid outlet when the upper portion is in the non-operative position. When the reconstitution device is actuated, physical access to the fluid outlet becomes possible. For example, in one embodiment, a notch in the upper portion is configured to expose the fluid outlet when the upper portion moves to the operative position. In some embodiments, the fluid outlet can be connected to one or more spikes via a flexible tube, whereby the fluid outlet is movable relative to the spikes. According to this embodiment, the fluid outlet can access and be removed from the lower housing through the notch when the upper portion is in the operative position. When removed, a delivery device (e.g., a syringe) can be coupled to the fluid outlet and used to withdraw the reconstituted pharmaceutical. 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 portion is in the operative position.

[0114] Some embodiments described in this specification use a flexible tube that allows a user to move a fluid outlet relative to a reconfiguration device housing, but other configurations can be used where the fluid outlet is physically blocked until the reconfiguration device is actuated. For example, in some embodiments, the fluid outlet can be rigidly attached to the reconfiguration device housing. In some embodiments, the fluid outlet can be fixed relative to the lower portion of the housing. In some embodiments, the fluid outlet can be movably fixed to the reconfiguration device housing. For example, in some embodiments, the fluid outlet can be connected to the reconfiguration device housing with a pin, whereby the fluid outlet can rotate relative to the housing. In such embodiments, actuation of the reconfiguration device can rotate the fluid outlet from a first rotational position to a second rotational position. In another embodiment, the fluid outlet can be disposed on a ball disposed within a socket formed on the housing of the reconfiguration device. 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 reconfiguration device housing, and the present disclosure is not so limited. For example, the fluid outlet can be disposed in the lower, middle, or upper portion (e.g., upper third, middle third, or lower third) of the reconfiguration device housing. The fluid outlet can be flexibly connected to the housing of the reconfiguration device, movable about a hinge or pivot, or 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 connected to a flexible tube disposed inside the reconstitution device housing when the fluid outlet is releasably attached to the housing. The fluid outlet may be firmly held in the lower, middle, or upper third of the reconstitution device housing and may become physically accessible to the user only after the reconstitution device has been activated. When the fluid outlet becomes physically accessible, a delivery device can be connected to the fluid outlet. For example, a delivery device (e.g., a syringe) can be connected to the fluid outlet in a twisting motion. Of course, the present disclosure is not so limited, and any suitable motion can be used to connect the delivery device to the fluid outlet. When the delivery device is connected, the user can pull or apply force to the fluid outlet using the delivery device to disconnect the fluid outlet from the reconstitution device housing. When disconnected, the fluid outlet can move relative to the reconstitution device housing, thereby extending the flexible tube.

[0116] The inventors have recognized the advantage of promoting a directional flow to ensure proper dosage and reconstitution. Specifically, the inventors have recognized the advantage of a check valve or other one-way valve in promoting a 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 and second containers. During the reconstitution process, the reconstitution fluid may flow from the first container to the second container and may be held within the second container by the check valve. Such an arrangement can help prevent backflow and loss of fluid or reconstituted pharmaceuticals from the second container.

[0117] In some embodiments, the transfer engine for the reconfiguration device includes a first flow path extending between the inlet and the first spike, a second flow path extending between the first spike and the second spike, and a third flow path extending between the second spike and the fluid outlet. In some embodiments, the 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 while preventing flow in the opposite direction. Thus, when a first container containing the reconstitution fluid is punctured and fluidly connected by the first spike, the fluid can flow from the first container through the second flow path into the second container. When a second container containing the reconstitution pharmaceutical is punctured and fluidly connected by the second spike, the fluid from the first container can flow into the second container, but may not be able to 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 pressure or higher than atmospheric pressure, whereby the pressure difference between the first container and the second container encourages the fluid in the first container to flow into the second container. The pressure difference can be configured such that all of the fluid from the first container flows through the check valve and toward the second container and can be mixed with the pharmaceutical for reconstitution. The check valve prevents backflow of the reconstituted agent and ensures that the correct dosage of the reconstituted pharmaceutical is retained in the second container and is accessible to a delivery device (e.g., a syringe) via the fluid outlet.

[0118] The inventors recognized the advantage of improving agitation and mixing during the reconstitution process without the need for the user to handle one or more containers. Specifically, the inventors recognized the advantage of a check valve disposed between a first container and a second container that holds fluid within the second container and prevents backflow into the first container. When a reconstituted or partially reconstituted pharmaceutical is withdrawn and placed into the second container using a delivery device (e.g., a syringe), the fluid can be agitated to promote mixing while remaining accessible to the delivery device within the second container. The delivery device can then be used to effectively agitate and mix the pharmaceutical to ensure complete dissolution or rehydration of the pharmaceutical prior to administration.

[0119] In some embodiments, the reconstitution device includes a first container and a second container disposed within the upper portion of the housing, and the upper portion of the housing at least partially surrounds the first and second containers. In some embodiments, the method of performing the reconstitution process includes applying a force to the upper portion to move the upper portion from a first non-operating position to a second operating position. The first container can be punctured by a first spike disposed at the lower portion of the housing, and the second container can be punctured by a second spike disposed at the lower portion of the housing as the upper portion moves to the second operating position. Upon puncturing, fluid can flow from the first container to the second container and occupy 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 a reverse flow (i.e., back towards the first container). The method also includes withdrawing at least a portion of the fluid from the second container using a syringe via a fluid outlet. Once at least a portion of the fluid has been withdrawn, the syringe can be used to re-inject the fluid into the second container. The syringe can be used to withdraw and re-inject the fluid from the second container until the drug within the second container is sufficiently mixed and reconstituted. While the fluid enters and exits the second container, the check valve can ensure that the fluid or pharmaceutical does not return to the first container. Once reconstituted, the drug can be completely withdrawn 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 delivery devices that are not necessarily used for reconstitution. For example, in some embodiments, a drug 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, a drug delivery device can be used to pool contents from multiple containers without reconstitution. However, in other embodiments, a drug delivery device can perform both reconstitution and pooling (e.g., accessing the contents of two or more containers containing fluid and one or more containers containing solid). Thus, since the present disclosure is not so limited, the various mechanisms and methods described herein are applicable to drug delivery devices having any number of containers.

[0121] The inventors also recognize the advantages of a reconstitution device or drug delivery device that provides an indication to a user practicing self-administration, either via one or more warnings of the reconstitution device itself or via a complementary device. A reconstitution or drug delivery device can provide visual, auditory, and / or tactile warnings to the user regarding the state of the reconstitution process, and such an arrangement can simplify the reconstitution or drug delivery process for the user.

[0122] In some embodiments, a reconstitution or drug delivery device can include a first container having a fluid (e.g., a reconstitution fluid) and a second container having a pharmaceutical (e.g., a lyophilized pharmaceutical). The reconstitution or drug delivery device can also include a power source (e.g., a battery), a processor, and at least one indicator (e.g., a warning module). The at least one indicator can include a visual indicator (e.g., an LED, a display screen, etc.), an auditory 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 delivery device during the reconstitution or drug delivery process. For example, in one embodiment, the at least one indicator can indicate when the reconstitution device is operating, the reconstitution fluid is flowing, and is being mixed with the pharmaceutical. In another example, the at least one indicator can indicate when the reconstitution fluid has had an appropriate time to mix with the pharmaceutical, thereby indicating when the drug solution is suitable for being withdrawn from the reconstitution device using a drug delivery device (e.g., a syringe). In yet another example, the reconstitution or drug delivery device can include a direction sensor (e.g., an accelerometer, a gyroscope, etc.), and the indicator can indicate when the reconstitution or drug delivery device is in a predetermined direction, or conversely, when the reconstitution or drug delivery device is in a direction different from the predetermined direction. In some embodiments, the reconstitution or drug 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 transmit one or more warnings to a remote device (e.g., a smartphone, a pager, a personal computer, a tablet, etc.). The remote device then provides a warning to the user via visual, auditory, and / or tactile indicators.

[0123] The inventors have also recognized the advantages of a medicament delivery device configured to communicate with one or more remote devices. The medicament 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 the remote device, thereby enabling the one or more remote devices to track the treatment schedule or otherwise record information regarding the use of the medicament delivery device. In some embodiments, the medicament delivery device can include a marker that is exposed or otherwise accessible (e.g., physically accessible, visually accessible, or wirelessly accessible) when the medicament delivery device is actuated. In other embodiments, when the medicament delivery device is actuated, the communication module of the medicament delivery device can be triggered to activate.

[0124] In some embodiments, the drug delivery device includes a housing having a lower portion and an upper portion that is movably engaged with the lower portion. Similar to the foregoing embodiments, the upper portion may be movable relative to the lower portion between a non-operating position (e.g., an upper position) and an operating position (e.g., a lower position). The drug 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 operating position. In some embodiments, the fluid outlet may not be accessible to the user when the upper portion is in the non-operating position. According to such embodiments, by moving the upper portion to the operating position, physical access to the fluid outlet and / or the fluid outlet can be exposed. The drug delivery device can 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 not be powered, whereby the drug delivery device does not include an onboard power source. In some embodiments, the marker is partially obscured when the upper portion is in the non-operating position and the user may be able to access the marker when the upper portion is in the operating position. For example, in some embodiments, the upper portion may surround the marker in the non-operating position and expose the marker in the operating position (e.g., via a notch). The marker can be used by a remote device to obtain information regarding the drug delivery device, such as dosage, manufacturing date, etc.

[0125] In some embodiments, the drug delivery device includes a housing having a lower portion and an upper portion that is movably engaged with the lower portion. Similar to the foregoing embodiments, the upper portion is movable relative to the lower portion between a non-operating position (e.g., an upper position) and an operating position (e.g., a lower position). The drug 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 operating position. In some embodiments, the fluid outlet may not be accessible to the user when the upper portion is in the non-operating position. According to such embodiments, moving the upper portion to the operating position can enable physical access to and / or expose the fluid outlet. The drug delivery device can also include a communication module configured to transmit messages via at least one communication protocol (e.g., Bluetooth®, Bluetooth Low-Energy, Wi-Fi, 802.15.4, ZigBee®, GSM®, HSPA, CDMA, and / or any other suitable protocol). The communication module may be configured to transmit messages containing information regarding the drug delivery device (e.g., dosage, drug identification, time, and / or one or more sensor values such as temperature, orientation) to a remote device (e.g., a smartphone). The drug delivery device can also include a trigger configured to activate the communication module when the upper portion is moved to the operating position. Such an arrangement can ensure that the communication module consumes little or no power prior to activation, whereby the power source of the drug delivery device has sufficient power for the desired storage life of the communication module. In some embodiments, the trigger may be a switch, a Hall effect sensor, a strain gauge, or any other suitable sensor configured to detect the upper portion moving to the operating position.

[0126] The inventors recognized the advantages of a reconfiguration device that provides mechanical advantage and / or electromechanical assistance to a user in order to reduce the force used to operate the reconfiguration device as compared to conventional reconfiguration devices. Such an arrangement may enable easier and more consistent activation of the reconfiguration device by the user.

[0127] In some embodiments, the upper portion of the housing and the lower portion of the housing are operatively coupled via a screw mechanism, and a rotational force applied to the screw mechanism applies a linear force to bring the upper portion closer to the lower portion, and the screw mechanism provides a mechanical advantage as compared to directly applying a linear force. As another example, in some embodiments, a lever may be coupled to the lower portion of the housing, and a linear force applied to the lever may amplify the force applied to the upper portion of the housing to move the upper portion of the housing toward the lower portion. In yet another embodiment, the upper housing may include an inclined plane squeezing mechanism that squeezes at least one wedge including an inclined plane in a direction parallel to the surface on which the reconfiguration device is disposed to push the upper housing portion toward the lower housing portion (or to push the two containers toward the corresponding spikes). Of course, the present disclosure is not so limited, and any suitable arrangement, including or not including a mechanical advantage, can be used for the reconfiguration device. Some embodiments of the reconfiguration device including 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 operating force of the reconfiguration device. For example, the reconfiguration device can 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 can include a power source (e.g., a battery) that can supply power to the electromechanical actuator. The actuator can be actuated by a user to correspondingly operate the reconfiguration device. Various user input devices including, but not limited to, buttons or switches can be used for such activation. In embodiments where a mechanical assist element (e.g., a spring) is used, the user can operate a release to actuate the reconfiguration device. That is, the spring or other mechanical assist element may be pre-biased (i.e., storing potential energy), which may be used to operate the device when released. Of course, the present disclosure is not so limited, so any mechanical or electromechanical auxiliary configuration, or combinations thereof, can be used in the reconfiguration device.

[0129] The inventors also recognized the advantages of a modular chemical solution delivery device that can be used to deliver a wide range of chemical solutions in different amounts. Specifically, the inventors recognized the advantages of a modular transfer engine that includes a plurality of adapters that can be exchanged or expanded according to 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. Further, the adapter can include a coupling spaced apart from at least one fluid channel that can be used to physically interlock the adapter with another adapter. Thus, the transfer engine can include any number of adapters in any desired configuration to deliver the chemical solution. The modular transfer engine can be used to reconstitute a lyophilized solid, or to pool a plurality of chemical solutions, or to access a single container.

[0130] In some embodiments, the drug delivery device may be modular. A modular drug delivery device can include an inlet adapter, an intermediate adapter, and an outlet adapter. The drug delivery device can be configured to use any number of intermediate adapters in a modular fashion to conform to a particular delivery volume. In some embodiments, the inlet adapter, the intermediate adapter, and the outlet adapter can all be configured to fluidly connect to a container. For example, the inlet adapter, the intermediate adapter, and the outlet adapter can all include spikes configured to pierce the container to fluidly connect the container to each adapter. The inlet adapter can include an inlet adapter fluid channel and an inlet adapter coupling. The intermediate adapter can 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 can include an outlet adapter fluid channel and an outlet adapter coupling. The first intermediate adapter coupling is configured to connect to the inlet adapter coupling, and the second intermediate adapter coupling is configured to connect to 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 fluid channels may be spaced apart from the couplings separately from the couplings, such that the adapters may be physically connected to each other (e.g., via the fluid channels) separately from the fluid connection (e.g., via the couplings). If additional intermediate adapters are desired, the additional intermediate adapters may be the same as the first intermediate adapter, or may be configured to be fluidly and physically attached 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 the same as the first intermediate adapter, but may nevertheless be configured to be fluidly and physically attached to the first intermediate adapter and the inlet adapter, or the first intermediate adapter and the outlet adapter.Of course, since the present disclosure is not so limited, any suitable number of intermediate adapters can be used. Further, it should be noted that the modular pharmaceutical delivery device may be used to reconstitute solid pharmaceuticals stored in one or more containers, to pool liquid pharmaceuticals from one or more containers or any combination of reconstitution and pooling, or to access the contents of only one container.

[0131] For purposes of the present disclosure, the term "coupled" (in all of its forms, coupling, coupled, being coupled, etc.) generally means joining two components directly or indirectly to each other. Such coupling may be essentially stationary or essentially movable, and may be achieved by two components and any additional intermediate members being integrally formed with each other or with the two components as a single unitary body, and may be essentially permanent or essentially removable or releasable, unless otherwise specified.

