Storage device for one or more medical containers

Abstract

To provide a pooling device for a single or a plurality of medical containers.SOLUTION: A medicinal fluid pooling device may be used to pool medicinal fluid in a plurality of containers to facilitate administration of the medicinal fluid to a patient. A medicinal pooling device may include spikes covered by spike sheaths which are pierced when a container of medicinal fluid is inserted into the medicinal pooling device. The medicinal pooling device may also include a cover configured to cover the spikes. The medicinal pooling device may also include a fluidic interface which may be used to fluidly connect the medicinal pooling device to an infusion pump or syringe.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Application No. 62 / 819,349, filed Mar. 15, 2019, and U.S. Provisional Application No. 62 / 740,475, filed Oct. 3, 2018, each of which is hereby incorporated by reference in its entirety.

[0002] The disclosed embodiments relate to a storage device for storing medicinal fluids from single or multiple medical containers.

Background Art

[0003] Medicinal fluids are often separately manufactured and packaged prior to use to preserve their chemical and physical stability. Medicinal fluids can be combined either at the time of administration, immediately prior to administration, by mixing the medicinal fluids, or concurrently or sequentially by administering the medicinal fluids.

[0004] Typically, these additional steps during administration are performed by a nurse or other healthcare provider who may need to administer the medicinal fluid to the patient according to special procedures. If additional medicinal fluids are required, the method of administration can be performed multiple times by a nurse or other healthcare provider for a given dosage.

[0005] Conventional methods and systems of administration may lack efficient procedures and may require many steps of connecting and disconnecting components and moving fluids through various components in a specific manner. The inventors recognize a need for a medicinal storage system that simplifies the administration of medicinal fluids to a patient.

Summary of the Invention

Means for Solving the Problems

[0006] In some embodiments, systems and methods are provided for administering a medicinal fluid to a patient from one or more containers. In some embodiments, the medicinal fluid storage device includes a hollow spike configured to puncture a medicinal fluid container and receive fluid therefrom, the spike comprising portions of different cross-sectional areas to facilitate sealing with an associated spike sheath. In some embodiments, the hollow spike of the medicinal fluid storage device is part of a port, the port having an associated cover that is removably connected to the port and covers the hollow spike. In some embodiments, the medical device may include a fluid interface having a housing that includes at least a portion of a fluid connector, including a Luer-operated valve.

[0007] In one embodiment, the medicinal fluid storage device includes a spike sheath, a spike having a body including a first body portion and a second body portion, tubing communicating with an internal channel of the spike, and a base coupled to the spike. The first and second body portions have different cross-sectional shapes, and the second body portion is configured to create a fluid seal with the spike sheath. The internal channel extends through the first and second body portions. The spike sheath is configured to compress and move toward the base when a force is applied to the spike sheath in the direction toward the base.

[0008] In another embodiment, the fluid interface of a medical device includes a fluid connector comprising a first end, a second end, and a Luer-operated valve for controlling fluid communication between the first and second ends; tubing communicating fluidly with the second end; and a housing comprising a first opening and a second opening. The housing contains at least a portion of the fluid connector, and the first end of the fluid connector is accessible.

[0009] In another embodiment, the medicinal fluid storage device includes a port containing a hollow spike, tubing communicating with the hollow spike and fluid, and a cover that is removably connected to the port and configured to cover the hollow spike.

[0010] In one embodiment, a method of using a storage device for storing a medicinal fluid includes the steps of: removing a cover to expose a port of the storage device, the port comprising a hollow spike and a spike sheath covering the spike; connecting a first container to the port by pressing the first container onto the spike, thereby puncturing the spike sheath and the first container with the spike, thereby enabling fluid communication between the internal volume of the first container and the spike; and connecting an infusion pump to tubing and moving the medicinal fluid through the tubing into the patient. The spike sheath forms a seal against the spike prior to the insertion of the first container into the port. The internal volume of the first container contains the medicinal fluid, and the spike is in fluid communication with the tubing.

[0011] In another embodiment, the wearable fluid storage device includes a housing, which includes a clip configured to allow the wearable fluid storage device to be attached to clothing; a first port formed within the housing and configured to receive a first container; and a first spike positioned within the first port and configured to puncture the first container when the first port receives the first container.

[0012] In another embodiment, the attachable fluid storage system includes a first attachable fluid storage device. The first attachable fluid storage device includes a first housing, which includes a first clip configured to allow the first attachable fluid storage device to be attached to clothing; a first port formed within the first housing and configured to receive a first container; a first spike located within the first port and configured to puncture the first container when the first port receives the first container; a first fluid outlet connector, which is fluidly connected to an associated device and configured to allow fluid communication between the first attachable fluid storage device and the associated device; a fluid inlet connector; and a first set of tubing connected to the first spike, the first fluid outlet connector, and the fluid inlet connector. The first set of tubing is configured to allow fluid communication between the fluid inlet connector, the first spike, and the first fluid outlet connector. The attachable fluid storage system also includes a second attachable fluid storage device. The second attachable fluid storage device includes a second housing, which includes a second clip configured to allow the second attachable fluid storage device to be attached to clothing; a second port formed within the second housing and configured to receive a second container; a second spike positioned within the second port and configured to puncture the second container when the second port receives the second container; a second fluid outlet connector, which is fluidly coupled to the first fluid inlet connector and configured to allow fluid communication between the second attachable fluid storage device and the first attachable fluid storage device; and a second set of tubing connected to the second spike and the second fluid outlet connector. The second set of tubing is configured to allow fluid communication between the second fluid outlet connector and the second spike.

[0013] In another embodiment, a method for administering a medicinal fluid to a patient includes the steps of: connecting a first container to a first port formed in a first housing by pressing the first container onto a first spike located in the first port; puncturing the first container with the first spike; enabling fluid communication between the first spike and the internal volume of the first container, wherein the internal volume of the first container contains the medicinal fluid. The method may also include the steps of: connecting an infusion set to a first fluid outlet connector via the first spike, enabling fluid communication between the infusion set and the internal volume of the first container; venting air located in the infusion set; and drawing the medicinal fluid from the internal volume of the first container into the infusion set.

