Medicinal fluid delivery device

Abstract

In some embodiments, a reconstitution or medicinal fluid delivery device includes a transfer mechanism including two fluidly connected spikes, each spike configured to pierce a container. A check valve can be disposed between the two spikes to allow one-way flow from one container to another. Physical access to a fluid outlet can be blocked by a housing until the reconstitution or medicinal fluid delivery device is actuated, whereupon physical access to the fluid outlet is permitted. The reconstitution or medicinal fluid delivery device can be placed on a flat surface and actuated by applying force in a single direction toward the flat surface.

Description

[0001] Related Applications

[0002] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application Serial No. 62 / 985,797, filed March 5, 2020, which is incorporated herein by reference in its entirety. TECHNICAL FIELD

[0003] The disclosed embodiments relate to pharmaceutical fluid delivery devices, such as reconstitution devices, and related methods of use. BACKGROUND

[0004] Pharmaceutical fluids are administered to patients through a variety of methods. These conventional methods generally include injection through a syringe, ingestion, or delivery through an infusion pump and needle. Controlled volumes of pharmaceutical fluids are prescribed and delivered through one or more of these methods.

[0005] In some cases, pharmaceutical products are manufactured in a dehydrated or otherwise non-constituted form, such as in lyophilized form. That is, the pharmaceutical can be stored and packaged as a dry substance that is combined and mixed with water or another reconstitution fluid prior to administration to a patient. In such cases, a predetermined amount of the pharmaceutical is provided to the patient or other healthcare provider along with, often, sterile water for injection to be mixed shortly before administration. SUMMARY

[0006] In some embodiments, systems and methods for administering a medicinal fluid to a patient are provided. In particular, a reconstitution system that allows for simplified reconstitution of a dry (e.g., powdered) medicinal product is provided. In some embodiments, the system allows for simplified access to a liquid medicament. In some embodiments, a reconstitution device includes a first fluid path including a first open end disposed in a first spike and an opposite end including an air inlet. In some embodiments, the device further includes a second fluid path having a second open end disposed in the first spike and a third open end disposed in a second spike. In some embodiments, a valve is disposed in the second fluid path between the second and third open ends. In some embodiments, a third fluid path includes a fourth open end disposed in the second spike and an opposite end including a fluid outlet. Thus, in some embodiments, the device includes two interconnected dual lumen spikes that allow for the transfer of fluid 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 can include a luer lock valve such that a syringe can be fluidly connected to the fluid outlet and the reconstituted medicinal fluid can be withdrawn from the device. In some embodiments, a container including a powdered drug can be configured to contain a low pressure or zero pressure vacuum such that sterile water or another fluid from another container can be forced into the drug-containing container without the manual application of pressure or pumping. In some embodiments, the pressure differential between the drug-containing container and the fluid-containing container can be great enough that fluid from the fluid-containing container is expelled into the drug-containing container, thereby agitating the drug to facilitate reconstitution.

[0007] In some embodiments, a reconstitution device can include a housing having an upper portion and a lower portion, where the lower portion is slidably received in the upper portion. In some embodiments, the upper portion can be configured to hold at least two containers, and the lower portion can include at least one spike for each of the at least two containers. In some embodiments, the upper portion can be configured to at least partially enclose the at least two containers and selectively keep the containers away from the spikes in the lower portion. In some embodiments, the upper portion can also be configured to apply a force to the at least two containers as the upper portion is slid from a first, unactuated position to a second, actuated position. In some embodiments, the at least two containers can be pierced by one or more spikes associated with the container when the upper portion is moved to the actuated position. In some embodiments, the containers can be in fluid communication after being pierced, such that fluid from one container can flow to the other container. In some embodiments, a first container can be under vacuum, such that fluid from a second container is pushed into the first container due to a pressure differential between the two containers.

[0008] In some embodiments, a reconstitution device includes a first fluid path having a first open end and an inlet, a second fluid path having a second open end and a third open end, the first open end and the second open end defining a first container receiving end, a valve positioned along the second fluid path between the second open end and the third open end, and a third fluid path having a fourth open end and an outlet, the third open end and the fourth open end defining a second container receiving end. The first container receiving end and the second container receiving end face the same direction.

[0009] In some embodiments, a reconstitution device includes a housing having a lower portion and an upper portion in slidable engagement with the lower portion, the upper portion being movable relative to the lower portion between an unactuated position and an actuated position, and a transfer engine disposed within the lower portion of the housing, the transfer engine having a first container receiving end and a second container receiving end facing the upper portion of the housing. The reconstitution device further includes a fluid outlet in fluid communication with the second container receiving end of the transfer engine. The upper portion engages a first container and a second container such that the first container and the second container are moved toward the first container receiving end and the second container receiving end, respectively, when the upper portion is moved from the unactuated position to the actuated position. Physical access to the fluid outlet is at least partially blocked when the upper portion is in the unactuated position and is permitted when the upper portion is in the actuated position.

[0010] In some embodiments, a reconstitution device includes a housing having a lower portion and an upper portion in slidable engagement with the lower portion, the upper portion being movable relative to the lower portion between an unactuated position and an actuated position. The reconstitution device further includes a transfer engine disposed within the lower portion of the housing, the transfer engine having a first container receiving end and a second container receiving end facing the upper portion of the housing, wherein the transfer engine and the lower portion are distinct components. The reconstitution device further includes a fluid outlet in fluid communication with the second container receiving end of the transfer engine.

[0011] In some embodiments, a reconstitution device includes a housing having a first portion and a second portion in movable engagement with the first portion, the first portion and the second portion being movable relative to each other between an unactuated configuration and an actuated configuration, a first spike coupled to the second portion of the housing, and a first ring coupled to the first portion of the housing and configured to at least partially enclose a shoulder of a first container to hold the first container relative to the first spike.

[0012] In some embodiments, a medical fluid delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion, the upper portion movable relative to the lower portion between an unactuated position and an actuated position; a fluid outlet configured to deliver fluid from a reservoir disposed within the housing when the upper portion is in the actuated position; and a marker at least partially obstructed in the unactuated position of the upper portion, and wherein the marker is accessible in the actuated position of the upper portion.

[0013] In some embodiments, a medical fluid delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion, the upper portion movable relative to the lower portion between an unactuated position and an actuated position; a fluid outlet configured to deliver fluid from a reservoir disposed within the housing when the upper portion is in the actuated 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 portion is moved from the unactuated position to the actuated position.

[0014] In some embodiments, a medical fluid delivery device includes an inlet adapter having an inlet container containing a medical fluid, an inlet spike configured to pierce the inlet container, wherein the inlet spike is configured to receive the medical fluid from the inlet container, an air inlet, an inlet adapter fluid channel fluidically connected to the inlet spike, and an inlet adapter coupling. The medical fluid delivery device also includes an intermediate adapter having an intermediate container containing a medical fluid or a medical solid, an intermediate spike configured to pierce the intermediate container, a first intermediate fluid channel fluidically connected to the intermediate spike and configured to fluidically connect to the inlet adapter fluid channel, a second intermediate fluid channel fluidically connected to the intermediate spike, a first intermediate adapter coupling configured to connect to the inlet adapter coupling to releasably attach the intermediate adapter to the inlet adapter, and a second intermediate adapter coupling. The medical fluid delivery device also includes an outlet adapter having an outlet container containing a medical solid, an outlet spike configured to pierce the outlet container, an outlet adapter fluid channel fluidically connected to the outlet spike and configured to fluidically connect to the second intermediate fluid channel, an outlet fluidically connected to the outlet spike, and an outlet adapter coupling configured to connect to the second intermediate adapter coupling to releasably attach the outlet adapter to the intermediate adapter.

[0015] In some embodiments, a medical fluid delivery device includes an inlet adapter having an inlet spike configured to pierce an inlet container, an air inlet, an inlet adapter fluid channel fluidically connected to the inlet spike, and an inlet adapter coupling spaced from the inlet adapter fluid channel. The medical fluid delivery device also includes an intermediate adapter having an intermediate spike configured to pierce an intermediate container, a first intermediate fluid channel fluidically connected to the intermediate spike and configured to fluidically connect to the inlet adapter fluid channel, a second intermediate fluid channel fluidically connected to the intermediate spike, a first intermediate adapter coupling configured to be received in the inlet adapter coupling to releasably interlock the intermediate adapter with the inlet adapter, and a second intermediate adapter coupling, wherein the first intermediate adapter coupling and the second intermediate coupling are spaced from the first intermediate fluid channel and the second intermediate fluid channel. The medical fluid delivery device also includes an outlet adapter having an outlet spike configured to pierce an outlet container, an outlet adapter fluid channel fluidically connected to the outlet spike and configured to fluidically connect to the second intermediate fluid channel, an outlet fluidically connected to the outlet spike, and an outlet adapter coupling configured to be received in the second intermediate adapter coupling to releasably interlock the outlet adapter with the intermediate adapter, wherein the outlet adapter coupling is spaced from the outlet adapter fluid channel.

[0016] In some embodiments, a medical fluid delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion, the upper portion being movable relative to the lower portion between an unactuated position and an actuated position. The medical fluid delivery device can include a transfer instrument disposed within the lower portion of the housing, the transfer instrument having a first container-receiving end facing the upper portion of the housing, and a fluid outlet in fluid communication with the transfer instrument. The upper portion can be configured to engage a first container such that, when the upper portion is moved from the unactuated position to the actuated position, the first container is moved toward the first container-receiving end. Physical access to the fluid outlet can be at least partially blocked when the upper portion is in the unactuated position. Physical access to the fluid outlet can be permitted when the upper portion is in the actuated position.

[0017] In some embodiments, a medical fluid delivery device includes an inlet adapter having an inlet spike configured to pierce an inlet container, an air inlet, and an inlet adapter fluid channel fluidically connected to the inlet spike. The medical fluid delivery device can also include a middle adapter having a middle spike configured to pierce a middle container, a first middle fluid channel fluidically connected to the middle spike and configured to fluidically connect to the inlet adapter fluid channel, and a second middle fluid channel fluidically connected to the middle spike. The medical fluid delivery device can also include an outlet adapter having an outlet spike configured to pierce an outlet container, an outlet adapter fluid channel fluidically connected to the outlet spike and configured to fluidically connect to the second middle fluid channel, and an outlet fluidically connected to the outlet spike. The medical fluid delivery device can also include an adapter plate. The inlet adapter, the middle adapter, and the outlet adapter can be configured to couple to the adapter plate.

[0018] It should be appreciated that the foregoing concepts and additional concepts discussed below can be arranged in any suitable combination, as the disclosure is not limited in this respect. Moreover, other advantages and novel features of the disclosure will become apparent from the following detailed description, when considered in conjunction with the non-limiting embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0019] The drawings are not intended to be to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures can be represented by a like numeral. For purposes of clarity, not every component can be called out in every drawing. In the drawings:

[0020] Figure 1 is a schematic view of one embodiment of a transfer instrument for a reconstitution device;

[0021] Figure 2 is a perspective view of one embodiment of a reconstitution device;

[0022] Figure 3 is a schematic view of one embodiment of a transfer instrument for a reconstitution device during a first stage of one embodiment of a reconstitution and medical fluid delivery process;

[0023] Figure 4 is a schematic view of a transfer instrument of during a second stage of a reconstitution and medical fluid delivery process of Figure 3 ; and

[0024] Figure 5 is a schematic view of a transfer device during a third phase of a reconstitution and medicinal fluid delivery process; Figure 3

[0025] Figure 6 is a schematic view of a transfer device during an optional fourth phase of a reconstitution and medicinal fluid delivery process; Figure 3

[0026] Figure 7 is a perspective view of an embodiment of a reconstitution device in an unactuated state;

[0027] Figure 8 is a perspective view of a reconstitution device in an actuated state of Figure 7

[0028] Figure 9 is a side elevational view of a reconstitution device of Figure 7

[0029] Figure 10A is a side elevational view of a reconstitution device of Figure 8

[0030] Figure 10B is a perspective view of a reconstitution device of Figure 10A

[0031] Figure 11 is a cross-sectional view of a reconstitution device of Figure 7

[0032] Figure 12 is a cross-sectional view of a reconstitution device of Figure 8

[0033] Figure 13 is a side elevational view of an embodiment of a transfer device of a reconstitution device;

[0034] Figure 14 is a top cross-sectional view of a transfer device taken along 14-14 of Figure 13

[0035] Figure 15 is a flow diagram of an embodiment of a reconstitution and medicinal fluid delivery process;

[0036] Figure 16 is a flow diagram of another embodiment of a reconstitution and medicinal fluid delivery process;

[0037] Figure 17 is a flow diagram of another embodiment of a reconstitution and medicinal fluid delivery process;

[0038] Figure 18 ​​​​​​​​​This is a schematic diagram of one implementation of a reconfiguration device that communicates with one or more remote devices;

[0039] Figure 19A This is a schematic diagram of another embodiment of the reconfiguration device in its first state;

[0040] Figure 19B It is in the second state. Figure 19A A schematic diagram of the reconfiguration device;

[0041] Figure 20A This is a schematic diagram of another implementation scheme of the reconfiguration device in its first state;

[0042] Figure 20B It is in the second state. Figure 20A A schematic diagram of the reconfiguration device;

[0043] Figure 21A This is a schematic diagram of another embodiment of the reconfiguration device in its first state;

[0044] Figure 21B It is in the second state. Figure 21A A schematic diagram of the reconfiguration device;

[0045] Figure 22 This is a perspective view of another embodiment of the transfer device;

[0046] Figure 23 yes Figure 22 A side cross-sectional view of the transfer device taken along line 23-23;

[0047] Figure 24 yes Figure 22 Top view cross-sectional view of the transfer device taken along line 24-24;

[0048] Figure 25 yes Figure 22 Top view cross-sectional view of the transfer device taken along line 25-25;

[0049] Figure 26 This is a perspective view of another embodiment of the transfer device;

[0050] Figure 27 yes Figure 26 A side cross-sectional view of the transfer device taken along line 27-27;

[0051] Figure 28 yes Figure 26 Top view cross-sectional view of the transfer device taken along line 28-28;

[0052] Figure 29 This is a cross-sectional schematic diagram of one embodiment of the pointed object;

[0053] Figure 30 is a cross-sectional schematic view of another embodiment of a spike;

[0054] Figure 31 is a cross-sectional schematic view of another embodiment of a spike;

[0055] Figure 32A is a schematic view of another embodiment of a reconstitution device in a first state;

[0056] Figure 32B is a schematic view of the reconstitution device of Figure 32A in a second state;

[0057] Figure 32C is a schematic view of the reconstitution device of Figure 32A in a third state;

[0058] Figure 32D is a schematic view of the reconstitution device of Figure 32A in a fourth state;

[0059] Figure 33 is a top perspective view of another embodiment of a transfer instrument;

[0060] Figure 34 is a top view of the transfer instrument of Figure 33 ;

[0061] Figure 35 is a bottom perspective view of the transfer instrument of Figure 33 ;

[0062] Figure 36 is an exploded perspective view of another embodiment of a reconstitution device;

[0063] Figure 37A is the reconstitution device of Figure 36 in a first state;

[0064] Figure 37B is the reconstitution device of Figure 37A in a second state;

[0065] Figure 37C is the reconstitution device of Figure 37A in a third state;

[0066] Figure 38 is an exploded perspective view of another embodiment of a reconstitution device;

[0067] Figure 39 is another exploded perspective view of the reconstitution device of Figure 38 ;

[0068] Figure 40A is the reconstitution device of Figure 38 Reconfiguration device;

[0069] Figure 40B It is in the second state. Figure 40A Reconfiguration device;

[0070] Figure 40C It is in the third state. Figure 40A Reconfiguration device;

[0071] Figure 40D It is in the fourth state. Figure 40A Reconfiguration device;

[0072] Figure 41 This is an exploded perspective view of another embodiment of the reconfiguration device;

[0073] Figure 42 yes Figure 41 Another exploded perspective view of the reconstructed device;

[0074] Figure 43A It is in the first state. Figure 41 Reconfiguration device;

[0075] Figure 43B It is in the second state. Figure 43A Reconfiguration device;

[0076] Figure 43C It is in the third state. Figure 43A Reconfiguration device;

[0077] Figure 44 yes Figure 40B A cross-sectional view of the reconstructed device taken along line 44-44;

[0078] Figure 45 yes Figure 44 A perspective cross-sectional view of the reconstructed device;

[0079] Figure 46 This is a perspective view of the container retaining ring;

[0080] Figure 47 yes Figure 40B Bottom view of the upper part of the reconstruction device;

[0081] Figure 48 yes Figure 47 Bottom perspective view of the upper part;

[0082] Figure 49 yes Figure 40B A perspective cross-sectional view of the reconstruction device taken along line 49-49;

[0083] Figure 50A This is an exploded plan view of another embodiment of the transfer device;

[0084] Figure 50B is a plan view of a transfer device; Figure 50A

[0085] Figure 51 is a schematic view of an embodiment of a transfer device adapter coupling;

[0086] Figure 52 is a plan view of another embodiment of a transfer device;

[0087] Figure 53 is a plan view of another embodiment of a transfer device;

[0088] Figure 54 is a plan view of another embodiment of a transfer device;

[0089] Figure 55 is a side view of another embodiment of a medicinal fluid delivery device;

[0090] Figure 56 is a side view of another embodiment of a medicinal fluid delivery device;

[0091] Figure 57 is a plan schematic view of another embodiment of a transfer device;

[0092] Figure 58 is a plan schematic view of another embodiment of a transfer device;

[0093] Figure 59 is a plan schematic view of another embodiment of a transfer device;

[0094] Figure 60 is a plan schematic view of another embodiment of a transfer device;

[0095] Figure 61A is a front schematic view of another embodiment of a medicinal fluid delivery device in a first state;

[0096] Figure 61B is a front schematic view of a medicinal fluid delivery device of Figure 61A in a second state;

[0097] Figure 62A is a front schematic view of another embodiment of a medicinal fluid delivery device in a first state;

[0098] Figure 62B is a front schematic view of a medicinal fluid delivery device of Figure 62A in a second state;

[0099] Figure 63 ​is a flowchart of another embodiment of a medicinal fluid delivery process;

[0100] Figure 64A is a front view schematic of another embodiment of a medicinal fluid delivery device in a first state;

[0101] Figure 64B is a front view schematic of the medicinal fluid delivery device in a second state; Figure 64A

[0102] Figure 65 is a schematic of one embodiment of a communication module; and

[0103] Figure 66 is a flowchart of another embodiment of a medicinal fluid delivery process. DETAILED DESCRIPTION

[0104] 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 otherwise non-constituent medicament (e.g., a medicament in lyophilized form). At each step, the nurse or other medical professional carefully avoids contamination as the reconstitution fluid is withdrawn from a package and discharged into a mixing container or medicament container. This process often involves handling multiple containers and syringes. Thus, the conventional reconstitution method performed by nurses and other medical professionals can be both time consuming and complex.

[0105] In some cases, it can be a more desirable option for a patient to perform reconstitution and administration for convenience and cost considerations. A difficult procedure that is already time consuming when performed by a medical professional can be challenging for a patient practicing self-administration. It can be desirable for patients practicing self-administration, as well as healthcare providers, to reduce the time consumption and complexity of medicinal fluid reconstitution and administration.

[0106] In view of the above, the inventors have recognized the benefit of a reconstitution device that allows a patient or healthcare provider to reconstitute and administer a medicament contained in one container with a reconstitution fluid in another container. The reconstitution device can enable a simpler reconstitution and administration process with fewer steps as compared to conventional reconstitution and administration processes. The reconstitution device can also allow reconstitution and administration with reduced container handling. Further, the reconstitution device can allow a smaller pressure to be applied to actuate the device than conventional devices, facilitating a user’s perception of easier actuation. Additionally, the reconstitution device can improve agitation and mixing of the medicament and reconstitution fluid.

[0107] ​In some embodiments, a transfer instrument can include multiple fluid paths in a compact arrangement that, for example, facilitates the transfer of fluid from a first container to a second container to reconstitute a drug located in the second container. In some embodiments, a reconstitution device includes a first fluid path including a first open end and an air inlet. The reconstitution device also includes a second fluid path having a second open end and a third open end. The first open end and the second open end can be parallel to each other and collectively define a first container receiving end. The reconstitution device also includes a valve positioned along the second fluid path between the second open end and the third open end. A third fluid path includes a fourth open end and a fluid outlet. The third open end and the fourth open end can be parallel to each other and collectively define a second container receiving end. In some embodiments, the container receiving ends can include spikes configured to pierce into a container. According to this embodiment, the device includes two interconnected double lumen spikes that allow fluid to be transferred 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 fluid path and the second open end of the second fluid path are disposed in a first spike. In some embodiments, the third open end of the second fluid path and the fourth open end of the third fluid path are disposed in a second spike. A portion of the first fluid path and a portion of the second fluid path can form a lumen of the first spike. A portion of the second fluid path and a portion of the third fluid path can form a lumen of the second spike. In some embodiments, the transfer instrument can be used with fluid delivery devices other than reconstitution devices (e.g., devices for pooling or devices for accessing individual containers). Thus, it should be appreciated that in some embodiments, the transfer instrument can include only a single container receiving end, rather than multiple container receiving ends.

[0108] In some embodiments, the fluid outlet can include a luer lock valve such that a syringe or other delivery device can be fluidly connected to the fluid outlet and the reconstituted pharmaceutical fluid can be withdrawn from the transfer instrument. However, in other embodiments, other suitable fluid outlets can be employed with the reconstitution device, including but not limited to luer activated devices, simple luer connectors or other threaded connectors, slip fit connectors, and pierceable septa. In some embodiments, the container including the powdered drug can be configured to contain a low pressure or zero pressure vacuum such that the sterile water or another fluid from another container can be forced into the drug containing container without manual application of pressure or pumping. In some embodiments, the pressure differential between the drug containing container and the fluid containing container can be great enough that fluid from the fluid containing container is expelled into the drug containing container at a speed that can help agitate the drug to facilitate reconstitution.

[0109] The inventors have also recognized the benefit of a self-contained reconstitution device that allows a reconstitution process to be performed by applying force in a single direction. A first container can be pre-provisioned in a reconstitution device containing a reconstitution fluid along with a second container containing a medicament. The reconstitution device can allow force to be applied to a housing to fluidly join the first container to the second container, allowing fluid to flow from the first container to the second container and reconstitute the medicament.

[0110] In some embodiments, a reconstitution device can include a housing having a lower portion and an upper portion, where the lower portion is slidably received in the upper portion, or vice versa. The upper portion can be configured to hold at least two containers, and the lower portion can include at least one spike for each of the at least two containers. The upper portion can be configured to at least partially enclose the at least two containers and selectively keep the containers away from the spikes disposed in the lower portion. The upper portion can also be configured to apply force to the at least two containers as the upper portion is slid from a first, unactuated position to a second, actuated position in which the upper portion is closer to the lower portion. In particular, a bottommost surface of the upper portion is closer to a base of the lower portion. As the upper portion is moved to the actuated position, the at least two containers can be pierced by one or more spikes associated with that container. After being pierced, the containers can be in fluid communication such that fluid from one container can flow to the other container. In some embodiments, a first container can be under vacuum such that fluid from a second container is pushed into the first container due to a pressure differential between the two containers. The lower portion 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 reconstitution device and provide a platform against which a user can apply force. In some embodiments, a top surface of the upper portion of the housing can be curved such that the reconstitution device can be unstable if a user attempts to use the upper portion as a base by resting the top surface of the upper portion on a flat surface. The instability can help indicate to the user that the device is placed in an incorrect orientation for use. Such an arrangement can also facilitate single orientation use of the reconstitution device. Such an arrangement can also improve ergonomics relative to conventional reconstitution devices. The curved surface can provide a natural place to rest a hand that corresponds in shape to other objects and surfaces that are commonly received in a user's palm. In this regard, the curved upper surface can create a positive transference, facilitating more preferred handling and operation of the reconstitution device.

