Pooling device for single or plurality of 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 under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 819,349, filed March 15, 2019, and U.S. Provisional Application No. 62 / 740,475, filed October 3, 2018, each of which is incorporated by reference in its entirety.

[0002] The disclosed embodiments relate to a storage device for storing medicated fluid from single or multiple medical containers. [Background technology]

[0003] Medicated fluids are often manufactured and packaged separately prior to use to preserve their chemical and physical stability. Medicated fluids may be combined at the time of administration, either by mixing the medicated fluids immediately prior to administration, or by administering the medicated fluids in parallel or sequentially.

[0004] Typically, these additional steps during administration are performed by a nurse or other medical personnel who may need to administer the medicated fluid to the patient according to a particular procedure. If additional medicated fluid is required, the method of administration may be performed by the nurse or other medical personnel multiple times for a given dosage.

[0005] Conventional administration methods and systems may lack efficient procedures and may require many steps to connect and disconnect components and move fluids through various components in a specific manner. The present inventors have recognized a need for a medicated reservoir system that simplifies the administration of medicated fluids to patients. Summary of the Invention [Means for solving the problem]

[0006] In some embodiments, a system and method for administering a medicated fluid to a patient from one or more containers is provided. In some embodiments, the medicated fluid storage device includes a hollow spike configured to puncture a medicated fluid container and receive fluid therefrom, the spike including portions of different cross-sectional areas to facilitate sealing with an associated spike sheath. In some embodiments, the hollow spike of the medicated fluid storage device is part of a port, the port having an associated cover that removably connects with the port and covers the hollow spike. In some embodiments, the medical device may include a fluid interface having a housing that contains at least a portion of a fluid connector including a Luer-activated 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 in fluid communication with an internal channel of the spike, and a base coupled to the spike. The first body portion and the second body portion 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 body portion and the second body portion. The spike sheath is configured to compress and move toward the base when a force is applied to the spike sheath in a direction toward the base.

[0008] In another embodiment, a fluid interface of a medical device includes a fluid connector including a first end, a second end, a luer-actuated valve that controls fluid communication between the first end and the second end, tubing in fluid communication with the second end, and a housing including a first opening and a second opening, wherein 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 including a hollow spike, tubing in fluid communication with the hollow spike, and a cover configured to removably connect to the port and cover the hollow spike.

[0010] In one embodiment, a method of using the storage device to store a medicated fluid includes removing a cover to expose a port of the storage device, the port including a hollow spike and a spike sheath covering the spike, connecting a first container to the port by pushing the first container onto the spike, causing the spike to puncture the spike sheath and the first container, allowing fluid communication between the interior volume of the first container and the spike, and coupling an infusion pump to the tubing and moving the medicated fluid through the tubing into the patient. The spike sheath forms a seal against the spike prior to insertion of the first container into the port. The interior volume of the first container contains the medicated fluid, and the spike is in fluid communication with the tubing.

[0011] In another embodiment, the wearable fluid storage device includes a housing including a clip configured to enable the wearable fluid storage device to be coupled to a garment, a first port formed in the housing and configured to receive a first container, and a first spike disposed in the first port and configured to puncture the first container when the first port receives the first container.

[0012] In another embodiment, the wearable fluid storage system includes a first wearable fluid storage device. The first wearable fluid storage device includes a first housing including a first clip configured to allow the first wearable fluid storage device to be coupled to a garment, a first port formed in the first housing and configured to receive a first container, a first spike disposed in the first port and configured to puncture the first container when the first port receives the first container, a first fluid outlet connector configured to be fluidly connected to an associated device and to allow fluid communication between the first wearable fluid storage device and the associated device, a fluid inlet connector, and a first tubing connected to the first spike, the first fluid outlet connector, and the fluid inlet connector. The first tubing is configured to allow fluid communication between the fluid inlet connector, the first spike, and the first fluid outlet connector. The wearable fluid storage system also includes a second wearable fluid storage device. The second wearable fluid storage device includes a second housing including a second clip configured to allow the second wearable fluid storage device to be coupled to a garment, a second port formed in the second housing and configured to receive the second container, a second spike disposed in the second port and configured to puncture the second container upon receipt of the second container by the second port, a second fluid outlet connector fluidly coupled to the first fluid inlet connector and configured to allow fluid communication between the second wearable fluid storage device and the first wearable fluid storage device, and second tubing connected to the second spike and the second fluid outlet connector, the second tubing configured to allow fluid communication between the second fluid outlet connector and the second spike.

[0013] In another embodiment, a method for administering a medicated fluid to a patient includes connecting a first container to a first port formed in a first housing by pushing the first container over a first spike disposed in the first port, puncturing the first container with the first spike and allowing fluid communication between the first spike and an internal volume of the first container, the internal volume of the first container containing the medicated fluid. The method may also include connecting an infusion set to a first fluid outlet connector via the first spike, allowing fluid communication between the infusion set and the internal volume of the first container, venting air disposed in the infusion set, and drawing the medicated fluid from the internal volume of the first container into the infusion set.

