Single or multiple container storage device

Abstract

To provide a storage device used for medical purposes.SOLUTION: A storage device 10 is provided for storing fluid from a container unit 12 having at least one container 14, 16. The device includes: an inlet port having at least one inlet channel configured to receive fluid or ambient air; and an outlet port 26 having at least one outlet channel configured to deliver fluid to a mounting part. Both inlet and outlet ports are located on the device. A cavity is provided to accommodate insertion of the container unit for storing fluid from at least one container. At least one spike is disposed within the cavity, and the at least one spike is configured to pierce a stopper of the at least one container when the container unit transitions from an upper position to a lower position.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (Related Applications) This application claims priority under U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 182,099, filed June 19, 2015, which is incorporated herein by reference.

[0002] The present disclosure relates generally to reservoir devices used for medical purposes, and more particularly to devices configured to reservoir contents from a medication container for concurrent use. [Background technology]

[0003] In many cases, pharmaceutical agents or fluids are separated prior to use due to their chemical and physical stability. Therefore, the fluids are individually packaged and stored until they are mixed together for intravenous administration to a patient. Traditionally, mixing of fluids is accomplished by a healthcare professional injecting a first fluid into a glass vial or container containing a second fluid. After mixing the first and second fluids, the mixed solution is drawn into a syringe and injected intravenously into the patient. In some cases, the two solutions are mixed in, or the mixed solution is transferred to, a larger container, such as an intravenous (IV) administration bag or set, prior to delivery to the patient.

[0004] Some medical fluids are administered sequentially without mixing. For example, a first fluid may be administered first to improve a condition, under which the second fluid may be delivered to or processed by the patient. An exemplary dual medical container unit for administering first and second fluids is described in commonly owned U.S. Patent No. 8,684,433, which is incorporated by reference. In some cases, several vials of medical fluid must be combined to provide the correct dose to the patient. Patients with certain immunodeficiency diseases are treated with infusions of relatively large volumes of immune globulin (IG) fluid. The first fluid medication is applied to improve the body's tolerance to the second medication, a relatively high-viscosity IG fluid. Traditionally, medical personnel administering the fluids verify the identity and concentration of the fluids, disinfect the corresponding stoppers of each container using a disinfectant such as alcohol, pierce the stoppers of each container for fluid delivery, use multiple syringes and reservoir bags to separately store the fluids from each container, and then administer the fluids to the patient sequentially. In some cases, the dual container unit is manually lifted or hung from an IV pole, whereby one or more of the fluids are delivered to the reservoir bag by gravity flow.

[0005] Due to this multi-step process, which is alternatively performed by the patient at home in some cases, traditional administration methods are prone to mishandling and errors. For example, bottles, vials, or other containers can be mishandled and even damaged or broken. Furthermore, several manual steps are currently required to achieve the desired sequence of administration in a sterile environment, and due to the large number of manual steps, a significant amount of time is wasted and considerable space is required to store equipment inventory during use. If the sterile administration of pharmaceutical fluids is compromised, bacterial or environmental contamination can occur. Any of these problems can adversely affect the administration of fluids to patients and their health.

[0006] Therefore, there is a need to develop an improved reservoir device that provides an improved method of administration for single or multiple medication containers in a simpler and more reliable manner. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 8,684,433 Summary of the Invention [Means for solving the problem]

[0008] The present disclosure is directed to a storage device for storing medical fluid from at least one medical container, which storage device integrates many of the manual steps described above. An important aspect of the storage device is that a central cavity configured to receive the medical container is provided for storing the medical fluid from the medical container without repeatedly loading different medical containers. An internal lumen spike is disposed within the cavity for piercing the stopper of each medical container, and a locking mechanism is provided for securely holding the medical container within the cavity of the storage device.

[0009] In some embodiments, two or more of the present storage devices are linkable or connectable in a complementary relationship so that separate medical containers are automatically administered to a user or patient in succession during operation without the need to exchange medical containers. By way of example only, the outlet of one of the present storage devices is linked or daisy-chained to the inlet of another storage device to facilitate seamless fluid path connection between all linked storage devices. In this configuration, two or more medicinal fluids can be administered to a user in relatively large volumes (in the range of several hundred ml) without disrupting or manipulating the medical containers. It is envisioned that linked storage devices can be inverted from the orientation described above.

[0010] In one embodiment, a storage device is provided for storing fluid from a container unit having at least one container, the storage device including an inlet port having at least one inlet channel configured to receive fluid or ambient air, and an outlet port having at least one outlet channel configured to deliver fluid to a mounting portion. Both the inlet and outlet ports are disposed on the device. A cavity is provided to accommodate insertion of the container unit to store fluid from the at least one container. At least one spike is disposed within the cavity and configured to pierce a stopper of the at least one container when the container unit transitions from the upper position to the lower position.

[0011] In another embodiment, a storage device is provided for storing a medical fluid, the storage device including a container unit having at least one container configured to store the fluid, the container unit being pre-attached to the storage device. The storage device also includes an inlet port having at least one inlet channel configured to receive the fluid or ambient air. An outlet port having at least one outlet channel is provided for delivering the fluid to the attachment. Both the inlet and outlet ports are disposed on the storage device. A cavity is provided to accommodate insertion of the container unit from the pre-attached position to store the fluid from the at least one container. At least one spike is disposed in the cavity and configured to pierce a stopper of the at least one container when the container unit transitions from the upper position to the lower position.

[0012] In yet another embodiment, a device is provided for storing a medical fluid, the device including a container unit having at least one container configured to store the fluid, the container unit being pre-attached to the storage device. An inlet port having at least one inlet channel is provided for receiving the fluid or ambient air. An outlet port having at least one outlet channel is provided for delivering the fluid to the attachment. Both the inlet and outlet ports are disposed on the storage device. A cavity is provided to accommodate insertion of the container unit from the pre-attached position to store the fluid from the at least one container. At least one spike is disposed within the cavity and configured to pierce the stopper of the at least one container when the container unit transitions from the upper position to the lower position. The storage device is complementary connectable to another storage device in a series arrangement relative to the longitudinal axis of each storage device to establish an uninterrupted supply of fluid from the connected storage device.

[0013] In yet another embodiment, a storage device is provided for storing fluid from a container unit having at least one container, the storage device including an inlet port having at least one inlet channel configured to receive fluid or ambient air. An outlet port having at least one outlet channel configured to deliver fluid to the attachment is also included in the storage device, the inlet and outlet ports being disposed on the storage device. A cavity is configured to accommodate insertion of the container unit to store fluid from the at least one container. At least one spike is disposed in the cavity and configured to pierce a stopper of the at least one container when the container unit transitions from the upper position to the lower position.

[0014] More specifically, the inlet port is connected via a corresponding tube to an outlet port in fluid communication with at least one spike, the at least one spike having a first spike channel connected to the at least one inlet channel, and a second spike channel connected to the at least one outlet channel. At least one of the inlet and outlet ports has a protective cover to protect the corresponding inlet and outlet channel from contamination, and the at least one spike protrudes normal to the inner surface of the base of the reservoir device.

[0015] A locking mechanism is provided for the storage device and configured to securely hold the container unit within the cavity during use, the locking mechanism preferably being located on an inner wall of the cavity. The cavity is configured to accommodate insertion of the container unit to store fluid from a single container. The at least one container is configured to store fluid, and the container unit is attached to the storage device. A lockout mechanism is provided for the storage device and configured to stop movement of the container unit from the upper position to the lower position.

[0016] A lockout pin is included for the container unit, the lockout pin being insertable into a slot located on the body of the container unit. A press bar is located on the container unit so that pressing the press bar downward causes the container unit to transition from the upper position to the lower position. Advantageously, the storage device is connectable in series with another storage device in a complementary relationship to establish an uninterrupted supply of fluid from the connected storage device. Preferably, the inlet port of a first storage device is configured to be insertable into the outlet port of a second storage device in a complementary relationship. The first and second storage devices are connected in series together in a complementary relationship with respect to the longitudinal axis of the storage device.

[0017] A cap remover is provided for the storage device, the cap remover being attached to at least one container and configured to remove a top cap of the at least one container. The leak prevention mechanism has a fluid connection assembly configured to control a fluid path within the storage device and an air connection assembly configured to control an air vent path within the storage device. The air connection assembly includes an air path connector connected to an inlet port of the storage device via a hydrophobic filter.

[0018] The fluid connection assembly includes a first fluid check valve connected to the outlet port of the storage device for selectively regulating directional fluid flow of the fluid, and a second fluid check valve connected to the inlet port of the storage device for selectively regulating directional fluid flow of the fluid. The first fluid check valve has a first fluid path connector configured for releasably and complementary connection to a second check valve of another storage device, and the second fluid check valve has a second fluid path connector configured for releasably and complementary connection to the first fluid check valve of another storage device. The cracking pressures of the first and second fluid check valves are in the range of 3 to 5 pounds per square inch.