[0111] The inventors have also recognized the benefit of providing feedback to the user to complete activation of the reconstitution device. Further, the inventors have recognized the benefit of one or more retention features that hold the reconstitution device in an actuated state to prevent repeated activation or removal of a used container in the reconstitution device. Additionally, such an arrangement can slow the migration of the upper portion of the housing away from the lower portion of the housing due to the resilience of the pierced septum of the container biasing the upper portion away from the lower portion.

[0112] In some embodiments, a reconstitution device can include a housing having a lower portion and an upper portion, wherein the lower portion is slidably received in the upper portion, and vice versa. The upper portion can be configured to hold at least two containers, and the lower portion can include at least one spike for each of the at least two containers. The upper portion can be configured to at least partially enclose the at least two containers and selectively hold the containers away from the spikes disposed in the lower portion. The upper portion can also be configured to apply a force to the at least two containers as the upper portion slides from a first, unactuated position to a second, actuated position in which the upper portion is closer to the lower portion. The upper portion of the housing can have at least one upper stop and the lower portion can have at least one lower stop. The at least one upper stop can be configured to engage the at least one lower stop as the upper housing moves to an actuated position to pierce each of the at least two containers. In some embodiments, the upper stop and the lower stop can be corresponding sleeves or flanges of the housing that abut each other to prevent further movement of the upper portion of the housing toward the lower portion of the housing. In some embodiments, the containers can act as upper stops that abut the lower portion of the housing (e.g., bottom out) as the upper housing moves to the actuated position. Upper stops and lower stops can be provided on any suitable portions of the upper and lower housings that can contact each other, as the present disclosure is not limited in this respect. In some embodiments, the upper and lower portions of the housing can include one or more retention features to enable the reconstitution device to be captured unidirectionally in the actuated position. The retention features can include flexible tabs, ratchets and pawls, hook and loop fasteners, adhesives, or another suitable arrangement for securing the two portions of the reconstitution device housing together upon actuation. For example, in one embodiment, a flexible tab disposed on the lower portion of the housing can engage a corresponding detent or recess on the upper portion of the housing as the upper portion is moved to the actuated position.

[0113] The inventors have also recognized the benefit of blocking physical user access to the fluid outlet prior to actuation of the device and permitting user access to the fluid outlet in response to actuation of the reconstitution device housing. In particular, the inventors have recognized the benefit of physically impeding access to the fluid outlet prior to reconstitution of the medicament. The reconstitution device housing can be arranged to only allow access to the fluid outlet after the two containers are fluidically joined such that fluid from the first container can flow to the second container containing the medicament for reconstitution. Such an arrangement can simplify the reconstitution and administration process and can further ensure that the medicament is reconstituted before the user attempts to couple a delivery device (e.g., a syringe, an infusion pump, etc.) to the reconstitution device. This can help prevent the user from prematurely drawing the medicament before reconstitution is complete. Additionally, in cases where a vacuum is employed to transfer fluid between the first and second containers, such an arrangement can ensure that the vacuum inside the containers is maintained until pressure equilibrium between the first and second containers. In particular, such an arrangement can avoid air being drawn into the fluid path via the fluid outlet.

[0114] In some embodiments, a reconstitution device includes a housing having a lower portion and an upper portion, where the lower portion is slidably received in the upper portion. The upper portion can be configured to hold at least two containers, and the lower portion can include at least one spike for each of the at least two containers. The upper portion can be configured to at least partially enclose the at least two containers and selectively hold the containers at a distance from the spikes disposed in the lower portion prior to device actuation. The upper portion can also be configured to apply a force to the at least two containers as the upper portion is slid from a first, unactuated position to a second, actuated position in which the upper portion is closer to the lower portion. In particular, a bottommost surface of the upper portion can be closer to a base of the lower portion. As the upper portion moves to the actuated position, the at least two containers can be pierced by one or more associated spikes. After being pierced, the containers can be in fluid communication such that fluid from one container can flow to a second container and a medicament in the second container can be reconstituted by the fluid from the first container. The spikes can be fluidically connected to a fluid outlet, which can be held in the lower portion of the housing. The upper portion of the housing is configured to cover the fluid outlet or otherwise block physical user access to the fluid outlet when the upper portion is in the unactuated position. When the reconstitution device is actuated, physical access to the fluid outlet can be permitted. For example, in one embodiment, a cutout on the upper portion is configured to expose the fluid outlet as the upper portion moves to the actuated position. In some embodiments, the fluid outlet can be connected to one or more spikes via a flexible tubing such that the fluid outlet is movable relative to the spikes. According to this embodiment, when the upper portion is in the actuated position, the fluid outlet can be accessed via the cutout and removed from the lower housing. Once removed, a delivery device (e.g., a syringe) can be coupled to the fluid outlet and used to withdraw the reconstituted medicament. In some embodiments, the fluid outlet can include a port cap configured to seal the fluid outlet and prevent air from entering a fluid path between the spikes and the fluid outlet prior to being removed. According to this embodiment, the port cap is not accessible and removed from the fluid outlet until the upper portion is in the actuated position.

[0115] While some embodiments described herein employ a flexible conduit that allows a user to move the fluid outlet relative to the reconstitution device housing, other configurations that physically block the fluid outlet prior to activation of the reconstitution device can be employed. For example, in some embodiments, the fluid outlet can be rigidly attached to the reconstitution device housing. In some embodiments, the fluid outlet can be fixed relative to the lower portion of the housing. In some embodiments, the fluid outlet can be movably fixed to the reconstitution device housing. For example, in some embodiments, the fluid outlet can be coupled to the reconstitution device housing by a pin such that the fluid outlet can be rotated relative to the housing. In such embodiments, activation of the reconstitution device can cause the fluid outlet to rotate from a first rotational position to a second rotational position. In another embodiment, the fluid outlet can be disposed on a ball disposed in a recess formed on the housing of the reconstitution device. In this arrangement, the angle of the fluid outlet relative to the housing can be adjusted, but the fluid outlet can not be removable from the housing. Of course, the fluid outlet can have any suitable arrangement and can be associated with any suitable portion of the reconstitution device housing as the present disclosure is not so limited. For example, the fluid outlet can be disposed on the lower portion, middle portion, or upper portion of the reconstitution device housing (e.g., at the top third, middle third, or bottom third). The fluid outlet can be flexibly connected to the reconstitution device housing, can be movable about a hinge or pivot, or can be fixed relative to the housing.

[0116] In some embodiments, the reconstitution device can include a fluid outlet releasably attached to the reconstitution device housing. The fluid outlet can also be coupled to a flexible conduit disposed inside the reconstitution device housing when the fluid outlet is releasably attached to the housing. The fluid outlet can be rigidly held at the lower, middle, or upper third of the reconstitution device housing and can only be physically accessible by a user after the reconstitution device housing is actuated. Once the fluid outlet is physically accessible, a delivery device can be coupled to the fluid outlet. For example, the delivery device (e.g., a syringe) can be coupled to the fluid outlet by a twisting motion. Of course, any suitable motion can be employed to couple a delivery device to a fluid outlet as the present disclosure is not so limited. Once the delivery device is coupled, a user can pull the fluid outlet through the delivery device or otherwise apply a force to the fluid outlet to unseat the fluid outlet from the reconstitution device housing. Once unseated, the fluid outlet can be moved relative to the reconstitution device housing, thereby extending the flexible conduit.

[0117] The inventors have recognized the benefit of facilitating directional flow to ensure proper dosing and reconstitution. In particular, the inventors have recognized the benefit of a check valve or other one-way valve in facilitating one-way flow from a first container to a second container. In some embodiments, the check valve or other one-way valve can be disposed in a fluid path between the first container and the second container. During the reconstitution process, reconstitution fluid can flow from the first container to the second container and can be retained in the second container by the check valve. This arrangement can help prevent fluid or reconstituted medicament from flowing back from the second container and being lost.

[0118] In some embodiments, a transfer instrument for a reconstitution device includes a first fluid path extending between an inlet and a first spike, a second fluid path extending between the first spike and a second spike, and a third fluid path extending between the second spike and a fluid outlet. In some embodiments, a check valve is positioned along the second fluid path. The check valve is configured to allow flow in a direction from the first spike to the second spike, but prevent flow in the opposite direction. Thus, if a first container containing reconstitution fluid is pierced by the first spike and fluidly connected with the first spike, fluid can flow from the first container, through the second fluid path, and into the second container. If a second container containing medicament for reconstitution is pierced by the second spike and fluidly connected with the second spike, the fluid from the first container can flow into the second container, but can not flow back to the first container due to the presence of the check valve. In some embodiments, the second container can contain at least a partial vacuum, while the internal pressure of the first container can be at atmospheric pressure or can be higher than atmospheric pressure, such that the fluid in the first container is urged to flow to the second container due to the pressure differential between the first and second containers. The pressure differential can be arranged such that all of the fluid in the first container flows through the check valve toward the second container, such that the fluid can mix with the medicament and reconstitute the medicament. The check valve inhibits backflow of reconstituted medicament, ensuring that the correct dose of reconstituted medicament is retained in the second container and can be accessed by a delivery device (e.g., a syringe) via the fluid outlet.

[0119] The inventors have also recognized the benefit of improving agitation and mixing without requiring user handling of one or more containers during the reconstitution process. In particular, the inventors have recognized the benefit of a check valve disposed between the first container and the second container that retains fluid in the second container and inhibits backflow to the first container. As the reconstituted or partially reconstituted medicament is withdrawn through a delivery device (e.g., a syringe) and deposited into the second container, the fluid can be agitated to facilitate mixing, but will remain accessible to the delivery device in the second container. The delivery device can then be used to effectively agitate and mix the medicament to ensure that the medicament is fully dissolved or rehydrated prior to administration.

[0120] In some embodiments, a reconstitution device includes a first container and a second container disposed within an upper portion of a housing, where the upper portion of the housing at least partially encloses the first container and the second container. In some embodiments, a method of performing a reconstitution process includes applying a force to an upper portion to move the upper portion from a first, unactuated position to a second, actuated position. Upon movement of the upper portion to the second, actuated position, a first spike disposed in a lower portion of the housing can pierce a first container, and a second spike disposed in the lower portion of the housing can pierce a second container. Once pierced, a fluid can flow from the first container to the second container to occupy a vacuum or low pressure volume in the second container. As the fluid flows from the first container to the second container, the fluid can flow through a check valve configured to prevent flow in the opposite direction (i.e., back toward the first container). The method further includes withdrawing at least a portion of the fluid from the second container through a fluid outlet by a syringe. Once at least a portion of the fluid is withdrawn, the syringe can be used to deposit the fluid back into the second container. The syringe can be used to withdraw fluid from the second container and deposit the fluid back into the second container until a medicament in the second container is sufficiently mixed and reconstituted. During the fluid being moved back and forth into and out of the second container, the check valve can ensure that no fluid or medicament backflows to the first container. Once reconstituted, the medicament can be fully withdrawn through the syringe for self-administration by a user or administration to a patient.

[0121] While some embodiments described herein relate to reconstitution devices, it should be appreciated that various features and methods described herein can be used with drug fluid delivery devices that are not necessarily used for reconstitution. For example, in some embodiments, a drug fluid delivery device can be used with only a single container (e.g., to access the contents of a single container for delivery to a patient). In another example, a drug fluid delivery device can be used to aggregate contents from multiple containers without reconstitution. However, in other embodiments, a drug fluid delivery device can perform both reconstitution and aggregation (e.g., access the contents of two or more containers containing fluids and one or more containers containing solids). Thus, various features and methods described herein are also applicable to drug fluid delivery devices having any number of containers, as the present disclosure is not so limited.

[0122] The inventors have also recognized the benefit of a reconstitution device or a drug fluid delivery device that provides a user with a prompt to practice self-administration via one or more alarms of the reconstitution device itself or through a supplemental device. The reconstitution or drug fluid delivery device can provide a user with visual, audible, and / or tactile alarms regarding the status of the reconstitution process, and such an arrangement can simplify the reconstitution or drug fluid delivery process for the user.

[0123] In some embodiments, a reconstitution or medicinal fluid delivery device can include a first container having a fluid (e.g., a reconstitution fluid) and a second container having a medicament (e.g., a lyophilized medicament). The reconstitution or medicinal fluid delivery device can also include a power source (e.g., a battery), a processor, and at least one indicator (e.g., an alarm module). The at least one indicator can include a visual indicator (e.g., an LED, a display screen, etc.), an audible indicator (e.g., a speaker), and / or a tactile indicator (e.g., an eccentric rotating mass actuator, a linear resonant actuator, a piezoelectric actuator, etc.). The at least one indicator can indicate one or more states of the reconstitution or medicinal fluid delivery device during a reconstitution or medicinal fluid delivery process. For example, in one embodiment, the at least one indicator can indicate when the reconstitution device is actuated and the reconstitution fluid is flowing and mixing with the medicament. In another example, the at least one indicator can indicate when the reconstitution fluid has mixed with the medicament for a suitable amount of time, indicating when it is appropriate to withdraw the medicinal fluid from the reconstitution device through a delivery device (e.g., a syringe). In yet another example, the reconstitution or medicinal fluid delivery device can include an orientation sensor (e.g., an accelerometer, a gyroscope, etc.) and the indicator can indicate when the reconstitution or medicinal fluid delivery device is in a predetermined orientation, or conversely when the reconstitution or medicinal fluid delivery device is in an orientation different from the predetermined orientation. In some embodiments, the reconstitution or medicinal fluid delivery device can include a communication device (e.g., a radio transceiver that transmits and receives radio signals using one or more of Bluetooth, Bluetooth Low Energy, Wi-Fi, 802.15.4, ZigBee, GSM, HSPA, CDMA, and / or any other suitable protocol). The communication device can be employed to communicate and transmit one or more alarms to a remote device (e.g., a smartphone, a pager, a personal computer, a tablet computer, etc.). The remote device can then provide the alarm to a user through a visual, audible, and / or tactile indicator.

[0124] The inventors have also recognized the benefits of a medicinal fluid delivery device configured to communicate with one or more remote devices. The medicinal fluid delivery device can be configured to communicate information to the one or more remote devices. For example, in some embodiments, a dose, a time, and / or one or more sensor values (e.g., temperature, orientation, etc.) can be communicated to the one or more remote devices so that the one or more remote devices can track a treatment regimen, or otherwise record information about the use of the medicinal fluid delivery device. In some embodiments, the medicinal fluid delivery device can include a marker that is revealed or otherwise accessible (e.g., physically accessible, visually accessible, or radio accessibly) once the medicinal fluid delivery device is actuated. In other embodiments, a communication module of the medicinal fluid delivery device can be activated by a trigger once the medicinal fluid delivery device is actuated.

[0125] In some embodiments, a medicinal fluid delivery device includes a housing having a lower portion and an upper portion movably engaged with the lower portion. Similar to previously discussed embodiments, the upper portion can be movable relative to the lower portion between an unactuated position (e.g., an upper position) and an actuated position (e.g., a lower position). The medicinal fluid delivery device can also include a fluid outlet configured to deliver fluid from a reservoir disposed within the housing when the upper portion is in the actuated position. In some embodiments, the fluid outlet can not be accessible to a user when the upper portion is in the unactuated position. According to such embodiments, moving the upper portion to the actuated position can permit physical access to the fluid outlet and / or reveal the fluid outlet. The medicinal fluid delivery device can also include a marker configured to be readable by a remote device (e.g., a smartphone) when accessible. For example, the marker can be a QR code, a bar code, a radio frequency identification (RFID) tag, a near field communication (NFC) tag, or another suitable marker. The marker can not require power such that the medicinal fluid delivery device does not include an on-board power source. In some embodiments, the marker can be partially obstructed when the upper portion is in the unactuated position and accessible to a user when the upper portion is in the actuated position. For example, in some embodiments, the upper portion can enclose the marker in the unactuated position and can reveal the marker (e.g., via a cutout) in the actuated position. The marker can be employed by a remote device to obtain information related to the medicinal fluid delivery device, such as a dose, a manufacture date, etc.

[0126] In some embodiments, a medical fluid delivery device includes a housing having a lower portion and an upper portion moveably engaged with the lower portion. Similar to previously discussed embodiments, the upper portion is moveable relative to the lower portion between an unactuated position (e.g., an upper position) and an actuated position (e.g., a lower position). The medical fluid delivery device can also include a fluid outlet configured to deliver fluid from a reservoir disposed within the housing when the upper portion is in the actuated position. In some embodiments, the fluid outlet can not be accessible to a user when the upper portion is in the unactuated position. According to such embodiments, moving the upper portion to the actuated position can permit physical access to the fluid outlet and / or reveal the fluid outlet. The medical delivery device can also include a communication module configured to send 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 can be configured to send messages to a remote device (e.g., a smartphone) including information related to the medical fluid delivery device (e.g., a dose, a drug identification, a time, and / or one or more sensor values such as temperature, orientation, etc.). The medical fluid delivery device can also include a trigger configured to activate the communication module when the upper portion is moved to the actuated position. Such an arrangement can ensure that the communication module draws little to no power prior to actuation, such that the power source of the medical fluid delivery device has sufficient power available for the communication module to be usable for a desired shelf life. In some embodiments, the trigger can be a switch, a Hall effect sensor, a strain gauge, or other suitable sensor configured to detect movement of the upper portion to the actuated position.

[0127] The inventors have also recognized the benefit of a reconstitution device that provides a mechanical advantage and / or an electromechanical assist to a user to reduce the force used to actuate the reconstitution device relative to conventional reconstitution devices. Such an arrangement can allow a user to more easily and consistently activate the reconstitution device.

[0128] In some embodiments, the upper portion of the housing and the lower portion of the housing can be operably coupled via a screw mechanism, where a rotational force applied to the screw mechanism exerts a linear force, thereby causing the upper portion to move closer to the lower portion, where the screw mechanism provides a mechanical advantage relative to a direct application of linear force. As another example, in some embodiments, a lever can be connected to the lower portion of the housing such that a linear force applied to the lever amplifies the force applied to the upper portion of the housing to move the upper portion of the housing toward the lower portion. In yet another embodiment, the upper housing can include a ramped planar extrusion mechanism, where extruding at least one wedge including a ramped plane in a direction parallel to the surface on which the reconstitution device is disposed can push the upper housing portion toward the lower housing portion (or alternatively, push the two containers toward the corresponding prongs). Of course, any suitable arrangement including or not including a mechanical advantage can be employed for the reconstitution device, as the present disclosure is not so limited. Reference is made to Figures 19A to 21B Further discussed are some embodiments of reconstitution devices including a mechanical advantage.

[0129] In some embodiments, the housing of the reconstitution device can include a mechanical or electromechanical actuator that reduces the force to activate the reconstitution device. For example, the reconstitution device can include one or more of a spring (e.g., compression, tension, torsion, air spring), a servo system, a motor, and a linear actuator. According to some embodiments, the reconstitution device can include a power source (e.g., a battery) that can supply power to the electromechanical actuator. The actuator can be actuated by a user to correspondingly actuate the reconstitution device. Various user input devices can be employed for such activation, including but not limited to a button or switch. In embodiments employing a mechanical assist element (e.g., a spring), a user can operate a release device to actuate the reconstitution device. That is, the spring or other mechanical assist element can be pre-biased (i.e., have stored potential energy), which can be used to actuate the device upon release. Of course, any mechanical or electromechanical assist configuration, or a combination thereof, can be employed in the reconstitution device, as the present disclosure is not so limited.

[0130] The inventors have also recognized the benefits of a modular medicinal fluid delivery device that can be employed to deliver a wide variety of medicinal fluids in different volumes. In particular, the inventors have recognized the benefits of a modular transfer instrument that can include a plurality of adapters that can be interchangeably or expandable as appropriate for a given fluid delivery application. An adapter can include at least one fluid channel configured to connect to at least one second fluid channel of another adapter. Further, the adapter can include a coupling separate and spaced from the at least one fluid channel that can be employed to physically interlock the adapter with another adapter. In this manner, the transfer instrument can include any number of adapters in any desired configuration to deliver medicinal fluids. The modular transfer instrument can be employed to reconstitute lyophilized solids, or to aggregate multiple medicinal fluids, or to access a single container.

[0131] In some embodiments, a medicinal fluid delivery device can be modular. The modular medicinal fluid delivery device can include an inlet adapter, an intermediate adapter, and an outlet adapter. The medicinal fluid delivery device can be arranged such that any number of intermediate adapters can be employed in a modular fashion to accommodate a particular delivery volume. In some embodiments, the inlet adapter, intermediate adapter, and outlet adapter can all be configured to be fluidically connected to a container. For example, the inlet adapter, intermediate adapter, and outlet adapter can all include a spike configured to pierce a container to fluidically connect the container to the respective adapter. The inlet adapter can include an inlet adapter fluid channel and an inlet adapter coupling. The intermediate adapter can include a first intermediate fluid channel, a second intermediate fluid channel, a first intermediate adapter coupling, and a second intermediate adapter coupling. The outlet adapter can include an outlet adapter fluid channel and an outlet adapter coupling. The first intermediate adapter coupling can be configured to connect with the inlet adapter coupling, and the second intermediate adapter coupling can be configured to connect with the outlet adapter coupling. Likewise, the inlet adapter fluid channel can be configured to fluidically connect to the first intermediate fluid channel, and the outlet adapter fluid channel can be configured to fluidically connect to the second intermediate fluid channel. The fluid channels can be separate and spaced apart from the couplings such that the adapters can be physically connected together (e.g., via the couplings) independent of fluidic connection (e.g., via the fluid channels). In the event additional intermediate adapters are needed, the additional intermediate adapters can be identical to the first intermediate adapter and can be configured to fluidically and physically attach to the first intermediate adapter and inlet adapter, or the first intermediate adapter and outlet adapter. In some embodiments, additional intermediate adapters can not be identical to the first intermediate adapter, but can be configured to fluidically and physically attach to the first intermediate adapter and inlet adapter, or the first intermediate adapter and outlet adapter. Of course, any suitable number of intermediate adapters can be employed as the present disclosure is not so limited. Additionally, it should be noted that a modular medicinal fluid delivery device can be employed to reconstitute a solid medicament stored in one or more containers, to aggregate liquid medicaments from one or more containers, or for any combination of reconstitution and aggregation, or to access the contents of only a single container.

[0132] For purposes of the present disclosure, the term "coupled" (in all of its forms: couple, coupled, coupling, etc.) generally means the joining of two components directly or indirectly to one another. Such joining can be stationary in nature or movable in nature; the joining can be permanent in nature or can be removable or releasable in nature; and the joining can be achieved with the two components and any additional intermediate members being integrally formed as a single unitary body with the two components or with the two components and any additional intermediate members being attached to one another.

[0133] While specific embodiments of the apparatus will be further described herein, other alternative embodiments of all components associated with this reconfiguration apparatus are interchangeable to suit different applications. Turning to the accompanying drawings, specific, non-limiting embodiments of the reconfiguration apparatus and corresponding methods are described in more detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments can be used individually and / or in any desired combination, as this disclosure is not limited to the only specific embodiments described herein.