[0014] The foregoing concepts and additional concepts discussed below may be arranged in any suitable combination, although it should be understood that the disclosure is not limited in this respect. Moreover, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings. The present invention provides, for example: (Item 1) 1. A medicinal fluid storage device, comprising: Spiked sheath and a spike having a body including a first body portion and a second body portion, the first body portion and the second body portion having different cross-sectional shapes, the second body portion configured to create a fluid seal with the spike sheath, an internal channel of the spike extending through the first body portion and the second body portion; tubing in fluid communication with an interior channel of the spike; a base coupled to the spike, the spike sheath configured to compress and move toward the base when a force is applied to the spike sheath in a direction toward the base; A medicinal fluid storage device comprising: (Item 2) 2. The medicinal fluid storage device of item 1, wherein the first body portion has a first major axis diameter and the second body portion has a second major axis diameter, the first major axis diameter being larger than the second major axis diameter. (Item 3) 2. The medicinal fluid storage device of claim 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) 2. The medicinal fluid storage device of claim 1, wherein the internal channel comprises an inlet and an outlet, the inlet and the outlet being in fluid communication through the spike sheath when the spike sheath is in a non-compressed position. (Item 5) 5. The medicinal fluid storage device according to item 4, wherein the inlet and the outlet each have a D-shaped cross-section, and the D-shaped cross-sections of the inlet and the outlet face each other. (Item 6) 2. The medicinal fluid storage device of claim 1, wherein the spike sheath includes 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 a direction toward the base, and the spike pierces the sheath tip when the sheath shaft moves toward the base. (Item 7) 7. The medicinal fluid storage device according to item 6, wherein the spike sheath includes at least one sealing ring disposed within the sheath shaft. (Item 8) 2. The medicinal fluid storage device of claim 1, wherein the first body portion has an elliptical cross-sectional shape and the second body portion has a circular cross-sectional shape. (Item 9) 2. The medicinal fluid storage device of item 1, wherein the medicinal fluid storage device is wearable. (Item 10) 10. The medicinal fluid storage device of item 9, further comprising a belt clip configured to releasably attach the medicinal fluid storage device to a belt worn by a patient. (Item 11) 10. The medicinal fluid storage device of item 9, further comprising a lid movable between an open position and a closed position, the lid being configured to enclose the spike and spike sheath in the closed position. (Item 12) Item 12. The medicinal fluid storage device of item 11, wherein the lid includes a hinge, the lid rotating about the hinge between the open position and the closed position. (Item 13) 1. A fluid interface of a medical device, the fluid interface comprising: a fluid connector comprising a first end, a second end, and a luer-actuated valve controlling fluid communication between the first end and the second end; tubing in fluid communication with the second end; a housing including a first opening and a second opening, the housing containing at least a portion of the fluid connector, a first end of the fluid connector being accessible; A fluid interface comprising: (Item 14) Item 14. The fluid interface of item 13, wherein the housing includes a bell-shaped end adjacent the first opening. (Item 15) Item 15. The fluid interface of item 14, wherein the bell-shaped end is configured to be received by one or more latches disposed on the medical device. (Item 16) Item 16. The fluid interface of item 15, wherein the one or more latches are disposed within an interface holder of the medical device. (Item 17) Item 14. The fluid interface of item 13, wherein the housing includes an indicator configured to communicate information to an operator of the medical device. (Item 18) Item 14. The fluid interface of item 13, wherein a first end of the fluid connector is accessible from the first opening and the tubing is disposed within the second opening. (Item 19) Item 14. The fluid interface of item 13, wherein a first end of the fluid connector protrudes out of the first opening and the tubing is disposed within the second opening. (Item 20) Item 14. The fluid interface of item 13, wherein the first end is configured to connect to an infusion pump. (Item 21) 21. The fluid interface of claim 20, wherein the first end is configured to connect to the infusion pump via a second fluid connector including a second luer-actuated valve. (Item 22) Item 14. The fluid interface of item 13, wherein the first end is configured to connect to a syringe. (Item 23) Item 14. The fluid interface of item 13, wherein the housing is attachable. (Item 24) 24. The fluid interface of claim 23, wherein the housing includes a belt clip configured to releasably attach the fluid interface to a belt worn by a patient. (Item 25) 1. A medicinal fluid storage device, comprising: a port including a hollow spike; tubing in fluid communication with the hollow spike; a cover configured to removably connect to the port and cover the hollow spike; A medicinal fluid storage device comprising: (Item 26) Item 26. The medicinal fluid storage device of item 25, wherein the cover includes an indicator configured to indicate a method of operation. (Item 27) Item 26. The medicinal fluid storage device of item 25, wherein the cover includes a pull tab configured to be pulled by an operator to disconnect the cover from the port. (Item 28) 26. The medicinal fluid storage device of item 25, wherein the periphery of the port and the periphery of the cover have complementary shapes, and the cover is at least partially inserted into the port when the cover is removably connected to the port. (Item 29) Item 26. The medicinal fluid storage device according to item 25, wherein the cover includes a receiving portion configured to receive a protrusion disposed within the port. (Item 30) 26. The medicinal fluid storage device according to item 25, wherein the ports are a plurality of ports each including a hollow spike, and the covers are a plurality of covers configured to removably connect to the plurality of ports and cover each of the hollow spikes. (Item 31) 26. The medicinal fluid storage device according to item 25, wherein the cover is made of a thermoformed plastic material. (Item 32) 26. The medicinal fluid storage device of claim 25, wherein the port comprises a recess. (Item 33) 26. The medicinal fluid storage device of claim 25, wherein the medicinal fluid storage device is wearable. (Item 34) 34. The medicinal fluid storage device of item 33, further comprising a belt clip configured to releasably attach the medicinal fluid storage device to a belt worn by a patient. (Item 35) 26. The medicinal fluid storage device of claim 25, wherein the cover is movable between an open position and a closed position, and the cover is configured to enclose the spike and spike sheath in the closed position. (Item 36) Item 36. The medicinal fluid storage device of item 35, wherein the cover includes a hinge, the cover rotating about the hinge between the open position and the closed position. (Item 37) 1. A method of using a storage device for storing a medicated fluid, comprising: removing a cover to expose a port of the storage device, the port including a hollow spike and a spike sheath covering the spike, the spike sheath forming a seal against the spike prior to insertion of a container into the port; connecting a first container to the port by pushing the first container onto the spike, causing the spike sheath and the first container to be pierced by the spike, allowing fluid communication between the spike and an interior volume of the first container, the interior volume of the first container containing a medicated fluid and the spike in fluid communication with tubing; coupling an infusion pump to the tubing and moving the medicated fluid through the tubing and into a patient; A method comprising: (Item 38) 38. The method of claim 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 sheath and second container to be punctured by the second spike to allow fluid communication between a second interior volume of the second container and the second spike, the second spike sheath forming a seal against the second spike, the second interior volume containing a second medicated fluid, and the second spike in fluid communication with a second tubing. (Item 39) 40. The method of claim 38, further comprising coupling a syringe to the second tubing and transferring the second medicated fluid into the syringe. (Item 40) removing a second cover to expose a second port of the storage device, the second port including a second hollow spike and a second spike sheath covering the second spike; connecting the second container to the port by pushing the second container onto the second spike, causing the second spike to pierce the second spike sheath and the second container, allowing fluid communication between the second spike and an interior volume of the second container, the interior volume of the second container containing a medicated fluid, and the second spike in fluid communication with the tubing; 38. The method of claim 37, further comprising: (Item 41) Item 41. The method of item 40, wherein the first container and the second container have different sizes. (Item 42) Item 41. The method according to item 40, wherein the volume of the first container is 1.25 to 300 mL. (Item 43) 43. The method of claim 42, wherein the volume of the first container and the volume of the second container are each selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL. (Item 44) 1. A wearable fluid storage device, comprising: a housing including a clip configured to allow the wearable fluid storage device to be coupled to a garment; a first port formed in the housing and configured to receive a first container; and a first spike disposed within the first port and configured to puncture the first container when the first port receives the first container; 1. A wearable fluid storage device comprising: (Item 45) Item 45. The wearable fluid storage device of item 44, further comprising a lid movable between an open position and a closed position, the lid being configured to enclose the first port in the closed position. (Item 46) Item 46. The wearable fluid storage device of item 45, wherein the lid includes a hinge, the lid rotating about the hinge between the open position and the closed position. (Item 47) Item 46. The wearable fluid storage device of item 45, wherein the housing comprises a latch configured to releasably secure to the lid in the closed position. (Item 48) Item 48. The wearable fluid storage device of item 47, wherein the latch is a flexible catch that is configured to secure to the lid in a non-flexed position and to release the lid in a flexed position. (Item 49) Item 45. The wearable fluid retention device according to item 44, wherein the clip is a belt clip configured to releasably attach the wearable fluid retention device to a belt worn by a patient. (Item 50) a fluid outlet connector configured to allow fluid communication between the wearable fluid storage device and an associated device; tubing connected to the first spike and the fluid outlet connector, the tubing configured to allow fluid communication between the fluid outlet connector and the first spike; 45. The wearable fluid storage device of claim 44, further comprising: (Item 51) Item 51. The wearable fluid storage device of item 50, wherein the fluid outlet connector comprises a luer-activated valve. (Item 52) 51. The wearable fluid storage device of claim 50, further comprising an associated device, the associated device being an infusion set, the infusion set being in fluid communication with the fluid outlet connector. (Item 53) Item 53. The wearable fluid storage device of item 52, wherein the infusion set includes a breathing valve configured to vent air disposed within the infusion set. (Item 54) a second port formed in the housing and configured to receive a second container; and a second spike disposed within the second port and configured to puncture the second container when the second port receives the second container, the tubing configured to connect to the second spike and enable fluid communication between the first spike, the second spike, and a fluid outlet connector; 51. The wearable fluid storage device of item 50, further comprising: (Item 55) 55. The wearable fluid storage device according to item 54, wherein the first container and the second container have different sizes. (Item 56) 55. The wearable fluid storage device according to item 54, 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 57) a third port formed in the housing and configured to receive a third container; and a third spike, the third spike being disposed within the third port and configured to puncture the third container when the third port receives the third container, the tubing being configured to connect to the third spike and enable fluid communication between the first spike, the second spike, the third spike, and a fluid outlet connector; 55. The wearable fluid storage device of item 54, further comprising: (Item 58) 58. The wearable fluid storage device of item 57, wherein at least one selected from the group of the first container, the second container, and the third container has a different size than at least one selected from the group of the first container, the second container, and the third container. (Item 59) 58. The wearable fluid storage device of item 57, wherein the first container, the second container, and the third container each have a volume selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL. (Item 60) 51. The wearable fluid storage device of item 50, further comprising a fluid inlet connector configured to enable fluid communication between the wearable fluid storage device and an associated fluid storage device, the tubing being 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) 1. A wearable fluid storage system comprising: A first wearable fluid storage device, the first wearable fluid storage device comprising: a first housing, the first housing including a first clip configured to allow the first wearable fluid storage device to be coupled to a garment; a first port formed in the first housing and configured to receive a first container; and a first spike disposed within the first port and configured to puncture the first container when the first port receives the first container; and a first fluid outlet connector configured to be fluidly connected to an associated device and to allow fluid communication between the first wearable fluid storage device and the associated device; A fluid inlet connector; a first tubing connected to the first spike, the first fluid outlet connector, and the fluid inlet connector, the first tubing configured to allow fluid communication between the fluid inlet connector, the first spike, and the first fluid outlet connector; A first wearable fluid storage device comprising: A second wearable fluid storage device, the second wearable fluid storage device comprising: a second housing including a second clip configured to allow the second wearable fluid storage device to be coupled to a garment; and a second port formed in the second housing and configured to receive a second container; and a second spike disposed within the second port and configured to puncture the second container when the second port receives the second container; and a second fluid outlet connector, the second fluid outlet connector fluidly coupled to the first fluid inlet connector and configured to allow fluid communication between the second wearable fluid storage device and the first wearable fluid storage device; a second tubing connected to the second spike and the second fluid outlet connector, the second tubing configured to allow fluid communication between the second fluid outlet connector and the second spike; a second wearable fluid storage device comprising: 1. A wearable fluid storage system comprising: (Item 62) Item 62. The wearable fluid storage system of item 61, further comprising storage tubing configured to fluidly couple the second fluid outlet connector to the fluid inlet connector, the storage tubing fluidly connecting the first spike and the second spike to the first fluid outlet connector. (Item 63) Item 62. The wearable fluid reservoir system of item 61, wherein the second fluid outlet connector is configured to be directly coupled to the fluid inlet connector. (Item 64) The first wearable fluid storage device further comprises: a third port formed in the first housing and configured to receive a third container; and a third spike disposed within the third port and configured to puncture the third container when the third port receives the third container, the first tubing being connected to the third spike and configured to enable fluid communication between the fluid inlet connector, the first spike, the third spike, and a first fluid outlet connector; Item 62. The wearable fluid storage system of item 61, comprising: (Item 65) The second wearable fluid storage device further comprises: a fourth port formed in the second housing and configured to receive a fourth container; and a fourth spike, the fourth spike being disposed within the fourth port and configured to puncture the fourth container when the fourth port receives the fourth container, the second tubing being configured to connect to the fourth spike and to enable fluid communication between the second spike, the fourth spike, and a second fluid outlet connector; 65. The wearable fluid storage system of item 64, comprising: (Item 66) Item 62. The wearable fluid retention system of item 61, wherein the first clip and the second clip are each configured as a belt clip configured to releasably attach the first housing and the second housing, respectively, to a belt worn by a patient. (Item 67) 62. The wearable fluid storage system of claim 61, further comprising an associated device, the associated device being an infusion set. (Item 68) Item 68. The wearable fluid storage system of item 67, wherein the infusion set includes a venting valve configured to vent air disposed within the infusion set. (Item 69) Item 62. The wearable fluid storage system of item 61, wherein the first container and the second container have different sizes. (Item 70) Item 62. The wearable fluid reservoir system of item 61, 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 71) 1. A method for administering a medicinal fluid to a patient, the method comprising: connecting a first container to a first port formed in a first housing by pushing the first container onto a first spike disposed in a first port, causing the first container to be punctured by the first spike and allowing fluid communication between the first spike and an interior volume of the first container, the interior volume of the first container containing a medicated fluid; connecting an infusion set via the first spike to a first fluid outlet connector that allows fluid communication between the infusion set and an interior volume of the first container; venting air disposed within the infusion set; drawing the medicated fluid from an interior volume of the first container into the infusion set; A method comprising: (Item 72) 72. The method of claim 71, further comprising disconnecting the infusion set from the first fluid outlet connector. (Item 73) Item 72. The method of item 71, further comprising attaching the first housing to clothing worn by the patient. (Item 74) Item 74. The method of 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) connecting a second container to the second port formed in the first housing by pushing the second container onto a second spike disposed in a second port, causing the second container to be pierced by the second spike and allowing fluid communication between the second spike and an internal volume of the second container, the internal volume of the second container containing a medicated fluid and the second spike in fluid communication with the first spike; drawing the medicated fluid from the interior volume of the second container into the infusion set; 72. The method of claim 71, further comprising: (Item 76) Item 76. The method of item 75, wherein the first container and the second container have different sizes. (Item 77) 76. The method of claim 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) connecting a third container to a third port formed in the first housing by pushing the third container onto a third spike disposed in a third port, causing the third container to be punctured by the third spike and allowing fluid communication between the third spike and an internal volume of the third container, the internal volume of the third container containing a medicated fluid, and the third spike in fluid communication with the first spike and the second spike; drawing the medicated fluid from the interior volume of the third container into the infusion set; 76. The method of claim 75, further comprising: (Item 79) Item 76. The method of item 75, further comprising disconnecting the infusion set from the first fluid outlet connector. (Item 80) connecting a third container to a third port formed in a second housing by pushing the third container onto a third spike disposed in a third port, causing the third container to be punctured by the third spike and allowing fluid communication between the third spike and an internal volume of the third container, the internal volume of the third container containing a medicated fluid; connecting the infusion set to a second fluid outlet connector, the second fluid outlet connector enabling fluid communication between the infusion set and an interior volume of the third container, via the third spike; venting air disposed within the infusion set; drawing the medicated fluid from the interior volume of the third container into the infusion set; 80. The method of claim 79, further comprising: (Item 81) connecting a fourth container to a fourth port formed in the second housing by pushing the fourth container onto a fourth spike disposed in a fourth port, causing the fourth container to be pierced by the fourth spike and allowing fluid communication between the fourth spike and an internal volume of the fourth container, the internal volume of the fourth container containing a medicated fluid and the fourth spike in fluid communication with the third spike; drawing the medicated fluid from the interior volume of the fourth container into the infusion set; 81. The method of claim 80, further comprising: (Item 82) connecting a third container to a third port formed in a second housing by pushing the third container onto a third spike disposed in a third port, causing the third container to be punctured by the third spike and allowing fluid communication between the third spike and an internal volume of the third container, the internal volume of the third container containing a medicated fluid; connecting a second fluid outlet connector to a fluid inlet connector, the second fluid outlet connector in fluid communication with the third spike, and the fluid inlet connector in fluid communication with the first fluid outlet connector, the first spike, and the second spike; drawing the medicated fluid from the interior volume of the third container into the infusion set; 76. The method of claim 75, further comprising: (Item 83) Item 83. The method of item 82, wherein connecting the second fluid outlet connector to the fluid inlet connector comprises connecting reservoir tubing with the second fluid outlet connector and the fluid inlet connector. (Item 84) 83. The method of claim 82, further comprising attaching the first housing and the second housing to clothing worn by the patient. (Item 85) 85. The method of claim 84, wherein attaching the first housing and the second housing to clothing worn by the patient comprises releasably attaching the first housing and the second housing to a belt worn by the patient. [Brief description of the drawings]

[0015] Non-limiting embodiments of the present invention will now be described, by way of example, with reference to the accompanying figures, which are schematic and are not intended to be drawn to scale. In the figures, each identical or nearly identical component shown is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, nor are every component of every embodiment of the present invention shown, and illustration is not necessary to enable those skilled in the art to understand the present invention.

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

[0017] [Diagram 2]FIG. 2 is a perspective view of the medicinal reservoir device of FIG. 1 with the cover removed.

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

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

[0020] [Diagram 5] FIG. 5 is a perspective view of one embodiment of a combination first and second fluid delivery system for use in the medicated reservoir device of FIG.

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

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

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

[0024] [Figure 8B] FIG. 8B is a perspective view of the spike and spike sheath of FIG. 8A in an assembled configuration.

[0025] [Figure 9A] FIG. 9A is a schematic of another embodiment of a spike and spike sheath.