[0014] The concepts described above and the additional concepts discussed below may be arranged in any preferred combination, but it should be understood that this disclosure is not limited in this respect. Furthermore, other advantages and novel features of this disclosure will become apparent from the detailed description of the various non-limiting embodiments below, when considered in conjunction with the accompanying drawings. The present invention provides, for example, the following: (Item 1) A medical fluid storage device, Spike sheath and, A spike having a body including a first body portion and a second body portion, wherein the first body portion and the second body portion have different cross-sectional shapes, the second body portion is configured to create a fluid seal with the spike sheath, and the internal channel of the spike extends through the first body portion and the second body portion, The internal channels of the spike and the pipes that communicate with the fluid, A base coupled to the spike, wherein the spike sheath is configured to compress and move toward the base when a force is applied to the spike sheath in the direction toward the base. A medical fluid storage device equipped with [a specific feature]. (Item 2) The medicinal fluid storage device according to item 1, wherein the first body portion has a first major axis diameter, and the second body portion has a second major axis diameter, and the first major axis diameter is greater than the second major axis diameter. (Item 3) The medicinal fluid storage device according to item 1, wherein the first body portion has a first minor axis diameter, and the second body portion has a second major axis diameter, the second major axis diameter being larger than the first minor axis diameter. (Item 4) The medicinal fluid storage device according to item 1, wherein the internal channel comprises an inlet and an outlet, and the inlet and the outlet are in fluid communication through the spike sheath when the spike sheath is in an uncompressible position. (Item 5) The medicinal fluid storage device according to item 4, wherein the inlet and outlet each have a D-shaped cross-section, and the D-shaped cross-sections of the inlet and outlet face each other. (Item 6) The medicinal fluid storage device according to item 1, wherein the spike sheath comprises a sheath base, a sheath shaft, and a sheath tip, the spike being received within the sheath shaft, the sheath shaft being configured to compress and move toward the sheath base when the force is applied to the spike sheath in the direction toward the base, and the spike puncturing the sheath tip as the sheath shaft moves toward the base. (Item 7) The medicinal fluid storage device according to item 6, wherein the spike sheath includes at least one seal ring disposed within the sheath shaft. (Item 8) The medicinal fluid storage device according to item 1, wherein the first main body portion has an elliptical cross-sectional shape, and the second main body portion has a circular cross-sectional shape. (Item 9) The aforementioned medicinal fluid storage device is the medicinal fluid storage device described in item 1, which can be attached. (Item 10) The medicinal fluid storage device according to item 9, further comprising a belt clip configured to be releasably attached to a belt worn by a patient. (Item 11) The medicinal fluid storage device according to item 9, further comprising a lid movable between an open position and a closed position, wherein the lid is configured to surround the spike and the spike sheath in the closed position. (Item 12) The medicinal fluid storage device according to item 11, wherein the lid includes a hinge, and the lid rotates about the hinge between the open position and the closed position. (Item 13) A fluid interface of a medical device, wherein the fluid interface is a fluid connector, the fluid connector including a first end, a second end, and a Luer-activated valve for controlling fluid communication between the first end and the second end, and a fluid connector tubing in fluid communication with the second end, and a housing including a first opening and a second opening, the housing containing at least a portion of the fluid connector, and the first end of the fluid connector being accessible, and a housing comprising a fluid interface. (Item 14) The fluid interface according to item 13, wherein the housing includes a bell-shaped end proximate to the first opening. (Item 15) The fluid interface according to item 14, wherein the bell-shaped end is configured to be received by one or more latches disposed on the medical device. (Item 16) The fluid interface according to item 15, wherein the one or more latches are disposed within an interface holder of the medical device. (Item 17) The fluid interface according to item 13, wherein the housing includes an indicator configured to communicate information to an operator of the medical device. (Item 18) The fluid interface according to item 13, wherein the first end of the fluid connector is accessible from the first opening, and the tubing is positioned within the second opening. (Item 19) The fluid interface according to item 13, wherein the first end of the fluid connector protrudes outward from the first opening, and the tubing is positioned within the second opening. (Item 20) The first end is configured to connect to an injection pump, as described in item 13. (Item 21) The fluid interface according to item 20, wherein the first end is configured to connect to the injection pump via a second fluid connector including a second Luer-operated valve. (Item 22) The first end is configured to connect to a syringe, as described in item 13. (Item 23) The housing is fitted with the fluid interface described in item 13. (Item 24) The fluid interface according to item 23, wherein the housing includes a belt clip configured to releasably attach the fluid interface to a belt worn by a patient. (Item 25) A medical fluid storage device, Ports including hollow spikes, The hollow spike and the pipes that are in fluid communication with it, A cover configured to be removably connected to the port and covering the hollow spike, A medical fluid storage device equipped with [a specific feature]. (Item 26) The medical fluid storage device according to item 25, wherein the cover includes an indicator configured to show the method of operation. (Item 27) The medical fluid storage device according to item 25, wherein the cover includes a pull tab, the pull tab is configured to be pulled by an operator to disconnect the cover from the port. (Item 28) The circumferential shape of the port and the circumferential shape of the cover, wherein the cover is inserted at least partially into the port when the cover is removably connected to the port, according to item 25. (Item 29) The medicinal fluid storage device according to item 25, wherein the cover includes a receiving portion configured to receive a projection located within the port. (Item 30) The medicinal fluid storage device according to item 25, wherein the ports are a plurality of ports, each containing a hollow spike, and the cover is a plurality of covers, each removablely connected to the plurality of ports and configured to cover each of the hollow spikes. (Item 31) The cover is made of a thermoformed plastic material, as described in item 25, for the medicinal fluid storage device. (Item 32) The port includes a recess, as described in item 25, for the medicinal fluid storage device. (Item 33) The aforementioned medicinal fluid storage device is a medicinal fluid storage device as described in item 25, which can be attached. (Item 34) The medicinal fluid storage device according to item 33, further comprising a belt clip configured to be releasably attached to a belt worn by a patient. (Item 35) The medicinal fluid storage device according to item 25, wherein the cover is movable between an open position and a closed position, and in the closed position, the cover is configured to surround the spike and the spike sheath. (Item 36) The medicinal fluid storage device according to item 35, wherein the cover includes a hinge, and the cover rotates about the hinge between the open position and the closed position. (Item 37) A method using a storage device for storing a medicinal fluid, Removing the cover and exposing the port of the storage device, wherein the port includes a hollow spike and a spike sheath covering the spike, the spike sheath forming a seal over the spike prior to insertion of a container into the port, The first container is connected to the port by pressing it onto the spike, the spike punctures the spike sheath and the first container, and fluid communication is enabled between the spike and the internal volume of the first container, wherein the internal volume of the first container contains a medicinal fluid, and the spike is in fluid communication with the tubing. The infusion pump is connected to the aforementioned tubes, and the medicinal fluid is moved into the patient through the aforementioned tubes. Methods that include... (Item 38) The method according to item 37, wherein the port includes a second hollow spike and a second spike sheath covering the second spike, and connecting the first container to the port causes the second spike to puncture the second spike sheath and the second container, enabling fluid communication between the second internal volume of the second container and the second spike, the second spike sheath forming a seal against the second spike, the second internal volume containing a second medicinal fluid, and the second spike being in fluid communication with the second tubing. (Item 39) The method according to item 38, further comprising connecting a syringe to the second tubes and moving the second medicinal fluid into the syringe. (Item 40) Removing the second cover and exposing the second port of the storage device, wherein the second port includes a second hollow spike and a second spike sheath covering the second spike, The second container is connected to the port by pressing it onto the second spike, the second spike punctures the second spike sheath and the second container, and fluid communication is enabled between the second spike and the internal volume of the second container, wherein the internal volume of the second container contains a medicinal fluid, and the second spike is in fluid communication with the tubing. The method described in item 37, further including the method described in item 37. (Item 41) The method according to item 40, wherein the first container and the second container have different sizes. (Item 42) The method according to item 40, wherein the volume of the first container is 1.25 to 300 mL. (Item 43) The method according to item 42, wherein the volume of the first container and the volume of the second container are selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL, respectively. (Item 44) A fluid storage device that can be attached, A housing, the housing includes a clip configured to allow the attachable fluid storage device to be attached to clothing, A first port, wherein the first port is formed within the housing and configured to receive a first container, A first spike, the first spike is positioned within the first port and configured to puncture the first container when the first port receives the first container. A mountable fluid storage device equipped with [a specific feature]. (Item 45) The attachable fluid storage device according to item 44, further comprising a lid movable between an open position and a closed position, wherein the lid is configured to surround the first port in the closed position. (Item 46) The mountable fluid storage device according to item 45, wherein the lid includes a hinge, and the lid rotates about the hinge between the open position and the closed position. (Item 47) The mountable fluid storage device according to item 45, wherein the housing comprises a latch configured to be releasably fixed to the lid in the closed position. (Item 48) The attachable fluid storage device according to item 47, wherein the latch is a flexible fastener configured to be fixed to the lid in a non-flexible position and to release the lid in a flexible position. (Item 49) The wearable fluid reservoir device according to item 44, wherein the clip is a belt clip configured to releasably attach the wearable fluid reservoir device to a belt worn by a patient. (Item 50) A fluid outlet connector configured to enable fluid communication between the mountable fluid storage device and a device associated with it, A set of pipes connected to the first spike and the fluid outlet connector, wherein the pipes are configured to enable fluid communication between the fluid outlet connector and the first spike. A mountable fluid storage device as described in item 44, further comprising the features described above. (Item 51) The fluid outlet connector is a mountable fluid storage device as described in item 50, including a Luer-operated valve. (Item 52) The attachable fluid storage device according to item 50, further comprising the associated device, wherein the associated device is an injection set, and the injection set is in fluid communication with the fluid outlet connector. (Item 53) The infusion set includes a breath valve configured to allow air to pass through, as described in item 52, which is an attachable fluid storage device. (Item 54) A second port, the second port being formed within the housing and configured to receive a second container, A second spike, the second spike positioned within the second port and configured to puncture the second container when the second port receives the second container, and the tubing connected to the second spike and configured to allow fluid communication between the first spike, the second spike, and the fluid outlet connector, and A mountable fluid storage device as described in item 50, further comprising the features described above. (Item 55) The first and second containers are of different sizes, as described in item 54, for the attachable fluid storage device. (Item 56) The attachable fluid storage device according to item 54, wherein the first and second containers each have volumes selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL. (Item 57) A third port, the third port being formed within the housing and configured to receive a third container, A third spike, the third spike positioned within the third port and configured to puncture the third container when the third port receives the third container, and the tubing connected to the third spike and configured to allow fluid communication between the first spike, the second spike, the third spike, and the fluid outlet connector, and A mountable fluid storage device as described in item 54, further comprising the features described above. (Item 58) The attachable fluid storage device according to item 57, wherein at least one selected from the group consisting of the first, second, and third containers has a different size from at least one selected from the group consisting of the first, second, and third containers. (Item 59) The attachable fluid storage device according to item 57, wherein the first container, the second container, and the third container each have volumes selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL. (Item 60) The attachable fluid storage device according to item 50, further comprising a fluid inlet connector configured to enable fluid communication between the attachable fluid storage device and a fluid storage device associated with it, wherein the tubing is connected to the fluid inlet connector and configured to enable fluid communication between the fluid inlet connector, the first spike, and the fluid outlet connector. (Item 61) A fluid storage system that can be attached, A first attachable fluid storage device, wherein the first attachable fluid storage device is A first housing, the first housing includes a first clip configured to allow the first attachable fluid storage device to be attached to clothing, A first port, the first port being formed within the first housing and configured to receive a first container, A first spike, the first spike being positioned within the first port and configured to puncture the first container when the first port receives the first container, A first fluid outlet connector, the first fluid outlet connector being fluidly connected to an associated device and configured to enable fluid communication between the first mountable fluid storage device and the associated device, Fluid inlet connector, A first set of tubing connected to the first spike, the first fluid outlet connector, and the fluid inlet connector, wherein the first set of tubing is configured to enable fluid communication between the fluid inlet connector, the first spike, and the first fluid outlet connector. A first attachable fluid storage device comprising, A second attachable fluid storage device, wherein the second attachable fluid storage device is A second housing, the second housing includes a second clip configured to allow the second attachable fluid storage device to be attached to clothing, A second port, the second port being formed within the second housing and configured to receive a second container, A second spike, the second spike being positioned within the second port and configured to puncture the second container when the second port receives the second container, A second fluid outlet connector, wherein the second fluid outlet connector is fluidly coupled to the first fluid inlet connector and configured to enable fluid communication between the second attachable fluid storage device and the first attachable fluid storage device, A second set of tubing connected to the second spike and the second fluid outlet connector, wherein the second set of tubing is configured to enable fluid communication between the second fluid outlet connector and the second spike. A second attachable fluid storage device comprising A mountable fluid storage system equipped with [a specific feature]. (Item 62) The mountable fluid storage system according to item 61, further comprising storage tubing configured to fluidly connect the second fluid outlet connector to the fluid inlet connector, wherein the storage tubing fluidly connects the first spike and the second spike to the first fluid outlet connector. (Item 63) The attachable fluid storage system according to item 61, wherein the second fluid outlet connector is configured to be directly coupled to the fluid inlet connector. (Item 64) The above-mentioned first attachable fluid storage device further, A third port, the third port being formed within the first housing and configured to receive a third container, A third spike, the third spike positioned within the third port and configured to puncture the third container when the third port receives the third container, and the first tubing connected to the third spike and configured to allow fluid communication between the fluid inlet connector, the first spike, the third spike, and the first fluid outlet connector, and A mountable fluid storage system as described in item 61, comprising: (Item 65) The second attachable fluid storage device described above further, A fourth port, the fourth port being formed within the second housing and configured to receive a fourth container, A fourth spike, the fourth spike being positioned within the fourth port and configured to puncture the fourth container when the fourth port receives the fourth container, and the second tubing being connected to the fourth spike and configured to allow fluid communication between the second spike, the fourth spike, and the second fluid outlet connector, and A mountable fluid storage system as described in item 64, comprising: (Item 66) The attachable fluid reservoir system according to item 61, wherein the first clip and the second clip are each configured as belt clips that are configured to releasably attach the first housing and the second housing to a belt worn by a patient, respectively. (Item 67) The attachable fluid storage system according to item 61, further comprising the associated device, wherein the associated device is an injection set. (Item 68) The attachable fluid storage system according to item 67, wherein the injection set includes a degassing valve configured to allow air to pass through the injection set. (Item 69) The first and second containers are of different sizes, as per the attachable fluid storage system described in item 61. (Item 70) The attachable fluid storage system according to item 61, wherein the first and second containers each have volumes selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL. (Item 71) A method for administering a medicinal fluid to a patient, wherein the method is: The first container is pressed onto a first spike positioned within the first port, thereby connecting the first container to the first port formed within the first housing, puncturing the first container with the first spike, and enabling fluid communication between the first spike and the internal volume of the first container, wherein the internal volume of the first container contains a medicinal fluid. The injection set is connected via the first spike to a first fluid outlet connector that enables fluid communication between the injection set and the internal volume of the first container, To allow air to circulate within the injection set, The medicinal fluid is drawn from the internal volume of the first container into the injection set. Methods that include... (Item 72) The method according to item 71, further comprising disconnecting the injection set from the first fluid outlet connector. (Item 73) The method according to item 71, further comprising attaching the first housing to clothing worn by the patient. (Item 74) The method according to item 73, wherein attaching the first housing to clothing worn by the patient includes releasably attaching the first housing to a belt worn by the patient. (Item 75) The second container is connected to the second port formed in the first housing by pressing the second container onto the second spike positioned within the second port, the second container is punctured by the second spike, and fluid communication is enabled between the second spike and the internal volume of the second container, wherein the internal volume of the second container contains a medicinal fluid, and the second spike is in fluid communication with the first spike. The medicinal fluid is drawn from the internal volume of the second container into the injection set. The method described in item 71, further including the method described in item 71. (Item 76) The method according to item 75, wherein the first and second containers have different sizes. (Item 77) The method according to item 75, wherein the first container and the second container each have a volume selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL. (Item 78) The third container is connected to the third port formed in the first housing by pressing the third container onto the third spike positioned within the third port, the third container is punctured by the third spike, and fluid communication is enabled between the third spike and the internal volume of the third container, wherein the internal volume of the third container contains a medicinal fluid, and the third spike is in fluid communication with the first spike and the second spike. The medicinal fluid is drawn from the internal volume of the third container into the injection set. The method described in item 75, further including the method described in item 75. (Item 79) The method of item 75, further comprising disconnecting the injection set from the first fluid outlet connector. (Item 80) The third container is connected to the third port formed in the second housing by pressing the third container onto the third spike positioned within the third port, the third container is punctured by the third spike, and fluid communication is enabled between the third spike and the internal volume of the third container, wherein the internal volume of the third container contains a medicinal fluid. The injection set is connected via the third spike to a second fluid outlet connector that enables fluid communication between the injection set and the internal volume of the third container, To allow air to circulate within the injection set, The medicinal fluid is drawn from the internal volume of the third container into the injection set. The method described in item 79, further including the method described in item 79. (Item 81) The fourth container is connected to the fourth port formed in the second housing by pressing the fourth container onto the fourth spike located in the fourth port, the fourth container is punctured by the fourth spike, and fluid communication is enabled between the fourth spike and the internal volume of the fourth container, wherein the internal volume of the fourth container contains a medicinal fluid, and the fourth spike is in fluid communication with the third spike. The medicinal fluid is drawn from the internal volume of the fourth container into the injection set. The method described in item 80, further including the method described in item 80. (Item 82) The third container is connected to the third port formed in the second housing by pressing the third container onto the third spike positioned within the third port, the third container is punctured by the third spike, and fluid communication is enabled between the third spike and the internal volume of the third container, wherein the internal volume of the third container contains a medicinal fluid. The second fluid outlet connector is connected to the fluid inlet connector, wherein the second fluid outlet connector is in fluid communication with the third spike, and the fluid inlet connector is in fluid communication with the first fluid outlet connector, the first spike, and the second spike. The medicinal fluid is drawn from the internal volume of the third container into the injection set. The method described in item 75, further including the method described in item 75. (Item 83) The method of item 82, wherein connecting the second fluid outlet connector to the fluid inlet connector includes connecting the second fluid outlet connector and the fluid inlet connector to storage pipes. (Item 84) The method according to item 82, further comprising attaching the first housing and the second housing to clothing worn by the patient. (Item 85) The method according to item 84, wherein attaching the first housing and the second housing to clothing worn by the patient includes releasably attaching the first housing and the second housing to a belt worn by the patient. [Brief explanation of the drawing]

[0015] Non-limiting embodiments of the present invention will be described by reference to accompanying drawings, which are schematic and not intended to be drawn to exact scale. In the drawings, each identical or substantially identical component shown is typically represented by a single number. For the purposes of clarity, not all components are labeled in all drawings, nor are all components of each embodiment of the present invention shown, and the illustrations are not necessary to enable those skilled in the art to understand the present invention.

[0016] [Figure 1] Figure 1 is a perspective view of one embodiment of a medicinal storage device.

[0017] [Figure 2]Figure 2 is a perspective view of the medicinal storage device shown in Figure 1, with the cover removed.

[0018] [Figure 3] Figure 3 is a perspective view of one embodiment of the first fluid distribution system.

[0019] [Figure 4] Figure 4 is a perspective view of one embodiment of the second fluid distribution system.

[0020] [Figure 5] Figure 5 is a perspective view of one embodiment of a combination of a first fluid distribution system and a second fluid distribution system for use in the pharmaceutical storage device of Figure 1.

[0021] [Figure 6] Figure 6 is an exploded view of the first fluid distribution system in Figure 3.

[0022] [Figure 7] Figure 7 is an exploded view of the second fluid distribution system in Figure 4.

[0023] [Figure 8A] Figure 8A is an exploded view of one embodiment of a spike and spike sheath.

[0024] [Figure 8B] Figure 8B is a perspective view of the spike and spike sheath from Figure 8A in their assembled form.

[0025] [Figure 9A] Figure 9A shows a schematic of another embodiment of the spike and spike sheath.

[0026] [Figure 9B] Figure 9B is a schematic diagram of the spike and spike sheath shown in Figure 9A after the container has been inserted onto the spike.

[0027] [Figure 10] Figure 10 is a cross-sectional view of another embodiment of the spike and spike sheath.

[0028] [Figure 11] Figure 11 shows a schematic of yet another embodiment of the spike.

[0029] [Figure 12] Figure 12 shows a schematic of yet another embodiment of the spike.

[0030] [Figure 13] Figure 13 shows a schematic of yet another embodiment of the spike.

[0031] [Figure 14] Figure 14 shows a schematic cross-sectional view of one embodiment of the first body portion of the spike.

[0032] [Figure 15] Figure 15 is a schematic diagram of another embodiment of the cross-section relating to the first body portion of the spike.

[0033] [Figure 16] Figure 16 is a schematic diagram of yet another embodiment of a cross-section relating to the first body portion of the spike.

[0034] [Figure 17] Figure 17 shows a schematic cross-sectional view of one embodiment of the second body portion of the spike.

[0035] [Figure 18] Figure 18 is a schematic diagram of another embodiment of the cross-section relating to the second body portion of the spike.

[0036] [Figure 19] Figure 19 is a schematic diagram of another embodiment of the cross-section relating to the second body portion of the spike.

[0037] [Figure 20A] Figure 20A is a perspective view of one embodiment of a fluid interface.

[0038] [Figure 20B] Figure 20B is an exploded view of the fluid interface shown in Figure 20A.

[0039] [Figure 21A] Figure 21A is a perspective view of another embodiment of the fluid interface.

[0040] [Figure 21B] Figure 21B is an exploded view of the fluid interface shown in Figure 21A.

[0041] [Figure 22A] Figure 22A is a top view of one embodiment of a medicinal storage device, including a cover.

[0042] [Figure 22B] Figure 22B is a top view of the medicinal storage device shown in Figure 22A, with the cover removed.

[0043] [Figure 23] Figure 23 is an exploded view of the medicinal storage device and cover shown in Figure 22A.

[0044] [Figure 24] Figure 24 illustrates one embodiment of a medicinal storage device used in combination with multiple container units.

[0045] [Figure 25] Figure 25 is a block diagram of one embodiment of a method for operating a medicinal storage device.

[0046] [Figure 26] Figure 26 is a perspective view of another embodiment of the medicinal storage device.

[0047] [Figure 27]Figure 27 is an exploded view of the medicinal storage device shown in Figure 26.

[0048] [Figure 28] Figure 28 is a perspective view of the medicinal storage device shown in Figure 26 when used in combination with multiple containers.

[0049] [Figure 29] Figure 29 is a front elevation view of various containers that can be used in conjunction with the medicinal storage device shown in Figure 26.

[0050] [Figure 30A] Figure 30A is a front perspective view of the medicinal storage device shown in Figure 26, with the lid in the closed position.

[0051] [Figure 30B] Figure 30B is a rear perspective view of the medicinal storage device shown in Figure 26, with the lid in the closed position.

[0052] [Figure 31] Figure 31 is a front elevation view of another embodiment of the medicinal storage device.

[0053] [Figure 32] Figure 32 is a front elevation view of one embodiment of a medicinal fluid storage system.

[0054] [Figure 33] Figure 33 is a front elevation view of another embodiment of the medicinal fluid storage system.

[0055] [Figure 34] Figure 34 is a front elevation view of yet another embodiment of the medicinal fluid storage system.

[0056] [Figure 35] Figure 35 is a front elevation view of yet another embodiment of the medicinal fluid storage system.