[0134] Figure 1 This is a schematic diagram of one embodiment of the transfer device 100, which can be used in a reconfiguration device or other hybrid device. (See diagram for example.) Figure 1 As shown, the transfer device includes a first tip 102 and a second tip 105, each configured to pierce a rubber stopper, diaphragm, or any other suitable seal of the container. The first tip 102 is associated with a first fluid path 103 and a second fluid path 104. Specifically, a first open end of the first fluid path is disposed in the first tip, as is a second open end of the second fluid path. The portions of the first and second fluid paths disposed in the first tip are parallel to each other and together define a first container receiving end. Figure 1 In one embodiment, a first fluid path is associated with inlet 108. In the depicted embodiment, the inlet is configured as an air inlet and includes a hydrophobic filter configured to allow air into the first fluid path while preventing any liquid from passing through the hydrophobic filter. Of course, any suitable inlet or vent that allows air into the transfer device can be used, as this disclosure is not limited thereto. In some embodiments, the air inlet may be configured as a check valve configured to allow air into the first fluid path while preventing air or fluid from leaving the first fluid path. A second fluid path extends between the first tip and the second tip 105. A check valve 109 is positioned along the second fluid path 104. The check valve 109 is configured to allow fluid and air to flow through the second fluid path in a direction from the first tip toward the second tip, but not vice versa. A third fluid path 107 has a fourth open end also disposed in the second tip and extends from the fourth open end to an outlet 111. The portions of the second and third fluid paths disposed in the second tip are parallel to each other and together they define a second container receiving end. The outlet of the depicted embodiment is configured as a Luer-activated valve. Of course, the transfer device 100 can be connected with any suitable valve or fluid outlet, as this disclosure is not limited thereto. For example, in other embodiments, the transfer device can employ another suitable fluid outlet, including but not limited to Luer-activated devices, simple Luer connectors or other threaded connectors, sliding-fit connectors, and puncture-resistant diaphragms. Figure 1 In embodiments of the transfer device, the transfer device further includes a drug filter 110 disposed in the third fluid path, the drug filter configured to filter any drug precipitates or undissolved medicament from the fluid flowing to the outlet.

[0135] According to Figure 1 the transfer device, the first container receiving end and the second container receiving end are each configured to receive a first container and a second container, respectively. The first container can be configured to contain a reconstitution fluid (e.g., sterile water for injection), while the second container can contain a medicament for reconstitution (e.g., a dry drug product). When the first container is pierced by the first spike 102 and the second container is pierced by the second spike 105, fluid from the first container can flow into the second container and mix with the medicament to form a medicinal fluid. The check valve 109 can retain the medicinal fluid in the second container and inhibit fluid flow from the second container back to the first container. Once the medicinal fluid is disposed in the second container, the medicinal fluid can be withdrawn via the outlet 111 using a delivery device such as a syringe. Reference is made to Figures 3 to 6 for further description of one embodiment of the reconstitution process.

[0136] Figure 2 is a perspective view of one embodiment of a reconstitution device 200. Figure 2 The reconstitution device shown can include a transfer device configured to reconstitute a medicinal fluid using two containers (e.g., similar to the transfer device of Figure 1 ). That is, the reconstitution device of Figure 2 is configured to accommodate two containers and reconstitute and deliver a drug. As Figure 2 shown, the reconstitution device includes a housing 201 having an upper portion 202 and a lower portion 204. According to Figure 2 the embodiment shown, the upper portion 202 is slidable relative to the lower portion 204 between an actuated position and an unactuated position. Examples of this sliding movement and associated features are discussed further with reference to Figures 7 to 12 the embodiment of Figure 2 the lower portion 204 is formed as a flat base by which the reconstitution device can be supported in a stable orientation on a flat surface such as a table, desk, countertop, or the like. In contrast, the upper portion 202 includes a rounded top surface 203 such that the reconstitution device cannot be supported in a stable orientation when placed on a flat surface with the rounded top. Thus, Figure 2 the housing 201 is configured to have a primary orientation in which the housing remains stable when placed on a flat surface. In this primary orientation, force can also be applied to the upper portion 202 while the lower portion 204 inhibits rotation of the housing. Additionally, the rounded top surface 203 is configured to provide a handle for a user to grasp, facilitating proper use of the reconstitution device.

[0137] according to Figure 2 In one embodiment, the reconfiguration device is configured to house two containers. As previously described, the two containers can be connected via a transfer device disposed within the reconfiguration device, an exemplary embodiment of which is described herein. Each of the containers may contain a specific dose of medication and / or reconfiguration fluid. Before reconfiguring and administering the medication fluid, the patient may wish to check that the correct size and dosage of the container is disposed within the reconfiguration device, especially where the container is enclosed by the upper portion 202 of the housing 201 and is not removable. Therefore, in Figure 2 In one implementation, the upper portion 202 includes windows 206A and 206B configured to allow a user to view the interior of the upper portion. Specifically, windows 206A and 206B are aligned with labels on containers disposed inside the housing, thereby allowing the user to obtain information related to the medication in the container, such as the type, volume, and dosage of the medication. Windows 206A and 206B have covers to prevent the user from inserting their fingers into the reconstructive device. Figure 2 In some embodiments, the upper portion further includes a window 210 to further improve label visibility. In some embodiments, window 210 allows a user to touch and rotate the container adjacent to the window to better view the container's label. Such windows may be positioned on opposite sides of the upper portion, allowing both containers within the housing to be visible and / or appropriately rotated to view the label. In some embodiments, the window in the reconfiguration device housing may include a magnifying glass to allow a user to more easily read text on containers within the reconfiguration device housing. In some embodiments, LEDs or other suitable lighting elements may be positioned inside the upper portion to illuminate any labels on the containers and / or provide one or more visual alerts to the user. Container illumination can be beneficial for medications requiring patient visualization. In some embodiments, the lighting elements may emit light of a wavelength at which the medication within the container is less prone to degradation. This arrangement may be beneficial for some photosensitive medications. In some embodiments, the reconfiguration device may not have any windows and may be arranged to conceal the container within the housing. As an example, this arrangement may be suitable for photosensitive medications that are easily photodegraded.

[0138] according to Figure 2In embodiments, the reconstitution device 200 is configured to block access to the fluid outlet of the transfer instrument disposed in the housing 201 prior to device actuation and subsequently permit access to the fluid outlet after device actuation. That is, the sliding of the upper portion 202 relative to the lower portion 204 selectively exposes or covers the fluid outlet depending on the position of the upper portion relative to the lower portion. In some embodiments, the reconstitution device blocks access to the fluid outlet by hiding the fluid outlet from the user and physically blocking access to the fluid outlet. In other embodiments, the fluid outlet is visible to the user prior to device actuation, but access to the fluid outlet is discouraged, for example, by a physical barrier.

[0139] In Figure 2 embodiments and as shown in Figures 9 to 10B the upper portion includes a slot 208 that forms part of a larger cutout that exposes the fluid outlet and allows the fluid outlet to be physically accessed and removed from the housing when the upper portion is in the actuated position as shown in Figures 10A to 10B

[0140] Figure 3 is a schematic view of one embodiment of a transfer instrument 100 for a reconstitution device during the first stage of one embodiment of a reconstitution and medicinal fluid delivery process. According to Figures 3 to 6 embodiments, the transfer instrument is similar to the embodiments described in Figure 1 The first fluid path 103 extends between the inlet 108 and a first open end disposed in the first spike 102. The second fluid path 104 extends between a second open end disposed in the first spike 102 and a third open end disposed in the second spike 105. The third fluid path 107 extends between a fourth open end disposed in the second spike and the outlet 111. The first spike defines a first container receiving end, while the second spike defines a second container receiving end. The inlet 108 is configured as a vent and includes a hydrophobic filter that allows air to flow into the transfer instrument, but prevents fluid from flowing out of the transfer instrument via the inlet. A check valve 109 can be included along the second fluid path 104. The check valve 109 is configured to allow fluid to flow in one direction along the second fluid path in a direction from the first spike toward the second spike. The outlet 111 is configured as a luer activated valve that can receive a delivery device (e.g., a syringe) capable of withdrawing the reconstituted medicinal fluid from the transfer instrument. According to Figures 3 to 6 embodiments, the transfer instrument further includes a drug filter 110 disposed in the third fluid path that is configured to filter any drug precipitates or undissolved medicament from flowing to the outlet. The drug filter can be positioned anywhere in the fluid path between the outlet 111 and the fourth open end of the third fluid path 107.​

[0141] like Figures 3 to 6 As shown in the embodiment, the transfer device 100 employs two containers. Specifically, the first container 300 is configured to be pierced by a first tip 102. The first container includes a reconstituted fluid 302 sealed by a stopper 304. The reconstituted fluid may be sterile water for injection or another suitable fluid. The stopper 304 is configured as a stopper with a diaphragm that can be pierced by the first tip 102. The stopper may be made of rubber, silicone, or any other suitable material. Of course, any suitable stopper or seal may be used, as this disclosure is not limited thereto. The second container 350 is configured to be pierced by a second tip 105. The second container includes a medication 352 disposed in the bottommost portion of the second container opposite the stopper 354. This arrangement ensures that the medication does not obstruct or otherwise inhibit the flow of fluid through the second fluid path 104 or the third fluid path 107 via the third and fourth opening ends, respectively. Of course, in other embodiments, the medication may be disposed in another portion of the second container, and this disclosure is not limited thereto. For example, the pharmaceutical agent may be positioned adjacent to and abutting the stopper 354. In some embodiments, although the pharmaceutical agent may be abutting the second tip 105 when the stopper 354 is punctured, the fluid flowing through it can disperse the pharmaceutical agent, keeping the fluid path unobstructed. In some embodiments, the puncturing tip of the tip can elevate the pharmaceutical agent and space it from the open end of the fluid path. Like the stopper of the first container, the stopper 354 of the second container is configured as a stopper with a diaphragm that can be punctured by the second tip 105. The pharmaceutical agent may be a lyophilized pharmaceutical product, which may be in powder form to facilitate dissolution in the reconstituted fluid. Of course, the pharmaceutical agent may take any suitable form, as this disclosure is not limited thereto. Figures 3 to 6 As shown in the embodiments, the first and second containers are inverted to allow gravity to push the fluid contained within the containers toward outlet 111 or another lower portion of the transfer device. In other words, in some embodiments, the first and second containers are arranged such that the air inside the containers is positioned at the end of the container opposite the tip. This arrangement ensures that the fluid is drawn through the tip before the air in the containers. Additionally, according to... Figures 3 to 6 The embodiment shown is a 10 mL container. However, any suitable container size may be used, including but not limited to containers with the following volumes: greater than or equal to 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, 40 mL, 50 mL, 75 mL, 100 mL, 200 mL, and 300 mL.

[0142] like Figure 3The first container 300 is inverted and positioned above the first spike 102, and the second container 350 is inverted and positioned above the second spike 105, as shown. The stoppers 304, 354 of the first and second containers, respectively, are spaced apart from the first and second spikes, respectively, such that the first and second containers remain sealed and not in fluid communication with the transfer device 100. Accordingly, Figure 3 The state shown can be the state of the reconstitution device just prior to initiating the reconstitution process. The first and second containers can be held in a spaced apart relationship relative to the spikes 102, 105 such that the fluid 302 in the first container and the medicament 352 in the second container remain sterile and ready for use during shipping, storage, and delivery to an end user or patient. In some embodiments, the transfer device 100 can be disposed in a first housing portion, while the first and second containers 300, 350 are disposed in a second housing portion. The second housing portion can be selectively movable relative to the first housing portion after the reconstitution process is initiated. When the reconstitution process has not been initiated, the second housing portion can ensure that the first and second containers remain sealed until the process is initiated. For example, in some embodiments, a pin or safety device can be removed or otherwise activated by a user to enable the containers to be pierced by the spikes. In another example, a threshold force can be required to be applied to the second housing portion before piercing of the first and second containers is permitted.

[0143] Figure 4 is a schematic view of the transfer device 100 during a second phase of the reconstitution and medicinal fluid delivery process Figure 3 According to the second phase of the process, the first and second containers 300, 350 have been pierced by the first and second spikes 102, 105, respectively. According to the embodiment shown in Figure 4 According to the second phase of the process, the first and second containers 300, 350 have been pierced by the first and second spikes 102, 105, respectively. According to the embodiment shown in Figure 4 According to the embodiment shown in Figure 4 According to the second phase of the process, the first and second containers 300, 350 have been pierced by the first and second spikes 102, 105, respectively. According to the embodiment shown in Figure 4As shown, the pressure differential can be so great that the fluid 302 is ejected from the third open end of the second fluid path 104 and impinges on the medicament 352 disposed on the end of the second container 350 opposite the second spike 105. As the fluid is pushed into the second container 350, the fluid mixes with the medicament and forms a medicinal fluid. The placement of the medicament on the bottom-most portion spaced apart from the second spike 105 is configured to allow the fluid jet 353 to impinge on the medicament and disperse the medicament to facilitate mixing of the medicament and the reconstituting fluid. In some embodiments, the medicament 352 dissolves in the reconstituting fluid. In other embodiments, the medicament rehydrates the medicament.

[0144] In some embodiments, at least one spike of a reconstitution device can include an open end for an internal lumen (i.e., fluid path) that directs fluid flow at an angle into a container. For example, in some embodiments, the lumen inside a spike can terminate in an open end disposed in one side of the spike. That is, the open end can be formed in a substantially vertical surface of the spike such that fluid flow through the spike is directed to the side relative to the piercing direction of the spike. In some embodiments, a spike can include multiple open ends for an internal lumen such that flow is directed out of multiple sides of the spike. In some embodiments, the open end can be angled relative to the piercing or insertion direction of the spike such that fluid flow is directed at the angle. In some embodiments, the open end of an internal lumen of a spike can be angled between 1 degree and 90 degrees relative to the piercing direction of the spike. Depending on the angle of the open end and the particular spike placement, different types of fluid flow can result when fluid flows out of the spike into a container. For example, flow angled relative to the piercing direction of the spike can create a vortex inside the container. In some embodiments, a spike can include a flow nozzle that creates a gentle or otherwise slow atomized spray. Without wishing to be bound by theory, depending on the flow, different medicaments can be more easily reconstituted. Additionally, some medicaments can be damaged by particularly harsh or forceful flow. Accordingly, the example embodiments described herein can employ any suitable spike placement to create a desired fluid flow inside a container.

[0145] As noted above, in some cases, different medicaments can be damaged or degraded by particularly harsh or strong flows. Additionally, some reconstituted medicaments can be susceptible to breaking down under high fluid shear. Accordingly, in some embodiments, one or more fluid paths of the transfer device can include a flow restrictor or otherwise be configured to limit the flow rate between the first container, the second container, and the outlet. For example, in some embodiments, the cross-sectional area of the diameter of the fluid path between the first container and the second container can be smaller than the cross-sectional area of the fluid path at other locations in the transfer device. In some embodiments, the cross-sectional area of the fluid path between the second container and the fluid outlet can be smaller than the cross-sectional area of the fluid path at other locations in the transfer device. In some embodiments, the fluid path can include a flow rate check valve configured to close if the fluid flow rate is too high. Such an arrangement can ensure that the fluid flows at the correct rate and that the medicament is not inadvertently damaged as it is withdrawn into the delivery device.

[0146] Of course, the reconstitution fluid and medicament can take any initial form to ultimately form a medicinal fluid, as the present disclosure is not so limited. Additionally, Figure 4 The illustrated example transfer devices and processes can be used to mix two fluids, as the present disclosure is not so limited. The two fluids can be the same fluid or different fluids.

[0147] According to Figure 4 embodiments, as the reconstitution fluid 302 flows into the second container 350, the check valve 109 prevents the fluid 302 from flowing back into the first container 300. The pressure differential between the first container 300 and the second container 350 can be arranged such that substantially all of the reconstitution fluid flows through the check valve 109. As fluid is expelled from the first container 300, air enters the inlet 108 to replace the flowing fluid. Thus, once the pressure between the first container, the second container, and the atmosphere equalizes, the first container can contain air, while the second container contains both the reconstitution fluid and the medicament. Such an arrangement can be beneficial to help prevent portions of the reconstitution fluid from flowing back into the first container 300. In some cases, fluid that flows back into the first container 300 can be difficult to withdraw from the transfer device. Additionally, the check valve can help ensure that the full dose of medicament remains in the second container 350 for mixing and reconstitution, and thus is able to be withdrawn via the outlet 111 in full dose or at an appropriate concentration.

[0148] In some embodiments, after the pressure between the first container 300, the second container 350, and the atmospheric pressure equalizes, the medicament has not yet fully combined with the reconstitution fluid. Accordingly, in some embodiments, a user can spin or shake the transfer device 100 or a device including the transfer device to ensure proper mixing of the reconstitution fluid 302 and the medicament 352. In some embodiments, as will be discussed further with reference to Figure 6 the delivery device can be used to agitate and mix the reconstitution fluid and the medicament.

[0149] Figure 5 During the third phase of the reconfiguration and pharmaceutical fluid delivery process Figure 3 A schematic diagram of the transfer device 100. (See diagram below.) Figure 5 As shown, the delivery device is connected to outlet 111. Figure 5 The delivery device is a syringe 400, which includes a handle 402 connected to a plunger 404. The syringe can be connected to an outlet via a Luer lock connector or any other suitable fluid and mechanical connection. Figure 5 In this state, the handle has been withdrawn in a direction away from the transfer device 100 to fill the syringe with... Figures 3 to 4 The pharmaceutical fluid 356 formed by the reconstituted pharmaceutical agent is shown. For example... Figure 5 As shown, check valve 109 prevents the pharmaceutical fluid from flowing back into the first container 300. As indicated by the dashed arrow, the pharmaceutical fluid is drawn from the second container 350 and replaced by air via inlet 108. According to... Figure 5 In this implementation, filter 110 filters out any drug deposits or undissolved medication to prevent transfer to the syringe. Therefore, if the medication fluid 356 is fully reconstituted, the fluid can be drawn into syringe 400 and subsequently administered to the patient using a suitable administration procedure.

[0150] In some implementations, further mixing steps may be performed to facilitate the reconfiguration or other mixing of the container contents. In some implementations, this mixing step may be optional. Figure 6 During the fourth phase of the remodeling and pharmaceutical fluid delivery process Figure 3 A schematic diagram of the transfer device. Specifically, in Figure 6 In the indicated state, syringe 400 is used to facilitate the mixing of the pharmaceutical fluid 356, thereby supplementing or replacing other mixing methods, such as the rotation and shaking of transfer device 100. According to Figure 5 In the illustrated state, with the pharmaceutical fluid at least partially aspirated into the syringe, the syringe handle 402 can be pushed toward the transfer device 100 to correspondingly move the plunger 404 and drive the pharmaceutical fluid back into the second container 350. This action facilitates the combination of the medication and the reconstituted fluid. Figure 6 As shown, the check valve prevents the pharmaceutical fluid from flowing back into the first container 300. Therefore, the backflow of the pharmaceutical fluid into the second container compresses the air in the second container and increases the pressure of the pharmaceutical fluid. The process of withdrawing a portion of the pharmaceutical fluid from the second container and dispensing that portion of the pharmaceutical fluid can be repeated until the pharmaceutical fluid is adequately combined for administration.

[0151] In some embodiments, the third fluid path 107 may include an air outlet that allows depressurization of the second container 350. In one embodiment, the air outlet may be arranged as a one-way vent, allowing air to escape from the second container 350 via the third fluid path 107, but preventing air from entering the second container. According to this embodiment, any source of air in the second container 350 may originate from the air inlet 108, allowing reconstituted fluid to be drawn from the first container into the second container. However, when the syringe 400 is used to mix the pharmaceutical fluid 356 by moving a portion of the pharmaceutical fluid back and forth in and out of the second container 350, the air outlet allows the fluid pressure to be effectively kept constant, thereby reducing the force required to deliver the fluid back into the second container. Of course, the air outlet may take the form of any suitable valve or filter and may be located on any suitable portion of the transfer device 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 fluid path 104. As another example, an air outlet may be provided on a second container (e.g., the base of the second container) so that pressurized air above the pharmaceutical fluid 356 can escape.

[0152] Figure 7 This is a perspective view of one embodiment of the reconfiguration device 200 in an unactivated state, and Figure 8 The reconfiguration device in an actuated state is shown. For example... Figures 7 to 8 As shown, the reconfiguration device includes a reference Figure 2 The described housing 201 is similarly arranged, comprising an upper portion 202 and a lower portion 204. The lower portion 204 includes an inner guide 205 that supports the upper portion 202 and allows the upper portion to slide relative to the lower portion 204. That is, the inner guide allows the upper portion to slide relative to the lower portion... Figure 7 The unacted position shown is the same as Figure 8 The movement is linear between the indicated actuation positions. When the upper portion is in the inactive position, the container disposed within the upper portion can be spaced apart from the transfer device disposed in the lower portion 204. That is, the container can remain sealed and fluidly disconnected from the transfer device. When the upper portion moves to... Figure 8 In the actuation position shown, the containers can move toward the transfer device, causing each container to be pierced by a point to establish fluid communication between the container and the transfer device, thereby initiating the reconfiguration process. (Refer to...) Figures 11 to 12 To further describe this arrangement.

[0153] In some embodiments, the inner guide can include one or more engagement features that slidably engage with one or more features on the upper portion 202. For example, the inner guide can have a groove shaped to receive a tab of the upper portion, where the tab can slide along the groove. These components can be reversed, such that the groove is on the upper portion and the tab is on the inner guide. Other sliding engagement arrangements can be used, such as other rails, elongate members that extend through the enclosed channel, or any other suitable sliding engagement arrangement.

[0154] According to Figures 7 to 8 embodiments of the reconstitution device 200 include an upper stop 207 formed on the upper portion 202 of the housing 201, and a lower stop 209 formed on the lower portion 204 of the housing. The upper and lower stops are formed as flanges configured to abut one another and prevent further movement of the upper portion 202 toward the lower portion 204 upon actuation of the reconstitution device. That is, the upper and lower stops define an actuation position at which the upper and lower stops contact one another. In Figures 7 to 8 embodiments, the upper and lower stops extend along the periphery of the upper and lower portions of the housing, respectively. Of course, in other embodiments, the stops can have any suitable arrangement, and the present disclosure is not limited in this regard.

[0155] Figure 9 is a side elevation view of the reconstitution device 200 of Figure 7 in an unactuated state, and Figure 10A is a side elevation view of the reconstitution device in an actuated state. Figures 9 to 10B Particular embodiments of the reconstitution device 200 are shown in detail how physical access to the fluid outlet 111 can be blocked prior to actuation. According to Figures 9 to 10B particular embodiments, the fluid outlet 111 can be at least partially hidden or enclosed within the housing 201 prior to actuation. Upon actuation, the fluid outlet 111 can be exposed such that it is accessible to a delivery device once the medicinal fluid is reconstituted. As Figure 9 shown, the upper portion 202 of the housing includes a slot 208 and a cutout 212 that form openings in the upper portion of the housing. However, in the position shown in Figure 9 nothing is accessible through the cutout 212 or the slot 208 except for a portion of the inner guide 205 of the lower portion 204 of the housing 201. However, as the upper portion is moved toward the lower portion, the cutout 212 aligns with the fluid outlet 111, permitting physical access to and removal of the fluid outlet. As Figure 9As shown, a fluid outlet 111 is disposed in a fluid outlet reservoir 213 formed in the lower portion 204. Therefore, when the cutout 212 is aligned with the fluid outlet reservoir 213, the fluid outlet 111 can be accessed through the cutout 212 and removed from the fluid outlet reservoir. For ease of removal, the fluid outlet includes a flexible strip 112. After the cutout 212 is aligned with the fluid outlet reservoir 213, a user is permitted to access the flexible strip 112. In some embodiments, the strip can be at least partially deployed when the cutout is aligned with the fluid outlet reservoir. The strip allows a user to pull the fluid outlet 111 from outside the housing 201, thereby facilitating its removal. According to... Figures 10A to 10B In one embodiment, the fluid outlet is connected to the associated transfer device via a flexible conduit 114, which allows the fluid outlet to be removed and manipulated while the housing 201 remains stationary. The flexible conduit 114 is aligned with a slot 208, which allows a portion of the flexible conduit to be released through the slot to allow manipulation of the fluid outlet. Therefore, in Figures 10A to 10B In one implementation, once multiple containers are punctured, fluid outlet 111 is exposed and can be accessed by a user to connect the delivery device. This arrangement ensures that the pharmaceutical fluid is at least partially reconstructed before the delivery device is connected.