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

[0133] Figure 1 is a schematic diagram of one embodiment of a transfer engine 100 that can be used in a reconfiguration device or other hybrid device. As shown in Figure 1, the transfer engine includes a first spike 102 and a second spike 105, each of which is configured to pierce a rubber stopper, a 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, the first open end of the first flow path, like the second open end of the second flow path, is disposed within the first spike. 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 Figure 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, the present disclosure is not so limited, and any suitable inlet or vent that allows air to enter the transfer engine can be used. In some embodiments, the air inlet may be configured as a check valve configured to allow air to enter 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 in a direction from the first spike to the second spike through the second flow path, but not in the reverse direction. A third flow path 107 also has a fourth open end disposed within the second spike and extends from the fourth open end to an outlet 111. The portions of the second and third flow paths disposed within the second spike are parallel to each other and together define a second container receiving end. The outlet of the illustrated embodiment is configured as a luer-activated valve. Of course, the present disclosure is not so limited, and any suitable valve or fluid outlet connection can be used with the transfer engine 100.For example, in other embodiments, other suitable fluid outlets including, but not limited to, a lure activation device, a simple lure or other threaded connector, a slip fit connector, and a pierceable septum can be used with the transfer engine. According to the embodiment of FIG. 1, the transfer engine also includes a drug filter 110 disposed in a third flow path and configured to filter drug precipitates or undissolved pharmaceuticals 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 for reconstitution (e.g., a dry formulation). When the first container is pierced by the first spike 102 and the second container is pierced by the second spike 105, the fluid from the first container can flow into the second container and mix with the pharmaceutical to form a medicament solution. The check valve 109 can hold the medicament solution in the second container and prevent backflow of the medicament solution from the second container to the first container. Once the medicament solution is disposed within the second container, it can be withdrawn through 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 an embodiment of the 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 pharmaceutical solution using two containers. That is, the reconstitution device of FIG. 2 is configured to receive two containers, reconstitute a drug, and deliver it. 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 operative position and a non-operative 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 that can support the reconstitution device in a stable orientation on a flat surface such as a table, desk, countertop, etc. In contrast, the upper portion 202 includes a rounded upper surface 203, whereby the reconstitution device is not supported in a stable orientation by the rounded upper portion when placed on a flat surface. Thus, the housing 201 shown in FIG. 2 is configured to have a primary orientation in which it is stable when the housing is placed on a flat surface. In this primary orientation, a force can be applied to the upper portion 202 while the lower portion 204 prevents rotation of the housing. Further, the rounded upper surface 203 is configured to provide a handle for the user to grip, facilitating the correct use of the reconstitution device.

[0136] According to the embodiment of FIG. 2, the reconstitution device is configured to accommodate two containers. As described above, the two containers may be joined by a transfer engine disposed in the reconstitution device, and an exemplary embodiment thereof is described herein. Each container may contain a specific dosage of a pharmaceutical and / or a reconstitution fluid. Prior to reconstituting and administering the pharmaceutical solution, the patient will want to confirm that the correct size and dosage container is placed within the reconstitution device, especially if the container is enclosed by the upper portion 202 of the housing 201 and is non-removable. Thus, in the embodiment of FIG. 2, the upper portion 202 includes windows 206A, 206B configured such that a user can view the interior of the upper portion. Specifically, the windows 206A, 206B can be aligned with the label of the container disposed inside the housing, and the user can obtain information regarding the pharmaceutical in the container, such as the type of drug, volume, dosage, etc. The windows 206A, 206B have covers that prevent the user from inserting a finger into the reconstitution device. According to the embodiment of FIG. 2, the upper portion also includes a window 210 that further improves the visibility of the label. In some embodiments, the window 210 allows the user to contact and rotate the container adjacent to the window to better view the label of the container. Such windows can be disposed on both sides of the upper portion, allowing both containers disposed within the housing to be visible and / or preferably rotated to view the label. In some embodiments, the windows of the reconstitution device housing may include magnifying lenses to allow the user to more easily read the text on the containers disposed within the reconstitution device housing. In some embodiments, an LED or other suitable lighting element can be disposed inside the upper portion to illuminate any label of the container and / or provide one or more visual warnings to the user. Illumination of the container can be beneficial for pharmaceuticals where visualization by the patient is desirable. In some embodiments, the lighting element can emit light at a wavelength at which the pharmaceutical disposed within the container is less likely to degrade. Such an arrangement can be beneficial for some photosensitive pharmaceuticals. In some embodiments, the reconstitution device may not have a window and may be arranged to hide the container inside the housing.As an example, such an arrangement may be suitable for photosensitive pharmaceuticals that are susceptible to light degradation.

[0137] According to the embodiment of FIG. 2, the reconfiguration device 200 is configured to prevent access to the fluid outlet of the transfer engine disposed within the housing 201 prior to device operation and subsequently enable access to the fluid outlet after device operation. That is, the sliding of the upper portion 202 relative to the 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 prevents access to the fluid outlet both by hiding the fluid outlet from the user and physically obstructing access to the fluid outlet. In other embodiments, the fluid outlet is visible to the user prior to device operation, but access to the fluid outlet is obstructed, for example, by a physical obstacle.

[0138] In the embodiment of FIG. 2, as shown in FIGS. 9-10B, the upper portion includes a slot 208 that forms a portion of a larger notch that exposes the fluid outlet and enables physical access and removal from the housing when the upper portion is in the operative position as shown in FIGS. 10A and 10B.

[0139] FIG. 3 is a schematic diagram of one embodiment of a transfer engine 100 for a reconstitution device during the first stage of a reconstitution and pharmaceutical fluid delivery process. According to the embodiments of FIGS. 3-6, the transfer engine is similar to the embodiment described in FIG. 1. The first flow path 103 extends between an inlet 108 and a first open end disposed at a first spike 102. The second flow path 104 extends between a second open end disposed at the first spike 102 and a third open end disposed at a second spike 105. The third flow path 107 extends between a fourth open end disposed at 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 flow into the transfer engine, but prevent fluid from flowing out of 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 fluid to flow unidirectionally in a direction from the first spike through the second flow path to the second spike. The outlet 111 is configured as a luer-activated valve that can receive a delivery device (e.g., a syringe) capable of withdrawing the reconstituted medical fluid from the transfer engine. According to the embodiments 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 pharmaceuticals from the fluid flowing to the outlet. The drug filter can be disposed at any location within the flow path between the outlet 111 and the fourth open end of the third flow path 107.

[0140] As shown in the embodiments of FIGS. 3-6, the two containers are used with a 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, the present disclosure is not so limited, and any suitable stopper or seal can be used. The second container 350 is configured to be punctured by the second spike 105. The second container contains a pharmaceutical 352 disposed at the bottommost part of the second container on the opposite side of the stopper 354. Such an arrangement can ensure that the flow of fluid through either the second flow path 104 or the third flow path 107 via the third and fourth open ends, respectively, is not blocked or otherwise inhibited by the pharmaceutical. Of course, in other embodiments, the pharmaceutical may be disposed in another part of the second container, and the present disclosure is not so limited. For example, the pharmaceutical may be disposed adjacent to and in contact with the stopper 354. In some embodiments, when the stopper 354 is punctured, even if the pharmaceutical is in contact with the second spike 105, the flow of fluid therethrough can break down the pharmaceutical so that the flow path remains free. In some embodiments, the piercing tip of the spike can lift the pharmaceutical and space it apart from the open end of the flow path. Similar to 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 may be a lyophilized formulation that can be in powder form to facilitate dissolution in the reconstitution fluid. Of course, the present disclosure is not so limited, so the pharmaceutical can take any suitable form. As shown in the embodiments of FIGS. 3-6, the first and second containers are inverted to allow gravity to urge the fluid in the containers towards the outlet 111 or otherwise towards the lower height portion of the transfer engine.Stated another way, in some embodiments, the first and second containers are arranged such that the air within the container is disposed within the container at an end opposite the spike. Such an arrangement can ensure that the fluid is drawn through the spike before the air within the container. Further, according to the embodiments of FIGS. 3-6, a 10 mL container is shown. However, 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 and above can be used, including but not limited to containers of any suitable size.

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

[0142] Figure 4 is a schematic view of the transfer engine 100 of FIG. 3 during the second stage of the reconstitution and pharmaceutical delivery process. According to the stage of FIG. 4, the first container 300 and the second container 350 are each punctured by a first spike 102 and a second spike 105. According to the embodiment of FIG. 4, the second container 350 is under at least partial vacuum, whereby the pressure inside the second container 350 is lower than the pressure inside the first container 300 and / or the atmospheric pressure around the transfer engine. Thus, as shown in FIG. 4, when the first and second containers are punctured simultaneously, the pressure differential 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 differential is so great that the fluid 302 may be discharged from the third open end of the second flow path 104 and impinge on the pharmaceutical 352 disposed at the end of the second container 350 opposite the second spike 105. As the fluid is forced into the second container 350, the fluid mixes with the pharmaceutical to form a pharmaceutical solution. The arrangement of the lowermost pharmaceutical spaced from the second spike 105 is configured such that the jet of fluid 353 impinges on the pharmaceutical and disperses to facilitate mixing of the pharmaceutical and the reconstitution fluid. In some embodiments, the pharmaceutical 352 dissolves in the reconstitution fluid. In other embodiments, the pharmaceutical rehydrates the pharmaceutical.

[0143] In some embodiments, at least one spike of the reconfiguration device can include an open end for an internal lumen (i.e., a flow path) that directs the fluid flow into the container at an angle. For example, in some embodiments, the inner lumen of the spike can terminate at an open end disposed on the side surface of the spike. That is, the open end can be formed in a plane substantially perpendicular to the spike, whereby the fluid flow through the spike is lateral to the piercing direction of the spike. In some embodiments, the spike can include a plurality of open ends for the lumen such that the flow is directed out from a plurality of sides of the spike. In some embodiments, the open end can be angled with respect to the piercing or insertion direction of the spike, such that the fluid flow is directed at that angle. In some embodiments, the open end of the inner lumen of the spike can be angled from 1 to 90 degrees with respect to the piercing direction of the spike. Depending on the angle of the open end and the particular spike arrangement, various types of fluid flows may be generated when the fluid flows from the spike into the container. For example, a flow angled with respect to the spike piercing direction may create a vortex inside the container. In some embodiments, the spike can include a flow nozzle that produces a gentle or otherwise slow atomizing spray. Without wishing to be bound by theory, different pharmaceuticals can be more easily reconfigured depending on the flow. Additionally, some pharmaceuticals can be damaged, particularly by harsh or strong flows. Thus, the exemplary embodiments described herein can generate a desired fluid flow inside the container using any suitable spike arrangement.

[0144] As described above, in some cases, different pharmaceuticals can be damaged or degraded by certain harsh or strong flows. Further, some reconstituted pharmaceuticals can be sensitive to degradation under high fluid shear. Thus, in some embodiments, one or more flow paths of the delivery engine can include a flow restrictor or, alternatively, can 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 cross-sectional area that is smaller than the cross-sectional area of the flow paths elsewhere in the delivery engine. In some embodiments, the flow path between the second container and the fluid outlet can have a cross-sectional area that is smaller than the cross-sectional area of the flow paths elsewhere in the delivery engine. In some embodiments, the flow path can include a check valve configured to close if the fluid flow rate is too high. Such a configuration can ensure that the fluid flows at an accurate velocity and that the pharmaceuticals are not accidentally damaged as they are withdrawn into the delivery device.

[0145] Of course, since the present disclosure is not so limited, the reconstituting fluid and the pharmaceuticals can take any initial form and ultimately form the medicament solution. Further, since the present disclosure is not so limited, the exemplary delivery engine and process shown in FIG. 4 can be used to mix two fluids. The two fluids can be the same fluid or different fluids.

[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 difference between the first container 300 and the second container 350 can be configured such that substantially all of the reconstitution fluid flows through the check valve 109. When the fluid is discharged from the first container 300, air enters the inlet 108 and replaces the flowing fluid. Thus, when the pressure equalizes 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. Such an arrangement can help prevent some of the reconstitution fluid from flowing back into the first container 300. In some cases, the fluid flowing back into the first container 300 may be difficult to draw out from the transfer engine. Further, the check valve may help ensure that the full dose of the pharmaceutical remains in the second container 350 where it is mixed and reconstituted, and thus the full dose or appropriate concentration can be drawn out through the outlet 111.

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

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

[0149] In some embodiments, an additional mixing step may be performed to facilitate reconstitution or other mixing of the contents of the container. This mixing step may be optional in some embodiments. FIG. 6 is a schematic view of the transfer engine of FIG. 3 during the fourth stage of reconstitution and reconstitution of the medicament delivery process. Specifically, in the state shown in FIG. 6, the syringe 400 is used to facilitate mixing of the medicament solution 356 and complements or replaces other mixing methods such as the rotation and oscillation of the transfer engine 100. From the state shown in FIG. 5, where the medicament solution is at least partially drawn into the syringe, the handle 402 of the syringe can be pushed towards the transfer engine 100, correspondingly moving the plunger 404 and driving the medicament solution back into the second container 350. Such an operation can facilitate the combination of the pharmaceutical and the reconstitution fluid. As shown in FIG. 6, backflow of the medicament solution into the first container 300 is prevented by a check valve. Thus, backflow of the medicament solution into the second container can compress the air in the second container and increase the pressure of the medicament solution. The process of withdrawing and depositing a portion of the medicament solution from the second container can be repeated until the medicament solution is sufficiently combined for administration.

[0150] In some embodiments, the third flow path 107 can include an air outlet that enables the second container 350 to be depressurized. In one embodiment, the air outlet can be arranged as a one-way vent, whereby air can escape from the second container 350 through the third flow path 107, but air cannot enter the second container. According to this embodiment, an air source disposed within the second container 350 can originate from the air inlet 108 such that the reconstituted fluid is drawn from the first container into the second container. However, when used to mix the medicament solution 356 by moving a portion of the medicament solution back and forth from the second container 350 using the syringe 400, the air outlet can enable the pressure of the fluid to be effectively maintained constant, thereby reducing the force that returns and deposits the fluid into the second container. Of course, the air outlet can take any suitable form of a valve or filter and can be disposed at any suitable portion of the transfer engine 100 and / or the second container 350. For example, the air outlet can be disposed on the second container side of the check valve 109 in the second flow path 104. As another example, the air outlet can be disposed in the second container (e.g., the bottom of the second container) such that pressurized air above the medicament solution 356 can escape.

[0151] FIG. 7 is a perspective view of one embodiment of the reconfiguration device 200 in a non-operating state, while FIG. 8 shows the reconfiguration device in an operating state. As shown in FIGS. 7-8, the reconfiguration device includes a housing 201 that includes an upper portion 202 and a lower portion 204 that are arranged in the same manner as 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. That is, the inner guide allows the upper portion to move linearly relative to the lower portion between the non-operating position shown in FIG. 7 and the operating position shown in FIG. 8. When the upper portion is in the non-operating position, the container disposed within the upper portion can be spaced apart from the transfer engine disposed in the lower portion 204. That is, the container may remain sealed and fluidly isolated from the transfer engine. When the upper portion moves to the operating position shown in FIG. 8, as shown in FIG. 8, the container moves toward the transfer engine and the container areas are each punctured by spikes to place the container in fluid communication with the transfer engine, thereby initiating the reconfiguration process. 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 mechanisms that slidably engage with a mechanism(s) on the upper portion 202. For example, the inner guide can have a groove shaped to receive fins on the upper portion, and the fins are slidable along the groove. The components may be reversed such that the groove is 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.

[0153] According to the embodiments of FIGS. 7-8, the reconfiguration 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 stop and the lower stop are then formed as ledges configured to abut against each other and prevent the upper portion 202 from moving further toward the lower portion 204 when the reconfiguration device is actuated. That is, the upper stop and the lower stop define an actuated position where the upper stop and the lower stop contact each other. In the embodiments of FIGS. 7-8, the upper and lower stops extend along the perimeter of the upper and lower portions of the housing, respectively. Of course, in other embodiments, the stops may have any suitable arrangement and the present disclosure is not limited thereto.