[0019] The air connection assembly includes an air path plug or end component having a blind cavity configured for releasably connecting to a complementary air path connector of another storage device. The fluid connection assembly includes a first female member having a first female member opening configured to accommodate insertion of a first male member of the fluid connection assembly. The fluid connection assembly also includes an assembly locking mechanism configured to releasably connect the first female and male members of the fluid connection assembly. Specifically, the first female member has a first seal fixture configured to prevent directional fluid flow, and the first male member has a second seal fixture configured to prevent directional fluid flow. Additionally, the first female member has a post depending from its inner upper surface, and the first male member has a backup washer having a central throughbore dimensioned to accommodate insertion of the post of the first female member. Also included within the air connection assembly is a second female member having a second female member opening configured to accommodate insertion of the second male member of the air connection assembly.

[0020] A hydrophobic filter is disposed within the second female member opening of the second female member, and the second male member is configured to create an airtight interference fit between the sheath and the second female member. Preferably, the second male member is enclosed by a sheath having an annular protrusion. A plurality of fluid and air pathway tubes are provided within the storage device, the pathway tubes being constructed and arranged to place at least one of the air vent pathway and the fluid pathway of the storage device in fluid communication with each other.

[0021] The air connection assembly is simultaneously connected to and shared by at least two containers of the storage device, and the fluid connection assembly preferably includes a first force-activated valve connected to the outlet port of the storage device for selectively regulating directional fluid flow of the fluid. The fluid connection assembly also includes a second force-activated valve connected to the inlet port of the storage device for selectively regulating directional fluid flow of the fluid. Included within the fluid connection assembly is a unidirectional check valve connected to the inlet port of the storage device for selectively regulating directional fluid flow of the fluid.

[0022] At least one spike is enclosed by a spike sheath, the spike sheath configured to fluidly connect the inlet and outlet ports of the storage device. The fluid connection assembly includes a spike connector and an access dome valve. Specifically, the access dome valve has an opening configured to accommodate insertion of the spike connector in a complementary relationship. The fluid connection assembly includes at least one of a hydrophobic filter and a hydrophilic filter. The hydrophobic filter is preferably connected to the inlet port of the storage device to selectively adjust the directional air flow of the storage device. Alternatively, or in addition, the hydrophilic filter is connected to the outlet port of the storage device to selectively adjust the directional air flow of the storage device.

[0023] The tray member includes at least one storage device integrated into the tray member in fluid communication therewith. Preferably, the tray member includes a flow cover having at least one flow passage and attached to the tray member to facilitate fluid communication. The tray member further includes a positioning valve configured to selectively adjust a flow path from at least one container. At least one hydrophobic filter is connected to at least one of the inlet port and the outlet port. Similarly, at least one hydrophilic filter is connected to at least one of the inlet port and the outlet port. In another embodiment, the tray member includes multiple storage devices integrated into the tray member in fluid communication therewith. In this configuration, the tray member preferably includes two separate tubes configured to transport two separate fluids from the multiple storage devices to the outlet port.

[0024] In yet another embodiment, a storage device is provided for storing a medical fluid, the storage device including a container unit having at least one container configured to store the fluid, the container unit attached to the storage device. An inlet port has at least one inlet channel configured to receive fluid or ambient air. An outlet port has at least one outlet channel configured to deliver fluid to a mounting portion, the inlet and outlet ports being disposed on the storage device. A cavity is configured to accommodate insertion of the container unit to store fluid from the at least one container. At least one spike is disposed within the cavity and configured to pierce a stopper of the at least one container when the container unit transitions from the upper position to the lower position. The storage device is complementary connectable to another storage device in a series arrangement for each connected storage device to establish an uninterrupted supply of fluid from the storage device. Also included within the storage device is a first wing configured to accommodate the outlet port and a second wing configured to accommodate the inlet port. The second wing is displaced vertically relative to the first wing.

[0025] The foregoing and other aspects and features of the present disclosure will become apparent to those skilled in the art from the following detailed description when considered in conjunction with the accompanying drawings. The present invention provides, for example, the following. (Item 1) A storage device

[10] for storing fluid from a container unit

[12] having at least one container [14, 16], said storage device comprising: an inlet port

[18] having at least one inlet channel [22, 24] configured to receive the fluid or ambient air; an outlet port

[26] having at least one outlet channel [32, 34] configured to deliver the fluid to a fitting, the inlet and outlet ports being disposed on the reservoir device; and a cavity

[40] configured to accommodate insertion of the container unit

[12] for storing the fluid from the at least one container [14, 16]; at least one spike [48, 50] disposed within the cavity; Equipped with a storage device, wherein the at least one spike is configured to pierce a stopper [44, 46] of the at least one container when the container unit transitions from an upper position to a lower position. (Item 2) Item 1, wherein the inlet port

[18] is connected to the outlet port

[26] in fluid communication with the at least one spike [48, 50] via a corresponding tube

[64] . (Item 3) 3. The reservoir device according to item 1 or 2, wherein the at least one spike [48, 50] has a first spike channel [62, 70] connected to the at least one inlet channel [22, 24]. (Item 4) 4. The storage device according to any one of items 1 to 3, wherein the at least one spike [48, 50] has a second spike channel [66, 72] connected to the at least one outlet channel [32, 34]. (Item 5) 5. The storage device according to any one of items 1 to 4, wherein at least one of the inlet and outlet ports [18, 26] has a protective cover

[38] to protect the corresponding inlet and outlet channels [22, 24; 32, 34] from contamination. (Item 6) 6. The storage device according to any one of items 1 to 5, wherein the at least one spike [48, 50] protrudes normal to the inner surface

[52] of the base

[54] of the storage device

[10] . (Item 7) 7. The storage device according to any one of items 1 to 6, wherein the storage device

[10] has a locking mechanism

[58] configured to securely hold the container unit

[12] within the cavity

[40] during use. (Item 8) Item 8. The storage device according to item 7, wherein the locking mechanism

[58] is disposed on an inner wall

[60] of the cavity

[40] . (Item 9) 9. The storage device according to any one of items 1 to 8, wherein the cavity

[40] is configured to accommodate insertion of the container unit

[12] for storing fluid from a single container [14, 16]. (Item 10) 10. The storage device according to any one of items 1 to 9, wherein the at least one container [14, 16] is configured to store the fluid, and the container unit

[12] is attached to the storage device

[10] . (Item 11) The storage device according to any one of items 1 to 10, wherein the storage device

[10] includes a lockout mechanism

[76] configured to stop the transition of the container unit

[12] from the upper position to the lower position. (Item 12) 12. The storage device according to any one of items 1 to 11, wherein the container unit

[12] includes a lockout pin

[76] insertable into a slot

[78] disposed on the body

[80] of the container unit

[12] . (Item 13) The storage device according to any one of items 1 to 12, wherein a press bar

[82] is disposed on the container unit

[12] , and the press bar moves the container unit

[12] from the upper position to the lower position by pressing the press bar downward. (Item 14) 14. The storage device according to any one of items 1 to 13, wherein the storage device

[10] is connectable in series with another storage device in a complementary relationship to establish an uninterrupted supply of fluid from the connected storage devices [74a, 74b, 74c]. (Item 15) 15. The storage device according to any one of items 1 to 14, wherein the inlet port of a first storage device [74a] is configured to be insertable into the outlet port [26b] of a second storage device [74b] in a complementary relationship. (Item 16) 16. The storage device according to any one of items 1 to 15, wherein the first storage device [74a] and the second storage device [74b] are connected together in series in a complementary relationship with respect to the longitudinal axis of each storage device. (Item 17) The storage device

[10] is attached to the at least one container [14, 16] and includes a cap remover

[0198] configured to remove the top cap

[42] of the at least one container. (Item 18) A storage device described in any of items 1 to 17, further comprising a leak prevention mechanism

[0102] , the leak prevention mechanism having a fluid connection assembly

[0104] configured to control a fluid path within the storage device

[10] , and an air connection assembly

[0106] configured to control an air ventilation path within the storage device. (Item 19) A storage device as described in Item 18, wherein the air connection assembly

[0106] includes an air path connector

[0116] connected to the inlet port

[18] of the storage device

[10] via a hydrophobic filter

[0118] . (Item 20) The storage device described in Item 18, wherein the fluid connection assembly

[0104] includes a first fluid check valve

[0108] connected to the outlet port

[26] of the storage device

[10] for selectively adjusting the directional fluid flow of the fluid. (Item 21) A storage device as described in Item 18, wherein the fluid connection assembly

[0104] includes a second fluid check valve

[0110] connected to the inlet port

[18] of the storage device

[10] for selectively adjusting the directional fluid flow of the fluid. (Item 22) A storage device as described in Item 20, wherein the first fluid check valve

[0108] has a first fluid pathway connector

[0112] configured for releasably and complementary connection to a second check valve

[0110] of another storage device. (Item 23) A storage device as described in Item 21, wherein the second fluid check valve

[0110] has a second fluid pathway connector

[0114] configured for releasably and complementary connection to the first fluid check valve

[0108] of another storage device. (Item 24) 21. The storage device according to item 20, wherein the cracking pressure of the first and second fluid check valves [108, 110] is in the range of 3 to 5 pounds per square inch. (Item 25) A storage device as described in Item 18, wherein the air connection assembly