[0156] like Figure 10B As shown, the fluid outlet 111 is disposed in the fluid outlet container 213 and is physically accessible to the user when the reconfiguration device is actuated. According to... Figure 10B In one embodiment, the fluid outlet 111 is a Luer activation device including external threads 113 configured to receive corresponding threads of a syringe or other delivery device. The fluid outlet 111 includes a flexible strip 112 configured to fold inside the reconfiguration device housing and then unfold when the device is actuated. The strip 112 may be formed of any suitable flexible material, including plastic film, rubber, etc. A user can pull the strip to remove the fluid outlet 111, which might otherwise be difficult to grasp and remove from the fluid outlet reservoir 213. In some embodiments, the strip 112 may be located on a flexible conduit 114 instead of the fluid outlet 111, allowing the flexible conduit to be used to remove the fluid outlet from the fluid outlet reservoir. In some embodiments, the strip may be a molded sleeve fitted onto at least a portion of the fluid outlet 111 and providing an area where a user can grasp the strip and use it to remove the fluid outlet from the fluid outlet reservoir.

[0157] Of course, although it is a reference Figures 9 to 10BOne embodiment of a housing that selectively allows physical access to a fluid outlet is shown and described, but other suitable configurations are contemplated. For example, in one embodiment, the upper housing may not include a cutout, but instead, the walls of the upper housing may be moved out of alignment with the fluid outlet reservoir. In another embodiment, a movable component (e.g., a cam, door, etc.) may be moved simultaneously with actuation of the housing of the reconfiguration device, thereby providing physical access to the fluid outlet only after actuation. In some embodiments, the fluid outlet may be visible to the user before the reconfiguration device is actuated, but may be at least partially blocked, making it impossible to physically access the fluid outlet. In one such embodiment, the fluid outlet reservoir may have an opening that is partially open when the reconfiguration device is not actuated. When the reconfiguration device is actuated, the opening of the reservoir may be enlarged or otherwise further opened, allowing the fluid outlet to be physically accessed through the opening. Of course, the fluid outlet may be retained in any suitable portion of the reconfiguration device housing before device actuation, including the lower or upper portion of the housing, as this disclosure is not limited thereto. In some embodiments, the upper portion of the housing is like... Figures 9 to 10B It is shaped as shown in the implementation scheme, but the housing is transparent, making the fluid outlet visible, but not physically accessible before the device is actuated.

[0158] Figure 11 yes Figure 7 A cross-sectional view of the reconstruction device taken along line 11-11 shows the reconstruction device in an unactuated state with a container, while Figure 12 yes Figure 8 A cross-sectional view of the reconfiguration device taken along line 12-12, showing the reconfiguration device in an actuated state with a container. (As shown) Figure 11 As shown and as previously discussed, the reconfiguration device includes a housing 201 having an upper portion 202 and a lower portion 204. The lower portion is slidably disposed within the upper portion, wherein an inner guide 205 provides a sliding interface with the upper portion. Figures 11 to 12 As shown, the first container 300 and the second container 350 are disposed in the upper portion 202. Figure 11 In this configuration, the first and second containers are spaced apart from the first tip 102 and the second tip 105 of the transfer device, respectively, thereby maintaining a seal between the first and second containers. Figure 12In this process, the first and second containers move toward the pointed objects 102 and 105, such that the pointed objects simultaneously pierce the stoppers 304 and 354 of the first and second containers. When moving from the unacted position to the actuated position, the user can place the lower portion 204 of the housing 201 on a flat surface as a base. The user can then apply force to the curved top surface 203 of the housing to move the upper portion 202 toward the lower portion 204, thereby moving the first and second containers 300 into contact with the pointed object. Once the first and second containers are pierced, the reconfiguration process can begin, as previously referenced. Figures 3 to 6 An exemplary implementation of the refactoring process is described.

[0159] It should be noted that, although Figures 11 to 12 A specific embodiment of housing 201 is shown, but the housing may take any suitable shape to allow the two containers to move selectively toward one or more container receiving ends of the fluid transfer device. For example, in one embodiment, the upper portion of the housing may be received inside the lower portion. As another embodiment, the top surface 203 of the housing may be unbent or only slightly bendable. Additionally, the upper housing may include one or more retaining features to secure the first container 300 and the second container 350 therein. For example, tabs, protrusions, and / or shelves corresponding to the shape of the containers may be used to maintain the spacing between the containers and the transfer device. Furthermore, in some embodiments, one or more biasing members may be used to bias the reconfiguration device toward an unactuated position, such that a threshold force must be applied to the upper portion to actuate the reconfiguration device.

[0160] In some embodiments, the transfer device may be a separate component from the lower portion of the housing. That is, the transfer device and housing of the reconfiguration device may be formed separately. The lower portion of the housing may include a slot or transfer device receiving portion configured to receive the transfer device. The transfer device may be secured to the lower portion using any suitable configuration, including but not limited to mechanical fasteners (e.g., screws, bolts, etc.), snap-fit ​​tabs, and adhesives (e.g., glue, epoxy resin, etc.). This arrangement allows for sterilization of the fluid pathway of the transfer device prior to 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 pharmaceutical containers or electronic devices. In some embodiments, having a transfer device that can be sterilized separately prior to assembly with the device housing avoids the need to sterilize the entire reconfiguration device, and therefore components sensitive to certain sterilization processes do not need to be exposed to such processes.

[0161] In some embodiments, the reconfiguration device can be stored and transported in a packaged container. The packaged container may be formed as a clamshell or blister pack, having a shape corresponding to the shape of the shell of the reconfiguration device. The packaged container may also include one or more protrusions or tabs that prevent movement of the upper portion of the shell relative to the lower portion of the shell, and vice versa. That is, one or more protrusions or tabs can engage the upper portion to hold it in an unacted position. This arrangement ensures that the reconfiguration device is not accidentally actuated during transport and storage.

[0162] In some embodiments, a reconfiguration device may include one or more locking latches that permanently lock the housing in the actuated position after the device is actuated. The reconfiguration device has a housing having an upper portion and a lower portion that are movable relative to each other between an actuated position and an inactive position. For example, in one embodiment, a latch disposed in the lower portion of the housing can capture and permanently hold the upper portion of the housing when the upper housing is moved to the actuated position. The latch may be disposed inside the housing so that it is inaccessible to a user. Thus, the housing can be effectively locked in the actuated position, and the upper portion cannot be moved back to the inactive position without damage. This arrangement prevents a user from disassembling the reconfiguration device or inhibits attempts to retrieve used containers from the reconfiguration device.

[0163] Figure 13 This is a side front view of one embodiment of the transfer device 100 of the reconfiguration apparatus. (See image.) Figure 13 As shown, the transfer device includes a first tip 102 and a second tip. Similar to the reference... Figure 1 The schematic diagram illustrates that a first tip 102 is associated with an air inlet 108 and a first fluid path 103. The air inlet includes a hydrophobic filter that allows air into the first fluid path 103 while preventing fluid from escaping. A second tip 105 is associated with a third fluid path 107 extending to a fluid outlet connector 115. The second fluid path extends between the first tip 102 and the second tip 105, as will be shown in the reference diagram. Figure 14 Further discussion is needed. According to... Figure 13 In one embodiment, fluid outlet 111 is connected to a third fluid path 107 via a flexible conduit 114, allowing the fluid outlet to move relative to the first and second tips. Fluid outlet 111 is configured as a Luer-activated valve and includes a rubber band 112 configured to assist the user in removing the fluid outlet from the reconfiguration device housing. Figure 13 In this implementation scheme, the fluid outlet 111 is adjacent to the air inlet 108, effectively forming a geometric loop for the transfer device. Additionally, in... Figure 13 In some of the embodiments shown, portions of all fluid paths are coplanar with each other within the transfer device.

[0164] In some embodiments, each of the tips 102, 105 of the transfer device 100 may have a corresponding sheath configured to seal and / or protect the fluid path provided in the transfer device. The sheath may be arranged to be compressible and to be destroyed by the tips 102, 105 when the container is punctured by the tips. This arrangement helps maintain the sterile fluid path of the transfer device during storage and transport of the reconstitution device. Additionally, in cases where one container is punctured before the other and fluidly connected to the transfer device, the sheath can provide a fluid seal for the tips, preventing any loss of reconstitution fluid or medication.

[0165] Figure 14 yes Figure 13 The top cross-sectional view of the transfer device 100, taken along section 14-14, shows the geometric arrangement of various fluid paths. (See diagram below.) Figure 14 As shown, a first fluid path 103 extends between the air inlet 108 and the location of the first tip 102. The first fluid path 103 defines a first lumen 120 in the first tip. A second fluid path 104 defines a second lumen 122 in the first tip and a third lumen 124 in the second tip 105. A check valve 109 is positioned along the second fluid path 104. Finally, a third fluid path 107 defines a fourth lumen 126 in the second tip and extends to a fluid outlet connector 115. As previously described, the fluid outlet connector can receive a flexible conduit that forms a continuous fluid path to a movable fluid outlet.

[0166] according to Figure 14 In one embodiment, the transfer device 100 is arranged in a compact rectangular shape. The parallel, loop-like arrangement of the fluid paths and the first tip 102 and the second tip 105 allows for a reduction in the size of the reconfiguration device containing the transfer device to facilitate transport and handling. That is, at least a portion of the fluid path bends on itself, rather than extending in a single linear path. Figure 14 As shown, portions of the first fluid path 103, the second fluid path 104, and the third fluid path 107 are all parallel to each other. In fact, each of the fluid paths has a portion parallel to the longitudinal axis XX of the transfer device. Furthermore, according to... Figure 14 In some embodiments shown, at least a portion of the first fluid path 103 may be mirrored across the longitudinal axis to form at least a portion of the second fluid path 104. Similarly, at least a portion of the second fluid path 104 may be mirrored across the longitudinal axis to form the third fluid path 107. Therefore, the fluid paths are at least partially symmetrical across the longitudinal axis to reduce the overall size of the transfer device. It should be noted that although... Figure 14The first, second, and third fluid paths include bends that change the direction of the fluid path, but any suitable arrangement can be used to change the direction of the fluid path. For example, in some embodiments, the fluid path may include one or more angular portions that change the direction of the fluid path.

[0167] Although Figure 14 The embodiments shown depict a rectangular transfer device, but in other embodiments, the transfer device may take any suitable shape. For example, the transfer device may be circular, elliptical, square, or another suitable shape, and this disclosure is not limited thereto.

[0168] according to Figure 14 In one implementation scheme, the transfer device 100 may have a rectangular size ideally suited for placement in a compact reconstruction apparatus. That is, the total width W of the transfer device is less than the total length L of the transfer device. Specifically, according to... Figure 14 In one embodiment, the ratio between length L and width W can be between 3 and 5. Therefore, the length of the transfer device can be 3 to 5 times longer than its width, making it ideally suited for accommodating linearly arranged containers. Since the transfer device may include a movable fluid outlet connected via flexible tubing (see...), Figure 13 Therefore, the fluid paths extending between the tips 102, 105, the inlet 108, and the fluid outlet connector 115 can be arranged in parallel to reduce the overall size of the reconfiguration device employing the transfer device. In other words, the first fluid path 103 and the third fluid path 107 are turned to extend parallel to the second fluid path 104, thereby reducing the overall length of the transfer device without significantly increasing its width. Of course, in other embodiments, any suitable length-to-width ratio can be used, as this disclosure is not limited thereto.

[0169] Figure 15is a flowchart of one embodiment of a process for reconstitution and medicinal fluid delivery. At step 500, a first container and a second container are provided within a housing, where an upper portion of the housing at least partially encloses the first and second containers. The first and second containers can include a reconstitution fluid and a medicament for reconstitution, respectively. In some embodiments, step 500 can be omitted and the process can begin at step 502. At step 502, a force is applied to the upper portion of the housing, moving the upper portion from a first, unactuated position to a second, actuated position. Applying a force to the upper portion can include applying a force to the upper portion in a linear direction toward a planar surface on which the housing is placed. At step 504, a first spike pierces the first container and a second spike pierces the second container as the upper portion moves to the actuated position. At step 506, fluid is allowed to flow from the first container to the second container to occupy a vacuum in the second container. Allowing fluid to flow to the second container can include moving the fluid through a check valve disposed between the first and second spikes and expelling the fluid into the second container at a rate that facilitates reconstitution. At step 508, the fluid is mixed with a drug product or medicament in the second container to produce a medicinal fluid. At step 510, a syringe (or other delivery device) is coupled to a fluid outlet to withdraw the medicinal fluid from the second container.

[0170] Figure 16is a flowchart of another embodiment of a process of reconstitution and medicinal fluid delivery. At step 600, a first container and a second container are provided within a housing, where an upper portion of the housing at least partially encloses the first container and the second container. The first container and the second container can include a reconstitution fluid and a medicament for reconstitution, respectively. In some embodiments, step 600 can be omitted, and the process can begin at step 602. At step 602, a force is applied to the upper portion of the housing, thereby moving the upper portion from a first, unactuated position to a second, actuated position. Applying the force to the upper portion can include applying the force to the upper portion in a linear direction toward a planar surface on which the housing is placed. At step 604, the first container is pierced with a first spike and the second container is pierced with a second spike as the upper portion is moved to the actuated position. At step 606, fluid is allowed to flow from the first container to the second container to occupy a vacuum in the second container. Allowing the fluid to flow to the second container can include moving the fluid through a check valve disposed between the first spike and the second spike, and expelling the fluid into the second container at a rate that facilitates reconstitution. At step 608, a syringe is coupled to a fluid outlet to withdraw at least a portion of the medicinal fluid from the second container. For example, in one embodiment, a syringe handle can be moved away from the fluid outlet. At step 610, the withdrawn portion of the medicinal fluid is delivered back into the second container through the syringe. For example, step 610 can be accomplished by pressing the syringe handle toward the fluid outlet, thereby increasing the pressure of the medicinal fluid.

[0171] In some embodiments, Figure 16 The illustrated steps 608 and 610 can be employed in a process where a vacuum does not exist, or a sufficient vacuum does not exist, in the second container to draw the reconstitution fluid from the first container into the second container. In such embodiments, the syringe can be used to draw the fluid from the first container into the second container, and ultimately into the syringe. Once the fluid is at least partially disposed within the syringe, the withdrawn portion of the fluid can be delivered back into the second container to mix the contents of the first and second containers together, and the process can be repeated until the contents of the first and second containers are sufficiently mixed.

[0172] Figure 17This is a flowchart of another embodiment of the reconfiguration and pharmaceutical fluid delivery process. At step 650, a first container and a second container are provided within a housing, wherein the upper portion of the housing at least partially encloses the first and second containers. The first and second containers may respectively comprise a reconfiguration fluid and a liquid pharmaceutical agent for reconfiguration. In some embodiments, step 650 may be omitted, and the process may begin at step 652. At step 652, a force is applied to the upper portion of the housing, causing the upper portion to move from a first unactuated position to a second actuated position. Applying the force to the upper portion may include applying the force in a linear direction toward the flat surface on which the housing is placed. At step 654, when the upper portion has moved to the actuated position, the first container is pierced with a first tip, and the second container is pierced with a second tip. At step 656, fluid is allowed to flow from the first container to the second container. Figure 17 In some embodiments, the fluid may not flow automatically from the first container to the second container. However, once the container is punctured, the reconstituted fluid and liquid medication can be at least partially mixed. At step 658, a syringe is attached to the fluid outlet to draw at least a portion of the medication fluid from the second container. For example, in one embodiment, the syringe handle may be removed from the fluid outlet. At step 658, all the liquid medication and reconstituted fluid can be drawn into the syringe in a single aspiration. At an optional step 660, the drawn portion of the medication fluid is returned to the second container via the syringe. For example, step 660 can be accomplished by pressing the syringe handle against the fluid outlet. Step 660 may be used if the medication and reconstituted fluid are not sufficiently mixed. In some cases, steps 658 and 660 may be repeated to more thoroughly mix the reconstituted fluid and medication.

[0173] Figure 18 This is a schematic diagram of one embodiment of a reconfiguration device 700 that communicates with one or more remote devices. (See diagram for example.) Figure 18 As shown, the reconstruction device is similar in shape and size to the reference. Figure 2 The reconfiguration device is described. The reconfiguration device includes a housing 701, which includes an upper portion 702 and a lower portion 704. The upper portion is configured to slide relative to the lower portion, and an inner guide 705 is received in the upper portion to support and guide the upper portion when it slides between an inactive and an actuated position. Figure 18According to one embodiment, the reconfiguration device 700 includes: a processor 708 (e.g., a programmable logic controller), which is disposed in a lower portion 704 together with a communication device 710; and an internal power supply configured as a battery 712. The processor is configured to execute a series of one or more computer-readable instructions stored in volatile or non-volatile memory disposed on the lower portion 704. The communication device is configured to transmit signals via 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 via one or more of the following: 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, lithium-ion, or alkaline battery, as this disclosure is not limited thereto.

[0174] In some embodiments, the reconfiguration device may include markings, such as QR codes or other identification labels (e.g., barcodes). Such markings may be used to allow the reconfiguration device to connect to an application (e.g., a smartphone app) or otherwise be tracked by a supplemental remote device (e.g., a smartphone). In some embodiments, scanning the QR code using a suitable reader or camera can import information about the drug dosage, drug identification, and / or the volume of the drug placed in the reconfiguration device into the supplemental remote device for display to the user. The supplemental device may also track time, dosage, frequency, drug batch information, and other medically relevant parameters, enabling the user or physician to monitor extended treatment processes. In some embodiments, the QR code or other markings may be concealed away from view within the reconfiguration device housing or otherwise obstructed to prevent access before the device is actuated. Once the device is actuated, the QR code can be exposed or otherwise accessed for scanning by the user.

[0175] According to some implementation plans and such Figure 18 As shown, the electronics of the reconfiguration device may only be activated after the reconfiguration device is actuated. That is, when the upper portion 702 is in the inactive position, the processor 708 and communication device 710 may be in a dormant, sleep, or electrically disconnected position. When the upper portion 702 moves to the actuated position (e.g., closer to the lower portion 704, such that, for example, the bottommost surface of the upper portion is closer to the base of the lower portion), one or more switches may be triggered to wake up the processor and communication device or connect them to the power supply. Therefore, the onboard power supply may not be depleted during transport and storage, and sufficient charge may be retained to power the reconfiguration device when it is actuated. Figure 18In one embodiment, the reconfiguration device includes a first Hall effect sensor 716 and a second Hall effect sensor 718 disposed in the lower portion 704 of the housing. The Hall effect sensors are configured to sense the instantaneous presence of a magnet 714 disposed on the upper housing. That is, the first Hall effect sensor is configured to sense when the upper portion 702 is in an inactive position, while the second Hall effect sensor is configured to sense when the upper portion 702 is in an activated position. When the magnet 714 moves to be adjacent to the second Hall effect sensor 718, the processor 708 and the communication device 710 can be activated. Of course, although... Figure 18 The image shows a Hall effect sensor, but any suitable switch or sensor can be used to determine the position of the upper part, including but not limited to linear potentiometers or microswitches.

[0176] In some implementation schemes and such Figure 18 As shown, the reconstruction device 700 may include one or more visual indicators 720 configured as LEDs, which indicate one or more states of the reconstruction device to a user. The visual indicators may be controlled by a processor 708 and can be activated by moving an upper portion 702 to an actuated position. The visual indicators may indicate one or more states of the reconstruction device while the reconstruction process is in progress. For example, in one embodiment, at least one indicator may indicate when the reconstruction device is actuated and when the reconstruction fluid is flowing and mixing with a pharmaceutical agent. In another example, at least one indicator may indicate, based on input from a real-time clock module, when the reconstruction fluid has been mixed with the pharmaceutical agent for an appropriate time, thereby indicating when it is appropriate to withdraw the pharmaceutical fluid from the reconstruction device by a delivery device (e.g., a syringe). According to one such example, one or more visual indicators 720 may display a first color when the reconstruction fluid is mixed with the pharmaceutical agent, and a second color once the reconstruction fluid has been mixed with the pharmaceutical agent for a predetermined time. In another such example, one or more visual indicators 720 may flash in a first mode when the reconstruction fluid is mixed with the pharmaceutical agent, and flash in a second mode or display a single color once the reconstruction fluid has been mixed with the pharmaceutical agent for a predetermined time. In yet another example, the reconstructing device may include an orientation sensor (e.g., an accelerometer, gyroscope, etc.) and an indicator may indicate when the reconstructing device is in a predetermined orientation, or conversely, when the reconstructing device is in an orientation different from the predetermined orientation. Of course, any of the above examples may be used individually or in any combination of them to convey desired information to the user, as this disclosure is not limited thereto.

[0177] The indication of status by the visual indicator can be coordinated by the processor 708, which can receive and process information from one or more sensors. In some embodiments, the visual indicator can be color-coded to convey the general status of the reconstitution device during the reconstitution process. For example, the visual indicator can light up red in an error state, yellow when the reconstitution fluid is mixing with the medicament inside the device, and green when ready to withdraw the medicinal fluid from the device. Of course, any suitable color or blinking pattern can be used to indicate any desired status, as the present disclosure is not so limited. In some embodiments, the communication device 710 can also communicate the status of the reconstitution device to a remote device, as further described below. In some embodiments, the reconstitution device can include one or more light sources configured to illuminate a container disposed within the reconstitution device.

[0178] According to Figure 18In embodiments, the reconstitution 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 communicated through such communication can be shared with one or more parties, who can use the information in different ways. The communication can be one-way communication in either direction, or two-way communication. The communication can utilize any suitable number of local or external networks, including the Internet, to communicate with the remote devices. For example, in some embodiments, the reconstitution device can use a short-range communication protocol to communicate with a base station or a local relay, such as Bluetooth, ZigBee, infrared transmission, and radio frequency (RF) communication. Thus, if the reconstitution device lacks remote communication capabilities, such as Wi-Fi or cellular network technology, or if the user has not activated these communication capabilities, the reconstitution device can still communicate wirelessly with a local relay. In some embodiments, the reconstitution device can also use a short-range communication protocol to communicate wirelessly with a proximate external device, such as a mobile device. In some embodiments, the reconstitution device can communicate wirelessly with other external devices over longer distances, such as directly with a remote server 724 or a personal computer 721. In some embodiments, the reconstitution device can send messages including information to one or more remote devices. The information can include time information, dosage, drug lot information, and other medically relevant parameters. In some embodiments, the reconstitution device can include a global positioning system (GPS) sensor configured to provide location information to the processor 708. In such embodiments, the information can include location information from the GPS sensor. In some embodiments, the reconstitution device can include an accelerometer configured to detect motion and / or orientation of the reconstitution device. In such embodiments, the information can include orientation, average acceleration, etc. from the accelerometer. In some embodiments, the reconstitution device can include a temperature sensor configured to detect temperature of the reconstitution device. In such embodiments, the information can include current temperature, average temperature, peak high temperature, peak low temperature, etc. from the temperature sensor.

[0179] In some embodiments, the reconstitution device 700 can directly and / or indirectly interact with a number of different parties that can utilize information from the reconstitution device and / or send commands or other information to the reconstitution device. As a first example, information from the reconstitution device can be sent directly or indirectly to the patient. The patient can obtain information from a visual indicator 720 on the reconstitution device, a mobile device 722 that can be running a companion application for the reconstitution device, or a remote server 724. As one example, the patient can use a mobile device to obtain information from the remote server 724 via an internet website or other program. In some embodiments, the user can have access to a "patient service" feature that can serve as a type of customer service for the user. The user can contact this service via a phone call, text message, website, live chat, or other suitable means of communication to obtain assistance related to the reconstitution device and / or the drug product. As one example, in some embodiments, the patient can use the patient service feature to receive training on how to use the reconstitution device and / or any accessories related to the reconstitution device, how to resolve any issues that can have arisen, or to ask any questions related to the reconstitution device or drug product. In some embodiments, the patient can use the patient service feature to help resolve issues related to payment and / or insurance. The patient service can need to access information from the patient's reconstitution device in order to help the patient resolve some of these issues. In some embodiments, the information can be obtained from the remote server 724.