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

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

[0028] [Figure 11] FIG. 11 is a schematic of yet another embodiment of a spike.

[0029] [Figure 12] FIG. 12 is a schematic of yet another embodiment of a spike.

[0030] [Figure 13] FIG. 13 is a schematic of yet another embodiment of a spike.

[0031] [Figure 14] FIG. 14 is a schematic of one embodiment of a cross section of a first body portion of a spike.

[0032] [Figure 15] FIG. 15 is a schematic of another embodiment of a cross section of a first body portion of a spike.

[0033] [Figure 16] FIG. 16 is a schematic of yet another embodiment of a cross section for a first body portion of a spike.

[0034] [Figure 17] FIG. 17 is a schematic of one embodiment of a cross section of a second body portion of a spike.

[0035] [Figure 18] FIG. 18 is a schematic of another embodiment of a cross section for a second body portion of a spike.

[0036] [Figure 19] FIG. 19 is a schematic of another embodiment of a cross section for a second body portion of a spike.

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

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

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

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

[0041] [Figure 22A] FIG. 22A is a top view of one embodiment of a medicated reservoir device including a cover.

[0042] [Figure 22B] FIG. 22B is a top view of the medicated reservoir device of FIG. 22A with the cover removed.

[0043] [Figure 23] FIG. 23 is an exploded view of the medicated reservoir device and cover of FIG. 22A.

[0044] [Figure 24] FIG. 24 depicts one embodiment of a medicated reservoir device in use with multiple container units.

[0045] [Diagram 25] FIG. 25 is a block diagram of one embodiment of a method for operating a medicated reservoir device.

[0046] [Figure 26] FIG. 26 is a perspective view of another embodiment of a medicated reservoir device.

[0047] [Figure 27]FIG. 27 is an exploded view of the medicated reservoir device of FIG.

[0048] [Figure 28] FIG. 28 is a perspective view of the medicated reservoir device of FIG. 26 in use with multiple containers.

[0049] [Figure 29] FIG. 29 is a front elevational view of various containers that may be used with the medicated reservoir device of FIG.

[0050] [Figure 30A] FIG. 30A is a front perspective view of the medicated reservoir device of FIG. 26 with the lid in a closed position.

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

[0052] [Diagram 31] FIG. 31 is a front elevational view of another embodiment of a medicated reservoir device.

[0053] [Diagram 32] FIG. 32 is a front elevation view of one embodiment of a medicinal fluid reservoir system.

[0054] [Diagram 33] FIG. 33 is a front elevation view of another embodiment of a medicated fluid reservoir system.

[0055] [Diagram 34] FIG. 34 is a front elevation view of yet another embodiment of a medicated fluid reservoir system.

[0056] [Diagram 35] FIG. 35 is a front elevation view of yet another embodiment of a medicated fluid reservoir system.

[0057] [Diagram 36]FIG. 36 depicts one embodiment of an infusion set for use with a medicated reservoir device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] During a typical administration process, multiple syringes may be used to mix the medicated fluids in a series of steps prior to injection into a patient. At each step, a nurse or other medical personnel takes care to ensure sterility as each individual fluid is drawn from its packaging and discharged into a mixing container. Even if the medicated fluids do not need to be premixed prior to injection into a patient, each fluid is typically drawn individually by a pump, syringe, or other suitable tool. If a larger dosage than that contained in a typical package is required for a particular patient, the process is typically repeated multiple times until the required dosage is reached. Thus, traditional administration methods performed by nurses or medical personnel can be time consuming and complicated.

[0059] In some cases, due to the frequency of treatment using some medicated fluids, self-administration is a preferred option for convenience and cost. A difficult procedure that is already time-consuming when performed by a medical professional can be difficult for patients to practice self-administration. Therefore, reducing the time consumption and complexity of medicated fluid administration is desirable for patients to self-administer for convenience and reduced impact on daily life.

[0060] In light of the above, the inventors have recognized the advantages of a medicated storage device that allows a patient to administer a medicated fluid contained in one or more containers. Compared to conventional administration processes, the storage device may allow the use of a simpler medicated fluid administration process having fewer steps. The storage device may also allow administration of increased dosages using multiple containers of medicated fluid, such that the steps of the administration process can be performed at once for a given dosage.

[0061] The inventors have also recognized the advantage of the spike and spike sheath, which allows for a simple sterile connection between a container of medicated fluid and a medicated storage device. The spike sheath may be broken by the container as it is inserted into the medicated storage device and begins to store and flow fluid to a patient device (e.g., an infusion pump, syringe, etc.). Thus, the patient does not need to puncture the container using a handheld syringe or other tool, which may be cumbersome or present sterility issues.

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

[0063] The inventors have also recognized the advantage of a fluid interface that allows for 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. Thus, a fluid interface that is sized and shaped to be easier to grasp can simplify and improve administration of medicinal fluids.

[0064] In some embodiments, the fluid interface includes a fluid connector and a housing. The housing may include a first and a second opening configured to provide access to the interior volume of the housing. The fluid connector may have a first end and a second end, the first end configured to be coupled to a patient device and the second end connected to tubing configured to carry the medicated fluid (e.g., from a medicated reservoir device). The fluid connector may be disposed and mounted within the interior volume of the housing, which may have a size and shape to increase ease of gripping and moving the housing by an operator. Thus, the housing may facilitate the medicated fluid administration process for a patient or medical personnel.

[0065] The inventors have also recognized the advantage of a removable cover for a medicated storage device that allows a patient to selectively access a port and connect to a container of medicated fluid. The cover may provide a simple method of communicating 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 medicated reservoir device includes at least one port, each port including at least one spike assembly. The port may be fitted into the reservoir device such that the spike assembly does not protrude out of the outermost end of the reservoir device. Each port of the medicated reservoir device may have an associated cover configured to cover at least one spike disposed within the port such that the at least one spike is inaccessible prior to removal of the cover. The cover may be removably connectable to the at least one port such that a patient or a medical practitioner may remove the cover during the administration process for the medicated fluid.

[0067] In some embodiments, the medicated 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 medicated fluid to the at least one fluid distribution system. The ports may include a plurality of spikes, which may be used to fluidly connect to multiple containers packaged together in a container unit. The fluid distribution system may include a fluid interface air filter, 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 such that gravity may be used to feed the medicated fluid to the fluid connector. The fluid distribution system may feed a single medicated fluid from multiple containers connected to different ports, or may feed a mixture of different medicated fluids connected to different ports. The air filter may allow air into the fluid distribution system to be replaced with any volume of fluid drawn from the fluid connector. The fluid connector may be configured to connect to any patient device that may be used to administer fluid to a patient, such as an infusion pump or a syringe. Prior to insertion of one or more containers, the ports may be enclosed with a cover that may be removed by the patient or medical personnel prior to connection of the container to the port.

[0068] In some embodiments, a method for administering a medicated fluid using a medicated reservoir device includes removing one or more covers to expose one or more ports of the reservoir device, connecting one or more containers of medicated fluid to the one or more ports, coupling a patient device to a fluid connector of a fluid distribution system, and drawing the medicated fluid from the one or more containers. The ports of the medicated reservoir device may include one or more spike assemblies, each including a hollow spike and a spike sheath covering the spike. Once the covers are removed and the spike assemblies are exposed, connecting the container to the spike may include pushing the container onto the spike, causing the spike sheath and the container to be punctured by the spike, allowing fluid communication between the spike and the interior volume of the container. In some embodiments, the spike sheath may form a seal against the spike, facilitating the transfer of the medicated fluid from the connected container to the spike, rather than allowing the fluid to leak out of the container outside the fluid distribution system. Once the containers are connected, the medicated fluid from the containers may flow through the spike and associated tubing to a fluid connector that may be used to connect the fluid distribution system to an infusion pump, syringe, or other device for administration into a patient. If more than one container is connected to a fluid distribution system, the total volume of fluid in each of the containers 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 medicated storage device to deliver different medicated fluids or to provide a mixture of different medicated fluids.

[0069] In some embodiments, the medicated storage device may be used to administer two or more medicated fluids in sequence. For example, a first fluid may be administered first and a second fluid may improve the conditions under which it is delivered to or processed by the patient. In some embodiments, the medicated 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 medicated fluid. An example of a dual medical container unit that may be used in conjunction with the medicated storage device is disclosed in "PACKAGING A DOUBLE MEDICINE CONTAINER UNIT," filed with the U.S. Patent and Trademark Office on April 26, 2012, and incorporated herein by reference. No. 8,684,433, entitled "COMPANYING REQUIREMENTS FOR MULTIPLE MEDICAL CONTAINERS." In the event that the present specification and a document incorporated by reference include conflicting and / or inconsistent disclosure, the present specification shall control. If two or more documents incorporated by reference include conflicting and / or inconsistent disclosure with respect to each other, the document having the later effective date shall control.

[0070] The inventors have also recognized the advantage of a reservoir device that may be wearable to allow patient freedom of movement during the fluid administration process. The wearable reservoir device may be coupled to clothing or otherwise secured to the patient, so that the patient is not restricted to a specific location, place, or area. The wearable reservoir device may also include a lid that is configured to secure one or more attached containers to the reservoir device so that patient movement does not interfere with the fluid administration process. Such an arrangement may significantly reduce the burden of performing an injection or other administration process for the patient by providing freedom of movement without compromising the administration process.

[0071] In some embodiments, the wearable reservoir device includes a housing having a clip. The housing may include one or more ports formed therein configured to receive one or more containers of medicated fluid to be administered during an injection process. The housing, ports, and clip may be arranged such that the housing and attached containers of medicated fluid may be suspended from a 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 suitable configuration for securing the housing and attached containers to the patient. In some embodiments, the housing may include a lid that is movable between a closed position, in which the one or more ports are enclosed, and an open position, in which the one or more ports are accessible. According to this embodiment, the lid may be closed once the one or more containers are placed in the one or more ports such that the containers are securely secured inside the ports. Such an arrangement may prevent bumps, collisions, or other dynamic movements that are common during daily activities from causing the one or more containers to fall off or otherwise interrupting the administration process.

[0072] The inventors have also recognized the advantage of a modular storage device, which allows 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 container that may be employed with the storage device. Thus, in some embodiments, the storage device may be connectable to other storage devices, increasing the total volume of fluid and / or the total number of containers available for the administration process.

[0073] In some embodiments, the modular storage device includes a fluid inlet connector and a fluid outlet connector. The fluid inlet connector and the fluid outlet connector may be interconnected to fluidically connect multiple modular storage devices to each other. In some embodiments, the fluid inlet connector and the fluid outlet connector may be connected with tubing. In this embodiment, the tubing may provide freedom of movement of the connected storage devices. Such an arrangement may be beneficial in wearable applications where multiple smaller storage devices may be easier to wear than a single bulky storage device. In other embodiments, the fluid inlet connector and the fluid outlet connector may be directly connectable to each other. According to this embodiment, the connected storage devices may reduce the number of fluidly connected and physically connected and independently operable structures, which may simplify the movement and / or wearing of the connected storage devices.

[0074] The inventors have also recognized the advantage of an infusion set that can vent air so that the infusion set can be used in series with multiple storage devices. In some cases, it may be desirable to use the same infusion set to disconnect from a first storage device and connect to a second storage device to complete the infusion process while delivering medicated fluid to a patient. For example, the volume of fluid deliverable from a single storage device may be insufficient for some dosages. Thus, in such cases, it may be desirable to safely connect to another storage device when additional volume of fluid is prescribed. The infusion set may include a breathing valve (i.e., a degassing valve, an air release valve, etc.) configured to prevent air bubbles that may form during the transition between storage devices from being administered to the patient.

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

[0076] According to 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. Without wishing to be bound by theory, the storage device of the exemplary embodiments herein may be configured to deliver a medicinal fluid having a viscosity of 10-30 cP. Of course, the storage device, infusion set, and associated accessories may be employed with any desired medicinal fluid, and the present disclosure is not so limited.