[0154] FIG. 9 is a side elevation view of the reconfiguration device 200 of FIG. 7 in a non-operating state, and FIG. 10A is a side elevation view of the reconfiguration device in an operating state. FIGS. 9-10B specifically show how physical access to the fluid outlet 111 of the reconfiguration device is obstructed prior to activation. According to the particular embodiment of FIGS. 9-10B, the fluid outlet 111 may be at least partially concealed or enclosed within the housing 201 prior to activation. During activation, the fluid outlet 111 may be exposed so that it can be accessed by the delivery device when the pharmaceutical solution is reconstituted. As shown in FIG. 9, the upper portion 202 of the housing includes a slot 208 and a notch 212 that form an opening in the upper portion 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 of the lower portion 204 of the housing 201. However, as the upper portion moves downward towards the lower portion, the notch 212 aligns with the fluid outlet 111, thereby enabling physical access and removal of the fluid outlet. As shown in FIG. 9, the fluid outlet 111 is disposed within 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 when the notch 212 is aligned with the fluid outlet receptacle 213. In some embodiments, the leash can be at least partially deployed when the notch aligns with the fluid outlet receptacle. The leash enables the user to pull the fluid outlet 111 from the outside of the housing 201, thereby facilitating its removal. According to the embodiment of FIGS. 10A-10B, the fluid outlet is connected via a flexible tube 114 to the associated transfer engine, enabling the fluid outlet to be removed and manipulated while the housing 201 remains stationary. The flexible tube 114 is aligned with the slot 208, allowing a portion of the flexible tube to be released through the slot, enabling the fluid outlet to be manipulated.Accordingly, in the embodiments of FIGS. 10A - 10B, when a plurality of containers are punctured, the fluid outlet 111 is exposed and becomes accessible to the user for connecting a delivery device. Such an arrangement can ensure that the medicament solution is at least partially reconstituted before the delivery device is connected.

[0155] As shown in FIG. 10B, the fluid outlet 111 is disposed within the fluid outlet receptacle 213 and is physically accessible to the user when the reconstitution device is actuated. According to the embodiment of FIG. 10B, the fluid outlet 111 is a luer - activated device that includes a male thread 113 configured to receive a corresponding thread of a syringe or other delivery device. The fluid outlet 111 includes a flexible leash 112 that is folded within the reconstitution device housing and configured to deploy when the device is actuated. The leash 112 may be formed of any suitable flexible material including plastic film, rubber, etc. The user can pull on the leash to remove the fluid outlet 111, or else it may 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 instead 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 conforms to at least a portion of the fluid outlet 111 and provides an area where the user can grasp the leash and use it to remove the fluid outlet from the fluid outlet receptacle.

[0156] Of course, an embodiment of the housing that selectively enables physical access to the fluid outlet is shown and described with reference to FIGS. 9-10B, although other suitable configurations are contemplated. For example, in one embodiment, the upper housing may not include a notch, but instead, the 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.) can move in conjunction with the operation of the housing of the reconfiguration device, thereby providing physical access to the fluid outlet only after operation. In some embodiments, the fluid outlet may be visible to the user prior to operation of the reconfiguration device, but may be at least partially blocked so that physical access to the fluid outlet is not possible. In such an embodiment, the fluid outlet receptacle can have an opening that is partially open when the reconfiguration device is not operating. When the reconfiguration device operates, the opening of the receptacle may be widened or otherwise further opened so that the fluid outlet can be physically accessed through the opening. Of course, the fluid outlet can be held in any suitable portion of the reconfiguration device housing, including the lower or upper portion of the housing, prior to operation of the device, as the present disclosure is not so limited. In some embodiments, the upper portion of the housing is shaped as shown in the embodiment of FIGS. 9-10B, but the housing is transparent, whereby the fluid outlet is visible but cannot be physically accessed prior to device operation.

[0157] FIG. 11 is a cross-sectional view of the reconfiguration device of FIG. 7 taken along line 11-11 showing the reconfiguration device with the container in the non-operating state, while FIG. 12 is a cross-sectional view of the reconfiguration device of FIG. 8 taken along line 12-12 showing the reconfiguration device with the container in the operating state. As shown in FIG. 11 and as previously explained, the reconfiguration device includes a housing 201 having an upper portion 202 and a lower portion 204. The lower portion is slidably disposed on the upper portion, and the inner guide 205 provides a sliding interface with the upper portion. As shown in FIGS. 11-12, the first container 300 and the second container 350 are disposed in the upper portion 202. In FIG. 11, the first and second containers are spaced from the first spike 102 and the second spike 105 of the transfer engine, respectively, whereby the first and second containers remain sealed. In FIG. 12, the first and second containers move towards the spikes 102, 105, whereby the spikes simultaneously pierce the stopper 304 of the first container and the stopper 354 of the second container. When moving from the non-operating position to the operating position, the user can place the lower portion 204 of the housing 201 on a flat surface to function as a base. The user can then apply a force to the curved upper surface 203 of the housing to move the upper portion 202 towards 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 pierced, the reconfiguration process can be initiated, an exemplary embodiment of which was previously described with reference to FIGS. 3-6.

[0158] Although certain embodiments of the housing 201 are shown in FIGS. 11-12, it should be noted that the housing can take any suitable shape to allow the two containers to move selectively towards one or more container receiving ends of the fluid transfer engine. For example, in one embodiment, the upper part of the housing can be received inside the lower part. As another embodiment, the upper surface 203 of the housing may not be curved, or may be curved to a lesser extent. Further, the upper housing can include one or more retaining mechanisms to fix the first container 300 and the second container 350 inside. For example, tabs, protrusions, and / or shelves corresponding to the shape of the container can be used to maintain the spacing between the container and the transfer engine. Further, in some embodiments, one or more biasing members are used to bias the reconfiguration device towards the non-operating position, thereby applying a threshold force to the upper part to activate the reconfiguration device.

[0159] In some embodiments, the transfer engine may be a separate component from the lower part of the housing. That is, the transfer engine and the housing of the reconfiguration device may be formed separately. The lower part of the housing can include slots or transfer engine receiving parts configured to receive the transfer engine. The transfer engine can be fixed to the lower part in any suitable configuration including, but not limited to, mechanical fasteners (e.g., screws, bolts, etc.), snap-fit tabs, and adhesives (e.g., adhesives, epoxies, etc.). Such an arrangement can make it possible to sterilize the flow path of the transfer engine before assembling it with the reconfiguration device housing. In some embodiments, the reconfiguration device can include other components that may be sensitive to a particular sterilization process, such as containers for pharmaceuticals or electronic devices. In some embodiments, having a transfer engine that can be sterilized individually before assembling with the device housing eliminates the need to sterilize the entire reconfiguration device, and thus there is no need to expose components sensitive to a particular sterilization process to such a process.

[0160] In some embodiments, the reconfiguration device can be stored and transported in a packaging container. The packaging container can be formed as a clam shell or blister pack having a shape corresponding to the shape of the housing of the reconfiguration device. The packaging container may also include one or more protrusions or tabs that prevent the upper portion of the housing from moving relative to the lower portion of the housing, or vice versa. That is, one or more protrusions or tabs can engage the upper portion to hold the upper portion in a non-operative position. Such an arrangement can ensure that the reconfiguration device does not accidentally activate during transport and storage.

[0161] In some embodiments, a reconfiguration device having a housing with an upper and a lower portion movable relative to each other between an operative position and a non-operative position may include one or more locking latches that permanently lock the housing in the operative position after the device is activated. For example, in one embodiment, a latch disposed in the lower portion of the housing can capture and permanently hold the upper portion of the housing when the upper housing moves to the operative position. The latch can be disposed inside the housing so as to be inaccessible to the user. Thus, the housing can be effectively locked in the operative position and the upper portion cannot be non-destructively returned to the non-operative position. Such an arrangement can prevent the user from disassembling the reconfiguration device or deter attempts to remove a used container from the reconfiguration device.

[0162] Figure 13 is a side elevation view of one embodiment of the transfer engine 100 of the reconstitution device. As shown in Figure 13, the transfer engine includes a first spike 102 and a second spike. Similar to the schematic diagram described with reference to Figure 1, the first spike 102 is associated with an air inlet 108 and a first flow path 103. The air inlet includes a hydrophobic filter that allows air to enter the first flow path 103 and prevents fluid from escaping from the first flow path. The second spike 105 is associated with a third flow path 107 that extends to a fluid outlet connector 115. The second flow path extends between the first spike 102 and the second spike 105, as further described with reference to Figure 14. According to the embodiment of Figure 13, the fluid outlet 111 is connected to the third flow path 107 via a flexible tube 114, whereby the fluid outlet can move relative to the first spike and the second spike. The fluid outlet 111 is configured as a luer-activated valve and includes a leash 112 configured to assist the user in removing the fluid outlet from the reconstitution device housing. According to the embodiment of Figure 13, the fluid outlet 111 is adjacent to the air inlet 108, whereby the transfer engine effectively forms a geometric circuit. Further, in some embodiments shown in Figure 13, portions of all the flow paths are in the same plane with respect to 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 the flow path disposed within the transfer engine. The sheath can be configured to be compressible and is ruptured by the spikes 102, 105 when the container is punctured by the spikes. Such an arrangement can help the sterilized flow path of the transfer engine maintain its sterilized state during storage and transportation of the reconstitution device. Further, the sheath can provide a fluid seal for the spikes to prevent loss of any reconstitution fluid or pharmaceuticals when one container is punctured and the other container is fluidly connected to the transfer engine prior to the other.

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

[0165] According to the embodiment of FIG. 14, the transfer engine 100 is arranged in a compact rectangular shape. The parallel circuit arrangement of the flow paths and the first and second spikes 102, 105 is such that it can reduce the size of the reconfiguration device including the transfer engine for ease of transportation and handling. That is, at least a portion of the flow path does not extend in a single straight path but curves over itself. As shown in FIG. 14, portions of the first flow path 103, the second flow path 104, and the third flow path 107 are all parallel to each other. In fact, each flow path has a portion parallel to the longitudinal axis X-X of the transfer engine. Further, according to some embodiments shown in FIG. 14, at least a portion of the first flow path 103 can be mirrored across the longitudinal axis X-X to form at least a portion of the second flow path 104. Similarly, at least a portion of the second flow path 104 can be mirrored across the longitudinal axis X-X to form the third flow path 107. Thus, the flow paths are at least partially symmetric across the longitudinal axis, reducing the overall size of the transfer engine. It should be noted that the first, second, and third flow paths of FIG. 14 include curved portions where the flow path changes direction, but any suitable arrangement can be used to change the direction of the flow path. For example, in some embodiments, the flow path can include one or more angled portions that transition the direction of the flow path.

[0166] The embodiment of FIG. 14 shows a rectangular transfer engine, but in other embodiments, the transfer engine can take any suitable shape. For example, the transfer engine may be circular, oval, square, or another suitable shape, and the present disclosure is not limited in this regard.

[0167] According to the embodiment of FIG. 14, the transfer engine 100 can have a rectangular size that is well-suited for placement in a compact reconfiguration device. That is, the overall width W of the transfer device is smaller 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 may be between 3 and 5. Thus, the length of the transfer engine may be three to five times longer than the width of the transfer engine, making it well-suited for accommodating linearly arranged containers. Since the transfer engine can include a movable fluid outlet connected via a flexible tube (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 the reconfiguration device employing the transfer engine. In other words, the first flow path 103 and the third flow path 107 wrap around so as to extend parallel to the second flow path 104, thereby reducing the overall length of the transfer engine without substantially increasing the width. Of course, since the present disclosure is not so limited, in other embodiments, any suitable length-to-width ratio can be used.

[0168] Figure 15 is a flowchart of an embodiment of a reconstitution and pharmaceutical delivery process. In step 500, a first and a second container are provided within a housing, and an upper portion of the housing at least partially surrounds the first and second containers. The first and second containers can each contain a reconstitution fluid and a pharmaceutical for reconstitution. In some embodiments, step 500 may be omitted and the process may begin at step 502. In step 502, a force is applied to the upper portion of the housing to move the upper portion from a first non-operating position to a second operating position. Applying a force to the upper portion can include applying a force to the upper portion in a linear direction toward the plane in which the housing is disposed. In step 504, when the upper portion moves to the operating position, the first container is punctured by a first spike and the second container is punctured by a second spike. In step 506, fluid is allowed to flow from the first container to the second container to occupy a vacuum portion within the second container. Allowing the fluid to flow to the second container can include moving the fluid through a check valve disposed between the first spike and the second spike and discharging the fluid to the second container at a rate that can help promote reconstitution. In step 508, the fluid is mixed with a formulation or pharmaceutical within the second container to produce a pharmaceutical solution. In step 510, a syringe (or other delivery device) is coupled to a fluid outlet to draw the pharmaceutical solution from the second container.

[0169] FIG. 16 is a flowchart of another embodiment of the reconstitution and medicament delivery process. At step 600, a first and a second container are provided within a housing, and an upper portion of the housing at least partially surrounds the first and second containers. The first and second containers can each contain a reconstitution fluid and a medicament for reconstitution. In some embodiments, step 600 may be omitted and the process may begin at step 602. At step 602, a force is applied to the upper portion of the housing to move the upper portion from a first non-operating position to a second operating position. Applying a force to the upper portion can include applying a force to the upper portion in a linear direction toward the plane in which the housing is disposed. At step 604, when the upper portion moves to the operating position, the first container is punctured by a first spike and the second container is punctured by a second spike. At step 606, fluid is allowed to flow from the first container to the second container to occupy a vacuum portion within the second container. Allowing fluid to flow to the second container can include moving the fluid through a check valve disposed between the first spike and the second spike and discharging the fluid to the second container at a rate that can help promote reconstitution. At step 608, a syringe is coupled to the fluid outlet to draw out at least a portion of the medicament from the second container. For example, in one embodiment, the syringe handle can be moved away from the fluid outlet. At step 610, the drawn-out portion of the medicament is returned to and deposited in the second container using the syringe. For example, step 610 can be achieved by pushing the syringe handle toward the fluid outlet to increase the pressure of the medicament.

[0170] In some embodiments, steps 608 and 610 shown in FIG. 16 can be used in a process where there is no vacuum in the second container or there is an 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 fluid from the first container into the second container and ultimately into the syringe. Once the fluid is at least partially disposed within the syringe, the withdrawn 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 is repeated until the contents of the first and second containers are well mixed.

[0171] FIG. 17 is a flowchart of another embodiment of the reconstitution and pharmaceutical delivery process. In step 650, a first and a second container are provided within a housing, and an upper portion of the housing at least partially surrounds the first and second containers. The first and second containers can each contain a reconstitution fluid and a liquid pharmaceutical for reconstitution. In some embodiments, step 650 may be omitted and the process may begin at step 652. In step 652, a force is applied to the upper portion of the housing to move the upper portion from a first non-operative position to a second operative position. Applying a force to the upper portion can include applying a force to the upper portion in a linear direction toward the plane in which the housing is disposed. In step 654, when the upper portion moves to the operative position, the first container is punctured by a first spike and the second container is punctured by a second spike. In step 656, fluid is enabled to flow from the first container to the second container. According to the embodiment of FIG. 17, the fluid may not automatically flow from the first container to the second container. Nevertheless, the reconstitution fluid and the liquid pharmaceutical can be at least partially mixed when the containers are punctured. In step 658, a syringe is connected to the fluid outlet to withdraw at least a portion of the pharmaceutical solution 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 pharmaceutical and the reconstitution fluid may be withdrawn into the syringe in a single draw. In step 660, the withdrawn portion of the pharmaceutical solution is returned to and deposited in 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 when the pharmaceutical and the reconstitution fluid are not sufficiently mixed. In some cases, steps 658 and 660 can be repeated to more completely mix the reconstitution fluid and the pharmaceutical.

