Drug delivery devices

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 hereby incorporated by reference in its entirety.

[0002] The disclosed embodiments relate to drug delivery devices such as reconfiguration 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 and mixed with water or another reconstitution fluid prior to administration to the patient. In such cases, a predetermined amount of the drug and, often, 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, systems and methods are provided for administering a drug solution to a patient. 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 a liquid drug. In some embodiments, the reconstitution device includes a first flow path having a first open end located within a first spike and an opposite end having an air inlet. In some embodiments, the device also includes a second flow path having a second open end located within the first spike and a third open end located within the second spike. In some embodiments, a valve is located within the second flow path between the second and third open ends. In some embodiments, the third flow path includes a fourth open end located within the second spike and an opposite end having 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 drug for reconstitution). In some embodiments, the fluid outlet may include a Luer lock valve, thereby allowing a syringe to be fluid-connected to the fluid outlet and the reconstituted drug solution to be drawn from the device. In some embodiments, the container containing the powdered drug may be configured to include a low-pressure or zero-pressure vacuum, thereby allowing sterile water or another fluid from another container to be forced into the drug-containing container without manual pressure or pumping. In some embodiments, the pressure difference between the drug-containing container and the fluid-containing container is large enough to allow the fluid from the fluid-containing container to be discharged into the drug-containing container, thereby allowing the drug to be agitated and reconstituted.

[0006] In some embodiments, the reconfiguration device may include a housing having an upper and a lower part, the lower part being slidably received in the upper part. In some embodiments, the upper part may be configured to hold at least two containers, and the lower part may include at least one spike for each of the at least two containers. In some embodiments, the upper part may be configured to selectively hold at least two containers at least partially, away from the spikes in the lower part. In some embodiments, the upper part may also be configured to apply force to at least two containers as the upper part slides from a first non-operating position to a second operating position. In some embodiments, as the upper part moves to the operating position, at least two containers may be punctured by the spike(s) associated with the containers. In some embodiments, the containers can be fluid-communicated once punctured, thereby allowing fluid from one container to flow into the other. In some embodiments, the first container may be under vacuum, thereby forcing fluid from the second container into the first container as a result of a pressure difference between the two containers.

[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 positioned 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, the third and fourth open ends defining a second container receiving end. The first and second container receiving ends face the same direction.

[0008] In some embodiments, the reconfiguration device includes a housing having a lower section and an upper section that slidably engages with the lower section; an upper section that is movable relative to the lower section between a non-operating position and an operating position; and a transfer engine located within the lower section of the housing, with a first container receiving end and a second container receiving end facing toward the upper section of the housing. The reconfiguration device also includes a fluid outlet that is in fluid communication with the second container receiving end of the transfer engine. The upper section engages with the first and second containers such that when the upper section moves from the non-operating position to the operating position, the first and second containers move toward the first and second container receiving ends, respectively. When the upper section is in the non-operating position, physical access to the fluid outlet is at least partially obstructed, and when the upper section 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 part and an upper part that slidably 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 reconfiguration device also includes a transfer engine located within the lower part of the housing, with a first and second container receiving end facing toward the upper part of the housing, and the transfer engine and the lower part being separate components. The reconfiguration device also includes a fluid outlet that is 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 with the first portion; first and second portions that are movable relative to each other between a non-operating configuration and an operating configuration; a first spike connected to the second portion of the housing; and a first ring connected to the first portion 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.

[0011] In some embodiments, the drug delivery device includes a housing having a lower part and an upper part that movably engages with the lower part; an upper part that is movable relative to the lower part 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 part is in the operating position; and 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.

[0012] In some embodiments, the drug delivery device includes a housing having a lower part and an upper part that movably engages with the lower part; an upper part that is movable relative to the lower part between a non-operating position and an operating position; a fluid outlet configured to deliver fluid from a container located within the housing when the upper part is in the operating position; a communication module configured to send messages via at least one communication protocol; and a trigger configured to activate the communication module when the upper part 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 puncture the inlet container and 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 medicinal solid; an intermediate spike configured to puncture the intermediate container; a first intermediate fluid channel fluidly connected to the intermediate spike and configured to fluidly connect to the inlet adapter fluid channel; a second intermediate fluid channel fluidly connected to the intermediate spike; a first intermediate adapter coupling configured to connect to the inlet adapter coupling for releasably mounting the intermediate adapter to the inlet adapter; and a second intermediate adapter coupling. The drug delivery device also includes an outlet adapter having an outlet container containing a medicinal solid; an outlet spike configured to puncture the outlet container; an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to a second intermediate fluid channel; an outlet fluidly connected to the outlet spike; and an outlet adapter coupling configured to connect to a second intermediate adapter coupling for releasably mounting 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 puncture an inlet container, an air inlet, an inlet adapter fluid channel fluid-connected to the inlet spike, and an inlet adapter coupling spaced apart from the inlet adapter fluid channel. The drug delivery device also includes an intermediate adapter having an intermediate spike configured to puncture an intermediate container, a first intermediate fluid channel fluid-connected to the intermediate spike and configured to fluid-connected to the inlet adapter fluid channel, a second intermediate fluid channel fluid-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 apart from the first and second intermediate fluid channels. The drug delivery device also includes an outlet adapter having an outlet spike configured to puncture an outlet container; an outlet adapter fluid channel fluidly connected to the outlet spike and configured to fluidly connect to a second intermediate fluid channel; an outlet fluidly connected to the outlet spike; and an outlet adapter coupling spaced apart from the outlet adapter fluid channel and configured to be received by a second intermediate adapter coupling to interlock the outlet adapter in a releasable manner to the intermediate adapter.

[0015] In some embodiments, the reconfiguration device includes a housing having a lower part and an upper part that slidably 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 drug delivery device may include a transfer engine located within the lower part of the housing, with a first container receiving end facing toward the upper part of the housing, and a fluid outlet that is in fluid communication with the transfer engine. The upper part may be configured to engage with the first container, thereby moving toward the first container receiving end when the upper part moves from a non-operating position to an operating position. Physical access to the fluid outlet may be at least partially obstructed when the upper part is in the non-operating position. When the upper part is in the operating position, physical access to the fluid outlet may be permitted.

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

[0017] This disclosure is not limited to these points, and it should be understood that the concepts described above, and any additional concepts described below, may be comprised of any suitable combination. Furthermore, other advantages and novel mechanisms of this disclosure will become apparent from the following detailed description of various non-limiting embodiments, 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 channel 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 of the second flow channel, A valve positioned 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 of the third flow path, The first container receiving end and the second container receiving end are facing the same direction. Reconfiguration device. (Item 2) The reconfiguration device according to item 1, wherein the inlet includes an air filter. (Item 3) The reconstruction 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 toward the third open end. (Item 5) The reconfiguration device according to item 1 or the preceding item, wherein the outlet is a Luer-operated valve. (Item 6) The reconfiguration device according to item 1, 2, 3, or 4, wherein the outlet is equipped with a luer. (Item 7) A reconfiguration device according to item 1 or any of the preceding items, wherein at least a portion of the first channel extends parallel to at least a portion of the second channel. (Item 8) A reconfiguration device according to item 1 or any of the preceding items, wherein at least a portion of the second channel extends parallel to at least a portion of the third channel. (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 channel extending from the first open end forms a first lumen of the first spike, and a portion of the second flow channel extending from the second open end forms a second lumen 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 channel extending from the third open end forms a first lumen of the second spike, and a portion of the third flow channel extending from the fourth open end forms a second lumen of the second spike. (Item 11) The reconstructive device according to item 10, wherein the third open end is inclined at an angle with respect to the puncture direction of the second spike. (Item 12) The reconstruction device according to item 11, wherein the angle is about 90 degrees. (Item 13) The reconstruction 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 reconstruction 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 reconstruction 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 a fluid. (Item 16) The reconstruction device according to item 15, wherein the fluid is sterile water for injection. (Item 17) The reconstruction 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 reconstruction 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 reconstruction 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 reconstruction 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 mirrored across the longitudinal axis to form the third flow path. (Item 22) A reconfiguration device according to item 1 or the preceding item, wherein the inlet is located adjacent to the outlet. (Item 23) The reconfiguration device according to item 1 or the preceding item, wherein the third channel is formed at least partially of a flexible tube. (Item 24) The reconfiguration device according to item 1 or the preceding item, wherein the outlet is movable relative to the first container receiving end and the second container receiving end. (Item 25) The reconfiguration device according to item 1 or a preceding item, further comprising a filter chamber disposed in the third flow path, wherein the first and second container receiving ends are located on the first side of the first and second flow paths, and the filter chamber is located on the second side opposite the first and second flow paths. (Item 26) A reconfiguration device according to item 1 or any of the preceding items, wherein the first flow path is located within a first housing, the third flow path is located within a second housing, and the second flow path is located at least partially within a tube extending between the first housing and the second housing. (Item 27) The reconfiguration device according to item 26, further comprising a filter chamber disposed in the third flow path, wherein the first and second container receiving ends are located on the first side of the first and second flow paths, and the filter chamber is located on the second side opposite the first and second flow paths. (Item 28) The reconstructive device according to item 26, wherein the tube is flexible. (Item 29) The reconstructive 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 mounted via an interlock arrangement having a projection that is received in a recess. (Item 32) The reconfiguration device according to item 1 or the preceding item, wherein the third flow path comprises a molded channel. (Item 33) A reconstitution device according to any one of items 1 to 31, wherein the third channel includes a hypotube. (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, wherein the upper part is movable relative to the lower part between a non-operating position and an operating position, A transfer engine is disposed within the lower part of the housing, with a first container receiving end and a second container receiving end facing the upper part of the housing. The transfer engine comprises a fluid outlet that is in fluid communication with the second container receiving end, The upper part is configured to engage with the first container and the second container when the upper part moves from the non-operating position to the operating position, thereby causing the first container and the second container to move toward 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, the upper part at least partially encloses the fluid outlet in the housing when the upper part is in the non-operating position, and the notch exposes the fluid outlet when the upper part is in the operating position. (Item 37) The reconfiguration device according to item 36, wherein the lower part has a fluid outlet receptacle, the fluid outlet is located 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. (Item 38) A reconfiguration device according to any one of items 35 to 37, further comprising a flexible leash connected to the fluid outlet. (Item 39) A reconfiguration device according to any one of items 35 to 37, wherein the fluid outlet is fixed to the lower part of the housing when the upper part is in the operating position. (Item 40) A reconfiguration device according to any one of items 35 to 37, wherein the fluid outlet is movable relative to the lower part of the housing when the upper part is in the operating position. (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, allowing the fluid outlet to move 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 retaining force of the clip on the housing is less than the retaining force of the cap on the fluid outlet. (Item 45) The reconfiguration device according to item 42, wherein the lower part of the housing includes a slot into which at least a portion of the clip is received for holding the fluid outlet in the housing when the upper part is in the non-operating position. (Item 46) A reconfiguration device as described in item 42, further comprising a second clip. (Item 47) A 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) A reconfiguration device according to any one of items 35 to 47, wherein the upper part includes a curved surface extending away from the lower part. (Item 49) A reconfiguration device according to any one of items 35 to 48, wherein the lower part includes a flat surface opposite to the upper part. (Item 50) The reconfiguration device according to any one of items 35 to 49, 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 51) The reconfiguration device according to item 50, wherein the warning module is configured to provide visual, audible, and / or tactile warnings. (Item 52) The warning module is a reconfiguration device as described in item 50, which transmits a warning message by wireless communication. (Item 53) The reconfiguration device according to any one of items 35 to 52, wherein the upper part includes at least one window configured to allow a user to see at least one of the first container and the second container. (Item 54) A reconfiguration device according to any one of items 35 to 53, wherein the first container receiving end is configured as a first spike and the second container receiving end is configured as a second spike. (Item 55) The first and second spikes are each dual lumen spikes, as described in item 54 of the reconfiguration device. (Item 56) The reconfiguration 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 puncture direction of the second spike. (Item 57) The reconstruction device described in item 56, wherein the angle is approximately 90 degrees. (Item 58) The reconfiguration 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 described in item 58, wherein the inlet is configured as a hydrophobic filter. (Item 60) A reconfiguration device according to any one of items 35 to 59, wherein the fluid outlet is a Luer-operated valve or Luer. (Item 61) A reconfiguration device according to any one of items 35 to 60, wherein the first container receiving end is in fluid communication with the second container receiving end in one direction. (Item 62) A reconfiguration device according to any one of items 35 to 60, wherein the upper part is slidably engaged with the lower part. (Item 63) A reconfiguration device according to any one of items 35 to 62, wherein the upper part includes at least one upper retaining mechanism, and the lower part 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 part in the operating position. (Item 64) A reconfiguration device according to any one of items 35 to 62, wherein the fluid outlet is releasably held within the housing until a 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, 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, wherein the first container receiving end and the second container receiving end face towards the upper part of the housing, and the transfer engine and the lower part are separate components. The fluid outlet of the transfer engine is in fluid communication with the second container receiving end, A reconfiguration device equipped with the following features. (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 retaining mechanism includes at least one selected from the group consisting of a mechanical fastener, a snap-fit ​​tab, and an adhesive. (Item 69) A 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 and second spikes are each dual lumen spikes. (Item 71) The reconfiguration device according to item 69, wherein the transfer engine includes an inlet configured to introduce air into the transfer engine. (Item 72) The reconstitution device according to item 71, wherein the inlet is configured as a hydrophobic filter. (Item 73) A reconfiguration device according to any one of items 66 to 72, wherein the fluid outlet is a Luer-operated valve or Luer. (Item 74) A reconfiguration device according to any one of items 66 to 73, wherein the upper part is slidably engaged with the lower part. (Item 75) A reconfiguration device according to any one of items 66 to 74, wherein the upper part includes at least one upper retaining mechanism, and the lower part 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 part in the operating position. (Item 76) A reconfiguration device according to any one of items 66 to 75, wherein the fluid outlet is releasably held within the housing until a 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 that movably engages 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, A first spike connected to the second portion of the housing, A first ring is connected to the first portion of the housing and configured to at least partially surround the shoulder of the first container and to hold the first container against the first spike, A reconfiguration device equipped with the following features. (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, and accommodates 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 portion of the first container, wherein the first ring has greater rigidity than the inner contact portion. (Item 81) The reconfiguration device according to item 80, wherein the inner contact portion is provided with a gasket. (Item 82) The reconfiguration device according to item 81, wherein the ring includes an inner surface having a groove, and the gasket seats in the groove. (Item 83) The reconfiguration device according to item 80, wherein the inner contact portion includes a molded nub. (Item 84) A 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) Reconfiguration device according to any one of items 78-85, further comprising a platform connected to the first portion of the housing and configured to contact the bottom of the first container, wherein moving the first portion toward the second portion from a non-operating configuration to an operating configuration presses the platform against the bottom of the first container, thereby moving the first container toward the first spike. (Item 87) A 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, wherein the plurality of arms are configured to at least partially surround the bottom of the first container. (Item 88) The reconfiguration 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 reconfiguration device according to item 78, wherein the first ring is fixed to the first portion, so that the first ring moves with the movement of the first portion. (Item 90) 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, When the upper part is in the operating position, a fluid outlet configured to deliver fluid from a container located within the housing, A marker that is at least partially obstructed in the upper non-operating position, and the marker is accessible in the upper operating position, A drug delivery device equipped with the following features. (Item 91) A drug delivery device as described in item 90, wherein the marker is a QR code (registered trademark). (Item 92) The drug delivery device according to item 91, wherein the aforementioned QR code (registered trademark) contains information readable by a remote device. (Item 93) A drug 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 drug delivery device according to item 92, wherein the remote device is a smartphone. (Item 95) The drug delivery device according to item 90, wherein the marker is a near-field communication tag. (Item 96) The drug delivery device according to item 95, wherein the marker is a radio frequency identification tag. (Item 97) A drug delivery device according to any one of items 90 to 96, wherein the upper part includes a marker window, the non-operating upper part surrounds the marker in the housing, and the marker window exposes the marker when the upper part is in the operating position. (Item 98) A drug delivery device according to any one of items 90 to 96, wherein the upper part of the non-operating position covers at least a portion of the marker, and the upper part of the operating position exposes the marker. (Item 99) A drug delivery device according to any one of items 90 to 96, wherein the opaque upper portion obscures at least a portion of the marker and at least partially obstructs the marker. (Item 100) The drug delivery device according to item 99, wherein the transparent portion 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, wherein the upper part is movable relative to the lower part between a non-operating position and an operating position, When the upper part is in the operating position, a fluid outlet configured to deliver fluid from a container located within the housing, A communication module configured to send 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 drug delivery device equipped with the following features. (Item 102) The drug 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 drug delivery device according to item 101, wherein the trigger includes a Hall effect sensor located at the lower part, and the trigger includes a magnet located at the upper part. (Item 104) The drug delivery device according to item 101, wherein the trigger includes a pressure sensor configured to detect pressure applied to the upper to move the upper to the operating position, and the trigger is configured to activate the communication module when a threshold pressure applied to the upper is detected by the pressure sensor. (Item 105) The drug delivery device according to item 101, wherein the trigger includes a light beam transmitter and a light beam receiver located at 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. (Item 106) A drug delivery device according to any one of items 101 to 105, wherein at least one of the communication protocols includes Bluetooth®. (Item 107) A drug delivery device according to any one of items 101 to 106, further comprising a sensor configured to provide information to the aforementioned communication module. (Item 108) The drug 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 drug delivery device according to item 107, wherein the sensor is an accelerometer configured to provide motion information to the communication module. (Item 110) A drug delivery device according to any one of items 101 to 109, wherein the trigger is configured to connect the communication module to a power source. (Item 111) A drug delivery device according to any one of items 101 to 110, wherein the communication module is configured to transmit a message comprising at least one selected from the group of dosage and drug identification. (Item 112) A drug delivery device according to item 90 or 101, wherein the upper portion in the non-operating position is configured to at least partially obstruct physical access to the fluid outlet, and the upper portion in the operating position is configured to allow physical access to the fluid outlet. (Item 113) The drug delivery device according to item 112, wherein the upper part includes a notch, the upper part in the non-operating position at least partially encloses the fluid outlet in the housing, and the notch exposes the fluid outlet when the upper part is in the operating position. (Item 114) The aforementioned container, The fluid is 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. The first spike is configured as follows, A drug delivery device as described in item 90 or 101, further comprising the above. (Item 115) The container is the first container, and the drug delivery device is The second container, The first spike is fluidly connected and configured to puncture the second container when the upper part moves from the non-operating position to the operating position, A drug delivery device according to item 114, further comprising a second spike configured as follows. (Item 116) A drug delivery device according to item 115, wherein the first container contains a freeze-dried solid, the second container contains a drug solution, and the upper part is configured to allow the drug solution to dissolve the freeze-dried solid at the operating position. (Item 117) An inlet container containing the liquid medicine, An inlet spike configured to puncture the inlet container, wherein the inlet spike is configured to receive the drug solution from the inlet container, Air inlet and An inlet adapter fluid channel fluid-connected to the inlet spike, Inlet adapter coupling, and inlet adapter including, An intermediate container containing a liquid or solid drug, An intermediate spike configured to puncture the intermediate container, A first intermediate fluid channel is configured to be fluid-connected to the intermediate spike and to be fluid-connected to the inlet adapter fluid channel, A second intermediate fluid channel is fluid-connected to the aforementioned intermediate spike, A first intermediate adapter coupling is configured to be connected to the inlet adapter coupling in order to releasably attach the intermediate adapter to the inlet adapter, An intermediate adapter including a second intermediate adapter coupling, An outlet container containing a medicinal solid, An outlet spike configured to puncture the aforementioned outlet container, An outlet adapter fluid channel is configured to be fluidly connected to the outlet spike and to be fluidly connected to the second intermediate fluid channel, The outlet connected to the outlet spike is fluid-connected, An outlet adapter including an outlet adapter coupling configured to connect to a second intermediate adapter coupling in order to releasably attach the outlet adapter to the intermediate adapter, A drug delivery device equipped with the following features. (Item 118) The drug delivery device according to item 117, wherein the outlet adapter coupling is connected to the inlet adapter coupling and configured to releasably attach the outlet adapter to the inlet adapter. (Item 119) The intermediate adapter is a first intermediate adapter, the intermediate container is a first intermediate container, and the drug delivery device is A second intermediate container containing a liquid or solid drug, A second intermediate spike configured to puncture the second intermediate container, A third intermediate fluid channel is configured to be fluidly connected to the second intermediate spike and to be fluidly connected to the second intermediate fluid channel, A fourth intermediate fluid channel fluid-connected to the second intermediate spike, wherein the fourth intermediate fluid channel is configured to be fluid-connected to the outlet adapter fluid channel, A third intermediate adapter coupling is 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 drug delivery device according to item 117, further comprising a second intermediate adapter including a fourth intermediate adapter coupling configured to connect to the outlet adapter coupling so as to releasably mount the second intermediate adapter in series with the outlet 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 drug delivery device is A second intermediate container containing a liquid or solid drug, A second intermediate spike configured to puncture the second intermediate container, A third intermediate fluid channel is configured to be fluid-connected to the second intermediate spike and to the inlet adapter 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, A third intermediate adapter coupling is connected to the second intermediate adapter coupling and configured to detachably attach the inlet adapter to the second intermediate adapter in a parallel configuration, A drug delivery device according to item 117, further comprising a second intermediate adapter, a fourth intermediate adapter coupling configured to connect to the second outlet adapter coupling so as to releasably mount the second intermediate adapter to the outlet adapter in a parallel configuration. (Item 121) The intermediate adapter is a first intermediate adapter, the intermediate container is a first intermediate container, and the drug delivery device is A second intermediate container containing a liquid or solid drug, A second intermediate spike configured to puncture the second intermediate container, A third intermediate fluid channel is configured to be fluid-connected to the second intermediate spike and to the inlet adapter 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, A third intermediate adapter coupling connected to the inlet adapter coupling, configured to releasably attach the inlet adapter to the second intermediate adapter in a parallel configuration, wherein the inlet adapter coupling is configured to connect simultaneously to both the first intermediate adapter coupling and the third intermediate adapter coupling, A drug delivery device according to item 117, further comprising a second intermediate adapter, a fourth intermediate adapter coupling configured to connect to the outlet adapter coupling so as to releasably mount the second intermediate adapter to the outlet adapter in a parallel configuration, wherein the outlet adapter coupling is configured to connect to both the second intermediate adapter coupling and the fourth intermediate adapter coupling simultaneously. (Item 122) An entrance spike configured to puncture the entrance container, Air inlet and An inlet adapter fluid channel fluid-connected to the inlet spike, An inlet adapter including an inlet adapter coupling spaced apart from the inlet adapter fluid channel, An intermediate spike configured to puncture the intermediate container, A first intermediate fluid channel is configured to be fluidly connected to the intermediate spike and to be fluidly connected to the inlet adapter fluid channel, A second intermediate fluid channel is fluid-connected to the aforementioned intermediate spike, A first intermediate adapter coupling is configured to be connected to the inlet adapter coupling in order to interlock the intermediate adapter so that it can be released to the inlet adapter, An intermediate adapter comprising a second intermediate adapter coupling, wherein the first intermediate adapter coupling and the second intermediate coupling are spaced apart from the first intermediate fluid channel and the second intermediate fluid channel, An exit spike configured to puncture the exit container, An outlet adapter fluid channel is configured to be fluidly connected to the outlet spike and to be fluidly connected to the second intermediate fluid channel, The outlet connected to the outlet spike is fluid-connected, An outlet adapter comprising: an outlet adapter coupling configured to be connected to the second intermediate adapter coupling so as to interlock the outlet adapter with the intermediate adapter in a releasable manner, wherein the outlet adapter coupling is spaced apart from the outlet adapter fluid channel; A drug delivery device equipped with the following features. (Item 123) The drug delivery device according to item 122, wherein the outlet adapter coupling is connected to the inlet adapter coupling and configured to interlock the outlet adapter so that it can be released to the inlet adapter. (Item 124) A drug delivery device according to item 117 or 122, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are located on the opposite side of the intermediate adapter. (Item 125) A drug 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) A drug 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 to each other. (Item 127) A first tube configured to fluidly connect the inlet adapter fluid channel and the first intermediate fluid channel, A drug 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) The aforementioned intermediate adapter is a first intermediate adapter, and the drug delivery device is A second intermediate spike configured to puncture a second intermediate container containing a drug solution or drug solid, A third intermediate fluid channel is configured to be fluidly connected to the second intermediate spike and to be fluidly connected 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 be fluidly connected to the outlet adapter fluid channel, A third intermediate adapter coupling is received by the second intermediate adapter coupling and configured to interlock the first intermediate adapter so that it can be released in series with the second intermediate adapter, The drug 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 interlock the second intermediate adapter so that it can be released in series with the outlet adapter. (Item 129) The intermediate adapter is a first intermediate adapter, the inlet adapter includes a second inlet adapter coupling, the outlet adapter includes a second outlet adapter coupling, and the drug delivery device is A second intermediate spike configured to puncture a second intermediate container containing a drug solution or drug solid, A third intermediate fluid channel is configured to be fluid-connected to the second intermediate spike and 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, A third intermediate adapter coupling is received by the second intermediate adapter coupling and configured to interlock the first intermediate adapter so that it can be released in parallel with the second intermediate adapter, The drug delivery device according to item 122, further comprising a second intermediate adapter including a fourth intermediate adapter coupling configured to receive the second outlet adapter coupling and to interlock the second intermediate adapter so that it can be released in parallel with the outlet adapter. (Item 130) The aforementioned intermediate adapter is a first intermediate adapter, and the drug delivery device is A second intermediate spike configured to puncture a second intermediate container containing a drug solution or drug solid, A third intermediate fluid channel is configured to be fluid-connected to the second intermediate spike and 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, A third intermediate adapter coupling, which is received by the inlet adapter coupling and configured to interlock the inlet adapter so that it can be released in parallel with the second intermediate adapter, wherein the inlet adapter coupling is configured to simultaneously receive both the first intermediate adapter coupling and the third intermediate adapter coupling, A drug delivery device according to item 122, further comprising a second intermediate adapter including a fourth intermediate adapter coupling configured to interlock the second intermediate adapter so that it can be released in parallel with the outlet adapter by receiving the outlet adapter coupling, wherein the outlet adapter coupling is configured to be simultaneously received by both the second intermediate adapter coupling and the fourth intermediate adapter coupling. (Item 131) A first tube configured to fluidly connect the inlet adapter fluid channel and the first intermediate fluid channel, A second tube configured to fluidly connect the second intermediate fluid channel and the third intermediate fluid channel, A drug delivery device according to item 119 or 128, further comprising a third tube configured to fluidly connect the fourth intermediate fluid channel and the outlet adapter fluid channel. (Item 132) A first tube configured to fluidly connect the inlet adapter fluid channel, the first intermediate fluid channel, and the third intermediate fluid channel, A drug delivery device according to item 119 or 128, further comprising a second tube configured to fluidly connect the second intermediate fluid channel, the fourth intermediate fluid channel, and the outlet adapter fluid channel. (Item 133) A drug delivery device according to item 117 or 122, wherein the first intermediate adapter coupling includes a neck and a tab, the tab having a tab width, the neck having a neck width, and the tab width being greater than the neck width, and the inlet adapter coupling includes a collar and a pocket, the collar having a collar width, the pocket having a pocket width, and the pocket width being greater than the collar width. (Item 134) The drug delivery device according to item 122, wherein when the intermediate adapter and the inlet adapter are interlocked, the inlet adapter coupling and the first intermediate adapter coupling are configured to resist relative movement of the inlet adapter and the intermediate adapter in a first direction and to allow relative movement of the inlet adapter and the intermediate adapter in a second direction across the first direction. (Item 135) A drug 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 is disposed within the lower part of the housing, with a first container receiving end facing the upper part of the housing, It comprises a fluid outlet that is in fluid communication with the transfer engine, The upper part is configured to engage with the first container, so that when the upper part moves from the non-operating position to the operating position, the first container moves toward the first container receiving end. A drug delivery device wherein 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. (Item 137) A drug delivery device according to item 136, wherein the upper part includes a notch, the upper part at least partially encloses the fluid outlet in the housing when the upper part is in the non-operating position, and the notch exposes the fluid outlet when the upper part is in the operating position. (Item 138) The drug delivery device according to item 137, wherein the lower part has a fluid outlet receptacle, the fluid outlet is located 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. (Item 139) A drug delivery device according to any one of items 136 to 138, further comprising a flexible leash connected to the fluid outlet. (Item 140) A drug delivery device according to any one of items 136 to 138, wherein the fluid outlet is fixed to the lower part of the housing when the upper part is in the operating position. (Item 141) A drug delivery device according to any one of items 136 to 138, wherein the fluid outlet is movable relative to the lower part of the housing when the upper part is in the operating position. (Item 142) A drug 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, for holding the fluid outlet in the housing. (Item 143) A drug delivery device according to item 142, wherein the clip is removable from the lower part of the housing when the upper part is in the operating position, allowing movement of the fluid outlet relative to the housing. (Item 144) A drug delivery device according to item 142, further comprising a cap covering at least a portion of the fluid outlet, wherein the retaining force of the clip on the housing is less than the retaining force of the cap on the fluid outlet. (Item 145) The drug delivery device according to item 142, wherein the lower part of the housing includes a slot into which at least a portion of the clip is received in order to hold the fluid outlet in the housing when the upper part is in the non-operating position. (Item 146) A drug delivery device as described in item 142, further comprising a second clip. (Item 147) A drug delivery device according to any one of items 136-139 or 141-146, wherein the fluid outlet is movable relative to the transfer engine. (Item 148) A drug delivery device according to any one of items 136 to 147, wherein the upper part includes a curved surface that extends away from the lower part. (Item 149) A drug delivery device according to any one of items 136 to 148, wherein the lower part includes a flat surface opposite to the upper part. (Item 150) A drug 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 drug delivery device according to item 150, wherein the warning module is configured to provide visual, audible, and / or tactile warnings. (Item 152) The drug delivery device according to item 150, wherein the warning module transmits a warning message via wireless communication. (Item 153) A drug delivery device according to any one of items 136 to 152, wherein the upper part includes at least one window configured to allow a user to view the first container. (Item 154) A drug delivery device according to any one of items 136 to 153, wherein the first container receiving end is configured as a first spike. (Item 155) The drug delivery device according to item 154, wherein the first spike is a dual lumen spike. (Item 156) The drug delivery device according to item 154, 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. (Item 157) A drug delivery device as described in item 156, wherein the angle is approximately 90 degrees. (Item 158) The drug delivery device according to item 154, wherein the transfer engine includes an inlet configured to introduce air into the transfer engine. (Item 159) A drug delivery device according to item 158, wherein the inlet is configured as a hydrophobic filter. (Item 160) A drug delivery device according to any one of items 136 to 159, wherein the fluid outlet is a Luer-operated valve or Luer. (Item 161) A drug delivery device according to any one of items 136 to 160, wherein the upper part is slidably engaged with the lower part. (Item 162) A drug delivery device according to any one of items 136 to 161, wherein the upper part includes at least one upper retaining mechanism, and the lower part 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 part in the operating position. (Item 163) A drug delivery device according to any one of items 136 to 161, wherein the fluid outlet is held in a releasable manner within the housing until the delivery device is connected to the fluid outlet. (Item 164) A drug 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 drug delivery device according to item 136, wherein the upper part is configured to engage with only a single container. (Item 166) An entrance spike configured to puncture the entrance container, Air inlet and An inlet adapter including an inlet adapter fluid channel fluid-connected to the inlet spike, An intermediate spike configured to puncture the intermediate container, A first intermediate fluid channel is configured to be fluid-connected to the intermediate spike and to be fluid-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 puncture the exit container, An outlet adapter fluid channel is configured to be fluidly connected to the outlet spike and to be fluidly connected to the second intermediate fluid channel, An outlet adapter including an outlet fluid-connected to the aforementioned outlet spike, Equipped with an adapter plate, A drug delivery device in which the inlet adapter, the intermediate adapter, and the outlet adapter are configured to be connected to the adapter plate. (Item 167) The drug delivery device according to item 166, wherein the inlet adapter, the intermediate adapter, and the outlet adapter are configured to be connected to the adapter plate by interference fit. (Item 168) The drug delivery device according to item 166, wherein the adapter plate includes studs configured to engage with the inlet adapter, the intermediate adapter, and the outlet adapter. (Item 169) A drug delivery device according to items 166-168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are located on the opposite side of the intermediate adapter. (Item 170) A drug delivery device according to items 166-168, wherein the first intermediate adapter coupling and the second intermediate adapter coupling are oriented at an oblique angle to each other. (Item 171) The drug delivery device according to items 166-168, 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 drug delivery device according to items 166-171, further comprising a second tube configured to fluidly connect the second intermediate fluid channel and the outlet adapter fluid channel. (Item 173) The aforementioned intermediate adapter is a first intermediate adapter, and the drug delivery device is A second intermediate spike configured to puncture a second intermediate container, A third intermediate fluid channel is configured to be fluidly connected to the second intermediate spike and to be fluidly connected to the second intermediate fluid channel, The second intermediate adapter further comprises 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 second intermediate adapter is configured to connect to the adapter plate. Drug delivery device as described in items 166-172.

