RU2806016C2 - Combining device for one or more medical containers - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: invention is related to medical fluid combining devices that can be used to combine multiple medical fluid containers to facilitate the administration of the medical fluid to a patient. The medical combining device may include puncheons covered with puncheon casings that are pierced when the medical fluid container is inserted into the medical combining device. The medical combining device may also include a lid configured to cover the puncheons.

EFFECT: medical combining device may also include a fluid adapter that can be used to fluidly couple the medical combining device to an infusion pump or syringe.

84 cl, 36 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 USC § 119(e) of US Provisional Application 62/819,349, filed March 15, 2019, and US Provisional Application 62/740,475, filed October 3, 2018, each which are incorporated herein by reference in their entirety.

FIELD OF TECHNOLOGY TO WHICH THE INVENTION RELATES

[0002] The disclosed embodiments relate to a combining device for combining medical fluids from one or multiple medical containers.

BACKGROUND OF THE INVENTION

[0003] Medical fluids are often manufactured and packaged separately prior to use to maintain their chemical and physical stability. Medical fluids can be combined during administration, either by mixing the medical fluids immediately prior to administration or by administering the medical fluids simultaneously or sequentially.

[0004] Typically, these additional steps during administration are performed by a nurse or other healthcare professional who may be required to follow a specialized procedure to administer medical fluids to a patient. In cases where additional medical fluids are required, the route of administration may be performed by a nurse or other healthcare professional multiple times for a given dose.

[0005] Conventional administration methods and systems may not be the optimal procedure and may require multiple steps of connecting and disconnecting components and moving fluid through various components in a specific manner. The inventors have identified a need for a medical coupling system that optimizes the administration of a medical fluid to a patient.

SUMMARY OF THE INVENTION

[0006] In some embodiments, systems and methods are provided for administering a medical fluid to a patient from one or more containers. In some embodiments, the medical fluid consolidation device includes a hollow punch configured to pierce and receive fluid from a medical fluid container, wherein the punch includes regions of varying cross-sectional areas to facilitate sealing with a corresponding shell punch. In some embodiments, the hollow punch of the medical fluid integration device is part of a cavity, and the cavity has a corresponding cover that is releasably coupled to the cavity to cover the hollow punch. In some embodiments, the medical device may include a fluid adapter including a housing that includes at least a fluid connector portion that includes a luer-activated valve.

[0007] In one embodiment, a medical fluid integration device includes a punch shell, a punch containing a shaft including a first shaft portion and a second shaft portion, a tubing system in fluid communication with an internal channel of the punch, and a base , connected to the punch. The first rod section and the second rod section have different cross-sectional shapes, wherein the second rod section is configured to form a fluid-tight seal with the punch shell. The internal channel extends through the first shaft portion and the second shaft portion. The punch shell is configured to compress and move towards the base when a force is applied to the punch shell in the direction of the base.

[0008] In another embodiment, a medical device fluid adapter includes a fluid connector including a first end, a second end, and a luer-activated valve controlling fluid communication between the first end and the second end, a tubing system, in fluid communication with the second end, and a housing including a first opening and a second opening. The housing accommodates at least a portion of the fluid connector, wherein the first end of the fluid connector is accessible.

[0009] In another embodiment, a medical fluid integration device includes a cavity including a hollow punch, a tubing system in fluid communication with the hollow punch, and a lid removably coupled to the cavity to cover the hollow punch.

[0010] In one embodiment, a method of using a combining device to combine a medical fluid includes removing a cover to expose a cavity of the combining device, the cavity including a hollow punch and a punch shell covering the punch, step at which the first container is connected to the cavity by pressing the first container on the punch, with the punch providing piercing of the shell of the punch and the first container to provide fluid communication between the internal volume of the first container and the punch, and the stage at which the infusion pump is connected to the tubing system to allow medical fluid to move through the tubing system and into the patient. The punch shell fits tightly against the punch before the first container is inserted into the cavity. The internal volume of the first container contains a medical fluid, and the punch is in fluid communication with the tubing system.

[0011] In another embodiment, the wearable fluid integration device includes a housing including an attachment means configured to attach the wearable fluid integration device to clothing, a first cavity formed in the housing and configured to receive the first containers, a first punch located in the first cavity and configured to pierce the first container when received by the first cavity of the first container.

[0012] In another embodiment, the wearable fluid pooling system includes a first wearable fluid pooling device. The first wearable fluid pooling device includes a first body including a first fastening means configured to attach the first wearable fluid pooling device to clothing, a first cavity formed in the first body and configured to receive a first container, a first punch located in the first cavity and configured to pierce the first container upon receiving the first cavity of the first container, a first fluid outlet connector configured to be fluidly coupled to the interacting device to provide fluid communication between the first wearable fluid coupling device and the interacting device , a fluid inlet connector, and a first tubing system connected to the first punch, the first fluid outlet connector, and the fluid inlet connector. The first tubing system is configured to provide fluid communication between the fluid inlet connector, the first punch, and the first fluid outlet connector. The wearable fluid pooling system also includes a second wearable fluid pooling device. The second wearable fluid storage device includes a second housing including a second attachment means configured to attach the second wearable fluid storage device to clothing, a second cavity formed in the second housing and configured to receive a second container, a second a punch located in the second cavity and configured to pierce the second container when the second cavity receives the second container; a second fluid outlet connector configured to be fluidly coupled to the first fluid inlet connector to provide fluid communication between the second wearable coupling device for fluids and a first wearable fluid combining device, and a second tubing system connected to a second punch and a second fluid outlet connector. The second tubing system is configured to provide fluid communication between the second fluid outlet connector and the second punch.

[0013] In another embodiment, a method of administering a medical fluid to a patient includes attaching a first receptacle to a first cavity formed in the first body by pressing the first receptacle against a first punch located in the first cavity to pierce the first container through a first punch to provide fluid communication between the first punch and an interior volume of the first container, wherein the interior volume of the first container contains a medical fluid. The method may also include connecting the infusion set to a first fluid outlet connector that provides fluid communication between the infusion set and the internal volume of the first container through a first punch, removing air distributed throughout the infusion set, and a step of withdrawing medical fluid from the internal volume of the first container into the infusion set.

[0014] It should be understood that the above concepts and the additional concepts described below can be arranged in any suitable combination, since the present invention is not limited in this regard. Moreover, from the following detailed description of various non-limiting embodiments, when considered in connection with the accompanying figures, other advantages and novel features of the present invention will become apparent.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Non-limiting embodiments of the present invention will be described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component shown is typically designated by a single numeral. For clarity, not every component is indicated in every figure, and not every component of every embodiment of the invention is shown where illustration is not necessary to enable those of ordinary skill in the art to understand the invention. On the figures:

[0016] FIG. 1 is a perspective view of one embodiment of a medical connecting device;

[0017] FIG. 2 is a general view of the medical connecting device shown in FIG. 1, without covers removed;

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

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

[0020] FIG. 5 is an overview of one embodiment of the combination of a first fluid distribution system and a second fluid distribution system for use in the medical union device shown in FIG. 1.

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

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

[0023] FIG. 8A is an exploded view of one embodiment of a punch and punch shell;

[0024] FIG. 8B is a perspective view of the punch and punch shell shown in FIG. 8A, assembled;

[0025] FIG. 9A is a schematic drawing of another embodiment of a punch and a punch shell;

[0026] FIG. 9B is a schematic drawing of the punch and punch shell shown in FIG. 9A, after the container is pierced with a punch.

[0027] FIG. 10 is a cross-sectional view of another embodiment of a punch and punch shell;

[0028] FIG. 11 is a schematic drawing of another embodiment of a punch;

[0029] FIG. 12 is a schematic drawing of yet another embodiment of a punch;

[0030] FIG. 13 is a schematic drawing of yet another embodiment of a punch;

[0031] FIG. 14 is a schematic cross-sectional drawing of one embodiment of a first punch rod portion;

[0032] FIG. 15 is a schematic drawing of another cross-sectional embodiment of a first punch rod portion;

[0033] FIG. 16 is a schematic drawing of yet another cross-sectional embodiment of a first punch rod portion;

[0034] FIG. 17 is a schematic drawing of one cross-sectional embodiment of a second punch rod portion;

[0035] FIG. 18 is a schematic drawing of another cross-sectional embodiment for a second punch rod portion;

[0036] FIG. 19 is a schematic drawing of another cross-sectional embodiment for a second punch rod portion;

[0037] FIG. 20A is a perspective view of one embodiment of a fluid transfer device;

[0038] FIG. 20B is an exploded view of the fluid transfer device shown in FIG. 20A;

[0039] FIG. 21A is an overview view of another embodiment of a fluid transfer device;

[0040] FIG. 21B is an exploded view of the fluid transfer device shown in FIG. 21A;

[0041] FIG. 22A is a top view of one embodiment of a medical joining device including covers;

[0042] FIG. 22B is a top view of the medical joining device shown in FIG. 22A, without covers removed.

[0043] FIG. 23 is an exploded view of the medical joining device and cap shown in FIG. 22A;

[0044] FIG. 24 depicts one embodiment of a medical combining device when used with multiple container units;

[0045] FIG. 25 is a flowchart of one embodiment of a method for using a medical combining device;

[0046] FIG. 26 is a perspective view of another embodiment of a medical connecting device;

[0047] FIG. 27 is an exploded view of the medical joining device shown in FIG. 26;

[0048] FIG. 28 is a general view of the medical connecting device shown in FIG. 26, when used with multiple containers;

[0049] FIG. 29 is a front elevation view of various containers that can be used in the medical combining device shown in FIG. 26;

[0050] FIG. 30A is a front view of the medical joining device shown in FIG. 26, with the lid in the closed position;

[0051] FIG. 30B is a general rear view of the medical joining device shown in FIG. 26, with the lid in the closed position;

[0052] FIG. 31 is a front elevation view of another embodiment of a medical joining device;

[0053] FIG. 32 is a front elevation view of one embodiment of a medical fluid integration system;

[0054] FIG. 33 is a front elevation view of another embodiment of a medical fluid integration system;

[0055] FIG. 34 is a front elevation view of yet another embodiment of a medical fluid integration system;

[0056] FIG. 35 is a front elevation view of yet another different embodiment of a medical fluid integration system; And

[0057] FIG. 36 is an illustration of one embodiment of an infusion set for use with a medical coupling device.

DETAILED DESCRIPTION OF OPTIONS FOR IMPLEMENTATION OF THE INVENTION

[0058] During a typical administration process, multiple syringes may be used in stages to mix the medical fluids before injecting the patient. At each step, the nurse or other healthcare professional pays attention to ensuring sterility as the individual fluids are drawn from their packaging and expelled into the mixing container. Even though the medical fluids do not need to be premixed before injection into the patient, each fluid is typically drawn out separately using a pump, syringe, or other suitable instrument. If a particular patient requires a dose greater than what is contained in a typical package, the process is usually repeated many times until the required dose is reached. Accordingly, conventional administration methods performed by nurses or health care professionals can be time-consuming and complex.

[0059] In some cases, due to the frequency of treatment with some medical fluids, self-administration is preferred due to convenience and cost. Complex procedures that are already time-consuming when performed by healthcare professionals can present a challenge for the self-administered patient. Accordingly, for convenience and to reduce the impact on the daily life of patients who self-administer, it is desirable to reduce the time and complexity of administering a medical fluid.

[0060] In light of the above, the inventors have discovered the benefits of a medical combining device that allows a patient to administer medical fluids contained in one or more containers. Compared with a conventional administration process, the combining device can provide a simplified administration process for medical fluids containing fewer steps. The combining device can also provide for the administration of an increased dose using multiple containers of medical fluid such that the steps of the administration process can be performed once for a given dose.

[0061] The inventors have also discovered advantages of the punch and punch shell, which allow a simple, sterile connection between the medical fluid container and the medical coupling device. The sheath of the punch may be ruptured by the container when the container is inserted into a medical pooling device to promote fluid pooling and flow into a patient device (eg, infusion pump, syringe, etc.). Accordingly, the patient is not required to pierce the container using a manual syringe or other instrument, which can be difficult or create sterility problems.

[0062] In some embodiments, the medical fluid integration device includes at least one punch cavity. The punch may include a first shaft portion and a second shaft portion, wherein the first shaft portion and the second shaft portion have different cross-sectional shapes. That is, the punch can move from a section of the rod with a first shape to a section of the rod with a second shape along the length of the punch. The second portion of the rod may be shaped to form a fluid-tight seal with the punch shell. The punch shell may be shaped to match the shape of the second shaft portion, and therefore the punch shell may create a fluid-tight seal around the punch when the punch is placed in the shell. The punch may include an internal channel extending the length of the punch, and therefore the medical fluid coupling device may be in fluid communication with the medical fluid container after the container is placed in the cavity. The punch may be connected to a tubing system that allows the medical fluid to be transferred to the patient device. The punch shell can seal the punch until the container is accepted, after which the shell can be torn and compressed by the container, thereby maintaining the sterility of the punch until connected to the container.

[0063] The inventors have also discovered the benefits of a fluid adapter that allows easy attachment of a patient device, such as an infusion pump or syringe. Typically, connecting devices for medical fluids (eg, luer-activated connectors) are small in size and difficult to grasp or otherwise manipulate when self-administering medical fluids. Accordingly, a fluid transfer device that is sized and shaped to facilitate gripping can simplify and improve the process of administering medical fluids.

[0064] In some embodiments, the fluid adapter includes a fluid connector and a housing. The housing may include first and second openings configured to provide access to the interior of the housing. The fluid connector may have a first end and a second end, wherein the first end is coupled to a patient device and the second end is coupled to a tubing system configured to deliver a medical fluid (eg, from a medical coupling device). The fluid connector may be located and secured within the interior of the housing, which may be sized and shaped to further facilitate the user's grip and movement of the housing. Accordingly, the housing may facilitate the administration of medical fluids to a patient or healthcare professional.

[0065] The inventors have also discovered the advantages of a releasable cover for a medical coupling device that provides selective patient access to cavities to attach containers of medical fluids. The closure may provide an easy way to communicate administration steps or other information to the patient for self-monitoring, as well as provide protection for any sterile components used to attach the containers.