[0172] FIG. 18 is a schematic diagram of an embodiment of a reconfiguration device 700 that communicates with one or more remote devices. As shown in FIG. 18, the reconfiguration device is similar in shape and size to the reconfiguration device described with reference to FIG. 2. The reconfiguration device includes a housing 701 that includes 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 that supports and guides the upper portion when sliding between a non-operating position and an operating position is received in the upper portion. According to the embodiment of FIG. 18, the reconfiguration device 700 includes a processor 708 (e.g., a programmable logic controller) disposed 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 series of one or more computer-readable instructions stored in a volatile or non-volatile memory disposed in the lower portion 704. The communication device is configured to transmit signals by at least one of wired and wireless protocols. For example, the communication 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 protocol. The battery 712 may be any suitable battery such as a NiMH, Li-ion, or alkaline battery, as the present disclosure is not so limited.

[0173] In some embodiments, the reconstitution device can include a marker such as a QR code (registered trademark) or other identification label (e.g., barcode). Such markers can be used to link the reconstitution device to an application (e.g., a smartphone application) or otherwise enable it to be tracked by a complementary remote device (e.g., a smartphone). In some embodiments, by scanning the QR code (registered trademark) using a suitable reader or camera, information regarding the dosage of the pharmaceutical, identification of the agent, and / or the amount of pharmaceutical disposed in the reconstitution device can be captured by a complementary remote device for display to the user. The complementary device can also track timing, dosage, frequency, drug lot information, and other medically relevant parameters to enable the user or physician to monitor an extended treatment process. In some embodiments, the QR code (registered trademark) or other marker can be hidden from view inside the reconstitution device housing or otherwise prevented from being accessed until before device activation. When the device is activated, the QR code (registered trademark) is displayed or otherwise made accessible for the user to scan.

[0174] According to some embodiments, and as shown in FIG. 18, the electronic device of the reconfiguration device can operate only when the reconfiguration device is activated. That is, when the upper portion 702 is in the non-operating position, the processor 708 and the communication device 710 may be in a dormant state, in a sleep state, or electrically disconnected from the power source. When the upper portion 702 moves to the operating position (e.g., approaches the lower portion 704 such that, for example, the bottommost surface of the upper portion approaches the base of the lower portion), one or more switches are triggered to activate the processor and the communication device or connect them to the power source. Thus, the on-board power source may not be consumed during transportation and storage and can 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 in the lower portion 704 of the housing. The Hall effect sensors are configured to sense the adjacent presence of a magnet 714 disposed in the upper housing. That is, the first Hall effect sensor is configured to sense when the upper portion 702 is in the non-operating position, and the second Hall effect sensor is configured to sense when the upper portion 702 is in the operating 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, although Hall effect sensors are shown in FIG. 18, any suitable switch or sensor, including but not limited to a linear potentiometer or a microswitch, can be used to determine the position of the upper portion.

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

[0176] The display of the status by the visual indicator may be adjusted by a processor 708 that can receive and process information from one or more sensors. In some embodiments, the visual indicator can be color-coded to relay the general status of the reconfiguration device during the reconfiguration process. For example, the visual indicator may light up red in the case of an error state, yellow when the reconstitution fluid is mixed with the pharmaceutical in the device, and green when the pharmaceutical solution is ready to be withdrawn from the device. Of course, the present disclosure is not so limited, and any appropriate color or blinking pattern can be used to indicate any desired status. In some embodiments, the communication device 710 can also communicate the status of the reconfiguration device to a remote device, as further described below. In some embodiments, the reconfiguration device can include one or more light sources configured to illuminate a container disposed within the reconfiguration 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 communication may be shared with one or more interested parties, and the interested parties can use the information in different ways. The communication may be unidirectional or bidirectional in either direction. The communication can utilize any suitable number of local or external networks, including the Internet, to communicate with the remote device. For example, in some embodiments, the reconfiguration device can use a short-range communication protocol to communicate with a base station or local relay such as Bluetooth®, ZigBee®, infrared transmission, and radio frequency (RF) communication. Thus, even if the reconfiguration device does not have a longer-range long-distance communication capability such as Wi-Fi or cellular network technology, or the user has not activated these communication functions, the reconfiguration device can communicate wirelessly with the local relay. In some embodiments, the reconfiguration device can also use a short-range communication protocol to communicate wirelessly with nearby external devices such as mobile devices. In some embodiments, the reconfiguration device can communicate wirelessly with other external devices, such as directly with the remote server 724 or the personal computer 721, over a longer distance. In some embodiments, the reconfiguration device can send a message containing information to one or more remote devices. This information may include time information, dosage, drug lot information, and other medical-related parameters. In some embodiments, the reconfiguration device can include a global positioning system (GPS) sensor configured to provide location information to the processor 708. In such embodiments, the information can include location information from the GPS sensor. In some embodiments, the reconfiguration device may include an accelerometer configured to detect the movement and / or orientation of the reconfiguration device. In such embodiments, the information can include orientation, average acceleration, etc. from the accelerometer.In some embodiments, the reconfiguration device may include a temperature sensor configured to detect the temperature of the reconfiguration device. In such embodiments, the information can include the current temperature, average temperature, peak maximum temperature, peak minimum temperature, etc. from the temperature sensor.

[0178] In some embodiments, the reconfiguration device 700 may interact directly and / or indirectly with a number of different parties that can utilize information from the reconfiguration device and / or send commands or other information to the reconfiguration device. As a first example, information from the reconfiguration device can be sent directly or indirectly to a patient. The patient can obtain information from a visual indicator 720 on the reconfiguration device, from a mobile device 722 that may be running a companion application to the reconfiguration device, or from a remote server 724. As an example, the patient can use the mobile device to obtain information from the remote server 724 via an Internet website or other program. In some embodiments, the user can access a "patient service" mechanism that functions as a type of customer service for the user. The user can connect to this service via phone, text, website, live chat, or other appropriate communication forms for assistance related to the reconfiguration device and / or dosing. As an example, in some embodiments, the patient can use the patient service function to receive training on how to use the reconfiguration device and / or any accessories associated with the reconfiguration device, how to troubleshoot any possible problems, or any questions related to the reconfiguration device or dosing. In some embodiments, the patient can use the patient service function to assist with payment and / or insurance-related issues. The patient service may need to access information from the patient's reconfiguration device to assist the patient with some of these issues. In some embodiments, the information can be obtained from the remote server 724.

[0179] In some embodiments, the reconfiguration device 700 can communicate directly or indirectly with healthcare providers such as hospitals, clinics, and staff such as nurses or doctors. The healthcare provider can obtain information from other external devices such as the remote server 724 or the mobile device 722 that receives information from the reconfiguration device 700. Alternatively, the healthcare provider may communicate directly with the reconfiguration device 700. Information that can be transmitted to the healthcare provider includes, but is not limited to, administration time, dosage, patient symptoms, etc. The healthcare provider can use the information to monitor patient compliance and / or determine the effectiveness of the medication and / or dosage plan for the patient. The healthcare provider can choose to, for example, educate and / or encourage the patient from the information, and / or adjust the patient's treatment. The communication between the reconfiguration device and the healthcare provider may be one-way or two-way communication. For example, in some embodiments, the healthcare provider can send messages such as reminders or warnings to the patient via the reconfiguration device itself or a mobile device used by the patient in combination with the reconfiguration device, for example, via an application operating on the mobile device that may be specific to the combination of the reconfiguration device and / or a particular treatment in which the reconfiguration device is being used. Via the mobile device application or the reconfiguration device itself, the patient can directly send questions and concerns to the healthcare provider, and the healthcare provider can provide a reply to the patient.

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

[0181] In some embodiments, the reconfiguration device 700 can communicate directly or indirectly with a payor, also known as an insurance company. The payor can use information from the reconfiguration device to monitor aspects such as patient compliance, medication effectiveness, and treatment plan effectiveness. In some embodiments, the payor may attempt to incentivize or reward certain behaviors. For example, the payor can provide a discount or offer a rebate to reward patients with good compliance. The payor can also incentivize compliance by sending treatment reminders or warnings to patients and / or healthcare providers.

[0182] In some embodiments, the information relayed through communication from and / or to the reconfiguration device 700 may be used for data analysis, which can be used by various stakeholders. For example, a provider (e.g., a manufacturer of pharmaceuticals and / or the reconfiguration device) can use information from the reconfiguration device to determine which functions are most used by the user at what times and what errors or problems are occurring. The information may be filtered into different categories such as age, gender, income, experience level, etc. In some embodiments, the information collected for data analysis may be anonymized and may not include PHI (protected health information). However, in other embodiments, the information may include PHI.

[0183] In some embodiments, information collected from the reconfiguration device 700 can help provide the performance of a pharmaceutical. The inventors recognize that outside of clinical trials, it can be difficult to evaluate the performance of a pharmaceutical when the pharmaceutical has become widely and generally available. Communication from the reconfiguration device as well as other information sources such as mobile devices and / or healthcare providers can help provide information regarding the performance of the pharmaceutical and / or the reconfiguration device. Information regarding a patient's symptoms and treatment progress can be collected from the patient, for example, via an electronic symptom diary incorporated into a companion app operating on a mobile device, and / or from a healthcare provider's notes taken during the patient's clinic visit. The information collected can help inform the supplier of future formulation and / or reconfiguration device designs and can help promote the use of the pharmaceutical using positive performance.

[0184] In some embodiments, information relayed through communication from and / or to the reconfiguration device 700 can be used to assist in supply chain management. The information may include an identification of which pharmaceuticals were used when (e.g., by transmitting a lot / batch number or other identifier associated with the pharmaceutical). The information may also include the geographical region of pharmaceutical use. Such information can help a pharmaceutical supplier understand the supply and demand of pharmaceuticals in various regions of the world, for example, as reflected by the actual use of the pharmaceuticals (as compared to being limited to prescription entry information). This can help the supplier understand whether to stock more or less of a drug in a particular region, whether to intensify marketing activities in a particular region, and / or whether past marketing activities have been effective in increasing demand.

[0185] In some embodiments, the reconfiguration device 700 can include a Near Field Communication (NFC) module that enables a remote device, such as a smartphone, to pair with the communication device 710. That is, the NFC module can relay pairing information to a device having a corresponding NFC module and can avoid a typical pairing process. Such a configuration can be beneficial to enable reconfiguration device communication without having to pre-pair the devices or otherwise prepare the remote device for a particular use with the reconfiguration device.

[0186] The embodiment of FIG. 18 shows a reconfiguration device, but it should be noted that in other embodiments, a device such as that of FIG. 18 may be a medicament delivery device configured to pool medicament solution, as opposed to reconstituting a solid medicament. Thus, the various mechanisms and methods described with reference to FIG. 18 are applicable also to a medicament delivery device configured to pool fluid, since the present disclosure is not so limited.

[0187] In addition to the above, it should be noted that the device of FIG. 18 is configured to access and deliver the contents of two containers, but any suitable number of containers may be used. For example, in some embodiments, a medicament delivery device as 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. Thus, since the present disclosure is not so limited, the various mechanisms and methods described with reference to FIG. 18 are applicable also to a medicament delivery or reconfiguration device having any number of containers.

[0188] Figures 19A - 19B are schematic diagrams of another embodiment of the reconfiguration device 800 in a non - operating state and an operating state, respectively. According to the depicted embodiment, the reconfiguration 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 inclined planes. The first and second actuators are configured to move within the housing 802 to operate the reconfiguration device. Specifically, the actuators are configured to move corresponding first wedge 808A and second wedge 808B. The first and second wedges are configured to move the first and second containers towards the base 804 of the housing 802 and to be punctured by a first spike and a second spike, respectively. That is, as shown in Figures 19A - 19B, the first and second actuators can be driven to be squeezed or otherwise pushed into the housing 802 to lower the first and second wedges towards the base 804 of the housing. When the inclined planes of the actuators and the wedges engage with each other, the lateral movement of the actuator is converted into a downward movement of the wedge, driving the container to be punctured. Such a configuration can provide a mechanical advantage for puncturing the container.

[0189] Figures 20A - 20B are schematic diagrams of another embodiment of the reconfiguration device 900 in a non - operating state and an operating state, respectively. As shown in Figures 20A - 20B, the reconfiguration device includes a housing having an upper part 902 and a lower part 904. The upper part is movable (e.g., slidable) relative to the lower part, and the upper part moves towards the lower part from a non - operating position to an operating position. The reconfiguration device includes a bolt 906 fixed to the lower part. A nut 908 and a handle 910 are threadedly connected to the bolt and fixed to the upper part. Thus, the user can turn the handle 910 to move the upper part towards the lower part and operate the reconfiguration device. By doing so, the first container 300 can be punctured with the first spike 102 and the second container 350 can be punctured with the second spike 105.

[0190] Figures 21A - 21B are schematic diagrams of another embodiment of the reconfiguration device 1000 in a non - operating state and an operating state, respectively. As shown in Figures 21A - 21B, the reconfiguration device includes a housing having an upper part 1002 and a lower part 1004. The upper part is movable (e.g., slidable) relative to the lower part, and the upper part moves towards the lower part from a non - operating position to an operating position. The reconfiguration device includes a lever 1008 rotatably coupled to the lower part 1004. The lever 1008 protrudes from a slot 1006 in the upper part 1002 such that the lever can apply a force to the upper part. Thus, to operate the reconfiguration device, the lever can move from the upper position shown in Figure 21A towards the lower part, correspondingly moving the upper part towards the lower part. By doing so, the first container 300 can be punctured by the first spike 102 and the second container 350 can be punctured by the second spike 105.

[0191] FIG. 22 is a perspective view of another embodiment of the 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 first plate and a flow path, and a third plate 1106 and a filter chamber 1117. The transfer engine includes an inlet 1109 (e.g., an air inlet) that may include a hydrophobic filter in some embodiments. The inlet is connected to a first flow path 1110 that curves 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 that allows a one-way flow from the first spike to the second spike is disposed in the second flow path. 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 into a filter chamber 1117 disposed between the second plate 1104 and the third plate 1106. The filter is disposed within the filter chamber and can effectively filter the chemical solution passing toward the fluid outlet. The arrangement of the filter chamber may allow for the use of a filter with a larger surface area. The filter chamber terminates at an outlet 1118, which may be formed as or connected 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. The first plate 1102 includes a first spike 1111 and a second spike 1114. The second plate 1104 forms a flow path with the first plate, and the filter chamber 1117 forms a flow path with the third plate 1106. The third plate forms a filter chamber with the second plate 1104. It should be noted that although 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 that form various flow paths. For example, in some embodiments, the transfer engine may be formed by two separate plates joined to each other to form a plurality of flow paths.