[0106] includes an air path plug

[0120] having a blind cavity

[0122] , the air path plug being configured for releasably and complementary connection to the air path connector

[0116] of another storage device. (Item 26) A storage device as described in Item 18, wherein the fluid connection assembly

[0104] includes a first female member

[0124] having a first female member opening

[0126] configured to accommodate insertion of the first male member

[0128] of the fluid connection assembly. (Item 27) A storage device as described in Item 26, wherein the fluid connection assembly

[0104] includes an assembly locking mechanism

[0130] configured to releasably connect the first female member and the first male member of the fluid connection assembly. (Item 28) A storage device as described in Item 26, wherein the first female member has a first seal fixture

[0138] configured to prevent directional fluid flow of the fluid. (Item 29) A storage device as described in Item 26, wherein the first male member has a second seal fixture

[0150] configured to prevent directional fluid flow of the fluid. (Item 30) A storage device as described in item 26, wherein the first female member has a post

[0146] depending from the inner upper surface of the first female member

[0124] . (Item 31) A storage device as described in item 30, wherein the first male member has a backup washer

[0160] having a central through bore

[0162] dimensioned to accommodate insertion of the post of the first female member. (Item 32) A storage device as described in item 18, wherein the air connection assembly includes a second female member

[0164] having a second female member opening

[0166] configured to accommodate insertion of the second male member

[0168] of the air connection assembly. (Item 33) A storage device as described in item 32, wherein a hydrophobic filter

[0118] is disposed within the second female member opening of the second female member. (Item 34) Item 33. The storage device of item 32, wherein the second male member is configured to create an airtight interference fit between the sheath and the second female member. (Item 35) A storage device as described in Item 32, wherein the second male member is enclosed in a sheath

[0172] having an annular protrusion

[0174] . (Item 36) Item 19. The storage device of item 18, wherein a plurality of fluid and air pathway tubes

[64] are provided within the storage device, the pathway tubes being constructed and arranged to place at least one of the air vent pathway and the fluid pathway of the storage device in fluid communication with one another. (Item 37) A storage device as described in Item 36, wherein the air connection assembly

[0106] is simultaneously connected to and shared by at least two containers of the storage device. (Item 38) A storage device as described in Item 18, wherein the fluid connection assembly

[0104] includes a first force-activated valve

[0182] connected to the outlet port of the storage device for selectively adjusting the directional fluid flow of the fluid. (Item 39) A storage device as described in Item 18, wherein the fluid connection assembly

[0104] includes a second force-activated valve

[0184] connected to the inlet port of the storage device for selectively adjusting the directional fluid flow of the fluid. (Item 40) A storage device as described in Item 18, wherein the fluid connection assembly

[0104] includes a one-way check valve

[0186] connected to the inlet port of the storage device to selectively adjust the directional fluid flow of the fluid. (Item 41) A storage device as described in Item 18, wherein the at least one spike is enclosed by a spike sheath

[0190] configured to connect the inlet and outlet ports of the storage device in fluid communication. (Item 42) A storage device as described in item 18, wherein the fluid connection assembly includes a spike connector

[0192] and an access dome valve

[0194] . (Item 43) A storage device as described in item 42, wherein the access dome valve

[0194] has an opening configured to accommodate insertion of the spike connector

[0192] in a complementary relationship. (Item 44) The storage device of item 18, wherein the fluid connection assembly includes at least one of a hydrophobic filter [118, 206] and a hydrophilic filter

[0208] . (Item 45) Item 45. The storage device according to item 44, wherein the hydrophobic filter [118, 206] is connected to an inlet port of the storage device to selectively adjust the directional air flow of the storage device. (Item 46) Item 45. A storage device as described in Item 44, wherein the hydrophilic filter

[0208] is connected to an outlet port of the storage device to selectively adjust the directional air flow of the storage device. (Item 47) A storage device described in any one of items 1 to 46, further comprising a tray member

[0210] , the tray member including at least one storage device incorporated therein in a fluid communication state. (Item 48) A storage device as described in Item 47, wherein the tray member

[0210] includes a flow cover

[0212] having at least one flow passage, the flow cover being attached to the tray member to promote the fluid communication. (Item 49) Item 50: The storage device of Item 47, wherein the tray member

[0210] includes a positioning valve

[0216] configured to selectively adjust the flow path from the at least one container. Item 49. The storage device according to any one of items 1 to 49, wherein at least one hydrophobic filter [118, 206] is connected to at least one of the inlet port and the outlet port. (Item 51) 51. The storage device according to any one of items 1 to 50, wherein at least one hydrophilic filter

[0208] is connected to at least one of the inlet port and the outlet port. (Item 52) A storage device described in any one of items 1 to 51, further comprising a tray member

[0210] , the tray member including a plurality of the storage devices embedded within the tray member in a fluid communication state. (Item 53) A storage device as described in Item 52, wherein the tray member

[0210] includes two separate tubes

[64] configured to transport two separate fluids from the plurality of storage devices to the outlet port. (Item 54) A storage device

[10] for storing a medicinal fluid, said storage device comprising: a container unit

[12] having at least one container [14, 16] configured to store the fluid, the container unit being attached to the storage device; an inlet port

[18] having at least one inlet channel [22, 24] configured to receive the fluid or ambient air; an outlet port

[26] having at least one outlet channel [32, 34] configured to deliver the fluid to a fitting, the inlet and outlet ports being disposed on the reservoir device; and a cavity

[40] configured to accommodate insertion of the container unit

[12] for storing the fluid from the at least one container [14, 16]; at least one spike [48, 50] disposed within the cavity; Equipped with the at least one spike is configured to pierce a stopper [44, 46] of the at least one container when the container unit moves from an upper position to a lower position; A storage device, wherein the storage device

[10] is complementary connectable to another storage device in a series arrangement for each connected storage device to establish an uninterrupted supply of the fluid from the storage device. (Item 55) Item 55. The storage device according to item 54, wherein the storage device

[10] includes a first wing

[88] configured to accommodate the outlet port and a second wing

[90] configured to accommodate the inlet port. (Item 56) 56. The storage device according to item 54 or 55, wherein the second wing

[90] is vertically displaced relative to the first wing

[88] . [Brief explanation of the drawings]

[0026] [Figure 1] FIG. 1 is a perspective view of a first embodiment of the present reservoir device, featuring an exemplary dual medical container unit and an exemplary set of infusion tubing. [Figure 2] FIG. 2 is a plan view of the reservoir device of FIG. 1, featuring exemplary inlet and outlet ports for fluid delivery and integrated spikes disposed laterally on the inner surface of the reservoir device for piercing the stopper of a corresponding medical container. [Figure 3] FIG. 3 is a partial plan view of the reservoir device of FIG. 2, featuring an exemplary outlet port disposed on an exterior surface of the reservoir device for releasably connecting to a set of infusion tubing. [Figure 4] FIG. 4 is a perspective view of a second embodiment of the present storage device having a lockout pin, illustrating an exemplary arrangement of two adjacent storage devices prior to connection. [Figure 5] FIG. 5 is a perspective view of the reservoir device of FIG. 4 after connection. [Figure 6] FIG. 6 is a schematic front view of the reservoir device of FIG. 5, featuring an exemplary illustration of fluid pathways between connected medical containers. [Figure 7]FIG. 7 is a side perspective view of a third embodiment of the present storage device, illustrating another example arrangement of two connected storage devices with different configurations for the lockout pin and inlet and outlet ports. [Figure 8] FIG. 8 is a rear perspective view of the storage devices of FIG. 7 when adjacent storage devices are interconnected. [Figure 9] FIG. 9 is a rear perspective view of the storage device of FIG. 7 with adjacent storage devices disconnected. [Figure 10] FIG. 10 is a schematic front view of the reservoir device of FIG. 5, featuring a leak prevention mechanism with fluid and air connection assemblies. [Figure 10A] FIG. 10A is a schematic front view of the leak prevention mechanism of FIG. 10, featuring an exemplary combination of two force-activated valves. [Figure 10B] FIG. 10B is a schematic front view of the leak prevention mechanism of FIG. 10, featuring an exemplary combination of a force-activated valve and a one-way check valve. [Figure 10C] FIG. 10C is a schematic front view of the leak prevention mechanism of FIG. 10, featuring an exemplary combination of a spike connector and an access dome valve. [Figure 11] FIG. 11 is a schematic front view of the storage devices of FIG. 10 when adjacent storage devices are interconnected via a leak prevention mechanism. [Figure 12] FIG. 12 is an exploded fragmentary vertical cross-section of the fluid connection assembly of FIG. [Figure 13] FIG. 13 is an exploded fragmentary vertical cross-section of the air connection assembly of FIG. [Figure 14] FIG. 14 is a vertical cross section of the leak prevention mechanism of FIG. 10 illustrating the fluid pathways of the fluid connection assembly. [Figure 15] FIG. 15 is a bottom view of the leak prevention mechanism of FIG. [Figure 16] FIG. 16 is a bottom view of the leak prevention mechanism of FIG. 10 configured to facilitate a dual medical container unit. [Figure 17A]17A is a top perspective view of an exemplary cap remover designed to be used with the reservoir device of FIG. 1. FIG. [Figure 17B] FIG. 17B is a bottom perspective view of the cap remover of FIG. 17A. [Figure 17C] 17C-17D illustrate an exemplary use of the cap remover of FIG. 17A. [Figure 17D] 17C-17D illustrate an exemplary use of the cap remover of FIG. 17A. [Figure 18] FIG. 18 is a schematic front view of the leak prevention mechanism of FIG. 10, featuring an exemplary combination of hydrophobic and hydrophilic filters. [Figure 19] FIG. 19 is an exploded perspective view of an exemplary tray incorporating the present storage devices in an in-line configuration. [Figure 20] FIG. 20 is an exploded perspective view of an exemplary modular unit featuring the present reservoir device with a hydrophobic filter. DETAILED DESCRIPTION OF THE INVENTION

[0027] Although specific embodiments of the storage device are described herein, other alternative embodiments of all components associated with the storage device are also interchangeable as suitable for different applications. The term "storage device," as used herein, refers to a device for accessing medicinal fluid from one or more medical containers for administering the medicinal fluid to a patient. Thus, not only storage devices used to administer medicinal fluid from a single container, but also storage devices used to administer medicinal fluid from several medical containers are contemplated.