[0066] In some embodiments, the medical integration device includes at least one cavity, wherein each cavity includes at least one punch assembly. The cavities may be located in recesses in the combining device such that the punch assemblies do not protrude beyond the outer edges of the combining device. Each cavity of the medical connecting device may have a corresponding cover configured to cover at least one punch located in the cavity such that the at least one punch is inaccessible until the cover is removed. The cap may be removably attached to at least one cavity such that the cap can be removed by a patient or healthcare professional during the administration of medical fluids.

[0067] In some embodiments, a medical fluid integration device includes a housing with a plurality of cavities and at least one fluid distribution system located within the housing. The plurality of cavities may include punches or other connectors suitable for fluid connection of one or more medical fluid containers to at least one fluid distribution system. The cavities may include multiple punches that can be used to fluidly connect multiple containers packaged together in a container unit. The fluid distribution system may include an air filter, a tubing system, and a fluid adapter fluid connector used to extract fluid from one or more containers after they have been fluidly coupled to the fluid distribution system. The cavities may be configured to receive one or more containers in an inverted position so that gravity can be used to deliver medical fluid to the fluid connector. The fluid distribution system may supply a single medical fluid from multiple containers attached to different cavities, or may supply a mixture of different medical fluids attached to different cavities. The air filter may pass air into the fluid distribution system to replace any volume of fluid withdrawn from the fluid connector. The fluid connector may be configured to attach to any patient device that can be used to administer fluid to a patient, such as an infusion pump or syringe. Prior to insertion of one or more containers, the plurality of cavities may be closed with a lid that may be removed by the patient or healthcare professional before the container is attached to the cavity.

[0068] In some embodiments, a method of administering a medical fluid using a medical combining device includes the step of removing one or more caps to expose one or more cavities of the combining device, the step of attaching one or more medical fluid containers to one or more more cavities, and the step of connecting the patient device to a fluid connector of the fluid distribution system to withdraw medical fluid from the one or more containers. The cavities of the medical combining device may include one or more punch assemblies, with each punch assembly including a hollow punch and a punch shell covering the punch. When the lid is removed and the punch assemblies are opened, attaching the container to the punch may include pressing the container onto the punch, causing the punch shell and container to be pierced by the punch to provide fluid communication between the punch and the interior of the container. In some embodiments, the punch shell may seal against the punch to support the movement of medical fluid from the attached container into the punch and prevent fluid from leaking from the container to the outside of the fluid distribution system. Once the container is attached, medical fluid from the container can flow through the punch and associated tubing into a fluid connector, which can be used to connect the fluid distribution system to an infusion pump, syringe, or other device for administration to a patient. If more than one container is connected to the fluid distribution system, the total volume of fluid in each of the containers may be summed and delivered as one volume to the fluid connector. In some embodiments, a medical integration device may use multiple fluid distribution systems to deliver different medical fluids or deliver a mixture of different medical fluids.

[0069] In some embodiments, a medical combining device can be used to administer two or more medical fluids in sequence. For example, the first fluid may be administered initially to improve the conditions under which the second fluid is delivered to or processed by the patient. In some embodiments, a medical combining device may be used with one or more container units that connect two or more containers, each container containing a different medical fluid. An example of a two-medical container unit that can be used with a medical combining device is described in US Patent No. 8,684,433, "PACKAGING FOR MULTIPLE MEDICAL CONTAINERS", filed in the US Patent Office on April 26, 2012 and incorporated herein by reference. To the extent that this specification and the document incorporated by reference include conflicting and/or inconsistent disclosures, this specification shall govern. If two or more documents incorporated by reference include disclosures that are inconsistent and/or inconsistent with each other, then the document having the later effective date shall control.

[0070] The inventors have also discovered the advantages of a unifying device that can be wearable to allow the patient to move freely during fluid administration. The wearable unifying device can be attached to clothing or otherwise secured to a patient, and therefore the patient is not limited to a particular position, location, or area. The wearable combining device may also include a cap configured to secure one or more attached containers to the combining device such that movement of the patient does not disrupt the fluid administration process. Such a design can significantly reduce the burden on the patient when performing an infusion or other administration process by providing freedom of movement without compromising the administration process.

[0071] In some embodiments, the wearable integration device includes a housing containing attachment means. The housing may include one or more cavities defined in the housing configured to receive one or more containers of medical fluid to be administered during the infusion process. The housing, cavities, and attachment means may be arranged such that the housing and attached medical fluid containers can be suspended from a patient. In some embodiments, the attachment means may be configured as a belt attachment means, configured to releasably attach the housing to a belt worn by the patient. In other embodiments, the securing means may be in the form of a bandage, strap, or other suitable configuration for securing the housing and attached one or more containers to the patient. In some embodiments, the housing may include a lid that is movable between a closed position, in which one or more cavities are closed, and an open position, in which one or more cavities are accessible. In accordance with this embodiment, the lids can be closed when one or more containers are located in one or more cavities so that the containers are securely secured within the cavities. Such a design may prevent bumping, bumping, or other dynamic movement common during daily activities when one or more containers are dislodged, or otherwise interrupting the insertion process.

[0072] The inventors have also discovered the advantages of a modular combining device that allows for the connection of multiple combining devices to increase the total volume of fluid being combined. In some cases, manufacturing, regulatory, or other restrictions may limit the size of the container that can be used with the combining device. Accordingly, in some embodiments, the combining device can be connected to other combining devices to increase the total volume of fluid and/or the total number of containers available for the injection process.

[0073] In some embodiments, the modular combining device includes a fluid inlet connector and a fluid outlet connector. The fluid inlet connector and the fluid outlet connector may be coupled to each other to provide fluid communication between multiple modular couplers. In some embodiments, the fluid inlet connector and the fluid outlet connector may be connected to the tubing system. In this embodiment, the tube system may allow freedom of movement of the connected connecting devices. This design may be advantageous in wearable applications where multiple smaller integration devices can be worn more easily than a single bulky integration device. In other embodiments, the fluid inlet connector and the fluid outlet connector may be directly connected to each other. In accordance with this embodiment, the connected joining devices can be fluidly coupled and physically connected to reduce the number of structures that can be manipulated independently, which can make the connected joining devices easier to move and/or carry.

[0074] The inventors have also discovered the advantages of an infusion set that can remove air so that the infusion set can be used in series with multiple combining devices. In some cases, it is desirable to disconnect the coupling device and attach a second coupling device to complete the infusion process when using the same infusion set to deliver medical fluid to a patient. For example, the volume of fluid delivered from one combining device may be insufficient for some doses. Accordingly, in such cases, it is desirable to safely connect another combining device if additional volume of fluid is required. The infusion set may include a breathing valve (ie, a degassing valve, an air release valve, etc.) configured to prevent the introduction into the patient of air bubbles that may form during the transition between the combining devices.

[0075] In some embodiments, the infusion set includes a tubing system containing a breathing valve, and a needle set containing at least one needle for delivering a medical fluid to a patient. The infusion set may include an inlet connector that allows connection of the infusion set to the coupling device, either directly (eg, to the fluid outlet connector of the coupling device) or indirectly (eg, through an infusion pump, regulator, or other device). Once connected to the combining device, the degassing valve may allow air to flow out of the tubing system to allow medical fluid from the combining device to replace said air. Accordingly, air will be removed from the infusion set tubing before being administered to the patient. Any additional air bubbles that form can also be removed by a breathing valve from the tubing system.

[0076] In accordance with exemplary embodiments described herein, the combining device and infusion set can be used with any number of medical or nutritional fluids that are delivered to the body (eg, subcutaneously). In some embodiments, the combining device and infusion set may be configured to combine and deliver 10% immunoglobulin for infusion (human), 20% immunoglobulin for subcutaneous injection (human) (e.g., CUVITRU), recombinant human hyaluronidase (e.g., HYQVIA) and/or other blood products. Without being limited by theory, the combination devices of the exemplary embodiments described herein may be configured to deliver medical fluids having a viscosity of 10-30 cP. Of course, the coupling device, infusion set and related accessories can be used with any desired medical fluid, so the present invention is not limited in this regard.

[0077] Although a specific embodiment of the present combining device will be described later in this application, other alternative embodiments of all components related to the present combining device may be used as replacements to meet the requirements of other applications. The term "combining device" as used herein means a device for selecting a medical fluid from one or more medical containers for administering the medical fluid to a patient. Therefore, the combining device is contemplated to be used for administering medical fluid from a single container as well as multiple medical containers.

[0078] FIG. 1 depicts one embodiment of a medical union device 10. The medical union 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 covering a receiving cavity. containers with medical fluid. In the embodiment shown in FIG. 1, the medical combining device is configured to supply two medical fluids, which can be combined from up to four containers for each fluid. The first medical fluid may be packaged together with the second medical fluid such that each cavity can receive both medical fluids simultaneously. In accordance with the present embodiment, the medical fluids are not mixed, but are supplied to the first fluid transfer device 102 and the second fluid transfer device 152 and can be sequentially delivered to the patient. The first and second medical fluids may be delivered through the first tube system 110 and the second tube system 160, respectively, to the first and second fluid transfer devices. As shown in FIG. 1, the first and second fluid adapters can be removably attached to the adapter holders 14 for storage and transportation.

[0079] In some cases, it is desirable to ensure the cleanliness of the medical joining device using a specified orientation during manufacture and transportation. According to the embodiment shown in FIG. 1, the medical integration device 10 may contain important components that may be in contact with the medical fluid, enclosed, or otherwise protected from the external environment. For example, the covers 300A, 300B, 300C, 300D may protect at least one internally located punch assembly insulated from external contamination and accidental damage that may occur to the medical coupling device during transportation and handling prior to use. The covers may also prevent the user from coming into contact with the punches while handling the medical coupling device before, during, and/or after use of the medical coupling device. Likewise, the adapter holders 14 may orient the first and second fluid adapters 102, 152 so as to protect any open end of the first fluid distribution system 100 and the second fluid distribution system 150. Of course, any suitable components, including, but not limited to, a plastic sheath or other sterile packaging, may be used to protect the sterility of the medical coupling device prior to initial use.

[0080] FIG. 2 shows the medical combining device 10 shown in FIG. 1, without covers removed 300A, 300B, 300C, 300D. When the covers are removed, the cavities 24 of the medical combining device are open. Each cavity includes a recess 16 configured to receive a container of medical fluid for integration and/or administration to a patient. As shown in FIG. 2, each cavity includes two punch assemblies 200. In each cavity, one punch assembly is fluidly coupled to the first fluid distribution system 100, and one punch assembly is fluidly coupled to the second fluid distribution system 150. Accordingly, each cavity can receive multiple containers of separate medical fluids for combination and administration. In the embodiment shown in FIG. 2, when containers containing medical fluids are inserted into the cavities, the containers may be pierced by one of the punch assemblies 20 to fluidically couple the container to one of the fluid distribution systems 100, 150.

[0081] As shown in FIG. 2, each cavity 24 may include components configured to align inserted containers, maintain sterility, or otherwise facilitate the medical administration process. For example, the cavities may include a recess 16 formed in the medical coupling device body 12 to allow the cavity to direct medical fluid to the container when the container is pushed onto the punch assembly 200 by a patient or healthcare professional. That is, a container of medical fluid with a perimeter shape responsive to the perimeter shape of the cavity can be aligned and guided automatically when the container is pressed into the punch assembly. The cavity may also include a guide 20 and a guide groove 22 configured to provide additional guidance and alignment to the insertion surfaces of medical fluid containers. In some embodiments, two containers of medical fluids may be physically coupled by a housing to form one container unit. Accordingly, the guide protrusion and guide groove may contact portions of the container block body to securely guide and align individual containers located within the block with the punch assemblies 200. In the embodiment shown in FIG. 2, the cavity includes at least one retainer receptacle 18 configured to releasably attach covers (covers 300A, 300B, 300C and 300D shown in FIG. 1) to the medical coupling device. The retainer socket 18 may also be used to releasably or permanently connect any receiving container or container assembly into a cavity to prevent removal. As such, in some embodiments, the medical union device's latch receptacles may be releasably connected to a corresponding cavity cover and permanently connected to a corresponding container. In some embodiments, the retainer receptacles may be configured to be releasably connected to both cavity covers and containers. The cavities may include any suitable leveling elements or locking elements, since the present invention is not limited in this regard.

[0082] In some embodiments, the cavity may include any suitable fluid connector that can be used to connect a medical fluid container to the fluid distribution system of the medical union device. For example, the cavity may include a punch or quick connectors. In some embodiments, the cavity may also include a recess and/or protrusion formed in the body of the medical coupling device. The recess and/or protrusion may be used to facilitate alignment and connection of the container to the cavity. In other embodiments, the cavity may be flush with the body of the medical coupling device. The cavity may have any other suitable design for connecting the fluid container to the fluid distribution system of the medical coupling device, since the present invention is not limited in this regard.

[0083] In some cases, it is desirable to maintain the sterility of a medical coupling device by prohibiting subsequent uses of the coupling device. Accordingly, in some embodiments, the medical integration device may be intended for single use as a disposable device. That is, the medical combining device may be configured to hinder or prevent reuse of the medical combining device. For example, as shown in FIG. 2, the latch receptacles 18 of the medical coupling device 10 may be configured to substantially prevent removal of a container attached to the cavity 24. Consequently, a user (eg, a patient or healthcare professional) may be prevented from replacing the medical fluid container in order to begin the second insertion process. It should be understood that any other suitable component, including mechanical interlocks and self-closing valves, can be used to prevent repeated use of the combining device.