[0193] As also shown in FIG. 23, the flow paths extend into the lumens of the first and second spikes. That is, the first flow path 1110 extends into a first lumen 1120 disposed within the first spike 1111. The third flow path 1115 extends into 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 circuitous configuration similar to the embodiments described above in this specification. That is, the first flow path 1110 and the third flow path 1115 are arranged in a mirror-image parallel arrangement with respect to the second flow path 1112. However, instead of the outlet 1118 being arranged adjacent to the inlet 1109, the outlet 1118 is arranged 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 inner cavity 1120. The second flow path 1112 extends from the second inner cavity 1122 into the third inner cavity 1124. The third flow path 1115 extends from the fourth inner cavity 1126 to the filter inlet 1116. FIG. 25 shows a filter chamber 1117 that extends in the shape of a racetrack or a square rectangle. The filter chamber is configured to receive and hold a planar filter (e.g., a 1 micron filter) that filters the fluid passing through the filter chamber. According to the embodiment of FIG. 25, the outlet 1118 is configured such that the fluid runs down from the filter inlet 1116 before being drawn back through the outlet and delivered to the patient. With such an arrangement, it is ensured that the fluid passes through the filter before being delivered. FIG. 26 is a perspective view of another embodiment of the transfer engine 1200. As shown in FIG. 26, the transfer engine includes two spike housings separated by a tube. That is, the first spike housing 1202 includes the first spike 1203 and the inlet 1204. The second spike housing 1210 includes the second spike 1211. The tube 1220 connects the spike housings. The tube 1220 may be flexible or rigid. Such an arrangement allows the center-to-center spacing of the spikes 1203, 1211 to be varied for different container sizes using the same spike housing. That is, the tube 1220 can be replaced to have various different lengths and can be adapted to embodiments of reconfiguration devices of different sizes.

[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 the first flow path 1205. The first flow path extends from the inlet to the first inner cavity 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 inner cavity 1207 disposed within the first spike. The second flow path is connected to a tube 1220, specifically the 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 inner cavity 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 inner cavity 1207 to the third inner cavity 1214. The check valve 1213 is disposed within the third flow path 1212 and allows one-way flow from the second inner cavity 1207 to the third inner cavity 1214. The second spike housing also includes a fourth inner cavity 1215 disposed within the second spike 1211. The fourth flow path 1216 extends between the fourth inner cavity 1215 and the filter chamber 1217. The filter chamber is then connected to an outlet 1218 through which fluid can be drawn from the transfer engine. A filter can be disposed within the filter chamber to filter the fluid drawn from the transfer engine.

[0196] FIG. 29 is a schematic cross-sectional view of one embodiment of spike 1300. As shown in FIG. 29, the spike includes a first flow path 1302 that terminates at a first open end 1304. According to the embodiment of FIG. 29, the first open end is angled by an angle α with respect to the spike insertion direction S. Specifically, the first open end is perpendicular to the spike piercing or insertion direction, and α is equal to 90 degrees. Thus, when fluid exits the first open end 1304 at high speed, the fluid can generate a vortex within the container to facilitate mixing of the reconstituted fluid and the pharmaceutical. As shown in FIG. 29, the spike includes a second flow path 1306 that terminates at 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 present disclosure is not so limited, so the first and second open ends may be symmetric or have any combination of angles with respect to the spike insertion direction.

[0197] FIG. 30 is a schematic cross-sectional view of another embodiment of spike 1400. As shown in FIG. 30, the spike includes a first flow path 1402 that terminates at a first open end 1404. According to the embodiment of FIG. 30, the first open end is angled by 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-vertical angle β equal to about 45 degrees. Thus, when fluid exits the first open end 1404 at high speed, the fluid can generate a vortex within the container to facilitate mixing of the reconstituted fluid and the pharmaceutical. As shown in FIG. 30, the spike includes a second flow path 1406 that terminates at 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 with respect to the spike insertion direction may be 15 degrees, 30 degrees, 60 degrees, 75 degrees, or any other angle from 1 to 90 degrees.

[0198] FIG. 31 is a schematic cross-sectional view of another embodiment of the spike 1500. As shown in FIG. 31, the spike includes a first flow path 1502 that terminates at a plurality of first open ends 1504A, 1504B, 1504C. According to the embodiment of FIG. 31, the first open ends are angled with respect to the spike insertion direction S. The arrangement of the first flow path having a plurality of open ends can change the flow characteristics of the fluid passing through the first flow path at high speed. For example, the plurality of open ends can reduce the overall force and velocity of the fluid exiting the first fluid flow path as compared to an arrangement having a single first open end. As shown in FIG. 31, the spike includes a second flow path 1506 that terminates at a second open end 1508. In contrast to the first open end, the second open end is parallel to the spike insertion or piercing direction.

[0199] In some embodiments, the reconfiguration device can include a fluid outlet that is releasably retained within the housing of the reconfiguration device until a delivery device is coupled thereto. FIGS. 32A - 32D depict schematic views of another embodiment of one such reconfiguration device 1600. As shown in FIGS. 32A - 32D, the reconfiguration 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 - operative position to an operative 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 reconfiguration device housing. That is, the fluid outlet 1610 is not physically accessible when the housing is in the non - operative position, but is physically accessible through the notch 1606 when the reconfiguration device is actuated. The fluid outlet 1610 is releasably retained within the reconfiguration device housing by a retainer 1608 configured to abut a protrusion 1612 disposed on the fluid outlet 1610. The retainer and the protrusion are arranged such that the coupling of a delivery device (e.g., a syringe) to the fluid outlet 1610 releases the fluid outlet from the reconfiguration device housing. The fluid outlet 1610 is then connected to a transfer engine of the reconfiguration device by a flexible tube 1616, so that the fluid outlet can be removed from and moved relative to the housing.

[0200] In the state shown in FIG. 32A, the reconfiguration device is in a non-operating state. That is, the upper part 1602 is not moving towards the lower part 1604. Accordingly, the notch 1606 is not aligned with the fluid outlet 1610, whereby the fluid outlet 1610 is not physically accessible to the user. According to the embodiment of FIG. 32A, when the device is not operating, the fluid outlet is completely retained within the housing, although other configurations are conceivable. For example, the fluid outlet may be partially disposed within the housing and blocked until the reconfiguration device is actuated. In some embodiments, the fluid outlet may be visible to the user prior to actuation of the reconfiguration device, although it may be at least partially blocked so as to be physically inaccessible. The fluid outlet 1610 is shown shaded with dashed hatching for clarity in FIG. 32A.

[0201] In the state shown in FIG. 32B, the reconfiguration device is operating. That is, the upper portion 1602 of the housing is moving toward the lower portion 1604 of the housing. As described with reference to other exemplary embodiments herein, the operation of the reconfiguration device can puncture a fluid container within the reconfiguration device housing. As shown in FIG. 32B, the notch 1606 is aligned with the fluid outlet 1610, whereby the fluid outlet 1610 is physically accessible to the user outside of the reconfiguration device housing. As shown in FIG. 32B, the protrusion 1612 of the fluid outlet 1610 is disposed inside the retainer 1608 (i.e., inside the retainer with respect to the reconfiguration device housing). Thus, while the fluid outlet 1610 is physically accessible, the retainer 1608 releasably holds the fluid outlet inside the reconfiguration device housing. Further, the retainer 1608 can provide frictional resistance to rotation of the fluid outlet 1610 within the reconfiguration device housing. In the embodiment of FIG. 32B, the retainer and the fluid outlet are configured to completely couple a delivery device to the fluid outlet and release the fluid outlet from the reconfiguration device housing. That is, in some embodiments, the fluid outlet can be held within the reconfiguration device housing until an appropriate delivery device is fully coupled to the reconfiguration 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 notch 1606 may be sized and shaped such that the upper portion 1602 of the housing can prevent the user from physically accessing the fluid outlet 1610 using something other than an appropriate delivery device. For example, the notch may be sized and shaped such that multiple fingers cannot be inserted through the notch to grip the fluid outlet 1610, but a delivery device such as a syringe can be inserted through the notch to interact with the fluid outlet. Thus, the notch 1606 facilitates the proper use of the delivery device and allows the fluid outlet to be coupled to the delivery device.

[0202] In the state shown in FIG. 32C, a delivery device (e.g., a syringe) 1614 is connected to a fluid outlet 1610 disposed inside the reconfiguration device. In the embodiments of FIGS. 32A - 32D, the fluid outlet 1610 includes male threads and is configured as a luer actuating device. Accordingly, the delivery device 1614 includes corresponding threads configured to engage the threads of the fluid outlet. When the reconfiguration device is in the state shown in FIG. 32B, the delivery device 1614 can be threadedly connected to the fluid outlet (e.g., by rotating the delivery device clockwise) while the retainer 1608 provides frictional resistance to maintain the rotational position of the fluid outlet. Since the delivery device is threadedly connected, the fluid outlet 1610 can be held within the reconfiguration device housing until the delivery device is fully connected to the fluid outlet. When the delivery device is fully connected, 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 connected to the fluid outlet and that the fluid outlet is releasable from the reconfiguration device housing.

[0203] As shown in FIG. 32D, the fluid outlet 1610 is released from the reconfiguration device housing and removed through the notch 1606. As described above, when the delivery device 1614 is threadedly connected to the fluid outlet 1610, the protrusion 1612 can pass through the retainer 1608. Accordingly, 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 reconfiguration device via a flexible tube 1616 so that the fluid outlet can be moved to a desired position. When the fluid outlet 1610 is removed from the reconfiguration device housing, the flexible tube 1616 can extend or unwind from the inside of the reconfiguration device housing.

[0204] An embodiment of a reconfiguration device housing that includes a fluid outlet that is releasably retained within the housing until a delivery device is connected is described with reference to FIGS. 32A-32D, although other configurations are contemplated and the present disclosure is not so limited in this regard. For example, in some embodiments, the fluid outlet may be connected to the reconfiguration device housing using a breakable and fragile connection that is broken by connecting the delivery device to the fluid outlet. In some embodiments, connecting the delivery device to the fluid outlet can release a latch that holds the fluid outlet within the reconfiguration device housing. In some embodiments, the fluid outlet may have a friction fit with the reconfiguration device housing, and the friction fit is eliminated when the delivery device is connected to the fluid outlet. The user can release the fluid outlet from the reconfiguration device housing using any suitable movement or combination of movements of the delivery device, including pushing, pulling, rotating, twisting, etc.

[0205] Another exemplary embodiment of the 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 may include an inlet 136 (e.g., an air inlet) that can include a hydrophobic filter. The transfer engine can include a filter chamber 137 that receives the hydrophobic filter of the inlet in some embodiments. 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 that includes 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 that allows a one-way flow from the first spike to the second spike is disposed in the second flow path. A third flow path that includes a fourth lumen 286 through the second spike 14 and a path 135 fluidly connects the second spike 14 to an outlet 298. In some embodiments, the tube can be connected to the outlet 298 to direct fluid to a fluid outlet (e.g., a luer connector or other connector) for administration to the user.

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

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

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

[0209] As shown in FIG. 33, in some embodiments, the transfer engine can include spike sheaths 85, 87 that cover spikes 11, 14 prior to operation of the reconfiguration device. When the container is pushed down over the spikes during operation, the spikes may pass through the spike sheaths and puncture into the container. In some embodiments, the spike sheaths serve to prevent foreign objects from entering the flow path by covering the lumen of the spikes prior to use and / or to prevent inadvertent early puncture of the container.

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

[0211] As described above, in some embodiments, the reconfiguration device can be configured such that physical access to the fluid outlet is blocked prior to operation. As previously described, in some embodiments, a flexible leash can be connected to the fluid outlet. User access to the flexible leash can be permitted by aligning a notch in the upper portion of the housing with the fluid outlet receptacle. According to one aspect, in some embodiments, the flexible leash, such as a pull tab, can be part of or otherwise attached to a cap that covers the fluid outlet. By pulling on the leash, the cap can be removed from the fluid outlet to 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 on the leash can remove the fluid outlet from the housing. In some embodiments, the holding force between the fluid outlet and the housing may be less than the holding force between the cap and the fluid outlet such that pulling on the pull tab first removes the fluid outlet from the housing and then the cap from the liquid outlet. However, in other embodiments, the fluid outlet is fixed relative to the housing and is not configured to be pulled out of the housing during use.

[0212] One exemplary embodiment of the reconfiguration device 3200 is shown in FIG. 36, and the device has a housing 420 having an upper part 421 and a lower part 422. The device includes a fluid outlet 430 fixed to the lower part 422 of the housing. In the exemplary embodiment of FIG. 36, the fluid outlet 430 may be formed using a flange 440 that can be attached to an extension 250 of the lower part 422 of the housing, or may be attached to the flange 440. In some embodiments, an additional flange may be disposed behind the extension 250 and attached to the tab to provide additional retention reinforcement. However, it should be understood that since this aspect is not so limited, the fluid outlet can be fixed to the lower part of the housing by any suitable attachment arrangement.

[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 upper part 421 of the housing is in a non-operating state, the inner surface of the upper part 421 presses against the pull tab 434, thereby causing the pull tab to be in a folded or otherwise compressed state. When the upper part 421 is pushed down, the notch 424 in the upper part 421 moves into alignment with the fluid outlet 430 and the cap 432, and thus the pull tab 434 can unfold and extend out from the notch 424 for access by the user.

[0214] FIGS. 37A-37C depict various operating stages of the reconfiguration device 3200. In FIG. 37A, the device is in a non-operating state. The notch 424 in the upper part 421 of the housing is spaced from the fluid outlet, and the pull tab may be in a folded state, for example, abutting against the inner surface of the upper part 421. Thus, physical access to the pull tab and the fluid outlet is blocked by the upper part of the housing. In some embodiments, the pull tab may not be visible. In other embodiments, the pull tab may be visible, for example, if the upper part is made of a transparent material, but the user may still not be able to access the pull tab.

[0215] To move the device to the operating state shown in FIG. 37B, the user can push down on the upper portion 421 of the housing and slide the upper portion 421 downward toward the lower portion 422 of the housing. 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 be deployed and extended from the notch 424.

[0216] The user can then pull on the pull tab 434 to remove the cap 432, thereby exposing the fluid outlet 430 as shown in FIG. 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 the reconfiguration device 3300 is shown in FIGS. 38-40D The device has a housing 820 with 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 using a clip 310 or otherwise attached to the clip 310. The clip 310 may have a first leg 317 and a second leg 319. Prior to actuation, the clip is removably coupled to the lower portion 822 of the housing. After actuation, the user can separate the clip from the lower housing by pulling the fluid outlet out of the housing. As seen in FIG. 39, the inner guide 823 of the lower portion 822 of the housing can include a slot 306 sized to receive the second leg 319 of the clip 310. The clip is shown in FIG. 38 as being fully engaged with the slot 306. With the clip 310 fully engaged with the slot 306 as shown in FIG. 38, the clip 310 and the slot 306 may be disposed vertically below the fluid outlet 830. However, in other embodiments, the clip and / or the slot can be disposed at a different position 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 device operation. When the user pulls the pull tab 842 after the device is activated, the second leg 319 slides through the slot 306 and exits, thus disconnecting the clip and the fluid outlet 830 from the lower portion 822 of the housing. Accordingly, the pull tab 842 can function as a leash that the user can pull to remove the fluid outlet from the housing. In some embodiments, the holding force of the cap 840 against the fluid outlet 830 may be greater than the holding force of the clip 310 against the lower portion 822 of the housing. Thus, when the pull tab 842 is pulled, the clip 310 may first exit the slot 306 and separate before the cap 840 separates from the fluid outlet 830.

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

[0220] Figures 40A - 40D depict various operating stages of the reconfiguration device 3300. In Figure 40A, the device is in a non - operating state. The notch 824 in the upper portion 821 of the housing is spaced from the fluid outlet 830, and the pull tab may be in a folded state abutting the inner surface of the upper portion 821. Accordingly, physical access to the pull tab and the fluid outlet is blocked by the upper portion of the housing.

[0221] To move the device to the operating state shown in Figure 40B, the user can push the upper portion 821 of the housing downward and slide the upper portion 821 downward toward the lower portion 822 of the housing. The downward movement of the upper portion 821 aligns the notch 824 with the fluid outlet and the cap 840 and enables the pull tab 842 to be deployed and extended from the notch 824.