[0077] Although a specific embodiment of the storage device will be described herein, other alternative embodiments of all components related to the storage device are interchangeable as suitable for different applications. The term "storage device" as used herein refers to a device for accessing medicated fluid from one or more medical containers to administer the medicated fluid to a patient. Thus, a storage device used to administer medicated fluid from a single container, as well as several medical containers, is also contemplated.

[0078] FIG. 1 depicts one embodiment of a medicated storage device 10. The medicated storage device includes a housing 12, a first fluid distribution system 100, a second fluid distribution system 150, and four covers 300A, 300B, 300C, 300D, each of which covers a port for receiving a container of medicated fluid. In the embodiment depicted in FIG. 1, the medicated storage device is configured to supply two medicated fluids, which may be stored from up to four containers per fluid. The first medicated fluid may be packaged with the second medicated fluid, such that each port may receive both medicated fluids simultaneously. According to this embodiment, the medicated fluids are not mixed, but rather may be independently supplied to the first fluid interface 102 and the second fluid interface 152 and delivered to the patient in succession. The first and second medicated fluids may be transported to the first and second fluid interfaces by the first tubing 110 and the second tubing 160, respectively. As shown in FIG. 1, the first and second fluid interfaces may be removably connected to an interface holder 14 for storage and transportation.

[0079] In some cases, it may be desirable to maintain the cleanliness of the medicated storage device using a predetermined manufacturing and shipping orientation. According to the embodiment shown in FIG. 1, the medicated storage device 10 may keep important components such that they may interface with the medicated fluid to be covered or otherwise protected from the external environment. For example, the cover 300A, 300B, 300C, 300D may keep the at least one spike assembly disposed therein isolated from external contaminants and accidental damage that may be encountered by the medicated storage device during shipping and handling prior to use. The cover may also prevent an operator from contacting the spike when handling the medicated storage device prior to, during, and / or after use of the medicated storage device. Similarly, the interface holder 14 may orient the first and second fluid interfaces 102, 152 in a manner that protects any exposed ends of the first and second fluid distribution systems 100, 150. Of course, any suitable components may be used to protect the sterility of the medicinal reservoir device prior to first use, including but not limited to a plastic sheath or other sterile packaging.

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

[0081] As shown in FIG. 2, each port 24 may include components configured to align an inserted container, promote sterility, or otherwise simplify the medicated administration process. For example, the port may include a recess 16 formed in the housing 12 of the medicated storage device that allows the container of medicated fluid to be guided by the port as the container is pushed onto the spike assembly 200 by the patient or medical personnel. That is, a medicated fluid container with a perimeter shape complementary to that of the port may be automatically aligned and guided as the container is pushed onto the spike assembly. The port may also include a guide protrusion 20 and a guide slot 22 configured to provide additional guiding and alignment surfaces for the insertion of the medicated fluid container. In some embodiments, two containers of medicated fluid may be physically coupled by the housing to form a single container unit. Thus, the guide protrusion and the guide slot may contact portions of the container unit housing to reliably guide and align the individual containers placed therein with the spike assembly 200. In the embodiment shown in FIG. 2, the port includes at least one latch receptacle 18 configured to removably connect a cover (covers 300A, 300B, 300C, and 300D shown in FIG. 1) to a medicated storage device. The latch receptacle 18 may also be used to removably or permanently couple any received container or container unit into the port and prevent removal. Thus, in some embodiments, the latch receptacle of the medicated storage device may be configured to removably couple with an associated port cover and permanently couple with an associated container. In some embodiments, the latch receptacle may be configured to removably couple with both the port cover and the container. The port may include any suitable matching or locking feature, and the present disclosure is not so limited.

[0082] In some embodiments, the port may include any suitable fluid coupling that may be used to connect a container of medicated fluid to a fluid distribution system of a medicated storage device. For example, the port may include a spike or a quick connect coupling. In some embodiments, the port may also include a recess and / or protrusion formed in the housing of the medicated storage device. The recess and / or protrusion may be used to facilitate alignment and connection of the container to the port. In other embodiments, the port may be flush with the housing of the medicated storage device. The port may have any other suitable arrangement for fluidly connecting the container to the fluid distribution system of the medicated storage device, and the present disclosure is not so limited.

[0083] In some cases, it may be desirable to maintain the sterility of the medicated storage device by preventing subsequent use of the storage device. Thus, in some embodiments, the medicated storage device may be configured for single use as a disposable device. That is, the medicated storage device may be configured to hinder or prevent reuse of the medicated storage device. For example, as shown in FIG. 2, the latch receptacle 18 of the medicated storage device 10 may be configured to substantially prevent removal of the container attached to the port 24. Thus, an operator (e.g., a patient or medical personnel) may not be able to replace the container of medicated fluid and initiate a second administration process. It should be understood that any other suitable components may be used to prevent multiple uses of the storage device, including mechanical restraints and self-closing valves.

[0084] FIG. 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 the fluid interface 102, tubing 110, an air filter 112, and four spike assemblies 200. According to the embodiment shown in FIG. 3, the first fluid connector may be configured to couple 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-actuated valve, a single shutoff valve, a double shutoff valve, a dry break valve, a bayonet-mounted coupler, or any other suitable valve that may prevent fluid from flowing out of the first fluid connector prior to coupling with the patient device. In some embodiments, the air filter 112 is configured as a hydrophobic one-way filter configured to allow filtered air to pass into the first fluid distribution system while substantially preventing medicated fluid from exiting. Thus, the air filter may allow the medicated fluid contained in the container to be drained by gravity toward the fluid interface without creating a negative pressure difference inside the container. The air filter may also allow passive drainage of the medicated fluid without a pump or other energy-driven flow-inducing device. As described above, each of the spike assemblies is configured to create fluid communication between the container of medicated fluid and the fluid distribution system. The tubing 110 interconnects each of the components in series, with the air filter disposed on one end of the tubing, the fluid interface disposed on the opposite end, and the spike assembly arranged therebetween. Of course, any suitable order of the fluid components of the fluid distribution line may be employed, and the disclosure is not so limited. For example, one or more air filters and / or fluid interfaces 102 may be disposed between any of the spike assemblies 200.

[0085] In some embodiments, the fluid distribution system may be configured to store and / or mix medicated fluids. In the embodiment shown in FIG. 3, the first fluid distribution system 100 may be used to connect up to four separate containers of medicated fluid. Because each spike assembly 200 is configured to flow to the next spike assembly, combining multiple containers effectively stores (i.e., combines) the medicated fluids 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 medicated fluids that 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. Additionally, the number of spike assemblies, fluid interfaces, air filters, and tubing may modify the flow rate of medicated fluid or mixed medicine delivered to the fluid interface. Of course, the medicated distribution system may be configured to store and / or combine any number of medicated fluids from any number of containers, and the disclosure is not so limited. In some embodiments, the fluid dispensing system may include a mixing chamber or other mixing feature configured to further mix the medicated fluid.

[0086] FIG. 4 is a perspective view of one embodiment of the second fluid distribution system 150. Similar to the first fluid distribution system of FIG. 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 FIG. 4, the fluid connector 170 includes a male adapter configured to be coupled to an infusion pump and disposed at the end of the fluid connector opposite the tubing. As discussed above, in some embodiments, the fluid connector 170 may include a luer-actuated valve or any other suitable valve that may prevent fluid flow prior to connection with the infusion pump. The second air filter 162 is configured to allow air to enter the fluid distribution system as medicated fluid is drawn from the fluid interface to replace the lost volume of fluid and filtered air. The spike assemblies 200 may be configured to be individually connected to a container of medicated fluid such that the total volume of the medicated fluid may be pooled and delivered directly to the fluid interface 152, rather than sourcing the medicated fluid directly from the container until the total dosage volume is reached. That is, after the container is connected to the fluid distribution system, the total dosage volume of the fluid may be delivered immediately to the patient via the fluid interface. The second fluid interface may have any number of suitable modifications to modify aspects of the medicated fluid delivery, including, but not limited to, changing the number of spike assemblies or air filters, changing the tubing size, changing the fluid interface coupling, and adding mixing components.

[0087] In some cases where multiple medicated fluids are administered to a patient in succession, there is a predetermined ratio of volumes between the medicated fluids for a given dosage. Thus, the medicated fluids may be packaged together (e.g., in a container unit) so that the medicated fluids can be administered in the appropriate ratio. In the case of sequential fluid administration, the medicated storage device may include both a first fluid distribution system and a second distribution system corresponding to the first medicated fluid and the second medicated fluid, respectively. 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 FIG. 3). Such an arrangement may be beneficial when the medicated fluids are packaged in an equal number of containers in a predetermined ratio. 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 separate medicated fluid dosages. Of course, the first and second fluid dispensing systems may have any suitable number of components for storing and / or mixing medicated fluids from multiple containers, and the disclosure is not so limited.

[0088] FIG. 5 depicts one embodiment of a combination of the first fluid distribution system 100 of FIG. 3 and the second fluid distribution system 150 of FIG. 4 configured for use in the medicated storage device of FIG. 1. As shown in FIG. 5, the first and second fluid distribution systems are not in fluid communication with each other. Thus, the combination shown in FIG. 5 is suitable for separate administration of medicated fluid to a patient via the first fluid interface 102 and the second fluid interface 152. The first and second fluid interfaces may be arranged such that spike assemblies 200 at corresponding positions along the distribution system are positioned within the same port of the medicated storage device (see FIG. 2). The combination of fluid distribution systems may be at least partially contained within a housing to protect and support the distribution systems as shown in FIG. 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 including a luer-activated valve disposed therein and configured to be connected to a syringe such that the contents of the first fluid distribution system may be withdrawn by the syringe. The female fluid connector may be disposed within the housing for ease of handling by the patient or medical personnel (see, e.g., 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 FIG. 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 medicated fluid and fluidly connects the container to the first distribution system. The internal channel of the spike 202 may be a dual lumen channel (i.e., two separate channels) with either side connected to the tubing 110. Thus, as fluid flows from the air filter toward the fluid interface 102, the fluid will travel up one side of the spike 202 and down the other side. If air is placed within the fluid distribution system 100, the air will be replaced with a fluid volume that flows up one side of the spike and down 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 the fluid distribution system. In embodiments where the spike includes a dual lumen interior channel, the spike sheath may fluidly connect the two lumens together, thereby allowing fluid to flow toward the fluid interface. The spike sheath may be configured to be disrupted as a container of medicated fluid is inserted over and pierced by the spike, such that the medicated fluid may be brought into fluid communication with the fluid distribution system without compromising the integrity of the fluid distribution system.

[0091] FIG. 7 depicts an exploded view of the second fluid distribution system 150 of FIG. 4. As described above, the second fluid distribution system includes a fluid interface 152 (housing is not shown in the figure), an air filter 162, a spike assembly 200, and tubing 160. As shown in FIG. 7, the fluid interface includes a male fluid connector 170. The male fluid connector includes a luer-activated valve and is accessible to an infusion pump operated by the patient or a medical professional. That is, the male fluid connector may be used to withdraw fluids to be pooled and / or mixed from the second fluid distribution system and inject into the patient during medicinal fluid administration. The male fluid connector may be disposed within the housing for ease of handling (see, for example, FIG. 4). The air filter 162 is connected to the tubing 160 via a tubing coupler 164. Similar to the first fluid distribution system of FIG. 6, the spike assembly 200 includes a spike 202 and a spike sheath 220, where the spike may include a dual lumen inner channel that is fluidly coupled by the spike sheath.

[0092] FIG. 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 FIG. 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 body portion and the second body portion form the shaft of the spike. A dual lumen internal channel extends through the shaft of the spike and terminates at an inlet opening 216A and an outlet opening 216B, which are fluidly connected to the inlet 204A and the outlet 204B, respectively. In some embodiments, as shown in FIG. 8A, the inlet opening 216A may be positioned vertically higher than the outlet opening 216B, which may facilitate the introduction of air into any container volume fluidly connected to the spike as the medicated fluid flows out through the outlet opening. A spike tip 214 is disposed on the first body portion and is configured to puncture the spike sheath 204 and the container into which the spike is pushed.