[0084] FIG. 3 is an overview of one embodiment of the first fluid distribution system 100. The first fluid distribution system includes a first fluid connector (not shown in the figure) of the fluid adapter 102, a tubing system 110, an air filter 112, and four punch assemblies 200. According to the embodiment shown in FIG. 3, the first fluid connector may be configured to be connected to any suitable patient device, such as a syringe or infusion pump, to withdraw fluid from the second fluid distribution system. In some embodiments, the fluid connector may include a luer-activated valve, a single check valve, a dual check valve, a dry rupture valve, a bayonet connector, or any other suitable valve that can prevent fluid from flowing out of the first fluid connector until connections to the patient device. In some embodiments, air filter 112 is configured as a hydrophobic unidirectional filter configured to allow passage of filtered air into the first fluid distribution system while substantially preventing the flow of medical fluid. Accordingly, the air filter can allow medical fluid contained in the container to flow by gravity toward the fluid transfer device without causing a negative pressure difference within the container. The air filter may also provide passive drainage of medical fluids without pumps or other mechanical flow devices. As previously described, all punch assemblies are configured to create fluid communication between the medical fluid containers and the fluid distribution system. A tube system 110 connects each of the components in series, with an air filter located at one end of the tube system, a fluid adapter located at the opposite end, and punch assemblies located between them. Of course, any suitable order of the fluid components of the fluid distribution line can be used, since the present invention is not limited in this regard. For example, one or more air filters and/or fluid adapter 102 may be located between any of the punch assemblies 200.

[0085] In some embodiments, the fluid distribution system may be configured to combine and/or mix medical fluids. In the embodiment shown in FIG. 3, the first fluid distribution system 100 can be used to connect to up to four separate medical fluid containers. Since each of the punch assemblies 200 is configured to flow fluid to the next punch assembly, the connection of multiple containers effectively combines (i.e., stacks) medical fluids for delivery via the fluid adapter 102 to any suitable patient device ( e.g. syringe, infusion pump, etc.). In some embodiments, the punch assemblies may be configured to receive different medical fluids that are mixed along the entire length of the tubing system 110. In some embodiments, a number of punch assemblies, fluid adapters, and air filters may be selected to combine and/or mix a given volume of fluid. In addition, the number of punch assemblies, fluid adapters, air filters, and tubing may vary the flow rate of medical fluid or compounded drug delivered to the fluid adapter. Of course, the medical fluid dispensing system may be configured to combine and/or stack any number of medical fluids from any number of containers, as the present invention is not limited in this regard. In some embodiments, the fluid distribution system may include a mixing chamber or other mixing elements that are configured to further mix medical fluids.

[0086] FIG. 4 is an overview of one embodiment of a second fluid distribution system 150. Similar to the first fluid distribution system shown in FIG. 3, the second fluid distribution system includes a second fluid connector 170 of the fluid adapter 152, a second air filter 162, and four punch assemblies 200. According to the embodiment shown in FIG. 4, fluid connector 170 is configured to connect to an infusion pump and includes a male adapter located at the end of the fluid connector opposite the tubing system. As described previously, in some embodiments, fluid connector 170 may include a luer-activated valve or any other suitable valve that can prevent fluid from flowing prior to connection with the infusion pump. The second air filter 162 is configured to pass air into the fluid distribution system when medical fluids are withdrawn from the fluid transfer device to replace the lost fluid volume with filtered air. The punch assemblies 200 may be configured to be individually coupled to the medical fluid containers so that the total volume of medical fluids can be combined and supplied directly to the fluid transfer device 152, rather than withdrawing the medical fluid directly from the container until it is reached. total dose volume. That is, after the containers are connected to the fluid distribution system, the total dose volume of the fluid can be delivered directly to the patient via the fluid transfer device. The second fluid adapter may have any number of suitable modifications to modify aspects of medical fluid delivery, including, but not limited to, changing the number of punch assemblies or air filters, changing tubing sizes, changing the connector of the fluid adapter, and adding mixing components.

[0087] In some cases, when several medical fluids are administered to a patient sequentially, there is a predetermined volume ratio between the medical fluids for a given dose. Accordingly, medical fluids can be packaged together (eg, in container units) so that the medical fluids can be administered in the correct ratio. In cases of sequential administration of fluids, the medical integration device may include both a first fluid distribution system and a second fluid distribution system corresponding in that order to the first medical fluid and the second medical fluid. In some embodiments, the second fluid distribution system 150 may include a number of components (eg, punch assemblies) equal to the number of components contained in the first fluid distribution system (see FIG. 3). This design may be useful when medical fluids are packaged in predetermined ratios in equal quantities of containers. In other embodiments, the first and second fluid distribution systems may differ in the number of components corresponding to the typical numbers of containers used to dispense individual medical fluids. Of course, the first and second fluid distribution systems may contain any suitable number of components for combining and/or mixing medical fluids from multiple containers, since the present invention is not limited in this regard.

[0088] FIG. 5 depicts one embodiment of the combination of the first fluid distribution system 100 shown in FIG. 3, and the second fluid distribution system 150 shown in FIG. 4, configured for use in the medical joining device shown in FIG. 1. As shown in FIG. 5, the first and second fluid distribution systems are not in fluid communication with one another. Accordingly, the combination shown in FIG. 5 is suitable for administering medical fluids to a patient separately via a first fluid transfer device 102 and a second fluid transfer device 152. The first fluid adapter and the second fluid adapter may be positioned such that the punch assemblies 200, at appropriate positions along the distribution systems, are located in the same cavity of the medical union 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] FIG. 6 is an exploded view of the first fluid distribution system 100 shown in FIG. 3. The fluid distribution system includes a female fluid connector 120 that includes a luer-activated valve disposed therein and is configured to connect to a syringe so that the contents of the first fluid distribution system can be drawn out by the syringe. The female fluid connector may be located in the housing for ease of handling by the patient or healthcare professional (see, for example, FIG. 3). In the embodiment shown in FIG. 6, the air filter 112 is connected to the tube system 110 by a tube coupling 114.

[0090] As shown in FIG. 6, the punch assemblies 200 each include a punch 202 and a punch shell 220. The punch is configured to pierce a container of medical fluid and includes an internal passage that fluidly connects the container to a first distribution system. The internal channel of the punch 202 may be a double lumen channel (ie, two separate channels) connected on each side to the tube system 110. Accordingly, as fluid flows from the air filter to the fluid transfer device 102, the fluid will move up one side of the punch 202 and down the other. In cases where there is air in the fluid distribution system 100, the air will flow up one side of the punch to replace the volume of fluid that flows down the opposite side towards the fluid adapter. The punch housing 220 is configured to form a seal around the punch so that fluid cannot leak from the fluid distribution system. In embodiments in which the punch includes a double-lumen internal channel, the punch shell may fluidly connect the two lumens, thereby allowing fluid to flow toward the fluid transfer device. The piercer shell may be ruptured when a container of medical fluid is mounted on and pierced by the piercer, and thus the medical fluid may be in fluid communication with the fluid distribution system without compromising the integrity of the fluid distribution system.

[0091] FIG. 7 is an exploded view of the second fluid distribution system 150 shown in FIG. 4. As previously described, the second fluid distribution system includes a fluid adapter 152 (housing not shown in the figure), an air filter 162, punch assemblies 200, and a tubing system 160. As shown in FIG. 7, the fluid adapter includes a male fluid connector 170. The male fluid connector includes a luer-activated valve and is available for connection to a patient or healthcare professional controlled infusion pump. That is, the male fluid connector may be used to withdraw combined and/or mixed fluid from the second fluid distribution system for infusion into a patient during administration of the medical fluid. The male fluid connector may be located in the housing (see, for example, FIG. 4) for ease of handling. The air filter 162 is connected to the tube system 160 by a tube coupling 164. Similar to the first fluid distribution system shown in FIG. 6, the punch assemblies 200 include a punch 202 and a punch shell 220, wherein the punch may include a double-lumen internal channel whose lumens are fluidly connected by a punch shell.

[0092] FIG. 8A is an exploded view of one embodiment of a punch assembly 200, including a punch 202 and a punch shell 220. As shown in FIG. 8A, the punch 202 includes an inlet 204A, an outlet 204B, a base 206, a first rod portion 210, and a second rod portion 212. Together, the first shaft portion and the second shaft portion form a punch shaft. The double-lumen internal passage extends through the punch shaft and ends at inlet 216A and outlet 216B, which are in fluid communication with inlet 204A and outlet 204B, respectively. In some embodiments, as shown in FIG. 8A, the inlet 216A is vertically higher than the outlet 216B, which can facilitate the introduction of air into a container of any volume fluidly connected to the punch as the medical fluid flows through the outlet. The tip 214 of the punch is located on the first section of the rod and is configured to pierce the shell 220 of the punch, as well as the container that is pushed onto the punch.

[0093] As shown in FIG. 8A, the punch shell 220 includes a shell tube 222, a shell base 224, and a shell end portion 226. The sheath base 224 is configured to support a sheath tube 222 and fits into a recess 208 formed in the base 206 of the punch 202. The sheath tube 222 defines an internal volume and is configured to fit around a punch shaft formed by the first shaft portion 210 and the second shaft portion 212. According to the embodiment shown in FIG. 8A, when the punch is placed in the punch shell, the tube and base create a seal around the second rod portion 212. In particular, an O-ring may be molded on the inside diameter of the sheath tube 222 (see, for example, FIG. 10) configured to form a seal against the second shaft portion 212 of the punch 202. The second shaft portion may have a circular cross-section that promotes applying uniform sealing force around the entire circumference of the inner O-rings to prevent fluid leakage. In some embodiments, multiple O-rings (eg, at least two O-rings) may be used to provide a seal margin between the punch shell and the punch. In other embodiments, the punch shell may provide a fluid-tight seal across the first shaft portion, base, or any other suitable component of the punch 202. The shell end portion 226 fluidly couples the inlet port 216A and the outlet port 216B such that fluid can leak from inlet to outlet when the container is not inserted into the punch assembly 200.

[0094] The inventors have discovered that, in some cases, it is desirable to reduce the number of components that are handled by the patient or healthcare professional during the administration of medical fluids. Additional contact and manipulation of sterile components may compromise their sterility or otherwise adversely affect patient care. Accordingly, in some embodiments, the punch shell may be configured to be ruptured by a container pierced onto the punch assembly 200 so that the patient or healthcare provider may not need to manipulate any component of the punch assembly. In some embodiments, the punch shell 220 may be formed from a material that can be pierced by the punch tip 214 and is also compressible. For example, the punch shell may be formed from a thin plastic material that can provide a fluid-tight seal to the punch but is easily torn and compressed. According to this embodiment, when the container is pressed against the punch assembly, the container can push the shell tube 222 and the shell end portion 226 towards the punch base 206. The sheath tube 222 may abut the recess 208 formed at the base of the punch and resist this movement, causing the sheath tube 222 to compress (e.g., fold/collapse and, in some cases, fold/accordion) toward the base. Because the end portion of the sheath contacts the tip 214 of the punch, it can be punctured and ruptured such that the end portion does not resist further compression of the sheath tube toward the base. During this process, the sheath base and sheath tube can maintain a fluid-tight seal around the second punch shaft portion 212 such that there is no fluid leakage when the punch creates fluid communication with the medical fluid container (e.g., when piercing the seal or container caps). In some embodiments, the inserted container may form a fluid-tight seal around the punch 202 instead of a shell when the shell is ruptured to prevent fluid leakage.

[0095] FIG. 8B depicts the punch 202 and punch shell 220 shown in FIG. 8A, in a fully assembled state, with the shell being placed over and receiving the first rod portion and the second rod portion (see FIG. 8A). As clearly shown in FIG. 8B, the shell base 224 is received into a recess 208 formed in the punch base 206. Accordingly, the casing is attached to the punch, and the base of the casing can resist transverse or longitudinal (ie, in the direction of the base) movement of the casing. The shell base may resist forces applied to the shell end portion 226 and/or shell tube 222 such that the shell end portion and/or shell tube is pressed downward against the base. In some embodiments, when the end portion of the sheath and the sheath tube are collapsed toward the base, the base of the sheath may maintain a fluid-tight seal around the punch so that medical fluid is not lost during the process.

[0096] FIG. 9A is a schematic cross-sectional drawing of another embodiment of a punch 202 and a punch shell 220. As described previously, the punch includes an inlet 204A in fluid communication with inlet 216A and an outlet 204B in fluid connection with outlet 216B. A double-lumen internal channel formed by the inlet and outlet extends along the length of the punch shaft formed by the first shaft portion 210 and the second shaft portion 212. The inlet and outlet are separate from each other and terminate at an inlet and an outlet near the punch tip 214. The first shaft portion and the second shaft portion extend from a base 206 that functions to support the punch and define at least the inlet and outlet portions.

[0097] As shown in FIG. 9A, the punch shell 220 fits tightly around the punch 202 such that the first shaft portion 210, the second rod portion 212, and the punch tip 214 are substantially enclosed by the punch shell. In some embodiments, the punch casing serves as a protective barrier to the punch, which may be sterile for use when opening a container of medical fluid. Accordingly, the shell can maintain the sterility of the punch until the punch is used to open the container. In the embodiment shown in FIG. 9A, the punch shell is in an uncompressed position and is configured to form a seal around the second punch shaft portion, and therefore fluid that flows from the inlet port 216A or the outlet port 216B cannot leak from the punch shell. Accordingly, the punch shell fluidly connects the inlet port to the outlet port and functions as a conduit for fluid flow between the two ports. For example, fluid flowing into and out of the inlet 204A may be directed by the punch shell into the outlet and out of the outlet 204B.

[0098] In some embodiments of a medical combining device where multiple punches may be used, the punch casings may provide selectivity in the number of medical fluid containers used with the medical combining device. For example, in a medical connecting device with four punches located in the fluid distribution system, a container of medical fluid may be pierced onto the punch to fluidly couple the interior volume of the container to the fluid distribution system. In this example, fluid can be transferred from the container throughout the fluid distribution system, including through the other three punches. The piercer shells on each of the other three piercers cause the piercers to function as normal channels and the fluid is not impeded unless some of the piercers are used during the insertion process. In some embodiments, punch housings may eliminate the need for complex valves or other devices that may control fluid flow, thereby simplifying the fluid distribution system. However, in other embodiments, the punch and/or fluid distribution system may also include check valves, adjustable valves, or any other suitable devices for regulating fluid flow.