[0028] 1-3 , the present storage device, generally designated as 10, is designed to store a medical fluid or substance from a medical container unit, generally designated as 12, having a first medical container 14 configured to store a first medical fluid and a second medical container 16 configured to store a second medical fluid. In some embodiments, the present storage device 10 is a disposable unit, avoiding potential contamination from reuse. As previously mentioned, an exemplary dual medical container unit 12 is described in commonly owned U.S. Patent No. 8,684,433, which is incorporated by reference. While other medical substances are also contemplated for use with the present device 10, in one embodiment, the first medical container 16 contains an enzyme that enlarges pores within the patient's subcutaneous space. The enlarged pores facilitate delivery by injection of a large volume of the relatively high-viscosity IG fluid contained within the second container 14. For example, without the enzyme, the expected injection of IG fluid is approximately 50 ml at a single site. However, with the enzyme, infusions in the range of 600 ml can be achieved at a single infusion site.

[0029] Although the container unit 12 is shown having two medical containers 14, 16, it is also contemplated that the container unit may have a single container (e.g., a syringe, vial, film bag, ampoule, and the like). In one embodiment, the storage device 10 has a generally rectangular shape when viewed from above, although other suitable shapes, such as oval, square, and other geometric shapes, are also contemplated. It is also contemplated that any number or combination of medical containers may be used for the storage device 10, as may be suitable for different applications.

[0030] The storage device 10 includes an inlet port 18 configured to receive medicinal fluid or ambient air, the inlet port being located on an outer wall 20 of the storage device. In some embodiments, as described in more detail below, the inlet port 18 receives medicinal fluid from an adjacent storage device when the storage devices are coupled together (FIGS. 4 and 5). Otherwise, the inlet port 18 serves as a vent for drawing in ambient air while the storage device 10 is not coupled to an adjacent storage device. As described below with respect to FIG. 6, when storage devices 10 are coupled together, proper venting of air between each device and the container has been found to improve continuous delivery of medication. Depending on the configuration of the container unit 12, the inlet port 18 may have one or more inlet channels 22, 24 that correspond to medical containers 14, 16 during use.

[0031] To deliver the medical fluid from the storage device 10, an outlet port 26 is located on the opposite side of the storage device's outer wall 20 from the inlet port 18 and is configured to deliver the medical fluid to an adjacent storage device or another medical attachment, such as an infusion tubing set 28. In some embodiments, the infusion tubing set 28 is removably connected at one end to the outlet port 26 of the storage device 10 and at an opposite end to a pumping system (not shown), such as a peristaltic pump or infusion device, for drawing the medical fluid from the storage device 10. Alternatively, a syringe (not shown) can be docked to the outlet port 26 for vacuum withdrawal of the medical fluid from the storage device 10.

[0032] Regulating the flow of medical fluid within the set of tubing 28 is achieved by adjusting at least one clamp 30 transversely relative to the longitudinal axis of the corresponding tubing. Other clamping devices that transition between occluding and non-occluding positions are envisioned as known in the art. Like the inlet port 18, the outlet port 26 may have one or more outlet channels 32, 34 that correspond to the medical containers 14, 16 during use.

[0033] In some embodiments, each channel 22, 24, 32, 34 has a resiliently deformable seal 36, such as an O-ring, located at the inlet of the corresponding channel to facilitate a friction-fit or slip connection between the connected inlet port 18 and outlet port 26, or between the outlet port 26 and the set of infusion tubing 28. It is envisioned that a removable protective cover 38 is friction-fit over or around each port 18, 26 to protect the corresponding inlet and outlet channels 22, 24, 32, 34 from contact or air contamination.

[0034] In some embodiments, a central opening or cavity 40 is provided that is configured to accommodate insertion of the medical container unit 12 for storing first and second medical fluids from the first and second medical containers 14, 16. Prior to insertion of the medical container unit 12 into the cavity 40, the top cap 42 of the medical container unit is removed to expose the corresponding first and second stoppers 44, 46 of the first and second containers 14, 16. Terminal sterilization of the stoppers 44, 46 is performed using a disinfectant such as alcohol, hydrogen peroxide, or the like.

[0035] A first luminal spike or needle 48 is disposed within the cavity 40 for piercing the first stopper 44 of the first medical container 14, and a second luminal spike or needle 50 is disposed within the cavity for piercing the second stopper 46 of the second medical container 16. Both spikes 48, 50 are preferably integrally attached laterally to an inner surface 52 of a base 54 of the reservoir device 10 such that the spikes project normal from the base to simultaneously pierce the first and second stoppers 44, 46 of the corresponding first and second medical containers 14, 16. In some cases, the first and second stoppers 44, 46 of the corresponding first and second containers 14, 16 are pierced separately as appropriate for different applications. In some embodiments, a protective removable sleeve or sheath 56 is provided for each spike 48, 50 to cover the sharp end point of each spike.

[0036] Initiation of medical fluid delivery is accomplished by inverting the container unit 12 so that the container unit transitions from an upper position to a lower position and inserting the container unit into the cavity 40. Specifically, in this depicted embodiment, during insertion, the first and second stoppers 44, 46 of the first and second containers 14, 16 are forced against and pierced by the first and second lumen spikes 48, 50, respectively. It is also envisioned that the protective seal provided by the sleeve 56 is breached upon inversion and downward insertion of the container unit 12. In this depicted embodiment, a bias-, clip-, or clamp-type locking mechanism 58 disposed on the interior wall 60 of the cavity 40 is provided to hold the container unit 12 spaced above the base 54 such that the spikes 48, 50 are inaccessible to the containers 14, 16 unless the containers are properly positioned on the appropriate spikes.

[0037] 2, to facilitate proper orientation of the container within the unit 12, the cavity 40 is dimensioned so that the container unit 12 can be aligned with the cavity and inserted only in the correct orientation. When the container 14, 16 is properly positioned within the cavity 40, the locking clips 58 are forced radially outward by the presence of the container, which allows the container unit 12 to nest, slide, or move downward relative to the base 54, enabling engagement between the container and the designated spikes 48, 50. The spikes 48, 50 puncture the stoppers 44, 46 of the corresponding containers 14, 16, initiating delivery of the respective contained medical fluids.

[0038] To facilitate fluid delivery of the first medical fluid, the first spike 48 has a first spike channel 62 connected to the first inlet channel 22 via corresponding tubing 64. Additionally, the first spike 48 has a second spike channel 66 connected to the first outlet channel 32 via corresponding tubing 64. In a preferred embodiment, at least one check valve 68 is inserted within or grounded to the tubing 64 to selectively control the directional flow of the medical fluid. The terms "tube" or "tubing" include or relate to any fixed or flexible fluid passage or pathway, such as a groove, either separate from or integral with the present reservoir device 10, and are envisioned to have various cross-sectional shapes (e.g., round, square, or other shapes) depending on the application and method of construction.

[0039] It is contemplated that tubing 64 will be configured to interconnect inlet port 18, spikes 48, 50, and outlet port 26, as is known in the art. As a result, upon activation of storage device 10, a continuous flow path will be established from inlet port 18 to outlet port 26, fluidly communicating with first container 14. As described in more detail below in the paragraphs relating to Figures 10-16, it is contemplated that a hydrophobic filter will also be used within tubing 64 or other suitable location of storage device 10 to allow air to pass through the storage device but prevent medicinal fluid from leaking therefrom. An additional check valve may be located below base 54 to prevent medicinal fluid from proceeding to adjacent units connected via spikes 48, 50.

[0040] More specifically, as illustrated in Figure 2, in a configuration in which the storage device 10 is not coupled to another storage device, ambient air is drawn into the first container 14 (shown in phantom in Figure 2) under the action of the pump system through the first inlet channel 22, corresponding tubing 64, and the first spike channel 62 of the first spike 48. As a result, the first medicinal fluid in the first container 14 is delivered to the first outlet channel 32 through the second spike channel 66 of the first spike 48 and corresponding tubing 64. An exemplary flow path of the air and first medicinal fluid is designated with dashed arrow A.