[0018] The attached drawings are not intended to be drawn to scale. In the drawings, identical or nearly identical components shown in various figures may be represented by similar numbers. For clarity, not all components are labeled in every drawing. [Brief explanation of the drawing]

[0019] [Figure 1] This is a schematic diagram of one embodiment of a transport engine for a reconfiguration device.

[0020] [Figure 2] This is a perspective view of one embodiment of a reconfiguration device.

[0021] [Figure 3] This is a schematic diagram of one embodiment of a transfer engine for a reconstitution device in the first stage of one embodiment of a reconstitution and drug delivery process.

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

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

[0024] [Figure 6] Figure 3 is a schematic diagram of the transport engine during the optional fourth stage of the reconfiguration and drug delivery process.

[0025] [Figure 7] This is a perspective view of one embodiment of a reconfiguration device in a non-operational state.

[0026] [Figure 8] Figure 7 is a perspective view of the reconfiguration device in operation.

[0027] [Figure 9] Figure 7 is a side elevation view of the reconstruction device.

[0028] [Figure 10A] Figure 8 is a side elevation view of the reconstruction device.

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

[0030] [Figure 11] This is a cross-sectional view of the reconstructed device in Figure 7, taken along line 11-11.

[0031] [Figure 12] This is a cross-sectional view of the reconstructed device in Figure 8, taken along line 12-12.

[0032] [Figure 13] This is a side elevation view of one embodiment of the transport engine for a reconfiguration device.

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

[0034] [Figure 15] This is a flowchart of one embodiment of the reconstitution and drug delivery process.

[0035] [Figure 16] This is a flowchart of another embodiment of the reconstitution and drug delivery process.

[0036] [Figure 17] This is a flowchart of one embodiment of the reconstitution and drug delivery process.

[0037] [Figure 18] This is a schematic diagram of one embodiment of a reconfiguration device that communicates with one or more remote devices.

[0038] [Figure 19A] This is a schematic diagram of another embodiment of the reconfiguration device in the first state.

[0039] [Figure 19B] This is a schematic diagram of the reconfigured device in the second state, as shown in Figure 19A.

[0040] [Figure 20A] This is a schematic diagram of yet another embodiment of the reconfiguration device in the first state.

[0041] [Figure 20B] This is a schematic diagram of the reconfigured device in the second state, as shown in Figure 20A.

[0042] [Figure 21A] This is a schematic diagram of another embodiment of the reconfiguration device in the first state.

[0043] [Figure 21B] This is a schematic diagram of the reconfigured device in the second state, as shown in Figure 21A.

[0044] [Figure 22] This is a perspective view of another embodiment of the transfer engine.

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

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

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

[0048] [Figure 26] This is a perspective view of another embodiment of the transfer engine.

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

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

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

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

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

[0054] [Figure 32A] This is a schematic diagram of another embodiment of the reconfiguration device in the first state.

[0055] [Figure 32B] This is a schematic diagram of the reconfiguration device in the second state, as shown in Figure 32A.

[0056] [Figure 32C] This is a schematic diagram of the reconfigured device in the third state, as shown in Figure 32A.

[0057] [Figure 32D] This is a schematic diagram of the reconfiguration device in the fourth state, as shown in Figure 32A.

[0058] [Figure 33] This is a top perspective view of another embodiment of the transfer engine.

[0059] [Figure 34] This is a top view of the transport engine shown in Figure 33.

[0060] [Figure 35] Figure 33 is a bottom perspective view of the transfer engine.

[0061] [Figure 36] This is an exploded perspective view of another embodiment of the reconfiguration device.

[0062] [Figure 37A] This is the reconfiguration device in the first state, as shown in Figure 36.

[0063] [Figure 37B] This is the reconfiguration device in the second state, as shown in Figure 37A.

[0064] [Figure 37C] This is the reconfiguration device in Figure 37A in the third state.

[0065] [Figure 38] This is an exploded perspective view of another embodiment of the reconfiguration device.

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

[0067] [Figure 40A] This is the reconfiguration device shown in Figure 38 in the first state.

[0068] [Figure 40B] This is the reconfiguration device in Figure 40A in the second state.

[0069] [Figure 40C] This is the reconfiguration device in Figure 40A in the third state.

[0070] [Figure 40D] This is the reconfiguration device in Figure 40A in the fourth state.

[0071] [Figure 41] This is an exploded perspective view of another embodiment of the reconfiguration device.

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

[0073] [Figure 43A] This is the reconfiguration device shown in Figure 41 in the first state.

[0074] [Figure 43B] This is the reconfiguration device in Figure 43A in the second state.

[0075] [Figure 43C] This is the reconfiguration device in the third state, as shown in Figure 43A.

[0076] [Figure 44] This is a cross-sectional view of the reconstructed device in Figure 40B, taken along line 44-44.

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

[0078] [Figure 46] This is a perspective view of the container holding ring.

[0079] [Figure 47] Figure 40B is a top view of the reconstruction device.

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

[0081] [Figure 49] Figure 40B is a perspective break view of the reconstructed device taken along line 49-49.

[0082] [Figure 50A] This is an exploded plan view of another embodiment of the transfer engine.

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

[0084] [Figure 51] This is a schematic diagram of one embodiment of a transfer engine adapter coupling.

[0085] [Figure 52] This is a plan view of another embodiment of the transfer engine.

[0086] [Figure 53] This is a plan view of another embodiment of the transfer engine.

[0087] [Figure 54] This is a plan view of another embodiment of the transfer engine.

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

[0089] [Figure 56] It is a side view of another embodiment of the liquid medicine delivery device.

[0090] [Figure 57] It is a schematic plan view of another embodiment of the transfer engine.

[0091] [Figure 58] It is a schematic plan view of another embodiment of the transfer engine.

[0092] [Figure 59] It is a schematic plan view of another embodiment of the transfer engine.

[0093] [Figure 60] It is a schematic plan view of another embodiment of the transfer engine.

[0094] [Figure 61A] It is a schematic front view of another embodiment of the liquid medicine delivery device in the first state.

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

[0096] [Figure 62A] It is a schematic front view of another embodiment of the liquid medicine delivery device in the first state.

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

[0098] <​​​​​​​This is a schematic front view of another embodiment of the drug delivery device in the first state.

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

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

[0102] [Figure 66] This is a flowchart of another embodiment of a drug delivery device. [Modes for carrying out 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 uncomposed pharmaceutical, such as a lyophilized pharmaceutical. At each step, the nurse or other healthcare professional takes care to avoid contamination as the reconstitution fluid is removed from its packaging and discharged into the mixing container or pharmaceutical container. Such a process typically involves handling multiple containers and syringes. Therefore, conventional reconstitution methods performed by nurses or other healthcare professionals can be time-consuming and complex.

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

[0105] In light of the above, the inventors recognized the advantages of a reconstitution device that allows 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, this reconstitution device can enable the use of a simpler reconstitution and administration process with fewer steps. The reconstitution device can also enable reconstitution and administration with reduced container handling. Furthermore, the reconstitution device can enable the use of less pressure to operate the device than conventional devices, promoting a more user-friendly operating sensation. In addition, the reconstitution device can improve the stirring and mixing of the pharmaceutical product and the reconstitution fluid.