[0099] According to the embodiment shown in FIG. 9A, the punch shell 220 includes a shell tube 222, a shell base 224, and a shell end portion 226. The sheath base may support a sheath tube 222 that extends from the base and defines an internal volume for receiving the punch 202. The sheath base and the sheath tube provide a fluid-tight seal around the punch rod formed by the first rod portion 210 and the second rod portion 212 . The end portion of the casing is designed to close the internal volume formed by the casing tube so that the punch casing creates a fluid-isolated volume around the punch capable of passing fluid between the inlet and outlet when the casing is in an uncompressed position. The sheath tube and the sheath end portion may be formed from a thin material that is compressible in the longitudinal direction toward the punch base 206. The sheath base 224 may assist in resisting force in the longitudinal direction such that a force applied to the sheath end portion 226 forces the sheath tube and/or the sheath end portion toward the base. The end portion of the shell may be configured to be pierced by the punch tip 214 when the punch shell is pressed toward the base of the punch.

[0100] In some cases, the punch 202 and/or the punch shell 220 may provide frictional resistance when the punch is used to pierce a container. Accordingly, in some embodiments, the punch 202 may include a lubricant placed on the punch tip 214, the first shaft portion 210, and/or the second shaft portion 212 to reduce frictional resistance. According to the embodiments shown in FIGS. 9A, the lubricant may be applied directly to the punch and enclosed within the punch shell. Of course, the lubricant may be applied to the outer surface of the punch shell or any other portion of the punch or punch shell, since the present invention is not limited in this regard. The lubricant may be any suitable lubricant for reducing frictional resistance between the punch, the punch shell, and/or the container when the punch is used to pierce the container, including, but not limited to, silicone lubricants (e.g., DOW CORNING 360), perfluoropolyether (PFPE - perfluoropolyether) lubricants (eg NYEMED 7471), synthetic hydrocarbon lubricants, esters and polyglycols.

[0101] FIG. 9B shows the punch 202 and punch shell 220 shown in FIG. 9A, after the container 400 has been punched onto the punch. The container includes a stopper 402 and an internal volume 404 in which medical fluid can be located. The plug 402 may be composed of a material that can be pierced by a punch 202 so that the inlet 204A and the outlet 204B can be made in fluid communication with the internal volume 404. For example, the plug can be made of a rubber material such as polyurethane, neoprene, latex, silicone, ethylene propylene diene rubber (EPDM), fluorine rubber (FKM) or any other suitable material. When the container is pushed onto the punch 202, the plug 402 first comes into contact with the punch shell 220 and applies a force to the punch shell in a longitudinal direction toward the punch base 206. When force is applied to the punch shell, the shell tube 222 is compressed toward the base of the punch and the end portion 226 of the shell is brought into contact with the tip 214 of the punch. After a specified amount of displacement of the punch shell, the tip of the punch pierces the punch shell and begins to pierce the plug 402. When the container is pushed completely onto the punch such that the punch completely pierces the container, the punch shell remains in contact with the plug and is compressed downward towards the base of the punch. As shown in FIG. 9B, the sheath tube and the broken end portion of the sheath can be folded multiple times (eg, into an accordion) to reduce the vertical space required. During this compression process, the sheath base 224 resists the force exerted by the container, allowing the sheath tube to compress. As shown in FIG. 9B, the punch shell is in a compressed position, and the internal volume 404 is in fluid communication with inlet 204A and outlet 204B.

[0102] According to the embodiment shown in FIG. 9B, plug 402 creates a fluid-tight seal around punch 202 after the punch pierces the plug. As shown in FIG. 9B, the sheath tube 222 is pierced through by the punch tip 214 and is compressed around the first punch shaft portion 210 by the action of the plug 402 such that the sheath no longer fits tightly against the punch shaft. The plug 402 creates a fluid-tight seal around the punch 202. The plug can be comprised of any material suitable for creating a fluid-tight seal around the punch, as the present invention is not limited in this regard.

[0103] In the embodiment shown in FIG. 9B, after the internal volume 404 of the container 400 is made in fluid communication with the inlet 216A and the outlet 216B, the medical fluid contained in the internal volume can flow into and fill the fluid distribution system. Inlet 204A may be connected to a piping system towards an air filter (see, for example, FIGS. 6-7) that filters air and passes air into the fluid distribution system. Outlet 204B may be connected to a tubing system toward a fluid transfer device (see, for example, FIGS. 6-7), which may be used to withdraw and administer medical fluid from the internal volume. According to the embodiment shown in FIG. 9B, the interior volume of the container may be located above the components of the fluid distribution system. Accordingly, any fluid present in the container may, by gravity, fill the fluid distribution system and flow toward the fluid transfer device. To replace the volume of fluid that flows from outlet 204B or otherwise leaves the interior of the container, air may be admitted into the interior via an air filter and through inlet 204A.

[0104] FIG. 10 is a cross-sectional view of another embodiment of a punch 202 and a punch shell 220. Similar to the embodiment shown in FIG. 9A, the punch includes an inlet 204A in fluid communication with inlet 216A, and an outlet 204B in fluid connection with outlet 216B. The inlet and outlet form a double-lumen internal channel extending along the length of the punch shaft formed by the first shaft portion 210 and the second shaft portion 212, and are separate from each other. The inlet and outlet end, respectively, at an inlet and an outlet near the punch tip 214. The first shaft portion and the second shaft portion extend from a base 206 that functions to support the punch and define at least the inlet and outlet portions.

[0105] As shown in FIG. 10, the punch shell 220 fits tightly around the punch 202 such that the first shaft portion 210, the second rod portion 212, and the punch tip 214 are substantially enclosed within the punch shell. According to the embodiment shown in FIG. 10, the punch shell serves as a protective barrier for the punch, which can be sterile for use when opening a container of medical fluid. Accordingly, the shell can maintain the sterility of the punch until the punch is used to open the container. As shown in FIG. 10, the punch shell is in an uncompressed position and is configured to form a seal around the second punch shaft portion, and therefore fluid that flows from the inlet 216A or the outlet 216B cannot leak from the punch shell. Accordingly, the punch shell fluidly connects the inlet port 216A to the outlet port 216B and functions as a conduit for fluid flow between the two ports. For example, fluid flowing into inlet 204A and flowing out of inlet 216A may be directed by the punch shell into outlet 216B and flow out of outlet 204B.

[0106] According to the embodiment shown in FIG. 10, the punch shell 220 includes a plurality of O-rings 228 located within the shell tube 222. The O-rings extend radially inward from the sheath tube to engage with the second punch rod portion 212. The O-rings may be formed together with the punch shell or may be formed separately (eg, as an O-ring) and then placed in the punch shell. According to the embodiment shown in FIG. 10, the O-rings and the second portion of the rod are round, so that the O-rings are evenly connected to the punch around the entire circumference of the punch. That is, the round shape promotes uniform tension around the entire circumference of the O-rings to create an evenly pressed seal. Without being limited by theory, the seal around the ellipsoidal second shaft portion may create variations in seal pressure around the circumference of the punch, which may result in a less reliable fluid-tight seal. According to the embodiment shown in FIG. 10, the second portion of the punch shaft includes a shoulder 218 onto which O-rings can be mounted to enhance sealing and attachment of the punch shell to the punch. Of course, the second shaft portion may have any suitable shape, since the present invention is not limited in this regard. According to the embodiment shown in FIG. 10, the punch shell includes two O-rings. Without being limited by theory, a single O-ring may be suitable for containing fluid leakage from the punch casing. In cases where one O-ring fails (eg, due to manufacturing, abuse, etc.), a second O-ring can provide a fluid-tight seal between the punch and the punch shell. Of course, any suitable number of O-rings can be used, since the present invention is not limited in this regard.

[0107] FIG. 11 is a schematic drawing of another embodiment of a punch 202 with different shapes of the first shaft portion 210 and the second shaft portion 212. In some cases, different sized and/or shaped portions of the punch shaft may affect the performance of the fluid-tight seal between the punch and the punch shell and/or container plug. That is, the punch shell and/or container plug may be shaped to correspond to the shape of at least one of the first shaft portion and the second shaft portion so that a proper fluid-tight seal can be formed around the punch so that the fluid is, Essentially, there is no possibility of leakage around the punch. According to the embodiment shown in FIG. 11, the first rod portion 210 has an elliptical cross-section having a major axis diameter greater than the diameter of the circular cross-section of the second rod portion 212. That is, the major axis of the first rod section 210 has a size that is larger than the major axis of the second rod section 212. The first shaft portion 210 abruptly transitions to the radius of the second shaft portion to form a shoulder 218. As shown in FIG. 11, shoulder 218 may function as a prong that serves to attach a punch shell or container plug. Alternatively or additionally, shoulder 218 may function as a seat for a punch shell O-ring. In some embodiments, such a design may provide additional radial space around the second shaft portion in which the sheath tube can be compressed, which may reduce the force used to break and compress the sheath.

[0108] In some embodiments, the first shaft portion and the second shaft portion may constitute any suitable punch portion. For example, the first shaft portion may form the majority of the punch shaft, while the second shaft portion is a small protrusion located on the first shaft portion. In another example, the transition between the first rod portion and the second rod portion may be so smooth that the first rod portion and the second rod portion are one component. In some embodiments, the first and second shaft portions may have different shapes and/or sizes. In other embodiments, the first and second sections of the rod may have the same shape and/or dimensions. Thus, the first and second shaft portions may be of any suitable shape and may define any two regions of the punch shaft.

[0109] FIG. 12 is a schematic drawing of yet another embodiment of a punch 202 including a first shaft portion 210 that is different in size from a second shaft portion 212. Similar to the embodiment shown in FIG. 11, the first section of the rod has an elliptical cross section. However, in the embodiment shown in FIG. 11, the width of the first portion of the rod shown corresponds to the minor axis of the elliptical cross section. In addition, the second rod portion 212 has a circular cross section. In this embodiment, the major axis of the second rod portion has a radial dimension larger (ie, has a larger diameter) than the minor axis of the first rod portion 210. The first shaft portion transitions sharply to the second shaft portion to form a shoulder 218. This design may improve the seal quality of the punch shell and/or container plug. For example, a plug pushed onto punch 202 may abut shoulder 218, and any hole due to defects in the plug caused by the first shaft portion may be sealed tightly by the second shaft portion. In another example, a punch shell located around the punch can stretch around a second shaft portion when compressed, improving the contact and seal provided by the punch shell. In some embodiments, the shoulder 218 may be inclined to provide a less abrupt transition between the first shaft portion and the second shaft portion.

[0110] FIG. 13 is a schematic drawing of yet another embodiment of a punch 202 including a first shaft portion 210 that is different in size from a second shaft portion 212. As shown in FIG. 13, the first portion of the rod has an elliptical cross-sectional shape with a major axis corresponding to the shown width, while the second portion of the rod has a circular cross-sectional shape. As shown in FIG. 13, the major axis of the first rod portion has a radial dimension larger (ie, has a larger diameter) than the major axis of the second rod portion. The transition between the first shaft portion and the second shaft portion may be so smooth that no shoulder or other abrupt change in shape is formed on the punch shaft. This design can facilitate the tight fit of the container onto the punch, since no sudden changes in shape can become an obstacle or otherwise provide greater resistance to the force applied to the container for the purpose of installation on the punch. The first shaft portions and the second shaft portions having different sizes may provide a seal to the container plug or punch shell even in the absence of abrupt transitions or sudden changes in shape.

[0111] FIG. 14 shows one embodiment of a cross-section of a first shaft portion 210 of a punch 202. The first shaft portion 210 includes an inlet hole 216A and an outlet hole 216B defined therein. As shown in FIG. 14, the first section of the rod has the shape of an elliptical cylinder with an elliptical cross section. Without being limited by theory, the elliptical cylinder shape may reduce the overall surface area of the punch 202 without compromising the inlet or outlet, which may reduce the force required for the punch to pierce the container and/or the punch shell. In the embodiment shown in FIG. 14, the inlet and outlet may be sized to define the sides of the first rod portion such that a small amount of additional area is occupied by the first rod portion. As shown in FIG. 14, the inlet port and the outlet port form a long side portion of the elliptical-cylindrical first rod portion.

[0112] FIG. 15 shows another embodiment of a cross section of the first portion 210 of the punch shaft 202. Similar to the embodiment depicted in FIG. 14, the first rod portion includes an inlet port 216A and an outlet port 216B. The first section of the rod has the shape of an elliptical cylinder with an elliptical cross section. Compared with the embodiment in FIG. 14, the inlet and outlet are oriented to form a portion of the short side surfaces of an elliptical cylinder. Such a design may provide additional structural support for the tip of the punch aligned with the center of the first portion of the rod.

[0113] FIG. 16 represents another embodiment of a cross section of the first portion 210 of the punch shaft 202. Similar to the embodiment depicted in FIG. 14-15, the first rod portion includes an inlet port 216A and an outlet port 216B. The first section of the rod has the shape of an elliptical cylinder with an elliptical cross section. Compared with the embodiment in FIG. 14-15, the inlet and outlet are each "D" shaped, with the inlet and outlet located opposite each other (i.e., the flat portions of the "D" shape face each other) . Such a design may provide additional structural support for the tip of the punch aligned with the center of the first portion of the rod. In addition, D-shaped lumens allow the wall thickness to be maintained throughout the first portion of the rod while providing a suitable cross-sectional area for the lumens. Of course, any suitable design and arrangement may be used for the first rod portion 210, inlet 216A, and outlet 216B, since the present invention is not limited in this regard.