[0057] [Figure 36]Figure 36 illustrates one embodiment of an infusion set for use in conjunction with a medicinal storage device. [Modes for carrying out the invention]

[0058] During a typical administration process, multiple syringes may be used to mix the medicinal fluid in a series of steps prior to injection into the patient. At each step, the nurse or other healthcare worker takes care to ensure that each fluid is sterile as it is drawn from its packaging and discharged into the mixing container. Even if the medicinal fluid does not need to be pre-mixed prior to injection into the patient, each fluid is typically drawn individually by a pump, syringe, or other suitable tool. If a larger dose than that contained in a typical package is required for a particular patient, the process is typically repeated multiple times until the required dose is reached. Thus, conventional administration methods performed by nurses or healthcare workers can be time-consuming and complex.

[0059] In some cases, self-administration is a preferred option for convenience and cost due to the frequency of treatment using several medicinal fluids. Difficult procedures that are already time-consuming when performed by healthcare professionals may be difficult for patients to practice self-administration. Therefore, reducing the time consumption and complexity of medicinal fluid administration is desirable for patients who self-administer, for convenience and reduced impact on daily life.

[0060] In light of the above, the inventors recognize the advantages of a medicinal fluid storage device that allows a patient to be administered a medicinal fluid contained in one or more containers. Compared to conventional administration processes, storage devices may enable the use of a simpler medicinal fluid administration process with fewer steps. Storage devices may also enable the administration of increased dosages by using medicinal fluids in multiple containers, so that the steps of the administration process can be performed at once for a predetermined dosage.

[0061] The inventors also recognize the advantages of spikes and spike sheaths, which enable a simple sterile connection between a medicinal fluid container and a medicinal fluid storage device. The spike sheath may be ruptured by the container as the container is inserted into the medicinal fluid storage device, begins to store the fluid, and starts to flow into a patient device (e.g., an infusion pump, syringe, etc.). Therefore, the patient does not need to puncture the container using a handheld syringe or other tool, which can be cumbersome or present sterility issues.

[0062] In some embodiments, the medicinal fluid storage device includes at least one port with a spike. The spike may include a first body portion and a second body portion, the first and second body portions having different cross-sectional shapes. That is, the spike may transition along the length of the spike from a body portion with the first shape to a body portion with the second shape. The second body portion may have a shape configured to create a spike sheath and a fluid seal. The spike sheath may have a shape complementary to that of the second body portion so that when the spike is received by the sheath, the spike sheath can create a fluid seal around the spike. The spike may include an internal channel extending along the length of the spike so that the medicinal fluid storage device can communicate with a medicinal fluid container when one container is received by the port. The spike may be connected to tubing that allows for the transfer of medicinal fluid to a patient device. The spike sheath may seal the spike until the container is received, thereby keeping the spike sterile until connection with the container, so that the sheath may be broken and compressed by the container.

[0063] The inventors also recognize the advantages of fluid interfaces in enabling easy connection of patient devices such as infusion pumps or syringes. Typically, medical-grade fluid connection devices (e.g., Luer-actuated connectors) are small and difficult to grasp or otherwise manipulate for self-administration of medicinal fluids. Therefore, fluid interfaces that are sized and molded to be easier to grasp can simplify and improve the administration of medicinal fluids.

[0064] In some embodiments, the fluid interface includes a fluid connector and a housing. The housing may include first and second openings configured to provide access to the internal volume of the housing. The fluid connector may have a first end and a second end, the first end configured to connect to a patient device, and the second end configured to connect to a tube configured to transport a medicinal fluid (e.g., from a medicinal fluid storage device). The fluid connector may be located and mounted within the internal volume of the housing, having a size and shape to increase the ease of grasping and moving the housing by the operator. Thus, the housing can facilitate the medicinal fluid administration process for a patient or healthcare worker.

[0065] The inventors also recognize the advantages of a removable cover for a medicinal fluid storage device that allows the patient to selectively access a port and connect to a container of medicinal fluid. The cover may provide a simple way to communicate administration steps or other information to the patient for self-treatment and may provide protection for any sterile components used to connect to the container.

[0066] In some embodiments, the medicinal fluid storage device includes at least one port, each port including at least one spike assembly. The ports may be fitted into the storage device such that the spike assembly does not protrude from the outermost end of the storage device. Each port of the medicinal fluid storage device may have an associated cover configured to cover at least one spike positioned within the port such that at least one spike is inaccessible prior to removal of the cover. The cover may be removablely connectable to at least one port so that a patient or healthcare worker can remove the cover during the administration process for the medicinal fluid.

[0067] In some embodiments, the medicinal fluid storage device includes a housing with a plurality of ports and at least one fluid distribution system disposed therein. The plurality of ports may include spikes or other connectors suitable for fluidly connecting one or more containers of medicinal fluid to at least one fluid distribution system. The ports may include a plurality of spikes, which may be used to fluidly connect a plurality of containers packaged together in a container unit. The fluid distribution system may include fluid interface air filters, tubing, and fluid connectors used to draw fluid from one or more containers once they are fluidly connected to the fluid distribution system. The ports may be configured to receive one or more containers in an inverted position so that gravity may be used to supply medicinal fluid to the fluid connectors. The fluid distribution system may supply a single medicinal fluid from a plurality of containers connected to different ports, or a mixture of different medicinal fluids connected to different ports. Air filters may allow air into the fluid distribution system to be replaced with any volume of fluid drawn from the fluid connectors. The fluid connectors may be configured to connect to any patient device that can be used to administer the fluid to a patient, such as an infusion pump or syringe. Prior to the insertion of one or more containers, multiple ports may be sealed with covers that can be removed by the patient or healthcare worker prior to the connection of containers to the ports.

[0068] In some embodiments, a method for administering a medicinal fluid using a medicinal fluid storage device includes the steps of: removing one or more covers to expose one or more ports of the storage device; connecting one or more containers of medicinal fluid to one or more ports; and connecting a patient device to a fluid connector of a fluid distribution system to draw the medicinal fluid from one or more containers. The ports of the medicinal fluid storage device may include one or more spike assemblies, each spike assembly including a hollow spike and a spike sheath covering the spike. Once the covers are removed and the spike assemblies are exposed, the step of connecting the containers to the spikes may include the step of pushing the containers onto the spikes, causing the spikes to puncture the spike sheath and container, thereby enabling fluid communication between the spikes and the internal volume of the containers. In some embodiments, the spike sheaths may form a seal against the spikes, facilitating the transfer of medicinal fluid from the connected containers to the spikes rather than allowing the fluid to leak out of the containers outside the fluid distribution system. Once the containers are connected, the medicinal fluid from the containers can flow through spikes and connected tubing to a fluid connector, which can be used to connect the fluid distribution system to an infusion pump, syringe, or other device for administration into the patient. If more than one container is connected to the fluid distribution system, the total volume of fluid in each container may be combined and delivered as a single volume at the fluid connector. In some embodiments, multiple fluid distribution systems may be used in a medicinal storage device to deliver different medicinal fluids or to provide mixtures of different medicinal fluids.

[0069] In some embodiments, the medicinal storage device may be used to administer two or more medicinal fluids in sequence. For example, conditions may be improved such that the first fluid is administered first, and the second fluid is delivered to or processed by the patient. In some embodiments, the medicinal storage device may be used in conjunction with one or more container units that hold two or more containers together, each container holding a different medicinal fluid. An embodiment of a dual medical container unit that may be used in conjunction with the medicinal storage device is incorporated herein by reference to the “PACKAGING” filed with the United States Patent and Trademark Office on April 26, 2012. This is described in U.S. Patent No. 8,684,433, titled “FOR MULTIPLE MEDICAL CONTAINERS”. In the event that this Specification and any document incorporated by reference contain conflicting and / or contradictory disclosures, this Specification shall prevail. In the event that two or more documents incorporated by reference contain conflicting and / or contradictory disclosures to each other, the document with the later effective date shall prevail.

[0070] The inventors also recognize the advantages of a storage device that may be attachable to allow patient mobility during the fluid administration process. The attachable storage device may be attached to clothing or otherwise fixed to the patient, so that the patient is not limited to a specific location, place, or area. The attachable storage device may also include a lid configured to fix one or more attached containers to the storage device so that patient movement does not interfere with the fluid administration process. Such an arrangement can greatly reduce the burden of performing infusion or other administration processes for the patient by providing mobility without impairing the administration process.

[0071] In some embodiments, the attachable storage device includes a housing having a clip. The housing may include one or more ports formed within the housing, configured to receive one or more containers of medicinal fluid to be administered during the infusion process. The housing, ports, and clip may be arranged so that the housing and the containers to which the medicinal fluid is to be attached can be suspended from the patient. In some embodiments, the clip may be configured as a belt clip, configured to releasably attach the housing to a belt worn by the patient. In other embodiments, the clip may be configured as a harness, strap, or other preferred configuration for securing the housing and the one or more containers to which the fluid is to be attached to the patient. In some embodiments, the housing may include a lid, which is movable between a closed position in which one or more ports are sealed and an open position in which one or more ports are accessible. According to this embodiment, the lid may be closed once one or more containers are placed in one or more ports so that the containers are securely fixed inside the ports. Such an arrangement can prevent bumps, collisions, or other dynamic movements common during daily activities from dislodging one or more containers or otherwise interrupting the administration process.

[0072] The inventors also recognize the advantages of modular storage devices, which allow multiple storage devices to be coupled together to increase the total volume of fluid stored. In some cases, manufacturing, regulatory, or other constraints may limit the size of the containers that may be used with the storage devices. Therefore, in some embodiments, storage devices may be connectable to other storage devices to increase the total volume of fluid and / or the total number of containers available for the dosing process.

[0073] In some embodiments, the modular storage device includes a fluid inlet connector and a fluid outlet connector. The fluid inlet and outlet connectors are interconnectable, and multiple modular storage devices may be fluidly connected to each other. In some embodiments, the fluid inlet and outlet connectors may be connected to tubing. In these embodiments, the tubing may provide a degree of freedom for the movement of the connected storage devices. Such an arrangement may be beneficial in installable applications where multiple smaller storage devices may be easier to install than a single bulky storage device. In other embodiments, the fluid inlet and outlet connectors may be directly interconnectable. According to this embodiment, the number of fluidly and physically connected and independently operable structures can be reduced, which can simplify the movement and / or installation of the connected storage devices.

[0074] The inventors also recognize the advantage of an infusion set that can be airtight so that the infusion set can be used in succession with multiple storage devices. In some cases, it may be desirable to use the same infusion set to deliver the medicinal fluid to the patient while disconnecting from a first storage device and connecting to a second storage device to complete the infusion process. For example, the volume of fluid that can be delivered from a single storage device may be insufficient for certain dosages. Therefore, in such cases, it may be desirable to safely connect to another storage device if an additional volume of fluid is prescribed. The infusion set may also include a breathing valve (i.e., a deaeration valve, air release valve, etc.) configured to prevent air bubbles that may form during transitions between storage devices from being administered to the patient.

[0075] In some embodiments, the infusion set includes tubing having a breathing valve and a needle set having at least one needle for delivering the medicinal fluid to the patient. The infusion set may include an inlet connector that allows the infusion set to be coupled to the storage device either directly (e.g., to the fluid outlet connector of the storage device) or indirectly (e.g., via an infusion pump, regulator, or other device). Once connected to the storage device, a deaeration valve may allow air to flow out of the tubing and allow the medicinal fluid from the storage device to replace the air. Thus, the air will be removed from the tubing of the infusion set before administration to the patient. Any additional bubbles that form may also be removed from the tubing by the breathing valve.

[0076] According to the exemplary embodiments described herein, the storage device and infusion set may be used in conjunction with any number of medicinal or nutritional fluids to be delivered to the body (e.g., subcutaneously). In some embodiments, the storage device and infusion set may be configured to store and deliver immunoglobulin infusion 10% (human), immunoglobulin subcutaneous (human) 20% (e.g., CUVITRU), recombinant human hyaluronidase (e.g., HYQVIA), and / or other blood products. Although not intended to be constrained by theory, the storage device in the exemplary embodiments herein may be configured to deliver medicinal fluids having a viscosity of 10–30 cP. Naturally, the storage device, infusion set, and associated accessories may be employed with any desired medicinal fluid, and this disclosure is not limited thereto.

[0077] While specific embodiments of the storage device will be described herein, other alternative embodiments of all components relating to the storage device are interchangeable to suit different applications. The term “storage device” as used herein refers to a device for accessing medicinal fluids from one or more medical containers for administering medicinal fluids to a patient. Thus, storage devices used for administering medicinal fluids from a single container will also be considered, along with several medical containers.

[0078] Figure 1 illustrates one embodiment of a medicinal fluid storage device 10. The medicinal fluid storage device includes a housing 12, a first fluid distribution system 100, a second fluid distribution system 150, and four covers 300A, 300B, 300C, and 300D that cover ports for receiving containers of medicinal fluids, respectively. In the embodiment depicted in Figure 1, the medicinal fluid storage device is configured to supply two medicinal fluids, which can be stored from up to four containers per fluid. The first medicinal fluid may be packaged together with the second medicinal fluid so that each port can receive both medicinal fluids simultaneously. According to this embodiment, the medicinal fluids may be supplied to the first fluid interface 102 and the second fluid interface 152 independently, without being mixed, and delivered sequentially to the patient. The first and second medicinal fluids may be transported to the first and second fluid interfaces by first tubing 110 and second tubing 160, respectively. As shown in Figure 1, the first and second fluid interfaces may be removably connected to the interface holder 14 for storage and transport.

[0079] In some cases, it may be desirable to maintain the cleanliness of the medicinal fluid storage device using a predetermined manufacturing and shipping orientation. According to the embodiment shown in Figure 1, the medicinal fluid storage device 10 may retain important components such that they interface with the medicinal fluid to be covered, or otherwise be protected from the external environment. For example, covers 300A, 300B, 300C, and 300D may keep at least one spike assembly located therein isolated from external contaminants and accidental damage that the medicinal fluid storage device may encounter during shipping and handling prior to use. The covers may also prevent operators from coming into contact with the spikes when handling the medicinal fluid storage device prior to use, during and / or after use. Similarly, interface holders 14 may be oriented to protect any exposed ends of the first and second fluid interfaces 102 and 152 of the first and second fluid distribution systems 100 and 150. Naturally, but not limited to, any suitable component, including a plastic sheath or other sterile packaging, may be used to protect the sterility of the medicinal storage device prior to its first use.

[0080] Figure 2 shows the medicinal fluid storage device 10 of Figure 1 with the covers 300A, 300B, 300C, and 300D removed. With the covers removed, the ports 24 of the medicinal fluid storage device are exposed. Each port includes a recess 16 configured to receive a container of medicinal fluid for storage and / or administration to a patient. As shown in Figure 2, each port includes two spike assemblies 200. In each port, one spike assembly is connected to a first fluid distribution system 100, and one spike assembly is fluidly connected to a second fluid distribution system 150. Thus, each port may accommodate multiple containers of separate medicinal fluids for storage and administration. In the embodiment shown in Figure 2, once a medicinal fluid container is inserted into the port, the container may be punctured by one of the spike assemblies 200, allowing the container to fluidly connect to one of the fluid distribution systems 100, 150.