[0106] In some embodiments, the transfer engine may include a plurality of compactly arranged flow paths to facilitate the transfer of fluid, for example, from a first container to a second container, thereby reconstituting the drug contained in the second container. In some embodiments, the reconstitution device includes a first flow path including a first open end and an air inlet. The reconstitution device also includes a second flow path having a second open end and a third open end. The first and second open ends are parallel to each other and together can define a first container receiving end. The reconstitution device also includes a valve positioned along the second flow path between the second and third open ends. The third flow path includes a fourth open end and a fluid outlet. The third and fourth open ends 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 transfer from a first container (e.g., containing sterile water) to a second container (e.g., containing a drug for reconstitution). In some embodiments, the first open end of the first flow path and the second open end of the second flow path are located within the first spike. In some embodiments, the third open end of the second flow path and the fourth open end of the third flow path are located within the second spike. A portion of the first flow path and a portion of the second flow path may form the lumen of the first spike. A portion of the second flow path and a portion of the third flow path may form the lumen of the second spike. In some embodiments, the transfer engine may be used in conjunction with fluid delivery devices other than the reconstitution device, such as a device for a pool or a device used to access a single container. Therefore, it should be understood that in some embodiments, the transfer engine may include only a single container receiving end, rather than multiple container receiving ends.

[0107] In some embodiments, the fluid outlet may include a Luer lock valve, thereby allowing a syringe or other delivery device to be fluidly connected to the fluid outlet and to draw the reconstituted drug solution from the device. However, in other embodiments, other suitable fluid outlets may be used in the reconstitution device, including, but not limited to, Luer actuating devices, simple Luer or other threaded connectors, slip-fit ​​connectors, and puncturable septa. In some embodiments, the container containing the powdered drug may be configured to include a low-pressure or zero-pressure vacuum, thereby allowing sterile water or another fluid from another container to be forced into the drug-containing container without manual pressure or pumping. In some embodiments, the pressure difference 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 also recognized the advantage 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-placed within a reconstitution device containing a reconstitution fluid, together with a second container containing a pharmaceutical drug. The reconstitution device can apply force to its housing to fluidize the first container to the second container, allowing the fluid to flow from the first container to the second container and reconstitute the pharmaceutical drug.

[0109] In some embodiments, the reconfiguration device may include a housing having an upper and a lower part, the lower part being slidably received in the upper part, or vice versa. The upper part may be configured to hold at least two containers, and the lower part may include at least one spike for each of the at least two containers. In some embodiments, the upper part may be configured to selectively hold at least two containers, at least partially, away from the spikes of the lower part. The upper part may be configured to apply force to at least two containers as it slides from a first non-operating position to a second operating position where the upper part approaches the lower part. Specifically, the bottom surface of the upper part is closer to the base of the lower part. When the upper part moves to the operating position, at least two containers can be punctured by the spike(s) associated with the containers. Once punctured, the containers can be fluid-communicated, thereby allowing fluid from one container to flow into the other. In some embodiments, the first container may be under vacuum, thereby forcing fluid from the second container into the first container as a result of a pressure difference between the two containers. The lower part of the housing can be formed as a base that can be placed on a flat surface (e.g., a table, countertop, etc.). The base can support the reconfiguration device and provide a platform from which the user can apply force. In some embodiments, the upper surface of the housing may be curved, thereby potentially causing the reconfiguration device to be unstable if the user attempts to use the upper surface as a base by placing it on a flat surface. This instability may serve to inform the user that the device is positioned in an unsuitable orientation for use. Such positioning may also promote a single orientation for using the reconfiguration device. Such positioning may also improve ergonomics compared to conventional reconfiguration devices. The curved surface can provide a natural place for the hand to rest, and its shape corresponds to other objects and surfaces that are commonly accepted in the user's palm. In this regard, the curved upper surface can lead to active movement, thereby promoting favorable handling and operation of the reconfiguration device.

[0110] The inventors also recognized the benefit of providing feedback to the user for the complete operation of the reconfiguration device. Furthermore, the inventors recognized the benefit of one or more holding mechanisms that hold the reconfiguration device in an operational state, thereby discouraging repeated activation or retrieval of used containers from the reconfiguration device. Moreover, such arrangements can mitigate 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 perforated partition wall of the container, which biases the upper part away from the lower part.

[0111] In some embodiments, the reconfiguration device may include a housing having a lower and an upper part, the lower part being slidably received in the upper part and / or vice versa. The upper part may be configured to hold at least two containers, and the lower part may include at least one spike for each of the at least two containers. In some embodiments, the upper part may be configured to selectively hold at least two containers, at least partially, away from the spikes of the lower part. The upper part may also be configured to apply force to at least two containers as the upper part slides from a first non-operating position to a second operating position where the upper part approaches the lower part. The upper part of the housing may have at least one upper stop, and the lower part may have at least one lower stop. At least one upper stop may be configured to engage with at least one lower stop when the upper housing moves to the operating position and punctures each of the at least two containers. In some embodiments, the upper and lower stops may be corresponding shelves or protrusions of the housing that abut each other to prevent the upper part of the housing from moving further toward the lower part of the housing. In some embodiments, the container may function as an upper stop that abuts against the lower part of the housing (e.g., reaching the bottom) when the upper housing moves to the working position. The disclosure is not limited thereto, and upper and lower stops may be located on any suitable parts of the upper and lower housings that can come into contact with each other. In some embodiments, the upper and lower parts of the housing may include one or more retaining mechanisms to allow the reconfiguration device to be captured in one direction in the working position. The retaining mechanisms may include a flexible tab, a ratchet and pawl, a hook, a hook-and-loop fastener, an adhesive, or another suitable arrangement for securing the two parts of the reconfiguration device housing together when in operation. For example, in one embodiment, a flexible tab located on the lower part of the housing may engage with a corresponding stopper or recess on the upper part of the housing when the upper part moves to the working 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 the first container can flow to a second container containing the pharmaceutical for reconstitution. Such an arrangement can simplify the reconstitution and administration process and further ensure that the pharmaceutical is reconstituted before the 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 and a lower part, the lower part being slidably received in the upper part. The upper part may be configured to hold at least two containers, and the lower part may include at least one spike for each of the at least two containers. The upper part may be configured to selectively hold at least two containers, at least partially, at a distance from spikes positioned in the lower part before the device is activated. The upper part may be configured to apply force to the at least two containers as the upper part slides from a first non-operating position to a second operating position where the upper part approaches the lower part. Specifically, the bottom surface of the upper part may be closer to the base of the lower part. When the upper part moves to the operating position, at least two containers can be punctured by one or more associated spikes. Once punctured, the containers can be fluid-communicated, thereby allowing fluid from one container to flow from the first container to the second container, and the pharmaceutical in the second container to be reconstituted by the fluid from the first container. The spikes may be fluid-connected to fluid outlets that can be held in the lower part of the housing. The upper part of the housing is configured to cover or otherwise prevent physical user access to the fluid outlet when the upper part is in a non-operating position. When the reconfiguration device is activated, physical access to the fluid outlet becomes possible. For example, in one embodiment, a notch in the upper part is configured to expose the fluid outlet when the upper part moves to the operating position. In some embodiments, the fluid outlet can be connected to one or more spikes via a flexible tube, thereby making the fluid outlet movable relative to the spikes. According to this embodiment, the fluid outlet can be accessed through the notch in the lower housing and removed from there when the upper part is in the operating position. Once removed, a delivery device (e.g., a syringe) can be connected to the fluid outlet and used to draw out the reconfigured pharmaceutical. In some embodiments, the fluid outlet may include a port cap configured to seal the fluid outlet and prevent air from entering the flow path between the spikes and the fluid outlet until it is removed. According to this embodiment, the port cap cannot be accessed or removed from the fluid outlet until the upper part is in the operating position.

[0114] Some embodiments described herein use a flexible tube that allows the user to move the fluid outlet relative to the reconfiguration device housing, but other configurations can be used in which the fluid outlet is physically prevented from moving until the reconfiguration device is activated. 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 to the bottom 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, thereby allowing the fluid outlet to rotate relative to the housing. In such embodiments, the activation of the reconfiguration device can rotate the fluid outlet from a first rotation position to a second rotation position. In another embodiment, the fluid outlet can be positioned on a ball located in 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 part of the reconfiguration device housing, and this disclosure is not limited in that way. For example, the fluid outlet can be located in the lower, middle, or upper part of the reconfiguration device housing (e.g., the upper third, middle third, or lower third). The fluid outlet can be flexibly connected to the housing of the reconfiguration device, movable around a hinge or pivot, or fixed to the housing.

[0115] In some embodiments, the reconfiguration device may include a fluid outlet that is releasably mounted to the reconfiguration device outlet. The fluid outlet may also be connected to a flexible tube located inside the reconfiguration device housing when the fluid outlet is releasably mounted to the housing. The fluid outlet may be firmly held in the lower, middle, or upper third of the reconfiguration device housing and may only be physically accessible to the user after the reconfiguration device housing has been operated. Once the fluid outlet is physically accessible, a delivery device can be connected to the fluid outlet. For example, a delivery device (e.g., a syringe) may be connected to the fluid outlet by a twisting motion. Of course, the disclosure is not limited thereto, and a delivery device may be connected to the fluid outlet using any suitable motion. Once the delivery device is connected, the user can detach the fluid outlet from the reconfiguration device housing by pulling or applying force to the fluid outlet using the delivery device. Once detached, the fluid outlet moves relative to the reconfiguration device housing, thereby extending the flexible tube.

[0116] The inventors recognized the advantages of facilitating directional flow to ensure appropriate dosage and reconstitution. Specifically, the inventors recognized the advantages of a check valve or other one-way valve in facilitating unidirectional flow from a first container to a second container. In some embodiments, a check valve or other one-way valve can be placed 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 in the second container by a check valve. Such an arrangement can help prevent backflow and loss of fluid or reconstituted pharmaceutical from the second container.

[0117] In some embodiments, the transfer engine for the reconstitution device includes a first flow path extending between an inlet and a first spike, a second flow path extending between the first spike and a second spike, and a third flow path extending between the second spike and a fluid outlet. In some embodiments, a check valve is positioned along the second flow path. The check valve is configured to allow flow from the first spike to the second spike but prevent flow in the opposite direction. Thus, if a first container containing the reconstitution fluid is punctured by the first spike and fluid-connected, the fluid can flow from the first container through the second flow path to the second container. If a second container containing the reconstitution drug is punctured by the second spike and fluid-connected, 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 may include at least a partial vacuum, but the internal pressure of the first container may be atmospheric pressure or higher, so that the pressure difference between the first and second containers encourages the fluid in the first container to flow into the second container. The pressure difference can be configured so that all of the fluid from the first container flows through a check valve towards the second container, where it is mixed with the pharmaceutical and reconstituted. The check valve prevents backflow of the reconstituted drug and ensures that the correct dosage of the reconstituted drug is held 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 requiring the user to handle one or more containers. Specifically, the inventors recognized the advantage of a check valve placed between a first container and a second container, which holds the fluid in the second container and prevents backflow into the first container. Once the reconstituted or partially reconstituted pharmaceutical product is drawn out and placed into the second container using a delivery device (e.g., a syringe), the fluid can be agitated to facilitate mixing, while the delivery device in the second container remains accessible. The pharmaceutical product can then be effectively agitated and mixed using the delivery device to ensure that the pharmaceutical product is completely dissolved or rehydrated before administration.

[0119] In some embodiments, the reconfiguration device includes a first and a second vessel located within the upper part of a housing, the upper part of which at least partially encloses the first and second vessels. In some embodiments, a method for performing the reconfiguration process includes applying force to the upper part to move it from a first non-operating position to a second operating position. The first vessel can be punctured with a first spike located at the bottom of the housing, and the second vessel can be punctured with a second spike located at the bottom of the housing, moving the upper part to the second operating position. Upon puncture, fluid flows from the first vessel to the second vessel, occupying a vacuum or low-pressure volume in the second vessel. As the fluid flows from the first vessel to the second vessel, the fluid can flow through a check valve configured to prevent flow in the opposite direction (i.e., back towards the first vessel). The method also includes drawing at least a portion of the fluid from the second vessel using a syringe through a fluid outlet. Once at least a portion of the fluid has been drawn, the fluid can be re-deposited into the second vessel using a syringe. Using a syringe, the fluid can be withdrawn from the second container and resorbed until the drug in the second container is thoroughly mixed and reconstituted. While the fluid is moving in and out of the second container, a check valve can be used to ensure that the fluid or drug 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 concern reconstitution devices, it should be understood that various mechanisms and methods described herein may be used with drug delivery devices that are not necessarily used for reconstitution. For example, in some embodiments, a drug delivery device may 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 may be used to pool contents from multiple containers without reconstitution. However, in other embodiments, a drug delivery device may perform both reconstitution and pooling (e.g., to access the contents of two or more containers containing fluids and one or more containers containing solids). Therefore, the disclosure is not so limited, and various mechanisms and methods described herein are also applicable to drug delivery devices having any number of containers.

[0121] The inventors also recognized the advantages of a reconstitution or drug delivery device that provides signals to a user practicing self-administration, either through one or more warnings on the reconstitution device itself or through a complementary device. The reconstitution or drug delivery device can provide the user with visual, auditory, and / or tactile warnings about the status of the reconstitution process, and such arrangements can simplify the reconstitution or drug delivery process for the user.

[0122] In some embodiments, the reconstitution or drug delivery device may include a first container having a fluid (e.g., reconstitution fluid) and a second container having a pharmaceutical product (e.g., lyophilized pharmaceutical product). The reconstitution or drug delivery device may 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 may 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 may indicate one or more states of the reconstitution or drug delivery device during the reconstitution or drug delivery process. For example, in one embodiment, at least one indicator may indicate when the reconstitution device is operating, the reconstitution fluid is flowing, and mixing with the pharmaceutical product. In another example, at least one indicator may indicate when the reconstitution fluid has had sufficient time to mix with the pharmaceutical product, thereby indicating when the drug solution is suitable for withdrawal from the reconstitution device using a delivery device (e.g., a syringe). In yet another example, the reconfiguration or drug delivery device may include a direction sensor (e.g., an accelerometer, gyroscope, etc.), and an indicator may show when the reconfiguration or drug delivery device is in a predetermined direction, or conversely, when the reconfiguration or drug delivery device is in a direction different from the predetermined direction. In some embodiments, the reconfiguration or drug delivery device may include a communication device (e.g., a radio transceiver that sends and receives radio signals using one or more of the following protocols: Bluetooth®, Bluetooth Low-Energy, Wi-Fi, 802.15.4, ZigBee®, GSM®, HSPA, CDMA, and / or any other suitable protocol). The communication device may be used to communicate and transmit one or more alerts to a remote device (e.g., a smartphone, pager, personal computer, tablet, etc.). The remote device then provides the alerts to the user by visual, auditory, and / or tactile indicators.

[0123] The inventors have also recognized the advantages of drug delivery devices configured to communicate with one or more remote devices. A drug 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 remote devices so that one or more remote devices can track a treatment schedule or otherwise record information regarding the use of the drug delivery device. In some embodiments, the drug delivery device may include a marker that is revealed or otherwise accessible (e.g., physically accessible, visually accessible, or wirelessly accessible) when the drug delivery device is activated. In other embodiments, when the drug delivery device is activated, the communication module of the drug delivery device may be activated by a trigger.

[0124] In some embodiments, the drug delivery device includes a housing having a lower section and an upper section that movably engages with the lower section. Similar to the embodiments described above, the upper section may be movable relative to the lower section between a non-operating position (e.g., upper position) and an operating position (e.g., lower position). The drug delivery device may also include a fluid outlet configured to deliver fluid from a container placed within the housing when the upper section is in the operating position. In some embodiments, the fluid outlet may be inaccessible to the user when the upper section is in the non-operating position. According to such embodiments, physical access to the fluid outlet and / or exposure of the fluid outlet can be made by moving the upper section to the operating position. The drug delivery device may also include a marker configured to be readable by a remote device (e.g., a smartphone) when accessible. For example, the marker may be a QR code®, a barcode, a radio frequency identification (RFID) tag, a near-field communication (NFC) tag, or another suitable marker. The marker may not be powered, thereby the drug delivery device does not include an onboard power supply. In some embodiments, the marker may be partially obscured when the top is in a non-operating position, and accessible to the user when the top is in an operating position. For example, in some embodiments, the top may surround the marker in the non-operating position and expose the marker in the operating position (e.g., through a notch). The marker can be used by a remote device to obtain information about the drug delivery device, such as dosage and manufacturing date.

[0125] In some embodiments, the drug delivery device includes a housing having a lower section and an upper section that movably engages with the lower section. Similar to the embodiments described above, the upper section is movable relative to the lower section between a non-operating position (e.g., upper position) and an operating position (e.g., lower position). The drug delivery device may also include a fluid outlet configured to deliver fluid from a container located within the housing when the upper section is in the operating position. In some embodiments, the fluid outlet may be inaccessible to the user when the upper section is in the non-operating position. According to such embodiments, moving the upper section to the operating position can enable physical access to the fluid outlet and / or expose the fluid outlet. The drug delivery device may 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 send messages to a remote device (e.g., a smartphone) containing information about the drug delivery device (e.g., dosage, drug identification, time, and / or one or more sensor values ​​such as temperature, orientation). The drug delivery device may also include a trigger configured to activate the communication module when the top moves to the activated position. Such an arrangement can ensure that the communication module consumes little to no power before activation, thereby ensuring that the power supply of the drug delivery device has sufficient power for the communication module for the desired shelf life. In some embodiments, the trigger may be a switch, a Hall effect sensor, a strain gauge, or other suitable sensor configured to detect the top moving to the activated position.

[0126] The inventors recognized the advantages of a reconfiguration device that provides the user with mechanical and / or electromechanical assistance in order to reduce the force used to operate the reconfiguration device compared to conventional reconfiguration devices. Such an arrangement may allow the user to start the reconfiguration device more easily and consistently.

[0127] In some embodiments, the upper and lower parts of the housing are operably connected via a screw mechanism, and the rotational force applied to the screw mechanism adds a linear force, bringing the upper part closer to the lower part, and the screw mechanism provides a mechanical advantage compared to directly applying a linear force. In another example, in some embodiments, a lever can be connected to the lower part of the housing, and the linear force applied to the lever can amplify the force applied to the upper part of the housing, causing the upper part of the housing to move downward. In yet another embodiment, the upper housing may include an inclined surface compression mechanism, which can push the upper housing portion toward the lower housing portion (or toward the corresponding spikes) by compressing at least one wedge containing an inclined surface in a direction parallel to the surface on which the reconfiguration device is placed. Of course, the disclosure is not limited in this way, and any suitable arrangement, with or without mechanical advantages, can be used in the reconfiguration device. Some embodiments of the reconfiguration device with mechanical advantages are further described with reference to Figures 19A–21B.

[0128] In some embodiments, the housing of the reconfiguration device may include mechanical or electromechanical actuators that reduce the operating force of the reconfiguration device. For example, the reconfiguration device may include one or more of the following: springs (e.g., compression, tension, torsion, pneumatic), servos, motors, and linear actuators. According to some embodiments, the reconfiguration device may include a power source (e.g., a battery) that can supply power to the electromechanical actuator. The actuator may be actuated by a user to actuate the reconfiguration device accordingly. Various user input devices, including but not limited to buttons or switches, may be used for such activation. In embodiments where a mechanical support element (e.g., a spring) is used, the user can actuate the reconfiguration device by operating its release. That is, the spring or other mechanical support element may be pre-energized (i.e., storing potential energy), which may be used to actuate the device when released. Of course, the disclosure is not so limited, and any mechanical or electromechanical support configuration, or combination thereof, may be used in the reconfiguration device.

[0129] The inventors also recognized the advantages of a modular drug delivery device that can be used to deliver a wide range of drug solutions in different quantities. Specifically, the inventors recognized the advantages of a modular transfer engine that includes multiple adapters that can be replaced or expanded according to a given fluid delivery application. An adapter may include at least one fluid channel configured to connect to at least one second fluid channel of another adapter. Furthermore, an adapter may 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 deliver drug solutions by including any number of adapters in any desired configuration. The modular transfer engine can be used to reconstitute lyophilized solids, to pool multiple drug solutions, or to access a single container.