[0114] FIG. 17 shows one embodiment of a cross-section of a second shaft portion 212 of a punch 202. The second shaft portion has a cylindrical shape with a circular cross-section including an inlet port 216A and an outlet port 216B disposed therein. Compared to the first shaft sections 210 shown in FIG. 14-16, the second rod portion 212 in the embodiment shown in FIG. 17 has a different shape with a larger area occupied by the second portion of the rod. Without being limited by theory, the shape of the second shaft portion may influence the quality of the fluid-tight seal formed between the second shaft portion and the punch shell and/or container plug. In some embodiments, the circular cross-sectional shape may provide a tight and reliable fluid-tight seal by maintaining uniform sealing pressure around the entire circumference of the second rod portion. Accordingly, in some embodiments, the first shaft portion and the second shaft portion may have different shapes and/or sizes to better perform different functions of the punch 202. For example, the first shaft portion may be formed in accordance with the embodiment shown in FIG. 14 to facilitate piercing of the punch shell and/or container plug, while the second shaft portion may be formed in accordance with the embodiment shown in FIG. 17 to maintain a fluid-tight seal between the punch and the punch shell and/or container plug. Of course, any suitable shapes can be used for the first shaft portion and the second shaft portion, since the present invention is not limited in this regard.

[0115] FIG. 18-19 represent other embodiments of a cross section of the second portion 212 of the punch rod 202. Similar to the embodiment shown in FIG. 17, the second sections of the rod shown in FIG. 18-19 are cylindrical in shape with a circular cross-section and include an inlet port 216A and an outlet port 216B disposed therein. According to the embodiment shown in FIG. 18, the inlet and outlet are circular in shape with a footprint smaller than the elliptical openings shown in FIG. 17. Accordingly, the shape and/or size of the inlet or outlet may vary between the first and second rod portions or within one of the first rod portion and the second rod portion. Alternatively, as shown in FIG. 19, the inlet 216A and the outlet 216B are each “D-shaped”, the “D-shaped” inlet being positioned opposite the “D-shaped” outlet. Of course, the inlet and outlet can be of any suitable shape in the second shaft portion, since the present invention is not limited in this regard.

[0116] FIG. 20A depicts one embodiment of a fluid transfer device 102 located at the end of a fluid distribution system. The fluid adapter includes a housing 104 that includes a first opening 106A and a second opening 106B. Housing 104 houses a female fluid connector 120 that protrudes from first opening 106A. The male fluid connector is configured to connect to a syringe for withdrawing fluid from the medical union device. The male fluid connector is connected to a tube 110 that enters the housing through a second opening 106B. The housing 104 is significantly larger than the male fluid connector, making the fluid adapter more convenient to handle and manipulate by the patient or healthcare professional using the fluid adapter.

[0117] As shown in FIG. 20A, the fluid adapter may include an indicator 130. The indicator is configured to display information related to the medical fluid supplied to the fluid adapter, commands related to the administration process, or other useful information related to the patient. or a healthcare professional. In some embodiments, the indicator may be a visual indicator, a tactile indicator (eg, raised braille dots), or a combination thereof. In the embodiment shown in FIG. 20A, the indicator has a text configuration. Alternatively or additionally, the indicator may have a prominent color or any other non-text marking that conveys information to the patient or healthcare professional. 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 transfer device 102 shown in FIG. 20A. As shown in FIG. 20B, the fluid adapter includes a housing divided into a first portion 104A and a second portion 104B, as well as a male fluid connector 120 located at least partially within the housing. As described previously, the housing 104 includes a first opening 106A and a second opening 106B that provides access to the interior volume defined by the housing. The first housing portion 104A also includes at least one latch 108A, and the second housing portion 104B includes at least one latch socket 108B configured to receive a latch. The retainer and retainer socket may serve to secure the first and second half-housings to enclose and secure the male fluid connector 120 .

[0119] As shown in FIG. 20B, male fluid connector 120 includes a first end 122A and a second end 122B. The first end is configured to interface with another suitable fluid connector, syringe, or other patient device (eg, infusion pump). The male fluid connector 120 may include a luer-activated valve or any other suitable valve that can maintain sterility or block the flow of medical fluid prior to attachment to the syringe. The first end 122A is configured to be located in and protrudes from the first housing opening 106A. The second end 122B is configured to be completely enclosed by the housing and retractable from the second opening 106B. Accordingly, a tube may be inserted through the second opening to provide fluid communication between the male fluid connector and the fluid distribution system. As shown in FIG. 20B, the male fluid connector also includes alignment members 124 that can secure the male fluid connector within the housing when the first portion 104A and the second portion 104B are combined to prevent significant relative movement between the housing and the male fluid connector.

[0120] FIG. 21A shows another embodiment of a fluid transfer device 152 located at the end of a fluid distribution system. Similar to the embodiment shown in FIG. 20A, the fluid adapter includes a housing 154 including a first opening 156A and a second opening 156B. A male fluid connector 170 is located in and extends from the first opening, and a tube 160 is located in and extends from the second opening 156B. An indicator 180 is located on the housing to provide information to a patient or healthcare professional using the fluid transfer device.

[0121] FIG. 21B is an exploded view of the fluid transfer device 152 shown in FIG. 21A. The fluid adapter body includes a first portion 154A and a second portion 154B that can be connected by a retainer 158A and a recess 158B. The housing defines an internal volume in which the male fluid connector 170 can be at least partially located. The first opening 156A and the second opening 156B provide access to the interior of the housing, either for components such as male fluid connector 170 and tubing 160, or for patient devices such as an infusion pump.

[0122] In the embodiment shown in FIG. 21B, the male fluid connector 170 is configured to connect to an infusion pump so that fluid can be automatically withdrawn 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 can maintain sterility or block the flow of medical fluid prior to connection to the infusion pump. In some embodiments, the male fluid connector may be configured to connect to 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 located in the first opening 156A in the fluid adapter housing and protrudes from the passage. The second end of the male fluid connector is configured to connect to a system of tubes leading to other components of the fluid distribution system. In the embodiment shown in FIG. 21B, the second end is located in the second housing opening and is accessible from the second tubing opening. The male fluid connector also includes alignment members 174 that secure the male fluid connector in the housing against rotation. In some embodiments, the alignment members 174 may be configured to lock the male fluid connector from translational and rotational movement relative to the body of the fluid device. Accordingly, the body and male fluid connector may, in fact, function as one component for manipulation and handling by a patient or healthcare professional.

[0123] In some embodiments, the body of the fluid adapter may have a flared, bell-shaped end. The bell-shaped end is configured to support a grip position by a user (eg, a patient or healthcare professional) that prevents the user from touching the fluid connector of the fluid adapter. That is, the bell-shaped end facilitates handling of the fluid adapter by the fluid adapter body rather than the fluid connector during normal use, thereby ensuring cleanliness of the fluid adapter. In addition, the bell-shaped end may be configured to be received by one or more latches on a corresponding housing of the combining device. Such a design may provide releasable attachment of the fluid transfer device to the body of the combining device for ease of short- or long-term storage before and/or after the insertion process (see, for example, FIG. 22B). The bell-shaped end may coincide with the first end of the fluid connector. For example, as shown in FIG. 20A, housing 104 has a flared, bell-shaped end on which the first end 122A of fluid connector 120 is located. As shown in FIG. 21A, housing 154 has a flared, bell-shaped end on which the first end 172A of fluid connector 170 is located.

[0124] In some embodiments, the first end of the fluid connector may be flush with the first opening of the fluid adapter body or recessed into the passage. Accordingly, the first opening may provide access to the first end of the fluid connector, and additional protection of the first end is provided by the housing. Likewise, in some embodiments, the second end of the fluid connector may be recessed into or flush with the second housing opening to provide additional physical protection to the second end while access is provided by the second opening. In other embodiments, at least one of the first end and the second end of the fluid connector may protrude from the housing in a manner that provides easier access to the fluid connector. The fluid adapter may have any suitable arrangement of the first and second ends of the fluid connector, including any combination of the above positions for each end of the fluid connector relative to the housing, since the present invention is not limited in this regard.

[0125] FIG. 22A is a top view of one embodiment of a medical joining device 10 including covers 300A, 300B, 300C, 300D. As previously described, the medical combining device includes cavities for receiving a block of containers. Each of the cavities is closed by a lid 300A, 300B, 300C, 300D, which tightly seals the cavity and seals the punch assemblies located in the cavities. Each lid may include an edge 302, ribs 304, a handle 306, a lid indicator 308, and latches 310. The edge is configured to fit the lid into a cavity and resist further movement into the cavity. Accordingly, the edge provides protection to the cavity and the punch assemblies located therein by securing the cover over the cavity. The purpose of the ribs is to provide structural rigidity to the cap, to ensure the cap's ability to resist external forces, and to provide protection to the enclosed cavity. The handle 306 may have a textured surface that provides a hard surface that a patient or healthcare professional can grasp and remove the cover to use the cavity. The handle or other receiving portion may also receive any projections that extend from the cavities, such as alignment members. The receiving portion may be shaped to respond to the shape of a protrusion extending from the cavities such that the protrusion may guide the associated lid when the lid is attached or removed. The cap indicator 308 can be used to provide information to a patient or healthcare professional regarding the administration process. For example, as shown in FIG. 22A, the cap indicators may indicate the desired order in which the caps should be removed and the cavities used. Cover retainers 310 may be used to releasably secure the cover to the cavity. The latches may be frangible, foldable, or otherwise operative in such a way that the secured cover can be selectively removed by the patient or healthcare professional. In some embodiments, the latches 310 may be configured to release the lid when sufficient pulling force is applied to the handle 306.

[0126] FIG. 22B is a top view of the medical combining device 10 shown in FIG. 22A, without covers removed 300A, 300B, 300C, 300D. As clearly shown in FIG. 22B, the cavities 24 can be opened for use when the covers are removed. Each cavity 24 may include at least one latch socket 18. The latch sockets may receive latch 310 located on the lid such that the lid can be releasably attached to the cavity. The number of fastener slots in the cavity may correspond to the number of fasteners located on the lid so that the lid can be releasably attached to the cavity. According to the embodiment shown in FIG. 22A-22B, the caps 300A, 300B, 300C, 300D are shaped to match the shape of the cavities 24. In some embodiments, the cap may be configured to be press-fitted into the cavity to releasably secure the cap to the cavity. That is, the lid can be made with rigid dimensions for installation in the cavity and attachment to the cavity by frictional force. Of course, the lid may include any suitable fastener that can releasably secure the lid to the cavity.

[0127] In some embodiments, the lid may be formed from a thermoformable plastic material. Accordingly, the lid may be thin and portions of the lid may be flexible in areas not reinforced by the ribs 304. When significant force is applied to the lid to selectively remove (eg, pull) the lid, the lid may flex to release the latches 310 or otherwise release from the groove. In some embodiments, the lid edge 302 may include a tab (see, for example, tab 312 in FIG. 24) that allows a patient or healthcare professional to remove the lid. In this embodiment, if the lid is flexible enough, the patient or healthcare professional can use the tab to separate the lid from the cavity. This design can reduce the force used to remove the cover, making operation easier. Of course, the lid may be formed from any suitable material, since the present invention is not limited in this regard.

[0128] FIG. 23 is an exploded view of the medical combining device 10 and the cap 300 shown in FIG. 22A. As previously described, the lid includes a lip 302, ribs 304, a handle 306, a lid indicator 308, and a latch 310. The lid has a shape (eg, a perimeter shape) responsive to the shape of a cavity 24 formed in the medical unit body 12. The edge 302 is configured to abut the housing 12 when the lid is releasably attached to the cavity. As shown in FIG. 23, clips 310 are compatible with clip slots 18 located on each side of the cavity. Accordingly, when the lid is in position over cavity 24, latch 310 engages this socket of latch 18 and thereby releasably secures the lid to the cavity. In the embodiment shown in FIG. 23, the handle 306 can be pulled with sufficient force to bend the latches 310 to release from the latching receptacles so that the lid can be selectively removed from the cavity. The handle 306 is also configured as a receiving portion that receives a guide 20 that extends from the cavity 24.

[0129] As shown in FIG. 23, cover ribs 304 are arranged radially around all punch assemblies 200. The ribs provide rigidity in the areas of the cover near the punch assemblies 200. That is, the covers are formed to provide maximum protection and force resistance on top of the punch assemblies to better protect the punches when handling the medical unifying device 10. As shown in FIG. 23, areas of the lid surrounded by ribs 304 may be raised to provide additional space between the lid and the punch assemblies. Accordingly, even if the caps are moved toward the punch assemblies, the additional space can prevent contact between the punch and the cap. Of course, the ribs can be located in any suitable position on the lid where additional rigidity is required, since the present invention is not limited in this regard.

[0130] FIG. 24 represents one embodiment of a medical combining device 10, when used with a plurality of container assemblies 400A, 400B, 400C. As shown in FIG. 24, the medical combining device combines fluid from six separate containers, with two containers in each container block 400A, 400B, 400C connected to three of the four cavities 24. Each of the container blocks is installed in a cavity in the medical combining device after the cover associated with each cavity was removed. As each container bank was installed, punches pierced each of the two containers in the container bank, creating fluid communication between the containers and the two fluid distribution systems 100, 150 to combine and deliver to the first fluid transfer device 102 and the second fluid transfer device 152. fluids

[0131] As shown in FIG. 24, the number of cavities used in the medical combining device 10 may correspond to a particular dose to be administered to a patient. Accordingly, during the administration process, the patient or healthcare professional may only remove the caps from the cavities to be used for the specific dose required. That is, the caps can be left in place to provide protection to the punch assembly; the cavity is not intended to be used for a specific dose. In the embodiment shown in FIG. 24, the lid includes a tab 312 that can be used to separate and remove the lid. Thus, during the administration process, the patient or healthcare professional can remove the cap and then attach the container assembly to the cavity until the required dose of medical fluids is delivered. Once the container units are attached and the containers are in fluid communication with the fluid distribution system, the first and second fluid adapters 102, 152 can be coupled to the patient device to deliver medical fluids for injection or infusion to the patient.