[0041] Once delivery of the first medical fluid is complete, delivery of the second medical fluid can be initiated by controlling the opening and closing of clamp 30 (FIG. 3). To facilitate fluid delivery of the second medical fluid, second spike 50 has a first spike channel 70 connected to second inlet channel 24 via corresponding tubing 64. Additionally, second spike 50 has a second spike channel 72 connected to second outlet channel 34 via corresponding tubing 64. As a result, upon activation of reservoir device 10, another continuous flow path is established from inlet port 18 to outlet port 26, in fluid communication with second container 16 (shown in phantom in FIG. 2).

[0042] Specifically, similar to the first spike 48, ambient air is drawn into the second container 16 under the action of the pump system through the second inlet channel 24, corresponding tubing 64, and the first spike channel 70 of the second spike 50. As a result, the second medical fluid in the second container 16 is delivered to the second outlet channel 34 through the second spike channel 72 of the second spike 50 and corresponding tubing 64. An exemplary flow path of the air and second medical fluid is designated with dashed arrow B.

[0043] 2 and 4-6, another embodiment of the present storage device 10 is generally designated as 74a, 74b, 74c. In FIGS. 4-6, corresponding components of the first, second, and third storage devices 74a, 74b, 74c are designated using reference numerals with the first three alphabetical (i.e., "a," "b," and "c") designations. Components shared with storage device 10 are designated using the same reference numerals. In the particular embodiment shown in storage devices 74a, 74b, 74c, a medical container unit 12 having first and second containers 14, 16 is attached to storage devices 74a, 74b, 74c as a pre-assembled unit.

[0044] More specifically, the first and second stoppers 44, 46 of the containers 14, 16 are inserted into the cavities 40 of the storage devices 74a, 74b, 74c and prepared to be pierced by the first and second spikes 48, 50 (FIG. 2). In the present storage devices 74a, 74b, 74c, it is envisioned that each device 74 will be distally sterilized, such as by gamma irradiation, to ensure a sterile fluid pathway. The spikes 48, 50 include protective sheaths 56 that are pierced and compressed as the containers 14, 16 are compressed, thereby keeping the spikes clean and the fluid pathway sterile until use.

[0045] The device 74 and container unit 12 are then assembled, sealed in a breathable package, and treated with a disinfectant, such as hydrogen peroxide vapor, to keep the stoppers 44, 46 and spikes 48, 50 sterile until use.

[0046] In this configuration, the first and second stoppers 44, 46 of the containers 14, 16 are pre-installed or pre-positioned in the upper position to be penetrated by the first and second spikes 48, 50. However, a lockout mechanism or pin 76 configured to stop the transition of the container unit 12 from the upper position to the lower position prevents premature activation of the storage devices 74a, 74b, 74c prior to use (e.g., during shipping and handling). The pin 76 thus performs a function similar to the locking clip 58 described above. It is envisioned that the lockout pin 76 is inserted into a slot 78 located on the body 80 of the container unit 12 between the first and second containers 14, 16, although other suitable configurations of the lockout pin are also envisioned.

[0047] After the lockout pin 76 is disengaged by withdrawing it from the body 80, a press bar 82 having a plurality of grooves 84 for improved gripping purposes is positioned above the container unit 12 and pressed downward, transitioning the container unit from the upper position to the lower position. This downward movement of the container unit 12 causes the first and second stoppers 44, 46 of the containers 14, 16 to be pierced by the corresponding first and second spikes 48, 50.

[0048] In some embodiments of the present storage devices, as in depicted embodiments 74a, 74b, and 74c, two or more storage devices may be serially linked together in a complementary relationship relative to the longitudinal axis of each storage device to establish an uninterrupted supply of medical fluid from the linked storage devices. For example, as illustrated in Figures 4 and 5, the inlet port 18a of a first storage device 74a is inserted into and complementary to the outlet port 26b of a second storage device 74b. In turn, the inlet port 18b of the second storage device 74b is inserted into the outlet 26c of a third storage device 74c to facilitate a seamless connection of the fluid pathway between all linked storage devices 74a, 74b, and 74c.

[0049] In this configuration, the first, second, and third storage devices 74a, 74b, 74c are connected or coupled in fluid communication with one another to provide a pathway between the storage devices for uninterrupted, continuous delivery of medical fluid. For example, a first medical fluid in the coupled first container 14a, 14b, 14c can be administered to a user without interrupting or manipulating the container. Similarly, a second medical fluid in the coupled second container 16a, 16b, 16c can be subsequently administered to a user. It is contemplated that the storage devices 74a, 74b, 74c can be arranged in any other suitable manner to facilitate administration of medical fluid. Additionally, the first and second medical fluids can be delivered to a user in reverse order, as appropriate for the application.

[0050] 5 and 6, an embodiment with flow paths for three linked first containers 14a, 14b, and 14c is shown for illustrative purposes. In this configuration, ambient air is drawn into the right first container 14c via the inlet port 18c and the first spike channel 62c of the first spike 48c. The second spike channel 66c of the first spike 48c is connected to the first spike channel 62b of the first spike 48b in the center first container 14b. Similarly, the second spike channel 66b of the first spike 48b is connected to the first spike channel 62a of the first spike 48a in the left first container 14a.

[0051] The second spike channel 66a of the first spike 48a is then connected to the pump system via the outlet port 26a shown to the left of the first container 14a in Figure 6. The other flow paths of the three linked second containers 16a, 16b, 16c are established in a similar manner.

[0052] In operation, negative or suction pressure generated by the pump system through port 26a results in uninterrupted, continuous delivery of the first medicinal fluid from the three first containers 14a, 14b, and 14c. Systems 74a-c have built-in air / fluid management features to provide continuous delivery of medication from each of the containers 14a-c. For example, initially, the fluid in the first left container 14a is drawn down by suction pressure applied to the fluid contents of container 14a via port 26a and spike channel 66a until a vacuum is generated above the fluid level in that container 14a. This buildup of vacuum pressure generates suction pressure on the fluid contents of container 14b via the fluid connection of spike channel 62a and inlet channel 18a to outlet channel 26b and spike channel 66b.

[0053] Suction pressure applied to the fluid contents in the first, central container 14b then draws the contents down until a similar vacuum is generated above the fluid level in that container. With vacuum generated in both containers 14a and 14b, suction pressure is generated against the fluid contents of container 14c via the fluid connection of spike channel 62b and inlet channel 18b to outlet channel 26c and spike channel 66c. Because container 14c is vented to the environment through line 18c, only a slight vacuum pressure is generated above the liquid contents of container 14c. Instead, the generated suction pressure is vented to the environment via spike channel 62c and inlet port 18c, causing air to be drawn into container 14c, which will empty first.

[0054] Container 14c will empty until the liquid level reaches below the entrance of spike channel 66c, thereby exposing the interior of the next container 14b to the environment through container 14c and allowing the fluid contents of container 14b to be emptied under the suction force of the pump system. Finally, after container 14b is emptied, container 14a is then emptied in a similar manner. Thus, the three containers 14a, 14b, 14c are automatically dispensed in succession in distal-to-proximal order until all of the containers are emptied.

[0055] The different volumetric capacities of each container 14a, 14b, 14c do not affect this sequential fluid delivery process. Exemplary volumetric capacities of standard vials include 25, 50, 100, 200, and 300 milliliters, although any other suitable size or combination of medical containers is envisioned. Referring now to Figures 2 and 7-9, yet another (third) embodiment of the present storage device 74 is generally designated as 86a, 86b. In Figures 7-9, corresponding components of the first and second storage devices 86a, 86b are indicated using reference numerals with the first two alphabetical (i.e., "a" and "b") designations. Components shared with storage device 74 are designated using the same reference numerals. A key difference characterized in storage devices 86a, 86b is that the storage devices are linked or daisy-chained together in a series configuration relative to the longitudinal axis of each storage device.

[0056] More specifically, each storage device 86a, 86b includes a first or left wing 88a, 88b configured to accommodate outlet ports 26a, 26b and a second or right wing 90a, 90b configured to accommodate inlet ports 18a, 18b. For the first storage device 86a shown in Figure 9, the first and second inlet channels 22a, 24a are disposed on the second wing 90a, and the first and second outlet channels 32a, 34a are disposed on the first wing 88a. The second storage device 86b has an identical configuration for the corresponding inlet and outlet channels.

[0057] 8 and 9, to establish a daisy-chained connection of two adjacent storage devices 86a, 86b, the second wing 90a of a first storage device 86a is complementary connected to the first wing 88b of the second storage device 86b. More specifically, in a preferred embodiment, the second wing 90a is positioned higher than the first wing 88b relative to an axis perpendicular to the longitudinal axes of the storage devices 86a, 86b. It is envisioned that the relative positions and configurations of the first and second wings 88b, 90a may be reversed from the orientation described above.