[0130] In some embodiments, the drug delivery device may be modular. A modular drug delivery device may include an inlet adapter, an intermediate adapter, and an outlet adapter. The drug delivery device may be configured to use any number of intermediate adapters in a modular manner to suit a specific delivery volume. In some embodiments, the inlet adapter, intermediate adapter, and outlet adapter may all be configured to fluidize to a container. For example, the inlet adapter, intermediate adapter, and outlet adapter may all include spikes configured to puncture the container and fluidize the container to the respective adapter. The inlet adapter may include an inlet adapter fluid channel and an inlet adapter coupling. The intermediate adapter may include a first intermediate fluid channel, a second intermediate fluid channel, a first intermediate adapter coupling, and a second intermediate adapter coupling. The outlet adapter may include an outlet adapter fluid channel and an outlet adapter coupling. The first intermediate adapter coupling may be configured to connect to the inlet adapter coupling, and the second intermediate adapter coupling may be configured to connect to the outlet adapter coupling. Similarly, the inlet adapter fluid channel may be configured to fluidize to the first intermediate fluid channel, and the outlet adapter fluid channel may be configured to fluidize to the second intermediate fluid channel. The fluid channels may be positioned separately from the couplings and spaced apart from them, so that the adapters may be physically connected to each other (e.g., via the fluid channels) in addition to the fluid connections (e.g., via the couplings). If additional intermediate adapters are desired, the additional intermediate adapters may be identical to the first intermediate adapter and may be configured to be fluidly and physically attached to the first intermediate adapter and inlet adapter, or to the first intermediate adapter and outlet adapter. In some embodiments, the additional intermediate adapters may not be identical to the first intermediate adapter, but may nevertheless be configured to be fluidly and physically attached to the first intermediate adapter and inlet adapter, or to the first intermediate adapter and outlet adapter.Of course, this disclosure is not limited in that way, and any number of intermediate adapters may be used. Furthermore, it should be noted that the modular drug 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 just one container.

[0131] For the purposes of this disclosure, the term “connection” (in all its forms, such as connecting, connecting, being connected, etc.) generally means joining two components directly or indirectly to one another. Such connections may be essentially stationary or essentially movable, and may be achieved by the two components and any additional intermediate members forming integrally with each other or with the two components as a single unit, and may be essentially permanent or essentially detachable or releaseable unless otherwise specified.

[0132] While specific embodiments of the device are described further herein, other alternative embodiments of all components related to the reconfiguration device are interchangeable to suit different applications. Specific non-limiting embodiments of the reconfiguration device and corresponding methods are described in further detail with reference to the drawings. Since this disclosure is not limited to the specific embodiments described herein, it should be understood that the various systems, components, mechanisms, and methods described in relation to 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 reconstitution device or other mixing device. As shown in Figure 1, the transfer engine includes a first spike 102 and a second spike 105, which are configured to puncture a rubber stopper, a stub, 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, as well as the second open end of the second flow path, are located within the first spike. The portions of the first and second flow paths located within the first spike are parallel to each other and together define the 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, but preventing any liquid from crossing the hydrophobic filter. Of course, the disclosure is not limited in this way, 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 into the first passage while preventing air or fluid from leaving the first passage. The second passage extends between the first spike and the second spike 105. A check valve 109 is positioned along the second passage 104. The check valve 109 is configured to allow fluid and air to flow through the second passage from the first spike to the second spike, but not the other way around. The third passage 107 also has a fourth open end, also positioned within the second spike, and extends from the fourth open end to the outlet 111. The portions of the second and third passages positioned within the second spike are parallel to each other and together define the second container receiving end. The outlet in the illustrated embodiment is configured as a Luer activated valve. Of course, this disclosure is not limited in that way, 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 Luer activation devices, simple Luer or other threaded connectors, slip-fit ​​connectors, and punctureable partitions, can be used with the transfer engine. According to the embodiment of Figure 1, the transfer engine also includes a drug filter 110 located 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 Figure 1, the first container receiving end and the second container receiving end are configured to receive the first container and the second container, respectively. The first container may be configured to contain a reconstitution fluid (e.g., sterile water for injection), and the second container may contain a pharmaceutical product for reconstitution (e.g., a dry formulation). When the first container is punctured by the first spike 102 and the second container is punctured by the second spike 105, the fluid from the first container flows into the second container and can mix with the pharmaceutical product to form a drug solution. A check valve 109 can hold the drug solution in the second container and prevent backflow of the drug solution from the second container to the first container. Once the drug solution is in the second container, it can be drawn out through the outlet 111 using a delivery device such as a syringe. One embodiment of the reconstitution process is further described with reference to Figures 3 to 6.

[0135] Figure 2 is a perspective view of one embodiment of the reconstitution device 200. The reconstitution device shown in Figure 2 may include a transport device (for example, a transport device similar to that in Figure 1) configured to reconstitute a drug solution using two containers. That is, the reconstitution device in Figure 2 is configured to house two containers, reconstitute a drug, and deliver it. As shown in Figure 2, the reconstitution device includes a housing 201 having an upper part 202 and a lower part 204. According to the embodiment shown in Figure 2, the upper part 202 is slidable relative to the lower part 204 between an operating position and a non-operating position. Examples of this sliding movement and associated mechanisms are further described with reference to embodiments in Figures 7 to 12. The lower part 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, or countertop. In contrast, the upper part 202 includes a rounded upper surface 203, thereby the reconstitution device is not supported in a stable orientation by the rounded upper surface when placed on a flat surface. Therefore, the housing 201 shown in Figure 2 is configured to have a primary orientation that is stable when the housing is placed on a flat surface. In this primary orientation, force can also be applied to the upper part 202 while the lower part 204 prevents the housing from rotating. Furthermore, the rounded upper surface 203 is configured to provide a handle for the user to grip, facilitating the correct use of the reconfiguration device.

[0136] According to the embodiment of Figure 2, the reconstitution device is configured to house two containers. As previously stated, the two containers may be joined by a transfer engine located in the reconstitution device, an exemplary embodiment thereof is described herein. Each container may contain a specific dosage of pharmaceuticals and / or reconstitution fluid. Before reconstituting and administering the drug solution, the patient will want to ensure that the correct sized and dosage containers are placed within the reconstitution device, especially if the containers are enclosed by the upper part 202 of the housing 201 and are not removable. Therefore, in the embodiment of Figure 2, the upper part 202 includes windows 206A, 206B configured to allow a user to see inside the upper part. Specifically, windows 206A, 206B can be aligned with the labels of the containers located inside the housing, allowing the user to obtain information about the pharmaceuticals in the containers, such as the type, volume, and dosage of the drug. Windows 206A, 206B have covers to prevent the user from inserting fingers into the reconstitution device. According to the embodiment of Figure 2, the upper part also includes a window 210 to further improve the visibility of the labels. In some embodiments, the window 210 allows the user to touch and rotate a container adjacent to the window to better view the container's label. Such windows may be located on both sides of the top, allowing both containers placed within the housing to be visible and / or preferably rotated to view their labels. In some embodiments, the window of the reconfiguration device housing may include a magnifying lens to allow the user to more easily read the text on the containers placed within the reconfiguration device housing. In some embodiments, an LED or other suitable lighting element may be placed inside the top to illuminate any label on the container and / or provide the user with one or more visual warnings. Container illumination may be beneficial for pharmaceuticals for which patient visualization is desirable. In some embodiments, the lighting element may emit light of a wavelength that does not easily decompose the pharmaceuticals placed within the containers. Such arrangement may be beneficial for some photosensitive pharmaceuticals. In some embodiments, the reconfiguration device may not have a window and may be arranged to conceal the containers inside the housing.For example, such a configuration may be suitable for photosensitive pharmaceuticals that are susceptible to photodegradation.

[0137] According to the embodiment shown in Figure 2, the reconfiguration device 200 is configured to prevent access to the fluid outlet of the transfer engine located within the housing 201 before device operation, and then to allow access to the fluid outlet after device operation. That is, the sliding of the upper part 202 relative to the lower part 204 selectively exposes or covers the fluid outlet depending on the position of the upper part relative to the lower part. In some embodiments, the reconfiguration device prevents access to the fluid outlet by both concealing 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 before device operation, but access to the fluid outlet is obstructed, for example, by a physical obstacle.

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

[0139] Figure 3 is a schematic diagram of one embodiment of a transfer engine 100 for a reconstitution device in the first stage of one embodiment of a reconstitution and drug delivery process. According to the embodiments of Figures 3 to 6, the transfer engine is similar to the embodiment described in Figure 1. A first flow path 103 extends between an inlet 108 and a first open end located on a first spike 102. A second flow path 104 extends between a second open end located on a first spike 102 and a third open end located on a second spike 105. A third flow path 107 extends between a fourth open end located on a 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 to 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 the fluid to flow in one direction through the second flow path from the first spike to the second spike. The outlet 111 is configured as a Luer activation valve capable of receiving a delivery device (e.g., a syringe) that can draw the reconstituted medical fluid from the transfer engine. According to embodiments of Figures 3 to 6, the transfer engine also includes a drug filter 110 located 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 located anywhere in the flow path between the outlet 111 and the fourth open end of the third flow path 107.

[0140] As shown in the embodiments in Figures 3 to 6, the two containers are used with a transfer engine 100. Specifically, the first container 300 is configured to be punctured by a 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 partition that can be punctured by the first spike 102. The stopper can be made from rubber, silicone, or other suitable material. Of course, the disclosure is not so limited, and any suitable stopper or seal can be used. The second container 350 is configured to be punctured by a second spike 105. The second container contains a pharmaceutical drug 352 located at the bottom of the second container opposite the stopper 354. Such an arrangement can ensure that the pharmaceutical drug does not block or otherwise obstruct 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. Of course, in other embodiments, the pharmaceutical may be located in a different part of the second container, and the disclosure is not limited in that way. For example, the pharmaceutical may be located adjacent to and in contact with the stopper 354. In some embodiments, when the stopper 354 is punctured, the fluid flow through it can disintegrate the pharmaceutical so that the flow path remains free, even if the pharmaceutical is in contact with the second spike 105. In some embodiments, the puncturing tip of the spike can lift the pharmaceutical, keeping it away 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 partition that can be punctured by the second spike 105. The pharmaceutical may be a lyophilized formulation that may be in powder form to facilitate dissolution in the reconstituted fluid. Of course, the disclosure is not limited in that way, and the pharmaceutical can take any suitable form. As shown in embodiments in Figures 3 to 6, the first and second containers are inverted to allow gravity to propel the fluid in the container toward the outlet 111 or otherwise a lower height portion of the transfer engine.In other words, in some embodiments, the first and second containers are arranged such that the air inside the container is located inside the container at the end opposite the spike. Such arrangement ensures that the fluid is drawn through the spike before the air inside the container. Furthermore, according to embodiments in Figures 3 to 6, a 10 mL container is shown. However, any suitable container of any size can be used, including but not limited to containers having volumes of 0.1 mL, 0.3 mL, 0.5 mL, 1 mL, 1.25 mL, 2 mL, 2.5 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 40 mL, 50 mL, 75 mL, 100 mL, 200 mL, and 300 mL or more.

[0141] As shown in Figure 3, the first container 300 is inverted and placed on the first spike 102. Similarly, the second container 350 is inverted and placed on the second spike 105. The stoppers 304 of the first container and 354 of the second container are spaced apart from the first and second spikes, respectively, so that the first and second containers remain sealed and do not have fluid communication with the transfer engine 100. Thus, the state shown in Figure 3 can be the state of the reconfiguration device immediately before initiating the reconfiguration process. The first and second containers can be held spaced apart from the spikes 102 and 105 so that the fluid 302 in the first container and the pharmaceutical 352 in the second container remain sterile and ready for immediate use during transport, storage, and delivery to the end user or patient. In some embodiments, the transfer engine 100 may be located in the first housing portion, and the first and second containers 300, 350 may be located in the second housing portion. The second housing portion may 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 may ensure that the first and second containers remain sealed until the process is started. For example, in some embodiments, a pin or safety device may be removed or otherwise activated by the user to allow the containers to be punctured by a 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 diagram of the transfer engine 100 of Figure 3 during the second stage of the reconstitution and drug delivery process. According to the stage in Figure 4, the first container 300 and the second container 350 are punctured by the first spike 102 and the second spike 105, respectively. According to the embodiment in Figure 4, the second container 350 is under at least partial vacuum, thereby 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 Figure 4, when the first and second containers are punctured simultaneously, the pressure difference between the first container 300 and the second container 350 prompts the reconstitution fluid 302 into the second container 350. In fact, as shown in Figure 4, the pressure difference is so large that the fluid 302 may be discharged from the third open end of the second flow path 104 and strike the pharmaceutical 352 located at the end of the second container 350 opposite the second spike 105. Once the fluid is pushed into the second container 350, it mixes with the pharmaceutical to form a drug solution. The placement of the pharmaceutical at the bottom, spaced apart from the second spike 105, is configured so that a jet of fluid 353 strikes and disperses the pharmaceutical, promoting mixing of the pharmaceutical with the reconstituted fluid. In some embodiments, the pharmaceutical 352 dissolves in the reconstituted fluid. In other embodiments, the pharmaceutical rehydrates the pharmaceutical.

[0143] In some embodiments, at least one spike of the reconfiguration device may include an open end for an internal lumen (i.e., a flow path) that directs the fluid flow into the container at a certain angle. For example, in some embodiments, the lumen inside the spike may terminate at an open end located on the side of the spike. That is, the open end may be formed on a substantially perpendicular surface of the spike, thereby directing the fluid flow through the spike perpendicular to the puncture direction of the spike. In some embodiments, the spike may include multiple open ends for the lumen so that the flow is directed outward from multiple sides of the spike. In some embodiments, the open ends may be angled with respect to the puncture or insertion direction of the spike, so that the fluid flow is directed at that angle. In some embodiments, the open end of the lumen inside the spike may be angled from 1 to 90 degrees with respect to the puncture direction of the spike. Depending on the angle of the open end and the particular arrangement of the spike, various types of fluid flow may be generated when the fluid flows from the spike into the container. For example, a flow inclined with respect to the spike puncture direction may generate vortices inside the container. In some embodiments, the spikes may include flow nozzles that produce a gentle or otherwise slow atomizing spray. While we do not wish to be constrained by theory, different pharmaceuticals can be more easily reconfigured depending on the flow. Furthermore, some pharmaceuticals can be damaged, especially 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, certain harsh or powerful flows can damage or degrade different pharmaceuticals. Furthermore, some reconstituted pharmaceuticals may be sensitive to decomposition under high fluid shear. Therefore, in some embodiments, one or more flow paths in a transfer engine may include a flow limiter or otherwise be configured to limit the flow between a first container, a second container, and an outlet. For example, in some embodiments, the diameter of the flow path between the first and second containers may have a smaller cross-sectional area than the cross-sectional area of ​​flow paths elsewhere in the transfer engine. In some embodiments, the flow path between the second container and the fluid outlet may have a smaller cross-sectional area than the cross-sectional area of ​​flow paths elsewhere in the transfer engine. In some embodiments, the flow path may include a flow check valve configured to close if the fluid flow rate is too high. Such a configuration can ensure that the fluid flows at the correct velocity and that the pharmaceuticals are not accidentally damaged when drawn into the delivery device.

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

[0146] According to the embodiment of Figure 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 may 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 fluid flowing through it. Thus, when the pressure is equal 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 may help prevent some of the reconstitution fluid from flowing back into the first container 300. In some cases, fluid flowing back into the first container 300 may be difficult to extract from the transfer engine. Furthermore, a check valve may help ensure that the entire dose of the drug remains in the second container 350 to be mixed and reconstituted, and therefore the entire dose or appropriate concentration can be drawn out through the outlet 111.

[0147] In some embodiments, when the pressure in the first vessel 300, the second vessel 350, and atmospheric pressure become equal, the pharmaceutical is not yet fully combined with the reconstitution fluid. Therefore, in some embodiments, the user can oscillate or shake the transfer engine 100 or a device containing a transfer engine to ensure proper mixing of the reconstitution fluid 302 and the pharmaceutical 352. In some embodiments, as further described with reference to Figure 6, a delivery device can be used to agitate and mix the reconstitution fluid and the pharmaceutical.

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

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

[0150] In some embodiments, the third passage 107 may include an air outlet that allows for depressurization of the second container 350. In one embodiment, the air outlet may be configured as a one-way vent, thereby allowing air to escape from the second container 350 through the third passage 107, but preventing air from entering the second container. According to this embodiment, the air source located within the second container 350 may originate from the air inlet 108, so that the reconstituted fluid is drawn from the first container into the second container. However, when the syringe 400 is used to mix the chemical 356 by moving a portion of the chemical back and forth in the second container 350, the air outlet can effectively maintain a constant fluid pressure, thereby reducing the force that would cause the fluid to return to and accumulate in the second container. Of course, the air outlet may take any suitable form of a valve or filter and may be located in any suitable part of the transfer engine 100 and / or the second container 350. For example, the air outlet may be located on the second container side of the check valve 109 in the second flow path 104. In another example, the air outlet may be located at the bottom of the second container (for example, the bottom of the second container) so that pressurized air above the chemical solution 356 can escape.

[0151] Figure 7 is a perspective view of one embodiment of the reconfiguration device 200 in a non-operating state, while Figure 8 shows the reconfiguration device in an operating state. As shown in Figures 7 and 8, the reconfiguration device includes a housing 201 including an upper 202 and a lower 204 arranged similarly to the housing described with reference to Figure 2. The lower 204 includes an inner guide 205 that supports the upper 202 and allows the upper to slide relative to the lower 204. That is, the inner guide allows the upper to move linearly relative to the lower between the non-operating position shown in Figure 7 and the operating position shown in Figure 8. When the upper is in the non-operating position, the container located within the upper can be separated from the transfer engine located within the lower 204. That is, the container may remain sealed and fluidly disconnected from the transfer engine. When the upper moves to the operating position shown in Figure 8, as shown in Figure 8, the container moves toward the transfer engine, and the container area is punctured by spikes, respectively, to fluidly connect the container to the transfer engine, thereby initiating the reconfiguration process. Such arrangements are described further with reference to Figures 11 and 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 202. For example, the inner guide may have a molded groove that receives an upper fin, the fin being slidable along the groove. The components may be reversed so that the groove is on the upper and the fin is on the inner guide. Other sliding engagement arrangements may be used, such as other rails, elongated members extending through enclosed channels, or any other suitable sliding engagement arrangement.

[0153] According to embodiments shown in Figures 7-8, the reconfiguration device 200 includes an upper stop 207 formed on the upper part 202 of the housing 201 and a lower stop 209 formed on the lower part 204 of the housing. The upper and lower stops are then formed as ledges configured to contact each other when the reconfiguration device is actuated, preventing the upper part 202 from moving further toward the lower part 204. That is, the upper and lower stops define an operating position in which the upper and lower stops contact each other. In embodiments of Figures 7-8, the upper and lower stops extend along the perimeter of the upper and lower parts of the housing, respectively. Of course, in other embodiments, the stops may have any suitable arrangement, and the disclosure is not limited thereto.

[0154] Figure 9 is a side elevation view of the reconfiguration device 200 of Figure 7 in a non-operational state, and Figure 10A is a side elevation view of the reconfiguration device in an operational state. Figures 9 to 10B specifically show how physical access to the fluid outlet 111 of the reconfiguration device is prevented before operation. According to certain embodiments of Figures 9 to 10B, the fluid outlet 111 may be at least partially concealed or sealed within the housing 201 before operation. When operational, the fluid outlet 111 may be exposed so that it can be accessed by the delivery device once the drug solution is reconfigured. As shown in Figure 9, the upper part 202 of the housing includes a slot 208 and a notch 212 that form an opening in the upper part of the housing. However, in the position shown in Figure 9, nothing can be accessed through the notch 212 or the slot 208 except for a portion of the inner guide 205 of the lower part 204 of the housing 201. However, as the upper part moves toward the lower part, the notch 212 aligns with the fluid outlet 111, thereby enabling physical access to and removal of the fluid outlet. As shown in Figure 9, the fluid outlet 111 is located in a fluid outlet receptacle 213 formed in the lower part 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 is aligned with the fluid outlet receptacle. The leash allows the user to pull the fluid outlet 111 from outside the housing 201, thereby facilitating its removal. According to the embodiments shown in Figures 10A and 10B, the fluid outlet is connected to the associated transfer engine via a flexible tube 114, allowing the fluid outlet to be removed and operated while the housing 201 remains stationary. The flexible tube 114 is aligned with a slot 208, allowing a portion of the flexible tube to be released through the slot, thereby enabling operation of the fluid outlet.Therefore, in the embodiments shown in Figures 10A and 10B, once multiple containers are punctured, the fluid outlets 111 are exposed and accessible to the user for connecting a delivery device. Such an arrangement can ensure that the drug solution is at least partially reconstituted before the delivery device is connected.