[0132] FIG. 25 is a flowchart of one embodiment of a method for using a medical combining device. At step 500, the patient or healthcare professional may remove the cover to expose the cavity of the medical uniting device. At step 502, the patient or healthcare professional can attach the container to the cavity by pressing the container onto the punch. When the container is pushed onto the punch, the container can be brought into fluid communication with the fluid distribution system of the medical coupling device. Steps 500 and 502 may be repeated as many times as necessary to achieve a specific dose of medical fluid. That is, for a higher dose, additional lids can be removed and additional containers can be attached to additional cavities. At step 504, a syringe may be attached to the tubing system for withdrawing the first medical fluid. The tubing system is part of a medical coupling device brought into fluid communication with the attached container(s), and may include a fluid connector that can be used to connect the syringe to the tubing system. In some embodiments, the patient or healthcare professional may inject the first medical fluid into the patient. At step 506, the patient or healthcare provider may attach an infusion pump to the tubing system to cause a second medical fluid to flow through the tubing system and into the patient. The infusion pump can be connected using a fluid connector, a luer-activated valve, or any other suitable fluid connector. In some embodiments, an infusion pump may be used instead of a syringe to withdraw the first medical fluid.

[0133] In some embodiments, the medical combining device may supply one or more medical fluids. Accordingly, depending on the number of fluids to be supplied by the combining device, any number of patient devices can be connected to the various fluid outlets of the combining device. For example, infusion pumps, syringes, intravenous infusion bags, and other suitable devices may be connected to the coupling device to possibly deliver a medical fluid to a patient. In the embodiment shown in FIG. 25, one or more steps 504 and 506 may be omitted from the method in cases where neither the syringe nor the infusion pump is suitable for delivering the medical fluid from the combining device. In some embodiments, one of steps 504 and 506 may be retained while the other is eliminated. For example, to deliver a single fluid, a patient or health care provider can simply attach an infusion pump to the coupling device, without attaching a syringe at all. Any suitable combination of steps may be used to administer one or more medical fluids to a patient, and the present invention is not limited in this regard.

[0134] FIG. 26 is an overview view of another embodiment of a medical coupling device 600 that is wearable by a patient to allow free movement of the patient during insertion. Without being limited by theory, a wearable device may influence mobility based at least in part on mass, mass distribution, and size. For example, a heavy, large object with a center of mass far away from a person may be uncomfortable and may interfere with movement when worn. Accordingly, the combining device shown in FIG. 26 is configured to minimize the size of the combining device to improve wearability while simultaneously combining medical fluids from multiple containers. As shown in FIG. 26, the combining device 600 includes a housing 602, which is shown transparent for clarity. The combining device also includes a first cavity 604A and a second cavity 604B, which are formed side by side in the housing. As shown in FIG. 26, the first cavity and the second cavity are formed close to each other and close to the edges of the body, and therefore the overall size of the combining device is minimized with respect to the volume of the combined containers. The unifying device also includes a base 603 that is configured to provide support for cavities and other various components located in the housing.

[0135] According to the embodiment shown in FIG. 26, the unifying device may be small enough to be worn by the patient for extended periods of time without compromising the unifying and fluid delivery functions. In some embodiments, the total volume occupied by the combining device may be less than or approximately equal to 800 cm ³ , 700 cm ³ , 600 cm ³ , 500 cm ³ , 400 cm ³ and/or any other suitable volume. In some embodiments, the total volume of the combining device may be 500-700 cm ³ . In some embodiments, the maximum longitudinal length of the combining device may be no greater than 15 cm, 12 cm, 10 cm, 8 cm, and/or any other suitable length. Accordingly, in some embodiments, the maximum width of the combining device may be no greater than 12 cm, 11 cm, 10 cm, 8 cm, and/or any other suitable width. Likewise, in some embodiments, the maximum thickness of the combining device may be no more than 10 cm, 8 cm, 6 cm, 4 cm, and/or any other suitable thickness. Such volumes and main maximum dimensions can ensure comfortable wearing of the combining device, with less interference with the ability to move. Of course, it is possible to use sizes larger or smaller than those given above, since the present invention is not limited in this regard. In addition, the wearable integration device may have any suitable weight with fluids, weight without fluids (ie, with containers of medical fluids attached), and weight distribution, as the present invention is not limited in this regard.

[0136] According to the embodiment shown in FIG. 26, the combining device includes a fluid distribution system 650 that is configured to combine fluid from a container that can be connected to the first cavity 604A and the second cavity 604B. As shown in FIG. 26, the combining device includes punches 200 located in the first cavity and the second cavity, the punches being configured to pierce and fluidly connect a container of medical fluid to the combining device. Punchers may include a punch shell, a shaft, dual channels, and/or other elements in accordance with exemplary embodiments described herein. The punches are connected by a tubing system 660 that forms a continuous fluid path terminating 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 flow into the fluid distribution system so that the fluid contained in the connected containers can flow freely under the influence of gravity or due to pumping, thereby preventing leakage of the fluid. The fluid outlet connector is secured to a fluid outlet 606 formed in the housing 602 and configured to receive the fluid connector so that fluid from the fluid distribution system can be supplied to a cooperating device (e.g., infusion set, infusion pump, other device drug delivery, etc.), a cooperating combining device (eg, for combining a fluid from several fluid combining devices), or other desired device or component. According to the embodiment shown in FIG. 26, fluid outlet connector 652 includes a luer-activated valve 654 that does not allow fluid to flow out of the fluid distribution system until a cooperating device or component having a corresponding luer-activated valve is attached to the outlet connector. fluid medium. Luer-activated valve 654, shown in FIG. 26 is a male luer-activated valve configured to mate with a female luer-activated valve. Of course, any suitable fluid connector with or without a luer-activated valve can be used, as the present invention is not limited in this regard.

[0137] According to the embodiment shown in FIG. 26, the combining device may be configured to accommodate containers of medical fluids having a suitable volume for the prescribed dose of the medical fluid. In some embodiments, each of the cavities 604A, 604B may be configured to receive containers having volumes 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 of any suitable volume can be used, since the present invention is not limited in this regard.

[0138] According to the embodiment shown in FIG. 26, the combining device may include a protective cover (eg, cap) 608 that is configured to selectively cover the first cavity 604A and the second cavity 604B to secure any containers disposed therein during insertion. As shown in FIG. 26, the lid is connected to the body 602 by a hinge 610. Accordingly, the lid is rotatable about the hinge between a closed position in which the first cavity and the second cavity are completely closed, and an open position in which the first cavity and the second cavity are open so that they can accept containers containing medical fluid. Of course, in other embodiments, the cover may be configured to interact with the housing in any suitable manner (e.g., completely removable, sliding, etc.) to move between open and closed positions, since the present invention is not limited in this regard . As shown in FIG. 26, the cover includes a latch socket 612 that is configured to receive a latch 613 located on the housing. The latch is configured as a bendable latch that fits into the latch socket to secure the lid when the lid is in the closed position and the latch is in the unpressed (i.e., unbent) position. Conversely, the latch is configured to release the cover when the latch is moved to a pressed position (ie, a folded position) in which the latch is released from the latch seat. Of course, any suitable locking structure may be used, including, but not limited to, magnetic latches and spring latches.

[0139] As shown in FIG. 26, the combining device may include a fastening means 614 configured to allow the combining device to be worn comfortably by a patient. The mounting means is secured to the housing 602 and is configured to support the weight of the combining device and any installed containers. The attachment means is configured as a belt attachment means that can be easily slid along the belt to secure the infusion pump to the patient's thighs. Of course, any suitable means, strap or bandage may be used to enable the patient to wear the unifying device, including, but not limited to, carabiners, Velcro fasteners, strap clips, a waist belt, shoulder straps, and the like, as the present the invention is not limited in this respect.

[0140] FIG. 27 is an exploded view of the medical combining device 600 shown in FIG. 26. As already noted, the combining device includes a housing 602 containing a first cavity 604A and a second cavity 604B, and a base 603. The fluid distribution system 650 is located in the housing and supported by the base, and includes punches 200 located in each of the cavities, an air filter 668, and a fluid outlet connector 652 containing a luer-activated valve 654. FIG. 27 does not show the fluid distribution system tubing system for clarity. The fluid outlet connector 652 is configured to be secured between the housing and the base at the outlet port portions 606A, 606B. The combining device also includes a cover 608 that is secured to the housing by a hinge 610. The cover can be selectively secured in the closed position by a latch 613 and a latch socket 612.

[0141] As shown in FIG. 27, the combining device includes an attachment means 614 that allows the combining device to be releasably secured to clothing worn by a patient. The fastening means includes an mounting portion 615 and a flexible portion 616. The mounting portion 615 is configured to be attached to a fastening means recess 617 formed in the combining device body 602. When the mounting portion 615 is placed in or otherwise attached to the fastening means recess 617, the mounting portion can support the entire weight of the combining device when the fastening means is attached to clothing worn by the patient. The flexible portion 616 is configured to flex outwardly from the body and receive a clothing item such as a belt. Accordingly, the flexible portion can be folded away from the body such that a belt or other item of clothing can be positioned between the flexible portion and the body. When released, the flexible portion may releasably catch a belt or item of clothing between the flexible portion and the body. Accordingly, the combining device can, in fact, be suspended from a belt or item of clothing by means of the fastening means. To remove an item of clothing, the flexible portion can be folded away from the body again and the belt or item of clothing can be removed. Of course, other fastening means designs are contemplated, including fastening means that are substantially rigid, and any suitable fastening means, fastener, fastener, buckle, or the like may be used. for hanging the unifying device on clothing, since the present invention is not limited in this regard.

[0142] FIG. 28 is an overview view of the medical unifying device 600 shown in FIG. 26, when used with the first container 402A and the second container 402B. According to the embodiment shown in FIG. 28, the combining device combines fluid from two containers of different sizes. That is, the first container 402A has a volume smaller than the second container 402B. The combining device supplies medical fluid from both containers to the fluid outlet connector 652 so that a dose greater than the dose delivered from either one of the containers can be administered. As shown in FIG. 28, the punches 200 are located in the internal volumes of the containers, and therefore the internal volumes of the containers are fluidly connected.

[0143] In contrast to the above-described embodiments, the first cavity and the second cavity are each configured to receive a single fluid container rather than a container bank containing at least two containers. Accordingly, the first container and the second container can be installed sequentially in the first cavity and the second cavity, respectively. For example, the patient may insert the first container into the first cavity, thereby piercing the first container and bringing its internal volume into fluid communication with the fluid distribution system. The patient may then insert a second container into the second cavity, thereby piercing the second container and bringing its internal volume into fluid communication with the fluid distribution system. Once one or both containers are attached, fluid can be withdrawn from the fluid outlet connector (eg, through an infusion set, infusion pump, other drug delivery device, etc.).

[0144] As shown in FIG. 28, the combiner lid 608 is in the open position, and the containers 402A, 402B and cavities 604A, 604B are open and accessible from the outside of the housing 602. However, in the closed position, the lid is releasably secured to the latch 613 within the latch socket 612. Accordingly, in the closed position, the lid will cover both the containers and the cavities and will not allow access to them from outside the housing. This design can prevent inadvertent removal of containers due to patient movement, jostling, or other force.

[0145] FIG. 29 is a front elevation view of various containers that can be used with the medical combining device shown in FIG. 26. Without being limited by theory, the combining device according to the embodiment shown in FIG. 26 can be used with a variety of medical fluid containers of different sizes. The containers may be sized and shaped to match the size and shape of the cavities formed in the housing, or may be of any suitable shape that fits within the boundaries of the housing and the lid of the combining 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 inner height of the body and the diameter of the combining device cavity. That is, the housing of the combining device can accommodate containers having a height of up to H1 and a diameter of up to D1. In contrast, the second container 402B has a second height H2 but retains a first diameter D1. Accordingly, the diameter of the second container corresponds to the internal diameter of the cavity on the combining device, but the height does not correspond to the internal height of the housing. However, containers with dimensions smaller than the internal dimensions of the housing may be accommodated in the unifying device and may be held in position by features of the combining device, such as friction with the punch, vial neck retainers, or other suitable structures. As shown in FIG. 29, the third container 402C compatible with the combining device has a second height H2 and a second diameter D2 that are smaller than the height and diameter of the first container 402A. By arranging containers with different sizes, the combining device allows the delivery of an accurate dose of medical fluid from standardized containers with multiple sizes.

[0146] FIG. 30A-30B are front perspective views and rear perspective views, respectively, of the medical combining device 600 shown in FIG. 26, with cover 608 in the closed position. As best shown in FIG. 30A-30B, when the lid is in the closed position, a latch 613 is located in the latch seat 612 to secure the lid in the closed position. Accordingly, the cavities and any containers located therein are secured and protected from forces caused by movement, shock, etc., which could interfere with the fluid connection of the containers. Thus, the combining device provides a compact, rugged and wearable module for combining and delivering medical fluid from multiple containers.

[0147] FIG. 31 is a front elevation view of another embodiment of a medical combining device 700 configured to combine medical fluids from up to three containers. Similar to the embodiment shown in FIG. 26, the combining 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 covers a first container 402A, a second container 402B, and a third container 402C located in cavities formed in the housing. The combining device includes a fluid distribution system (not shown) that creates a continuous fluid path 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, medical fluid may flow from the containers into the fluid outlet connector as indicated by arrow 758. Of course, in other embodiments, the medical fluid may flow in any suitable direction, including toward the fluid inlet connector, such as the present invention is not limited in this regard. The outlet may be connected to a cooperating device (eg, an infusion set, an infusion pump, another drug delivery device, etc.) or other connecting device to supply medical fluid from each of the three containers. The inlet is configured to receive medical fluid from another combining device or a corresponding medical fluid source so that, if necessary, medical fluids from multiple containers and/or multiple sources can be combined. Below, with reference to FIG. 32-35 the functions of the fluid inlet connector will be further described.

[0148] FIG. 32 is a front elevation view of one embodiment of a medical fluid pooling system including a first wearable pooling device 600A and a second wearable pooling device 600B for combining fluids from more containers than a single fluid pooling device. As shown in FIG. 32, each of the combiners is configured to receive two receptacles, the first combiner comprising a first receptacle 402A and a second receptacle 402B, while the second combiner includes a third receptacle 402C and a fourth receptacle 402D. Each combiner includes a fluid outlet connector 652 and a fluid inlet connector 656 that allow the combiners to be connected in series. That is, as shown in FIG. 32, the fluid outlet connectors are configured with the fluid inlet connectors of other connecting devices. Specifically, the fluid outlet connector 652 of the first combiner 600A is connected to the fluid inlet connector 656 of the second combiner 600B. The fluid outlet connectors 652 shown in FIG. 32 include a male luer-activated valve, and the fluid inlet connectors 656 include a female luer-activated valve. Of course, in other embodiments, the fluid outlet connector and the inlet connector may use any suitable interface or valve configuration, as the present invention is not limited in this regard.