[0058] It is also preferred that the first and second inlet channels 22a, 24a extend downward from the lower surface of the second wing 90a, and the first and second outlet channels 32b, 34b extend upward from the upper surface of the first wing 88b. Thus, daisy-chained coupling of storage devices 86a, 86b is achieved by pressing the second wing 90a of the first storage device down onto the first wing 88b of the second storage device such that the inlet channels 22a, 24a of the first storage device are inserted into the outlet channels 32b, 34b of the second storage device in a complementary arrangement.

[0059] 2, 7, and 9, another feature of the reservoir device 86a, 86b is that the protective cover 38 has an elongated body configured to accommodate the contours or profiles of the first and right wings 88a, 88b, 90a, 90b. Optionally, the protective cover 38 has an auxiliary port 92 configured to deliver medical fluid from the medication containers 16a and 16b through the corresponding outlet ports 26a, 26b into a syringe, for example, docked to the auxiliary port 92. The protective cover 38 also has a set of tubing configured to deliver medical fluid from the other containers 14a and 14b to an infusion pump connected to a patient for infusion. Instead of the lockout pin 76 (FIG. 5), a locking spacer 94 is provided to prevent the container unit 12 from transitioning to the lower position. First, the locking spacer 94 is inserted into a circumferentially extending annular groove 96 located on the upper portion 98 of the corresponding storage device 86a, 86b to lock the receptacle unit 12 in the upper position.

[0060] After the locking spacers 94 are removed from the storage devices 86a, 86b by pulling on the rings 100 attached to the spacers, similar to the lockout pins 76, the press bars 82 of the container units 12 are pushed downward to move the container units from the upper position to the lower position. This downward movement of the container units 12 causes the first and second stoppers 44, 46 of the containers 14, 16 to be pierced by the corresponding first and second spikes 48, 50.

[0061] 2, 6, and 10, an exemplary leak prevention mechanism is generally designated as 102 and is designed to prevent unwanted air or fluid leakage from the storage device 10. Components shared with the storage device 10 are designated using the same reference numerals. Included within the leak prevention mechanism 102 is a fluid connection assembly generally designated as 104 that is configured to control a fluid path within the storage device 10, and an air connection assembly generally designated as 106 that is configured to control an air vent path within the storage device. It is envisioned that the leak prevention mechanism 102 is applicable to all embodiments of the storage devices 10, 74, 86 described above.

[0062] In a preferred embodiment, the fluid connection assembly 104 includes a first fluid valve 108 integrated into the outlet port 26 of the first storage device 74 for selectively regulating fluid flow of the medical fluid from the first container 14. The first fluid valve 108 is typically closed when not connected to another device or tubing connector and mechanically open when connected to another device or tubing connector, allowing fluid flow through the connector 114. The fluid connection assembly 104 includes a second fluid check valve 110 connected to the inlet port 18 of the first storage device 74 for selectively regulating directional fluid flow of the medical fluid into the first container 14.

[0063] It is envisioned that fluid check valve 110 is a one-way valve that allows a fluid path only toward first container 14 when the first and second fluid check valves are in their resting positions, so that medicinal fluid within the first container does not leak out of the container. First valve 108 has a first fluid pathway connector 112 configured for releasably and complementary connection to a second check valve 110 of another storage device. Optionally, second check valve 110 has a second fluid pathway connector 114 configured for releasably and complementary connection to first check valve 108 of another storage device.

[0064] In use, the first fluid valve 108 prevents fluid flow from the first container 14 when the storage device 74 is not connected to another storage device. The valve is mechanically open, allowing free fluid flow, when connected to another device 74. The second fluid check valve 110 prevents leakage from the connector 114 when the device 74 is not connected to another storage device, and also prevents unwanted leakage between connected storage devices 74. An exemplary cracking pressure of the fluid check valve 110 is approximately 3-5 pounds per square inch (PSI), allowing the valve to be opened by fluid pressure generated by a connected pump.

[0065] To selectively regulate the directional airflow of the storage device 74, the air connection assembly 106 includes an air pathway connector 116 connected to the inlet port 18 of the first storage device 74 via a hydrophobic filter 118. Specifically, the hydrophobic filter 118 is connected at one end to the air pathway connector 116 and at the opposite end to the spike 48 downstream of the fluid check valve 110. As is known in the art, the hydrophobic filter 118 allows air to pass through but prevents fluid from progressing through the filter. Thus, the hydrophobic filter 118 prevents undesired leakage of medicinal fluid from the air pathway connector 116. Alternatively, it is envisioned that other suitable hydrophilic filters may be suitable for different applications.

[0066] An air path plug or end component 120 having a blind cavity 122 is provided in the air connection assembly 106 and is configured for releasable complementary connection to an air path connector 116 of another storage device. When the air path plug 120 and the air path connector 116 are mated or complementary connected, the air vent path within the storage device 74 is obstructed or blocked by the blind cavity 122, thereby effectively preventing air leakage.

[0067] 2, 6, and 11, it is envisioned that a first storage device 74a is coupled or daisy-chained to a second storage device 74b (FIG. 11). Corresponding components of the leak prevention mechanisms 102a, 102b and the first and second storage devices 74a, 74b are designated using reference numerals with the first two alphabetical (i.e., "a" and "b") designations. In this configuration, the air path plug 120b of the second air connection assembly 106b is matingly or complementary connected to the air path connector 116a of the first air connection assembly 106a. Thus, when the first and second storage devices 74a, 74b are linked or daisy-chained, the air ventilation paths of the connected storage devices are automatically closed or blocked, except for the air ventilation path of the most distal device in the daisy-chained devices (e.g., the air ventilation path defined by the air path connector 116b of the second air connection assembly 106b).

[0068] For the fluid path, the first fluid pathway connector 112b of the first fluid valve 108b of the second fluid connection assembly 104b is matingly or complementary connected to the second fluid pathway connector 114a of the second fluid check valve 110a of the first fluid connection assembly 104a. It is envisioned that a pump system is also connected to the first fluid pathway connector 112a of the first fluid valve 108a of the first fluid connection assembly 104a and is in fluid communication with the container 14a.

[0069] In this configuration, the connected first valves 108a, 108b are mechanically opened by the first fluid pathway connectors 112a, 112b to allow fluid communication between the pump system and the storage devices 74a, 74b. However, neither of the second check valves 110a, 110b need to be mechanically opened because fluid flow from the second storage device 74b to the first storage device 74a is already accommodated by the unidirectional second check valve 110a. Only the first valves 108a, 108b that do not allow fluid flow from the containers 14a, 14b are mechanically opened.

[0070] As similarly described above, ambient air is drawn into the container 14b of the second storage device 74b through the air pathway connector 116b and the hydrophobic filter 118b of the air connection assembly 106b. At the same time, the second check valve 110b of the second fluid connection assembly 104b of the second storage device 74b prevents fluid leakage from the container 14b. As a result, the negative pressure, such as a vacuum, generated by the pump system results in uninterrupted, sequential delivery of the medicinal fluid from the containers 14a, 14b without any undesired fluid leakage.

[0071] 10 and 12, the fluid connection assembly 104 preferably includes a female member 124 having a female member opening 126 configured to accommodate insertion of a male member 128 of the fluid connection assembly. To securely attach the female member 124 to the male member 128, a snap-fit ​​assembly locking mechanism, generally designated as 130, is provided within the fluid connection assembly 104 and configured to releasably connect the female and male members 124, 128 together.

[0072] In a preferred embodiment, locking mechanism 130 includes at least one locking tab or protrusion 132 disposed on the inner surface of sidewall 134 of female member 124 and at least one recess or groove 136 disposed on the outer surface of male member 128. When male member 128 is slidably inserted into female member opening 126, locking tab 132 and corresponding recess 136 of locking mechanism 130 engage and latch to securely hold female and male members 124, 128 in place, thereby initiating directional fluid flow of the medical fluid as designated by arrow C. Other locking mechanism configurations, such as annular lock and release grooves, lateral wings, etc., are also envisioned.

[0073] An important aspect of the fluid connection assembly 104 is that the female member 124 has a first seal retainer 138 attached to its outer upper surface to provide a fluid-tight compression seal. It is envisioned that the first seal retainer 138 has a first concave side 140 and an opposing first convex side 142, and the seal is designed to open when pressure is applied against the first concave or convex sides 140, 142. Preferably, the first seal retainer 138 is generally dome-shaped and made from a flexible elastomeric material. It is envisioned that a first slit or gap 144 having a predetermined length is disposed approximately in the center of the first seal retainer 138 such that the slit is tightly closed at rest and opens when pressure is applied against the first concave or convex sides 140, 142.

[0074] More specifically, first slit 144 of first seal retainer 138 prevents fluid flow of the medicinal fluid when first seal retainer is in a resting position. However, when negative pressure generated by the pump system is applied to convex side 142 of first seal retainer 138, first slit 144 opens, allowing fluid flow of the medicinal fluid, as designated by arrow C. It is contemplated that other suitable types of check valves, such as spring-loaded ball check valves, duckbill valves, umbrella valves, diaphragm valves, etc., may also be suitable for use.