[0155] As shown in Figure 10B, the fluid outlet 111 is located within the fluid outlet receptacle 213 and is physically accessible to the user when the reconfiguration device is activated. According to the embodiment in Figure 10B, the fluid outlet 111 is a Luer-activated device including 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 configured to fold within the reconfiguration device housing and unfold when the device is activated. The leash 112 may be formed of any suitable flexible material, including plastic film, rubber, etc. The user can remove the fluid outlet 111 by pulling the leash, but it may otherwise be difficult to grasp and remove it from the fluid outlet receptacle 213. In some embodiments, the leash 112 may be located 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 a flexible tube. In some embodiments, the leash may be a molded sleeve that fits onto at least a portion of the fluid outlet 111 and provides an area from which a user can grasp the leash and use it to remove the fluid outlet from the fluid outlet receptacle.

[0156] Of course, one embodiment of the housing that selectively allows physical access to the fluid outlet is shown and described with reference to Figures 9–10B, but other suitable configurations are contemplated. For example, in one embodiment, the upper housing does not have to 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, door, etc.) may move simultaneously 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 before the operation of the reconfiguration device, but may be at least partially blocked so that the fluid outlet is not physically accessible. In one such embodiment, the fluid outlet receptacle may have an opening that is partially open when the reconfiguration device is not operating. When the reconfiguration device is operating, 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 may be held in any suitable part of the reconfiguration device housing, including the lower or upper part of the housing, before the operation of the device, as this disclosure is not so limited. In some embodiments, the top of the housing is molded as shown in the embodiments of Figures 9 to 10B, but the housing is transparent, so that the fluid outlet is visible but not physically accessible before the device is activated.

[0157] Figure 11 is a cross-sectional view of the reconfiguration device of Figure 7 taken along line 11-11 showing the reconfiguration device with a non-operating vessel, while Figure 12 is a cross-sectional view of the reconfiguration device of Figure 8 taken along line 12-12 showing the reconfiguration device with an operating vessel. As shown in Figure 11 and described earlier, the reconfiguration device includes a housing 201 having an upper part 202 and a lower part 204. The lower part is slidably positioned on the upper part, and an inner guide 205 provides a sliding interface with the upper part. As shown in Figures 11 and 12, the first vessel 300 and the second vessel 350 are positioned on the upper part 202. In Figure 11, the first and second vessels are spaced apart from the first spike 102 and the second spike 105 of the transfer engine, respectively, thereby keeping the first and second vessels sealed. In Figure 12, the first and second containers move toward the spikes 102 and 105, thereby causing the spikes to simultaneously puncture the stopper 304 of the first container and the stopper 354 of the second container. When moving from the non-operating position to the operating position, the user can place the lower part 204 of the housing 201 on a flat surface to function as a base. The user can then apply force to the curved upper surface 203 of the housing to move the upper part 202 toward the lower part 204, thereby moving the first and second containers 300 and 350 into contact with the spikes. Once the first and second containers are punctured, the reconstruction process can be initiated, an exemplary embodiment thereof has been previously described with reference to Figures 3 to 6.

[0158] While specific embodiments of the housing 201 are shown in Figures 11-12, it should be noted that the housing can take any suitable shape to allow two containers to selectively move toward one or more container receiving ends of a fluid transfer engine. For example, in one embodiment, the upper part of the housing can be housed inside the lower part. In another embodiment, the upper surface 203 of the housing may not be curved, or may be curved to a lesser extent. Furthermore, the upper housing can include one or more retaining mechanisms to secure the first container 300 and the second container 350 inside. For example, tabs, protrusions, and / or shelves corresponding to the shape of the containers can be used to maintain the distance between the containers and the transfer engine. Furthermore, in some embodiments, one or more biasing members are required to bias the reconfiguration device toward a 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 housing of the reconfiguration device may be formed separately. The lower part of the housing may include a slot or transfer engine receiving portion configured to receive the transfer engine. The transfer engine can be secured to the lower part with any suitable configuration, including but not limited to mechanical fasteners (e.g., screws, bolts, etc.), snap-fit ​​tabs, and adhesives (e.g., glue, epoxy, etc.). Such an arrangement may allow the flow path of the transfer engine to be sterilized before assembly with the reconfiguration device housing. In some embodiments, the reconfiguration device includes other components that may be sensitive to certain sterilization processes, such as containers for pharmaceuticals or electronic devices. In some embodiments, having a transfer engine that can be sterilized separately before assembly with the device housing eliminates the need to sterilize the entire reconfiguration device and therefore eliminates the need to expose components sensitive to certain sterilization processes to such processes.

[0160] In some embodiments, the reconfiguration device can be stored and transported in a packaging container. The packaging container may be formed as a clamshell 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 part of the housing from moving relative to the lower part of the housing, or vice versa. That is, one or more protrusions or tabs can engage with the upper part to hold the upper part in a non-operating position. Such an arrangement can ensure that the reconfiguration device does not accidentally operate during transport and storage.

[0161] In some embodiments, a reconfiguration device having a housing with an upper and lower portion movable relative to each other between an operating position and a non-operating position may include one or more locking latches that permanently lock the housing in the operating position after the device has been activated. For example, in one embodiment, a latch located at the lower portion of the housing can capture and permanently hold the upper portion of the housing when the upper housing moves to the operating position. The latch can be located inside the housing so as not to be accessible to the user. Thus, the housing can be effectively locked in the operating position and the upper portion cannot be returned to the non-operating position non-destructively. Such an arrangement can prevent a user from disassembling the reconfiguration device or deter an attempt 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 reconfiguration 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 will be 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, thereby allowing the fluid outlet to move relative to the first and second spikes. 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 reconfiguration device housing. According to the embodiment shown in Figure 13, the fluid outlet 111 is adjacent to the air inlet 108, thereby effectively forming a geometric circuit of the transfer engine. Furthermore, in some embodiments shown in Figure 13, all parts of the flow path are coplanar with each other within the transfer engine.

[0163] In some embodiments, each of the spikes 102, 105 of the transfer engine 100 may have a corresponding sheath configured to seal and / or protect the flow path located within the transfer engine. The sheath may be configured to be compressible and to be destroyed by the spikes 102, 105 when a container is punctured by the spikes. Such an arrangement may help the sterile flow path of the transfer engine maintain its sterile state during storage and transport of the reconstitution device. Furthermore, the sheath may 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.

[0164] Figure 14 is a top cross-sectional view of the transfer engine 100 of Figure 13 taken along 14-14, showing the geometric arrangement of various flow paths. As shown in Figure 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 the first lumen 120 within the first spike. The second flow path 104 defines the second lumen 122 within the first spike and the third lumen 124 within the second spike 105. The check valve 109 is positioned along the second flow path 104. Finally, the third flow path 107 defines the fourth lumen 126 within the second spike and extends to the fluid outlet connector 115. As previously mentioned, the fluid outlet connector can receive a flexible tube that generates a continuous flow path to the movable fluid outlet.

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

[0166] Although the embodiment in Figure 14 shows a rectangular transport engine, in other embodiments the transport engine can take any suitable shape. For example, the transport engine may be circular, elliptical, square, or any other suitable shape, and the disclosure is not limited in this respect.

[0167] According to the embodiment of Figure 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 Figure 14, the ratio between length L and width W may be 3 to 5. Thus, the length of the transfer engine may be 3 to 5 times longer than the width of the transfer engine, making it well suited for housing in a linearly arranged container. The transfer engine may include a movable fluid outlet connected via a flexible tube (see Figure 13), so that the flow paths extending parallel to the spikes 102, 105 and the inlet 108 and the fluid outlet connector 115 can 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 curve around 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, the disclosure is not so limited, and in other embodiments, any suitable length-to-width ratio may be used.

[0168] Figure 15 is a flowchart of one embodiment of the reconstitution and drug delivery process. In step 500, the first and second containers are provided within a housing, the top of which encloses the first and second containers at least partially. The first and second containers may each contain a reconstitution fluid and a drug for reconstitution. In some embodiments, step 500 may be omitted, and the process may begin in step 502. In step 502, a force is applied to the top of the housing, moving the top from a first non-operating position to a second operating position. Applying a force to the top may include applying a force linearly toward the plane in which the housing is positioned. In step 504, as the top moves to the operating position, the first container is punctured with a first spike and the second container is punctured with a second spike. In step 506, the fluid is allowed to flow from the first container to the second container, occupying the vacuum in the second container. Enabling the fluid to flow into the second container may include moving the fluid through a check valve positioned between the first and second spikes and discharging the fluid into the second container at a rate that may help facilitate reconstitution. In step 508, the fluid is mixed with the formulation or drug in the second container to produce a drug solution. In step 510, a syringe (or other delivery device) is connected to the fluid outlet to draw the drug solution from the second container.

[0169] Figure 16 is a flowchart of another embodiment of the reconstitution and drug delivery process. In step 600, the first and second containers are provided within a housing, the top of which encloses the first and second containers at least partially. The first and second containers may each contain a reconstitution fluid and a drug for reconstitution. In some embodiments, step 600 may be omitted, and the process may begin in step 602. In step 602, a force is applied to the top of the housing, moving the top from a first non-operating position to a second operating position. Applying a force to the top may include applying a force linearly toward the plane in which the housing is positioned. In step 604, as the top moves to the operating position, the first container is punctured with a first spike and the second container is punctured with a second spike. In step 606, the fluid is allowed to flow from the first container to the second container, occupying the vacuum in the second container. Enabling the fluid to flow into the second container may include moving the fluid through a check valve positioned between the first and second spikes and discharging the fluid into the second container at a rate that can help facilitate reconstitution. In step 608, the syringe is connected to the fluid outlet to withdraw at least a portion of the drug solution from the second container. For example, in one embodiment, the syringe handle may be moved away from the fluid outlet. In step 610, the withdrawn portion of the drug solution is returned to the second container and deposited using the syringe. For example, step 610 may be achieved by pushing the syringe handle toward the fluid outlet to increase the pressure of the drug solution.

[0170] In some embodiments, steps 608 and 610 shown in Figure 16 can be used in processes where there is no vacuum in the second container or the vacuum is insufficient to draw the reconstituted fluid from the first container to the second container. In such embodiments, a syringe can be used to draw the fluid from the first container to the second container and finally into the syringe. Once the fluid is at least partially in the syringe, the drawn portion of the fluid is deposited back into the second container, allowing the contents of the first and second containers to mix with each other, and the process is repeated until the contents of the first and second containers are thoroughly mixed.

[0171] Figure 17 is a flowchart of another embodiment of the reconstitution and drug delivery process. In step 650, the first and second containers are provided within a housing, the top of which encloses the first and second containers at least partially. The first and second containers may each contain a reconstitution fluid and a liquid drug for reconstitution. In some embodiments, step 650 may be omitted, and the process may begin in step 652. In step 652, a force is applied to the top of the housing, moving the top from a first non-operating position to a second operating position. Applying a force to the top may include applying a force linearly toward the plane in which the housing is positioned. In step 654, as the top moves to the operating position, the first container is punctured with a first spike and the second container is punctured with a second spike. In step 656, the fluid is made available to flow from the first container to the second container. According to the embodiment of Figure 17, the fluid does not necessarily have to flow automatically from the first container to the second container. Nevertheless, the reconstituted fluid and the liquid drug can be at least partially mixed once the container is punctured. In step 658, the syringe is connected to the fluid outlet to draw out at least a portion of the drug 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 drug solution and the reconstituted fluid may be drawn into the syringe in a single draw. In step 660, the drawn portion of the drug solution is returned to the second container and deposited using the syringe. For example, step 660 can be achieved by pushing the syringe handle toward the fluid outlet. Step 660 can be used if the drug solution and the reconstituted fluid are not sufficiently mixed. In some cases, steps 658 and 660 can be repeated to more completely mix the reconstituted fluid and the drug solution.

[0172] Figure 18 is a schematic diagram of one embodiment of a reconfiguration device 700 for communicating with one or more remote devices. As shown in Figure 18, the reconfiguration device is similar in shape and size to the reconfiguration device described with reference to Figure 2. The reconfiguration device includes a housing 701 including an upper part 702 and a lower part 704. The upper part is configured to slide relative to the lower part, and an inner guide 705 is received in the upper part to support and guide the upper part when sliding between a non-operating position and an operating position. According to the embodiment of Figure 18, the reconfiguration device 700 includes a processor 708 (e.g., a programmable logic controller) located in the lower part 704, along with a communication device 710 and an internal power supply configured as a battery 712. The processor is configured to execute one or more computer-readable instructions stored in a set of volatile or non-volatile memory located in the lower part 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 the following protocols: 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 this disclosure is not so limited.

[0173] In some embodiments, the reconfiguration device may include a marker such as a QR code® or other identification label (e.g., a barcode). Such a marker can be used to link the reconfiguration device to an application (e.g., a smartphone application) or, otherwise, to enable tracking by a complementary remote device (e.g., a smartphone). In some embodiments, by scanning the QR code® using a suitable reader or camera, information regarding drug dosage, drug identification, and / or the amount of drug placed in the reconfiguration device can be captured by a complementary remote device for display to the user. The complementary device may 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® or other marker may be hidden from view inside the reconfiguration device housing or otherwise prevented from being accessed before the device is activated. Once the device is activated, the QR code® is displayed or otherwise made accessible for the user to scan.

[0174] According to some embodiments and as shown in Figure 18, the electronics of the reconfiguration device can only be operated when the reconfiguration device is activated. That is, when the upper part 702 is in a non-operating position, the processor 708 and the communication device 710 may be in a hibernation state, sleep state, or electrically disconnected from the power supply. When the upper part 702 moves to the operating position (for example, by moving closer to the lower part 704, thereby, for example, the bottom surface of the upper part approaching the base of the lower part), one or more switches are triggered to start the processor and the communication device or connect them to the power supply. Thus, the onboard power supply may not be depleted during transport and storage and can hold enough charge to power the reconfiguration device when the device is activated. According to the embodiment of Figure 18, the reconfiguration device includes a first Hall effect sensor 716 and a second Hall effect sensor 718 located in the lower part 704 of the housing. The Hall effect sensors are configured to sense the adjacent presence of a magnet 714 located in the upper housing. That is, the first Hall effect sensor is configured to sense when the upper part 702 is in a non-operating position, and the second Hall effect sensor is configured to sense when the upper part 702 is in an 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 the Hall effect sensors are shown in Figure 18, the position of the upper part can be determined using any suitable switch or sensor, including but not limited to linear potentiometers or microswitches.

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

[0176] The display of status by the visual indicator may be coordinated 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 state 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 reconfiguration fluid is mixed with the pharmaceutical in the device, and green when the pharmaceutical solution is ready to be drawn out of the device. Of course, this disclosure is not limited in that way, and any appropriate color or flashing pattern can be used to indicate any desired state. In some embodiments, a communication device 710 may also communicate the state of the reconfiguration device to a remote device, as will be further described below. In some embodiments, the reconfiguration device may include one or more light sources configured to illuminate a container placed within the reconfiguration device.

[0177] According to the embodiment shown in Figure 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 parties, who may use the information in different ways. The communication may be unidirectional or bidirectional. The communication may utilize any number of local or external networks, including the Internet, to communicate with the remote devices. For example, in some embodiments, the reconfiguration device may use short-range communication protocols to communicate with base stations or local relays, such as Bluetooth®, ZigBee®, infrared transmission, and radio frequency (RF) communication. Thus, even if the reconfiguration device does not have longer-range communication capabilities such as Wi-Fi or cellular network technology, or if the user has not activated these communication functions, the reconfiguration device can communicate wirelessly with local relays. In some embodiments, the reconfiguration device may also use short-range communication protocols to communicate wirelessly with nearby external devices, such as mobile devices. In some embodiments, the reconfiguration device can communicate wirelessly over longer distances with other external devices, such as directly with a remote server 724 or a personal computer 721. In some embodiments, the reconfiguration device can send messages containing information to one or more remote devices. This information may include time information, dosage, drug lot information, and other medically relevant parameters. In some embodiments, the reconfiguration device may include a Global Positioning System (GPS) sensor configured to provide location information to a processor 708. In such embodiments, the information may 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 may include orientation, mean acceleration, and the like 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 may 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 may utilize information from the reconfiguration device and / or transmit commands or other information to the reconfiguration device. As a first example, information from the reconfiguration device may be transmitted directly or indirectly to a patient. The patient may 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 may use a mobile device to obtain information from the remote server 724 via an internet website or other program. In some embodiments, the user may have access to a “patient services” mechanism that functions as a type of customer service to the user. The user may connect to this service via telephone, text, website, live chat, or other appropriate form of communication for assistance related to the reconfiguration device and / or medication. As an example, in some embodiments, the patient may use the patient services function to receive training on how to use the reconfiguration device and / or any accessories related to the reconfiguration device, how to troubleshoot any problems that may arise, or any questions related to the reconfiguration device or medication. In some embodiments, the patient may use the patient services function to receive assistance with payment and / or insurance issues. Patient services may need to access information from the patient's reconfiguration device to assist the patient with some of these issues. In some embodiments, this information can be obtained from a remote server 724.

[0179] In some embodiments, the reconfiguration device 700 can communicate directly or indirectly with healthcare providers, such as hospitals and clinics, and their staff, such as nurses or doctors. Healthcare providers may obtain information from a remote server 724 or other external devices, such as a mobile device 722 that receives information from the reconfiguration device 700. Alternatively, healthcare providers may communicate directly with the reconfiguration device 700. Information that may be transmitted to healthcare providers includes, but is not limited to, administration times, dosages, and patient symptoms. Healthcare providers can use the information to monitor patient compliance and / or determine the effectiveness of medication and / or dosage plans for patients. From the information, healthcare providers may, for example, choose to educate and / or encourage patients and / or adjust their treatment. Communication between the reconfiguration device and healthcare providers may be one-way or two-way. For example, in some embodiments, healthcare providers may be able to send messages, such as reminders or alerts, to the patient via the reconfiguration device itself or to a mobile device used by the patient in conjunction with the reconfiguration device, for example, via an application running on the mobile device which may be specific to use with the reconfiguration device and / or a particular treatment in which the reconfiguration device is used. Through the application on the mobile device or the reconfiguration device itself, the patient can send questions or concerns directly to the healthcare provider, and the healthcare provider can provide replies to the patient.

[0180] In some embodiments, 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, and the patient's symptoms.

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

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

[0183] In some embodiments, information collected from the reconstituted device 700 may be useful in providing information on the performance of a drug. The inventors recognize that, outside of clinical trials, it can be difficult to evaluate the performance of a drug once it is widely distributed to the public. Communication from the reconstituted device, as well as from other sources such as mobile devices and / or healthcare providers, can be useful in providing information on the performance of the drug and / or the reconstituted device. Information on the patient's symptoms and treatment progress can be collected from the patient, for example, through an electronic symptom diary embedded in a companion app running on a mobile device, and / or from notes taken by healthcare providers during the patient's clinic visits. The collected information can be useful in informing suppliers of the design of future formulations and / or reconstituted devices, and may be useful in promoting the use of the drug using positive performance data.

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

[0185] In some embodiments, the reconfiguration device 700 may 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, thereby avoiding the typical pairing process. Such a configuration may be beneficial in enabling reconfiguration device communication without requiring the devices to be pre-paired or otherwise prepared for specific use with the reconfiguration device.

[0186] While the embodiment shown in Figure 18 illustrates a reconstitution device, it should be noted that in other embodiments, a device like the one in Figure 18 may be a drug delivery device configured to pool drug solutions, as opposed to reconstituting solid pharmaceuticals. Therefore, the various mechanisms and methods described with reference to Figure 18 are applicable to drug delivery devices configured to pool fluids, and this disclosure is not so limited.

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

[0188] Figures 19A and 19B are schematic diagrams of another embodiment of the reconfiguration device 800 in a non-operational and operational 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 surfaces. 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 the corresponding first wedge 808A and second wedge 808B. The first and second wedges are configured to move the first and second containers toward the base 804 of the housing 802, puncturing them with a first spike and a second spike, respectively. That is, as shown in Figures 19A and 19B, the first and second actuators can be compressed or otherwise pushed into the housing 802 to drive the first and second wedges downward toward the base 804 of the housing. When the actuators and the inclined surfaces of the wedges engage with each other, the lateral movement of the actuators is converted into the downward movement of the wedges, driving and puncturing the container. Such a configuration can provide mechanical advantages for puncturing the container.

[0189] Figures 20A and 20B are schematic diagrams of another embodiment of the reconfiguration device 900 in a non-operational and operating state, respectively. As shown in Figures 20A and 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 moves toward the lower part from a non-operational 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 screw-connected to the bolt and fixed relative to the upper part. Thus, a user can operate the reconfiguration device by turning the handle 910 to move the upper part toward the lower part. In doing so, the first spike 102 can puncture the first container 300 and the second spike 105 can puncture the second container 350.