[0081] As shown in Figure 2, each port 24 may include components configured to align the inserted container, promote sterility, or otherwise simplify the drug administration process. For example, a port may include a recess 16 formed within the housing 12 of the drug storage device, which allows the drug fluid container to be guided by the port as the container is pushed onto the spike assembly 200 by a patient or healthcare worker. That is, a drug fluid container with a circumferential shape complementary to that of the port may be automatically aligned and guided as the container is pressed onto the spike assembly. The port may also include a guide projection 20 and a guide slot 22 configured to provide an additional guiding and aligning surface for the insertion of the drug fluid container. In some embodiments, two drug fluid containers may be physically coupled by the housing to form a single container unit. Thus, the guide projection and guide slot can contact portions of the container unit housing to ensure that the individual containers placed therein are guided and aligned with the spike assembly 200. In the embodiment shown in Figure 2, the port includes at least one latch receptacle 18 configured to removably connect a cover (covers 300A, 300B, 300C, and 300D shown in Figure 1) to a medicinal storage device. The latch receptacle 18 may also be used to removably or permanently bind any receiving container or container unit into the port to prevent removal. Thus, in some embodiments, the latch receptacle of the medicinal storage device may be configured to removably bind to an associated port cover and permanently bind to an associated container. In some embodiments, the latch receptacle may be configured to removably bind to both the port cover and the container. The port may include any preferred matching or locking features, and the disclosure is not limited thereto.

[0082] In some embodiments, the port may include any suitable fluid coupler that can be used to connect a container of medicinal fluid to the fluid distribution system of the medicinal storage device. For example, the port may include a spike or a quick-connect coupler. In some embodiments, the port may also include recesses and / or protrusions formed within the housing of the medicinal storage device. The recesses and / or protrusions may be used to facilitate the alignment and connection of the container to the port. In other embodiments, the port may be coplanar with the housing of the medicinal storage device. The port may have any other suitable arrangement for fluidly connecting the container to the fluid distribution system of the medicinal storage device, and the disclosure is not limited thereto.

[0083] In some cases, it may be desirable to maintain the sterility of the medicinal fluid storage device by preventing subsequent use of the storage device. Therefore, in some embodiments, the medicinal fluid storage device may be configured for single use as a disposable device. That is, the medicinal fluid storage device may be configured to prevent or inhibit reuse of the medicinal fluid storage device. For example, as shown in Figure 2, the latch receptacle 18 of the medicinal fluid storage device 10 may be configured to substantially prevent the removal of the container attached to the port 24. Thus, it may be impossible for the operator (e.g., patient or healthcare worker) to replace the container of medicinal fluid and initiate a second administration process. It should be understood that any other suitable components, including mechanical locks and self-closing valves, may be used to prevent multiple uses of the storage device.

[0084] Figure 3 is a perspective view of one embodiment of the first fluid distribution system 100. The first fluid distribution system includes a first fluid connector (not shown) of a fluid interface 102, tubing 110, an air filter 112, and four spike assemblies 200. According to the embodiment shown in Figure 3, the first fluid connector may be configured to connect to any suitable patient device, such as a syringe or infusion pump, to draw fluid from the second fluid distribution system. In some embodiments, the fluid connector may include a Luer-operated valve, a single shut-off valve, a double shut-off valve, a dry-break valve, a bayonet-mounted coupler, or any other suitable valve that can prevent fluid from flowing out of the first fluid connector prior to connecting to the patient device. In some embodiments, the air filter 112 is configured as a hydrophobic unidirectional filter that allows filtered air to pass into the first fluid distribution system while substantially preventing the medicinal fluid from flowing out. Therefore, the air filter can allow the medicinal fluid contained in the container to be discharged toward the fluid interface by gravity without forming a negative pressure difference inside the container. The air filter can also enable passive discharge of the medicinal fluid without the need for a pump or other energy-driven fluid induction device. As described above, each spike assembly is configured to create a fluid communication between the container of medicinal fluid and the fluid distribution system. The tubing 110 interconnects each of its components in series, with the air filter located on one end of the tubing, the fluid interface located on the opposite end, and the spike assembly arranged between them. Naturally, any preferred order of the fluid components of the fluid distribution line may be adopted, and the disclosure is not limited thereto. For example, one or more air filters and / or fluid interfaces 102 may be located between any of the spike assemblies 200.

[0085] In some embodiments, the fluid distribution system may be configured to store and / or mix medicinal fluids. In the embodiment shown in Figure 3, the first fluid distribution system 100 may be used to connect up to four separate containers of medicinal fluid. Each spike assembly 200 is configured to flow into the next spike assembly, so connecting multiple containers effectively stores (i.e., combines) the medicinal fluid for delivery to any suitable patient device (e.g., syringe, infusion pump, etc.) via the fluid interface 102. In some embodiments, the spike assemblies may be configured to receive different medicinal fluids, which are mixed throughout the tubing 110. In some embodiments, the number of spike assemblies, fluid interfaces, and air filters may be selected to store and / or mix a predetermined volume of fluid. Furthermore, the number of spike assemblies, fluid interfaces, air filters, and tubing can modify the flow rate of the medicinal fluid or mixed drug supplied to the fluid interface. Naturally, the medicinal distribution system may be configured to store and / or combine any number of medicinal fluids from any number of containers, and this disclosure is not limited thereto. In some embodiments, the fluid distribution system may include a mixing chamber or other mixing feature configured to further mix the medicinal fluid.

[0086] Figure 4 is a perspective view of one embodiment of the second fluid distribution system 150. Similar to the first fluid distribution system in Figure 3, the second fluid distribution system includes a second fluid connector 170 of the fluid interface 152, a second air filter 162, and four spike assemblies 200. According to the embodiment shown in Figure 4, the fluid connector 170 includes a male adapter configured to be coupled to an injection pump and positioned at the end of the fluid connector facing the tubing. As discussed above, in some embodiments, the fluid connector 170 may include a Luer-operated valve or any other suitable valve that can prevent fluid flow prior to connection with the injection pump. The second air filter 162 is configured to allow air to enter the fluid distribution system as the medicinal fluid is drawn out of the fluid interface, replacing the lost volume of fluid with filtered air. The spike assembly 200 may be configured to connect individually to a medicinal fluid container so that the total volume of medicinal fluid can be stored and supplied directly to the fluid interface 152, rather than directly procuring the medicinal fluid from the container until the total dose volume is reached. That is, after the container is connected to the fluid distribution system, the total dose volume of fluid may be immediately delivered to the patient via the fluid interface. The second fluid interface may have any number of preferred modifications to modify aspects of medicinal fluid delivery, including, but not limited to, changes in the number of spike assemblies or air filters, changes in tubing sizes, changes in fluid interface couplers, and additions of mixed components.

[0087] In some cases, when multiple medicinal fluids are administered to a patient sequentially, there exists a predetermined ratio of volumes between the medicinal fluids for a given dosage. Therefore, the medicinal fluids may be packaged together (e.g., in a container unit) so that they can be administered in the appropriate ratio. In the case of sequential fluid administration, the medicinal fluid storage device may include both a first fluid distribution system and a second distribution system, each corresponding to a first and second medicinal fluid. In some embodiments, the second fluid distribution system 150 may include an equal number of components (e.g., spike assemblies) contained within the first fluid distribution system (see Figure 3). Such an arrangement may be beneficial when the medicinal fluids are packaged in a predetermined ratio in an equal number of containers. In other embodiments, the first and second fluid distribution systems may have different numbers of components corresponding to a typical number of containers used for the dosage of the separate medicinal fluids. Naturally, the first and second fluid distribution systems may have any number of suitable components for storing and / or mixing medicinal fluids from multiple containers, and the disclosure is not limited thereto.

[0088] Figure 5 illustrates one embodiment of a combination of the first fluid distribution system 100 of Figure 3 and the second fluid distribution system 150 of Figure 4, configured for use in the medicinal fluid storage device of Figure 1. As shown in Figure 5, the first and second fluid distribution systems do not have fluid communication with each other. Therefore, the combination shown in Figure 5 is suitable for separate administration of medicinal fluids to patients via the first fluid interface 102 and the second fluid interface 152. The first and second fluid interfaces may be arranged such that the spike assembly 200 at corresponding positions along the distribution system is located within the same port of the medicinal fluid storage device (see Figure 2). The combination of fluid distribution systems may be at least partially contained within a housing to protect and support the distribution system, as shown in Figure 2.

[0089] Figure 6 depicts an exploded view of the first fluid distribution system 100 of Figure 3. The fluid distribution system includes a female fluid connector 120, which includes a Luer-operated valve, located within it and configured to connect to a syringe, so that the contents of the first fluid distribution system can be drawn out by a syringe. The female fluid connector may be located within a housing for ease of handling by a patient or healthcare worker (see, for example, Figure 3). In the embodiment of Figure 6, the air filter 112 is coupled to the tubing 110 by a tubing coupler 114.

[0090] As shown in Figure 6, each spike assembly 200 includes a spike 202 and a spike sheath 220. The spike includes an internal channel configured to puncture a container of medicinal fluid, fluidly connecting the container to the first distribution system. The internal channel of the spike 202 may be a double-lumen channel (i.e., two separate channels), with either side connected to the tubing 110. Thus, as the fluid flows from the air filter toward the fluid interface 102, the fluid will flow upward along one side of the spike 202 and downward along the other side. If air is placed within the fluid distribution system 100, the air will replace the fluid volume, flowing upward along one side of the spike and downward along the opposite side toward the fluid interface. The spike sheath 220 is configured to create a seal around the spike so that the fluid cannot escape from the fluid distribution system. In embodiments where the spike includes a double-lumen internal channel, the spike sheath may be fluidly connected to both lumens, thereby allowing the fluid to flow toward the fluid interface. The spike sheath may be configured to break as a container of medicinal fluid is inserted onto the spike and thereby punctured, so that the medicinal fluid can be fluidly communicated with the fluid distribution system without compromising the integrity of the fluid distribution system.

[0091] Figure 7 depicts an exploded view of the second fluid distribution system 150 of Figure 4. As described above, the second fluid distribution system includes a fluid interface 152 (housing not shown in the figure), an air filter 162, a spike assembly 200, and tubing 160. As shown in Figure 7, the fluid interface includes a male fluid connector 170. The male fluid connector includes a Luer-operated valve and provides access to an infusion pump operated by the patient or healthcare worker. That is, the male fluid connector may be used to draw fluid to be stored and / or mixed from the second fluid distribution system and infused into the patient during medicinal fluid administration. The male fluid connector may be located inside a housing for ease of handling (see, for example, Figure 4). The air filter 162 is connected to the tubing 160 via a tubing coupler 164. Similar to the first fluid distribution system in Figure 6, the spike assembly 200 includes a spike 202 and a spike sheath 220, the spike may include a double-lumen internal channel to which is fluidly coupled by the spike sheath.

[0092] Figure 8A depicts an exploded view of one embodiment of a spike assembly 200, including a spike 202 and a spike sheath 220. As shown in Figure 8A, the spike 202 includes an inlet 204A, an outlet 204B, a base 206, a first body portion 210, and a second body portion 212. Together, the first and second body portions form the shaft of the spike. A double-lumen internal channel extends through the shaft of the spike and terminates at inlet openings 216A and outlet openings 216B, which are fluidly connected to the inlet 204A and outlet 204B, respectively. In some embodiments, as shown in Figure 8A, the inlet opening 216A may be positioned higher and vertically than the outlet opening 216B, which may facilitate the introduction of air into any container volume fluidly connected to the spike as the medicinal fluid flows out through the outlet opening. The spike tip 214 is positioned on the first body portion and is configured to puncture the spike sheath 204 and the container to which the spike is pushed upward.

[0093] As shown in Figure 8A, the spike sheath 220 includes a sheath shaft 222, a sheath base 224, and a sheath tip 226. The sheath base 224 supports the sheath shaft 222 and is configured to fit into a recess 208 formed within the base 206 of the spike 202. The sheath shaft 222 defines an internal volume and is configured to fit around the spike shaft formed by a first body portion 210 and a second body portion 212. According to the embodiment shown in Figure 8A, when the spike is received by the spike sheath, the shaft and base create a seal around the second body portion 212. In particular, a seal ring (see, for example, Figure 10) may be molded on the inner diameter of the sheath shaft 222, configured to create a seal with the second body portion 212 of the spike 202. The second body portion may have a circular cross-section, which facilitates the application of a uniform sealing force across the entire circumference of the internal seal ring, preventing fluid leakage. In some embodiments, multiple seal rings (e.g., two or more seal rings) may be used to provide redundancy in the seal between the spike sheath and the spike. In other embodiments, the spike sheath may form a fluid seal with the first body portion, base, or any other suitable component of the spike 202. The sheath tip 226 is fluidly connected to the inlet opening 216A and the outlet opening 216B so that fluid can flow from the inlet to the outlet when the container is not inserted onto the spike assembly 200.

[0094] The inventors recognize that in some cases it may be desirable to reduce the number of components handled by the patient or healthcare worker during the drug fluid administration process. Additional touch and handling of sterile components may impair their sterility or otherwise adversely affect the patient's treatment. Therefore, in some embodiments, the spike sheath may be configured to be destroyed by a container inserted onto the spike assembly 200 so that the patient or healthcare worker does not need to handle any component of the spike assembly. In some embodiments, the spike sheath 220 may be formed from a material that is puncturable by the spike tip 214 and is also compressible. For example, the spike sheath may be formed from a thin plastic that can provide a fluid seal for the spike but is easily broken and compressible. According to this embodiment, as the container is pressed onto the spike assembly, the container may cause the sheath shaft 222 and sheath tip 226 to be pushed toward the spike base 206. The sheath shaft 222 may abut against a recess 208 formed within the spike base, resisting this movement and resulting in compression of the sheath shaft 222 toward the base (e.g., folding / curling, in some cases folding / curling in an accordion-like manner). As the sheath tip comes into contact with the spike tip 214, the tip may be punctured and broken so that it does not resist further compression of the sheath shaft toward the base. During this process, the sheath base and sheath shaft may maintain a fluid seal around the second body portion 212 of the spike so that no fluid is lost when the spike creates fluid communication with the container of medicinal fluid (e.g., by puncturing the seal or stopper of the container). In some embodiments, the inserted container may form a fluid seal around the spike 202 instead of the sheath as the sheath is broken to prevent fluid loss.

[0095] Figure 8B depicts the fully assembled spike 202 and spike sheath 220 of Figure 8A, where the sheath is installed across and receives the first and second body portions (see Figure 8A). As clearly shown in Figure 8B, the sheath base 224 is received in a recess 208 formed within the spike base 206. Thus, the sheath is fixed to the spike, and the sheath base can resist lateral or longitudinal movement of the sheath (i.e., in the direction toward the base). The sheath base can resist forces applied to the sheath tip 226 and / or sheath shaft 222 such that the sheath tip and / or sheath shaft are compressed downward toward the base. In some embodiments, as the sheath tip and sheath shaft round toward the base, the sheath base may maintain a fluid seal around the spike so that no medicinal fluid is lost during the process.