[0093] As shown in FIG. 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 within a recess 208 formed in the base 206 of the spike 202. The sheath shaft 222 defines an interior volume and is configured to fit around the spike shaft formed by the first body portion 210 and the second body portion 212. According to the embodiment shown in FIG. 8A, when the spike is received by the spike sheath, the shaft and the base create a seal around the second body portion 212. In particular, a seal ring (see, e.g., FIG. 10) may be molded onto an 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 encourages a uniform sealing force to be applied across the entire circumference of the inner seal ring to prevent fluid leakage. In some embodiments, multiple seal rings (e.g., two or more seal rings) may be used to provide redundancy to the seal between the spike sheath and the spike. In other embodiments, the spike sheath may create a fluid seal with the first body portion, the base, or any other suitable component of the spike 202. The sheath tip 226 fluidly connects to the inlet opening 216A and the outlet opening 216B such that fluid may flow from the inlet to the outlet when a container is not inserted onto the spike assembly 200.

[0094] The inventors have recognized that in some cases, it may be desirable to reduce the number of components handled by the patient or medical personnel during the medicinal fluid administration process. Additional touching and handling of sterile components may compromise their sterility or otherwise adversely affect the patient's treatment. Thus, in some embodiments, the spike sheath may be configured to be broken by a container inserted onto the spike assembly 200, such that the patient or medical personnel may not need to handle any components of the spike assembly. In some embodiments, the spike sheath 220 may be formed from a material that can be pierced 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 breakable and compressible. According to this embodiment, as the container is pressed onto the spike assembly, it may force the sheath shaft 222 and the sheath tip 226 towards the spike base 206. The sheath shaft 222 may abut against a recess 208 formed in the spike base, resisting this motion and resulting in the sheath shaft 222 compressing towards the base (e.g., folding / curling, in some cases in an accordion-like fashion). As the sheath tip contacts the spike tip 214, it may be punctured and broken so that the tip does not resist further compression of the sheath shaft towards the base. During this process, the sheath base and sheath shaft may maintain a fluid seal around the spike's second body portion 212 so that when the spike creates fluid communication with a container of medicated fluid (e.g., by puncturing a seal or stopper of the container), no fluid is lost. In some embodiments, the container being inserted may form a fluid seal around the spike 202 instead of the sheath as the sheath is broken to prevent fluid loss.

[0095] FIG. 8B depicts the spike 202 and spike sheath 220 of FIG. 8A fully assembled, with the sheath placed over and receiving the first and second body portions (see FIG. 8A). As clearly shown in FIG. 8B, the sheath base 224 is received within a recess 208 formed in the base 206 of the spike. Thus, the sheath is secured to the spike, and the sheath base may resist lateral or longitudinal (i.e., in a direction toward the base) movement of the sheath. The sheath base may resist a force applied to the sheath tip 226 and / or sheath shaft 222 such that the sheath tip and / or sheath shaft compress downward toward the base. In some embodiments, as the sheath tip and sheath shaft curl toward the base, the sheath base may maintain a fluid seal around the spike so that no medicated fluid is lost during the process.

[0096] 9A depicts a cross-sectional schematic of another embodiment of 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. A dual lumen internal channel formed by the inlet and outlet extends the length of the spike shaft formed by first body portion 210 and second body portion 212. The inlet and outlet terminate in inlet and outlet openings that are separate from one another and disposed adjacent spike tip 214. The first and second body portions extend out from a base 206, which supports the spike and forms at least a portion of the inlet and outlet.

[0097] As shown in FIG. 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 serves as a protective barrier for the spike, which may be sterile for use in opening a container of medicinal fluid. Thus, the sheath may maintain the sterility of the spike until the moment the spike is used to open the container. In the embodiment of FIG. 9A, the spike sheath is in a non-compressed position and is configured to create a seal around the second body portion of the spike such that any fluid exiting the inlet opening 216A or the outlet opening 216B cannot escape the spike sheath. Thus, the spike sheath fluidly couples the inlet opening to the outlet opening and serves as a conduit for fluid to pass between the two. For example, fluid flowing into the inlet 204A and out the inlet opening may be transported by the spike sheath into the outlet opening and out the outlet 204B.

[0098] In some embodiments of medicated storage devices in which multiple spikes may be employed, the spike sheath may provide selectivity in the number of containers of medicated fluid to be used with the medicated storage device. For example, in a medicated storage device with four spikes arranged along a fluid distribution system, a container of medicated fluid may be inserted onto one spike, fluidly connecting the interior volume of the container to the fluid distribution system. In this example, fluid may be transmitted from the container throughout 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 normally as conduits, and fluid is not impeded during the administration process if some of the spikes are not used. In some embodiments, the spike sheaths may eliminate the need for complex valves or other devices that may regulate fluid flow, thereby simplifying the fluid distribution system. However, in other embodiments, the spikes and / or the 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 FIG. 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, which extends from the base and forms an interior volume configured to receive the spike 202. The sheath base and the sheath shaft create a fluid seal around the spike shaft formed by the first body portion 210 and the second body portion 212. The sheath tip serves to cap the interior volume formed by the sheath shaft such that when the sheath is in a non-compressed position, the spike sheath creates a fluidically sealed volume around the spike suitable for transporting fluid between the inlet and the outlet. The sheath shaft and the sheath tip may be formed from a thin material that is compressible longitudinally toward the spike base 206. The sheath base 224 may act to resist forces in the longitudinal direction such that a 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 pierced 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. Thus, 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 that is configured to reduce frictional resistance. According to the embodiment shown in FIG. 9A, the lubricant may be disposed directly on the spike and covered by the spike sheath. Of course, the lubricant may be disposed on the exterior of the spike sheath or on any other portion of the spike or spike sheath, and the present disclosure is not so limited. 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, including, but not limited to, silicone lubricants (e.g., DOW CORNING 360), perfluoropolyether (PFPE) lubricants (e.g., NYEMED 7471), synthetic hydrocarbon lubricants, esters, and polyglycols.

[0101] 9B shows the spike 202 and spike sheath 220 of FIG. 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 medicated fluid may be disposed. The stopper 402 may be made of a material that is capable of being punctured by the spike 202 such that the inlet 204A and the outlet 204B may be brought into fluid communication with 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 pushed onto the spike 202, the stopper 402 first contacts the spike sheath 220 and applies a 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 forced into contact with the spike tip 214. After a predetermined amount of displacement of the spike sheath, the spike tip punctures the spike sheath and begins to puncture the stopper 402. As the container is pushed fully onto the spike so that the spike fully punctures the container, the spike sheath remains in contact with the stopper and is compressed downward toward the spike base. As shown in FIG. 9B, the sheath shaft and the broken sheath tip may fold on 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, allowing the sheath shaft to compress. As shown in FIG. 9B, the spike sheath is in a compressed position and the interior volume 404 is in fluid communication with the inlet 204A and the 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 pierces the stopper. As shown in Figure 9B, the sheath shaft 222 is pierced by the spike tip 214 and compressed by the stopper 402 around the first body portion 210 of the spike shaft such 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 so limited.

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

[0104] FIG. 10 depicts a cross-sectional view of another embodiment of spike 202 and spike sheath 220. Similar to the embodiment of FIG. 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. A dual lumen internal channel formed by the inlet and outlet extends the length of the spike shaft, which is formed by first body portion 210 and second body portion 212, and is separate from one another. The inlet and outlet terminate in inlet and outlet openings, respectively, disposed adjacent spike tip 214. The first and second body portions extend out from a base 206, which supports the spike and forms at least a portion of the inlet and outlet.

[0105] As shown in FIG. 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 FIG. 10, the spike sheath serves as a protective barrier for the spike, which may be sterile for use in opening a container of medicinal fluid. Thus, the sheath may maintain the sterility of the spike until the moment the spike is used to open the container. As shown in FIG. 10, the spike sheath is in a non-compressed position and is configured to create a seal around the second body portion of the spike such that any fluid exiting the inlet opening 216A or the outlet opening 216B cannot escape the spike sheath. Thus, the spike sheath fluidly couples the inlet opening 216A to the outlet opening 216B and serves as a conduit for fluid to pass between the two. For example, fluid flowing into the inlet 204A and out of the inlet opening 216A is transported by the spike sheath into the outlet opening 216B and out of the outlet 204B.

[0106] According to the embodiment of FIG. 10, the spike sheath 220 includes a plurality of seal rings 228 disposed inside the sheath shaft 222. The seal rings extend radially inward from the sheath shaft and engage the spike second body portion 212. The seal rings may be formed with the spike sheath or may be formed separately (e.g., as an O-ring) and then positioned within the spike sheath. According to the embodiment shown in FIG. 10, the seal rings and the second body portion are circular such that the seal rings engage the spike uniformly across the entire circumference of the spike. That is, the circular shape promotes uniform tension throughout the entire circumference of the seal ring, creating a uniformly pressurized seal. While not wishing to be bound by theory, sealing around an oval shaped second body portion may create a variation in seal pressure along the circumference of the spike, which may result in a less sticky fluid seal. According to the embodiment of FIG. 10, the second body portion of the spike includes a step 218 in which the seal ring may seat to aid in sealing and secure the spike sheath to the spike. Of course, the second body portion may have any suitable shape and the disclosure is not so limited. According to the embodiment shown in FIG. 10, the spike sheath includes two seal rings. Without wishing to be bound by theory, a single seal ring may be suitable to prevent fluid from escaping the spike sheath. If the single seal ring is compromised (e.g., by manufacturing, rough handling, etc.), the second seal ring may maintain a fluid seal between the spike and the spike sheath. Of course, any suitable number of seal rings may be employed and the disclosure is not so limited.

[0107] FIG. 11 shows a schematic of yet another embodiment of a spike 202 with a differently shaped first body portion 210 and a second body portion 212. In some cases, the differently sized and / or shaped body portions of the spike may affect the fluid seal 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 such that a proper fluid seal may be created around the spike and fluid is substantially prevented from escaping around the spike. According to the embodiment shown in FIG. 11, the first body portion 210 has an elliptical cross section with a major axis diameter larger 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 larger than the major axis of the second body portion 212. The first body portion 210 makes an abrupt transition to the radius of the second body portion, creating a step 218. As shown in FIG. 11, the step 218 may function as a barb that serves to connect a spike sheath or a container stopper. Alternatively, or in addition, the step 218 may function as a seat for a seal ring of the spike sheath. In some embodiments, such an arrangement may provide additional radial space around the second body portion within which the sheath shaft may compress, which may reduce the force used to break and compress the sheath.

[0108] In some embodiments, the first body portion and the second body portion may constitute any suitable portion 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 disposed on the first body portion. As another example, the first body portion and the second body portion may seamlessly transition between each other such that the first body portion and the second body portion 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 suitable form and may form any two regions of the spike shaft.

[0109] FIG. 12 is a schematic of yet another embodiment of a spike 202 including a first body portion 210 having different dimensions than a second body portion 212. As with the embodiment of FIG. 11, the first body portion has an elliptical cross section. However, in the embodiment shown in FIG. 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 makes an abrupt transition to the second body portion, forming a step 218. Such an arrangement may facilitate sealing with the spike sheath and / or the container stopper. For example, a stopper pushed onto the spike 202 may abut against the step 218, and any holes of imperfections in the stopper created by the first body portion may be sealed by the second body portion. As another example, a spike sheath disposed around the spike may stretch around the second body portion when compressed, increasing contact and improving the seal provided by the spike sheath. In some embodiments, the step 218 may be sloped to provide a less abrupt transition between the first and second body portions.