[0190] Figures 21A and 21B are schematic diagrams of another embodiment of the reconfiguration device 1000 in a non-operational and operational state, respectively. As shown in Figures 21A and 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 toward the lower part from a non-operational position to an operational position. The reconfiguration device includes a lever 1008 rotatably connected to the lower part 1004. The lever 1008 protrudes from a slot 1006 in the upper part 1002 so that the lever can apply force to the upper part. Thus, in order to operate the reconfiguration device, the lever is moved toward the lower part from the upper position shown in Figure 21A, thereby moving the upper part toward the lower part in a corresponding manner. In this way, the first spike 102 can puncture the first container 300 and the second spike 105 can puncture the second container 350.

[0191] Figure 22 is a perspective view of another embodiment of the transfer engine 1100. As shown in Figure 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 first plate and a flow path, and a second plate 1104 forming a third plate 1106 and a filter chamber 1117. In some embodiments, the transfer engine includes an inlet 1109 (e.g., an air inlet) which may include a hydrophobic filter. 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 is located in the second flow path to allow unidirectional flow from the first spike to the second spike. A third flow path 1115 extends from the second spike 1114 and includes a filter inlet 1116. The filter inlet allows the fluid to flow from the third flow path between the first plate 1102 and the second plate 1104 to a filter chamber 1117 located between the second plate 1104 and the third plate 1106. A filter is placed within the filter chamber to effectively filter the chemical solution passing toward the fluid outlet. The arrangement of the filter chamber may allow 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 the earlier embodiments described herein.

[0192] Figure 23 is a side cross-sectional view of the transfer engine of Figure 22 taken along line 23-23. As shown in Figure 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. Although the transfer engine of Figure 22 is formed of three separate plates, it should be noted that the transfer engine may be formed of a single integrated part or of any appropriate number of components that form various flow paths. For example, in some embodiments, the transfer engine may be formed of two separate plates joined together to form multiple flow paths.

[0193] As shown in Figure 23, the channels extend into the lumens of the first and second spikes. Specifically, the first channel 1110 extends into the first lumen 1120 located within the first spike 1111. The third channel 1115 extends into the fourth lumen 1126 located within the second spike 1114.

[0194] Figure 24 is a top cross-sectional view of the transfer engine of Figure 22 taken along line 24-24, and Figure 25 is a top cross-sectional view of the transfer engine of Figure 22 taken along line 25-25. As shown in Figure 24, the flow paths are arranged in a circuit configuration similar to the embodiments described above herein. That is, the first flow path 1110 and the third flow path 1115 are arranged mirror-parallel to the second flow path 1112. However, instead of the outlet 1118 being adjacent to the inlet 1109, the outlet 1118 is located on the opposite side of the transfer engine, opposite the filter inlet 1116. As shown in Figure 24, the first flow path 1110 extends into the first lumen 1120. The second flow path 1112 extends from the second lumen 1122 into the third lumen 1124. The third flow path 1115 extends from the fourth lumen 1126 to the filter inlet 1116. Figure 25 shows a filter chamber 1117 extending 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 Figure 25, the outlet 1118 is configured so that the fluid flows down from the filter inlet 1116 and is delivered to the patient before being drawn back through the outlet. Such an arrangement ensures that the fluid passes through the filter before being delivered. Figure 26 is a perspective view of another embodiment of the transfer engine 1200. As shown in Figure 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. Connecting the spike housings is a tube 1220. The tube 1220 may be flexible or rigid. Such an arrangement allows the intercenter spacing of spikes 1203 and 1211 to be varied for various container sizes using the same spike housing. That is, tubes 1220 can be replaced to have different lengths to accommodate embodiments of reconfiguration devices of different sizes.

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

[0196] Figure 29 is a schematic cross-sectional view of one embodiment of the spike 1300. As shown in Figure 29, the spike includes a first flow path 1302 terminating at a first open end 1304. According to the embodiment of Figure 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 puncture or insertion direction, and α is equal to 90 degrees. Thus, if the fluid exits the first open end 1304 at high speed, the fluid can generate vortices in the container to facilitate mixing of the reconstituted fluid and the pharmaceutical. As shown in Figure 29, the spike includes a second flow path 1306 terminating 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, and the first and second open ends may be symmetrical or have any combination of angles with respect to the spike insertion direction.

[0197] Figure 30 is a schematic cross-sectional view of another embodiment of the spike 1400. As shown in Figure 30, the spike includes a first flow path 1402 terminating at a first open end 1404. According to the embodiment of Figure 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-perpendicular angle β equal to about 45 degrees. Thus, if the fluid exits the first open end 1404 at high speed, the fluid can generate vortices within the container to facilitate mixing of the reconstituted fluid and the pharmaceutical. As shown in Figure 30, the spike includes a second flow path 1406 terminating 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 or 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 between 1 and 90 degrees.

[0198] Figure 31 is a schematic cross-sectional view of another embodiment of the spike 1500. As shown in Figure 31, the spike includes a first flow path 1502 terminating at a plurality of first open ends 1504A, 1504B, 1504C. According to the embodiment of Figure 31, the first open ends are angled with respect to the spike insertion direction S. The arrangement of the first flow path with 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 compared to an arrangement with a single first open end. As shown in Figure 31, the spike includes a second flow path 1506 terminating at a second open end 1508. In contrast to the first open ends, the second open ends are parallel to the spike insertion or puncture direction.

[0199] In some embodiments, the reconfiguration device may include a fluid outlet that is releasably held within the housing of the reconfiguration device until a delivery device is coupled. Figures 32A–32D illustrate schematic diagrams of another embodiment of one such reconfiguration device 1600. As shown in Figures 32A–32D, the reconfiguration device includes a housing having an upper part 1602 and a lower part 1604. The upper part is movable (e.g., slidable) relative to the lower part, and the upper part moves toward the lower part from a non-operating position to an operating position. The upper part 1602 of the housing includes a notch 1606 configured to selectively provide physical access to a fluid outlet 1610 located inside the reconfiguration device housing. That is, the fluid outlet 1610 is not physically accessible when the housing is in the non-operating position, but is physically accessible through the notch 1606 when the reconfiguration device is operating. The fluid outlet 1610 is releasably held inside the reconfiguration device housing by a retainer 1608 configured to abut against a projection 1612 located on the fluid outlet 1610. The retainer and projection are positioned so that the connection of the delivery device (e.g., a syringe) to the fluid outlet 1610 frees the fluid outlet from the reconfiguration device housing. The fluid outlet 1610 is then connected to the reconfiguration device's transfer engine by a flexible tube 1616, allowing the fluid outlet to be detached from the housing and moved.

[0200] In the state shown in Figure 32A, the reconfiguration device is in a non-operational state. That is, the upper part 1602 has not moved toward the lower part 1604. Therefore, the notch 1606 is not aligned with the fluid outlet 1610, and thereby the fluid outlet 1610 is not physically accessible to the user. According to the embodiment in Figure 32A, when the device is not operating, the fluid outlet is completely contained within the housing, but other configurations are possible. For example, the fluid outlet may be partially located within the housing and blocked until the reconfiguration device is activated. In some embodiments, the fluid outlet may be visible to the user before the reconfiguration device is activated, but may be at least partially blocked so that the fluid outlet is not physically accessible. The fluid outlet 1610 is shown in Figure 32A with dashed diagonal shading for clarity.

[0201] In the state shown in Figure 32B, the reconfiguration device is in operation; that is, the upper part 1602 of the housing is moving toward the lower part 1604 of the housing. As described with reference to other exemplary embodiments described herein, the operation of the reconfiguration device allows for the puncture of the fluid vessel within the reconfiguration device housing. As shown in Figure 32B, the notch 1606 is aligned with the fluid outlet 1610, thereby making the fluid outlet 1610 physically accessible by the user outside the reconfiguration device housing. As shown in Figure 32B, the projection 1612 of the fluid outlet 1610 is positioned inside the retainer 1608 (i.e., inside the retainer relative to the reconfiguration device housing). Thus, although the fluid outlet 1610 is physically accessible, the retainer 1608 holds the fluid outlet in a releaseable manner inside the reconfiguration device housing. Furthermore, the retainer 1608 can provide frictional resistance against rotation of the fluid outlet 1610 within the reconfiguration device housing. In the embodiment of Figure 32B, the retainer and fluid outlet are configured to fully connect a delivery device to the fluid outlet, thereby releasing the fluid outlet from the reconfiguration device housing. That is, in some embodiments, the fluid outlet can be retained within the reconfiguration device housing until a suitable delivery device is fully connected to the reconfiguration device. In the embodiment of Figure 32B, the retainer is configured to allow a rotational force to be applied to the fluid outlet 1610 by the delivery device, as further described with reference to Figure 32C, thereby releasing the projection 1612 from the retainer. According to the embodiment of Figure 32B, the notch 1606 may be sized and shaped such that the upper part 1602 of the housing prevents a user from physically accessing the fluid outlet 1610 with anything other than a suitable delivery device. For example, the notch may be sized and shaped such that multiple fingers cannot be inserted through the notch to grasp the fluid outlet 1610, but a delivery device such as a syringe can be inserted through the notch to interact with the fluid outlet. In this way, the notch 1606 can facilitate the proper use of the delivery device and connect the fluid outlet to the delivery device.

[0202] In the configuration shown in Figure 32C, a delivery device (e.g., a syringe) 1614 is connected to a fluid outlet 1610 located inside the reconfiguration device. In the embodiments of Figures 32A to 32D, the fluid outlet 1610 includes a male thread and is configured as a Luer actuating device. Thus, the delivery device 1614 includes a corresponding thread configured to engage with the thread of the fluid outlet. When the reconfiguration device is in the configuration shown in Figure 32B, the delivery device 1614 can be screw-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 screw-connected, the fluid outlet 1610 can be held within the reconfiguration device housing until the delivery device is fully connected to the fluid outlet. Once the delivery device is fully connected, further rotation of the delivery device can overcome the frictional resistance of the retainer 1608 and rotate the fluid outlet 1610 to the configuration shown in Figure 32C, where the projection 1612 is no longer aligned with the retainer 1608. This rotation of the fluid outlet can indicate to the user that the delivery device is fully coupled to the fluid outlet and that the fluid outlet can be released from the reconfigurable device housing.

[0203] As shown in Figure 32D, the fluid outlet 1610 is released from the reconfiguration device housing and removed through the notch 1606. As previously mentioned, once the delivery device 1614 is screw-connected to the fluid outlet 1610, the projection 1612 can pass through the retainer 1608. Therefore, by pulling the delivery device 1614, the fluid outlet 1610 can be removed through the notch 1606. As shown in Figure 32D, the fluid outlet is connected to the reconfiguration device via a flexible tube 1616 so that the fluid outlet 1610 can be moved to the 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] One embodiment of a reconfigurable device housing, including a fluid outlet that is releasably held within the housing until a delivery device is connected, is described with reference to Figures 32A–32D, but other configurations are contemplated and the disclosure is not so limited in this respect. For example, in some embodiments, the fluid outlet may be connected to the reconfigurable device housing using a fragile connection that can be broken by connecting a delivery device to the fluid outlet. In some embodiments, connecting a delivery device to the fluid outlet can release a latch that holds the fluid outlet within the reconfigurable device housing. In some embodiments, the fluid outlet may have a friction fit with the reconfigurable device housing, and the friction fit is released when a delivery device is connected to the fluid outlet. A user can release the fluid outlet from the reconfigurable device housing using any suitable operation or combination of operations of the delivery device, including pushing, pulling, rotating, twisting, etc.

[0205] Another exemplary embodiment of the transfer engine 2100 is shown in Figures 33 to 35. As shown in Figure 33, the transfer engine includes a first spike 11 and a second spike 14. As shown in Figure 35, in some embodiments, the transfer engine includes an inlet 136 (e.g., an air inlet) which may include a hydrophobic filter. In some embodiments, the transfer engine may include a filter chamber 137 that receives the hydrophobic filter of the inlet. 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, comprising a second lumen 282, a tube 290, and a third lumen 293, connects the first spike 11 to the second spike 14. The third lumen 293 extends through the second spike 14. A check valve 271 is located in the second flow path to allow unidirectional flow from the first spike to the second spike. A third flow path, comprising a fourth lumen 286 and a pathway 135 through the second spike 14, fluidly connects the second spike 14 to an outlet 298. In some embodiments, the tube can be connected to the outlet 298 to guide the fluid to a fluid outlet (e.g., a Luer connector or other connector) for administration to a user.

[0206] The first spike 11 may be formed as part of 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 together via an interlock 280. In some embodiments, the interlock 280 may be formed by a projection 284 on the second plate 264 that is received in a recess 283 on the first plate 262. It should be understood that the positions of the projection and recess may be reversed. Furthermore, other interlock shapes may be used, such as multiple projections / recesses, other jigsaw shapes, or any other suitable shape.

[0207] In the exemplary embodiments shown in Figures 33 to 35, the path 135 is a molded channel that is molded as part of the second plate 264 or otherwise can be 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 embodiment is not limited in that way.

[0208] In the exemplary embodiments shown in Figures 33 to 35, the tube 290 connects the first spike 11 to the second spike 14. In some embodiments, plates 262 and 264 may include recesses 78 and 79, respectively, to accommodate the tube 290. However, it should be understood that in other embodiments, the first and second spikes can be connected instead of the tube using a molded path or other suitable arrangement.

[0209] As shown in Figure 33, in some embodiments, the transfer engine may include spike sheaths 85, 87 that cover the spikes 11, 14 before the reconfiguration device is activated. When the container is pressed down onto the spikes during operation, the spikes may pass through the spike sheaths and puncture into the container. In some embodiments, the spike sheaths help prevent foreign matter from entering the flow path and / or prevent accidental premature puncture of the container by covering the lumen of the spikes before use.

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

[0211] As described above, in some embodiments, the reconfiguration device may be configured such that physical access to the fluid outlet is prevented before operation. As previously stated, in some embodiments, a flexible leash can be connected to the fluid outlet. User access to the flexible leash may be permitted by aligning a notch at the top of the housing with the fluid outlet receptacle. According to one embodiment, in some embodiments, the flexible leash, for example, a pull tab, may be part of a cap covering the fluid outlet, or otherwise attached to the cap. By pulling the leash, the cap can be removed from the fluid outlet, exposing 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, so that pulling the leash can remove the fluid outlet from the housing. In some embodiments, the retaining force between the fluid outlet and the housing may be less than the retaining force between the cap and the fluid outlet, so that pulling the pull tab first removes the fluid outlet from the housing, and then the cap from the fluid outlet. However, in other embodiments, the fluid outlet is fixed relative to the housing and is not configured to be pulled out from the housing during use.

[0212] One exemplary embodiment of the reconfiguration device 3200 is shown in Figure 36, the device having 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 Figure 36, the fluid outlet 430 may be formed using a flange 440 which can be attached to an extension 250 of the lower part 422 of the housing, or it may be attached to the flange 440. In some embodiments, an additional flange may be positioned behind the extension 250 and attached to a tab to provide further retaining reinforcement. However, it should be understood that the embodiment is not so limited, and the fluid outlet may be fixed to the lower part of the housing by any suitable mounting arrangement.

[0213] A cap 432 having a pull tab 434 covers a 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 pushes the pull tab 434, thereby causing the pull tab to be folded or otherwise compressed. When the upper part 421 is pressed down, a notch 424 in the upper part 421 moves to align with the fluid outlet 430 and the cap 432, so that the pull tab 434 can be unfolded and extended out of the notch 424 for user access.

[0214] Figures 37A to 37C depict various operating stages of the reconfiguration device 3200. In Figure 37A, the device is in a non-operating state. The notch 424 in the upper part 421 of the housing is spaced apart 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 obstructed by the upper part of the housing. In some embodiments, the pull tab may be invisible. 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 remain unable to access the pull tab.

[0215] To move the device to the operating state shown in Figure 37B, the user can push the upper part 421 of the housing downward, causing it to slide downward toward the lower part 422 of the housing. The downward movement of the upper part 421 aligns the notch 424 with the fluid outlet 430 and cap 432, allowing the pull tab 434 to unfold and extend from the notch 424.

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

[0217] Another exemplary embodiment of the reconfiguration device 3300 is shown in Figures 38 to 40D. The device has a housing 820 having an upper part 821 and a lower part 822. The device includes a fluid outlet 830 movable relative to the lower part 822 of the housing. As shown in the exploded views of Figures 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. Before operation, the clip is removably coupled to the lower part 822 of the housing. After operation, the user can separate the clip from the lower housing by pulling the fluid outlet out of the housing. As seen in Figure 39, the inner guide 823 of the lower part 822 of the housing may include a slot 306 sized to receive the second leg 319 of the clip 310. The clip is shown fully engaged with the slot 306 in Figure 38. As shown in Figure 38, with 310 fully engaged with slot 306, the clip 310 and slot 306 may be positioned vertically below the fluid outlet 830. However, in other embodiments, the clip and / or slot may be positioned at different locations relative to the fluid outlet, such as vertically above, to the left, or to the right of the fluid outlet.

[0218] In this exemplary embodiment, a cap 840 with a pull tab 842 can cover the fluid outlet 430 before the device is activated. When the user pulls the pull tab 842 after the device has been activated, the second leg 319 slides through the slot 306 and comes out, thus disconnecting the clip and the fluid outlet 830 from the lower part 822 of the housing. Thus, 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 retaining force of the cap 840 on the fluid outlet 830 may be greater than the retaining force of the clip 310 on the lower part 822 of the housing. Therefore, when the pull tab 842 is pulled, the clip 310 may come out of the slot 306 and detach first before the cap 840 detaches from the fluid outlet 830.

[0219] In some embodiments, the notch 824 in the upper part 821 includes an expanding opening 825 that can accommodate the movement of the clip 310 through the notch.

[0220] Figures 40A to 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 part 821 of the housing is spaced apart from the fluid outlet 830, and the pull tab may be in a folded state, abutting against the inner surface of the upper part 821. Thus, physical access to the pull tab and the fluid outlet is obstructed by the upper part of the housing.

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

[0222] Next, the user can pull the pull tab 842. When the pull tab 842 is pulled while the retaining force of the cap 840 against the fluid outlet is greater than the retaining force of the clip 310 against the lower part 822 of the housing, the clip will exit the slot 306 in the lower part 822. As a result, as shown in Figure 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 has been released from the lower part 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 Figure 40D. In some embodiments, the user can pull the pull tab 842 with one hand to pull the cap 840 away from the fluid outlet 830, while holding the fluid outlet 830, the clip 310, and / or a portion of the tube 313 with the other hand.

[0223] Another exemplary embodiment of the reconfiguration device 3350 is shown in Figures 41–43C, the device having a housing 920 having an upper part 921 and a lower part 922. Similar to the exemplary embodiment in Figure 38, the reconfiguration device 3300 includes a fluid outlet 940 movable relative to the lower part 922 of the housing. However, in this embodiment, as shown in Figures 41 and 42, the fluid outlet 940 is formed by two clips, a first clip 320 and a second clip 322, or otherwise attached to them. Before operation, the first clip 320 and the second clip 322 are removably coupled to the lower part 922 of the housing. In some embodiments, the inner guide 928 may include two extending tabs 360, each having a slot 55. In some embodiments, the slots may be defined by two opposite arms 51, 53. In other embodiments, the slots may be through holes through the tabs. Before activating the reconfiguration device, the clips 320 and 322 of the fluid outlet 940 can be received into the slot 55 to connect the fluid outlet to the lower part 922 of the housing. As shown in Figure 41, with the clips 320 and 322 received into the slot 55, the slot 55 and the clips 320 and 322 may be adjacent to the left and right sides of the fluid outlet. However, in other embodiments, the clips and / or slots may be positioned at different locations relative to the fluid outlet, for example, perpendicularly above and below the fluid outlet.

[0224] In some embodiments, the notch 924 includes expanding openings 925, 926 to accommodate the movement of a clip through the notch.

[0225] In this exemplary embodiment, the cap 930 with the pull tab 932 can cover the fluid outlet 940 before the device is activated. When the user pulls the pull tab 932 after the device has been activated, the clips 320, 322 slide out through the slot 55, thus disengaging the clips and the fluid outlet 940 from the lower part 922 of the housing. Thus, the pull tab 932 can function as a leash that the user can pull to remove the fluid outlet from the housing. In some embodiments, the retaining force of the cap 930 on the fluid outlet 940 may be greater than the retaining force of the clips 320, 322 on the lower part 822 of the housing. Therefore, when the pull tab 932 is pulled, the clips 320, 322 may first slide out of the slot 55 and detach before the cap 930 detaches from the fluid outlet 940.