[0222] Next, the user can pull the pull tab 842. When the pull tab 842 is pulled with the holding force of the cap 840 against the fluid outlet being greater than the holding force of the clip 310 against the lower portion 822 of the housing, the clip will come out of the slot 306 in the lower portion 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 the pull tab 842. After the fluid outlet 830 is disconnected from the lower portion 822 of the housing, the user can continue to pull 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 the pull tab 842 with one hand and hold a portion of the fluid outlet 830, the clip 310, and / or the tube 313 with the other hand to separate the cap 840 from the fluid outlet 830.

[0223] Another exemplary embodiment of the reconfiguration device 3350 is shown in FIGS. 41-43C, and 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 reconfiguration 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 by or otherwise attached to two clips, a first clip 320 and a second clip 322. Prior to operation, 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 passing through the tab. Prior to operating the reconfiguration device, the clips 320, 322 of the fluid outlet 940 can be received within the slot 55 to couple the fluid outlet to the lower portion 922 of the housing. As shown in FIG. 41, with the clips 320, 322 received within the slot 55, the slot 55 and the clips 320, 322 can be adjacent to the left and right sides of the fluid outlet. However, in other embodiments, the clips and / or slots can be disposed at different positions relative to the fluid outlet, for example, vertically above and below the fluid outlet.

[0224] In some embodiments, the notch 924 includes expansion 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 device operation. When a user pulls the pull tab 932 after the device is activated, the clips 320, 322 slide out through the slots 55, thus disconnecting the clips and the fluid outlet 940 from the lower portion 922 of the housing. Thus, the pull tab 932 can 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 on the fluid outlet 940 may be greater than the holding force of the clips 320, 322 on the lower portion 822 of the housing. Thus, when the pull tab 932 is pulled, the clips 320, 322 may first separate from the slots 55 before the cap 930 separates from the fluid outlet 940.

[0226] Figures 43A - 43C depict various operating stages of the reconfiguration device 3350. In Figure 43A, the device is in a non - operating state. The notch 924 in the upper portion 921 of the housing is spaced from the fluid outlet 940, and the pull tab may be in a folded state abutting the inner surface of the upper portion 921. Thus, physical access to the pull tab and the fluid outlet is obstructed by the upper portion 921 of the housing.

[0227] To move the device to the operating state shown in Figure 43B, the user can push the upper portion 921 of the housing downward and slide the upper portion 921 downward toward the lower portion 922 of the housing. The downward movement of the upper portion 921 aligns the notch 924 with the fluid outlet and the cap 930, enabling the pull tab 932 to deploy and extend from the notch 924.

[0228] Next, the user can pull the pull tab 932. When the pull tab 932 is pulled with the holding force of the cap 930 against the fluid outlet being greater than the holding force of the clips 320, 322 against the lower portion 922 of the housing, the clips will come out of the slots 55 in the lower portion 922. As a result, as shown in FIG. 43C, both the cap 930 and the fluid outlet 940 attached to the cap can be pulled out of the housing when the user pulls the pull tab 932. After the fluid outlet 940 is disconnected from the lower portion 922 of the housing, the user can continue to pull the pull tab 932 to remove the cap 930 from the fluid outlet 940, thereby exposing the fluid outlet 940.

[0229] It should be understood that the embodiment of FIG. 38 uses a single clip and the embodiment of FIG. 41 uses two clips, but any number of clips can be used.

[0230] According to one aspect, the reconfiguration device can include one or more mechanisms that help hold the container. Such holding mechanisms can help position the container, for example, to prevent premature puncture of the container and / or to assist in puncturing the container by facilitating alignment of the spike and the container during spiking. In some embodiments, the container holding mechanism may be coupled to a portion of the housing that moves during operation. For example, in an embodiment where the upper portion of the housing is pushed downward by the user to operate the reconfiguration device, one or more container holding mechanisms may be coupled to the upper portion of the housing.

[0231] In some embodiments, the container holding mechanism includes a ring that surrounds a portion of the container to hold the container. In some embodiments, the ring can be configured to surround the shoulder portion of the container. The inner surface of the ring can be contoured to conform to the shape of the shoulder portion of the container.

[0232] In the exemplary embodiments shown in FIGS. 38-40D and FIGS. 44-48, the reconfiguration device includes a first ring 740 surrounding the first container 300 and a second ring 750 surrounding the second container 350. As will be described in more detail below, the rings can be attached to the upper portion 821 of the housing. By surrounding the containers, the rings can serve to limit the left and right 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 conform to the shape of the shoulders 35 of the container. For example, the ring 750 has an inner surface 744 with a varying 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 in contact with the formed inner surface of the ring, the ring can serve to limit the movement of the container towards the spike. When the upper portion 821 of the housing moves towards the lower portion 822 of the housing during operation of the device, the ring attached to the upper portion 821 of the housing moves towards the spike, thus allowing the container to move towards the spike for piercing.

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

[0236] It should be understood that the container holding mechanism can engage with different parts of the container. For example, in some embodiments, the container holding mechanism can engage with the side wall, shoulder, neck, crimp, and / or any other suitable part of the container body.

[0237] The attachment of the ring to the housing is described herein. As seen in FIG. 46, the ring 740 may include a plurality of radially extending extensions 742, each of which may include a recess 743. As seen in FIGS. 45, 47, and 48, the upper portion 821 of the housing includes a plurality of protrusions 745 shaped to conform to the shape of the recesses of the ring. In the exemplary embodiments of the figures, the recesses and protrusions are semi-elliptical. The ring is attached to the upper portion of the housing by fitting the protrusions of the upper portion 821 into the recesses of the ring. In some embodiments, additional holding reinforcement, such as an adhesive or fastener, can be used to reinforce the attachment. However, in other embodiments, the ring is simply held to the upper portion of the housing by 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 upper portion of the housing and the protrusions are located on the ring. Further, although the protrusions and recesses shown in the figures are semi-elliptical, it should be understood that they may be hemispherical, prismatic, conical, frustoconical, trapezoidal prismatic, or any other suitable shape.

[0238] In some embodiments, the attachment of the ring to the housing may be achieved by an adhesive, fastener, and / or other attachment arrangement, as an alternative to or in addition to the mating arrangement of the protrusions and recesses described above.

[0239] It should be understood that the ring can be omitted in some embodiments. In some embodiments, an adhesive, fastener, or other attachment arrangement can be used to hold the container(s) to the housing.

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

[0241] In the exemplary embodiments shown in FIGS. 47-49, the reconfiguration device includes a plurality of arms 456 extending from an upper portion 821 of the housing. As shown in FIG. 49, which is a perspective cross-sectional view showing a portion of containers 300, 350 received in the upper portion 821 of the housing, the plurality of arms 456 surround the containers 300, 350. The plurality of arms 456 are disposed radially outside the containers and receive the bottom ends of the containers.

[0242] In some embodiments, the reconfiguration device may include a platform that abuts against the bottom end of the container. The platform serves to fill the gap between the housing and the container and can prevent the container from moving within the housing before operation, for example during transportation.

[0243] In the exemplary embodiments shown in FIGS. 47-48, the reconfiguration device includes platforms 450, 451 configured to abut against the bottom ends of the containers. In the exemplary embodiments, the platforms are arcuate. However, in other embodiments, the platforms may be circular, elliptical, square, dome-shaped, or any other suitable shape. The platforms may be made of foam, elastomer, silicone, or other suitable materials.

[0244] In some embodiments, the reconfiguration device may have a modular design that allows for accommodation of different container sizes within the same housing. For example, platforms 450, 451 may be interchangeable with platforms of other heights and / or radii of curvature to accommodate various container sizes. For example, by using a platform of a greater height, a shorter container can still be used within the same housing. Similarly, the plurality of arms 456 may be interchangeable with other arms, e.g., arms arranged at different distances to accommodate containers of different diameters. In some embodiments, the plurality of arms and / or the platform may be pre-formed or otherwise pre-attached to a plate that can be attached inside the upper portion 821 of the housing. Plates having different combinations of arms and / or platforms are manufactured to accommodate various container sizes and shapes. The upper portion of the housing can be configured to attach to any of these plates, thus enabling the housing to have a modular design that can accommodate containers of different sizes using the same housing. Further, rings 740, 750 can also be interchanged with rings of different inner diameters to accommodate different container sizes.

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

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

[0247] FIG. 50A is an exploded plan view of another embodiment of the transfer engine 3400. According to the embodiment of FIG. 50A, the transfer engine is modular, whereby the number of fluid connections of the transfer engine can be increased or decreased to attach a desired number of containers. In the configuration shown in FIG. 50A, the transfer engine is configured to fit three containers. 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 that may include a hydrophobic filter or a check valve in some embodiments. The second inlet spike channel is connected to an inlet adapter fluid channel 3410 and allows fluid to flow out of the connected container and out of the inlet adapter. In a particular embodiment of FIG. 50A, the inlet adapter fluid channel 3410 terminates at an inlet fluid connector 3412 configured to receive a tube in the illustrated embodiment. Of course, in other embodiments, the present disclosure is not so limited and other fluid connectors can be used. Due to the fluid arrangement of the inlet adapter 3402, when the inlet spike punctures the inlet container and fluid flows out of the inlet adapter fluid channel 3410, air can be introduced into the container through the first inlet spike channel 3406. In some embodiments, the inlet adapter 3402 may include a check valve configured to allow a one-way flow out of the spike and through the inlet adapter fluid channel 3410. Such an arrangement can ensure that fluid does not flow through the first inlet spike channel 3406 and towards the air inlet.

[0248] According to the embodiment of FIG. 50A, the inlet adapter 3402 includes an inlet adapter coupling 3414 configured to enable the inlet adapter to be releasably attached to another adapter (e.g., the 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, and the pocket 3418 is configured to receive a first intermediate adapter coupling 3435 having a corresponding shape. As 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 be unable to move relative to each other in a first direction. In a particular example of FIG. 50A, when releasably coupled, the intermediate adapter and the inlet adapter can resist relative movement with respect to each other 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), enabling the adapters to be released from each other. According to the embodiment of FIG. 50A, the inlet adapter coupling is symmetric. In other embodiments, the inlet adapter may have an irregular shape, or may have any suitable shape to enable the adapters to interlock, as the present 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 by a corresponding coupling. In the embodiment of FIG. 50A, the inlet adapter coupling is separated and spaced from the inlet adapter fluid channel 3410, whereby the physical and fluid connections are separated. Such an arrangement can be beneficial for manufacturing simplicity and connection reliability.

[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 the collar 3416 of the inlet adapter coupling 3414. Similarly, the tab is configured to engage 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 be securely interlocked with each other. 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 coupling of a corresponding shape (e.g., the outlet adapter coupling 3456). In the embodiment of FIG. 50A, the first intermediate adapter coupling and the second intermediate adapter coupling 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 other copies of the intermediate adapter. That is, another intermediate adapter may be exchanged with the intermediate adapter 3420, or the transfer engine 3400 may be extended using another intermediate adapter (e.g., see the exemplary embodiment of FIG. 52). The first intermediate adapter coupling (such as the first intermediate adapter coupling 3435) may be received in the second intermediate adapter coupling 3438. Thus, the desired number of intermediate adapters can be added to expand the number of spikes to accommodate the desired number of containers that can ultimately deliver the drug solution to the patient.

[0250] As shown in FIG. 50A, the intermediate adapter 3420 includes an intermediate spike 3422 configured to pierce an 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 at an intermediate fluid connector 3430 (e.g., a tube 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 at an intermediate fluid connector 3434 (e.g., a tube 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 to the inlet adapter fluid channel 3410 (e.g., via a tube). The second intermediate fluid channel is configured to be connected to the outlet adapter fluid channel 3448. Thus, the intermediate adapter is configured to form a flow 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 that includes 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 at an outlet fluid connector 3450 (e.g., a tube 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 that may allow fluid from the transfer engine 3400 to ultimately flow to a patient. In other embodiments, since the present disclosure is not so limited, an infusion set or other delivery device can be directly connected to the outlet 3452.

[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 within a 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 be received within the inlet adapter coupling 3414 to removably attach the outlet adapter to the inlet adapter. Such an arrangement is beneficial when only two containers are connected to the transfer engine such 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 within the inlet adapter coupling 3414. Thus, the collar 3416 engages the neck 3436 and the pocket 3418 engages 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 within the second intermediate adapter coupling 3438, whereby the intermediate adapter and the outlet adapter 3440 are releasably connected. Thus, the inlet adapter, the intermediate adapter, and the outlet adapter are all physically connected to each other via couplings.

[0254] Separate from the physical connection of the coupling, the adapter is 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 such that fluid can be delivered to the 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 the first tube 3460. The first tube is connected to the inlet fluid connector 3412 and the first intermediate fluid connector 3430. The outlet adapter fluid channel 3448 is connected to the second intermediate fluid channel 3432 using the second tube 3462. The second tube is connected to the outlet fluid connector 3450 and the second intermediate fluid connector 3434. Thus, the inlet adapter, the intermediate adapter, and the outlet adapter are fluidly connected in series arrangement. In some embodiments, the fluid connectors may be quick connect tube connectors. In some embodiments, the adapter may include an integral tube configured to interconnect the tubes of other adapters. In such embodiments, quick connect fittings or other fittings can be used. In other embodiments, since the present disclosure is not so limited, any suitable connector can be used to fluidly connect the adapters.

[0255] Note that while tubes and tube connectors are used in the embodiment of FIG. 50B, any suitable flow path can be used to fluidly interconnect the various adapters. For example, the tubes interconnecting the adapters may be rigid tubes or flexible tubes. Further, in some embodiments, the adapter may include an integral fluid connector and path separated from the coupling to enable fluid connection without additional components such as tubes.

[0256] In some embodiments, the transfer engines of FIGS. 50A-50B may be used for reconfiguration or pooling. In some embodiments, the intermediate adapter and / or the outlet adapter may be configured to receive and connect a container that houses a solid pharmaceutical (e.g., a lyophilized solid). In other embodiments, the intermediate adapter and / or the outlet adapter may be configured to receive and connect a container that houses a pharmaceutical solution. Since the present disclosure is not so limited, any number of containers that house solid pharmaceuticals or pharmaceutical solutions can be used with the transfer engines according to the embodiments described herein.

[0257] The spike channel and the fluid channel are separately described and labeled in the embodiments of FIGS. 50A-50B, but it should be noted that in other embodiments, the spike channel and the fluid channel can be regarded as a single component. For example, the adapter may be shaped such that the fluid channel forms the spike channel.

[0258] As described above, the modular transfer engines of FIGS. 50A-50B can be configured in a wide array of different shapes to accommodate any desired number of containers. For example, in some embodiments, the inlet adapter and the 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, the inlet adapter and the 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). Thus, the number of adapters may be expanded or contracted as desired for any number of containers including, but not limited to, two, three, four, five, six, seven, and eight containers.

[0259] 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, but 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 stated, the intermediate adapter coupling or the outlet adapter coupling can be configured as a socket configured to receive a protruding inlet adapter coupling. In some embodiments, the adapter coupling may include a socket portion and a protruding portion, whereby the coupling receives the corresponding protruding portion of another coupling and is also received in the corresponding socket portion of another coupling. Accordingly, since the present disclosure is not so limited, any suitable coupling can be used that physically connects the adapters to each other for any of the embodiments described herein.

[0260] FIG. 51 is a schematic view of one embodiment of a transfer engine adapter coupling showing an exemplary mating engagement for securing together the adapters of a transfer engine. 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 within 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 match the shape and size of the second coupling. The tab 3554 is configured to be received within 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 a width smaller than the width 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 (e.g., within 1% of the pocket width) than 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 (e.g., within 1% of the collar width) than 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., the collar width B is smaller than the pocket width A). Similarly, the tab width C is larger than the neck width D (i.e., the neck width D is smaller than the tab width C). Thus, when the second coupling is received within the first coupling, the couplings cannot move relative to each other in a plane (e.g., the x-y plane). However, in the illustrated embodiment, the couplings can move relative to each other in a second direction perpendicular to the plane (e.g., the z direction). In other embodiments, the couplings can be prevented from moving relative to each other in a first direction and enabled to move relative to each other in a second direction. In some embodiments, the second direction may be transverse (e.g., perpendicular) to the first direction.