[0180] In some embodiments, the reconstitution device 700 can communicate directly or indirectly with a healthcare provider, such as a hospital, clinic, etc., and personnel, such as a nurse or doctor. The healthcare provider can obtain information from a remote server 724 or from other external devices, such as a mobile device 722, that receive information from the reconstitution device 700. Alternatively, the healthcare provider can communicate directly with the reconstitution device 700. Information that can be sent to the healthcare provider includes, but is not limited to, when a dose was taken, how much drug was delivered, symptoms experienced by the patient, etc. The healthcare provider can use the information to monitor patient compliance and / or to determine efficacy of the drug and / or the dosage regimen of the drug used by the patient. Based on the information, the healthcare provider can, for example, select to provide educational training and / or encouragement to the patient, and / or can adjust the patient's treatment. The communication between the reconstitution device and the healthcare provider can be one-way or two-way communication. For example, in some embodiments, the healthcare provider can be able to send messages, such as reminders or alerts, to the patient via the reconstitution device itself, or to a mobile device used by the patient in conjunction with the reconstitution device, for example, via an application running on the mobile device that can be specific to the reconstitution device and / or the particular treatment for which the reconstitution device is being used. Through the application on the mobile device, or through the reconstitution device itself, the patient can be able to send questions or concerns directly to the healthcare provider, who can then respond back to the patient.

[0181] In some embodiments, information communicated from the reconstitution device 700 can be integrated with the patient's electronic health record. The record can include information such as when a dose was taken, how much drug was delivered, symptoms experienced by the patient, etc.

[0182] In some embodiments, the reconstitution device 700 can communicate directly or indirectly with a payer (also referred to as an insurance company). The payer can use information from the reconstitution device to monitor aspects such as patient compliance, drug efficacy, and efficacy of the treatment regimen. In some embodiments, the payer can attempt to encourage or reward certain behaviors. For example, the payer can reward patients with good compliance by reducing rates or providing discounts. The payer can also encourage compliance by sending treatment reminders or alerts to the patient and / or the healthcare provider.

[0183] In some embodiments, information delivered through communications from and / or to the reconstitution device 700 can be used for data analysis that can be used by multiple parties. For example, a supplier (e.g., a manufacturer of the drug and / or the reconstitution device) can use information from the reconstitution device to determine what features are most often used by users, when errors or issues occur, what errors or issues occur, etc. The information can be able to be sorted into different categories, such as age, gender, income, level of experience, etc. In some embodiments, the information collected for data analysis can be anonymous and free of PHI (patient health information). However, in other embodiments, the information can contain PHI.

[0184] In some embodiments, information collected from the reconstitution device 700 can help provide performance of the drug. The inventors have learned that it can be difficult to assess performance of a drug when it has been disseminated to a wider public outside of a clinical trial. Communications from the reconstitution device, as well as other sources such as mobile devices and / or healthcare providers, can help provide information about performance of the drug and / or the reconstitution device. Information about a patient's symptoms and treatment progress can be collected from the patient, e.g., via an electronic symptom diary built into a companion application running on the mobile device, and / or can be collected from notes made by a healthcare provider during a patient's medical visit. The collected information can help a supplier understand future formulations and / or reconstitution device designs, and positive performance can be used to help promote use of the drug.

[0185] In some embodiments, information delivered through communications from and / or to the reconstitution device 700 can be used to assist with supply chain management. The information can include identification of what drug is used, and when the drug is used (e.g., by sending a batch / lot number or other identifier associated with the drug). Information can also include a geographic area in which the drug is used. Such information can help a drug supplier understand supply and demand for the drug, e.g., in various regions of the world, as reflected by actual use of the drug (as compared to being limited to prescription fill information). This can help a supplier understand whether more or less of the drug should be stocked in certain regions, whether marketing efforts should be increased in certain regions, and / or whether past marketing efforts have effectively increased demand.

[0186] In some embodiments, the reconstitution device 700 can include a near field communication (NFC) module that allows a remote device, similar to a smartphone, to pair with the communication device 710. That is, the NFC module can deliver pairing information to a device having a corresponding NFC module, allowing the typical pairing process to be avoided. Such an arrangement can be beneficial to enable reconstitution device communications without pre-pairing the device or otherwise preparing the remote device specifically for the reconstitution device.

[0187] It should be noted that while Figure 18 embodiments depict a reconstitution device, in other embodiments, a device similar to Figure 18 may be a medical fluid delivery device configured to aggregate medical fluid rather than reconstitute a solid medicament. Accordingly, various features and methods described with reference to Figure 18 are also applicable to a medical fluid delivery device configured for aggregating fluid as the present disclosure is not so limited.

[0188] In addition to the above, it should be noted that while Figure 18 devices are configured for accessing and delivering the contents of two containers, any suitable number of containers can be employed. For example, in some embodiments, a medical fluid delivery device similar to that described with reference to Figure 18 may include a single container, two containers, three containers, four containers, five containers, or any suitable number of containers. Accordingly, various features and methods described with reference to Figure 18 are also applicable to a medical fluid delivery device or reconstitution device having any number of containers as the present disclosure is not so limited.

[0189] Figures 19A to 19B is a schematic illustration of another embodiment of a reconstitution device 800 in an unactuated state and an actuated state, respectively. According to the depicted embodiment, the reconstitution device includes a housing 802 containing a first container 300 and a second container 350. The device also includes a first actuator 806A and a second actuator 806B arranged as inclined planes. The first and second actuators are configured to move into the housing 802 to actuate the reconstitution device. Specifically, the actuators are configured to move corresponding first and second wedges 808A, 808B. The first and second wedges are configured to move the first and second containers toward a base 804 of the housing 802 to be pierced by first and second spikes, respectively. That is, as Figures 19A to 19B illustrated, the first and second actuators can be squeezed or otherwise pressed into the housing 802 to drive the first and second wedges downward toward the base 804 of the housing. Because the inclined planes of the actuators and wedges interface with one another, lateral movement of the actuators is converted to downward movement of the wedges to drive and pierce the containers. This arrangement can provide a mechanical advantage in piercing the containers.

[0190] Figures 20A to 20B is a schematic illustration of another embodiment of a reconstitution device 900 in an unactuated state and an actuated state, respectively. As Figures 20A to 20BAs shown, the reconstitution device includes a housing having an upper portion 902 and a lower portion 904. The upper portion is movable (e.g., slidable) relative to the lower portion, with the upper portion moving from an unactuated position toward the lower portion to an actuated position. The reconstitution device includes a bolt 906 that is fixed to the lower portion. A nut 908 and a handle 910 are threadably coupled to the bolt and are fixed relative to the upper portion. Accordingly, a user can turn the handle 910 to move the upper portion toward the lower portion and actuate the reconstitution device. Doing so can pierce the first container 300 with the first spike 102 and the second container 350 with the second spike 105.

[0191] Figures 21A to 21B is another embodiment of a reconstitution device 1000 in unactuated and actuated states, respectively. As shown, the reconstitution device includes a housing having an upper portion 1002 and a lower portion 1004. The upper portion is movable (e.g., slidable) relative to the lower portion, with the upper portion moving from an unactuated position toward the lower portion to an actuated position. The reconstitution device includes a lever 1008 that is rotatably coupled to the lower portion 1004. The lever 1008 protrudes from a slot 1006 in the upper portion 1002, such that the lever can apply a force to the upper portion. Accordingly, to actuate the reconstitution device, the lever can be moved downward from an upper position toward the lower portion to correspondingly move the upper portion toward the lower portion. Doing so can pierce the first container 300 with the first spike 102 and the second container 350 with the second spike 105. Figures 21A to 21B Figure 21A

[0192] Figure 22 is another embodiment of a reconstitution device 1000 in unactuated and actuated states, respectively. As shown, the reconstitution device includes a housing having an upper portion 1002 and a lower portion 1004. The upper portion is movable (e.g., slidable) relative to the lower portion, with the upper portion moving from an unactuated position toward the lower portion to an actuated position. The reconstitution device includes a lever 1008 that is rotatably coupled to the lower portion 1004. The lever 1008 protrudes from a slot 1006 in the upper portion 1002, such that the lever can apply a force to the upper portion. Accordingly, to actuate the reconstitution device, the lever can be moved downward from an upper position toward the lower portion to correspondingly move the upper portion toward the lower portion. Doing so can pierce the first container 300 with the first spike 102 and the second container 350 with the second spike 105. Figure 22 ​​As shown, the transfer device includes a first tip 1111 and a second tip 1114 formed as part of a first plate 1102. The transfer device also includes a second plate 1104 that forms a fluid passage with the first plate and a filter chamber 1117 with a third plate 1106. The transfer device includes an inlet 1109 (e.g., an air inlet), which in some embodiments may include a hydrophobic filter. The inlet is connected to a first fluid path 1110 that bends into and extends upward along the first tip 1111. A second fluid path 1112 extends from the first tip 1111 to the second tip 1114. A check valve 1119 is disposed in the second fluid path, allowing unidirectional flow from the first tip to the second tip. A third fluid path 1115 extends from the second tip 1114 and includes a filter inlet 1116. The filter inlet allows fluid to flow from a third fluid path between the first plate 1102 and the second plate 1104 to a filter chamber 1117 disposed between the second plate 1104 and the third plate 1106. The filter can be positioned within the filter chamber to effectively filter the pharmaceutical fluid flowing toward the fluid outlet. The arrangement of the filter chamber allows for the use of filters with a large surface area. The filter chamber terminates at an outlet 1118, which can be formed as or coupled to any suitable fluid connector discussed with reference to the previous embodiments described herein.

[0193] Figure 23 yes Figure 22 A side cross-sectional view of the transfer device taken along line 23-23. (See figure) Figure 23 As shown, the transfer device is formed by three different plates. The first plate 1102 includes a first tip 1111 and a second tip 1114. The second plate 1104 forms a fluid path with the first plate and forms a filter chamber 1117 with the third plate 1106. The third plate forms a filter chamber with the second plate 1104. It should be noted that although... Figure 22 The transfer device is formed from three different plates, but it can also be formed from a single integral piece or any suitable number of components that form various fluid paths. For example, in some embodiments, the transfer device may be formed from two different plates connected together to form multiple fluid paths.

[0194] Similarly, Figure 23 As shown, the fluid path extends into the lumens of the first and second tips. That is, the first fluid path 1110 extends into the first lumen 1120 disposed in the first tip 1111. The third fluid path 1115 extends into the fourth lumen 1126 disposed in the second tip 1114.

[0195] Figure 24 yes Figure 22is a top cross-sectional view of the transfer device taken along line 24-24, and Figure 25 is Figure 22 is a top cross-sectional view of the transfer device taken along line 25-25. As Figure 24 shown, the fluid paths are arranged in a loop-like configuration similar to the embodiments discussed previously herein. That is, the first fluid path 1110 and the third fluid path 1115 are disposed in a mirrored parallel arrangement with respect to the second fluid path 1112. However, instead of the outlet 1118 being disposed adjacent to the inlet 1109, the outlet 1118 is disposed on the opposite side of the transfer device from the filter inlet 1116. As Figure 24 shown, the first fluid path 1110 extends into the first lumen 1120. The second fluid path 1112 extends from the second lumen 1122 and into the third lumen 1124. The third fluid path 1115 extends from the fourth lumen 1126 to the filter inlet 1116. Figure 25 The filter chamber 1117 is shown extending in a racetrack or squarish rectangular shape. 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 Figure 25 the embodiments, the outlet 1118 is configured such that fluid flows down from the filter inlet 1116, then is drawn back up through the outlet for delivery to the patient. This arrangement ensures that the fluid is filtered before being delivered. Figure 26 is a perspective view of another embodiment of a transfer device 1200. As Figure 26 shown, the transfer device includes two spike housings that are separated by a tube. That is, the first spike housing 1202 includes a first spike 1203 and an inlet 1204. The second spike housing 1210 includes a second spike 1211. Connecting the spike housings is a tube 1220. The tube 1220 can be flexible or rigid. This arrangement allows for the center-to-center spacing of the spikes 1203, 1211 to be varied for various container sizes using the same spike housing. That is, the tube 1220 can be swapped to have various different lengths to accommodate different size embodiments of the reconstitution device.

[0196] Figure 27 is Figure 26 is a side cross-sectional view of the transfer device 1200 taken along line 27-27, and Figure 28 is a top cross-sectional view of the transfer device taken along line 28-28. As Figures 27 to 28As shown, transfer device 1200 has a linear layout. First spike housing 1202 includes an inlet connected to a first fluid path 1205. The first fluid path extends from the inlet to a first lumen 1206 disposed in first spike 1203. In some embodiments, air inlet 1204 can include a hydrophobic filter to prevent fluid loss in the transfer device while allowing air to enter the transfer device. The first spike housing also includes a second fluid path 1208 connected to a second lumen 1207 disposed in the first spike. The second fluid path is connected to tube 1220, and specifically to tube fluid path 1221. Second spike housing 1210 includes a third fluid path 1212 connected to tube fluid path 1221 and extending to a third lumen 1214 disposed in second spike 1211. Thus, second fluid path 1208, tube fluid path 1221, and third fluid path 1212 form a continuous fluid path from second lumen 1207 to third lumen 1214. A check valve 1213 is disposed in third fluid path 1212 and allows one-way flow from second lumen 1207 to third lumen 1214. The second spike housing also includes a fourth lumen 1215 disposed in second spike 1211. A fourth fluid path 1216 extends between fourth lumen 1215 and filter chamber 1217. The filter chamber, in turn, is connected to an outlet 1218 at which fluid can be withdrawn from the transfer device. A filter can be disposed in the filter chamber to filter the fluid withdrawn from the transfer device.

[0197] Figure 29 is a cross-sectional schematic view of one embodiment of spike 1300. As shown, the spike includes a first fluid path 1302 that terminates in a first open end 1304. According to embodiments of the present disclosure, the first open end is at an angle a relative to the spike insertion direction S. Specifically, the first open end is perpendicular to the spike penetration or insertion direction and a is equal to 90 degrees. Thus, if fluid exits the first open end 1304 rapidly, the fluid can create a vortex in the container to aid in the mixing of the reconstituted fluid and medicament. As shown, the spike includes a second fluid path 1306 that terminates in a second open end 1308. In contrast to the first open end, the second open end is parallel to the spike insertion direction. Of course, in other embodiments, the first and second open ends can be symmetrical or have any combination of angles relative to the spike insertion direction, as the present disclosure is not so limited. Figure 29 Figure 29 Figure 29 is a cross-sectional schematic view of another embodiment of spike 1400. As shown, the spike includes a first fluid path 1402 that terminates in a first open end 1404. According to embodiments of the present disclosure, the first open end is at an angle a relative to the spike insertion direction S. Specifically, the first open end is perpendicular to the spike penetration or insertion direction and a is equal to 90 degrees. Thus, if fluid exits the first open end 1404 rapidly, the fluid can create a vortex in the container to aid in the mixing of the reconstituted fluid and medicament. As shown, the spike includes a second fluid path 1406 that terminates in a second open end 1408. In contrast to the first open end, the second open end is parallel to the spike insertion direction. Of course, in other embodiments, the first and second open ends can be symmetrical or have any combination of angles relative to the spike insertion direction, as the present disclosure is not so limited.

[0198] Figure 30 is a cross-sectional schematic view of another embodiment of spike 1400. As shown, the spike includes a first fluid path 1402 that terminates in a first open end 1404. According to embodiments of the present disclosure, the first open end is at an angle a relative to the spike insertion direction S. Specifically, the first open end is perpendicular to the spike penetration or insertion direction and a is equal to 90 degrees. Thus, if fluid exits the first open end 1404 rapidly, the fluid can create a vortex in the container to aid in the mixing of the reconstituted fluid and medicament. As shown, the spike includes a second fluid path 1406 that terminates in a second open end 1408. In contrast to the first open end, the second open end is parallel to the spike insertion direction. Of course, in other embodiments, the first and second open ends can be symmetrical or have any combination of angles relative to the spike insertion direction, as the present disclosure is not so limited. Figure 30 ​​As shown, the pointed object includes a first fluid path 1402 terminating at a first opening end 1404. According to... Figure 30 In one embodiment, the angle between the first open end and the insertion direction S of the tip is angle β. Specifically, the first open end is inclined at a non-perpendicular angle β relative to the insertion direction of the tip, said non-perpendicular angle being approximately 45 degrees. Therefore, if the fluid rapidly exits the first open end 1404, the fluid can generate eddies in the container to facilitate the reconfiguration of the mixing of the fluid and the agent. Figure 30 As shown, the tip includes a second fluid path 1406 terminating at a second opening 1408. In contrast to the first opening, the second opening is parallel to the tip insertion direction. Of course, in other embodiments, the first or second opening may be tilted at any suitable angle relative to the tip insertion direction. In some embodiments, the angle of the opening relative to the tip insertion direction may be 15 degrees, 30 degrees, 60 degrees, 75 degrees, or any other angle between 1 degree and 90 degrees.

[0199] Figure 31 This is a cross-sectional schematic diagram of another embodiment of the pointed object 1500. (See diagram below.) Figure 31 As shown, the pointed object includes a first fluid path 1502 terminating at a plurality of first open ends 1504A, 1504B, 1504C. According to... Figure 31 In one embodiment, the first open end is angled relative to the insertion direction S of the tip. The arrangement of a first fluid path with multiple open ends can alter the flow characteristics of fluid rapidly passing through the first fluid path. For example, compared to an arrangement with a single first open end, multiple open ends can reduce the total force and velocity of the fluid leaving the first fluid flow path. Figure 31 As shown, the pointed object includes a second fluid path 1506 terminating at a second opening end 1508. In contrast to the first opening end, the second opening end is parallel to the direction of insertion or puncture of the pointed object.

[0200] In some implementations, the reconfiguration device may include a fluid outlet that is releasably retained within the housing of the reconfiguration device until it is connected to the delivery device. Figures 32A to 32D A schematic diagram of another embodiment of such a reconfiguration device 1600 is depicted. (See diagram below.) Figures 32A to 32DAs shown, the reconstitution device includes a housing having an upper portion 1602 and a lower portion 1604. The upper portion is movable (e.g., slidable) relative to the lower portion, with the upper portion moving from an unactuated position toward the lower portion to an actuated position. The upper portion 1602 of the housing includes a cutout 1606 configured to selectively provide physical access to a fluid outlet 1610 disposed inside the reconstitution device housing. That is, the fluid outlet 1610 is not physically accessible when the housing is in the unactuated position, but is physically accessible by the cutout 1606 when the reconstitution device is actuated. The fluid outlet 1610 is releasably held inside the reconstitution device housing by a retainer 1608 configured to abut a protrusion 1612 disposed on the fluid outlet 1610. The retainer and protrusion are arranged such that coupling of a delivery device (e.g., a syringe) to the fluid outlet 1610 releases the fluid outlet from the reconstitution device housing. The fluid outlet can then be removed from the housing and moved, as the fluid outlet 1610 is connected to the transfer instrument of the reconstitution device by a flexible conduit 1616.

[0201] In FIG. 32A In the state shown, the reconstitution device is in an unactuated state. That is, the upper portion 1602 has not yet been moved toward the lower portion 1604. As a result, the cutout 1606 is not aligned with the fluid outlet 1610, such that the fluid outlet 1610 is not physically accessible to a user. According to FIG. 32A embodiments, the fluid outlet is held entirely within the housing when the device is unactuated, although other configurations are contemplated. For example, the fluid outlet can be partially disposed in the housing and blocked until the reconstitution device is actuated. In some embodiments, the fluid outlet can be visible to a user prior to actuation of the reconstitution device, but can be at least partially blocked such that the fluid outlet can not be physically accessed. In FIG. 32A The fluid outlet 1610 is shown as shaded with a slash through it for clarity in

[0202] In FIG. 32B In the state shown, the reconstitution device has been actuated. That is, the upper portion 1602 of the housing has been moved toward the lower portion 1604 of the housing. As discussed with reference to other example embodiments described herein, actuation of the reconstitution device can pierce a fluid container within the reconstitution device housing. As FIG. 32B shown, the cutout 1606 is aligned with the fluid outlet 1610, such that the fluid outlet 1610 is physically accessible by a user outside the reconstitution device housing. As FIG. 32BAs shown, the protrusion 1612 of the fluid outlet 1610 is disposed inside the retainer 1608 (i.e., disposed on the inner side of the retainer relative to the reconfiguration device housing). Therefore, although the fluid outlet 1610 is physically accessible, the retainer 1608 releasably retains the fluid outlet inside the reconfiguration device housing. Additionally, the retainer 1608 provides frictional resistance to prevent rotation of the fluid outlet 1610 within the reconfiguration device housing. FIG. 32B In some embodiments, the retainer and fluid outlet are configured such that fully engaging the delivery device with the fluid outlet releases the fluid outlet from the reconfiguration device housing. That is, in some embodiments, the fluid outlet may remain within the reconfiguration device housing until a suitable delivery device is fully engaged with the reconfiguration device. FIG. 32B In one embodiment, the retainer is configured to allow rotational force to be applied to the fluid outlet 1610 via a delivery device to release the protrusion 1612 from the retainer, as referenced. FIG. 32C Further discussion is needed. According to... FIG. 32B In one embodiment, the size and shape of the slit 1606 can be designed such that the upper portion 1602 of the housing prevents a user from physically accessing the fluid outlet 1610 using anything other than a suitable delivery device. For example, the slit can be designed such that multiple fingers may not be able to penetrate the slit to grasp the fluid outlet 1610, but a delivery device, such as a syringe, can be inserted through the slit to engage with the fluid outlet. In this way, the slit 1606 facilitates the proper use of the delivery device to connect the fluid outlet to the delivery device.

[0203] exist FIG. 32C In the illustrated state, the delivery device (e.g., a syringe) 1614 is connected to the fluid outlet 1610 located inside the reconstruction device. FIGS. 32A-32D In one embodiment, the fluid outlet 1610 includes an external thread and is configured as a Luer-activated device. Therefore, the delivery device 1614 includes a corresponding thread configured to engage the thread of the fluid outlet. When the reconfiguration device is in... FIG. 32B In the indicated state, the delivery device 1614 is threadedly connected to the fluid outlet (e.g., by clockwise rotation of the delivery device), while the retainer 1608 provides frictional resistance to maintain the rotational position of the fluid outlet. Because the delivery device is threadedly connected, the fluid outlet 1610 can be held within the reconfiguration device housing until the delivery device is fully connected to the fluid outlet. Once the delivery device is fully connected, further rotation of the delivery device overcomes the frictional resistance of the retainer 1608 and rotates the fluid outlet 1610 to the indicated position. FIG. 32CThe state shown is such that the protrusion 1612 is no longer aligned with the retainer 1608. This rotation of the fluid outlet provides the user with an indication that the delivery device is fully connected to the fluid outlet and that the fluid outlet can be released from the reconfiguration device housing.

[0204] like FIG. 32D As shown, fluid outlet 1610 has been released from the reconfiguration device housing and removed via cutout 1606. As previously described, once delivery device 1614 is threadedly connected to fluid outlet 1610, protrusion 1612 can disengage from retainer 1608. Therefore, pulling delivery device 1614 allows fluid outlet 1610 to be removed via cutout 1606. FIG. 32D As shown, the fluid outlet is connected to the reconfiguration device via a flexible conduit 1616, allowing the fluid outlet 1610 to be moved to a desired location. When the fluid outlet 1610 is removed from the reconfiguration device housing, the flexible conduit 1616 can extend or unfold from inside the reconfiguration device housing.

[0205] Although reference FIGS. 32A-32D One embodiment of a reconfiguration device housing is described, comprising a fluid outlet releasably retained within the housing until coupled to a delivery device. However, other configurations are contemplated, and this disclosure is not limited thereto. For example, in some embodiments, the fluid outlet may be coupled to the reconfiguration device housing via a fragile connection that may break upon coupling the delivery device to the fluid outlet. In some embodiments, coupling the delivery device to the fluid outlet releases a latch that retains the fluid outlet within the reconfiguration device housing. In some embodiments, the fluid outlet may form a frictional fit with the reconfiguration device housing, wherein coupling the delivery device to the fluid outlet overcomes the frictional fit. The user may use any suitable movement or combination of movements of the delivery device to release the fluid outlet from the reconfiguration device housing, including pushing, pulling, rotating, and twisting.