[0149] According to the embodiment shown in FIG. 32, the combining devices include a mechanical connector 618 that is configured to mechanically couple the first wearable combining device 600A to the second wearable combining device 600B. In some cases, it is desirable to mechanically connect together multiple wearable unifying devices such that they can be treated as a single unit by the patient. However, it may also be desirable to provide flexibility to the connected joining units so that the connected joining devices do not become bulky and less comfortable to wear. Accordingly, as shown in FIG. 32, the mechanical connector 618 is configured as a hinge that allows the combining devices to rotate relative to each other about a longitudinal axis (ie, an axis extending from top to bottom relative to the page). This design ensures that the connected joining units conform to the shape of the patient's body when the connected joining devices are worn. For example, wearable coupling devices may be wrapped around a user's belt such that both coupling devices can be easily suspended from a belt worn by the patient via the belt clip means. Of course, the mechanical connector can be any suitable fastener that couples the movement of the connecting devices in at least one direction, since the present invention is not limited in this regard.

[0150] FIG. 33 is a front elevation view of another embodiment of a medical fluid pooling system including a first wearable pooling device 600A and a second wearable pooling device 600B. In some cases, it is desirable to be able to independently manipulate the connected joining devices to allow the joining devices to be independently attached to clothing or otherwise worn. Such a design may improve the user's comfort since a large number of small, independent devices may be less inconvenient to wear or attach to clothing than a single large device. Accordingly, similar to the embodiment shown in FIG. 32, the fluid outlet connector 652 of the first combiner is coupled to the fluid inlet connector 656 of the second combiner to allow administration of medical fluid from a maximum of four containers 402A, 402B, 402C, 402D. However, in contrast to the embodiment shown in FIG. 32, the fluid inlet connector and the fluid outlet connector are connected by a union tube 670, which allows the first union device and the second union device to move relatively freely within a distance limited by the length of the tube 670. Thus, the first wearable union device can be independently attached for wear to the patient's clothing or body before or after connecting the connecting devices via a tube. As shown in FIG. 33, the combining tube includes a tube outlet connector 672 and a tube inlet connector 674 that connect, respectively, to a fluid outlet connector 652 and a fluid inlet connector 656 of the combiners. The combining tube may be of any suitable length to provide the required range of independent movement and placement of the combining devices.

[0151] In accordance with the embodiments depicted in FIGS. 32-33, a method of administering a medical fluid to a patient may include obtaining or providing a first wearable pooling device 600A and an additional second wearable pooling device 600B, and a corresponding number of containers for combining a prescribed volume of the medical fluid. The method may also include attaching the first container 402A to a first cavity formed in the first housing 602 of the first combining device 600A, causing the first container to be pierced into fluid communication with the fluid distribution system of the first combining device. The method may further include attaching a second container 402B to a second cavity formed in the first body of the first fluid combiner 600A, causing the second container to be pierced into fluid communication with the fluid distribution system of the first fluid combiner. If the two containers are sufficient for the prescribed dose, the method may include connecting the fluid outlet of the first combining device to an infusion set, infusion pump, other drug delivery device, or other cooperating device for delivery to a patient. If additional receptacles are required, the method may include attaching a third receptacle 402C to the second wearable combining device 600B in a manner similar to attaching the first and second receptacles. Additionally, the method may include attaching a fourth receptacle 402D to a second wearable combining device such that the second wearable combining device combines fluid from both the third receptacle and the fourth receptacle. Once the desired number of receptacles are connected to the second wearable coupling device, the method may include connecting the second wearable coupling device to the first wearable coupling device (e.g., from a fluid outlet connector of the second wearable coupling device to a fluid inlet connector of the first wearable coupling device). combining device or vice versa). Alternatively, in some embodiments, the method may include delivering all of the medical fluid available from the first wearable coupling device to the patient and then disconnecting the first coupling device from the infusion set, infusion pump, other delivery device medication or other interacting device. In this embodiment, the method may further include attaching a second coupling device after the first coupling device has been disconnected so that fluid delivery to the patient can be resumed. The above method steps can be repeated as necessary to combine and/or deliver a suitable volume of fluid to the patient. That is, any suitable number of coupling devices with attached containers can be sequentially connected to each other or sequentially connected to and disconnected from an infusion set, infusion pump, other drug delivery device or cooperating device for delivering a medical fluid to a patient, since the present invention is not limited in this regard.

[0152] FIG. 34 is a front elevation view of another embodiment of a medical fluid coupling system that includes a first wearable coupling device 800A, a second wearable coupling device 800B, and a third wearable coupling device 800C, which provides a modular coupling system for any fluid coupling required. number of containers containing medical fluids. In particular, the medical fluid integration system shown in FIG. 34 allows the patient to minimize the overall volume and size of the unifying system to make it more comfortable to wear, while being expandable to provide a variety of different prescribed dosages. As shown in FIG. 34, each of the containers is configured to receive one container. That is, the first combiner includes a first receptacle 402A, the second combiner includes a second receptacle 402B, and the third combiner includes a third receptacle 402C. The containers are secured within the cavities formed in the body 802 of each combiner by means of a lid 808, which is secured in the closed position by a latch 813. The base 803 of each combiner provides support for the internal components of the combiner. Similar to the embodiment shown in FIG. 32, the joining devices include a first mechanical connector 818A and a second mechanical connector 818B that connect the joining devices to each other for ease of handling and/or attachment to a patient's clothing or body.

[0153] Similar to the embodiments depicted in FIG. 32-33, each of the combining devices 800A, 800B, 800C shown in FIG. 34 may be independently coupled to each other or to an infusion set, infusion pump, other drug delivery device, or other cooperating device. In the state shown in FIG. 34, the fluid outlet connector 854 of the first combiner is connected to the fluid inlet connector 856 of the second combiner 800B. The fluid outlet connector 854 of the second combiner is similarly connected to the fluid inlet connector 856 of the third combiner 800C. Accordingly, medical fluid from each of the containers located in the three combiners is combined and accessible from the fluid outlet connector 854 of the third combiner 800C or, in some embodiments, the fluid inlet connector 856 of the first combiner 800A. Accordingly, the fluid may be delivered to the infusion pump, infusion set, other drug delivery device, or other interacting device from three containers simultaneously. Of course, in other embodiments, any suitable number of combining devices and containers can be used to obtain the required dose of medical fluid, since the present invention is not limited in this regard.

[0154] FIG. 35 is a front elevation view of yet another different embodiment of a coupling system for medical fluids, including a first wearable coupling device 800A, a second wearable coupling device 800B, and a third wearable coupling device 800C, which provide a modular coupling system for fluid coupling of any number of medical fluid containers required and to allow the coupling devices to move freely relative to each other within a distance limited by the length of the tube 870. As previously noted, in some cases it is desirable to allow wearable coupling devices to move in order to facilitate attachment of the coupling devices to clothing or otherwise reduce single total volume of a single connected unifying system. Accordingly, as shown in the embodiment shown in FIG. 35, the wearable combining devices are connected by a combining tube 870, which allows the combining devices to move independently relative to each other within a distance determined by the length of the tube 870. The connecting devices shown in FIG. 35 are similar to the devices shown in FIG. 34, wherein each combining device receives one container (eg, a first container 402A, a second container 402B, and a third container 402C), and each combining device includes a fluid inlet connector 856 and a fluid outlet connector 854. Each of the sets of pooling tubes 870 includes a tube outlet connector 872 and a tube inlet connector 874 that connect, respectively, to a fluid outlet connector 854 and a fluid inlet connector 856 of the poolers. Accordingly, when a combining tube is connected, a continuous passage for fluid is created between the internal volumes of the containers located in each combining device. In the embodiment shown in FIG. 35, an infusion set, infusion pump, other drug delivery device, or other cooperating device may be connected to the fluid outlet connector 854 of the third combining device 800C to deliver fluid simultaneously from all three containers 402A, 402B, 402C. Of course, any suitable number of containers and combining devices can be used, since the present invention is not limited in this regard. Moreover, instead of connecting the coupling devices to each other, the coupling devices can be connected in series with an infusion set, infusion pump, other drug delivery device or cooperating device to deliver a suitable volume of fluid, since the present invention is not limited in this regard.

[0155] FIG. 36 depicts one embodiment of an infusion set 900 including a breathing valve (i.e., a degassing valve, an air release valve, etc.) 909 configured to allow the infusion set to be connected and disconnected in series with one or more coupling devices in accordance with exemplary embodiments described in this application. As shown in FIG. 36, the infusion set includes an infusion set inlet 902, an infusion tube 904, a pump mechanism 910, an outlet tube 906, and an infusion set outlet 908, which together form a continuous fluid path. The pump mechanism is configured to force fluid (eg, from a coupling device) toward the outlet 908 of the infusion set. The infusion set inlet 902 is configured to connect to a fluid supply source, such as a fluid outlet connector, a fluid inlet connector, or other fluid connectors of exemplary embodiments described herein. According to the embodiment shown in FIG. 36, a vent valve is positioned in line with the inlet tube 904. The vent valve is configured to remove air pockets that may be present in the inlet tube. For example, when the infusion set is first used with a fluid supply, air within the infusion set can be removed by priming the pump mechanism and/or allowing fluid to flow from the fluid supply. In addition, the vent valve may remove additional air bubbles that may form during fluid delivery to prevent air from entering the fluid stream. When the infusion set is disconnected from the first fluid supply (eg, the first coupling device), the infusion set may become at least partially refilled with air. Accordingly, when the infusion set is connected to a second fluid supply (eg, a second pooling device), the breathing valve may again remove air distributed throughout the infusion set to provide a continuous flow of fluid to the patient. Accordingly, the breathing valve may allow fluid supply sources to be changed without requiring the patient to switch infusion sets.

[0156] As shown in FIG. 36, the infusion set also includes a needle set 920, which is connected to the infusion set outlet 908 via a needle set connector 932. The needle set shown in FIG. 36 is branched into four directions, that is, the fluid channel from the outlet of the infusion set is divided into a first needle channel 934A, a second needle channel 934B, a third needle channel 934C and a fourth needle channel 934D. At the end of each needle channel are infusion needles 936A, 936B, 936C, 936D, which are used to deliver fluid subcutaneously to the patient. Of course, in other embodiments, the needle set may include any suitable number of needles, including, but not limited to, one needle, two needles (i.e., bifurcated), and three needles (i.e., branched). three directions), since the present invention is not limited in this regard.

[0157] Although the present teachings have been described in connection with various embodiments and examples, the present teachings are not intended to be limited to these embodiments or examples. To the contrary, the present teachings embrace various alternatives, modifications, and equivalents, as will be apparent to those skilled in the art. Accordingly, the above description and drawings are for exemplary purposes only.

Claims (145)