[0261] An embodiment of the coupling is shown in FIG. 51, and it should be noted that in other embodiments, other couplings can be used. For example, the coupling pair used to physically connect a plurality of adapters may be a dovetail and a dovetail groove, a T-slot and a T-slot adapter, or any other suitable coupling. In some embodiments, the coupling may include a poka-yoke tab configured to assist the user in aligning and connecting a plurality of adapters. In some embodiments, the coupling can have a shape configured to control the directionality of the transfer engine formed by the plurality of 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 the 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 is added to enable the transfer engine to connect to four containers. 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 at intermediate fluid connectors 3612, 3616 (e.g., tube 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 FIG. 52, the fluid connection between the adapters is made using tubes, similar to FIG. 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 previously described with reference to FIGS. 50A - 50B, in FIG. 52, the physical connection between the adapters via the coupling is separated from and / or spaced apart from the fluid connection between the adapters.

[0264] In the embodiment of FIG. 52, various adapters are fluidly connected and physically connected in a series arrangement. In other embodiments, the adapters may be fluidly connected or physically connected in a parallel arrangement. For example, in some embodiments, an inlet adapter, a first intermediate adapter, and a second intermediate adapter may all be fluidly connected to an outlet adapter. For example, the tubes from each of the inlet adapter, the first intermediate adapter, and the second intermediate adapter can be joined 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 where one or more fluid channels are configured as inlets, the fluid channels may include check valves configured to allow air to flow 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 air to flow 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 flow into the channels but do not allow fluid to flow out of the channels. Of course, since the present disclosure is not so limited, any suitable parallel, series, or combination of parallel and series fluid configurations can be used to deliver the chemical solution from the transfer engine. An additional example of a fluid configuration having a combination of parallel and series flow paths is described with reference to the exemplary embodiment of FIG. 53.

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

[0266] FIG. 53 is a plan view of another embodiment of a transfer engine 3700 that includes a plurality of intermediate couplings configured to expand the container capacity 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 configurations described with reference to the embodiments 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 intermediate adapter and the second intermediate adapter are mirror images of each other (e.g., across the y-axis) and are generally configured to provide two spikes in the space of a single intermediate adapter as shown and described with reference to FIGS. 50A-50B. The first and second intermediate adapters are configured to be releasably attached to the inlet adapter and the outlet adapter simultaneously.

[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 each terminate at intermediate fluid connectors 3712, 3716. 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, whereby the first intermediate adapter coupling occupies at least a portion (e.g., half) of the inlet adapter coupling. The second intermediate adapter coupling 3719 receives the outlet adapter coupling 3456. Similar to 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 (e.g., half) of the outlet adapter coupling. Of course, in other embodiments, since the present disclosure is not so limited, the first intermediate adapter coupling and the second intermediate adapter coupling can engage any portion of the corresponding coupling.

[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 intermediate fluid connectors 3732, 3736 (e.g., tube connectors). 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 particular embodiment of FIG. 53, engages at least a portion (e.g., half) of the inlet adapter coupling. The fourth intermediate adapter coupling receives the outlet adapter coupling 3456 and, in the particular embodiment of FIG. 53, receives at least a portion (e.g., half) of the outlet adapter coupling. Thus, both the first intermediate adapter and the second intermediate adapter connect to and releasably interlock with the inlet adapter and the outlet adapter simultaneously.

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

[0270] In the embodiment of FIG. 53, Y-junctions are used to interconnect the various adapters, but in other embodiments, the adapters can include multiple fluid channels or an integral fluid junction to facilitate the parallel connection of multiple intermediate adapters. For example, the inlet adapter includes a plurality of fluid connectors (e.g., two tube connectors) such that the inlet adapter can accommodate a plurality of tubes, and both fluid connectors are fluidly connected to the inlet adapter fluid channel. Thus, the inlet adapter includes an internal Y-junction, whereby the inlet adapter can be interconnected to the two intermediate adapters using a direct tube without a Y-junction. Similarly, the outlet adapter also includes a plurality of fluid connectors (e.g., two tube connectors) such that the outlet adapter can accommodate a plurality of tubes, and both fluid connectors are fluidly connected to the outlet adapter fluid channel. The inlet adapter and the outlet adapter 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 present disclosure is not so limited.

[0271] FIG. 54 is a plan view of another embodiment of a transfer engine 3800 showing an alternative layout of the adapter. In some cases, it may be desirable to reduce the footprint of the adapter for a given number of containers, or otherwise it may be desirable to reduce the specific dimensions of the transfer engine. For example, in the embodiment of FIG. 54 discussed above, the transfer engine is arranged linearly, which reduces the overall width of the transfer engine by giving it a longer length. However, to reduce the overall maximum dimension (e.g., width or length), the adapter can be arranged in a zigzag pattern as shown in FIG. 54. In the embodiment of FIG. 4, the fluid arrangement is the same as 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 adapter and the outlet adapter are arranged in the same manner as in FIGS. 50A - 50B. Similarly, the fluid arrangements of the first intermediate adapter and the second intermediate adapter are the same as those of FIG. 52. However, in contrast to the embodiment of FIG. 52, the intermediate adapter couplings are angled with respect to each other, 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 by 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 with respect to each other. The first intermediate adapter coupling is aligned with a first axis E-E, and the second intermediate adapter coupling is aligned with a second axis F-F. The axis E-E and the axis F-F are inclined at an angle α with respect to each other. In the embodiment of FIG. 54, the angle between the first intermediate adapter coupling and the second intermediate adapter coupling is 90 degrees (e.g., α = 90 degrees), whereby the couplings are orthogonal to each other. In other embodiments, the intermediate couplings may be inclined at an acute angle with respect to each other (e.g., α < 90 degrees). In still other embodiments, the intermediate couplings may be inclined at an obtuse angle with respect to each other (e.g., α > 90 degrees). In the embodiment of FIG. 54, the third intermediate adapter coupling and the fourth intermediate adapter coupling are angled with respect to each other 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 angle between the third and fourth intermediate adapter couplings.

[0273] FIG. 55 is a side view of another embodiment of the chemical 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 series fluid arrangement via a first tube 4416 and a second tube 4418. All of the adapters are disposed in the 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 integrally formed with the lower portion 4402 or formed as a separate component. As shown in FIG. 55, the adapter plate 4404 includes a plurality of depressions 4406 formed by studs 4408. The depressions and studs are sized and shaped to receive the adapters and prevent relative movement therebetween. The studs 4408 engage (e.g., by interference fit) with a first adapter base 4411, a second adapter base 4413, and a third adapter base 4415 to prevent relative movement between the adapters. In some embodiments shown in FIG. 55, the studs are configured to engage the sides of the adapter bases. In this way, the bases of the adapters are releasably connected to each other via the adapter plate 4404 and are couplings that cannot move relative to each other in a first direction (e.g., the x-y plane). Of course, in the embodiment of FIG. 55, the studs 4408 engage the sides of the adapter bases, but in other embodiments, the studs may engage any suitable portion of the adapter. For example, in some embodiments, the adapter bases can include adapter depressions (e.g., grooves) configured to receive the studs. In some embodiments, the adapter bases may include studs configured to be received in the depressions of the adapter plate. Of course, the present disclosure is not so limited, and any suitable number of studs and depressions may be used as couplings on the adapter bases and adapter plates to enable the plurality of adapters to be releasably connected to each other.Furthermore, while the embodiment of FIG. 55 includes three adapters, any suitable number of adapters can be used in an arrangement similar to that of FIG. 55. Similarly, while the embodiment of FIG. 55 includes adapters in a series arrangement, the present disclosure is not so limited, and any suitable fluid or physical arrangement can be used (e.g., matrix, zigzag, etc.).

[0274] FIG. 56 is a side view of another embodiment of the liquid 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 portion 4502 of the housing. According to the embodiment of FIG. 56, the lower portion of the housing is configured to form an interference fit with the adapters. In the illustrated embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. Next, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 prevents relative movement between the adapters through clamping and friction. In the configuration shown in FIG. 56, the adapters may not be able to move relative to each other 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, whereby the adapters 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 portion 4502 of the housing to function as a coupling between the adapters. In some embodiments shown in FIG. 56, the lower portion 4502 includes a lead-in 4504 configured to guide the adapters to a predetermined position and facilitate the formation of an interference fit between the lower portion and the adapters 4510, 4512, 4514. Of course, since the present disclosure is not so limited, any suitable configuration having an interference fit, including embodiments without a lead-in, may be used for the lower portion. Further, although the embodiment of FIG. 56 includes three adapters, any suitable number of adapters may be used in an arrangement similar to FIG. 56.Similarly, the embodiment of FIG. 55 includes an adapter in a serial physical arrangement, but the present disclosure is not so limited and any suitable physical arrangement can be used (e.g., matrix, zigzag, etc.).

[0275] FIG. 57 is a schematic plan view of another embodiment of the transfer engine 4600. In the embodiment of FIG. 57, "I" is the inlet adapter, "M" is the intermediate adapter, "O" is the outlet adapter, and is described in accordance with the exemplary embodiments described herein. The arrows indicate the flow paths between the adapters. The relative arrangement 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 positions shown in FIG. 57. In the embodiment of FIG. 57, the physical arrangement is zigzag, similar to that shown in FIG. 54. Further, the adapters are fluid-connected in a series fluid arrangement, and the fluid flows sequentially from the inlet adapter, through the two intermediate adapters, to the outlet adapter, and the chemical solution can be delivered to the user via a suitable delivery device.

[0276] FIG. 58 is a schematic plan view of another embodiment of the transfer engine 4700. In the embodiment of FIG. 58, "I" is the inlet adapter, "M" is the intermediate adapter, "O" is the outlet adapter, and is described in accordance with the exemplary embodiments described herein. The arrows indicate the flow paths between the adapters. The relative arrangement 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 positions shown in FIG. 58. In the embodiment of FIG. 58, the physical arrangement is a diamond matrix. Further, the adapters are fluid-connected in a parallel fluid arrangement, and the fluid flows individually from the inlet adapter and the two intermediate adapters to the outlet adapter. The resulting chemical solution can be delivered to the user from the outlet adapter via a suitable delivery device.

[0277] Figure 59 is a schematic plan view of another embodiment of the transfer engine 4800. In the embodiment of Figure 59, "I" is the inlet adapter, "M" is the intermediate adapter, and "O" is the outlet adapter, which is described according to the exemplary embodiments described herein. The arrows indicate the flow paths between the adapters. The relative arrangement 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 positions shown in Figure 59. In the embodiment of Figure 59, the physical arrangement is a diamond matrix. Further, the adapters are fluidly connected in a fluid arrangement that is partially parallel and partially in series. Specifically, the fluid flows individually from two inlet adapters to one intermediate adapter. Then, the fluid flows from the intermediate adapter to the outlet adapter. The resulting chemical solution can be delivered to the user from the outlet adapter via a suitable delivery device.

[0278] Figure 60 is a schematic plan view of another embodiment of the transfer engine 4900. In the embodiment of Figure 60, "I" is the inlet adapter, "M" is the intermediate adapter, and "O" is the outlet adapter, which is described according to the exemplary embodiments described herein. The arrows indicate the flow paths between the adapters. The relative arrangement 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 positions shown in Figure 60. In the embodiment of Figure 60, the physical arrangement is a square matrix. Further, the adapters are fluidly connected in a series fluid arrangement as shown in Figure 57. Specifically, the fluid sequentially flows from the inlet adapter through two intermediate adapters to the outlet adapter. The resulting chemical solution can be delivered to the user from the outlet adapter via a suitable delivery device.

[0279] The exemplary embodiments described herein are arranged in linear, inclined, and matrix patterns, but the present disclosure is not so limited, so in other embodiments, the transfer engines may be arranged in a square matrix, hexagonal pattern, or any other suitable geometric pattern. In some embodiments, the adapter may include any number of couplings such that a plurality of transfer engines can 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, and the first and second inlet adapter couplings are each configured to connect to a separate intermediate adapter coupling in a parallel configuration. Such an arrangement can provide a fluid arrangement similar to the embodiment of FIG. 53, but other fluid configurations are contemplated. In some embodiments, the outlet adapter may include a first outlet adapter coupling and a second outlet adapter coupling, and the first and second outlet adapter couplings are each configured to connect to a separate intermediate adapter coupling in a parallel configuration.

[0280] FIG. 61A is a front side schematic view of another embodiment of the chemical solution delivery device 3900 in a first state, and FIG. 61B shows the chemical solution 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 the non-operating position shown in FIG. 61A and the operating position shown in FIG. 61B. As in some of the foregoing embodiments, the upper portion is configured to slide along an inner guide 3912. The upper portion includes a fluid outlet notch 3904 configured to expose a fluid outlet and enable physical access to the fluid outlet when the upper portion moves to the operating position. In the embodiment of FIGS. 61A-61B, the notch 3904 is configured to align with the fluid outlet 3914 when the upper portion is in the operating position. Of course, any arrangement for selectively enabling access to the fluid outlet can 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 present 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 embodiments of FIGS. 61A-61B, the marker is a QR code (registered trademark) 3916 disposed at the lower portion 3910 of the housing. In some embodiments, as shown in FIGS. 61A-61B, the QR code (registered trademark) is at least partially obstructed by the upper portion when the upper portion is in the non-operating position. Specifically, since the opaque portion of the upper portion hides the marker, the QR code (registered trademark) is hidden and not visible when the upper portion is in the non-operating position. However, in the operating position, the marker window 3906 formed in the upper portion aligns with the QR code (registered trademark) to expose the QR code (registered trademark) to the user, making the QR code (registered trademark) accessible. Thus, when the medicament delivery device is activated, the user can scan the QR code (registered trademark) using the remote device. The QR code (registered trademark) can relay information such as dosage, drug lot information, etc. to the remote device when scanned. That is, the QR code (registered trademark) can contain information readable by the remote device. In some embodiments, the marker window 3906 may be formed as a hole in the upper portion. In some embodiments, the marker window 3906 may be a transparent portion of the upper portion configured to align with the marker when the upper portion is in the operating position. Of course, since the present disclosure is not so limited, the QR code (registered trademark) can be made accessible to the user in any suitable configuration. For example, in some embodiments, the upper portion can cover at least a portion of the marker in the non-operating position and expose the marker without a window in the operating position. The configuration of FIGS. 61A-61B can enable the transfer of information to the remote device without a power source mounted on the pairing or medicament delivery device.

[0282] FIG. 62A is a front side schematic view of another embodiment of the chemical solution delivery device 4000 in the first state, and FIG. 62B shows the chemical solution delivery device in the 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 the non-operating position shown in FIG. 62A and the operating position shown in FIG. 62B. As in the foregoing embodiments, the upper portion is configured to slide along the inner guide 4012. The upper portion includes a fluid outlet notch 4004 configured to expose a fluid outlet and enable physical access to the fluid outlet when the upper portion moves to the operating position. In the embodiment of FIGS. 62A-62B, the notch 4004 is configured to align with the fluid outlet 4014 when the upper portion is in the operating position. Of course, any configuration for selectively enabling access to the fluid outlet can be used in accordance with other exemplary embodiments described herein.