[0096] Figure 9A shows a schematic cross-sectional view of another embodiment of the spike 202 and spike sheath 220. As described above, the spike includes an inlet 204A, which is fluidly connected to an inlet opening 216A, and an outlet 204B, which is fluidly connected to an outlet opening 216B. The double-lumen internal channel formed by the inlet and outlet extends to the length of the spike shaft, which is formed by the first body portion 210 and the second body portion 212. The inlet and outlet are separate from each other and terminate at the inlet and outlet openings, which are located adjacent to the spike tip 214. The first and second body portions extend outward from the base 206, which support the spike and form at least a portion of the inlet and outlet.

[0097] As shown in Figure 9A, the spike sheath 220 fits over the spike 202 such that the first body portion 210, the second body portion 212, and the spike tip 214 are substantially enclosed by the spike sheath. In some embodiments, the spike sheath acts as a protective barrier for the spike, which may be sterile for use when opening a container of medicinal fluid. Thus, the sheath can maintain the sterility of the spike until the moment it is used to open the container. In the embodiment of Figure 9A, the spike sheath is configured to create a seal around the second body portion of the spike such that any fluid, in its uncompressed position and exiting through the inlet opening 216A or the outlet opening 216B, cannot escape from the spike sheath. Thus, the spike sheath fluidly connects the inlet opening to the outlet opening and acts as a conduit for the fluid to pass between the two. For example, fluid flowing into inlet 204A and out of inlet opening can be transported by the spike sheath into outlet opening and flow out of outlet 204B.

[0098] In some embodiments of a medicinal fluid storage device, where multiple spikes may be employed, the spike sheath may provide selectivity in the number of medicinal fluid containers used in conjunction with the medicinal fluid storage device. For example, in a medicinal fluid storage device with four spikes arranged along a fluid distribution system, the medicinal fluid container may be inserted onto one spike, and the internal volume of the container may be fluidly connected to the fluid distribution system. In this embodiment, the fluid may be transmitted from the container through the entire fluid distribution system, including through the three remaining spikes. The spike sheaths on each of the three remaining spikes allow the spikes to function as normal conduits, and the fluid is not obstructed if some of the spikes are not used during the administration process. In some embodiments, the spike sheath may simplify the fluid distribution system by eliminating the need for complex valves or other devices that can regulate fluid flow. However, in other embodiments, the spikes and / or fluid distribution system may also include check valves, adjustable valves, or any other suitable devices for regulating fluid flow.

[0099] According to the embodiment shown in Figure 9A, the spike sheath 220 includes a sheath shaft 222, a sheath base 224, and a sheath tip 226. The sheath base may support the sheath shaft 222, extending from the base and forming an internal volume configured to receive the spike 202. The sheath base and sheath shaft create a fluid seal around the spike shaft, which is formed by the first body portion 210 and the second body portion 212. The sheath tip serves to cap the internal volume formed by the sheath shaft so that, when the sheath is in an uncompressible position, the spike sheath creates a fluidly sealed volume around the spike suitable for transporting fluid between the inlet and outlet. The sheath shaft and sheath tip may be formed from a thin material that is compressible longitudinally toward the spike base 206. The sheath base 224 may serve to resist longitudinal forces such that the force applied to the sheath tip 226 compresses the sheath shaft and / or the sheath tip toward the base. The sheath tip may be configured to be punctured by the spike tip 214 when the spike sheath is compressed toward the spike base.

[0100] In some cases, the spike 202 and / or the spike sheath 220 may provide frictional resistance when the spike is used to puncture a container. Therefore, in some embodiments, the spike 202 may include a lubricant disposed on the spike tip 214, the first body portion 210, and / or the second body portion 212, configured to reduce frictional resistance. According to the embodiment shown in Figure 9A, the lubricant may be disposed directly on the spike and covered by the spike sheath. Naturally, the lubricant may be disposed outside the spike sheath or on the spike or any other part of the spike sheath, and the disclosure is not limited thereto. The lubricant may be any suitable lubricant for reducing frictional resistance between the spike, spike sheath, and / or container when the spike is used to puncture the container, but is not limited to, silicone lubricants (e.g., DOW CORNING 360), perfluoropolyether (PFPE) lubricants (e.g., NYEMED 7471), synthetic hydrocarbon lubricants, esters, and polyglycols.

[0101] Figure 9B shows the spike 202 and spike sheath 220 of Figure 9A after the container 400 has been inserted onto the spike. The container includes a stopper 402 and an internal volume 404 in which a medicinal fluid may be placed. The stopper 402 may be made of a material that can be punctured by the spike 202 so that the inlet 204A and outlet 204B can be fluidly connected to the internal volume 404. For example, the stopper may be made of a rubber material such as polyurethane, neoprene, latex, silicone, EPDM, FKM, or any other suitable material. As the container is pressed onto the spike 202, the stopper 402 first contacts the spike sheath 220, applying force to the spike sheath longitudinally toward the spike base 206. As force is applied to the spike sheath, the sheath shaft 222 is compressed toward the spike base, and the sheath tip 226 is brought into contact with the spike tip 214. After a predetermined amount of displacement of the spike sheath, the spike tip begins to pierce the spike sheath and the stopper 402. As the container is fully pushed onto the spike so that the spike completely pierces the container, the spike sheath remains in contact with the stopper and is compressed downward toward the spike base. As shown in Figure 9B, the sheath shaft and the broken sheath tip may fold over themselves multiple times (e.g., in an accordion-like manner) to occupy less vertical space. During this compression process, the sheath base 224 resists the force applied by the container and allows the sheath shaft to compress. As shown in Figure 9B, the spike sheath is in the compressed position, and the internal volume 404 is in fluid communication with the inlet 204A and outlet 204B.

[0102] According to the embodiment shown in Figure 9B, the stopper 402 creates a fluid seal around the spike 202 once the spike punctures the stopper. As shown in Figure 9B, the sheath shaft 222 is punctured by the spike tip 214 and compressed by the stopper 402 around the first body portion 210 of the spike shaft so that the sheath no longer forms a seal against the spike shaft. The stopper 402 creates a fluid seal around the spike 202. The stopper may be made of any suitable material for creating a fluid seal against the spike, and the disclosure is not limited thereto.

[0103] In the embodiment depicted in Figure 9B, once the internal volume 404 of the container 400 is fluidly connected to the inlet opening 216A and the outlet opening 216B, the medicinal fluid contained within the internal volume can flow and fill the fluid distribution system. The inlet 204A may be connected to tubing in the direction of an air filter that filters air and allows air to enter the fluid distribution system (see, for example, Figures 6-7). The outlet 204B may be connected to tubing in the direction of a fluid interface that can be used to draw the medicinal fluid from the internal volume and administer it (see, for example, Figures 6-7). According to the embodiment in Figure 9B, the internal volume of the container may be positioned above the components of the fluid distribution system. Therefore, any fluid placed therein can be driven by gravity to fill the fluid distribution system and flow toward the fluid interface. Air may be introduced into the internal volume via the air filter and the inlet 204A and flow out of the outlet 204B, or otherwise replace the volume of fluid leaving the internal volume of the container.

[0104] Figure 10 depicts a cross-sectional view of another embodiment of the spike 202 and spike sheath 220. Similar to the embodiment in Figure 9A, the spike includes an inlet 204A, which is fluidly connected to an inlet opening 216A, and an outlet 204B, which is fluidly connected to an outlet opening 216B. The double-lumen internal channel formed by the inlet and outlet extends along the length of the spike shaft and is separate from each other, formed by the first body portion 210 and the second body portion 212. The inlet and outlet terminate at inlet and outlet openings, respectively, which are located adjacent to the spike tip 214. The first and second body portions extend outward from a base 206, supporting the spike and forming at least portions of the inlet and outlet.

[0105] As shown in Figure 10, the spike sheath 220 fits over the spike 202 such that the first body portion 210, the second body portion 212, and the spike tip 214 are substantially enclosed by the spike sheath. According to the embodiment of Figure 10, the spike sheath acts as a protective barrier for the spike, which may be sterile for use when opening a container of medicinal fluid. Thus, the sheath can maintain the sterility of the spike until the moment the spike is used to open the container. As shown in Figure 10, the spike sheath is configured to create a seal around the second body portion of the spike such that any fluid, in an uncompressed position and exiting through the inlet opening 216A or the outlet opening 216B, cannot escape from the spike sheath. Thus, the spike sheath fluidly connects the inlet opening 216A to the outlet opening 216B and acts as a conduit for the fluid to pass between the two. For example, fluid flowing into inlet 204A and out through inlet opening 216A is transported by the spike sheath into outlet opening 216B and flows out through outlet 204B.

[0106] According to the embodiment shown in Figure 10, the spike sheath 220 includes a plurality of seal rings 228 positioned inside the sheath shaft 222. The seal rings extend radially inward from the sheath shaft and engage with the second body portion 212 of the spike. The seal rings may be formed with the spike sheath or may be formed separately (e.g., as O-rings) and subsequently positioned within the spike sheath. According to the embodiment shown in Figure 10, the seal rings and the second body portion are circular so that the seal rings traverse the entire circumference of the spike and engage uniformly with the spike. That is, the circular shape promotes uniform tension throughout the entire circumference of the seal rings, creating a uniformly pressurized seal. Although not desired to be constrained by theory, a seal around an elliptical second body portion may create variations in sealing pressure along the circumference of the spike, which may result in a fluid seal that is hardly stuck. According to the embodiment shown in Figure 10, the second body portion of the spike includes a stepped portion 218 in which a seal ring can seat, facilitate the seal, and secure the spike sheath to the spike. Naturally, the second body portion may have any preferred shape, and the disclosure is not limited thereto. According to the embodiment shown in Figure 10, the spike sheath includes two seal rings. Although not desired to be constrained by theory, a single seal ring may be preferred to prevent fluid from escaping from the spike sheath. If the single seal ring is damaged (e.g., by manufacturing, rough handling, etc.), a second seal ring may maintain the fluid seal between the spike and the spike sheath. Naturally, any number of preferred seal rings may be employed, and the disclosure is not limited thereto.

[0107] Figure 11 schematically shows yet another embodiment of the spike 202, comprising a first body portion 210 and a second body portion 212, which are molded differently. In some cases, the differently sized and / or molded body portions of the spike may affect the fluid sealing performance between the spike and the spike sheath and / or the container stopper. That is, the spike sheath and / or the container stopper may have a shape complementary to at least one of the first and second body portions so that a proper fluid seal can be created around the spike and substantially prevented from the fluid escaping around the spike. According to the embodiment shown in Figure 11, the first body portion 210 has an elliptical cross-section having a major axis diameter greater than the diameter of the circular cross-section of the second body portion 212. That is, the major axis of the first body portion 210 has a diameter greater than the major axis of the second body portion 212. The first body portion 210 abruptly transitions to the radius of the second body portion, creating a stepped portion 218. As shown in Figure 11, the stepped portion 218 may function as a return, which serves to connect the spike sheath or container stopper. Alternatively, or in addition, the stepped portion 218 may function as a seat for the sealing ring of the spike sheath. In some embodiments, such an arrangement may provide an additional radial space around the second body portion in which the sheath shaft can be compressed, which may reduce the forces used to break and compress the sheath.

[0108] In some embodiments, the first and second body portions may constitute any preferred part of the spike. For example, the first body portion may form the majority of the spike shaft, while the second body portion is a small projection positioned on the first body portion. In another embodiment, the first and second body portions may transition seamlessly between each other, so that the first and second body portions are a single component. In some embodiments, the first and second body portions may have different shapes and / or dimensions. In other embodiments, the first and second body portions may have the same shape and / or dimensions. Thus, the first and second body portions may take any preferred form and may form any two regions of the spike shaft.

[0109] Figure 12 schematic of yet another embodiment of the spike 202, including a first body portion 210 having different dimensions from a second body portion 212. Similar to the embodiment in Figure 11, the first body portion has an elliptical cross-section. However, in the embodiment shown in Figure 11, the width of the first body portion shown corresponds to the minor axis of the elliptical cross-section. In addition, the second body portion 212 has a circular cross-section. In this embodiment, the major axis of the second body portion is radially larger (i.e., has a larger diameter) than the minor axis of the first body portion 210. The first body portion abruptly transitions into the second body portion, forming a stepped portion 218. Such an arrangement may facilitate a seal with the spike sheath and / or the container stopper. For example, a stopper pressed onto the spike 202 may abut against the stepped portion 218, and any imperfections in the stopper created by the first body portion may be sealed by the second body portion. In another embodiment, a spike sheath positioned around the spike may, when compressed, expand around the second body portion, increasing contact and improving the seal provided by the spike sheath. In some embodiments, the stepped portion 218 may be inclined to provide a less abrupt transition between the first and second body portions.

[0110] Figure 13 schematic of yet another embodiment of the spike 202, including a first body portion 210 having different dimensions from a second body portion 212. As shown in Figure 13, the first body portion has an elliptical cross-sectional shape, with its major axis corresponding to the indicated width, while the second body portion has a circular cross-sectional shape. As shown in Figure 13, the major axis of the first body portion is radially larger (i.e., has a larger diameter) than the major axis of the second body portion. The first body portion transitions seamlessly into the second body portion so that no steps or other discontinuities are formed within the spike shaft. Such an arrangement may facilitate consistent insertion of the container onto the spike, as discontinuities are not captured or, otherwise, cannot be significantly resisted by the force applied to the container to insert it onto the spike. The first and second body portions, sized differently, may provide a seal for the container stopper or spike sheath, even in the case of abrupt transitions or lack of discontinuities.

[0111] Figure 14 shows one embodiment of a transverse cross-section of the first body portion 210 of the spike 202. The first body portion 210 includes an inlet opening 216A and an outlet opening 216B formed therein. As shown in Figure 14, the first body portion has an elongated cylindrical shape with an elliptical transverse cross-section. Although not desired to be constrained by theory, the elongated cylindrical shape can reduce the total surface area of ​​the spike 202 without compromising the inlet or outlet opening, which can reduce the force required to puncture a container and / or spike sheath with the spike. In the embodiment of Figure 14, the inlet and outlet openings may be sized to form sides of the first body portion such that a small amount of surplus area is occupied by the first body portion. As shown in Figure 14, the inlet and outlet openings form part of the long side of the first body portion of the elongated cylinder.

[0112] Figure 15 shows another embodiment of the lateral cross-section of the first body portion 210 of the spike 202. Similar to the embodiment in Figure 14, the first body portion includes an inlet opening 216A and an outlet opening 216B. The first body portion has an elongated cylindrical shape with an elliptical lateral cross-section. Compared to the embodiment in Figure 14, the inlet and outlet openings are oriented to form part of the shorter side of the elongated cylinder. Such an arrangement may provide additional structural support for the spike tip, which is aligned with the center of the first body portion.