[0075] The female member 124 is envisioned to have a tubular post 146 depending from approximately the center of the inner upper surface of the female member 124 within the female member opening 126 along the female member's longitudinal axis. Preferably, the tubular post 146 has a sloped or beveled outer surface 148 with a leading geometry that results in a funnel-shaped outer wall. Specifically, the outer diameter of the tubular post 146 gradually increases toward the inner upper surface of the female member 124. Other suitable geometric shapes, such as square, rectangular, hexagonal, etc., are also envisioned for the post 146.

[0076] Another important aspect of the fluid connection assembly 104 is that the male member 128 is generally tubular and has a second seal retainer 150 attached to its inner surface to provide a fluid-tight compression seal. Like the first seal retainer 138, the second seal retainer 150 also has a second concave side 152 and an opposing second convex side 154. As previously mentioned, the second seal retainer 150 has the same configuration as the first seal retainer 138 and operates similarly to the first seal retainer. However, it should be noted that the first and second seal retainers 138, 150 are oriented in opposite directions to prevent fluid leakage from the fluid connection assembly 104.

[0077] More specifically, the first seal retainer 138 is disposed on the outer upper surface of the female member 124 such that the first convex side 142 faces upward along the longitudinal axis of the female member in the direction of fluid flow, as designated by arrow C. In contrast, the second seal retainer 150 is disposed on the inner surface of the male member 128 such that the second convex side 154 faces downward along the longitudinal axis of the male member, against the direction of fluid flow, as designated by arrow C. Thus, at rest, the second slit or gap 156 of the second seal retainer 150 prevents fluid flow of the medical fluid from the male member 128, and the first slit or gap 144 of the first seal retainer 138 prevents fluid flow of the medical fluid from the female member 124.

[0078] It is envisioned that the male member 128 has a female member opening 158 configured to accommodate insertion of the tubular post 146 of the female member 124. An elastomeric backup washer 160 having a central through bore 162 is disposed on the inner surface of the male member 128 near its upper end. Because the central through bore 162 of the backup washer 160 is sized to accommodate insertion of the tubular post 146 of the female member 124, the inner diameter of the through bore is slightly smaller than the smallest outer diameter of the tubular post. Thus, as the tubular post 146 of the female member 124 is gradually inserted into the central through bore 162 of the backup washer 160, a fluid-tight interference fit is formed between the tubular post and the backup washer. When the tubular post 146 is fully inserted, it opens the slit 156, allowing fluid communication between the female member 124 and the male member 128.

[0079] 10 and 13, air connection assembly 106 preferably includes a female member 164 having a female member opening 166 configured to accommodate insertion of a male member 168 of the air connection assembly. An important aspect of female member 164 of air connection assembly 106 is that hydrophobic filter 118 is disposed near the lower end of the inner surface of female member 164. For example, hydrophobic filter 118 can be attached to the inner surface of female member 164 by chemical adhesive, solvent bonding, ultrasonic welding, or other conventional fastening techniques.

[0080] The rigid cylindrical body 170 of the male member 168 is enclosed in a flexible elastomeric sheath 172 having an annular protrusion 174. As the male member 168 is gradually inserted into the female member opening 166, the annular protrusion creates an airtight interference fit between the sheath and the female member 164. Therefore, the outer diameter of the annular protrusion 174 preferably slightly exceeds the inner diameter of the female member opening 166. The hollow inner portion 176 of the male member 168 is shown for illustrative purposes, however, any suitable solid or semi-solid material can be separately inserted into or integrally formed with the inner portion of the male member, as suitable for the application.

[0081] 2, 10-12, and 14, an exemplary fluid pathway of the fluid connection assembly 104 is illustrated in FIG. 14. As previously mentioned, it is envisioned that a pump system will be connected to the male member 128 of the fluid connection assembly 104. The pump system will have a tubing set with a female connector 124 similar to that on the reservoir device. When the tubing set with the female connector 124 is connected to the reservoir device, the inner tubular post 146 of the female connector 124 will open a slit 156 in the male connector 128 of the reservoir device, thereby allowing fluid flow of medicinal fluid from the medical container 14 through the second spike channel 66 and the outlet port 26.

[0082] When the female member 124 of the fluid connection assembly 104 is connected to the male member 128 of another adjacent storage device 74, negative pressure causes the first seal retainer 138 of the female member to open. As a result, medical fluid from the adjacent storage device will flow through the first spike channel 62 and the inlet port 18 into the medical container 14 to establish an uninterrupted supply of medical fluid from the linked or daisy-chained storage devices. It is contemplated that the seal retainers 138, 150 and the washer 160 are made from a flexible, resilient material, such as a synthetic resin or plastic, rubber, or the like. It is contemplated that other suitable materials may be suitable for the application.

[0083] It is contemplated that the medical fluid fluid pathway of the storage device 74 may be incorporated into the injection molded assembly as an integral unit. For example, in some embodiments, the male member 128 of the fluid connection assembly 104 is preferably integrally attached perpendicularly to the base 54 of the storage device 74, such that the male member projects normal from the base. In this configuration, when the female member 124 and male member 128 are connected to one another, as also shown in FIGS. 8 and 9 , an improved secure coupling of the coupled storage devices is achieved, thereby preventing undesired disassembly of the coupled devices. It is also contemplated that the relative positions and configurations of the female and male members 124, 128 may be reversed from the orientation described above.

[0084] 10-12, 14, and 15, it is envisioned that a plurality of fluid and air path grooves 178 are molded into the base 54 of the reservoir device 74 to form at least a portion of the fluid path for the medical fluid. In this configuration, the inlet port 18 and the outlet port 26 are integrated into the grooves 178 as a single unit to provide a seamless fluid and air path transition from the spike 48 to the fluid and air connection assemblies 104, 106.

[0085] More specifically, for the fluid pathway, the female member opening 126 of the female member 124 of the fluid connection assembly 104 is connected to the first spike channel 62 of the spike 48 via a groove 178 that is in fluid communication with the medical container 14, and the second spike channel 66 of the spike 48 is connected to the male member opening 158 of the male member 128 of the fluid connection assembly using another groove, thereby forming a continuous fluid pathway from the female member 124 to the male member 128.

[0086] For the air vent path, the female member opening 166 of the female member 164 of the air connection assembly 106 is connected to the first spike channel 62 of the spike 48 via a groove 178 that is in fluid communication with the medical container 14 so that ambient air is drawn into the medical container 14 when the female member of the air connection assembly is not blocked by the male member 168 of the air connection assembly.

[0087] In some embodiments, a protective plate 180 (FIG. 14) is used to cover and seal the fluid and air pathways defined by the grooves 178. Attachment of the plate 180 to the base 54 is achieved by chemical adhesives, solvent bonding, ultrasonic welding, or other conventional fastening techniques. The shape of the plate 180 is variable depending on the shape of the grooves, although it is envisioned that other suitable geometric shapes, such as square, rectangular, or oval shapes, may be suitable for the application.

[0088] 1, 2, 14, and 16, another exemplary layout of grooves 178 of the leak prevention mechanism 102 is illustrated, the grooves being constructed and arranged to facilitate dual medical container units 12. Corresponding components of the fluid connection assembly 104 are indicated using reference numerals with the first two alphabetical (i.e., "a" and "b") designations. An important aspect of this groove configuration is that two separate or distinct fluid connection assemblies 104a, 104b are included within the leak prevention mechanism 102, but only one air connection assembly 106 is included and is shared by the first and second spikes 48, 50.

[0089] Specifically, the female member opening 166 of the female member 164 of the air connection assembly 106 is connected via the groove 178 to both the first spike channel 62 of the first spike 48 and the first spike channel 70 of the second spike 50 such that ambient air received through the female member of the air connection assembly flows simultaneously into both the first and second medical containers 14, 16. A "T" shaped air vent path layout of the groove 178 is shown for illustrative purposes, although other suitable arrangements, such as "Y" and "V" shaped layouts, are envisioned as being suitable for the application.

[0090] 2, 10A-10C, and 14, it is also envisioned that fluid connection assembly 104 includes a first force-activated valve 182 (FIG. 10A) connected to outlet port 26 of reservoir device 74 for selectively regulating directional fluid flow of the fluid. In a similar configuration, fluid connection assembly 104 includes a second force-activated valve 184 (FIG. 10A) connected to inlet port 18 of reservoir device 74 for selectively regulating directional fluid flow of the fluid.

[0091] 10B, a second force-activated valve 184 is disposed between the second fluid check valve 110 and the first spike 48 and connected to the inlet port 18 such that fluid flow from the connector 114 is controlled by operation of the second force-activated valve to prevent fluid leakage from the fluid connection assembly 104. A unidirectional check valve 186 is preferably connected to at least one of the inlet port 18 and the outlet port 26 of the storage device 74 to selectively regulate the directional fluid flow of fluid.

[0092] Specifically, to activate second force-activated valve 184 and thus allow fluid flow within inlet port 18, first medical container 14 is pushed downward, transitioning the first medical container from an upper position to a lower position, as designated by arrow D ( FIG. 10B ). This downward movement of first medical container 14 causes upper portion 188 of first medical container 14 to depress corresponding force-activated valve 184, allowing fluid flow from connector 114. Conversely, when second force-activated valve 184 is not activated, fluid flow is prevented within inlet port 18. Other suitable locations along the fluid or air flow connecting inlet port 18 and outlet port 26 are also envisioned as suitable for different applications.