[0226] Figures 43A to 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 part 921 of the housing is spaced apart from the fluid outlet 940, and the pull tab may be in a folded state, abutting against the inner surface of the upper part 921. Thus, physical access to the pull tab and the fluid outlet is obstructed by the upper part 921 of the housing.

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

[0228] Next, the user can pull the pull tab 932. When the pull tab 932 is pulled while the retaining force of the cap 930 on the fluid outlet is greater than the retaining force of the clips 320, 322 on the lower part 922 of the housing, the clips will exit the slots 55 in the lower part 922. As a result, as shown in Figure 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 has been released from the lower part 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] While the embodiment in Figure 38 uses a single clip and the embodiment in Figure 41 uses two clips, please understand that any number of clips can be used.

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

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

[0232] In the exemplary embodiments shown in Figures 38 to 40D and Figures 44 to 48, the reconfiguration device includes a first ring 740 surrounding a first container 300 and a second ring 750 surrounding a second container 350. As will be described in more detail below, the rings can be attached to the upper part 821 of the housing. By surrounding the containers, the rings can serve to restrict the lateral movement of the containers.

[0233] In some embodiments, the container can rest on a portion of the ring. As seen in Figure 44, the rings 740, 750 are contoured to conform to the shape of the shoulder 35 of the container. For example, the ring 750 has an inner surface 744 with a changing diameter, forming a contoured surface. The inner surface 744 transitions from a first diameter to a second smaller diameter to adapt to 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 molded inner surface of the ring, the ring can act to restrict the container from moving toward the spike. When the upper part 821 of the housing moves toward the lower part 822 of the housing during device operation, the ring attached to the upper part 821 of the housing moves toward the spike, thus allowing the container to move toward the spike for puncture.

[0235] In some embodiments, the inner contact portion can be 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 may be a gasket, a molded nub, radially inward-extending fingers, or any other suitable contact portion. For example, in one exemplary embodiment, the inner surface of the ring may include a circumferential groove into which a gasket is housed.

[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 walls, shoulders, neck, crimp, and / or any other suitable parts of the container body.

[0237] The attachment of the ring to the housing is described here. As seen in Figure 46, the ring 740 may include a plurality of radially extending portions 742, each of which may contain a recess 743. As seen in Figures 45, 47, and 48, the upper part 821 of the housing includes a plurality of projections 745 molded to match the shape of the ring's recesses. In the exemplary embodiments shown in the figures, the recesses and projections are semi-elliptical. The ring is attached to the top of the housing by engaging the projections of the upper part 821 with the recesses of the ring. In some embodiments, the attachment can be reinforced using further retention reinforcement such as adhesive or fasteners. However, in other embodiments, the ring is held to the top of the housing simply by a snap-fit ​​engagement between the projections and recesses. The projections and recesses may be reversed, so as to be understood, the recesses are located on the top of the housing and the projections are located on the ring. Furthermore, while the protrusions and recesses shown in the figure are semi-elliptical, it should be understood that they may be hemispherical, prismatic, conical, frustoconical, trapezoidal, or any other suitable shape.

[0238] In some embodiments, the ring may be attached to the housing by adhesive, fasteners, and / or other mounting arrangements, as an alternative to, or in addition to, the above-described interlocking arrangement of protrusions and recesses.

[0239] It should be understood that the ring can be omitted in some embodiments. In some embodiments, the container(s) can be held to the housing using adhesive, fasteners, or other mounting arrangements.

[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 its movement.

[0241] In the exemplary embodiments shown in Figures 47-49, the reconfiguration device includes a plurality of arms 456 extending from the upper part 821 of the housing. As shown in Figure 49, a perspective cross-sectional view showing a portion of the containers 300, 350 received at the upper part 821 of the housing, the plurality of arms 456 surround the containers 300, 350. The plurality of arms 456 are positioned radially outward of the containers and receive the bottom edges of the containers.

[0242] In some embodiments, the reconfiguration device may include a platform that abuts the bottom edge of the container. The platform fills the gap between the housing and the container, preventing the container from moving within the housing before operation, for example, during transport.

[0243] In the exemplary embodiments shown in Figures 47-48, the reconfiguration device includes platforms 450, 451 configured to abut against the bottom edge of the container. In the exemplary embodiments, the platforms are arched. 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 material.

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

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

[0246] In the exemplary embodiment shown in Figure 45, the inner guide 823 may include a groove 760 that receives a fin 314, which slides within the groove 760, allowing the upper part 821 to move slidably relative to the lower part 822.

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

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

[0249] As shown in Figure 50A, the intermediate adapter 3420 includes a first intermediate adapter coupling 3435. The first intermediate adapter coupling includes a neck 3436 and a tab 3437. The neck 3436 is configured to engage with a collar 3416 of the inlet adapter coupling 3414. Similarly, the tab is configured to engage with a pocket 3418 of the inlet adapter coupling. As further described with reference to Figure 51, the arrangement of the neck, pocket, collar, and tab allows the adapters to be reliably interlocked with each other. As shown in Figure 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., an outlet adapter coupling 3456). In the embodiment of Figure 50A, the first and second intermediate adapter couplings are located on opposite sides of the intermediate adapter, but other configurations are contemplated, as further described with reference to Figure 54. In some embodiments shown in Figure 50A, the second intermediate adapter coupling may share the same shape and size as the inlet adapter coupling 3414. In such configurations, the intermediate adapter 3420 may be replaced or expanded with other copies of the intermediate adapter. That is, another intermediate adapter may be used to replace the intermediate adapter 3420, or the transfer engine 3400 may be expanded using another intermediate adapter (see, for example, the exemplary embodiment in Figure 52). The first intermediate adapter coupling (e.g., the first intermediate adapter coupling 3435) may be accepted into the second intermediate adapter coupling 3438. Thus, additional intermediate adapters may be added to expand the number of spikes to accommodate a desired number of containers that can ultimately deliver the drug solution to the patient.

[0250] As shown in Figure 50A, the intermediate adapter 3420 includes an intermediate spike 3422 configured to puncture the intermediate container. The intermediate spike includes a first intermediate spike channel 3424 fluid-connected to a first intermediate fluid channel 3428. Similar to the inlet adapter, the first intermediate fluid channel terminates with an intermediate fluid connector 3430 (e.g., a tube connector). The intermediate spike also includes a second intermediate spike channel 3426 fluid-connected to a second intermediate fluid channel 3432. Similar to the first intermediate fluid channel, the second intermediate fluid channel also terminates with an intermediate fluid connector 3434 (e.g., a tube connector). As described according to the embodiment in Figure 50A and further described with reference to Figure 50B, the first intermediate fluid channel is configured to be fluid-connected (e.g., via a tube) to the inlet adapter fluid channel 3410. 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 isolated from the first intermediate adapter coupling 3435 and the second intermediate adapter coupling 3438.

[0251] According to the embodiment of Figure 50A, the transfer engine 3400 includes an outlet adapter 3440. The outlet adapter includes an outlet spike 3442, which includes a first outlet spike channel 3444 fluid-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 with an outlet fluid connector 3450 (e.g., a tube connector). The outlet spike also includes a second outlet spike channel 3446 fluid-connected to an outlet 3452. The outlet 3452 is connected to an infusion set coupling 3454, which can allow fluid from the transfer engine 3400 to eventually flow to the patient. In other embodiments, the disclosure is not so limited, and an infusion set or other delivery device may be directly connected to the outlet 3452.

[0252] As shown in Figure 50A, the outlet adapter 3440 includes an outlet adapter coupling 3456. In the embodiment of Figure 50A, the outlet adapter coupling is configured to be received by a second intermediate adapter coupling 3438. The outlet adapter coupling has the same size and shape as that of the first intermediate adapter coupling 3435. Therefore, if desired, the outlet adapter coupling can also be received within the inlet adapter coupling 3414 to detachably attach the outlet adapter to the inlet adapter. Such an arrangement is beneficial when only two vessels are connected to the transfer engine, as the intermediate adapter 3420 can be omitted.

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

[0254] Apart from the physical connection of the coupling, the adapter is fluid-connected to form a continuous flow path between the inlet spike 3404, the intermediate spike 3422, the outlet spike 3442, and finally the outlet 3452, so that the fluid can be delivered to the patient via an infusion set or other delivery device (e.g., a syringe). As shown in Figure 50B, the inlet adapter fluid channel 3410 is fluid-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, intermediate adapter, and outlet adapter are fluid-connected in series. In some embodiments, the fluid connectors may be quick-connect tube connectors. In some embodiments, the adapter may include an integrated tube configured to interconnect the tubes of other adapters. In such embodiments, quick-connect fittings or other fittings can be used. In other embodiments, the disclosure is not so limited, and any suitable connector can be used to fluidize the adapters.

[0255] In the embodiment shown in Figure 50B, tubes and tube connectors are used, but it should be noted that any suitable flow path can be used to fluidly interconnect various adapters. For example, the tubes interconnecting the adapters may be rigid or flexible tubes. Furthermore, in some embodiments, the adapter may include an integrated 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 shown in Figures 50A and 50B may be used for reconfiguration or pooling. In some embodiments, the intermediate adapter and / or outlet adapter may be configured to receive and connect a container for containing a solid pharmaceutical product (e.g., a lyophilized solid). In other embodiments, the intermediate adapter and / or outlet adapter may be configured to receive and connect a container for containing a liquid pharmaceutical product. The disclosure is not so limited, and any number of containers for containing solid pharmaceutical products or liquid pharmaceutical products may be used with the transfer engines according to the embodiments described herein.

[0257] Although the spike channel and fluid channel are described and labeled separately in the embodiments of Figures 50A and 50B, it should be noted that in other embodiments, the spike channel and fluid channel may be considered as a single component. For example, the adapter may be molded so that the fluid channel forms the spike channel.

[0258] As described above, the modular transfer engines in Figures 50A and 50B can be configured in a wide range of array configurations to accommodate a desired number of containers. For example, in some embodiments, the inlet and outlet adapters may be used together to deliver fluid from two containers (e.g., an inlet container and an outlet container). In another example, in some embodiments, the inlet and outlet adapters may be used together 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 shown in Figures 50A and 50B, the inlet adapter coupling is configured to receive an intermediate adapter coupling or an 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, the intermediate adapter coupling or the outlet adapter coupling may be configured as a socket configured to receive a protruding inlet adapter coupling. In some embodiments, the coupling of the adapter may include a socket portion and a protruding portion, so that the coupling receives a corresponding protruding portion of another coupling and also receives a corresponding socket portion of another coupling. Therefore, the disclosure is not so limited, and any suitable coupling that can physically connect the adapters to each other may be used for any embodiment described herein.

[0260] Figure 51 is a schematic diagram of one embodiment of a transfer engine adapter coupling, showing an exemplary mating engagement for securing the adapters of a transfer engine together. As shown in Figure 51, the first coupling 3500 is configured as a socket and includes a collar 3502 and a pocket 3504. The second coupling 3550 is configured to be received by the first coupling 3500 and includes a neck 3552 and a tab 3554. As shown in Figure 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 by the pocket 3504, and the collar 3502 is configured to engage with the neck 3552. As shown in Figure 51, the collar 3502 and the neck 3552 have widths smaller than the widths of the pocket 3504 and the tab 3554. Specifically, the pocket 3504 has a pocket width A, the collar 3502 has a collar width B, the tab 3554 has a tab width C, and the neck 3552 has a neck width D. The pocket width A is approximately equal to the tab width C, and the tab width is slightly smaller than the pocket width (e.g., within 1% of the pocket width) so that the tab fits into the pocket. Similarly, the collar width B is approximately equal to the neck width D, and the neck width is slightly smaller than the collar width (e.g., within 1% of the collar width) so that the neck fits into the collar. The pocket width A is greater than the collar width B (i.e., the collar width B is smaller than the pocket width A). Similarly, the tab width C is greater than the neck width D (i.e., the neck width D is smaller than the tab width C). Therefore, when the second coupling is received by the first coupling, the couplings cannot move relative to each other in a plane (e.g., the xy-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 the first direction and allowed to move relative to each other in the second direction. In some embodiments, the second direction may be lateral (e.g., perpendicular) to the first direction.

[0261] One embodiment of the coupling is shown in Figure 51, and it should be noted that other couplings may be used in other embodiments. For example, a coupling pair used to physically connect multiple adapters may be a mortise-to-tenon, a T-slot-to-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 the multiple adapters. In some embodiments, the coupling may have a shape configured to control the direction of the transfer engine formed by the multiple adapters. For example, in some embodiments, the adapter coupling may be capable of connecting in a single direction.

[0262] Figure 52 is a plan view of another embodiment of the transfer engine 3600. According to the embodiment of Figure 52, the transfer engine is similar to that of Figures 50A-50B, except that a second intermediate adapter 3602 is added to enable the transfer engine to connect to four vessels. That is, the transfer engine includes an inlet adapter 3402, a first intermediate adapter 3420, and an outlet adapter 3440, having the same configuration as those of Figures 50A-50B. In the embodiment of Figure 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 are terminated with intermediate fluid connectors 3612, 3616 (e.g., tube connectors). The second intermediate adapter includes the third intermediate adapter coupling 3618 and the fourth intermediate adapter coupling 3620. The third intermediate adapter coupling 3618 is received by the second intermediate adapter coupling 3438. The fourth intermediate adapter coupling receives the outlet adapter coupling 3456. Thus, the second intermediate adapter coupling can be releasably mounted and / or interlocked with the second intermediate adapter coupling and the outlet adapter coupling in series. According to the embodiment of Figure 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 by the inlet adapter coupling 3414. Correspondingly, in some embodiments, the fourth intermediate adapter coupling can receive the first intermediate adapter coupling 3435.

[0263] As shown in Figure 52, the fluid connection between the adapters is made using tubes, similar to Figure 50B. Specifically, the first tube 3460 fluidly connects the inlet adapter fluid channel 3410 to the first intermediate fluid channel 3428. The second tube 3462 fluidly connects the second intermediate fluid channel 3432 to the third intermediate fluid channel 3610. Finally, the third tube 3464 fluidly connects the fourth intermediate fluid channel 3614 to the outlet adapter fluid channel 3448. As previously mentioned with reference to Figures 50A to 50B, in Figure 52, the physical connection between the adapters via the coupling is separate from and / or separated from the fluid connection between the adapters.

[0264] In the embodiment shown in Figure 52, various adapters are fluid-connected and physically connected in series. In other embodiments, the adapters may be fluid-connected or physically connected in parallel. For example, in some embodiments, the inlet adapter, the first intermediate adapter, and the second intermediate adapter may all be fluid-connected to the 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-joint. 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 each fluid channel but to prevent fluid from escaping through each fluid channel. In some other embodiments, the fluid channels may include hydrophobic filters configured to allow air to flow into each fluid channel but to prevent fluid from escaping through each fluid channel. In the embodiment shown in Figure 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 prevent fluid from flowing out of the channels. Of course, the disclosure is not limited thereto, and any suitable parallel, series, or combination of parallel and series fluid configurations can be used to deliver chemicals from a transfer engine. Additional examples of fluid configurations having a combination of parallel and series flow paths are described with reference to the exemplary embodiment shown in Figure 53.

[0265] As illustrated by the exemplary embodiments described herein, the disclosure is not so limited that any suitable number of check valves can be used in one or more fluid channels of the adapter. The check valves can ensure unidirectional 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 fluid from escaping through the air inlet while allowing air to be discharged from the attached container. However, in the alternative case where the fluid channel is a fluid inlet, the check valve can force unidirectional flow. Thus, in some embodiments, the adapter can include at least one check valve in the fluid channel, thereby allowing the adapter to be used modularly in configurations with air inlets or configurations with fluid inlets. Of course, the disclosure is not so limited that any suitable arrangement or number of check valves can be used in the adapter.

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

[0267] As shown in Figure 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 and second intermediate spike channels are terminated at intermediate fluid connectors 3712 and 3716, respectively. Finally, the first intermediate adapter includes a first intermediate adapter coupling 3718 and a second intermediate adapter coupling 3719. According to the embodiment of Figure 53, the first intermediate adapter coupling is received by the inlet adapter coupling 3414. The first intermediate adapter coupling is configured to be received on the first side of the inlet adapter coupling, thereby the first intermediate adapter coupling occupies at least a portion of the inlet adapter coupling (e.g., half of the inlet adapter coupling). The second intermediate adapter coupling 3719 receives the outlet adapter coupling 3456. Similar to the first intermediate adapter coupling, the second intermediate adapter coupling is configured to receive the first portion of the outlet adapter coupling. Specifically, in the embodiment of Figure 53, the second intermediate adapter is configured to receive at least a portion of the outlet adapter coupling (e.g., half of the outlet adapter coupling). Of course, in other embodiments, the disclosure is not so limited, and the first and second intermediate adapter couplings can engage with any portion of the corresponding couplings.

[0268] As shown in Figure 53, the second intermediate adapter 3720 is a mirror image (e.g., across the y-axis) of the first intermediate adapter 3702. Therefore, the second intermediate adapter contains 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 and fourth intermediate spike channels are terminated by intermediate fluid connectors 3732 and 3736 (e.g., tube connectors), respectively. 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 a particular embodiment of Figure 53, engages with at least a portion of the inlet adapter coupling (e.g., half of the inlet adapter coupling). The fourth intermediate adapter coupling receives the outlet adapter coupling 3456 and, in a particular embodiment of Figure 53, receives at least a portion of the outlet adapter coupling (e.g., half of the outlet adapter coupling). Thus, both the first and second intermediate adapters are simultaneously connected to and releasably interlocked with the inlet and outlet adapters.

[0269] As shown in Figure 53, the transfer engine 3700 is arranged in a partially series and partially parallel fluid configuration. The inlet adapter is fluid-connected to both the first intermediate adapter and the second intermediate adapter via a first tube 3460 and a second tube 3462. The first and second tubes are connected at a Y-joint 3461 and fluid-connected to the inlet adapter fluid channel 3410. The outlet adapter is also fluid-connected to both the first intermediate adapter and the second intermediate adapter via a third tube 3464 and a fourth tube 3466. The third and fourth tubes are connected at a second Y-joint 3465 and fluid-connected to the outlet adapter fluid channel 3448. Thus, the intermediate adapters are not fluid-connected to each other in a continuous manner, but rather in parallel between the inlet adapter and the outlet adapter. However, the fluid flow 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 shown in Figure 53, a Y-joint is used to interconnect various adapters, but in other embodiments, the adapter may include multiple fluid channels or an integrated fluid joint to facilitate the parallel connection of multiple intermediate adapters. For example, an inlet adapter may include multiple fluid connectors (e.g., two tube connectors) so that the inlet adapter can accommodate multiple tubes, and both fluid connectors are fluidly connected to the inlet adapter fluid channel. Thus, the inlet adapter may include an internal Y-joint so that the inlet adapter can be interconnected to two intermediate adapters using a direct pipe without a Y-joint. Similarly, an outlet adapter may also include multiple fluid connectors (e.g., two tube connectors) so that the outlet adapter can accommodate multiple tubes, and both fluid connectors are fluidly connected to the outlet adapter fluid channel. The inlet and outlet adapters may include any number of appropriate fluid channels and corresponding fluid connectors so that any number of intermediate adapters can be connected in parallel, as this disclosure is not limited in that way.

[0271] Figure 54 is a plan view of another embodiment of the transfer engine 3800 showing an alternative layout of the adapters. In some cases, it may be desirable to reduce the footprint of the adapters relative to a given number of vessels, or otherwise to reduce certain dimensions of the transfer engine. For example, in the embodiment of Figure 54 discussed earlier, 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 dimensions (e.g., width or length), the adapters can be arranged in a zigzag pattern as shown in Figure 54. In the embodiment of Figure 4, the fluid arrangement is similar to that of Figure 52. That is, the transfer engine includes an inlet adapter 3402, a first intermediate adapter 3802, a second intermediate adapter 3810, and an outlet adapter 3440. The inlet and outlet adapters are arranged similarly to those in Figures 50A and 50B. Similarly, the fluid arrangement of the first and second intermediate adapters is similar to that of Figure 52. However, in contrast to the embodiment shown in Figure 52, the intermediate adapter couplings are angled relative to each other, as will be further described below.