[0113] Figure 16 shows yet another embodiment of the lateral cross-section of the first body portion 210 of the spike 202. Similar to the embodiments in Figures 14-15, the first body portion includes an inlet opening 216A and an outlet opening 216B. The first body portion has an elongated cylindrical shape with an elliptical lateral cross-section. Compared to the embodiments in Figures 14-15, the inlet opening and the outlet opening each have a "D" shape, and the inlet opening and the outlet opening face each other (i.e., the flat portions of the "D" face each other). Such an arrangement can result in additional structural support for the spike tip, which is aligned with the center of the first body portion. In addition, the D-shaped lumen allows for a consistent wall thickness to be maintained throughout the first body portion while maintaining a suitable cross-sectional area of ​​the lumen. Naturally, the first body portion 210, the inlet opening 216A, and the outlet opening 216B may employ any preferred structure and arrangement, and the present disclosure is not so limited.

[0114] Figure 17 shows one embodiment of a lateral cross-section of the second body portion 212 of the spike 202. The second body portion has a cylindrical shape with a circular lateral cross-section and includes an inlet opening 216A and an outlet opening 216B located therein. Compared with the first body portion 210 shown in Figures 14-16, the second body portion 212 of the embodiment in Figure 17 has a different shape, with a larger area occupied by the second body portion. Although not desired to be constrained by theory, the shape of the second body portion may affect the quality of the fluid seal formed between the second body portion and the spike sheath and / or container stopper. In some embodiments, a circular cross-sectional shape may provide a consistent and reliable fluid seal by promoting uniform sealing pressure around the entire circumference of the second body portion. Therefore, in some embodiments, the first and second body portions may have different shapes and / or sizes to better perform different functions of the spike 202. For example, the first body portion may be formed to facilitate puncture of the spike sheath and / or container stopper, according to the embodiment shown in Figure 14, while the second body portion may be formed to facilitate a fluid seal between the spike and the spike sheath and / or container stopper, according to the embodiment shown in Figure 17. Naturally, any preferred shape for the first and second body portions may be employed, and the disclosure is not limited thereto.

[0115] Figures 18-19 show another embodiment of the lateral cross-section of the second body portion 212 of the spike 202. Similar to the embodiment shown in Figure 17, the second body portion shown in Figures 18-19 has a cylindrical shape with a circular lateral cross-section and includes an inlet opening 216A and an outlet opening 216B located therein. According to the embodiment shown in Figure 18, the inlet and outlet openings are formed within a circular shape, with a smaller area occupied by the elliptical opening in Figure 17. Therefore, the shape and / or size of the inlet or outlet opening may vary between the first and second body portions or within one of the first and second body portions. Alternatively, as shown in Figure 19, the inlet opening 216A and the outlet opening 216B each have a "D" shape, with the inlet opening "D" facing the outlet opening "D". Naturally, the inlet and outlet openings may have any preferred shape within the second body portion, and this disclosure is not limited thereto.

[0116] Figure 20A shows one embodiment of a fluid interface 102 located at the end of a fluid distribution system. The fluid interface includes a housing 104, which includes a first opening 106A and a second opening 106B. The housing 104 holds a female fluid connector 120, which protrudes outward from the first opening 106A. The female fluid connector is configured to connect to a syringe for drawing fluid from a medical storage device. The female fluid connector connects to tubing 110, which enters the housing through the second opening 106B. The housing 104 is significantly larger than the female fluid connector, making the fluid interface easier to handle and operate for patients or healthcare professionals using the fluid interface.

[0117] As shown in Figure 20A, the fluid interface may include an indicator 130. The indicator is configured to show information related to the medicinal fluid supplied to the fluid interface, instructions related to the administration process, or other useful information related to the patient or healthcare worker. In some embodiments, the indicator may be a visual indicator, a tactile indicator (e.g., a raised dot in Braille), or a combination of the two. In the embodiment of Figure 20A, the indicator is configured as text. Alternatively, or in addition, the indicator may be a distinctly different color or any other non-textual marking that conveys information to the patient or healthcare worker. Naturally, but not limited to, any preferred combination of indicators, including textual markings, non-textual markings, symbols, raised dots, and colors, may be used.

[0118] Figure 20B is an exploded view of the fluid interface 102 of Figure 20A. As shown in Figure 20B, the fluid interface includes a housing that is divided into a first part 104A and a second part 104B, and a female fluid connector 120 located at least partially inside the housing. As described above, the housing 104 includes a first opening 106A and a second opening 106B, which allow access to the internal volume defined by the housing. The first part 104A of the housing also includes at least one latch 108A, and the second part 104B of the housing includes at least one latch receptacle 108B configured to receive the latch. The latch and latch receptacle may be used to fasten the first and second halves of the housing together and to surround and fasten the female fluid connector 120.

[0119] As shown in Figure 20B, the female fluid connector 120 includes a first end 122A and a second end 122B. The first end is configured to connect another suitable fluid connector to a syringe or another patient device (e.g., an infusion pump). Prior to connection to the syringe, the female fluid connector 120 may include a Luer-operated valve or any other suitable valve that can promote sterility or prevent the flow of medicinal fluid. The first end 122A is positioned within a first opening 106A of the housing and is arranged to protrude outward from there. The second end 122B is fully enclosed within the housing and is arranged to be fitted rearward through the second opening 106B. Thus, tubing can be inserted through the second opening and the female fluid connector can be fluidly connected to a fluid distribution system. As shown in Figure 20B, the female fluid connector also includes a matching feature 124, which, when the first part 104A and the second part 104B are combined, can secure the female fluid connector to the inside of the housing and prevent significant relative movement between the housing and the female fluid connector.

[0120] Figure 21A shows another embodiment of the fluid interface 152, which is located at the end of the fluid distribution system. Similar to the embodiment in Figure 20A, the fluid interface includes a housing 154 which includes a first opening 156A and a second opening 156B. A male fluid connector 170 is located in the first opening and protrudes outward from there, and tubing 160 is located in the second opening 156B and extends from there. An indicator 180 is located on the housing to communicate information to a patient or healthcare worker using the fluid interface.

[0121] Figure 21B is an exploded view of the fluid interface 152 of Figure 21A. The housing of the fluid interface includes a first part 154A and a second part 154B, which may be coupled together by a latch 158A and a receptacle 158B. The housing defines an internal volume in which a male fluid connector 170 may be at least partially disposed. A first opening 156A and a second opening 156B provide access into the internal volume of the housing for either the male fluid connector 170 and components such as tubing 160, or patient devices such as an infusion pump.

[0122] In the embodiment shown in Figure 21B, the male fluid connector 170 is configured to connect to an infusion pump so that fluid can be automatically drawn from the fluid distribution system by the infusion pump. Prior to connection to the infusion pump, the male fluid connector may include a Luer-operated valve or any other suitable valve that can promote sterility or prevent the flow of medicinal fluid. In some embodiments, the male fluid connector may be configured to connect to other patient devices such as syringes. The male fluid connector includes a first end 172A and a second end 172B. In the embodiment shown in Figure 21B, the first end 172A is located in a first opening 156A within the housing of the fluid interface and protrudes outward from there. The second end of the male fluid connector is configured to connect to tubing to other components of the fluid distribution system. In the embodiment shown in Figure 21B, the second end is located in a second opening in the housing and is accessible to tubing from the second opening. The male fluid connector also includes a matching feature 174 that rotates and locks the male fluid connector within the housing. In some embodiments, the matching feature 174 may be configured to translate and rotate the male fluid connector relative to the housing of the fluid device. Thus, the housing and the male fluid connector can effectively function as a single component for the purpose of operation and handling by a patient or healthcare worker.

[0123] In some embodiments, the fluid interface housing may have a flared, bell-shaped end. The bell-shaped end is configured to facilitate a gripping position by the operator (e.g., patient or healthcare worker) and prevents the operator from touching the fluid connector of the fluid interface. That is, the bell-shaped end facilitates handling of the fluid interface by the fluid interface housing rather than the fluid connector during normal use, thereby maintaining the cleanliness of the fluid interface. In addition, the bell-shaped end may be configured to be received by one or more latches on the housing to which the storage device is associated. Such an arrangement may allow the fluid interface to be releasably attached to the storage device housing for convenient temporary or permanent storage before and / or after the administration process (see, for example, Figure 22B). The bell-shaped end may coincide with the first end of the fluid connector. For example, as shown in Figure 20A, the housing 104 has a flared, bell-shaped end on which the first end 122 of the fluid connector 120 is located. As shown in Figure 21A, the housing 154 has a flared, bell-shaped end on which the first end 172A of the fluid connector 170 is located.

[0124] In some embodiments, the first end of the fluid connector may be coplanar with or fitted together with a first opening in the housing of the fluid interface. Thus, the first opening may provide access to the first end of the fluid connector, while additional protection is provided to the first end by the housing. Similarly, in some embodiments, the second end of the fluid connector may be fitted together with or coplanar with a second opening in the housing, providing additional physical protection for the second end, while access is provided by the second opening. In other embodiments, at least one of the first and second ends of the fluid connector may protrude outward from the housing to provide easier access to the fluid connector. The fluid interface may have any preferred arrangement of the first and second ends of the fluid connector, including any of the aforementioned combination positions for each end of the fluid connector relative to the housing, and the disclosure is not limited thereto.

[0125] Figure 22A shows a top view of one embodiment of the medicinal storage device 10, including covers 300A, 300B, 300C, and 300D. As described above, the medicinal storage device includes ports for receiving container units. Each port is covered by a cover 300A, 300B, 300C, and 300D, which seals the port and protects the spike assembly placed within the port. Each cover may include a periphery 302, ribs 304, a handle 306, a cover indicator 308, and a latch 310. The periphery is configured to seat the cover within the port and resist further movement into the port. Thus, the periphery provides protection for the port and the spike assembly placed therein by supporting the cover across the port. The ribs provide structural rigidity for the cover and are configured to ensure that the cover is able to resist external forces and provide protection for the covered port. The handle 306 may include a textured surface that provides a solid surface from which a patient or healthcare worker can grasp and remove the cover for use of the port. The handle or any other receiving portion may also receive any projections extending outward from the port, such as matching features. The receiving portion may have a shape complementary to that of the projections extending outward from the port, so that when the cover is attached or removed, the projections can guide the cover to which they are associated. A cover indicator 308 may be used to communicate information about the administration process to the patient or healthcare worker. For example, as shown in Figure 22A, the cover indicator may indicate the preferred order in which the cover should be removed and the port used. A cover latch 310 may be used to removably secure the cover to the port. The latch may be destructible, bendable, or otherwise actuated so that the secured cover can be selectively removed by the patient or healthcare worker. In some embodiments, the latch 310 may be configured to release the cover when sufficient pulling force is applied to the handle 306.

[0126] Figure 22B is a top view of the medicinal storage device 10 of Figure 22A with covers 300A, 300B, 300C, and 300D removed. As clearly shown in Figure 22B, the ports 24 can be exposed for use when the covers are removed. Each port 24 may include at least one latch receptacle 18. The latch receptacle may receive a latch 310, which is positioned on the cover, so that the cover can be removably secured to the port. The number of latch receptacles in a port may correspond to the number of latches, which are positioned on the cover, so that the cover can be securely secured to the port. According to the embodiments shown in Figures 22A-22B, the covers 300A, 300B, 300C, and 300D have shapes corresponding to those of the ports 24. In some embodiments, the covers may be configured to be fitted into the ports and to removably secure the covers to the ports. In other words, the cover may be precisely sized to fit inside the port and be secured to the port by friction. Naturally, the cover may include any suitable fastening arrangement that allows the cover to be removably secured to the port.

[0127] In some embodiments, the cover may be formed from a thermoformed plastic material. Therefore, the cover may be thin, and portions of the cover may be flexible where they are not reinforced by the ribs 304. When a significant force is applied to the cover to selectively remove it (e.g., pull it), the cover may flex, releasing the latch 310, or otherwise loosening the cover from the slot. In some embodiments, the periphery 302 of the cover may include a pull tab (see, for example, pull tab 312 in Figure 24) that allows a patient or healthcare worker to remove the cover. According to this embodiment, if the cover is sufficiently flexible, a patient or healthcare worker may use the pull tab to peel the cover away from the port. Such an arrangement may reduce the force used to remove the cover and simplify the operation. Naturally, the cover may be formed from any preferred material, and this disclosure is not limited thereto.

[0128] Figure 23 is an exploded view of the medicinal storage device 10 and cover 300 of Figure 22A. As described above, the cover includes a periphery 302, a rib 304, a handle 306, a cover indicator 308, and a latch 310. The cover has a shape (e.g., circumferential shape) complementary to that of the port 24 formed within the housing 12 of the medicinal storage device. The periphery 302 is configured to abut against the housing 12 when the cover is removably secured to the port. As shown in Figure 23, the latch 310 is aligned with a latch receptacle 18 located on both sides of the port. Thus, when the cover is in place across the port 24, the latch 310 engages with its latch receptacle 18, removably securing the cover to the port. In the embodiment shown in Figure 23, the handle 306 may bend the latch 310 and be pulled with sufficient force to engage and disengage the latch receptacle, so that the cover can be selectively removed from the port. The handle 306 also constitutes a receiving portion that accommodates a guide projection 20 extending outward from the port 24.

[0129] As shown in Figure 23, the ribs 304 of the cover are arranged radially around each of the spike assemblies 200. The ribs provide rigidity within the area of ​​the cover near the spike assemblies 200. That is, the cover is formed to provide maximum protection and resistance to upward forces on the spike assemblies in order to better protect the spikes during handling of the medicinal storage device 10. As shown in Figure 23, the area of ​​the cover surrounded by the ribs 304 may be raised to provide additional spacing between the cover and the spike assemblies. Thus, even if the cover is displaced toward the spike assemblies, the additional spacing can prevent contact between the spikes and the cover. Of course, the ribs may be arranged at any preferred location on the cover where additional rigidity is desirable, and the disclosure is not limited thereto.

[0130] Figure 24 shows one embodiment of the medicinal storage device 10 when used in combination with multiple container units 400A, 400B, and 400C. As shown in Figure 24, the medicinal storage device stores fluid from six separate containers, with two containers in each container unit 400A, 400B, and 400C connected to three of the four ports 24. Each container unit is inserted into the ports within the medicinal storage device after the cover associated with each port is removed. As each container unit is inserted, a spike punctures each of the two containers within the container unit to store and deliver the fluid to the first fluid interface 102 and the second fluid interface 152, thereby fluidizing the containers to the two fluid distribution systems 100 and 150.

[0131] As shown in Figure 24, the number of ports used in the medicinal fluid storage device 10 can correspond to a specific dosage for administration to a patient. Therefore, during the administration process, the patient or healthcare worker may remove the cover only from the ports to be used for the desired specific dosage. That is, the cover may be left in place to maintain protection of the spike assembly when the ports should not be used for a specific dosage. In the embodiment shown in Figure 24, the cover includes a pull tab 312, which may be used to peel off and remove the cover. Thus, during the administration process, the patient or healthcare worker may peel off the cover and then connect the container unit to the ports until the desired dosage of medicinal fluid is reached. After the container unit is connected and the container is fluidly connected to the fluid distribution system, the first and second fluid interfaces 102, 152 may be connected to the patient device to supply the medicinal fluid for injection or infusion into the patient.