[0110] FIG. 13 is a schematic of yet another embodiment of a spike 202 including a first body portion 210 having different dimensions than a second body portion 212. As shown in FIG. 13, the first body portion has an elliptical cross-sectional shape with a major axis corresponding to the width shown, while the second body portion has a circular cross-sectional shape. As shown in FIG. 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 seamlessly transitions into the second body portion such that no shoulder or other discontinuities are formed in the spike shaft. Such an arrangement may facilitate consistent insertion of a container onto the spike, as the discontinuities may not be trapped or otherwise significantly resisted by forces applied to the container to insert it onto the spike. Differently sized first and second body portions may provide a seal for a container stopper or spike sheath even in the case of an abrupt transition or lack of discontinuity.

[0111] FIG. 14 illustrates 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 FIG. 14, the first body portion has an elongated cylindrical shape with an elliptical transverse cross-section. Without wishing to be bound by theory, the elongated cylindrical shape may reduce the total surface area of ​​the spike 202 without compromising the inlet or outlet openings, which may reduce the force required to pierce a container and / or spike sheath with the spike. In the embodiment of FIG. 14, the inlet and outlet openings may be sized to form a side of the first body portion such that a small amount of excess area is occupied by the first body portion. As shown in FIG. 14, the inlet and outlet openings form a portion of the long side of the elongated cylindrical first body portion.

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

[0113] FIG. 16 shows yet another embodiment of a transverse cross section of the first body portion 210 of the spike 202. Similar to the embodiment of FIGS. 14-15, the first body portion includes an inlet opening 216A and an outlet opening 216B. The first body portion has an oblong cylindrical shape with an elliptical transverse cross section. Compared to the embodiment of FIGS. 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 may provide additional structural support for the spike tip that is aligned with the center of the first body portion. In addition, the D-shaped lumen allows a consistent wall thickness to be maintained throughout the first body portion while maintaining a suitable cross-sectional area of ​​the lumen. Of course, the first body portion 210, the inlet opening 216A, and the outlet opening 216B may adopt any suitable structure and arrangement, and the present disclosure is not so limited.

[0114] FIG. 17 illustrates one embodiment of a transverse cross-section of the second body portion 212 of the spike 202. The second body portion has a cylindrical shape with a circular transverse cross-section and includes an inlet opening 216A and an outlet opening 216B disposed therein. Compared to the first body portion 210 illustrated in FIGS. 14-16, the second body portion 212 of the embodiment of FIG. 17 has a different shape in which more area is occupied by the second body portion. Without wishing to be bound 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 a uniform sealing pressure around the entire circumference of the second body portion. Thus, in some embodiments, the first body portion and the second body portion 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 puncturing 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 promote a fluid seal between the spike and the spike sheath and / or container stopper, according to the embodiment shown in Figure 17. Of course, any suitable shapes for the first and second body portions may be employed, and the disclosure is not so limited.

[0115] 18-19 show another embodiment of a transverse cross section of the second body portion 212 of the spike 202. Similar to the embodiment shown in FIG. 17, the second body portion shown in FIG. 18-19 has a cylindrical shape with a circular transverse cross section and includes an inlet opening 216A and an outlet opening 216B disposed therein. According to the embodiment shown in FIG. 18, the inlet opening and the outlet opening are formed in a circular shape, and less area is occupied by the elliptical opening of FIG. 17. Thus, the shape and / or size of the inlet opening or the 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 FIG. 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". Of course, the inlet and outlet openings may have any suitable shape within the second body portion, and the disclosure is not so limited.

[0116] 20A shows one embodiment of a fluid interface 102 disposed at the end of a fluid distribution system. The fluid interface includes a housing 104 including a first opening 106A and a second opening 106B. The housing 104 holds a female fluid connector 120, which protrudes out of the first opening 106A. The female fluid connector is configured to connect to a syringe to withdraw fluid from the medicated 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 easy to handle and manipulate by the patient or medical personnel using the fluid interface.

[0117] As shown in FIG. 20A, the fluid interface may include an indicator 130. The indicator is configured to show information related to the medicated fluid being delivered to the fluid interface, instructions related to the administration process, or other useful information related to the patient or medical practitioner. 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 FIG. 20A, the indicator is configured as text. Alternatively, or in addition, the indicator may be a distinct color or any other non-text marking that conveys information to the patient or medical practitioner. Of course, any suitable combination of indicators may be used, including, but not limited to, text markings, non-text markings, symbols, raised dots, and colors.

[0118] FIG. 20B is an exploded view of the fluid interface 102 of FIG. 20A. As shown in FIG. 20B, the fluid interface includes a housing split into a first portion 104A and a second portion 104B, and a female fluid connector 120 disposed 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 an interior volume defined by the housing. The first portion 104A of the housing also includes at least one latch 108A, and the second portion 104B of the housing includes at least one latch receptacle 108B configured to receive the latch. The latch and the latch receptacle may be used to secure the first and second halves of the housing together and to enclose and secure the female fluid connector 120.

[0119] As shown in FIG. 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 with a syringe or another patient device (e.g., an infusion pump). The female fluid connector 120 may include a luer-activated valve or any other suitable valve that may facilitate sterility or prevent the flow of medicated fluid prior to connection to a syringe. The first end 122A is arranged to be disposed within and protrude out of the first opening 106A of the housing. The second end 122B is arranged to be fully enclosed within the housing and fitted back from the second opening 106B. Thus, tubing may be inserted through the second opening to fluidly connect the female fluid connector to a fluid distribution system. As shown in FIG. 20B, the female fluid connector also includes alignment features 124 that, when the first and second portions 104A, 104B are combined, may 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 a fluid interface 152 disposed at the end of a fluid distribution system. Similar to the embodiment of Figure 20A, the fluid interface includes a housing 154 including a first opening 156A and a second opening 156B. A male fluid connector 170 is disposed within and protrudes out of the first opening, and tubing 160 is disposed within and extends from the second opening 156B. An indicator 180 is disposed on the housing to communicate information to a patient or medical personnel using the fluid interface.

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

[0122] In the embodiment shown in FIG. 21B, the male fluid connector 170 is configured to mate with an infusion pump so that fluid can be automatically drawn from the fluid distribution system by the infusion pump. The male fluid connector may include a luer-activated valve or any other suitable valve that may facilitate sterility or block the flow of medicated fluid prior to connection to the infusion pump. In some embodiments, the male fluid connector may be configured to mate with other patient devices, such as a syringe. The male fluid connector includes a first end 172A and a second end 172B. In the embodiment shown in FIG. 21B, the first end 172A is disposed within and protrudes out of a first opening 156A in the housing of the fluid interface. The second end of the male fluid connector is configured to mate with tubing to other components of the fluid distribution system. In the embodiment shown in FIG. 21B, the second end is disposed within and is accessible to tubing from a second opening in the housing. The male fluid connector also includes alignment features 174 that rotationally secure the male fluid connector within the housing. In some embodiments, the alignment features 174 may be configured to translationally and rotationally secure the male fluid connector relative to the housing of the fluidic device. Thus, the housing and male fluid connector may effectively function as a single component for purposes of operation and handling by the patient or medical personnel.

[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 an operator (e.g., a patient or medical personnel) that 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 an associated housing of a reservoir device. Such an arrangement may allow the fluid interface to be releasably attached to a reservoir device housing for convenient temporary or permanent storage before and / or after the administration process (see, e.g., FIG. 22B). The bell-shaped end may coincide with a first end of the fluid connector. For example, as shown in FIG. 20A, the housing 104 has a flared, bell-shaped end where the first end 122 of the fluid connector 120 is located. As shown in FIG. 21A, the housing 154 has a flared, bell-shaped end in 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 flush with or fitted with the first opening of 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 flush with or fitted with the second opening of the housing to provide 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 out of the housing such that easier access to the fluid connector is provided. The fluid interface may have any suitable 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 present disclosure is not so limited.

[0125] FIG. 22A shows a top view of one embodiment of a medicated reservoir device 10 including covers 300A, 300B, 300C, 300D. As described above, the medicated reservoir device includes a port for receiving a container unit. The port is covered by a cover 300A, 300B, 300C, 300D, respectively, which seals the port and protects a spike assembly disposed within the port. Each cover may include a perimeter 302, ribs 304, a handle 306, a cover indicator 308, and a latch 310. The perimeter is configured to seat the cover within the port and resist further movement into the port. Thus, the perimeter provides protection for the port and the spike assembly disposed therein by supporting the cover over the port. The ribs are configured to provide structural rigidity for the cover and ensure that the cover is able to resist external forces and provide protection for the port that is covered. The handle 306 may include a textured surface that provides a solid surface by which the patient or medical practitioner may grasp and remove the cover for use of the port. The handle or any other receiving portion may also receive any protrusions extending out from the port, such as a matching feature. The receiving portion may have a shape complementary to that of the protrusions extending out from the port, such that the protrusions may guide the associated cover as the cover is attached or removed. The cover indicator 308 may be used to communicate information regarding the administration process to the patient or medical practitioner. For example, as shown in FIG. 22A, the cover indicator may indicate the desired order in which the cover should be removed and the port used. The cover latch 310 may be used to removably secure the cover to the port. The latch may be breakable, bendable, or otherwise actuatable so that the secured cover may be selectively removed by the patient or medical practitioner. In some embodiments, the latch 310 may be configured to release the cover when a sufficient pulling force is applied to the handle 306.

[0126] FIG. 22B is a top view of the medicinal storage device 10 of FIG. 22A with the covers 300A, 300B, 300C, 300D removed. As clearly shown in FIG. 22B, the ports 24 may be exposed for use once the covers are removed. Each port 24 may include at least one latch receptacle 18. The latch receptacles may receive latches 310 disposed on the cover such that the cover may be removably secured to the port. The number of latch receptacles in the port may correspond to the number of latches disposed on the cover such that the cover may be securely secured to the port. According to the embodiment shown in FIG. 22A-22B, the covers 300A, 300B, 300C, 300D have a shape corresponding to that of the port 24. In some embodiments, the covers may be configured to be interference-fitted into the port to removably secure the covers to the port. That is, the cover may be closely sized to fit within the port and secured to the port by friction. Of course, the cover may include any suitable fastening arrangement that can removably secure the cover to the port.

[0127] In some embodiments, the cover may be formed from a thermoformed plastic material. Thus, the cover may be thin and portions of the cover may be flexible where not reinforced by ribs 304. When a significant force is applied to the cover to selectively remove (e.g., pull) the cover, the cover may flex and release the latch 310 or otherwise loosen the cover from the slot. In some embodiments, the periphery 302 of the cover may include a pull tab (see, e.g., pull tab 312 in FIG. 24 ) that allows a patient or medical practitioner to remove the cover. According to this embodiment, if the cover is sufficiently flexible, the patient or medical practitioner 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. Of course, the cover may be formed from any suitable material and the present disclosure is not so limited.

[0128] FIG. 23 is an exploded view of the medicated storage device 10 and cover 300 of FIG. 22A. As described above, the cover includes a perimeter 302, a rib 304, a handle 306, a cover indicator 308, and a latch 310. The cover has a shape (e.g., a circumferential shape) complementary to that of the port 24 formed in the housing 12 of the medicated storage device. The perimeter 302 is configured to abut the housing 12 when the cover is removably secured to the port. As shown in FIG. 23, the latch 310 is aligned with the latch receptacles 18 disposed on either side of the port. Thus, when the cover is in place over the port 24, the latch 310 engages with the latch receptacle 18 and removably secures the cover to the port. 23, the handle 306 may be pulled with sufficient force to bend the latch 310 and disengage the latch receptacle so that the cover may be selectively removed from the port. The handle 306 is also configured as a receiving portion that receives the guide projection 20 that extends out from the port 24.

[0129] As shown in FIG. 23, the ribs 304 of the cover are arranged radially around each of the spike assemblies 200. The ribs provide stiffness in 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 of the spike assemblies to better protect the spikes during handling of the medicinal storage device 10. As shown in FIG. 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 may prevent contact between the spikes and the cover. Of course, the ribs may be arranged in any suitable location on the cover where additional stiffness is desired, and the present disclosure is not so limited.