[0206] exist FIGS. 33-35 Another illustrative embodiment of the transfer device 2100 is shown in the figure. For example... FIG. 33 As shown, the transfer device includes a first tip 11 and a second tip 14. FIG. 35As shown, the transfer device includes an inlet 136 (e.g., an air inlet), which in some embodiments can include a hydrophobic filter. In some embodiments, the transfer device can include a filter chamber 137 to receive the hydrophobic filter of the inlet. The inlet 136 is connected to a first fluid path 291, which forms a first lumen through the first prong 11. A second fluid path, including a second lumen 282, a conduit 290, and a third lumen 293, connects the first prong 11 to the second prong 14. The third lumen 293 extends through the second prong 14. Disposed in the second fluid path is a check valve 271, which allows one-way flow from the first prong to the second prong. A third fluid path, including a fourth lumen 286 extending through the second prong 14 and a passageway 135, fluidically connects the second prong 14 to an outlet 298. In some embodiments, a tube can be connected to the outlet 298 to direct fluid out to a fluid outlet (e.g., a luer connector or other connector) for administration to a user.

[0207] The first prong 11 can be formed as part of or otherwise attached to a first plate 262, and the second prong 14 can be formed as part of or otherwise attached to a second plate 264. The first and second plates can interlock with one another via interlocking means 280. In some embodiments, the interlocking means 280 can be formed by receiving a protrusion 284 on the second plate 264 within a notch 283 on the first plate 262. It should be appreciated that the locations of the protrusion and notch can be reversed. Further, other interlocking shapes can be used, such as multiple protrusions / notches, other snap shapes, or any other suitable shape.

[0208] In FIGS. 33-35 In the illustrative embodiment of FIG. 1, the passageway 135 is a molded channel that can be molded as part of or otherwise attached to the second plate 264. However, it should be appreciated that other implementations of the passageway 135 are possible. In other embodiments, the passageway 135 can be a tube, a hypotube, or any other suitable arrangement, as this aspect is not limited in this respect.

[0209] In FIGS. 33-35 In the illustrative embodiment of FIG. 1, the conduit 290 connects the first prong 11 to the second prong 14. In some embodiments, the plates 262, 264 can include notches 78, 79, respectively, to accommodate the conduit 290. However, it should be appreciated that in other embodiments, a molded passageway or any other suitable arrangement can be used instead of a conduit to connect the first and second prongs.

[0210] As can be seen in FIG. 33In some embodiments, the transfer device can include a spike sheath 85, 87 that covers the spikes 11, 14 prior to actuation of the reconstitution device. As the container is pushed down onto the spikes during actuation, the spikes can puncture the spike sheath and pierce into the container. In some embodiments, the spike sheath can help prevent foreign matter from entering the fluid pathway and / or help prevent accidental premature piercing of the container by covering the lumen of the spike prior to use.

[0211] The spike sheath can be made of silicone, plastic, elastomer, or any other suitable material.

[0212] As discussed above, in some embodiments, the reconstitution device can be configured such that physical access to the fluid outlet can be blocked prior to actuation. Also as discussed above, in some embodiments, a flexible tab can be coupled to the fluid outlet. Access to the flexible tab can be permitted after a cutout on the upper portion of the housing is aligned with the fluid outlet receptacle. According to one aspect, in some embodiments, the flexible tab, such as a pull tab, can be part of or otherwise attached to a cap that covers the fluid outlet. Pulling the tab can remove the cap from the fluid outlet to expose the fluid outlet for connection to another component, such as a syringe or other delivery device. In some embodiments, the fluid outlet can be movable relative to the housing such that pulling the tab can remove the fluid outlet from the housing. In some embodiments, the holding force between the fluid outlet and the housing can be less than the holding force between the cap and the fluid outlet such that pulling the pull tab first causes the fluid outlet to be removed from the housing and then causes the cap to be removed 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 of the housing during use.

[0213] In FIG. 36 One illustrative embodiment of a reconstitution device 3200 is shown in FIG. 32, in which the device has a housing 420 with an upper portion 421 and a lower portion 422. The device includes a fluid outlet 430 that is fixed to the lower portion 422 of the housing. In FIG. 36 In the illustrative embodiment, the fluid outlet 430 can be formed with or otherwise attached to a flange 440, which in turn can be attached to the extension 250 of the lower portion 422 of the housing. In some embodiments, an additional flange can be positioned behind the extension 250 and can be attached to the tab to provide further holding reinforcement. However, it should be appreciated that the fluid outlet can be fixed to the lower portion of the housing by any suitable attachment arrangement as this aspect is not limited in this respect.

[0214] A cap 432 with a pull tab 434 covers the fluid outlet 430. The pull tab 434 can be flexible such that when the upper portion 421 of the housing is in an unactuated state, the inner surface of the upper portion 421 is pressed against the pull tab 434 such that the pull tab is in a folded or otherwise compressed state. When the upper portion 421 is pushed down, the cutout 424 on the upper portion 421 can move into alignment with the fluid outlet 430 and the cap 432, thereby allowing the pull tab 434 to unfold and extend out of the cutout 424 for a user to access.

[0215] FIGS. 37A-37C Various operational stages of the reconstitution device 3200 are depicted. In FIG. 37A the device is in an unactuated state. The cutout 424 of the upper portion 421 of the housing is spaced apart from the fluid outlet, and the pull tab can be in a folded state, e.g., abutting the inner surface of the upper portion 421. Thus, physical access to the pull tab and the fluid outlet is blocked by the upper portion of the housing. In some embodiments, the pull tab can be hidden from view. In other embodiments, the pull tab can be visible (e.g., if the upper portion is made of a transparent material), but the pull tab can remain inaccessible to a user.

[0216] To move the device to FIG. 37B the actuated state shown, a user can push down on the upper portion 421 of the housing, thereby causing the upper portion 421 to slide down toward the lower portion 422 of the housing. The downward movement of the upper portion 421 brings the cutout 424 into alignment with the fluid outlet 430 and the cap 432, thereby allowing the pull tab 434 to unfold and extend out of the cutout 424.

[0217] The user can then pull on the pull tab 434 to remove the cap 432, thereby exposing the fluid outlet 430, as FIG. 37C shown. With the fluid outlet 430 exposed, the user can proceed to attach a syringe or other delivery device to the fluid outlet 430.

[0218] Another illustrative embodiment of a reconstitution device 3300 is shown in FIGS. 38-40D which the device has a housing 820 with an upper portion 821 and a lower portion 822. The device includes a fluid outlet 830 that is movable relative to the lower portion 822 of the housing. As FIG. 38 and FIG. 39As shown in the exploded view, the fluid outlet 830 may be formed together with the clip 310 or otherwise attached to the clip. The clip 310 may have a first leg 317 and a second leg 319. Before actuation, the clip is removably coupled to the lower portion 822 of the housing. After actuation, the user can separate the clip from the lower housing by pulling the fluid outlet out of the housing. As can be seen in... FIG. 39 In the lower portion 822 of the housing, the inner guide 823 may include a slot 306, the slot being sized to receive the second leg 319 of the clip 310. The clip... FIG. 38 The middle is shown as being fully engaged with slot 306. (As shown) FIG. 38 As shown, with clip 310 fully engaged with slot 306, clip 310 and slot 306 can be positioned vertically below fluid outlet 830. However, in other embodiments, clip and / or slot can be positioned at different locations relative to fluid outlet, such as vertically above, to the left or right of fluid outlet.

[0219] In this illustrative embodiment, a cap 840 with a pull tab 842 covers the fluid outlet 430 before the device is actuated. When the user pulls the pull tab 842 after the device has been actuated, the second leg 319 slides through and away from the slot 306, thereby separating the clamp and the fluid outlet 830 from the lower portion 822 of the housing. Thus, the pull tab 842 can be used as a pull strap for removing the fluid outlet from the housing. In some embodiments, the holding force of the cap 840 on the fluid outlet 830 may be greater than the holding force of the clamp 310 on the lower portion 822 of the housing. Therefore, pulling the pull tab 842 may first cause the clamp 310 to leave and separate from the slot 306, and then cause the cap 840 to separate from the fluid outlet 830.

[0220] In some embodiments, the cutout 824 of the upper portion 821 may include an extended opening 825 to accommodate movement of the clip 310 through the cutout.

[0221] FIGS. 40A-40D The various operational stages of the reconfiguration device 3300 are depicted. FIG. 40A In this configuration, the device is in an inactive state. The cutout 824 of the upper portion 821 of the housing is spaced apart from the fluid outlet 830, and the pull tab can be folded and abuts against the inner surface of the upper portion 821. Therefore, physical contact with the pull tab and the fluid outlet can be blocked by the upper portion of the housing.

[0222] In order to move the device FIG. 40BIn the illustrated actuated state, a user can push down on the upper portion 821 of the housing, causing the upper portion 821 to slide downward toward the lower portion 822 of the housing. The downward movement of the upper portion 821 aligns the cutout 824 with the fluid outlet and the cap 840, allowing the pull tab 842 to be pulled out and extend from the cutout 824.

[0223] The user can then pull the pull tab 842. Because the holding force of the cap 840 on the fluid outlet is greater than the holding force of the clip 310 on the lower portion 822 of the housing, pulling the pull tab 842 causes the clip to disengage the slot 306 of the lower portion 822 of the housing. Thus, as shown in FIG. 40C 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 detached from the lower portion 822 of the housing, the user can continue to pull the pull tab 842 to remove the cap 840 from the fluid outlet 830, exposing the fluid outlet 830, as shown in FIG. 40D In some embodiments, the user can pull the pull tab 842 with one hand while holding the fluid outlet 830, the clip 310, and / or a portion of the tubing 313 with the other hand to pull the cap 840 off of the fluid outlet 830.

[0224] Another illustrative embodiment of a reconstitution device 3350 is shown in FIGS. 41-43C where the device has a housing 920 with an upper portion 921 and a lower portion 922. Similar to the illustrative embodiment of FIG. 38 the reconstitution device 3300 includes a fluid outlet 940 that is movable relative to the lower portion 922 of the housing. However, in this embodiment, as shown in FIG. 41 and FIG. 42 the fluid outlet 940 is formed with or otherwise attached to two clips, a first clip 320 and a second clip 322. Prior to actuation, the first clip 320 and the second clip 322 are removably coupled to the lower portion 922 of the housing. In some embodiments, the inner guide 928 can include two extension tabs 360, each having a slot 55. In some embodiments, the slot can be defined by two opposing arms 51, 53. In other embodiments, the slot can be a through-hole through the tab. Prior to actuation of the reconstitution device, the clips 320, 322 of the fluid outlet 940 can be received within the slots 55 to couple the fluid outlet to the lower portion 922 of the housing. As FIG. 41As shown, with the clips 320, 322 received within the slots 55, the slots 55 and clips 320, 322 can flank the left and right sides of the fluid outlet. However, in other embodiments, the clips and / or slots can be positioned at different locations relative to the fluid outlet, such as vertically above and below the fluid outlet.

[0225] In some embodiments, the cutout 924 can include expanded openings 925, 926 to accommodate movement of the clips through the cutout.

[0226] In this illustrative embodiment, a cap 930 having a pull tab 932 can cover the fluid outlet 940 prior to actuation of the device. When a user pulls the pull tab 932 after the device has been actuated, the clips 320, 322 slide through and out of the slots 55, thereby separating the clips and fluid outlet 940 from the lower portion 922 of the housing. Thus, the pull tab 932 can serve as a string that a user can pull to remove the fluid outlet from the housing. In some embodiments, the holding force of the cap 930 on the fluid outlet 940 can be greater than the holding force of the clips 320, 322 on the lower portion 822 of the housing. Thus, pulling the pull tab 932 can first cause the clips 320, 322 to exit and separate from the slots 55, and then cause the cap 930 to separate from the fluid outlet 940.

[0227] FIGS. 43A-43C Various operational stages of the reconstitution device 3350 are depicted. In FIG. 43A the device is in an unactuated state. The cutout 924 of the upper portion 921 of the housing is spaced apart from the fluid outlet 940, and the pull tab can be in a folded state, abutting the inner surface of the upper portion 921. Thus, physical access to the pull tab and fluid outlet can be blocked by the upper portion 921 of the housing.

[0228] To move the device to FIG. 43B the actuated state shown, a user can push down on the upper portion 921 of the housing, causing the upper portion 921 to slide down toward the lower portion 922 of the housing. The downward movement of the upper portion 921 aligns the cutout 924 with the fluid outlet and cap 930, allowing the pull tab 932 to unfold and extend out of the cutout 924.

[0229] The user can then pull the pull tab 932. Because the holding force of the cap 930 on the fluid outlet is greater than the holding force of the clips 320, 322 on the lower portion 922 of the housing, pulling the pull tab 932 causes the clips to exit the slots 55 of the lower portion 922 of the housing. Thus, as FIG. 43CAs shown, when the user pulls on the pull tab 932, both the cap 930 and the fluid outlet 940 attached to the cap can be pulled out of the housing. After the fluid outlet 940 has been detached from the lower portion 922 of the housing, the user can continue to pull on the pull tab 932 to remove the cap 930 from the fluid outlet 940, thereby exposing the fluid outlet 940.

[0230] While FIG. 38 Embodiments of the present disclosure use a single clip and FIG. 41 Embodiments of the present disclosure use two clips, but it should be appreciated that any number of clips can be used.

[0231] According to one aspect, the reconstitution device can include one or more features that help hold the container. Such holding features can help position the container, for example, to help prevent premature piercing of the container, and / or to assist in piercing of the container by facilitating alignment of the container with the spike during spiking. In some embodiments, the container holding features can be coupled to a portion of the housing that moves during actuation. For example, in embodiments in which the upper portion of the housing is pushed downward by a user to actuate the reconstitution device, one or more container holding features can be coupled to the upper portion of the housing.

[0232] In some embodiments, the container holding features include a ring that surrounds a portion of the container to hold the container. In some embodiments, the ring can be configured to surround a shoulder portion of the container. The inner surface of the ring can have a contour to accommodate the shape of the shoulder portion of the container.

[0233] In FIGS. 38-40D and FIGS. 44-48 In the illustrative embodiment shown, the reconstitution device includes a first ring 740 that surrounds the first container 300 and a second ring 750 that surrounds the second container 350. As will be discussed in greater detail below, the rings can be attached to the upper portion 821 of the housing. By surrounding the containers, the rings can be used to limit the side-to-side movement of the containers.

[0234] In some embodiments, the containers can rest on a portion of the rings. As can be seen in FIG. 44 In some embodiments, the rings 740, 750 have a contour to accommodate the shape of the shoulder 35 of the containers. For example, the ring 750 has an inner surface 744 that changes in diameter, thereby forming a contoured surface. The inner surface 744 transitions from a first diameter to a second, smaller diameter to accommodate the contour of the shoulder 35 of the container 350. In some embodiments, the cross-section of the inner surface can form an S-shape.

[0235] Because the shoulder of the container abuts the contoured inner surface of the ring, the ring can be used to limit movement of the container toward the spike. As the upper portion 821 of the housing moves toward the lower portion 822 of the housing during actuation of the device, the ring attached to the upper portion 821 of the housing moves toward the spike, thereby permitting movement of the container toward the spike for piercing.

[0236] In some embodiments, an inner contact can be coupled to the inner surface of the ring. The inner surface of the ring can have a greater stiffness than the inner contact. The inner contact can act as a finer dimensional setting member that can assist in reducing the gap with the container. The inner contact can be a grommet, a shaped tab, a radially inwardly extending finger, or any other suitable contact. For example, in one illustrative embodiment, the inner surface of the ring can include a circumferential groove within which a grommet is seated.

[0237] It should be appreciated that the container retention feature can engage with different portions of the container. For example, in some embodiments, the container retention feature can engage with the body sidewall, the shoulder, the neck, the curl, and / or any other suitable portion of the container.

[0238] Attachment of the ring to the housing will now be discussed. As can be seen in FIG. 46 , the ring 740 can include a plurality of radially extending extensions 742, each of which can include a recess 743. As can be seen in FIG. 45 , FIG. 47 , and FIG. 48 , the upper portion 821 of the housing includes a plurality of protrusions 745 shaped to match the shape of the recesses on the ring. In the illustrative embodiment of the figures, the recesses and protrusions are semi-ellipsoids. By mating the protrusions of the upper portion 821 with the recesses of the ring, the ring is attached to the upper portion of the housing. In some embodiments, additional retention enhancements such as adhesives or fasteners can be used to strengthen the attachment. However, in other embodiments, the ring is simply retained to the upper portion of the housing by a snap fit engagement between the protrusions and recesses. It should be appreciated that the protrusions and recesses can be reversed, such that the recesses are on the upper portion of the housing and the protrusions are on the ring. Furthermore, while the protrusions and recesses shown in the figures are semi-ellipsoids, it should be appreciated that they can be hemispheres, rectangular prisms, cones, truncated cones, trapezoidal prisms, or any other suitable shape.

[0239] In some embodiments, as an alternative or in addition to the protrusion and recess mating arrangement discussed above, attachment of the ring to the housing can be achieved via adhesives, fasteners, and / or other attachment arrangements.

[0240] It will be appreciated that these loops can be omitted in some embodiments. In some embodiments, an adhesive, fastener, or other attachment arrangement can be used to hold one or more containers relative to the housing.

[0241] In some embodiments, the container retention feature includes a plurality of arms that at least partially enclose a portion of the container to limit movement of the container.

[0242] In FIGS. 47-49 In the illustrated embodiment, the reconstitution device includes a plurality of arms 456 extending from the upper portion 821 of the housing. As shown, the plurality of arms 456 enclose the containers 300, 350, which is a perspective cross-sectional view showing a portion of the containers 300, 350 received within the upper portion 821 of the housing. The plurality of arms 456 are positioned radially outward of the containers and receive the bottom ends of the containers. FIG. 49

[0243] In some embodiments, the reconstitution device can include a platform that abuts the bottom end of the container. The platform can be used to fill the gap between the housing and the container to prevent the container from moving within the housing prior to actuation, for example, during shipping.

[0244] In FIGS. 47-48 In the illustrated embodiment, the reconstitution device includes a platform 450, 451 configured to abut the bottom end of the container. In the illustrated embodiment, the platform is arc-shaped. However, in other embodiments, the platform can be circular, oval, square, dome-shaped, or any other suitable shape. The platform can be made of foam, elastomer, silicone, or any other suitable material.

[0245] In some embodiments, the reconstitution device can have a modular design that can allow for different container sizes to be accommodated under the same housing. For example, the platform 450, 451 can be interchangeable with other platforms of different heights and / or radii of curvature to accommodate different container sizes. For example, shorter containers can still be used with the same housing by using a platform with a higher height. Similarly, the plurality of arms 456 can be interchangeable with other arms, for example, arms positioned at different distances to accommodate different diameter containers. In some embodiments, the plurality of arms and / or the platform can be pre-formed or otherwise pre-attached to a plate that can be attached to the interior of the upper portion 821 of the housing. Plates with different combinations of arms and / or platforms can be manufactured to accommodate a wide variety of container sizes and shapes. The upper portion of the housing can be configured to attach to any of these plates, permitting the housing to have a modular design in which the same housing can be used to accommodate different container sizes. Furthermore, the loops 740, 750 can also be interchangeable with loops of different inner diameters to accommodate different container sizes.

[0246] ​As discussed above, in some embodiments, the reconstitution device can include one or more engagement features that permit the upper and lower portions of the housing to slidably engage one another. In some embodiments, the inner guide can include one or more engagement features that slidably engage one or more features on the upper portion. For example, the inner guide can have a groove shaped to receive a tab of the upper portion, where the tab can slide along the groove. These components can be reversed, such that the groove is on the upper portion and the tab is on the inner guide. Other sliding engagement arrangements can be used, such as other rails, elongate members that extend through a closed channel, or any other suitable sliding engagement arrangement.

[0247] In FIG. 45 In the illustrative embodiment shown, the inner guide 823 can include a groove 760 that receives a tab 314 that slides within the groove 760 to allow the upper portion 821 to slidably move relative to the lower portion 822.

[0248] FIG. 50A is an exploded plan view of another embodiment of a transfer instrument 3400. According to FIG. 50A embodiments, the transfer instrument is modular such that the number of fluid connections of the transfer instrument can be increased or decreased to attach a desired number of containers. In FIG. 50A the configuration shown, the transfer instrument is configured to hold three containers. As FIG. 50A shown, the transfer instrument 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 can be fluidly connected to an air inlet, which in some embodiments can include a hydrophobic filter or a check valve. The second inlet spike channel is connected to an inlet adapter fluid channel 3410 that allows fluid to flow out of the inlet adapter from a connected container. In FIG. 50A particular embodiments, the inlet adapter fluid channel 3410 terminates in an inlet fluid connector 3412, which in the depicted embodiment is configured to receive a tubing. Of course, in other embodiments, other fluid connectors can be employed as the present disclosure is not so limited. Once the inlet spike pierces an inlet container, the fluid arrangement of the inlet adapter 3402 allows air to be introduced into the container via the first inlet spike channel 3406 as fluid flows out of the inlet adapter fluid channel 3410. In some embodiments, the inlet adapter 3402 can include a check valve configured to allow one-way flow out of the spike through the inlet adapter fluid channel 3410. This arrangement can ensure that fluid does not flow through the first inlet spike channel 3406 toward the air inlet.

[0249] according to FIG. 50A In one implementation, the entry adapter 3402 includes an entry adapter connector 3414 configured to allow the entry adapter to be releasably attached to other adapters (e.g., intermediate adapter 3420). Specifically, in FIG. 50A In one implementation, the inlet adapter connector is configured to releasably attach (e.g., interlock) the inlet adapter to the intermediate adapter 3420. FIG. 50A The intermediate adapter connector includes a retaining ring 3416 and a recess 3418, the recess being configured to receive a first intermediate adapter connector 3435 having a corresponding shape. (See reference...) FIG. 50B Further discussion reveals that when the first intermediate adapter connector 3435 and the inlet adapter connector 3414 engage and interlock, the intermediate adapter 3420 and the inlet adapter may not be able to move relative to each other in the first direction. FIG. 50A In a specific instance, when releasably interlocked, the intermediate adapter and the inlet adapter resist relative movement of each other in a plane (e.g., the xy plane). However, when releasably interlocked, the inlet adapter connector and the intermediate adapter connector allow relative movement in a second direction (e.g., the z-direction) to allow the adapters to release from each other. FIG. 50A In one embodiment, the inlet adapter connector is symmetrical. In other embodiments, the inlet adapter may be irregularly shaped or have any suitable shape that allows adapter interlocking, as this disclosure is not limited thereto. FIG. 50A In one implementation, the inlet adapter connector is configured to receive a corresponding connector. In other implementations, the inlet adapter connector may be configured to be received within a corresponding connector. FIG. 50A In this implementation, the inlet adapter connector and the inlet adapter fluid channel 3410 are separate and isolated, ensuring that any physical interconnection and fluid connection are independent. This arrangement can benefit from simplified manufacturing and reliable connections.

[0250] like FIG. 50A As shown, the intermediate adapter 3420 includes a first intermediate adapter connector 3435. The first intermediate adapter connector includes a neck 3436 and a tab 3437. The neck 3436 is configured to engage a retaining ring 3416 of the inlet adapter connector 3414. Similarly, the tab is configured to engage a recess 3418 of the inlet adapter connector. (See reference...) FIG. 51 Further discussion reveals that the arrangement of the neck, recess, retaining ring, and protrusion allows the adapters to reliably interlock with each other. For example... FIG. 50A As shown, the intermediate adapter also includes a second intermediate adapter connector 3438. The second intermediate adapter connector is configured to receive a corresponding shaped connector (e.g., outlet adapter connector 3456).FIG. 50A In one implementation, the first intermediate adapter connector and the second intermediate adapter connector are positioned on opposite sides of the intermediate adapter, but as shown in the reference... FIG. 54 Further discussion could explore other configurations. For example... FIG. 50A In some embodiments shown, the second intermediate adapter connector may share the same shape and dimensions as the inlet adapter connector 3414. In this arrangement, the intermediate adapter 3420 may be interchangeable with other copies of the intermediate adapter or expanded using other copies. That is, another intermediate adapter may be used to replace the intermediate adapter 3420, or another intermediate adapter may be used to expand the transfer device 3400 (e.g., see...). FIG. 52 (Exemplary implementation). A first intermediate adapter connector (e.g., similar to the first intermediate adapter connector 3435) may be received in the second intermediate adapter connector 3438. Thus, intermediate adapters can be added as needed to expand the number of tips to correspond to the desired number of containers that can ultimately deliver the pharmaceutical fluid to the patient.