[0132] Figure 25 is a block diagram of one embodiment of a method for operating a medicinal fluid storage device. In block 500, a patient or healthcare worker may remove a cover to expose a port of the medicinal fluid storage device. In block 502, a patient or healthcare worker may connect a container to a port by pushing the container onto a spike. As the container is pushed onto the spike, it may be made to fluidly communicate with the fluid distribution system of the medicinal fluid storage device. Blocks 500 and 502 may be repeated as many times as necessary to reach a specific dosage of medicinal fluid. That is, with respect to the increased dosage, an additional cover may be removed and an additional container may be connected to an additional port. In block 504, a syringe may be connected to tubing to draw out the first medicinal fluid. The tubing may be part of the medicinal fluid storage device, which is in fluid communication with the container to be connected, and may include a fluid connector that can be used to connect the syringe to the tubing. In some embodiments, the patient or healthcare worker may inject the first medicinal fluid into the patient. In block 506, the patient or healthcare worker may connect an infusion pump to tubing and move the second medicinal fluid into the patient through the tubing. The infusion pump may be connected using a fluid connector via a Luer-actuated valve or any other suitable fluid coupler. In some embodiments, the infusion pump may be used to draw the first medicinal fluid instead of a syringe.

[0133] In some embodiments, the medicinal fluid storage device may supply one or more medicinal fluids. Therefore, depending on the number of fluids to be supplied by the storage device, any number of patient devices may be coupled to the various fluid outlets of the storage device. For example, infusion pumps, syringes, IV bags, and other suitable devices may all be coupled to the storage device for the final delivery of medicinal fluids to the patient. In the embodiment of Figure 25, one or more of blocks 504 and 506 may be excluded from the method if neither a syringe nor an infusion pump is suitable for delivering medicinal fluids from the storage device. In some embodiments, one of blocks 504 and 506 may be retained while the other is excluded. For example, with respect to the delivery of a single fluid, the patient or healthcare worker may simply couple an infusion pump to the storage device without coupling to a syringe at all. Any preferred combination of steps may be used to administer one or more medicinal fluids to a patient, and the present disclosure is not limited thereto.

[0134] Figure 26 is a perspective view of another embodiment of a medicinal fluid storage device 600, which is worn by the patient during the administration process and configured to allow the patient free movement. Although not desired to be constrained by theory, a device worn can affect mobility, at least in part, based on weight, weight distribution, and size. For example, a heavy, bulky object with its center of mass far from the person can be cumbersome and, when worn, can hinder mobility. Therefore, the storage device shown in Figure 26 is configured to minimize the size of the storage device and improve wearability while storing medicinal fluids from multiple containers. As shown in Figure 26, the storage device 600 includes a housing 602, which is shown transparent for clarity. The storage device also includes a first port 604A and a second port 604B, which are formed juxtaposed within the housing. As shown in Figure 26, the first and second ports are formed close together and close to the end of the housing so that the overall size of the storage device is minimized relative to the volume of the container in which it is stored. The storage device also includes a base 603, which is configured to support the ports and various other components located within the housing.

[0135] According to the embodiment shown in Figure 26, the storage device may have a size that is suitable for long-term wear by the patient without sacrificing storage and fluid delivery functionality. In some embodiments, the total volume occupied by the storage device is 800 cm³. 3 , 700cm 3 , 600cm 3 , 500cm 3 , 400cm 3 , and / or any other suitable volume may be less than or approximately equal to it. In some embodiments, the total volume of the storage device is 500-700 cm³. 3It may also be the case that, in some embodiments, the maximum longitudinal length of the storage device may be less than or equal to 15 cm, 12 cm, 10 cm, 8 cm, and / or any other suitable length. Correspondingly, in some embodiments, the maximum width of the storage device may be less than or equal to 12 cm, 11 cm, 10 cm, 8 cm, and / or any other suitable width. Similarly, in some embodiments, the maximum thickness of the storage device may be less than or equal to 10 cm, 8 cm, 6 cm, 4 cm, and / or any other suitable thickness. Such volume and main maximum dimensions may hardly interfere with mobility and may allow the storage device to be easily mounted. Naturally, sizes greater than or less than those described above may also be employed, and the disclosure is not so limited. Furthermore, the mountable storage device may have any suitable dry weight, wet weight (i.e., the medicinal fluid container to be mounted), and weight distribution, and the disclosure is not so limited.

[0136] According to the embodiment of Figure 26, the storage device includes a fluid distribution system 650, which is configured to store fluid from a container, which may be connected to a first port 604A and a second port 604B. As shown in Figure 26, the storage device includes a spike 200, positioned within the first and second ports, which is configured to puncture a container of medicinal fluid and fluidly connect to the storage device. The spike may include a spike sheath, shape, dual channel, and / or other features according to the exemplary embodiments described herein. The spike is connected via tubing 660, which forms a persistent fluid channel, one end of which terminates in an air filter 668 and the other end of which terminates in a fluid outlet connector 652. The air filter is configured to allow air into the fluid distribution system so that the fluid contained in the container to be fitted can flow freely under gravity or from pressurization while preventing the fluid from escaping. The fluid outlet connector is fixed within a fluid outlet port 606 formed within the housing 602 and is configured to receive the fluid connector so that fluid inside the fluid distribution system can be delivered to associated devices (e.g., infusion sets, infusion pumps, other drug delivery devices, etc.), associated storage devices (e.g., for storing fluid from multiple fluid storage devices), or other desired devices or components. According to the embodiment in Figure 26, the fluid outlet connector 652 includes a Luer-actuated valve 654, which prevents the flow of fluid out of the fluid distribution system until an associated device or component having a corresponding Luer-actuated valve is connected to the fluid outlet connector. The Luer-actuated valve 654 in Figure 26 is a male Luer-actuated valve configured to interface with a female Luer-actuated valve. Naturally, any suitable fluid connector may be employed, with or without a Luer-actuated valve, and the disclosure is not so limited.

[0137] According to the embodiment shown in Figure 26, the storage device may be configured to accommodate a container of medicinal fluid having a suitable volume for the prescribed dosage of the medicinal fluid. In some embodiments, ports 604A and 604B may be configured to accommodate a container having a volume greater than or approximately equal to 1.25 mL, 2.5 mL, 5 mL, 10 mL, 20 mL, 30 mL, 40 mL, 50 mL, and / or any other suitable volume. Naturally, any container with any suitable volume may be employed, and the disclosure is not limited thereto.

[0138] According to the embodiment shown in Figure 26, the storage device may include a lid (e.g., a cover) 608 configured to selectively enclose the first port 604A and the second port 604B during the administration process and to secure to any container placed therein. As shown in Figure 26, the lid is attached to the housing 602 via a hinge 610. Thus, the lid is configured to rotate about the hinge between a closed position in which the first and second ports are completely sealed and an open position in which the first and second ports are opened to receive a container of medicinal fluid. Of course, in other embodiments, the lid may be configured to interact with the housing and move between the open and closed positions in any preferred manner (e.g., fully removable, sliding, etc.), and the disclosure is not limited thereto. As shown in Figure 26, the lid includes a latch receptacle 612 configured to receive a latch 613 located on the housing. The latch is configured as a deflectable latch, which enters the latch receptacle and locks to the lid when the lid is in the closed position and the latch is in the unbiased (i.e., non-flexible) position. Conversely, the latch is configured to release the lid when it is moved to the biased (i.e., flexible) position so that the latch is removed from the latch receptacle. Naturally, but not limited to, any preferred latch arrangement may be employed, including magnetic latches and spring-loaded fasteners.

[0139] As shown in Figure 26, the reservoir device may include a clip 614 configured to allow the patient to easily attach the reservoir device. The clip is fixed to the housing 602 and configured to support the weight of the reservoir device and any container to be inserted. The clip is configured as a belt clip that can easily slide across a belt and hold the infusion pump around the patient's waist. Naturally, but not limited to, any suitable clip, strap, or harness, including carabiners, hook and loop fasteners, strap buckles, waistbands, shoulder straps, etc., may be employed to allow the patient to attach the reservoir device, and the disclosure is not so limited.

[0140] Figure 27 is an exploded view of the medicinal storage device 600 of Figure 26. As described above, the storage device includes a housing 602 and a base 603, having a first port 604A and a second port 604B. Located within the housing and supported by the base is a fluid distribution system 650, which includes a fluid outlet connector 652 having a spike 200, an air filter 668, and a Luer-operated valve 654, each located within the respective ports. The tubing of the fluid distribution system is omitted from Figure 27 for clarity. The fluid outlet connector 652 is configured to be fixed between the housing and the base in the outlet port portions 606A and 606B. The storage device also includes a lid 608, which is mounted on the housing via a hinge 610. The lid can be selectively fixed in the closed position using a latch 613 and a latch receptacle 612.

[0141] As shown in Figure 27, the storage device includes a clip 614, which allows the storage device to be releasably coupled to clothing worn by the patient. The clip includes a mounting portion 615 and a flexible portion 616. The mounting portion 615 is configured to be fixed to a clip receptacle 617 formed within the housing 602 of the storage device. Once the mounting portion 615 is received within the clip receptacle 617, or otherwise mounted thereon, the mounting portion can support the entire weight of the storage device when the clip is coupled to clothing worn by the patient. The flexible portion 616 is biased toward the outside of the housing and is configured to receive clothing such as a belt. Thus, the flexible portion may bend away from the housing so that a belt or other clothing can be positioned between the flexible portion and the housing. When released, the flexible portion may releasably trap the belt or clothing between the flexible portion and the housing. Therefore, the storage device can effectively be suspended from a belt or garment by clips. To remove the garment, the flexible portion may be bent again away from the housing, and the belt or garment may be removed. Naturally, other arrangements of clips, including substantially rigid clips, may also be considered, and any suitable clips, fasteners, latches, buckles, etc., may be employed to suspend the storage device from clothing, and the disclosure is not limited thereto.

[0142] Figure 28 is a perspective view of the medicinal fluid storage device 600 of Figure 26 when used in combination with the first container 402A and the second container 402B. According to the embodiment shown in Figure 28, the storage device stores fluid from two differently sized containers; that is, the first container 402A has a smaller volume than the second container 402B. The storage device supplies medicinal fluid from both containers to the fluid outlet connector 652 so that a larger dose can be administered than that supplied by either container alone. As shown in Figure 28, the spike 200 is positioned within the internal volume of the containers so that the internal volumes of the containers are fluidly connected.

[0143] In contrast to the embodiments described above, the first and second ports are each configured to receive a single container of fluid, as opposed to a container unit having more than one container. Thus, the first and second containers may be inserted into the first and second ports, respectively, in a sequential manner. For example, a patient may insert the first container into the first port, thereby puncturing the first container and connecting its internal volume to the fluid distribution system. The patient may then insert the second container into the second port, thereby puncturing the second container and connecting its internal volume to the fluid distribution system. Once one or both containers are connected, the fluid may be drawn out from the fluid outlet connector (e.g., through an infusion set, infusion pump, other drug delivery device, etc.).

[0144] As shown in Figure 28, when the storage device lid 608 is in the open position, the containers 402A, 402B and ports 604A, 604B are exposed and accessible from outside the housing 602. However, in the closed position, the lid is releasably fixed to a latch 613 inside the latch receptacle 612. Thus, when in the closed position, the lid will cover both the containers and ports, making them inaccessible from outside the housing. Such an arrangement can prevent unintentional removal of the containers due to patient movement, impact, or other forces.

[0145] Figure 29 is a front elevation view of various containers that may be used in conjunction with the medicinal fluid storage device of Figure 26. Although it is not desired to be constrained by theory, the storage device according to the embodiment of Figure 26 may be used in conjunction with various containers of medicinal fluids of different sizes. The containers may be sized and molded according to the size and shape of the port formed within the housing, or they may have any preferred shape that fits within the boundaries of the housing and lid of the storage device. As shown in Figure 29, the first container 402A has a first height H1 and a first diameter D1, which may correspond to the internal height of the housing and the diameter of the port of the storage device. That is, the housing of the storage device may house a container having a maximum height H1 and a maximum diameter D1. In contrast, the second container 402B has a second height H2 but maintains the first diameter D1. Thus, the diameter of the second container corresponds to the internal diameter of the port on the storage device, but the height does not correspond to the internal height of the housing. Furthermore, containers with dimensions smaller than those of the internal dimensions of the housing may also be housed within the storage device and may be held in place by features of the storage device, such as friction with spikes, latches that secure to the ring portion of the bottle, or other suitable arrangements. As shown in Figure 29, a third container 402C compatible with the storage device includes a second height H2 and a second diameter D2, both of which are smaller than those of the first container 402A. By accommodating containers of different sizes, the storage device enables the delivery of precise dosages of medicinal fluids from various standardized container sizes.

[0146] Figures 30A and 30B depict a front and rear perspective view of the medicinal fluid storage device 600 of Figure 26, respectively, with the lid 608 in the closed position. As best shown in Figures 30A and 30B, when the lid is in the closed position, the latch 613 is located within the latch receptacle 612 and is fixed to the lid. Thus, the port and any containers placed therein are fixed and protected from forces resulting from movement, collision, etc., that could interfere with the fluid connection of the containers. Therefore, the storage device provides a compact, protected, and attachable package for storing and delivering medicinal fluids from multiple containers.

[0147] Figure 31 is a front elevation view of another embodiment of a medicinal fluid storage device 700 configured to store medicinal fluids from up to three containers. Similar to the embodiment in Figure 26, the storage device includes a housing 702, a base 703, and a lid 708. The lid is secured in a closed position by a latch 713 and encloses a first container 402A, a second container 402B, and a third container 402C, which are located within ports formed in the housing. The storage device includes a fluid distribution system (not shown) which creates a persistent fluid channel between each of the containers. The fluid distribution system includes a fluid outlet connector 754 and a fluid inlet connector 756. According to the embodiment shown in Figure 31, the medicinal fluid is configured to flow from the container to the fluid outlet connector as indicated by the arrow 758. Naturally, in other embodiments, the medicinal fluid may flow in any preferred direction, including toward the fluid inlet connector, and the present disclosure is not limited thereto. The outlet may be connected to an associated device (e.g., an infusion set, infusion pump, other drug delivery device, etc.) or another storage device, supplying the medicinal fluid from each of the three containers. The inlet is configured to receive the medicinal fluid from another storage device or an associated medicinal fluid source, so that the medicinal fluid may be stored from multiple containers and / or multiple sources, as desired. The functionality of the fluid inlet connector will be discussed further below with reference to Figures 32-35.