[0130] FIG. 24 illustrates one embodiment of the medicated storage device 10 in use with multiple container units 400A, 400B, 400C. As shown in FIG. 24, the medicated storage device stores fluid from six separate containers, with two containers in each container unit 400A, 400B, 400C connected to three of the four ports 24. Each container unit is inserted into a port in the medicated storage device after the cover associated with each port is removed. As each container unit is inserted, the spike punctures each of the two containers in the container unit for storing and delivering fluid to the first fluid interface 102 and the second fluid interface 152, placing the containers in fluid communication with the two fluid distribution systems 100, 150.

[0131] As shown in FIG. 24, the number of ports used in the medicated storage device 10 may correspond to a particular dosage for administration to a patient. Thus, during the administration process, the patient or medical practitioner may remove the cover only from the port to be used for the desired particular dosage. That is, the cover may be left in place to maintain protection of the spike assembly if the port is not to be used for the particular dosage. In the embodiment shown in FIG. 24, the cover includes a pull tab 312, which may be used to peel and remove the cover. Thus, during the administration process, the patient or medical practitioner may peel the cover and subsequently connect a container unit to the port until the desired dosage of medicated 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 deliver the medicated fluid for injection or infusion into the patient.

[0132] FIG. 25 is a block diagram of one embodiment of a method for operating a medicated storage device. In block 500, a patient or medical practitioner may remove a cover to expose a port of the medicated storage device. In block 502, a patient or medical practitioner may connect a container to the port by pushing the container onto the spike. As the container is pushed onto the spike, the container may be brought into fluid communication with the fluid dispensing system of the medicated storage device. Blocks 500 and 502 may be repeated as many times as necessary to reach a particular dosage of medicated fluid. That is, for increased dosages, additional covers may be removed and additional containers may be connected to additional ports. In block 504, a syringe may be coupled to the tubing to withdraw a first medicated fluid. The tubing may be part of the medicated storage device that is in fluid communication with the connected container and may include a fluid connector that may be used to connect the syringe to the tubing. In some embodiments, the patient or medical practitioner may inject the first medicated fluid into the patient. In block 506, the patient or medical practitioner may couple an infusion pump to the tubing and move the second medicated fluid through the tubing and into the patient. The infusion pump may be coupled using a fluid connector, via a Luer-activated valve or any other suitable fluid coupling. In some embodiments, the infusion pump may be used to withdraw the first medicated fluid instead of a syringe.

[0133] In some embodiments, the medicated reservoir device may deliver one or more medicated fluids. Thus, any number of patient devices may be coupled to the various fluid outlets of the reservoir device, depending on the number of fluids to be delivered by the reservoir device. For example, an infusion pump, a syringe, an IV bag, and other suitable devices may all be coupled to the reservoir device for the ultimate delivery of the medicated fluid to the patient. In the embodiment of FIG. 25, one or more of blocks 504 and 506 may be eliminated from the method if neither a syringe nor an infusion pump is suitable for delivering the medicated fluid from the reservoir device. In some embodiments, one of blocks 504 and 506 may be kept while the other is eliminated. For example, for delivery of a single fluid, the patient or medical personnel may simply couple an infusion pump to the reservoir device without coupling to a syringe at all. Any suitable combination of steps may be used to administer one or more medicated fluids to a patient, and the disclosure is not so limited.

[0134] FIG. 26 is a perspective view of another embodiment of a medicated storage device 600 configured to be worn by a patient during the administration process and to allow the patient free mobility. Without wishing to be bound by theory, the device worn may affect mobility based at least in part on weight, weight distribution, and size. For example, a heavy bulky object with a center of mass far away from the person may be cumbersome and inhibit mobility when worn. Thus, the storage device shown in FIG. 26 is configured to minimize the size of the storage device and improve wearability while storing medicated fluids from multiple containers. As shown in FIG. 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 side-by-side within the housing. As shown in Figure 26, the first and second ports are formed close together and close to the ends of the housing such that the overall size of the storage device is minimized relative to the volume of the stored container. The storage device also includes a base 603, which is configured to support the ports and various other components disposed within the housing.

[0135] According to the embodiment shown in Figure 26, the reservoir device may have a suitably small size for extended wear by the patient without sacrificing reservoir and fluid delivery functionality. In some embodiments, the total volume occupied by the reservoir device is less than 800 cm. 3 , 700cm 3 , 600cm 3 , 500cm 3 , 400cm 3 , and / or any other suitable volume. In some embodiments, the total volume of the reservoir device is between 500 and 700 cm 3In some embodiments, the maximum longitudinal length of the reservoir 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 reservoir 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 reservoir 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 major maximum dimensions may allow the reservoir device to be easily worn without significantly interfering with mobility. Of course, sizes greater than or less than those listed above may also be employed, and the disclosure is not so limited. Furthermore, the wearable reservoir device may have any suitable dry weight, wet weight (i.e., with the medicated fluid container attached), and weight distribution, and the disclosure is not so limited.

[0136] According to the embodiment of FIG. 26, the storage device includes a fluid distribution system 650 configured to store fluid from a container that may be connected to a first port 604A and a second port 604B. As shown in FIG. 26, the storage device includes a spike 200 disposed within the first port and the second port, configured to puncture a container of medicated fluid and fluidly connect to the storage device. The spike may include a spike sheath, shape, dual channel, and / or other features according to exemplary embodiments described herein. The spike is connected via tubing 660 that forms a continuous fluid channel that terminates in an air filter 668 at one end and a fluid outlet connector 652 at the other end. The air filter is configured to allow air to enter into the fluid distribution system so that the fluid contained within the attached container may flow freely under gravity or from pumping while preventing the fluid from escaping. The fluid outlet connector is secured within a fluid outlet port 606 formed within the housing 602 and is configured to receive a fluid connector such that fluid inside the fluid distribution system can be delivered to an associated device (e.g., an infusion set, an infusion pump, other drug delivery device, etc.), an associated storage device (e.g., for storing fluid from multiple fluid storage devices), or other desired device or component. According to the embodiment of FIG. 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 of FIG. 26 is a male luer-actuated valve configured to interface with a female luer-actuated valve. Of course, 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 of FIG. 26, the reservoir device may be configured to accommodate a container of medicated fluid having a suitable volume for a prescribed dosage of the medicated fluid. In some embodiments, ports 604A, 604B may each 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. Of course, a container with any suitable volume may be employed, and the disclosure is not so limited.

[0138] According to the embodiment of FIG. 26, the reservoir device may include a lid (e.g., cover) 608, which is configured to selectively enclose the first port 604A and the second port 604B during the administration process and secure to any container disposed therein. As shown in FIG. 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 fully enclosed, and an open position in which the first and second ports are open to receive a container of medicated 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 suitable manner (e.g., fully removable, sliding, etc.), and the present disclosure is not so limited. As shown in FIG. 26, the lid includes a latch receptacle 612, which is configured to receive a latch 613 disposed on the housing. The latch is configured as a deflectable latch that enters the latch receptacle and secures to the lid when the lid is in the closed position and the latch is in an unbiased (i.e., unflexed) position. Conversely, the latch is configured to release the lid when the latch is moved to a biased (i.e., deflected) position such that the latch is removed from the latch receptacle. Of course, any suitable latch arrangement may be employed, including, but not limited to, magnetic latches and spring-loaded catches.

[0139] 26, the reservoir device may include a clip 614 configured to allow the patient to easily wear the reservoir device. The clip is secured to the housing 602 and configured to support the weight of the reservoir device and any inserted containers. The clip is configured as a belt clip that may be easily slid over a belt to hold the infusion pump around the patient's waist. Of course, any suitable clip, strap, or harness may be employed to allow the patient to wear the reservoir device, including, but not limited to, carabiners, hook and loop fasteners, strap buckles, waistbands, shoulder straps, and the like, and the disclosure is not so limited.

[0140] FIG. 27 is an exploded view of the medicated reservoir device 600 of FIG. 26. As described above, the reservoir device includes a housing 602 having a first port 604A and a second port 604B, and a base 603. Disposed within the housing and supported by the base is a fluid distribution system 650 including a spike 200, an air filter 668, and a fluid outlet connector 652 having a luer-activated valve 654 disposed within each of the ports. The tubing of the fluid distribution system is omitted from FIG. 27 for clarity. The fluid outlet connector 652 is configured to be secured between the housing and the base within the outlet port portions 606A, 606B. The reservoir device also includes a lid 608, which is mounted to the housing via a hinge 610. The lid is selectively securable in a closed position using a latch 613 and a latch receptacle 612.

[0141] As shown in FIG. 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 secured to a clip receptacle 617 formed in the housing 602 of the storage device. When the mounting portion 615 is received in or otherwise mounted to the clip receptacle 617, 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 exterior of the housing and is configured to receive an article of clothing, such as a belt. Thus, the flexible portion may be flexed away from the housing such that a belt or other article of clothing may be positioned between the flexible portion and the housing. When released, the flexible portion may releasably capture the belt or article of clothing between the flexible portion and the housing. Thus, the storage device may in effect be suspended from a belt or article of clothing by the clip. To remove the article of clothing, the flexible portion may again be flexed away from the housing and the belt or article of clothing may be removed. Of course, other arrangements of clips, including substantially rigid clips, are contemplated and any suitable clip, clasp, latch, buckle, or the like may be employed to suspend the storage device from clothing, and the disclosure is not so limited.

[0142] Figure 28 is a perspective view of the medicated storage device 600 of Figure 26 when used with a first container 402A and a 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 delivers medicated fluid from both containers to a fluid outlet connector 652 such that a larger dosage can be administered than that delivered by either of the containers alone. As shown in Figure 28, the spike 200 is disposed within the interior volumes of the containers such that the interior volumes of the containers are fluidly connected.

[0143] In contrast to the previous embodiment, 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 a first container into the first port, thereby puncturing the first container and fluidically connecting its internal volume to the fluid distribution system. The patient may then insert a second container into the second port, thereby puncturing the second container and fluidically connecting its internal volume to the fluid distribution system. Once one or both of the containers are connected, fluid may be drawn from the fluid outlet connector (e.g., through an infusion set, infusion pump, other drug delivery device, etc.).

[0144] 28, with the storage device lid 608 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 secured with the inner latch 613 of the latch receptacle 612. Thus, when in the closed position, the lid will cover both the containers and the ports, rendering them inaccessible from outside the housing. Such an arrangement may prevent unintentional removal of the containers from patient movement, collision, or other forces.

[0145] FIG. 29 is a front elevational view of various containers that may be used with the medicated storage device of FIG. 26. Without wishing to be bound by theory, the storage device according to the embodiment of FIG. 26 may be used with a variety of containers of medicated fluids of different sizes. The containers may be sized and shaped according to the size and shape of the port formed in the housing, or they may have any suitable shape that fits within the confines of the housing and lid of the storage device. As shown in FIG. 29, the first container 402A has a first height H1 and a first diameter D1, which may correspond to the interior height of the housing and the diameter of the port of the storage device. That is, the housing of the storage device may accommodate 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 inner diameter of the port on the storage device, but the height does not correspond to the interior height of the housing. It should be noted that containers with dimensions less than those of the housing's internal dimensions may also be accommodated within the storage device and held in place via features of the storage device, such as friction with a spike, a latch that secures to a bottle collar, or other suitable arrangement. As shown in FIG. 29, a third container 402C compatible with the storage device includes a second height H2 and a second diameter D2, both of which are less than those of the first container 402A. By accommodating containers of different sizes, the storage device allows for the delivery of precise dosages of medicated fluid from a variety of standardized container sizes.

[0146] 30A-30B depict front and rear perspective views, respectively, of the medicated storage device 600 of FIG. 26 with the lid 608 in a closed position. As best shown in FIGS. 30A-30B, when the lid is in the closed position, the latch 613 is disposed within the latch receptacle 612 and secured to the lid in the closed position. Thus, the port and any containers disposed therein are secured and protected from forces due to movement, impact, etc. that may interfere with the fluid connection of the containers. Thus, the storage device provides a compact, protected, wearable package for storing and delivering medicated fluids from multiple containers.