[0251] like FIG. 50A As shown, the intermediate adapter 3420 includes an intermediate tip 3422 configured to pierce an intermediate container. The intermediate tip includes a first intermediate tip channel 3424 fluidly connected to a first intermediate fluid channel 3428. Similar to the inlet adapter, the first intermediate fluid channel terminates in an intermediate fluid connector 3430 (e.g., a pipe connector). The intermediate tip also includes a second intermediate tip channel 3426 fluidly connected to a second intermediate fluid channel 3432. Similar to the first intermediate fluid channel, the second intermediate fluid channel also terminates in an intermediate fluid connector 3434 (e.g., a pipe connector). According to... FIG. 50A The implementation plan, and if referenced FIG. 50B Further discussion reveals that the first intermediate fluid channel is configured to be fluidly connected to the inlet adapter fluid channel 3410 (e.g., via a pipe). 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 fluid path from the inlet adapter to the outlet adapter. Similar to the inlet adapter 3402, the fluid channels of the intermediate adapter are separate from the first intermediate adapter connector 3435 and the second intermediate adapter connector 3438.

[0252] according to FIG. 50AIn one embodiment, the transfer device 3400 includes an outlet adapter 3440. The outlet adapter includes an outlet tip 3442, which includes a first outlet tip channel 3444 fluidly connected to an outlet adapter fluid channel 3448. Similar to the inlet adapter 3402 and intermediate adapter 3420, the outlet adapter fluid channel terminates at an outlet fluid connector 3450 (e.g., a tubing connector). The outlet tip also includes a second outlet tip channel 3446 fluidly connected to an outlet 3452. The outlet 3452 is connected to an infusion set connector 3454, which allows fluid from the transfer device 3400 to ultimately flow to the patient. In other embodiments, an infusion set or other delivery device may be directly connected to the outlet 3452, as this disclosure is not limited thereto.

[0253] like FIG. 50A As shown, the export adapter 3440 includes an export adapter connector 3456. In FIG. 50A In one embodiment, the outlet adapter connector is configured to be received in the second intermediate adapter connector 3438. The outlet adapter connector has dimensions and shape that match those of the first intermediate adapter connector 3435. Therefore, if desired, the outlet adapter connector can also be received in the inlet adapter connector 3414 to releasably attach the outlet adapter to the inlet adapter. This arrangement may only be advantageous when both containers are connected to the transfer apparatus, such that the intermediate adapter 3420 can be omitted.

[0254] FIG. 50B It is in the assembly and configuration stage. FIG. 50A A plan view of the transfer device. (See attached image.) FIG. 50B As shown, the first intermediate adapter connector 3435 is received in the inlet adapter connector 3414. Therefore, the retaining ring 3416 engages the neck 3436 and the recess 3418 engages the tab 3437. Thus, the inlet adapter 3402 and the intermediate adapter 3420 are releasably interlocked. Similarly, as... FIG. 50B As shown, the outlet adapter connector 3456 is received in the second intermediate adapter connector 3438, such that the intermediate adapter and the outlet adapter 3440 are releasably interlocked. Therefore, the inlet adapter, intermediate adapter, and outlet adapter are all physically connected to each other via connectors.

[0255] Independent of the physical connection of the connectors, the adapter is fluidly connected to form a continuous fluid passage between the inlet tip 3404, the intermediate tip 3422, the outlet tip 3442, and the final outlet 3452, allowing fluid to be delivered to the patient via an infusion set or other delivery device (e.g., a syringe). FIG. 50BAs shown, the inlet adapter fluid channel 3410 is fluidically connected to the first intermediate fluid channel 3428 with a first tube 3460. The first tube is coupled to the inlet fluid connector 3412 and the first intermediate fluid connector 3430. The outlet adapter fluid channel 3448 is coupled to the second intermediate fluid channel 3432 with a second tube 3462. The second tube is coupled to the outlet fluid connector 3450 and the second intermediate fluid connector 3434. Thus, the inlet adapter, intermediate adapter, and outlet adapter are fluidically connected in a series arrangement. In some embodiments, the fluid connectors can be quick connect tube connectors. In some embodiments, the adapters can include integrated tubes configured to interconnect the tubes of the other adapters. In such embodiments, quick connect fittings or other fittings can be employed. In other embodiments, any suitable connectors can be employed to fluidically connect the adapters as the present disclosure is not so limited.

[0256] It should be noted that while tubes and tube connectors are employed in the embodiments of FIG. 50B any suitable fluid pathways can be employed to fluidically interconnect the various adapters. For example, the tubing interconnecting the adapters can be rigid or flexible tubing. Additionally, in some embodiments, the adapters can include integrated fluid connectors and pathways separate from the couplings to allow for fluid connections without the need for additional components such as tubing.

[0257] In some embodiments, FIGS. 50A-50B The transfer apparatus of the embodiments of

[0258] It should be noted that while the spike channel and fluid channel are described and labeled separately in the embodiments of FIGS. 50A-50B In other embodiments, the spike channel and fluid channel can be considered a single component. For example, the adapters can be molded such that the fluid channel forms the spike channel.

[0259] As previously discussed, FIGS. 50A-50BThe modular transfer apparatuses described herein can be configured in a variety of different configurations to accommodate a desired number of containers. For example, in some embodiments, an inlet adapter and an outlet adapter can be employed together to deliver fluid from two containers (e.g., an inlet container and an outlet container). As another example, in some embodiments, an inlet adapter and an outlet adapter can be employed with two intermediate adapters to deliver fluid from four containers (e.g., an inlet container, a first intermediate container, a second intermediate container, and an outlet container). In this manner, the number of adapters can be scaled up and down as needed for any number of containers, including but not limited to two containers, three containers, four containers, five containers, six containers, seven containers, and eight containers.

[0260] While the modular transfer apparatuses described herein are described in the context of a transfer apparatus having three adapters (e.g., an inlet adapter, an outlet adapter, and an intermediate adapter), the present disclosure is not so limited. In some embodiments, a transfer apparatus can include more than three adapters. For example, in some embodiments, a transfer apparatus can include four adapters, five adapters, six adapters, seven adapters, eight adapters, nine adapters, ten adapters, or more. FIGS. 50A-50B While in some embodiments of the modular transfer apparatuses described herein, the inlet adapter coupling is configured to receive the intermediate adapter coupling or the outlet adapter coupling as a socket, in other embodiments, the arrangement can be reversed. That is, in some embodiments, the intermediate adapter coupling or the outlet adapter coupling can be configured to receive the inlet adapter coupling. In other words, the intermediate adapter coupling or the outlet adapter coupling can be configured as a socket that is configured to receive a protruding inlet adapter coupling. In some embodiments, the couplings of the adapters can include a socket portion and a protruding portion, such that the coupling receives a corresponding protruding portion of another coupling and is also received in a corresponding socket portion of another coupling. Thus, for any of the embodiments described herein, any suitable coupling can be employed whereby the adapters can be physically connected to one another, as the present disclosure is not so limited.

[0261] FIG. 51 is a schematic view of one embodiment of a transfer apparatus adapter coupling showing an exemplary mating engagement for securing the adapters of a transfer apparatus together. As shown in FIG. 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 in the first coupling 3500 and includes a neck 3552 and a tab 3554. As shown in FIG. 51 the shape and size of the first coupling matches the shape and size of the second coupling. The tab 3554 is configured to be received in the pocket 3504, and the collar 3502 is configured to engage the neck 3552. As shown in FIG. 51As shown, the collar 3502 and the neck 3552 have a width that is less than the width of the pocket 3504 and the tab 3554. Specifically, the pocket 3504 has a pocket width A, the collar 3502 has a collar width B, the tab 3554 has a tab width C, and the neck 3552 has a neck width D. The pocket width A is approximately equal to the tab width C, with the tab width being slightly less than the pocket width (e.g., within 1% of the pocket width) to allow the tab to fit within the pocket. Likewise, the collar width B is approximately equal to the neck width D, with the neck width being slightly less than the collar width (e.g., within 1% of the collar width) to allow the neck to fit within the collar. The pocket width A is greater than the collar width B (i.e., the collar width B is less than the pocket width A). Likewise, the tab width C is greater than the neck width D (i.e., the neck width D is less than the tab width C). Thus, when the second coupling is received in the first coupling, the couplings cannot move relative to each other in a plane (e.g., the x-y plane). However, the couplings are able to move relative to each other in a second direction (e.g., the z-direction), which in the depicted embodiment is perpendicular to the plane. In other embodiments, the couplings can be prevented from moving relative to each other in a first direction, and the couplings can be able to move relative to each other in a second direction. In some embodiments, the second direction can be transverse (e.g., perpendicular) to the first direction.

[0262] It should be noted that while one embodiment of a coupling is shown in FIG. 51 , in other embodiments other couplings can be employed. For example, the coupling pair employed to physically connect the plurality of adapters can be a tongue and groove, a T-slot and T-slot adapter, or any other suitable coupling. In some embodiments, the coupling can include a foolproof tab configured to assist a user in aligning and connecting the plurality of adapters. In some embodiments, the coupling can have a shape configured to control the directionality of a transfer instrument formed by the plurality of adapters. For example, in some embodiments, the adapter coupling can be able to connect in a single orientation.

[0263] FIG. 52 is a plan view of another embodiment of a transfer instrument 3600. According to the embodiment of FIG. 52 , the transfer instrument is similar to the transfer instrument of FIGS. 50A-50B , except that a second intermediate adapter 3602 is added to allow the transfer instrument to connect to four containers. That is, the transfer instrument includes an inlet adapter 3402, a first intermediate adapter 3420, and an outlet adapter 3440 having a configuration similar to FIGS. 50A-50B . In FIG. 52In one implementation, the second intermediate adapter 3602 is identical to the first intermediate adapter. That is, the second intermediate adapter includes a second intermediate tip 3604 having a third intermediate tip channel 3606 connected to a third intermediate fluid channel 3610 and a fourth intermediate tip channel 3608 connected to a fourth intermediate fluid channel 3614. The third intermediate fluid channel 3610 and the fourth intermediate fluid channel 3614 terminate at intermediate fluid connectors 3612 and 3616 (e.g., pipe connectors). The second intermediate adapter also includes a third intermediate adapter connector 3618 and a fourth intermediate adapter connector 3620. The third intermediate adapter connector 3618 is received in a second intermediate adapter connector 3438. The fourth intermediate adapter connector receives an outlet adapter connector 3456. Therefore, the second intermediate adapter connector can be configured in series and releasably attached to and / or interlocked with the second intermediate adapter connector and the outlet adapter connector. FIG. 52 In some implementations, the second intermediate adapter connector is interchangeable with the first intermediate adapter connector. Therefore, if needed, a third intermediate adapter connector can be received in the inlet adapter connector 3414. Correspondingly, in some implementations, a fourth intermediate adapter connector can receive the first intermediate adapter connector 3435.

[0264] like FIG. 52 As shown, similar to FIG. 50B Fluid connections between adapters are made via pipes. Specifically, a first pipe 3460 fluidly connects the inlet adapter fluid passage 3410 to a first intermediate fluid passage 3428. A second pipe 3462 fluidly connects the second intermediate fluid passage 3432 to a third intermediate fluid passage 3610. Finally, a third pipe 3464 fluidly connects the fourth intermediate fluid passage 3614 to the outlet adapter fluid passage 3448. (See previous reference...) FIGS. 50A-50B The discussion is in FIG. 52 In this system, the physical connection between adapters via connectors and the fluid connection between adapters are separate and / or spaced apart.

[0265] exist FIG. 52In embodiments, the various adapters are fluidly and physically connected in a series arrangement. In other embodiments, the adapters can be fluidly or physically connected in a parallel arrangement. For example, in some embodiments, the inlet adapter, the first intermediate adapter, and the second intermediate adapter can all be fluidly connected to the outlet adapter. For example, the tubing from each of the inlet adapter, the first intermediate adapter, and the second intermediate adapter can join at a Y-junction into the outlet adapter fluid passageway 3448. In such embodiments, the first intermediate fluid passageway 3428 and the third intermediate fluid passageway 3610 can function as air inlets. In embodiments where one or more fluid passageways are configured as inlets, the fluid passageways can include check valves configured to allow air into the respective fluid passageway but inhibit fluid from escaping via the respective fluid passageway. In some other embodiments, the fluid passageways can include hydrophobic filters configured to allow air into the respective fluid passageway but inhibit fluid from escaping via the respective fluid passageway. In FIG. 52 In embodiments, the first intermediate fluid passageway 3428 and the third intermediate fluid passageway 3610 can include check valves to allow air into the passageways but not fluid out of the passageways. Of course, any suitable parallel, series fluid configuration, or combination of parallel and series fluid configurations can be employed to deliver a medicinal fluid from a transfer set as the present disclosure is not so limited. Additional examples of fluid configurations having combinations of parallel and series flow paths will be discussed with reference to FIG. 53 Exemplary embodiments of the present disclosure.

[0266] According to exemplary embodiments described herein, any suitable number of check valves can be employed in one or more fluid passageways of an adapter as the present disclosure is not so limited. Check valves can ensure one-way flow of fluid from an adapter regardless of whether the fluid passageway is used as an air inlet. In the case where the fluid passageway is an air inlet, the check valve can inhibit fluid from escaping via the air inlet while allowing air to vent to a connected container. However, in the alternative case where the fluid passageway is a fluid inlet, the check valve can enforce one-way flow. In this way, in some embodiments, an adapter can include at least one check valve in a fluid passageway such that the adapter can be modularly employed in a configuration having air inlets or in a configuration having fluid inlets. Of course, any suitable arrangement of check valves or any suitable number of check valves can be employed in an adapter as the present disclosure is not so limited.

[0267] FIG. 53 is a plan view of another embodiment of a transfer set 3700 that includes a plurality of intermediate couplings configured to expand the container capacity of the transfer set while maintaining a physically compact footprint. According to FIG. 53The implementation scheme, the transfer device includes having, as referenced FIGS. 50A-50B The implementation scheme describes the configuration of the inlet adapter 3402 and the outlet adapter 3440. For example... FIG. 53 As shown, the transfer device includes a first intermediate adapter 3702 and a second intermediate adapter 3720. In FIG. 53 In some implementations, the first intermediate adapter and the second intermediate adapter are mirror images of each other (e.g., mirror images across the y-axis) and are typically configured in a manner similar to a reference. FIGS. 50A-50B Two pointed prongs are provided in the space of the single intermediate adapter shown and described. The first and second intermediate adapters are configured to be releasably attached to both the inlet and outlet adapters simultaneously.

[0268] like FIG. 53 As shown, the first intermediate adapter 3702 includes a first intermediate tip 3704 having a first intermediate tip channel 3706 and a second intermediate tip channel 3708. The first intermediate tip channel is fluidly connected to a first intermediate fluid channel 3710. The second intermediate tip channel is fluidly connected to a second intermediate fluid channel 3714. The first and second intermediate tip channels each terminate at intermediate fluid connectors 3712 and 3716. Finally, the first intermediate adapter includes a first intermediate adapter connector 3718 and a second intermediate adapter connector 3719. According to... FIG. 53 In one embodiment, a first intermediate adapter connector is received in an inlet adapter connector 3414. The first intermediate adapter connector is configured to be received on a first side of the inlet adapter connector such that it occupies at least a portion of the inlet adapter connector (e.g., half of the inlet adapter connector). A second intermediate adapter connector 3719 receives an outlet adapter connector 3456. Similar to the first intermediate adapter connector, the second intermediate adapter connector is configured to receive a first portion of the outlet adapter connector. Specifically, in FIG. 53 In one embodiment, the second intermediate adapter is configured to receive at least a portion of the output adapter connector (e.g., half of the output adapter connector). Of course, in other embodiments, the first and second intermediate adapter connectors may engage any portion of the corresponding connectors, as this disclosure is not limited thereto.

[0269] like FIG. 53As shown, the second intermediate adapter 3720 is a mirror image of the first intermediate adapter 3702 (e.g., mirror image across the y-axis). Therefore, the second intermediate adapter includes the same components as the first intermediate adapter. The second intermediate adapter 3720 includes a second intermediate tip 3724 having a third intermediate tip channel 3726 and a fourth intermediate tip channel 3728. The third intermediate tip channel is fluidly connected to a third intermediate fluid channel 3730. The fourth intermediate tip channel is fluidly connected to a fourth intermediate fluid channel 3734. The third and fourth intermediate tip channels each terminate at intermediate fluid connectors 3732 and 3736 (e.g., pipe connectors). Finally, the second intermediate adapter includes a third intermediate adapter connector 3738 and a second intermediate adapter connector 3739. The third intermediate adapter connector is received in the inlet adapter connector 3414 and... FIG. 53 In a specific embodiment, at least a portion of the inlet adapter connector (e.g., half of the inlet adapter connector) is engaged. The fourth intermediate adapter connector receives the outlet adapter connector 3456, and... FIG. 53 In a particular implementation, at least a portion (e.g., half of the export adapter connector) is received. Therefore, the first intermediate adapter and the second intermediate adapter are simultaneously connected together with the inlet adapter and the outlet adapter and are releasably interlocked.

[0270] like FIG. 53 As shown, the transfer device 3700 is arranged in a partially series and partially parallel fluid configuration. The inlet adapter is fluidly connected to both the first and second intermediate adapters via a first tube 3460 and a second tube 3462. The first and second tubes are connected at a Y-joint 3461 and fluidly connected to the inlet adapter fluid passage 3410. The outlet adapter is also fluidly connected to both the first and second intermediate adapters via a third tube 3464 and a fourth tube 3466. The third and fourth tubes are connected at a second Y-joint 3465 and fluidly connected to the outlet adapter fluid passage 3448. Therefore, the intermediate adapters are not fluidly connected in series with each other, but rather in parallel between the inlet and outlet adapters. However, the fluid flow from the inlet adapter passes through both intermediate adapters before reaching the outlet adapter, and in this way, the transfer device has a series fluid configuration between the inlet adapter, intermediate adapters, and outlet adapter.

[0271] Although FIG. 54In some embodiments, the Y-shaped junction is employed to interconnect the various adapters, but in other embodiments, the adapters can include multiple fluid channels or integrated fluid junctions to facilitate parallel connection of multiple intermediate adapters. For example, the inlet adapter can include multiple fluid connectors (e.g., two tube connectors) such that the inlet adapter can accommodate multiple tubes, with the fluid connectors both fluidly connected to the inlet adapter fluid channel. Thus, the inlet adapter can include an internal Y-shaped junction such that straight tubes without a Y-shaped junction can be used to interconnect the inlet adapter to two intermediate adapters. Likewise, the outlet adapter can also include multiple fluid connectors (e.g., two tube connectors) such that the outlet adapter can accommodate multiple tubes, with the fluid connectors both fluidly connected to the outlet adapter fluid channel. The inlet and outlet adapters can include any suitable number of fluid channels and corresponding fluid connectors such that any number of intermediate adapters can be connected in parallel, as the present disclosure is not so limited.

[0272] FIG. 54 is a plan view of another embodiment of a transfer apparatus 3800 showing an alternative layout of adapters. In some cases, it can be desirable to reduce the footprint of the adapters for a given number of containers, or it can otherwise be desirable to reduce a particular dimension of the transfer apparatus. For example, in the previously discussed FIG. 54 embodiment, the transfer apparatus is arranged in a linear pattern, which reduces the overall width of the transfer apparatus by having a longer length. However, to reduce the overall maximum dimension (e.g., width or length), the adapters can be arranged in a zigzag pattern as shown in FIG. 4 In the embodiment of FIG. 52 the fluid arrangement is similar to that of FIGS. 50A-50B That is, the transfer apparatus includes an inlet adapter 3402, a first intermediate adapter 3802, a second intermediate adapter 3810, and an outlet adapter 3440. The arrangement of the inlet and outlet adapters is similar to those of FIG. 52 Likewise, the fluid arrangement of the first and second intermediate adapters is similar to that of FIG. 52 However, in contrast to the embodiment of FIG. 54 the intermediate adapter couplings are angled relative to one another, as discussed further below.

[0273] As shown in FIG. 54The first intermediate adapter 3802 includes a first intermediate adapter coupling 3804 and a second intermediate adapter coupling 3806. The second intermediate adapter includes a third intermediate adapter coupling 3812 and a fourth intermediate adapter coupling 3814. The first intermediate adapter coupling 3804 is received in the inlet adapter coupling 3414. The second intermediate adapter coupling receives the third intermediate adapter coupling. Finally, the fourth intermediate adapter coupling receives the outlet adapter coupling 3456. As FIG. 54 illustrated, the first intermediate adapter coupling 3804 and the second intermediate adapter coupling 3806 are angled relative to one another. The first intermediate adapter coupling is aligned with the first axis E-E, and the second intermediate adapter coupling is aligned with the second axis F-F. The axes E-E and F-F are angled relative to one another by an angle a. In FIG. 54 embodiments, the angle between the first intermediate adapter coupling and the second intermediate adapter coupling is 90 degrees (e.g., a = 90 degrees) such that the couplings are orthogonal to one another. In other embodiments, the angle of the intermediate couplings relative to one another can be an acute angle (e.g., a < 90 degrees). In other embodiments, the angle of the intermediate couplings relative to one another can be an obtuse angle (e.g., a > 90 degrees). In FIG. 55 embodiments, the angle of the third intermediate adapter coupling and the fourth intermediate adapter coupling relative to one another is equal to the angle between the first intermediate adapter coupling and the second intermediate adapter coupling. In some embodiments, the angle between the first intermediate adapter coupling and the second intermediate adapter coupling can be different than the third intermediate adapter coupling and the fourth intermediate adapter coupling.

[0274] FIG. 55 is a side view of another embodiment of a medicinal fluid delivery device 4400. As FIG. 55 illustrated, 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) that are connected in a serial fluidic arrangement via a first tube 4416 and a second tube 4418. The adapters are all disposed in a lower portion 4402 of a housing. In accordance with FIG. 55 embodiments, the lower portion of the housing includes an adapter plate 4404 that is configured to physically couple the modular adapters together. The adapter plate 4404 can be integrally formed with the lower portion 4402 or formed as a separate component. As FIG. 55As shown, the adapter plate 4404 includes a plurality of recesses 4406 formed by posts 4408. The dimensions and shapes of the recesses and posts are designed together to receive the adapters and suppress relative movement between them. The posts 4408 are configured to engage the first adapter base 4411, the second adapter base 4413, and the third adapter base 4415 (e.g., via an interference fit) to suppress relative movement between the adapters. FIG. 55 In some embodiments shown, the posts are configured to engage the sides of the adapter bases. In this way, the adapter bases are connectors that are releasably connected to each other via adapter plates 4404 and cannot move relative to each other in a first direction (e.g., the xy plane). Of course, although in FIG. 55 In one embodiment, the post 4408 engages the side of the adapter base; however, in other embodiments, the post may engage any suitable portion of the adapter. For example, in some embodiments, the adapter base may include an adapter recess (e.g., a tenon) configured to receive the post. In some embodiments, the adapter base may include a post configured to receive in a recess in the adapter plate. Of course, any suitable number of posts and recesses may be used as couplings in the adapter base and adapter plate, allowing multiple adapters to be releasably connected to each other, as this disclosure is not limited thereto. Additionally, although FIG. 55 The implementation scheme includes three adapters, but any suitable number of adapters can be used for similar applications. FIG. 55 In the arrangement of the layout. Similarly, although FIG. 56 The implementation scheme includes adapters arranged in series, but any suitable fluid or physical arrangement (e.g., matrix, zigzag, etc.) may be adopted, as this disclosure is not limited thereto.