[0148] Figure 32 depicts a front elevation view of one embodiment of a medicinal fluid storage system, which includes a first attachable storage device 600A and a second attachable storage device 600B for storing fluids from multiple containers rather than a single fluid storage device. As shown in Figure 32, each storage device is configured to accommodate two containers; the first storage device has a first container 402A and a second container 402B, while the second storage device has a third container 402C and a fourth container 402D. Each storage device includes a fluid outlet connector 652 and a fluid inlet connector 656, which allows the storage devices to be connected in sequence. That is, as shown in Figure 32, the fluid outlet connector is configured to connect to the fluid inlet connector of another storage device. In particular, the fluid outlet connector 652 of the first storage device 600A is connected to the fluid inlet connector 656 of the second storage device 600B. The fluid outlet connector 652 in Figure 32 includes a male Luer-operated valve, and the fluid inlet connector 656 includes a female Luer-operated valve. Naturally, in other embodiments, the fluid outlet and inlet connectors may employ any suitable connection or valve configuration, and the disclosure is not limited thereto.

[0149] According to the embodiment shown in Figure 32, the storage device includes a physical connector 618 configured to physically secure the first wearable storage device 600A to the second wearable storage device 600B. In some cases, it is desirable to physically connect multiple wearable storage devices together so that they can be treated as a single unit by the patient. However, it may also be desirable to allow flexibility in the combined storage unit so that the combined storage devices are not cumbersome and do not affect wearability. Therefore, as shown in Figure 32, the physical connector 618 is configured as a hinge, which allows the storage devices to rotate relative to each other about a longitudinal axis (i.e., an axis extending up and down relative to the page). Such an arrangement may allow the combined storage unit to conform to the shape of the patient's body when the combined storage devices are worn. For example, the wearable storage devices may be wrapped around the wearer's waist so that both storage devices can be easily suspended from a belt worn by the patient using belt clips. Naturally, the physical connector may be any suitable fastener that couples to the movement of the storage device in at least one direction, and the disclosure is not limited thereto.

[0150] Figure 33 is a front elevation view of another embodiment of a medicinal fluid storage system, including a first attachable storage device 600A and a second attachable storage device 600B. In some cases, it may be desirable to allow the connected storage devices to be operated independently and to allow the storage devices to be independently attached to clothing or otherwise attached. Such an arrangement may improve wearer comfort, as many small, independent devices are less cumbersome to attach or attach to clothing than a single large device. Therefore, as in the embodiment of Figure 32, the fluid outlet connector 652 of the first storage device is connected to the fluid inlet connector 656 of the second storage device, allowing for the administration of medicinal fluids from up to four containers 402A, 402B, 402C, and 402D. However, in contrast to the embodiment of Figure 32, the fluid inlet and outlet connectors are connected by a reservoir tubing 670, which allows for free relative movement of the first and second reservoir devices within a distance limit defined by the length of the tubing 670. Thus, the first attachable reservoir device may be independently attached to and fitted to the patient's clothing or body before or after the reservoir device is connected to the tubing. As shown in Figure 33, the reservoir tubing includes a tubing outlet connector 672 and a tubing inlet connector 674, which connect to the fluid outlet connector 652 and fluid inlet connector 656 of the reservoir device, respectively. The reservoir tubing may have any preferred length to allow for a desired range of independent movement and placement of the reservoir device.

[0151] According to the embodiment shown in Figures 32-33, a method for administering a medicinal fluid to a patient may include the steps of obtaining or providing a first attachable storage device 600A and an optional second attachable storage device 600B, and a number of associated containers for storing a prescribed volume of the medicinal fluid. The method may also include the steps of connecting the first container 402A to a first port formed in the first housing 602 of the first storage device 600A, puncturing the first container, and establishing fluid communication with the fluid distribution system of the first storage device. The method may further include the steps of connecting the second container 402B to a second port formed in the first housing of the first storage device 600A, puncturing the second container, and establishing fluid communication with the fluid distribution system of the first fluid storage device. If two containers are suitable for the prescribed dosage, the method may include the step of connecting the fluid outlet of the first storage device to an infusion set, infusion pump, other drug delivery device, or other associated device for delivery to the patient. If additional containers are desired, the method may include the step of connecting a third container 402C to the second attachable storage device 600B in a manner similar to that of the first and second containers. In addition, the method may include the step of connecting a fourth container 402D to the second attachable storage device so that the second attachable storage device stores fluid from both the third and fourth containers. Once the desired number of containers are connected to the second attachable storage device, the method may include the step of connecting the second attachable storage device to the first attachable storage device (for example, from the fluid outlet connector of the second attachable storage device to the fluid inlet connector of the first attachable storage device or vice versa). Alternatively, in some embodiments, the method may include the steps of delivering all available medicinal fluid from a first attachable storage device to a patient, and subsequently disconnecting the first storage device from an infusion set, infusion pump, other drug delivery device, or other associated device.In this embodiment, the method may further include the step of connecting to a second storage device once the first storage device has been disconnected, so that delivery of the fluid to the patient can be resumed. These methods may be repeated as needed to store and / or deliver a suitable volume of fluid to the patient. That is, any number of suitable storage devices with connected containers may be connected in succession to each other, or in succession to an infusion set, infusion pump, other drug delivery device, or associated device, and disconnected from there, for the delivery of medicinal fluid to the patient, and the disclosure is not limited thereto.

[0152] Figure 34 is a front elevation view of yet another embodiment of a medicinal fluid storage system, which includes a first attachable storage device 800A, a second attachable storage device 800B, and a third attachable storage device 800C, providing a modular storage system for fluid connection to any desired number of medicinal fluid containers. In particular, the medicinal fluid storage system of Figure 34 allows patients to minimize the total volume and size of the storage system and increase attachability, while still being expandable to accommodate various prescribed dosages. As shown in Figure 34, each container is configured to accommodate a single container; that is, the first storage device includes a first container 402A, the second storage device includes a second container 402B, and the third storage device includes a third container 402C. The containers are secured inside ports formed within the housing 802 of each storage device by lids 808, which are held in a closed position using latches 813. The base 803 of each storage device supports the internal components of the storage device. Similar to the embodiment in Figure 32, the storage device includes a first physical connector 818A and a second physical connector 818B, which connect the storage devices together and simplify handling and / or attachment to the patient's clothing or body.

[0153] Similar to the embodiments shown in Figures 32-33, the storage devices 800A, 800B, and 800C in Figure 34 may be connected independently, to each other, or to an infusion set, infusion pump, other drug delivery device, or other associated device. In the configuration shown in Figure 34, the fluid outlet connector 854 of the first storage device is connected to the fluid inlet connector 856 of the second storage device 800B. The fluid outlet connector 854 of the second storage device is similarly connected to the fluid inlet connector 856 of the third storage device 800C. Thus, the medicinal fluids from each of the containers located within the three storage devices are stored together and accessible from the fluid outlet connector 854 of the third storage device 800C, or, in some embodiments, from the fluid inlet connector 856 of the first storage device 800A. Therefore, the fluids may be delivered simultaneously from the three containers to an infusion pump, infusion set, other drug delivery device, or other associated device. Naturally, in other embodiments, any number of suitable storage devices and containers may be employed to achieve the desired dosage of medicinal fluid, and the disclosure is not limited thereto.

[0154] Figure 35 is a front elevation view of yet another embodiment of a medicinal fluid storage system, which provides a modular storage system for fluid connection to any desired number of medicinal fluid containers and for providing free movement of the storage devices relative to each other within distance limits defined by the lengths of the tubing 870. The embodiment includes a first attachable storage device 800A, a second attachable storage device 800B, and a third attachable storage device 800C. As described above, in some cases it may be desirable to allow free relative movement of the attachable storage devices to clothing, or otherwise reduce the bulkiness of a single connected storage system. Therefore, as shown in the embodiment of Figure 35, the attachable storage devices are interconnected with the storage tubing 870, which allows the storage devices to move independently relative to each other within distance limits defined by the lengths of the tubing 870. The storage devices in Figure 35 are similar to those in Figure 34, with each storage device housing a single container (e.g., a first container 402A, a second container 402B, and a third container 402C), and each storage device includes a fluid inlet connector 856 and a fluid outlet connector 854. Each set of storage tubing 870 includes a tubing outlet connector 872 and a tubing inlet connector 874, which connect to the fluid outlet connector 854 and fluid inlet connector 856 of the storage device, respectively. Thus, when the storage tubing is connected, a continuous fluid path is created between the internal volumes of the containers located within each of the storage devices. In the embodiment of Figure 35, an infusion set, infusion pump, other drug delivery device, or other associated device may be coupled to the fluid outlet connector 854 of the third storage device 800C to simultaneously deliver fluid from all three containers 402A, 402B, and 402C. Naturally, any suitable number of containers and storage devices may be employed, and the disclosure is not limited thereto. In addition, rather than interconnecting the storage devices with one another, the storage devices may be connected sequentially to an infusion set, infusion pump, other drug delivery device, or associated device to deliver an appropriate volume of fluid, and the disclosure is not limited thereto.

[0155] Figure 36 depicts one embodiment of an infusion set 900 having a breathing valve (i.e., a degassing valve, air release valve, etc.) 909 configured to allow the infusion set to be successively coupled to and uncoupled from one or more storage devices, according to exemplary embodiments described herein. As shown in Figure 36, the infusion set includes an infusion set inlet 902, inlet tubing 904, a pump engine 910, outlet tubing 906, and an infusion set outlet 908, which together form a continuous flow path. The pump engine is configured to pump fluid (e.g., from a storage device) toward the infusion set outlet 908. The infusion set inlet 902 is configured to be coupled to a fluid source such as a fluid outlet connector, a fluid inlet connector, or other fluid connectors in exemplary embodiments described herein. According to the embodiment of Figure 36, the breathing valve is positioned inline with the inlet tubing 904. The breathing valve is configured to ventilate an air pocket, which may be located within the inlet tubing. For example, when the infusion set is first used with a fluid source, the air inside the infusion set may be vented to prime the pump engine and / or allow the fluid to flow from the fluid source. In addition, the breathing valve may vent additional bubbles that can form during fluid delivery and block the passage of air in the fluid flow. When the infusion set is disconnected from the first fluid source (e.g., the first storage device), the infusion set may be refilled with air, at least partially. Thus, when the infusion set is connected to a second fluid source (e.g., the second storage device), the breathing valve may again vent the air placed inside the infusion set, allowing a continuous fluid flow to be delivered to the patient. Thus, the breathing valve may allow for the switching of fluid sources without requiring the patient to switch the infusion set.

[0156] As shown in Figure 36, the infusion set also includes a needle set 920, which connects the infusion set outlet 908 to the needle set connector 932. The needle set in Figure 36 is four-pronged, meaning that the fluid channel from the infusion set outlet is split into a first needle channel 934A, a second needle channel 934B, a third needle channel 934C, and a fourth needle channel 934D. Positioned at the ends of each needle channel are infusion needles 936A, 936B, 936C, and 936D, which can be used to subcutaneously deliver the fluid to the patient. Of course, in other embodiments, the needle set may include any preferred number of needles, including, but not limited to, a single needle, two needles (i.e., bipronged), and three needles (i.e., tripronged), and the present disclosure is not so limited.

[0157] While this instruction is described in conjunction with various embodiments and examples, it is not intended to be limited to such embodiments or examples. In contrast, this instruction includes various alternatives, modifications, and equivalents, as will be understood by those skilled in the art. Therefore, the foregoing description and drawings are merely examples.

Claims

1. A medicinal fluid storage device, wherein the medicinal fluid storage device is The casing and A first port located on the housing, wherein the first port includes a first spike, A second port located on the aforementioned housing, wherein the second port includes a second spike, A pipe connecting the first spike and the second spike, A first cover configured to be removably connected to the first port so as to cover the first spike, A second cover is configured to be removably connected to the second port so as to cover the second spike, and Equipped with, A medicinal fluid storage device, wherein each of the first cover and the second cover includes an indicator configured to show the order in which the first cover and the second cover should be removed and the first port and the second port should be used.

2. The medicinal fluid storage device according to claim 1, wherein each of the first cover and the second cover includes a pull tab, the pull tab being configured to be pulled by an operator to disconnect the cover from the port.

3. The circumferential aspect of the first port and the circumferential aspect of the first cover have complementary shapes, and the first cover is at least partially inserted into the first port when the first cover is removably connected to the port, according to claim 1.

4. The medicinal fluid storage device according to claim 1, wherein the first cover includes a receiving portion configured to receive a projection located within the first port.

5. The medicinal fluid storage device according to claim 1, wherein the first cover and the second cover are made of a plastic material.

6. The medicinal fluid storage device according to claim 1, wherein each of the first port and the second port includes a recess.

7. The medicinal fluid storage device according to claim 1, further comprising a belt clip, the belt clip being configured to be releasably attached to a belt worn by a patient.

8. The medicinal fluid storage device according to claim 1, further comprising a first spike sheath covering the first spike, wherein the first spike sheath forms a seal over the first spike prior to inserting the first container into the first port.

9. The medicinal fluid storage device according to claim 1, further comprising a second spike sheath covering the second spike, wherein the second spike sheath forms a seal over the second spike prior to inserting the second container into the second port.

10. The aforementioned pharmaceutical fluid storage device is A first container configured to be connected to a first port by being pressed onto the first spike, wherein the first container enables fluid communication between the first spike and the internal volume of the first container by puncturing the first container by the first spike, and the internal volume of the first container contains a medicinal fluid. A second container is configured to be connected to the second port by being pressed onto the second spike, wherein the second container enables fluid communication between the second spike and the internal volume of the second container by causing the second container to be punctured by the second spike, and the internal volume of the second container contains a medicinal fluid. The medicinal fluid storage device according to claim 1, further comprising the above.

11. The medicinal fluid storage device according to claim 10, further comprising a first container unit, the first container being part of the first container unit, the first container unit further comprising a third container, the first port including a third spike, the first container unit being configured to be connected to the first port, the first container unit enabling fluid communication between a third internal volume of the third container and the third spike by causing the third container to be punctured by the third spike, a third spike sheath forming a seal with respect to the third spike, the third internal volume containing a third medicinal fluid, and the third spike being in fluid communication with a second tubing.

12. The medicinal fluid storage device according to claim 11, further comprising a syringe, wherein the syringe is configured to be coupled to the second tubing, thereby causing the third medicinal fluid to move into the syringe.

13. The medicinal fluid storage device according to claim 10, further comprising a first spike sheath, the first spike sheath covering the first spike, and the first spike sheath forming a seal over the first spike prior to inserting the first container into the first port.

14. The medicinal fluid storage device according to claim 11, wherein the first container and the third container are of different sizes.

15. The pharmaceutical fluid storage device according to claim 13, wherein the volume of the first container is 1.1 mL to 300 mL.

16. The medicinal fluid storage device according to claim 11, wherein the volume of the first container and the volume of the third container are each selected from the group consisting of 5 mL, 10 mL, 20 mL, and 40 mL.

17. The medicinal fluid storage device according to claim 1, wherein the first port is a recess for accommodating the first spike, and the first cover is configured to cover the first port.

18. The medicinal fluid storage device according to claim 1, wherein the second port is a recess for accommodating the second spike, and the second cover is configured to cover the second port.

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