[0283] The embodiments of FIGS. 62A-62B include a marker configured to selectively communicate information to a remote device. In the embodiments 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 non-operating position. However, in the operating position, a marker window 4006 formed in the upper portion aligns with the NFC tag, exposing the NFC tag to the user and making the NFC tag accessible. In some embodiments, the upper portion may be formed of an NFC signal impedance or other radio frequency (RF) shield such that the NFC tag is at least partially blocked by the upper portion when the upper portion is in the non-operating position. According to such embodiments, the NFC tag may not be activated by the remote device until it aligns with a window through which the NFC tag may be radio-transparent. In other embodiments, the visual indicator of the location where the user can read the NFC tag may be at least partially blocked by the upper portion in the non-operating position. According to such embodiments, the window can reveal the visual indicator of the location where the user can read the NFC tag. Thus, when the medicament delivery device is activated, the user can scan the NFC tag using a remote device. The NFC tag can relay information such as dosage, drug lot information, etc. to the remote device. In some embodiments, the marker window 4006 can be formed as a hole in the upper portion. In some embodiments, the marker window 4006 may be a radio-transparent portion of the upper portion 4002. Of course, since the present disclosure is not so limited, the NFC tag can be made accessible to the user in any suitable arrangement. The arrangement of FIGS. 62A-62B can enable information to be transferred to the remote device without a power source mounted on the medicament delivery device since the NFC tag can be wirelessly powered by the remote device.

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

[0285] FIG. 64A is a front side schematic view of another embodiment of a chemical solution delivery device 4200 including a communication module in a first state, and FIG. 64B shows the chemical solution delivery device of FIG. 64A in a second state. According to the embodiments of FIGS. 64A-64B and similar to the foregoing 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 a non-operating position shown in FIG. 64A and an operating position shown in FIG. 64B. Similar to the foregoing embodiments, the upper portion is configured to slide along an inner guide 4212. The upper portion includes a fluid outlet notch 4204 configured to expose a fluid outlet and enable physical access to the fluid outlet when the upper portion moves to the operating position. In the embodiments of FIGS. 64A-64B, the notch 4204 is configured to align with a fluid outlet 4214 when the upper portion is in the operating position. Of course, any arrangement for selectively enabling access to the fluid outlet may be used in accordance with other exemplary embodiments described herein.

[0286] The embodiments of FIGS. 64A-64B include a communication module 4230 and are configured to communicate with one or more remote devices (e.g., user devices). The communication and related functions are the same as those described with reference to the embodiment of FIG. 18. The communication module will be further described with reference to FIG. 65. According to the embodiments of FIGS. 64A-64B, the communication module can be easily attached to the lower part 4210. The communication module may be self-contained, whereby the liquid drug delivery device can easily communicate with the remote device when paired with a trigger.

[0287] According to the embodiments of FIGS. 64A-64B, the drug delivery device 4200 includes a trigger configured to activate the communication module 4230. Two examples of the trigger are shown in the embodiments of FIGS. 64A-64B, and these can be used alone in other embodiments. First, the device includes a switch 4224 (e.g., a microswitch) configured to engage an engagement portion 4203 of the upper portion 4202 of the housing. The engagement portion 4203 of FIGS. 64A-64B is a lip, but in other embodiments, the engagement portion may be a housing wall, an internal protrusion or mechanism, or any other suitable mechanism of the upper portion 4202 of the housing. The switch is configured to be activated (e.g., depressed) when the upper portion is moved to the activated 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 on 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, and the light beam transmitter is configured to emit a light beam 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 operating. In some embodiments, the trigger of the drug 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. Although two examples of the trigger are shown in FIGS. 64A-64B, the present disclosure is not so limited, and any suitable sensor can be used to activate the communication module. For example, a strain gauge or other pressure sensor can be disposed on the upper portion and configured to detect a force or pressure applied to the upper portion by the user. When the detected force or pressure exceeds a threshold force or pressure, the communication module can be activated.As another example, as previously described with reference to other exemplary embodiments of the present specification, a Hall effect sensor can be used to detect the upward movement to the operating position and activate the communication module. As yet another example, a proximity sensor can be used to detect the upward movement to the operating position and activate the communication module.

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

[0289] In some embodiments, the communication module can include additional components that can provide additional functionality to facilitate the use of the medical delivery device. For example, in some embodiments, the communication 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 of the medical fluid delivery device. In some embodiments, the vibration motor may be configured to provide a tactile warning to the user, as described with reference to other embodiments herein. As another example, in some embodiments, the communication module may include a speaker. In some embodiments, the speaker may be configured to provide an audible warning to the user, as described with reference to other embodiments herein.

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

[0291] While some of the above embodiments show a reconstitution device, in other embodiments, devices similar to these embodiments may be a medicament delivery device configured to pool a medicament solution, as opposed to reconstituting a solid medicament, or may be configured to access only the contents of a single container. It should be noted that, accordingly, the various mechanisms and methods described with reference to these embodiments are applicable to medicament delivery devices configured to pool a fluid or to access only the contents of a single container, as the present 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 medicament 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 medicament delivery or reconstitution devices having any number of containers, as the present disclosure is not so limited.

[0293] The present teachings have been described in connection with various embodiments and examples, but the present teachings are not intended to be limited to such embodiments. On the contrary, the present teachings include various alternatives, modifications, and equivalents, as would be understood by those skilled in the art. Accordingly, the foregoing description and drawings are for illustrative purposes only.

Claims

**Claim 1**: A housing having a lower part and an upper part that movably engages with the lower part, wherein the upper part is movable relative to the lower part between a non-operating position and an operating position, and the housing; A transfer engine disposed within the lower part of the housing, with a first container receiving end and a second container receiving end facing towards the upper part of the housing; A fluid outlet in fluid communication with the second container receiving end of the transfer engine; Comprising; The upper part is configured to engage with a first container and a second container when the upper part moves from the non-operating position to the operating position, whereby the first container and the second container move towards the first container receiving end and the second container receiving end respectively; A reconfiguration device in which, when the upper part is in the non-operating position, physical access to the fluid outlet is at least partially blocked, and when the upper part is in the operating position, physical access to the fluid outlet is permitted. **Claim 2**: The reconfiguration device according to claim 1, wherein the upper part includes a notch, and when the upper part is in the non-operating position, the upper part at least partially surrounds the fluid outlet within the housing, and when the upper part is in the operating position, the notch exposes the fluid outlet. **Claim 3**: The reconfiguration device according to claim 2, wherein the lower part has a fluid outlet receptacle, the fluid outlet is disposed within the fluid outlet receptacle, and moving the upper part to the operating position aligns the notch with the fluid outlet receptacle and exposes the fluid outlet. **Claim 4**: The reconfiguration device according to any one of claims 1 to 3, further comprising a flexible leash connected to the fluid outlet. **Claim 5**: The reconfiguration device according to any one of claims 1 to 3, wherein when the upper part is in the operating position, the fluid outlet is fixed relative to the lower part of the housing. **Claim 6**: The reconfiguration device according to any one of claims 1 to 3, wherein when the upper part is in the operating position, the fluid outlet is movable relative to the lower part of the housing. **Claim 7**: The reconfiguration device according to claim 6, wherein the fluid outlet is connected to the second container receiving end by a flexible tube. **Claim 8**: The reconfiguration device according to claim 6, further comprising a clip attached to the fluid outlet and connected to the lower part of the housing when the upper part is in the non-operating position, for holding the fluid outlet to the housing. **Claim 9**: The reconfiguration device according to claim 8, wherein when the upper part is in the operating position, the clip is removable from the lower part of the housing, enabling movement of the fluid outlet relative to the housing. **Claim 10**: The reconfiguration device according to claim 8, further comprising a cap covering at least a portion of the fluid outlet, wherein the holding force of the clip on the housing is less than the holding force of the cap on the fluid outlet. **Claim 11**: The reconfiguration device according to claim 8, wherein the lower part of the housing includes a slot for receiving at least a portion of the clip to hold the fluid outlet to the housing when the upper part is in the non-operating position. **Claim 12**: The reconfiguration device according to claim 8, further comprising a second clip. **Claim 13**: The reconfiguration device according to any one of claims 1 - 4 or 6 - 12, wherein the fluid outlet is movable relative to the transfer engine. **Claim 14**: The reconfiguration device according to any one of claims 1 - 13, wherein the upper part includes a curved surface extending in a direction away from the lower part. **Claim 15**: The reconfiguration device according to any one of claims 1 - 14, wherein the lower part includes a flat surface on the side opposite to the upper part. **Claim 16**: The reconfiguration device according to any one of claims 1 - 15, further comprising a warning module configured to warn the user when the upper part moves from the non-operating position to the operating position. **Claim 17**: The reconfiguration device according to claim 16, wherein the warning module is configured to provide a visual warning, an audible warning, and / or a tactile warning. **Claim 18**: The reconfiguration device according to claim 16, wherein the warning module transmits a warning message by wireless communication. **Claim 19**: The reconfiguration device according to any one of claims 1 - 18, wherein the upper part includes at least one window configured such that the user can see at least one of the first container and the second container.

20. The reconfiguration device according to any one of claims 1 to 19, wherein the first container receiving end is configured as a first spike, and the second container receiving end is configured as a second spike.

21. The reconfiguration device according to claim 20, wherein the first spike and the second spike are each a dual lumen spike.

22. The reconfiguration device according to claim 20, wherein the second spike includes at least one open end of a flow path inclined at an angle with respect to the puncture direction of the second spike.

23. The reconfiguration device according to claim 22, wherein the angle is about 90 degrees.

24. The reconfiguration device according to claim 20, wherein the transfer engine includes an inlet configured to admit air into the transfer engine.

25. The reconfiguration device according to claim 24, wherein the inlet is configured as a hydrophobic filter.

26. The reconfiguration device according to any one of claims 1 to 25, wherein the fluid outlet is a Luer activated valve or a Luer.

27. The reconfiguration device according to any one of claims 1 to 26, wherein the first container receiving end is in fluid communication with the second container receiving end in one direction.

28. The reconfiguration device according to any one of claims 1 to 26, wherein the upper portion is slidably engaged with the lower portion.

29. The reconfiguration device according to any one of claims 1 to 28, wherein the upper portion includes at least one upper retaining mechanism, the lower portion includes at least one lower retaining mechanism, and the upper retaining mechanism and the lower retaining mechanism are configured to engage with each other to hold the upper portion in the operating position.

30. The reconfiguration device according to any one of claims 1 to 28, wherein the fluid outlet is releasably held within the housing until a delivery device is coupled to the fluid outlet.

31. The reconfiguration device according to claim 30, wherein the fluid outlet is rigidly attached to the housing until a 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.

32. A housing having a lower portion and an upper portion movably engaged with the lower portion, the upper portion being movable relative to the lower portion between a non-operating position and an operating position, A transfer engine disposed within the lower portion of the housing, the first container receiving end facing towards the upper portion of the housing, and the transfer engine; A fluid outlet in fluid communication with the transfer engine; Comprising: The upper portion is configured to engage with a first container, such that when the upper portion moves from the non-operating position to the operating position, the first container moves towards the first container receiving end; When the upper portion is in the non-operating position, physical access to the fluid outlet is at least partially obstructed, and when the upper portion is in the operating position, physical access to the fluid outlet is permitted, a chemical solution delivery device. **Claim 33**: The chemical solution delivery device according to claim 32, wherein the upper portion includes a notch, and when the upper portion is in the non-operating position, the upper portion at least partially surrounds the fluid outlet within the housing, and when the upper portion is in the operating position, the notch exposes the fluid outlet. **Claim 34**: The chemical solution delivery device according to claim 33, wherein the lower portion has a fluid outlet receptacle, the fluid outlet is disposed within the fluid outlet receptacle, and moving the upper portion to the operating position aligns the notch with the fluid outlet receptacle and exposes the fluid outlet. **Claim 35**: The chemical solution delivery device according to any one of claims 32 to 34, further comprising a flexible leash connected to the fluid outlet. **Claim 36**: The chemical solution delivery device according to any one of claims 32 to 34, wherein when the upper portion is in the operating position, the fluid outlet is fixed relative to the lower portion of the housing. **Claim 37**: The chemical solution delivery device according to any one of claims 32 to 34, wherein when the upper portion is in the operating position, the fluid outlet is movable relative to the lower portion of the housing. **Claim 38**: The chemical solution delivery device according to claim 37, further comprising a clip attached to the fluid outlet and connected to the lower portion of the housing when the upper portion is in the non-operating position to hold the fluid outlet to the housing. **Claim 39**: The chemical solution delivery device according to claim 38, wherein when the upper portion is in the operating position, the clip is removable from the lower portion of the housing to enable movement of the fluid outlet relative to the housing.

40. The chemical solution delivery device according to claim 38, further comprising a cap covering at least a portion of the fluid outlet, wherein the holding force of the clip with respect to the housing is smaller than the holding force of the cap with respect to the fluid outlet.

41. The chemical solution delivery device according to claim 38, wherein the lower part of the housing includes a slot in which at least a portion of the clip is received to hold the fluid outlet in the housing when the upper part is in the non-operating position.

42. The chemical solution delivery device according to claim 38, further comprising a second clip.

43. The chemical solution delivery device according to any one of claims 32 - 35 or 37 - 42, wherein the fluid outlet is movable relative to the transfer engine.

44. The chemical solution delivery device according to any one of claims 32 - 43, comprising a curved surface extending in a direction away from the lower part to the upper part.

45. The chemical solution delivery device according to any one of claims 32 - 44, wherein the lower part includes a flat surface opposite to the upper part.

46. The chemical solution delivery device according to any one of claims 32 - 45, further comprising a warning module configured to warn a user when the upper part moves from the non-operating position to the operating position.

47. The chemical solution delivery device according to claim 46, wherein the warning module is configured to provide a visual warning, an audible warning, and / or a tactile warning.

48. The chemical solution delivery device according to claim 46, wherein the warning module transmits a warning message by wireless communication.

49. The chemical solution delivery device according to any one of claims 32 - 48, wherein the upper part includes at least one window configured such that a user can see the first container.

50. The chemical solution delivery device according to any one of claims 32 - 49, wherein the first container receiving end portion is configured as a first spike.

51. The chemical solution delivery device according to claim 50, wherein the first spike is a dual lumen spike.

52. The chemical solution delivery device according to claim 50, wherein the first spike includes at least one open end of a flow path inclined at an angle with respect to the puncture direction of the first spike.

53. The chemical solution delivery device according to claim 52, wherein the angle is about 90 degrees.

54. The chemical solution delivery device according to claim 50, wherein the transfer engine includes an inlet configured to introduce air into the transfer engine.

55. The chemical solution delivery device according to claim 54, wherein the inlet is configured as a hydrophobic filter.

56. The chemical solution delivery device according to any one of claims 32 to 55, wherein the fluid outlet is a Luer actuating valve or a Luer.

57. The chemical solution delivery device according to any one of claims 32 to 56, wherein the upper part is slidably engaged with the lower part.

58. The chemical solution delivery device according to any one of claims 32 to 57, wherein the upper part includes at least one upper holding mechanism, the lower part includes at least one lower holding mechanism, and the upper holding mechanism and the lower holding mechanism are configured to engage with each other to hold the upper part in the operating position.

59. The chemical solution delivery device according to any one of claims 32 to 57, wherein the fluid outlet is releasably held within the housing until the delivery device is connected to the fluid outlet.

60. The chemical solution delivery device according to claim 59, wherein the fluid outlet is firmly attached to the housing until the delivery device is connected to the fluid outlet, and the fluid outlet is movable relative to the housing after the delivery device is connected to the fluid outlet.

61. The chemical solution delivery device according to claim 32, wherein the upper part is configured to engage with only a single container.

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