[0275] FIG. 56 This is a side view of another embodiment of the pharmaceutical fluid delivery device 4500. (See image) FIG. 56 As shown, 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). The fluid connections of the adapters are not in... FIG. 56 As shown, however, the adapters can be arranged in series, in parallel, or any other suitable configuration for fluid connection to deliver the contents of the three containers. All adapters are located in the lower portion 4502 of the housing. According to... FIG. 56In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction. FIG. 56 In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction. FIG. 56 In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction. FIG. 56 In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction. FIG. 56 In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction. FIG. 55 In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction. FIG. 57 In the depicted embodiment, the lower portion of the housing is configured to apply pressure to the first adapter base 4511 and the third adapter base 4515. In turn, the first adapter base and the third adapter base 4515 are configured to apply pressure to the second adapter base 4513. Thus, the interference fit between the lower housing and the first adapter base 4511, the second adapter base 4513, and the third adapter base 4515 inhibits relative movement between the adapters via interference and friction. When in the configuration shown, the adapters can not be able to move relative to one another in a first direction (e.g., the x-y plane). If a force greater than a threshold force is applied in a second direction (e.g., the z-direction), the frictional force can be overcome such that the adapters can move relative to the other adapters in the second direction. Thus, in the depicted embodiment, the adapters can be moved relative to one another in the z-direction.

[0276] FIG. 57 is a plan view schematic of another embodiment of a transfer instrument 4600. In the depicted embodiment, as discussed according to the exemplary embodiments described herein, "I" is an inlet adapter, "M" is a middle adapter, and "O" is an outlet adapter. The arrows depict the fluidic path between the adapters. The relative positioning of the adapters depicts the physical arrangement of the transfer instrument. In some embodiments, the adapters can include various couplings and / or mate with a lower portion of a housing to hold the adapters in the physical position depicted. In the depicted embodiment, the physical arrangement is a zigzag, which is similar to FIG. 57 FIG. 57 FIG. 54 FIG. 58 ​​​The physical arrangement shown. Additionally, the adapters are fluidically connected in a series fluidic arrangement, where fluid flows sequentially from the inlet adapter, through both intermediate adapters, and to the outlet adapter, where the medicinal fluid can be delivered to a user via a suitable delivery device.

[0277] FIG. 58 is a plan view schematic of another embodiment of a transfer device 4700. In FIG. 58 embodiments, as discussed according to the exemplary embodiments described herein, "I" is an inlet adapter, "M" is a middle adapter, and "O" is an outlet adapter. Arrows depict the fluidic pathway between the adapters. The relative positioning of the adapters depicts the physical arrangement of the transfer device. In some embodiments, the adapters can include various couplings and / or mate with a lower portion of the housing to retain the adapters in FIG. 58 the physical position depicted. In FIG. 59 embodiments, the physical arrangement is a diamond matrix. Additionally, the adapters are fluidically connected in a parallel fluidic arrangement, where fluid flows from the inlet adapter and both middle adapters to the outlet adapter, respectively. The resulting medicinal fluid can be delivered from the outlet adapter to a user via a suitable delivery device.

[0278] FIG. 59 is a plan view schematic of another embodiment of a transfer device 4800. In FIG. 59 embodiments, as discussed according to the exemplary embodiments described herein, "I" is an inlet adapter, "M" is a middle adapter, and "O" is an outlet adapter. Arrows depict the fluidic pathway between the adapters. The relative positioning of the adapters depicts the physical arrangement of the transfer device. In some embodiments, the adapters can include various couplings and / or mate with a lower portion of the housing to retain the adapters in FIG. 59 the physical position depicted. In FIG. 60 embodiments, the physical arrangement is a diamond matrix. Additionally, the adapters are fluidically connected in a partially parallel, partially series fluidic arrangement. Specifically, fluid flows from both inlet adapters to a single middle adapter, respectively. Fluid then flows from the middle adapter to the outlet adapter. The resulting medicinal fluid can be delivered from the outlet adapter to a user via a suitable delivery device.

[0279] FIG. 60 is a plan view schematic of another embodiment of a transfer device 4900. In FIG. 60In the embodiments described herein, as discussed in the exemplary embodiments, "I" is the inlet adapter, "M" is the intermediate adapter, and "O" is the outlet adapter. Arrows depict fluid paths between the adapters. The relative positioning of the adapters depicts the physical arrangement of the transfer device. In some embodiments, the adapter may include various couplings and / or mate with the lower portion of the housing to retain the adapter. FIG. 60 The physical location described. FIG. 57 In this implementation scheme, the physical arrangement is a square matrix. Additionally, the adapter is similar to... FIG. 53 The fluid is fluidly connected in series. Specifically, the fluid flows sequentially from the inlet adapter, through two intermediate adapters, and to the outlet adapter. The resulting pharmaceutical fluid can be delivered to the user from the outlet adapter via a suitable delivery device.

[0280] Although the exemplary embodiments described herein are arranged in linear, angled, and matrix patterns, in other embodiments, the transfer devices may be arranged in a square matrix, hexagonal pattern, or any other suitable geometric pattern, as this disclosure is not limited thereto. In some embodiments, the adapter may include any number of connectors, allowing multiple transfer devices to be arranged in a desired matrix configuration. For example, the adapter may include one connector, two connectors, three connectors, four connectors, or any other suitable number of connectors. In some embodiments, the inlet adapter may include a first inlet adapter connector and a second inlet adapter connector, wherein the first and second inlet adapter connectors are each configured to be connected in parallel to a separate intermediate adapter connector. This arrangement can provide a similar FIG. 61A The fluid arrangement is as described in the embodiments, but other fluid configurations are contemplated. In some embodiments, the outlet adapter may include a first outlet adapter connector and a second outlet adapter connector, wherein the first outlet adapter connector and the second outlet adapter connector are each configured to be connected in parallel to a separate intermediate adapter connector.

[0281] FIG. 61B This is a front view of another embodiment of the pharmaceutical fluid delivery device 3900 in its first state, and FIGS. 61A-61B The pharmaceutical fluid delivery device in its second state is shown. According to... FIG. 61A In one embodiment, the device includes a housing having an upper portion 3902 and a lower portion 3910. The housing is configured to receive a single container, but in other embodiments, any suitable number of containers can be disposed within the housing. The upper portion is configured to... FIG. 61B The unacted position shown is the same as FIGS. 61A-61Bbetween the illustrated actuation positions. As in some previously discussed embodiments, the upper portion is configured to slide along the inner guide 3912. The upper portion includes a fluid outlet cutout 3904 configured to reveal the fluid outlet and allow physical access to the fluid outlet when the upper portion is moved to the actuation position. In FIGS. 61A-61B embodiments, the cutout 3904 is configured to align with the fluid outlet 3914 when the upper portion is in the actuation position. Of course, any arrangement that selectively allows access to the fluid outlet can be employed according to other example embodiments described herein. In some alternative embodiments, the fluid outlet can be physically accessible regardless of the state of the upper portion 3902, as the disclosure is not so limited.

[0282] FIGS. 61A-61B embodiments include a marker configured to selectively communicate information to a remote device (e.g., a user device such as a smartphone). In FIGS. 61A-61B embodiments, the marker is a QR code 3916 disposed on the lower portion 3910 of the housing. In some embodiments as FIG. 62A illustrated, when the upper portion is in the unactuated position, the QR code is at least partially obstructed by the upper portion. Specifically, when the upper portion is in the unactuated position, the QR code is hidden and not visible because an opaque portion of the upper portion obscures the marker. In the actuation position, however, a marker window 3906 formed in the upper portion aligns with the QR code to expose the QR code to the user, making the QR code accessible. Thus, once the medicinal fluid delivery device is actuated, the user can scan the QR code with a remote device. The QR code can communicate information to the remote device when scanned, such as a dose, drug lot information, etc. That is, the QR code can include information that can be read by the remote device. In some embodiments, the marker window 3906 can be formed as a hole in the upper portion. In some embodiments, the marker window 3906 can be a transparent portion of the upper portion configured to align with the marker when the upper portion is in the actuation position. Of course, the QR code can be made accessible to the user by any suitable arrangement, as the disclosure is not so limited. For example, in some embodiments, in the absence of a window, the upper portion can cover at least a portion of the marker in the unactuated position and reveal the marker in the actuation position. FIG. 62B The arrangement can allow information to be communicated to a remote device without the need for pairing or storing power on the medicinal fluid delivery device.

[0283] FIGS. 62A-62B is a front view of another embodiment of a medicinal fluid delivery device 4000 in a first state, and FIG. 62A is shown in a second state. According to FIG. 62BIn embodiments, the device includes a housing having an upper portion 4002 and a lower portion 4010. The housing is configured to receive a single container, although any suitable number of containers can be disposed within the housing in other embodiments. The upper portion is configured to move between an unactuated position, shown in FIGS. 62A-62B FIGS. 62A-62B As in previously discussed embodiments, the upper portion is configured to slide along an inner guide 4012. The upper portion includes a fluid outlet cutout 4004 configured to reveal a fluid outlet and allow physical access to the fluid outlet when the upper portion is moved to the actuated position. In embodiments, FIGS. 62A-62B The cutout 4004 is configured to align with the fluid outlet 4014 when the upper portion is in the actuated position, of course, any arrangement that selectively allows access to the fluid outlet can be employed in accordance with other example embodiments described herein.

[0284] FIGS. 62A-62B Embodiments include a marker configured to selectively communicate information to a remote device. In embodiments, FIG. 63 The marker is an NFC tag 4016 disposed on the lower portion 4010 of the housing, of course, any arrangement that selectively allows access to the fluid outlet can be employed in accordance with other example embodiments described herein. FIG. 64A As shown, the NFC tag is enclosed by the upper portion in the unactuated position. However, in the actuated position, a marker window 4006 formed in the upper portion aligns with the NFC tag to reveal the NFC tag to the user so that the NFC tag is accessible. In some embodiments, the upper portion can be formed of an NFC signal blocker or other radio frequency (RF) shield so that the NFC tag is at least partially blocked by the upper portion when the upper portion is in the unactuated position. In accordance with such embodiments, the remote device can be unable to activate the NFC tag until the NFC tag is aligned with the radio transparent window. In other embodiments, a visual indicator where the user can read the NFC tag can be at least partially blocked by the upper portion in the unactuated position. In accordance with such embodiments, the window can reveal the visual indicator where the user can read the NFC tag. Thus, once the medicinal fluid delivery device is actuated, the user can scan the NFC tag with a remote device. The NFC tag can communicate information to the remote device, such as a dose, drug lot information, etc. In some embodiments, the marker window 4006 can be formed as a hole in the upper portion. In some embodiments, the marker window 4006 can be a radio transparent portion of the upper portion 4002. Of course, the NFC tag can be made accessible to the user by any suitable arrangement as the disclosure is not so limited. FIG. 64B The arrangement can allow information to be communicated to a remote device without the need to store a power source on the medicinal fluid delivery device as the NFC tag can be powered wirelessly by the remote device. ​

[0285] FIG. 64A is a flowchart of another embodiment of a medicinal fluid delivery process. As shown in step 4100, a first container is provided within a housing, where an upper portion of the housing at least partially encloses the first container. In step 4102, a force is applied to the upper portion to move the upper portion from an unactuated position to an actuated position. In some embodiments, moving the upper portion to the actuated position can pierce the first container. In step 4104, a marker is exposed as the upper portion is moved to the second actuated position. For example, a window formed in the upper portion can align with the marker. In some embodiments, moving the upper portion to the actuated position can also make a fluid outlet physically accessible, as further discussed in accordance with other example embodiments herein. In step 4106, fluid is allowed to flow from the first container to the fluid outlet. For example, as previously discussed, moving the upper portion to the actuated position can fluidically connect the first container to the fluid outlet (e.g., via a spike).

[0286] FIGS. 64A-64B is a front view schematic of another embodiment of a medicinal fluid delivery device 4200 including a communication module in a first state, and FIG. 64A shows the medicinal fluid delivery device of FIG. 64B in a second state. In accordance with FIGS. 64A-64B embodiments and similar to previously discussed embodiments, the device includes a housing having an upper portion 4202 and a lower portion 4210. The housing is configured to receive a single container, although any suitable number of containers can be disposed within the housing in other embodiments. The upper portion is configured to move between an unactuated position shown in FIGS. 64A-64B and an actuated position shown in FIG. 18 As in previously discussed embodiments, the upper portion is configured to slide along an inner guide 4212. The upper portion includes a fluid outlet cutout 4204 configured to reveal a fluid outlet and allow physical access to the fluid outlet when the upper portion is moved to the actuated position. In FIG. 65 embodiments, the cutout 4204 is configured to align with the fluid outlet 4214 when the upper portion is in the actuated position. Of course, any arrangement that selectively allows access to the fluid outlet can be employed in accordance with other example embodiments described herein.

[0287] FIGS. 64A-64B embodiments include a communication module 4230 and are configured to communicate with one or more remote devices (e.g., user devices). The communication and related functionality is similar to that discussed with reference to the embodiments of FIGS. 64A-64B . The communication module will be further discussed with reference to FIGS. 64A-64B In accordance with FIGS. 64A-64BIn this implementation scheme, the communication module can be easily attached to the lower part 4210. The communication module can be self-contained, allowing the pharmaceutical fluid delivery device to easily communicate with the remote device when paired with the trigger.

[0288] according to FIGS. 64A-64B In one embodiment, the pharmaceutical fluid delivery device 4200 includes a trigger configured to activate the communication module 4230. FIG. 65 The implementation shows two instances of the trigger, which may be used alone in other implementations. First, the device includes a switch 4224 (e.g., a microswitch) configured to engage the engagement portion 4203 of the upper portion 4202 of the housing. FIG. 65 The engagement portion 4203 is a lip, but in other embodiments, the engagement portion may be a housing wall, an internal protrusion or feature, or any other suitable feature of the upper portion 4202 of the housing. The switch is configured to activate (e.g., pressed) when the upper portion is moved to an actuated position. That is, the switch is configured to move from a first switch position to a second switch position via the upper portion. Next, the device includes a beam sensor 4226 disposed in the lower portion 4210 for emitting a beam 4227. Specifically, the beam sensor includes a beam emitter and a beam receiver, wherein the beam emitter is configured to emit a beam received by the beam receiver. The upper portion 4202 includes a protrusion 4206 configured to physically block the beam when the upper portion is in the actuated position. The beam sensor is configured to detect when the beam is interrupted, thereby determining that the upper portion is actuated. In some embodiments, a trigger of the pharmaceutical fluid delivery device can connect the communication module 4230 to a power source. Once the communication module is activated by one or both triggers, the communication module can send one or more messages including information to a remote device. Although in FIG. 65 Two examples of triggers are shown, but any suitable sensor can be used to wake up the communication module, as this disclosure is not limited thereto. For example, a strain gauge or other pressure sensor may be disposed in the upper portion and configured to detect force or pressure applied to the upper portion by a user. The communication module may be activated when the detected force or pressure exceeds a threshold force or pressure. As another example, a Hall effect sensor may be used to detect movement of the upper portion to the actuation position and wake up the communication module, as discussed previously with reference to other exemplary embodiments herein. As yet another example, a proximity sensor may be used to detect movement of the upper portion to the actuation position and wake up the communication module.

[0289] FIG. 66 This is a schematic diagram of one implementation scheme of the communication module 4230. (For example...) ​As shown, the communication module includes a processor 4232 that can be configured to execute computer-readable instructions stored in a non-transitory memory. The communication module also includes a power source 4234 (e.g., a battery) configured to power the various components of the communication module. The communication module also includes a communication device 4236, which can be a radio transceiver employing any suitable radio communication protocol (e.g., Bluetooth, Bluetooth Low Energy, Wi-Fi, 802.15.4, ZigBee, GSM, HSPA, CDMA, etc.). In some embodiments, as shown, the communication module can optionally include one or more sensors 4238 configured to provide information to the communication module. The sensors can 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 can be included in messages sent by the communication module to one or more remote devices. Of course, any suitable sensors can be used as part of the communication module as the present disclosure is not so limited. ​

[0290] In some embodiments, the communication module can include additional components that can provide additional functionality to aid in the use of the medical delivery device. For example, in some embodiments, the communication module can include a vibration motor configured to agitate the device. In some embodiments, the vibration motor can be employed to assist in mixing various fluids and solids of a medical fluid delivery device. In some embodiments, the vibration motor can be configured to provide a tactile alert to a user, as discussed with reference to other embodiments described herein. As another example, in some embodiments, the communication module can include a speaker. In some embodiments, the speaker can be configured to provide an audible alert to a user, as discussed with reference to other embodiments described herein.

[0291] ​ ​is a flowchart of another embodiment of a pharmaceutical fluid delivery process. As shown in step 4300, a first container is provided within a housing, where an upper portion of the housing at least partially encloses the first container. In step 4302, a force is applied to the upper portion to move the upper portion from an unactuated position to an actuated position. In some embodiments, moving the upper portion to the actuated position can pierce the first container. In step 4304, a communication module is activated with a trigger when the upper portion is moved to the actuated position. For example, a switch can be depressed by the upper portion when the upper portion is moved to the actuated position. In some embodiments, moving the upper portion to the actuated position can also make a fluid outlet physically accessible, as further discussed in accordance with other example embodiments herein. In step 4306, fluid is allowed to flow from the first container to the fluid outlet. For example, as previously discussed, moving the upper portion to the actuated position can fluidically connect the first container to the fluid outlet (e.g., via a spike).

[0292] It should be noted that while some of the above embodiments depict reconstitution devices, in other embodiments, devices similar to these embodiments can be pharmaceutical fluid delivery devices configured to gather pharmaceutical fluid, rather than reconstitute a solid medicament, or can be configured to access the contents of only a single container. Thus, various features and methods described with reference to these embodiments are also applicable to pharmaceutical fluid delivery devices configured to gather fluid or access the contents of only a single container, as the present disclosure is not so limited.

[0293] In addition to the above, it should be noted that while some of the devices discussed above are configured to access and deliver the contents of two containers, any suitable number of containers can be employed. For example, in some embodiments, pharmaceutical fluid delivery devices similar to those described above can include a single container, two containers, three containers, four containers, five containers, or any suitable number of containers. Thus, various features and methods described above are also applicable to pharmaceutical fluid delivery devices or reconstitution devices having any number of containers, as the present disclosure is not so limited.

[0294] While the present teachings have been described in connection with various embodiments and implementations, the present teachings are intended to cover all alternatives, modifications, and equivalents. Accordingly, the description is not intended to limit the scope of the present teachings.

Claims

1. A reconfiguration apparatus, the reconfiguration apparatus comprising: A housing having a lower portion and an upper portion movably engaged with the lower portion, the upper portion being movable relative to the lower portion between an unactuated position and an actuated position; A transfer device disposed within the lower portion of the housing, the transfer device having a first container receiving end and a second container receiving end facing the upper portion of the housing; and A fluid outlet, which is in fluid communication with the second container receiving end of the transfer device. The upper portion is configured to engage the first container and the second container such that when the upper portion moves from the unacted position to the actuthically position, the first container and the second container move toward the first container receiving end and the second container receiving end, respectively. When the upper portion is in the inactive position, it at least partially blocks physical access to the fluid outlet, and when the upper portion is in the actuated position, it allows physical access to the fluid outlet, wherein the upper portion includes a cut, wherein when the upper portion is in the inactive position, the upper portion at least partially encloses the fluid outlet in the housing, and wherein when the upper portion is in the actuated position, the cut exposes the fluid outlet.

2. The reconfiguration apparatus of claim 1, wherein the lower portion has a fluid outlet reservoir and the fluid outlet is positioned within the fluid outlet reservoir, and wherein moving the upper portion to the actuated position aligns the cut with the fluid outlet reservoir to expose the fluid outlet.

3. The reconfiguration apparatus of claim 1 or 2, wherein the reconfiguration apparatus further comprises a flexible strip connected to the fluid outlet.

4. The reconfiguration apparatus of claim 1 or 2, wherein when the upper portion is in the actuated position, the fluid outlet is fixed relative to the lower portion of the housing.

5. The reconfiguration apparatus of claim 1 or 2, wherein when the upper portion is in the actuated position, the fluid outlet is movable relative to the lower portion of the housing.

6. The reconfiguration apparatus of claim 5, wherein the fluid outlet is connected to the second container receiving end via a flexible conduit.

7. The reconfiguration apparatus of claim 5, further comprising a clamp attached to the fluid outlet and engaged with the lower portion of the housing when the upper portion is in the unactuated position to retain the fluid outlet to the housing.

8. The reconfiguration apparatus of claim 7, wherein the clamp is removable from the lower portion of the housing when the upper portion is in the actuated position to allow the fluid outlet to move relative to the housing.

9. The reconfiguration apparatus of claim 7, further comprising a cap covering at least a portion of the fluid outlet, wherein the clamp has a lesser holding force between the clamp and the housing than the cap has a lesser holding force between the cap and the fluid outlet.

10. The reconfiguration apparatus of claim 7, wherein the lower portion of the housing includes a slot through which at least a portion of the clamp is received when the upper portion is in the inactive position to retain the fluid outlet to the housing.

11. The reconstruction apparatus of claim 7, wherein the reconstruction apparatus further comprises a second clamp.

12. The reconstruction apparatus of claim 1, wherein the fluid outlet is movable relative to the transfer device.

13. The reconfiguration apparatus of claim 1, wherein the upper portion includes a curved surface extending in a direction away from the lower portion.

14. The reconfiguration apparatus of claim 1, wherein the lower portion includes a flat surface opposite the upper portion.

15. The reconfiguration apparatus of claim 1, further comprising an alarm module configured to issue an alarm to a user when the upper portion moves from the inactive position to the activated position.

16. The reconfiguration apparatus of claim 15, wherein the alarm module is configured to provide visual alarms, auditory alarms, and / or tactile alarms.

17. The reconfiguration apparatus of claim 15, wherein the alarm module transmits alarm messages via wireless communication.

18. The reconstruction apparatus of claim 1, wherein the upper portion includes at least one window configured to allow a user to view at least one of the first container and the second container.

19. The reconfiguration apparatus of claim 1, wherein the first container receiving end is configured as a first tip, and the second container receiving end is configured as a second tip.

20. The reconfiguration apparatus of claim 19, wherein the first tip and the second tip are each a dual-lumen tip.

21. The reconstruction apparatus of claim 19, wherein the second tip includes at least one open end of the fluid path that is inclined at an angle relative to the piercing direction of the second tip.

22. The reconfiguration apparatus of claim 21, wherein the angle is approximately 90 degrees.

23. The reconfiguration apparatus of claim 19, wherein the transfer device includes an inlet configured to allow air to enter the transfer device.

24. The reconfiguration apparatus of claim 23, wherein the inlet is configured as a hydrophobic filter.

25. The reconfiguration apparatus of claim 1, wherein the fluid outlet is a Luer activation valve or a Luer connector.

26. The reconfiguration apparatus of claim 1, wherein the first container receiving end and the second container receiving end are in unidirectional fluid communication.

27. The reconfiguration apparatus of claim 1, wherein the upper portion and the lower portion are slidably engaged.

28. The reconfiguration apparatus of claim 1, wherein the upper portion includes at least one upper retaining feature, the lower portion includes at least one lower retaining feature, and the upper retaining feature and the lower retaining feature are configured to engage with each other to retain the upper portion in the actuated position.

29. The reconfiguration apparatus of claim 1, wherein the fluid outlet is releasably retained within the housing until the delivery device is coupled to the fluid outlet.

30. The reconfiguration apparatus of claim 29, wherein the fluid outlet is rigidly attached to the housing until the delivery device is coupled to the fluid outlet, and wherein the fluid outlet is movable relative to the housing after the delivery device is coupled to the fluid outlet.

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