[0147] FIG. 31 is a front elevational view of another embodiment of a medicated storage device 700 configured to store medicated fluid from up to three containers. Similar to the embodiment of FIG. 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 disposed within ports formed in the housing. The storage device includes a fluid distribution system (not shown), which creates a continuous 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 FIG. 31, the medicated fluid is configured to flow from the containers to the fluid outlet connector, as indicated by arrow 758. Of course, in other embodiments, the medicated fluid may flow in any suitable direction, including toward the fluid inlet connector, and the disclosure is not so limited. The outlets may be connected to an associated device (e.g., an infusion set, infusion pump, other drug delivery device, etc.) or another storage device to supply medicated fluid from each of the three containers. The inlets are configured to receive medicated fluid from another storage device or associated medicated fluid source such that medicated fluid may be stored from multiple containers and / or multiple sources, as desired. The functionality of the fluid inlet connectors will be discussed further below with reference to Figures 32-35.

[0148] FIG. 32 depicts a front elevation view of one embodiment of a medicated fluid storage system including a first wearable storage device 600A and a second wearable storage device 600B to store fluid from multiple containers than a single fluid storage device. As shown in FIG. 32, the storage devices are each configured to accommodate two containers, with the first storage device having 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 FIG. 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. 32 includes a male Luer-actuated valve and fluid inlet connector 656 includes a female Luer-actuated valve. Of course, in other embodiments, the fluid outlet and inlet connectors may employ any suitable connection or valve configuration, and the disclosure is not so limited.

[0149] According to the embodiment of FIG. 32, the storage device includes a physical connector 618, which is configured to physically fasten the first wearable storage device 600A to the second wearable storage device 600B. In some cases, it is desirable to physically couple multiple wearable storage devices together so that they can be handled as a single unit by the patient. However, it may also be desirable to allow flexibility of the combined storage unit so that the combined storage device is not cumbersome and does not affect wearability. Thus, as shown in FIG. 32, the physical connector 618 is configured as a hinge, which allows the storage devices to rotate relative to each other about a vertical 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 waist of the wearer so that both of the storage devices can be easily suspended from a belt worn by the patient using a belt clip. Of course, the physical connector may be any suitable fastener that couples to movement of the storage device in at least one direction, and the disclosure is not so limited.

[0150] FIG. 33 is a front elevational view of another embodiment of a medicated fluid storage system including a first wearable storage device 600A and a second wearable 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 secured to clothing or otherwise worn. Such an arrangement may improve the comfort of the wearer, since many small independent devices are less cumbersome to wear or attach to clothing than a single large device. Thus, similar to the embodiment of FIG. 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 administration of medicated fluid from up to four containers 402A, 402B, 402C, 402D. However, in contrast to the embodiment of FIG. 32, the fluid inlet and outlet connectors are connected by a reservoir tubing 670, which allows 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 wearable reservoir device may be independently secured and worn on the patient's clothing or body before or after the reservoir device is connected with the tubing. As shown in FIG. 33, the reservoir tubing includes a tubing outlet connector 672 and a tubing inlet connector 674, which connect to the reservoir device's fluid outlet connector 652 and fluid inlet connector 656, respectively. The reservoir tubing may have any suitable length to allow a desired range of independent movement and placement of the reservoir devices.

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

[0152] FIG. 34 is a front elevational view of yet another embodiment of a medicated fluid storage system including a first wearable storage device 800A, a second wearable storage device 800B, and a third wearable storage device 800C, providing a modular storage system for fluidly connecting to any desired number of medicated fluid containers. In particular, the medicated fluid storage system of FIG. 34 allows the patient to minimize the total volume and size of the storage system and increase wearability, while still being expandable to accommodate various prescribed dosages. As shown in FIG. 34, the containers are each 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 a port formed in the housing 802 of each storage device by a lid 808, which is held in a closed position using a latch 813. A base 803 of each storage device supports the internal components of the storage device. Similar to the embodiment of Figure 32, the storage devices include a first physical connector 818A and a second physical connector 818B that couple the storage devices together and simplify handling and / or coupling to a patient's clothing or body.

[0153] Similar to the embodiment of Figs. 32-33, each of the storage devices 800A, 800B, 800C of Fig. 34 may be connected independently, to each other, or to an infusion set, an infusion pump, other drug delivery devices, or other associated devices. In the state shown in Fig. 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, medicated fluids from each of the containers disposed in the three storage devices are stored together and are accessible from the fluid outlet connector 854 of the third storage device 800C, or, in some embodiments, the fluid inlet connector 856 of the first storage device 800A. Thus, fluids may be delivered from the three containers simultaneously to an infusion pump, an infusion set, other drug delivery devices, or other associated devices. Of course, in other embodiments, any suitable number of storage devices and containers may be employed to achieve the desired dosage of medicated fluid, and the disclosure is not so limited.

[0154] 35 is a front elevational view of yet another embodiment of a medicated fluid storage system including a first wearable storage device 800A, a second wearable storage device 800B, and a third wearable storage device 800C, which provides a modular storage system for fluidly connecting to any desired number of medicated fluid containers and providing free movement of the storage devices relative to each other within the distance limits defined by the length of the tubing 870. As described above, in some cases it may be desirable to allow free relative movement of the wearable storage devices to simplify attachment of the storage devices to a garment or otherwise reduce the integrated bulkiness of a single connected storage system. Thus, as shown in the embodiment of FIG. 35, the wearable storage devices are interconnected with the storage tubing 870, which allows the storage devices to be independently movable relative to each other within the distance limits defined by the length of the tubing 870. The reservoir devices of FIG. 35 are similar to those of FIG. 34, with each reservoir device housing a single container (e.g., first container 402A, second container 402B, and third container 402C), and each reservoir device including a fluid inlet connector 856 and a fluid outlet connector 854. Each reservoir tubing 870 set includes a tubing outlet connector 872 and a tubing inlet connector 874, which connect to the fluid outlet connector 854 and the fluid inlet connector 856 of the reservoir device, respectively. Thus, when the reservoir tubing is connected, a continuous fluid pathway is created between the interior volumes of the containers disposed within each of the reservoir devices. In the embodiment of FIG. 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 reservoir device 800C to deliver fluid from all three containers 402A, 402B, 402C simultaneously. Of course, any suitable number of containers and storage devices may be employed, and the disclosure is not so limited. Additionally, rather than interconnecting the storage devices to one another, the storage devices may be connected in series to an infusion set, infusion pump, other drug delivery device, or associated device to deliver the appropriate volume of fluid, and the disclosure is not so limited.

[0155] FIG. 36 depicts one embodiment of an infusion set 900 having a breathing valve (i.e., degassing valve, air release valve, etc.) 909 configured to allow the infusion set to be coupled and uncoupled sequentially from one or more reservoir devices, according to exemplary embodiments described herein. As shown in FIG. 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 reservoir 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 connector of exemplary embodiments described herein. According to the embodiment of FIG. 36, the breathing valve is positioned in-line with the inlet tubing 904. The breathing valve is configured to vent air pockets that may be disposed within the inlet tubing. For example, when the infusion set is first used with a fluid source, air inside the infusion set may be vented to prime the pump engine and / or allow fluid to flow from the fluid source. In addition, the breathing valve may vent additional air bubbles that may form during fluid delivery and block the passage of air in the fluid flow. When the infusion set is disconnected from a first fluid source (e.g., a first storage device), the infusion set may at least partially refill with air. Thus, when the infusion set is connected to a second fluid source (e.g., a second storage device), the breathing valve may again vent air located within the infusion set and allow a sustained fluid flow to be delivered to the patient. Thus, the breathing valve may allow for interchange of fluid sources without requiring the patient to switch infusion sets.

[0156] As shown in FIG. 36, the infusion set also includes a needle set 920, which connects the infusion set outlet 908 and a needle set connector 932. The needle set of FIG. 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. Disposed at the end of each needle channel is an infusion needle 936A, 936B, 936C, 936D, which can be used to subcutaneously deliver fluid to a patient. Of course, in other embodiments, the needle set may include any suitable number of needles, including, but not limited to, a single needle, two needles (i.e., bifurcated), and three needles (i.e., trifurcated), and the present disclosure is not so limited.

[0157] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those skilled in the art. Thus, the foregoing description and drawings are by way of example only.

Claims

1. A medicinal fluid storage device, comprising: A housing and a first port disposed on the housing, the first port including a first spike; a second port disposed on the housing, the second port including a second spike; a tubing connecting the first spike and the second spike; a first cover configured to removably connect to the first port so as to cover the first spike; a second cover configured to removably connect to the second port so as to cover the second spike; and A medicinal fluid storage device comprising:

2. The medicinal fluid storage device of claim 1, wherein each of the first cover and the second cover includes an indicator configured to indicate a method of operation.

3. The medicinal fluid storage device of 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.

4. A medicinal fluid storage device as described in claim 1, wherein the periphery of the first port and the periphery 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.

5. A medicinal fluid storage device as described in claim 1, wherein the first cover includes a receiving portion configured to receive a protrusion disposed within the first port.

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

7. A medicinal fluid storage device as described in claim 1, wherein each of the first port and the second port includes a recess.

8. A medicinal fluid storage device as described in claim 1, wherein the medicinal fluid storage device is wearable.

9. The medicinal fluid storage device of claim 1, further comprising a belt clip, the belt clip configured to releasably attach the medicinal fluid storage device to a belt worn by a patient.

10. A medicinal fluid storage device as described in claim 1, wherein the first cover is movable between an open position and a closed position, and wherein the first cover is configured to surround the first spike in the closed position.

11. A medicinal fluid storage device as described in claim 10, wherein the first cover includes a hinge, and the cover rotates about the hinge between the open position and the closed position.

12. The medicinal fluid storage device of claim 1, further comprising a first spike sheath covering the first spike, the first spike sheath forming a seal against the first spike prior to insertion of a first container into the first port.

13. The medicinal fluid storage device of claim 1, further comprising a second spike sheath covering the second spike, the second spike sheath forming a seal against the second spike prior to insertion of a second container into the second port.

14. A system comprising:

1. A storage device for storing a medicinal fluid, the storage device comprising: a first cover configured to be removed to expose a first port of the storage device, the first port including a first spike; a second cover configured to be removed to expose a second port of the storage device, the second port including a second spike; A storage device comprising: a first container configured to be connected to the first port by being pushed onto the first spike, the first container being pierced by the first spike to allow fluid communication between the first spike and an interior volume of the first container, the interior volume of the first container containing a medicated fluid, the first spike being in fluid communication with tubing; a second container configured to be connected to the second port by being pushed onto the second spike, the second container being pierced by the second spike to allow fluid communication between the second spike and an interior volume of the second container, the interior volume of the second container containing a medicated fluid, and the second spike being in fluid communication with the tubing; Equipped with The system, wherein the tubing is configured to allow the medicated fluid to travel through the tubing.

15. The system of claim 14, 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 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 allowing the third container to be punctured by the third spike, a third spike sheath forming a seal against the third spike, the third internal volume containing a third medicinal fluid, and the third spike in fluid communication with a second tubing.

16. The system of claim 15, further comprising a syringe configured to be coupled to the second tubing such that the third medicinal fluid is moved into the syringe.

17. The system of claim 14, further comprising a first spike sheath, the first spike sheath covering the first spike, the first spike sheath forming a seal against the first spike prior to insertion of the first container into the first port.

18. The system of claim 15, wherein the first container and the third container are different sizes.

19. The system described in claim 17, wherein the volume of the first container is 1.1 mL to 300 mL.

20. The system described in claim 15, wherein each of the volumes of the first container and the third container is selected from the group of 5 mL, 10 mL, 20 mL, and 40 mL.

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