[0093] Similarly, activation of the first or second force-activated valves 182, 184 shown in Figure 10A is achieved by mating or complementary interconnection of a first fluid pathway connector 112 of a fluid connection assembly 104 of a storage device 74 with a second fluid pathway connector 114 of a fluid connection assembly 104 of another storage device. As previously mentioned, an exemplary interconnection of two adjacent storage devices 74a, 74b is shown in Figure 11.

[0094] It is also envisioned that at least one of the spikes 48, 50 is enclosed by a spike sheath 190 (shown in phantom in FIG. 14 ) configured to fluidly connect the inlet and outlet ports 18, 26 of the reservoir device 74. For example, in an initial position, the spike sheath 190 simultaneously and tightly encloses the first spike channel 62 and the second spike channel 66 of the first spike 48, thereby allowing air or fluid flow between the inlet and outlet ports 18, 26 of the reservoir device 74.

[0095] However, as shown in Figure 10B, the spike sheath 190 is pierceable and compressible as the container 14 is pushed down. As previously described, when the first medical container 14 transitions from the upper position to the lower position, as designated by arrow D, the spike sheath 190 is also pushed downward by the upper portion 188 of the container 14 from the upper position shown in Figure 14 to the lower position shown in Figure 10B. This movement of the container 14 causes the spike sheath 190 to rupture, achieving fluid flow between the inlet and outlet ports 18, 26.

[0096] 10C and 14, the fluid connection assembly 104 includes a spike connector 192 and an access dome valve 194. The spike connector 192 is preferably connected to the inlet port 18 of the reservoir device 74, and the access dome valve 194 is preferably connected to the outlet port 26 of the reservoir device. As previously mentioned, the access dome valve 194 has a configuration similar to the second seal retainer 150 of the snap-fit ​​locking mechanism 130 shown in FIG. 14. In this configuration, the access dome valve 194 has an opening or throughbore 162 configured to accommodate insertion of the spike connector 192 in a complementary relationship.

[0097] 1, 8, and 17A-17D, the storage devices 74 include a cap remover 198 attached to at least one of the storage devices and configured to remove the top cap 42 of a corresponding container. In a preferred embodiment, the cap remover 198 includes a central cavity 200 having a head region 202 and a tail region 204, the head and tail regions preferably disposed inwardly and oppositely to one another around the cavity. In use, the head region 202 of the cap remover 198 engages or grasps the top cap 42 and pivots about a point near the tail region 204 to release the top cap, as designated by arrow E (FIG. 17C). A generally round or oval shape of the cap remover 198 is shown in FIGS. 17A-17C for illustrative purposes, although it is envisioned that other suitable shapes or designs, such as multi-sided or irregular shapes, may also be suitable for use.

[0098] 17D, it is envisioned that the head region 202 of the cap remover 198 is preferably integrally formed with the base 54 of the storage device 10. In this configuration, the head region 202 of the cap remover 198 is fixedly attached to the base 54 of the storage device 10 without the tail region 204. During use, the top cap 42 of the medical container unit 12 is positioned in an upside-down position adjacent to the storage device 10 so that the head region 202 on the base 54 can engage or fit snugly with the top cap of the container. The container 14 is then pivoted about the opposite point of the head region 202 relative to the top cap 42 so that the container is pulled away from the storage device 10 to open the top cap, as designated by arrow E'.

[0099] 1, 10, and 18, it is envisioned that in some embodiments, the fluid connection assembly 104 includes at least one of a hydrophobic filter 206 and a hydrophilic filter 208. In some embodiments, the hydrophobic filter 206 is connected to the inlet port 18 of the storage device 10 to selectively adjust the directional air / fluid flow of the storage device. Conversely, the hydrophilic filter 208 is connected to the outlet port 26 of the storage device 10 to selectively adjust the directional fluid and air flow of the storage device.

[0100] In the exemplary configuration of FIG. 18 constructed and arranged to facilitate a dual medical container unit 12, a first hydrophobic filter 206′ is connected to a first inlet port 18′ for a first medical container 14 configured to store a first medical fluid. Similarly, a second hydrophobic filter 206″ is connected to a second inlet port 18″ for a second medical container 16 configured to store a second medical fluid. Thus, the first and second hydrophobic filters 206′, 206″ advantageously allow air to vent without any undesirable fluid leakage from the inlet ports 18′, 18″.

[0101] To selectively control the directional fluid flow of the first or second medical fluid, the hydrophilic filter 208 is connected to both the first outlet port 26′ for the first medical container 14 and the second outlet port 26″ for the second medical container 16. In this configuration, the hydrophilic filter 208 advantageously allows air to vent until it is wetted by the first or second medical fluid, after which the hydrophilic filter allows only the medical fluid to proceed through the fluid pathway connector 112.

[0102] By way of example only, when the first medical container 14 is being emptied of fluid, the hydrophilic filter 208 prevents air from passing through the hydrophilic filter and being infused into the patient. This air blockage also stops any fluid flow and causes the pump to sound an alarm, which signals the patient / caregiver to move the positioning valve 216 to open the flow path to the second medical container 16. Pump operation is then resumed, infusing the contents of the second medical container 16. If the hydrophilic filter 208 is also installed at the outlet port 216", the hydrophilic filter prevents air from passing through the filter and being infused into the patient when the medical container 16 is empty. This air blockage stops any fluid flow and causes the pump to sound an alarm, signaling the patient / caregiver that the infusion of the second medical fluid is complete. It is envisioned that other suitable arrangements of the hydrophobic and hydrophilic filters 206, 208 may be suitable for different applications.

[0103] 1, 6, 7, 10, 11, and 19, it is envisioned that a tray member 210 includes at least one present storage device 74 coupled in a series arrangement, with the storage devices incorporated into the tray member in fluid communication. In FIG. 19, four storage devices 74 are incorporated into the tray member 210, although it is envisioned that any number or embodiment of storage devices is suitable for the application. A flow cover 212 having at least one flow channel or passage 214 is attached to the tray member 210 to facilitate fluid communication between the storage devices 74. Preferably, a first flow passageway 214' is provided for connection to a first medical container 14, and a separate second flow passageway 214" is provided for connection to a second medical container 16. In this example, the tray member 210 includes a plurality of storage devices 74 integrated therein in fluid communication. Additionally, the tray member 210 includes two separate tubes or passageways 214', 214" configured to convey two separate fluids from the first and second medical containers 14, 16 to the outlet port 52. Components shared with the storage device 10 shown in Figures 1, 6 and 11 are designated with the same reference numbers.

[0104] The tray member 210 preferably includes a positioning valve 216 configured to selectively enable or regulate a fluid pathway from at least one of the first and second medical containers 14, 16. For example, the positioning valve 216 is a manual switch or stopcock having a twist valve configured to selectively enable and block fluid flow from the first and / or second medical containers 14, 16. It is also envisioned that the positioning valve 216 provides valved access to prevent fluid flow when the tubing set 28 is removed from the tray member 210. In a preferred embodiment, a spike cap 218 is provided to protect the spike sheath 190 and spikes 48, 50. By way of example, in FIG. 19 , the fluid pathway connector 112 is replaced at point 108 with the positioning valve 216 for use from one pathway to the other. It is envisioned that the positioning valve 216 has a luer lock connector and is axially rotatable so that the user controls the fluid delivered to the user.

[0105] 1, 4, 7-9, and 20, the storage devices 74, 86a are preferably constructed and arranged as stackable, connectable modular units. Components shared with the storage devices 10, 74, 86a are designated using the same reference numerals. Also shown in FIGS. 4 and 7-9, the storage device 86a is envisioned to include a first wing 88a configured to accommodate the outlet port 26a and a second wing 90a configured to accommodate the inlet port 18a.

[0106] As shown in FIG. 20, for example, a first hydrophobic filter 118′ is disposed in the inlet port 18a and connected to the first spike 48, and a second hydrophobic filter 118″ is disposed in the second wing 90a and connected to the second spike 50 to prevent undesired leakage of the first and second medicinal fluids. Other suitable arrangements of the hydrophobic filters 118′, 118″ are contemplated as being suitable for different applications.

[0107] As shown in FIG. 20 , it is envisioned that the reservoir device 86a includes a flow cover 212 having at least one dedicated flow path or passageway 214′, 214″ to facilitate fluid flow from each spike 48, 50. Each flow path 214′, 214″ is branched or separated according to the spike channel 62, 66, 70, 72 of the corresponding spike 48, 50 using a dividing member 220. It is also envisioned that at least one protective plate or cover 222 is provided to seal exposed fluid or air pathways or passageways associated with the reservoir device 86a. Additionally, at least one cap member 224 is provided to removably block fluid or air pathways or passageways associated with the reservoir device 86a.

[0108] While particular embodiments of the present storage device have been described herein, it will be understood by those skilled in the art that changes and modifications may be made therein without departing from the present disclosure in its broader aspects as set forth in the following claims.

Claims

[Claim 1] The invention described in this specification.

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