[0272] As shown in Figure 54, the first intermediate adapter 3802 includes the first intermediate adapter coupling 3804 and the second intermediate adapter coupling 3806. The second intermediate adapter includes the third intermediate adapter coupling 3812 and the 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 Figure 54, the first intermediate adapter coupling 3804 and the second intermediate adapter coupling 3806 are angled relative to each other. The first intermediate adapter coupling aligns with the first axis EE, and the second intermediate adapter coupling aligns with the second axis FF. Axes EE and FF are inclined relative to each other at an angle α. In the embodiment shown in Figure 54, the angle between the first intermediate adapter coupling and the second intermediate adapter coupling is 90 degrees (e.g., α = 90 degrees), so that the couplings are orthogonal to each other. In other embodiments, the intermediate couplings may be inclined acutely relative to each other (e.g., α < 90 degrees). In yet another embodiment, the intermediate couplings may be inclined obliquely relative to each other (e.g., α > 90 degrees). In the embodiment shown in Figure 54, the third and fourth intermediate adapter couplings are angled relative 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 that between the third and fourth intermediate adapter couplings.

[0273] Figure 55 is a side view of another embodiment of the drug delivery device 4400. As shown in Figure 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 adapters are located in the lower part 4402 of the housing. According to the embodiment of Figure 55, the lower part of the housing includes an adapter plate 4404 configured to physically connect the modular adapters together. The adapter plate 4404 may be formed integrally with the lower part 4402 or may be formed as a separate component. As shown in Figure 55, the adapter plate 4404 includes a plurality of recesses 4406 formed by studs 4408. Together, the recesses and studs are sized and shaped to receive the adapters and prevent relative movement between them. Stud 4408 is configured to engage with the first adapter base 4411, the second adapter base 4413, and the third adapter base 4415 (e.g., by interference fit) to prevent relative movement between the adapters. In some embodiments shown in Figure 55, the stud is configured to engage with the side of the adapter base. Thus, the bases of the adapters are coupled together, releasably connected to each other via the adapter plate 4404, and cannot move relative to each other in a first direction (e.g., the xy-plane). Of course, in the embodiments of Figure 55, stud 4408 engages with the side of the adapter base, but in other embodiments, stud may engage with any suitable part of the adapter. For example, in some embodiments, the adapter base may include an adapter recess (e.g., a tenon) configured to receive a stud. In some embodiments, the adapter base may include a stud configured to receive a recess in the adapter plate. Of course, the disclosure is not so limited, and any suitable number of studs and recesses may be used as couplings in the adapter base and adapter plate to releasably connect multiple adapters to each other.Furthermore, although the embodiment in Figure 55 includes three adapters, any suitable number of adapters can be used in a similar arrangement to that in Figure 55. Similarly, although the embodiment in Figure 55 includes a series arrangement of adapters, the disclosure is not so limited, and any suitable fluid or physical arrangement can be used (e.g., matrix, zigzag, etc.).

[0274] Figure 56 is a side view of another embodiment of the drug delivery device 4500. As shown in Figure 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 not shown in Figure 56, the adapters may be fluidly connected in series, parallel, or any other suitable configuration to deliver the contents of the three containers. All adapters are located in the lower part 4502 of the housing. According to the embodiment of Figure 56, the lower part of the housing is configured to form interference fits with the adapters. In the illustrated embodiment, the lower part of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. The first and third adapter bases 4515 are then configured to apply pressure to the second adapter base 4513. Therefore, 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 interference and friction. In the configuration shown in Figure 56, the adapters may not be able to move relative to each other in a first direction (e.g., the xy-plane). If a force greater than the threshold force is applied in a second direction (e.g., the z-direction), the frictional force may be overcome, thereby causing the adapters to move in the second direction relative to the other adapters. Therefore, in the embodiment of Figure 56, the adapter bases 4511, 4513, and 4515 work together with the lower part 4502 of the housing to function as couplings between the adapters. In some embodiments shown in Figure 56, the lower part 4502 includes a lead-in 4504 configured to guide the adapters into place and facilitate the formation of interference fits between the lower part and the adapters 4510, 4512, and 4514. Of course, this disclosure is not limited in that way, and any suitable configuration having an interference fit, including embodiments without a lead-in, can be used at the bottom. Furthermore, although the embodiment in Figure 56 includes three adapters, any suitable number of adapters can be used in a similar arrangement to that in Figure 56.Similarly, while the embodiment in Figure 55 includes an adapter in a series physical arrangement, the disclosure is not limited in this way, and any suitable physical arrangement can be used (e.g., matrix, zigzag, etc.).

[0275] Figure 57 is a schematic plan view of another embodiment of the transfer engine 4600. In the embodiment of Figure 57, “I” is the inlet adapter, “M” is the intermediate adapter, and “O” is the outlet adapter, which are described according to the exemplary embodiments described herein. 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 may include various couplings and / or cooperate with the lower part of the housing to hold the adapters in the physical positions shown in Figure 57. In the embodiment of Figure 57, the physical arrangement is zigzag, as shown in Figure 54. Furthermore, the adapters are fluid-connected in a series fluid arrangement, and the fluid flows sequentially from the inlet adapter through two intermediate adapters to the outlet adapter, and the chemical can be delivered to the user via a suitable delivery device.

[0276] Figure 58 is a schematic plan view of another embodiment of the transfer engine 4700. In the embodiment of Figure 58, "I" is the inlet adapter, "M" is the intermediate adapter, and "O" is the outlet adapter, which are described according to the exemplary embodiments described herein. 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 Figure 58. In the embodiment of Figure 58, the physical arrangement is a rhombic matrix. Furthermore, 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 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 an inlet adapter, “M” is an intermediate adapter, and “O” is an outlet adapter, which are described according to the exemplary embodiments described herein. 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 Figure 59. In the embodiment of Figure 59, the physical arrangement is a rhombic matrix. Furthermore, the adapters are fluid-connected in a partially parallel, partially series fluid arrangement. In particular, the fluid flows individually from two inlet adapters to one intermediate adapter. The fluid then flows from the intermediate adapter to the outlet adapter. The resulting chemical can be delivered from the outlet adapter to the user 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 are described according to the exemplary embodiments described herein. 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. Furthermore, the adapters are fluid-connected in a series fluid arrangement as shown in Figure 57. Specifically, the fluid flows sequentially from the inlet adapter through two intermediate adapters to the outlet adapter. The resulting chemical can be delivered from the outlet adapter to the user via a suitable delivery device.

[0279] The exemplary embodiments described herein are arranged in linear, inclined, and matrix patterns, but the disclosure is not so limited, so in other embodiments, the transfer engines may be arranged in a square matrix, a hexagonal pattern, or any other suitable geometric pattern. In some embodiments, the adapter may include any number of couplings so that multiple 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, 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 in Figure 53, but other fluid configurations are possible. In some embodiments, the outlet adapter may include a first outlet adapter coupling and a second outlet adapter coupling, each configured to connect to a separate intermediate adapter coupling in a parallel configuration.

[0280] Figure 61A is a schematic front view of another embodiment of the drug delivery device 3900 in a first state, and Figure 61B shows the drug delivery device in a second state. According to the embodiments of Figures 61A to 61B, the device includes a housing having an upper part 3902 and a lower part 3910. The housing is configured to receive a single container, but in other embodiments, any suitable number of containers may be placed inside the housing. The upper part is configured to move between a non-operating position shown in Figure 61A and an operating position shown in Figure 61B. As in some of the embodiments described above, the upper part is configured to slide along an inner guide 3912. The upper part includes a fluid outlet notch 3904 configured to expose the fluid outlet and allow physical access to the fluid outlet when the upper part is moved to the operating position. In the embodiments of Figures 61A to 61B, the notch 3904 is configured to align with the fluid outlet 3914 when the upper part is in the operating position. Of course, any arrangement for selectively allowing access to the fluid outlet can be used according to other exemplary embodiments described herein. In some alternative embodiments, the fluid outlet may be physically accessible regardless of the state of the upper 3902, as this disclosure is not so limited.

[0281] Embodiments in Figures 61A to 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 Figures 61A to 61B, the marker is a QR code® 3916 located at the lower part 3910 of the housing. In some embodiments, as shown in Figures 61A to 61B, the QR code® is at least partially obscured by the upper part when the upper part is in a non-operating position. Specifically, the opaque portion of the upper part hides the marker, so when the upper part is in a non-operating position, the QR code® is hidden and not visible. However, in the operating position, a marker window 3906 formed in the upper part aligns with the QR code®, exposing the QR code® to the user and making it accessible. Thus, when the drug delivery device is activated, the user can scan the QR code® using a remote device. When scanned, the QR code® can relay information such as dosage and drug lot information to the remote device. In other words, the QR code (registered trademark) can contain information that can be read by a remote device. In some embodiments, the marker window 3906 may be formed as an upper hole. In some embodiments, the marker window 3906 may be an upper transparent portion configured to align with the marker when the upper portion is in the working position. Of course, the disclosure is not limited thereto, and the QR code (registered trademark) can be made accessible to a user in any suitable configuration. For example, in some embodiments, the upper portion may cover at least a portion of the marker in the non-working position and expose the marker without a window in the working position. The configurations in Figures 61A to 61B can enable the transfer of information to a remote device without a power supply mounted on the pairing or drug delivery device.

[0282] Figure 62A is a schematic front view of another embodiment of the drug delivery device 4000 in a first state, and Figure 62B shows the drug delivery device in a second state. According to the embodiments of Figures 62A to 62B, the device includes a housing having an upper part 4002 and a lower part 4010. The housing is configured to receive a single container, but in other embodiments, any suitable number of containers may be placed inside the housing. The upper part is configured to move between a non-operating position shown in Figure 62A and an operating position shown in Figure 62B. As in the embodiments described above, the upper part is configured to slide along an inner guide 4012. The upper part includes a fluid outlet notch 4004 configured to expose the fluid outlet and allow physical access to the fluid outlet when the upper part is moved to the operating position. In the embodiments of Figures 62A to 62B, the notch 4004 is configured to align with the fluid outlet 4014 when the upper part is in the operating position. Of course, any configuration for selectively allowing access to the fluid outlet can be used according to other exemplary embodiments described herein.

[0283] Embodiments in Figures 62A to 62B include a marker configured to selectively communicate information to a remote device. In the embodiments of Figures 62A to 62B, the marker is an NFC tag 4016 located at the bottom 4010 of the housing. As shown in Figures 62A to 62B, the NFC tag is enclosed by the top in the non-operating position. However, in the operating position, a marker window 4006 formed in the top aligns with the NFC tag, revealing the NFC tag to the user and making it accessible. In some embodiments, the top may be formed of an NFC signal impedance or other radio frequency (RF) shield such that the NFC tag is at least partially obscured by the top when the top is in the non-operating position. According to such embodiments, the NFC tag may not be activated by the remote device until the NFC tag is aligned with a window that may be radio-transparent. In other embodiments, a visual indicator of where the user can read the NFC tag may be at least partially obscured by the top in the non-operating position. According to such embodiments, a window can reveal a visual indicator of where the user can read the NFC tag. Therefore, when the drug delivery device is activated, the user can scan the NFC tag using a remote device. The NFC tag can relay information such as dosage and drug lot information to the remote device. In some embodiments, the marker window 4006 can be formed as an upper hole. In some embodiments, the marker window 4006 may be a wireless transparent portion of the upper part 4002. Of course, the disclosure is not limited thereto, and the NFC tag can be made accessible to the user in any suitable arrangement. The arrangement in Figures 62A to 62B allows the NFC tag to be wirelessly powered by the remote device, thus enabling the transfer of information to the remote device without a power supply mounted on the drug delivery device.

[0284] Figure 63 is a flowchart of another embodiment of the drug delivery process. As shown in step 4100, a first container is provided in a housing, with the top of the housing at least partially enclosing the first container. In step 4102, force is applied to the top to move it from a non-operating position to an operating position. In some embodiments, moving the top to the operating position allows the first container to be punctured. In step 4104, as the top moves to a second operating position, a marker is exposed. For example, a window formed in the top can be aligned with the marker. In some embodiments, as further described according to other exemplary embodiments herein, moving the top to the operating position can also make a fluid outlet physically accessible. In step 4106, the fluid is made able to flow from the first container to the fluid outlet. For example, as described above, moving the top to the operating position allows the first container to be fluid-connected to the fluid outlet (e.g., via a spike).

[0285] Figure 64A is a schematic front view of another embodiment of the drug delivery device 4200 including a communication module in a first state, and Figure 64B shows the drug delivery device of Figure 64A in a second state. According to the embodiments of Figures 64A to 64B, and as with the embodiments described above, the device includes a housing having an upper part 4202 and a lower part 4210. The housing is configured to receive a single container, but in other embodiments, any suitable number of containers may be placed inside the housing. The upper part is configured to move between a non-operating position shown in Figure 64A and an operating position shown in Figure 64B. As with the embodiments described above, the upper part is configured to slide along an inner guide 4212. The upper part includes a fluid outlet notch 4204 configured to expose a fluid outlet and allow physical access to the fluid outlet when the upper part is moved to the operating position. In the embodiments of Figures 64A to 64B, the notch 4204 is configured to align with the fluid outlet 4214 when the upper part is in the operating position. Of course, any configuration to selectively allow access to the fluid outlet may be used according to other exemplary embodiments described herein.

[0286] The embodiments in Figures 64A to 64B include a communication module 4230, 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 in Figure 18. The communication module will be further described with reference to Figure 65. According to the embodiments in Figures 64A to 64B, the communication module can be easily mounted on the lower part 4210. The communication module may be self-contained, thereby allowing it to easily communicate with the remote device when the drug delivery device is paired with a trigger.

[0287] According to embodiments of Figures 64A to 64B, the drug delivery device 4200 includes a trigger configured to activate a communication module 4230. Two examples of triggers are shown in embodiments of Figures 64A to 64B, and these can be used individually in other embodiments. Firstly, the device includes a switch 4224 (e.g., a microswitch) configured to engage with an engaging portion 4203 of the upper part 4202 of the housing. In Figures 64A to 64B, the engaging portion 4203 is a lip, but in other embodiments, the engaging portion may be a housing wall, an internal projection or mechanism, or any other suitable mechanism of the upper part 4202 of the housing. The switch is configured to be activated (e.g., pressed down) when the upper part moves to an operating position. That is, the switch is configured to move from a first switch position to a second switch position by the upper part. Secondly, the device includes a light beam sensor 4226 located in the lower part 4210 that emits a light beam 4227. Specifically, the light beam sensor includes a light beam transmitter and a light beam receiver, the light beam transmitter being configured to emit a light beam received by the light beam receiver. The upper part 4202 includes a projection 4206 configured to physically block the light beam when the upper part is in the operating position. The light beam sensor is configured to detect when the light beam is blocked, thereby determining that the upper part is operating. In some embodiments, the trigger for the drug delivery device may connect a communication module 4230 to a power source. When the communication module is activated by one or both triggers, the communication module can send one or more messages containing information to a remote device. Two examples of triggers are shown in Figures 64A and 64B, but the disclosure is not limited in that way, and the communication module can be activated using any suitable sensor. For example, a strain gauge or other pressure sensor may be placed on the upper part and configured to detect a force or pressure applied to the upper part by a user. When the detected force or pressure exceeds a threshold force or pressure, the communication module may be activated.As another example, as previously mentioned with reference to other exemplary embodiments of this specification, a Hall effect sensor can be used to detect the movement of the upper part to the operating position and activate the communication module. As yet another example, a proximity sensor can be used to detect the movement of the upper part to the operating position and activate the communication module.

[0288] Figure 65 is a schematic diagram of one embodiment of a communication module 4230. As shown in Figure 65, the communication module includes a processor 4232 which may be configured to execute computer-readable instructions stored in non-temporary memory. The communication module also includes a power supply 4234 (e.g., a battery) configured to power various components of the communication module. The communication module also includes a communication device 4236 which 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 Figure 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 a message transmitted by the communication module to one or more remote devices. Of course, this disclosure is not limited in that way, and any suitable sensor can be used as part of the communication module.

[0289] In some embodiments, the communication module may 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 vibrating motor configured to agitate the device. In some embodiments, the vibrating motor can be used to help mix various fluids and solids in the medical fluid delivery device. In some embodiments, the vibrating motor may be configured to provide tactile warnings to the user, as described with reference to other embodiments described herein. As another example, in some embodiments, the communication module may include a speaker. In some embodiments, the speaker may be configured to provide audible warnings to the user, as described with reference to other embodiments described 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 in a housing, with the top of the housing at least partially enclosing the first container. In step 4302, force is applied to the top to move it from a non-operating position to an operating position. In some embodiments, moving the top to the operating position allows the first container to be punctured. In step 4304, a communication module is activated by a trigger when the top moves to the operating position. For example, a switch may be pressed by the top when the top moves to the operating position. In some embodiments, moving the top to the operating position can also make a fluid outlet physically accessible, as will be further described according to other exemplary embodiments herein. In step 4306, the fluid is made able to flow from the first container to the fluid outlet. For example, as described above, moving the top to the operating position allows the first container to be fluid-connected to the fluid outlet (e.g., via a spike).

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

[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, drug delivery devices like those described above may include one container, two containers, three containers, four containers, five containers, or any suitable number of containers. Therefore, the disclosure is not so limited, and the various mechanisms and methods described above are also applicable to drug delivery or reconstitution devices having any number of containers.

[0293] While this instruction has been described in relation to various embodiments and examples, it is not intended to be limited to such embodiments. Rather, this instruction encompasses a variety of substitutes, modifications, and equivalents, as will be understood by those skilled in the art. Accordingly, the foregoing description and drawings are illustrative only.

Claims

1. A reconfiguration device, wherein the reconfiguration device is 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 first spike connected to a first plate, wherein the first plate is located within the housing, and the first spike is configured to puncture a first container containing a reconstitution fluid, A second spike connected to a second plate, wherein the second plate is located within the housing, the first and second plates are connected via an interlock, and the second spike is configured to puncture a second container containing a pharmaceutical product which is reconstituted by the reconstitution fluid to form a drug solution. The inlet that is in fluid communication with the first spike, A fluid channel connecting the first spike and the second spike, An outlet in fluid communication with the second spike, the outlet being configured to deliver the liquid medicine out of the second container, and A reconfiguration device equipped with the following features.

2. The reconfiguration device according to claim 1, wherein the inlet is provided with an air inlet.

3. The reconstruction device according to claim 1, further comprising a hydrophobic filter at the inlet.

4. The reconfiguration device according to claim 1, wherein the interlock comprises a protrusion and a recess.

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

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

7. The reconfiguration device according to claim 6, wherein the second container includes a vacuum, thereby the fluid in the first container is at a pressure higher than the pressure inside the second container.

8. The reconfiguration device according to claim 1, wherein the outlet is movable relative to the upper part of the housing.

9. A first sheath covering at least a portion of the first spike, A second sheath covering at least a portion of the second spike and The reconfiguration device according to claim 1, further comprising:

10. The reconstruction device according to claim 1, further comprising a first tube that fluidly connects the inlet to the second spike.

11. The reconfiguration device according to claim 1, further comprising a first path for fluidly connecting the second spike to the outlet.

12. A reconfiguration device, wherein the reconfiguration device is 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 first spike connected to a first base component, the first base component being located within the housing, and the first spike being configured to puncture a first container containing a reconstitution fluid, A second spike connected to a second base component, the second base component being located within the housing, the first and second base components being connected through an interlocking array, and the second spike being configured to puncture a second container containing a pharmaceutical product which is reconstituted by the reconstitution fluid to form a drug solution, The inlet that is in fluid communication with the first spike, A fluid channel connecting the first spike and the second spike, An outlet in fluid communication with the second spike, the outlet being configured to deliver the liquid medicine out of the second container, and A reconfiguration device equipped with the following features.

13. The reconfiguration device according to claim 12, wherein the interlocking array comprises at least one intermediate component, the at least one intermediate component connecting the first base component to the second base component.

14. The reconfiguration device according to claim 13, further comprising a third spike connected to at least one intermediate component.

15. The reconfiguration device according to claim 12, wherein the first base component and the second base component are directly attached to each other.

16. The reconfiguration device according to claim 12, wherein the inlet is an air inlet.

17. The reconstruction device according to claim 12, further comprising a hydrophobic filter at the inlet.

18. The reconfiguration device according to claim 12, wherein the interlocking component comprises a protrusion and a recess.

19. The reconfiguration device according to claim 12, wherein the interlocking array has a jigsaw shape.

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

21. The reconfiguration device according to claim 20, wherein the second container includes a vacuum, thereby the fluid in the first container is at a pressure higher than the pressure inside the second container.

22. The reconfiguration device according to claim 12, wherein the outlet is movable relative to the upper part of the housing.

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

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