1. A connecting device for medical fluids, containing: punch shell; punch containing: a rod including a first rod section and a second rod section, wherein the first rod section and the second rod section have different cross-sectional shapes, wherein the second rod section is configured to form a fluid-tight seal with the punch shell, and wherein the inner channel of the punch continues through the first shaft portion and the second shaft portion; And the tip of the punch connected to the rod; a tube system in fluid communication with the internal channel of the punch; And a base connected to the punch, wherein the punch shell is configured to compress and move toward the base when a force is applied to the punch shell in the direction of the base. 2. The medical fluid coupling device of claim 1, wherein the punch tip is connected to the first shaft portion. 3. The medical fluid integration device of claim 1 or 2, wherein the first shaft portion has a first diameter along a major axis and the second shaft portion has a second diameter along a major axis, wherein the first diameter along the major axis is greater than the second diameter along a major axis. major axis. 4. The medical fluid integration device of claim 1 or 2, wherein the first shaft portion has a first diameter along a minor axis and the second shaft portion has a second diameter along a major axis, wherein the second diameter along the major axis is greater than the first diameter along a major axis. minor axis. 5. The medical fluid coupling device of claim 1 or 2, wherein the internal channel comprises an inlet and an outlet, the inlet and outlet being in fluid communication via a punch shell when the punch shell is in an uncompressed position. 6. The medical fluid combining device of claim 5, wherein the inlet and outlet each have a D-shaped cross-section, the D-shaped inlet and outlet cross-sections being opposite each other. 7. The medical fluid coupling device of claim 1 or 2, wherein the punch shell includes a shell base, a shell tube, and a shell end portion, wherein the punch is received into the shell tube, wherein the shell tube is capable of being compressed and moved toward the base of the shell when a force is applied to the shell of the punch in the direction of the base, and the punch pierces the end portion of the shell as the shell tube moves towards the base. 8. The medical fluid coupling device of claim 7, wherein the punch shell includes at least one O-ring located in the shell tube. 9. The medical fluid combining device according to claim 1 or 2, wherein the first shaft portion has an elliptical cross-sectional shape and the second shaft portion has a circular cross-sectional shape. 10. The medical fluid coupling device according to claim 1 or 2, wherein the medical fluid coupling device is wearable. 11. The medical fluid coupling device of claim 10, further comprising a belt attachment means configured to releasably attach the medical fluid coupling device to a belt worn by the patient. 12. The medical fluid coupling device of claim 10, further comprising a lid movable between an open position and a closed position, the lid being configured to cover the punch and the punch shell in the closed position. 13. The medical fluid coupling device of claim 12, wherein the lid includes a hinge and the lid is rotatable between an open position and a closed position about the hinge. 14. A medical device fluid adapter, wherein the fluid adapter comprises: a fluid connector including a first end, a second end, and a luer-activated valve controlling fluid communication between the first end and the second end; a tube in fluid communication with the second end; And a housing including a first opening and a second opening, the housing housing at least a portion of a fluid connector, wherein the first end of the fluid connector is accessible, and wherein the housing includes a bell-shaped end proximate the first opening. 15. The fluid transfer device of claim 14, wherein the bell-shaped end is configured to receive one or more fasteners located on the medical device. 16. The fluid adapter of claim 15, wherein the one or more fasteners are located in the medical device adapter holder. 17. The fluid transfer device of claim 14, wherein the housing includes an indicator configured to communicate information to a user of the medical device. 18. The fluid adapter of claim 14, wherein the first end of the fluid connector is accessible from the first opening and the conduit is located in the second opening. 19. The fluid adapter of claim 14, wherein the first end of the fluid connector extends from the first opening and a tube is disposed in the second opening. 20. The fluid adapter according to claim 14, wherein the first end is configured to connect to an infusion pump. 21. The fluid adapter of claim 20, wherein the first end is configured to connect to the infusion pump via a second fluid connector including a second luer-activated valve. 22. The fluid transfer device of claim 14, wherein the first end is configured to connect to a syringe. 23. The fluid transfer device of claim 14, wherein the housing is wearable. 24. The fluid transfer device of claim 23, wherein the housing includes a belt attachment means configured to releasably attach the fluid transfer device to a belt worn by the patient. 25. A connecting device for medical fluids, comprising: a cavity including a hollow punch; a tube system in fluid communication with the hollow punch; And a cover configured to be detachably connected to the cavity for closing the hollow punch. 26. The medical fluid integration device of claim 25, wherein the cap includes an indicator configured to indicate the method of use. 27. The medical fluid coupling device of claim 25, wherein the cap includes a tab that is removable by a user for detaching the cap from the cavity. 28. The medical fluid coupling device of claim 25, wherein the perimeter of the cavity and the perimeter of the cap have responsive shapes, the cap being at least partially inserted into the cavity when the cap is releasably attached to the cavity. 29. The medical fluid integration device of claim 25, wherein the lid includes a receiving portion configured to receive a projection located in the cavity. 30. The medical fluid integration device of claim 25, wherein the cavity is a plurality of cavities each including a hollow punch, and wherein the cap is a plurality of caps removably attached to the plurality of cavities to cover each from hollow punches. 31. The medical fluid fusion device of claim 25, wherein the lid is comprised of a thermoformable plastic material. 32. The medical fluid integration device of claim 25, wherein the cavity comprises a recess. 33. The medical fluid coupling device of claim 25, wherein the medical fluid coupling device is wearable. 34. The medical fluid coupling device of claim 33, further comprising a belt attachment means configured to releasably attach the medical fluid coupling device to a belt worn by the patient. 35. The medical fluid coupling device of claim 25, wherein the lid is movable between an open position and a closed position, the lid being configured to cover the punch and the punch shell in the closed position. 36. The medical fluid coupling device of claim 35, wherein the lid includes a hinge and the lid rotates between an open position and a closed position about the hinge. 37. A method of using a combining device for combining a medical fluid, comprising the steps of: removing the cover to reveal the cavity of the combining device, the cavity including a hollow punch and a punch shell covering the punch, the punch shell being tightly adjacent to the punch before the container is installed in the cavity; connecting the first container to the cavity by pressing the first container onto the punch to ensure that the shell of the punch and the first container are pierced by the punch to provide fluid communication between the punch and the internal volume of the first container, wherein the internal volume of the first container contains a medical fluid and the punch is in fluid communication environment with a tube system; And connecting an infusion pump to the tubing system to allow the medical fluid to move through the tubing system and into the patient. 38. The method of claim 37, wherein the cavity includes a second hollow punch and a second punch shell covering the second punch, wherein attaching the first container to the cavity allows the second punch shell and the second container to be pierced by the second punch to provide fluid communication a medium between a second internal volume of the second container and a second punch, the second punch shell being in close contact with the second punch, the second internal volume containing a second medical fluid, the second punch being in fluid communication with the second tubing system. 39. The method of claim 38, further comprising the step of connecting the syringe to the second tubing system to allow movement of the second medical fluid into the syringe. 40. The method according to claim 37, further comprising the steps of: removing a second cover to expose a second cavity of the combining device, the second cavity comprising a second hollow punch and a second punch shell covering the second punch; And connecting the second container to the cavity by pressing the second container onto the second punch to pierce the second shell of the punch and the second container by the second punch to provide fluid communication between the second punch and the internal volume of the second container, wherein the internal volume of the second container contains a medical fluid and the second punch is in fluid communication with the tubing system. 41. The method of claim 40, wherein the first container and the second container have different sizes. 42. The method according to claim 40, in which the volume of the first container is 1.25-300 ml. 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. 44. A wearable fluid integration device comprising: a housing including an attachment means configured to attach the wearable fluid combining device to the clothing; a first cavity formed in the housing and configured to receive the first container; And a first punch located in the first cavity and configured to pierce the first container when the first cavity receives the first container; a second cavity formed in the housing and configured to receive a second container; And a second punch located in the second cavity and configured to pierce the second container when the second cavity receives the second container, wherein the tubing system is connected to the second punch and configured to provide fluid communication between the first punch, the second punch and the fluid outlet connector. 45. The wearable fluid integration device of claim 44, further comprising a lid movable between an open position and a closed position, the lid being configured to close the first cavity in the closed position. 46. The wearable fluid integration device of claim 45, wherein the lid includes a hinge and the lid rotates between an open position and a closed position about the hinge. 47. A wearable fluid integration device according to claim 45, wherein the housing contains a latch configured to detachably secure the lid in the closed position. 48. The wearable fluid integration device of claim 47, wherein the latch is a flexible latch, and wherein the latch is configured to secure the lid in an unflexed position and release the lid in a folded position. 49. The wearable fluid pooling device of claim 44, wherein the attachment means is a belt-mounting means configured to releasably attach the wearable fluid pooling device to a belt worn by the patient. 50. A wearable fluid integration device according to claim 44, further comprising: a fluid outlet connector configured to provide fluid communication between the wearable fluid connecting device and the interacting device; And a tubing system connected to the first punch and the fluid outlet connector, wherein the tubing system is configured to provide fluid communication between the fluid outlet connector and the first punch. 51. The wearable fluid integration device of claim 50, wherein the fluid outlet connector includes a luer-activated valve. 52. The wearable fluid coupling device of claim 50, further comprising a cooperating device, wherein the cooperating device is an infusion set, and wherein the infusion set is in fluid communication with the fluid outlet connector. 53. The wearable fluid integration device of claim 52, wherein the infusion set includes a breathing valve configured to remove air distributed throughout the infusion set. 54. The wearable fluid integration device of claim 44, wherein the first container and the second container have different sizes. 55. The wearable fluid pooling device of claim 44, 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. 56. A wearable fluid integration device according to claim 44, further comprising: a third cavity formed in the housing and configured to receive a third container; And a third punch located in the third cavity and configured to pierce the third container when the third cavity receives the third container, wherein the tube system is connected to the third punch and is configured to provide fluid communication between the first punch, the second punch, the third punch and the outlet connector fluid medium. 57. The wearable fluid pooling device of claim 56, wherein at least one container selected from the group of a first container, a second container, and a third container has a different size than at least one container selected from the group of first container, second container and third container. 58. The wearable fluid pooling device of claim 56, 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. 59. The wearable fluid coupler of claim 50, further comprising a fluid inlet connector configured to provide fluid communication between the wearable fluid coupler and the cooperating fluid coupler, wherein the tubing system is connected to the inlet a fluid connector and configured to provide fluid communication between the fluid inlet connector, the first punch and the fluid outlet connector. 60. A wearable fluid integration system comprising: a first wearable fluid pooling device comprising: a first body including a first fastening means configured to attach a first wearable fluid integration device to clothing, a first cavity formed in the first housing and configured to receive a first container, a first punch located in the first cavity and configured to pierce the first container when the first cavity receives the first container, a first fluid outlet connector configured to be fluidly coupled to the interacting device to provide fluid communication between the first wearable fluid coupling device and the interacting device, a fluid inlet connector and a first tubing system connected to the first punch, the first fluid outlet connector, and the first fluid inlet connector, the first tubing system configured to provide fluid communication between the fluid inlet connector, the first punch, and the first fluid outlet connector; And a second wearable fluid integration device comprising: a second body including a second attachment means configured to attach a second wearable fluid integration device to the clothing, a second cavity formed in the second housing and configured to receive a second container, a second punch located in the second cavity and configured to pierce the second container when the second cavity receives the second container, a second fluid outlet connector configured to be fluidly coupled to the first fluid inlet connector to provide fluid communication between the second wearable fluid coupler and the first wearable fluid coupler, and a second tubing system connected to the second punch and the second fluid outlet connector, the second tubing system configured to provide fluid communication between the second fluid outlet connector and the second punch. 61. The wearable fluid coupling system of claim 60, further comprising a coupling tube configured to fluidly couple the second fluid outlet connector to the fluid inlet connector, wherein the coupling tube fluidly connects the first punch and the second punch to the the first fluid outlet connector. 62. The wearable fluid integration system of claim 60, wherein the second fluid outlet connector is configured to be directly coupled to the fluid inlet connector. 63. The wearable fluid pooling system of claim 60, wherein the first wearable fluid pooling device further comprises: a third cavity formed in the first body and configured to receive a third container; And a third punch located in the third cavity and configured to pierce the third container when the third cavity receives the third container, wherein the first tube system is connected to the third punch and configured to provide fluid communication between the fluid inlet connector, the first punch, the third punch and a first fluid outlet connector. 64. The wearable fluid integration system of claim 63, wherein the second wearable fluid integration device further comprises: a fourth cavity formed in the second body and configured to receive a fourth container; And a fourth punch located in the fourth cavity and configured to pierce the fourth container when the fourth cavity receives the fourth container, wherein the second tube system is connected to the fourth punch and is configured to provide fluid communication between the second punch, the fourth punch and the second fluid outlet connector environment. 65. The wearable fluid integration system of claim 60, wherein the first attachment means and the second attachment means are each configured as a belt attachment means configured to releasably attach the first body and the second body, respectively, to a belt being worn. patient. 66. The wearable fluid coupling system of claim 60, further comprising a cooperating device, wherein the cooperating device is an infusion set. 67. The wearable fluid integration system of claim 66, wherein the infusion set includes a degassing valve configured to remove air distributed throughout the infusion set. 68. The wearable fluid integration system of claim 60, wherein the first container and the second container are of different sizes. 69. The wearable fluid pooling system of claim 60, 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. 70. A method of administering a medical fluid to a patient, comprising the steps of: attaching the first container to the first cavity formed in the first body by pressing the first container onto the first punch located in the first cavity, ensuring that the first container is pierced by the first punch to provide fluid communication between the first punch and the internal volume of the first container, wherein the internal volume of the first container contains a medical fluid; connecting the infusion set to the first fluid outlet connector, which provides fluid communication between the infusion set and the internal volume of the first container through the first punch; remove air distributed throughout the infusion set; And medical fluid is taken from the internal volume of the first container into the infusion set. 71. The method of claim 70, further comprising the step of disconnecting the infusion set from the first fluid outlet connector. 72. The method of claim 70, further comprising the step of attaching the first body to clothing worn by the patient. 73. The method of claim 72, wherein the step of attaching the first body to a garment worn by the patient comprises releasably attaching the first body to a belt worn by the patient. 74. The method according to claim 70, further comprising the steps of: attaching a second container to a second cavity formed in the first body by pressing the second container onto a second punch located in the second cavity, ensuring that the second container is pierced by means of the second punch to provide fluid communication between the second punch and the internal volume of the second container, while the internal volume of the second container contains a medical fluid and the second punch is in fluid communication with the first punch; And medical fluid is taken from the internal volume of the second container into the infusion set. 75. The method of claim 74, wherein the first container and the second container have different dimensions. 76. The method of claim 74, 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. 77. The method according to claim 74, further comprising the steps of: attaching a third container to a third cavity formed in the first body by pressing the third container onto a third punch located in the third cavity, ensuring piercing of the third container through the third punch to provide fluid communication between the third punch and the internal volume of the third container, while the internal volume of the third container contains a medical fluid and the third punch is in fluid communication with the first punch and the second punch; And medical fluid is taken from the internal volume of the third container into the infusion set. 78. The method of claim 74, further comprising the step of disconnecting the infusion set from the first fluid outlet connector. 79. The method according to claim 78, further comprising the steps of: attaching a third container to a third cavity formed in the second body by pressing the third container onto a third punch located in the third cavity, ensuring piercing of the third container through the third punch to provide fluid communication between the third punch and the internal volume of the third container, while the internal volume of the third container contains a medical fluid; connecting the infusion set to a second fluid outlet connector, which provides fluid communication between the infusion set and the internal volume of the third container through a third punch; remove air distributed throughout the infusion set; And medical fluid is taken from the internal volume of the third container into the infusion set. 80. The method according to claim 79, further comprising the steps of: connecting the fourth container to the fourth cavity formed in the second body by pressing the fourth container onto the fourth punch located in the fourth cavity, ensuring the fourth container is pierced by the fourth punch to ensure fluid communication between the fourth punch and the internal volume of the fourth container, while the internal volume of the fourth container contains a medical fluid and the fourth punch is in fluid communication with the third punch; And medical fluid is taken from the internal volume of the fourth container into the infusion set. 81. The method according to claim 74, further comprising the steps of: attaching a third container to a third cavity formed in the second body by pressing the third container onto a third punch located in the third cavity, ensuring piercing of the third container through the third punch to provide fluid communication between the third punch and the internal volume of the third container, while the internal volume of the third container contains a medical fluid; connecting a second fluid outlet connector to a fluid inlet connector, wherein the second fluid outlet connector is in fluid communication with the third punch and the fluid inlet connector is in fluid communication with the first fluid outlet connector, the first punch, and the second punch; And medical fluid is taken from the internal volume of the third container into the infusion set. 82. The method of claim 81, wherein the step of connecting the second fluid outlet connector to the fluid inlet connector comprises connecting the second fluid outlet connector and the fluid inlet connector via a connecting tube. 83. The method of claim 81, further comprising the step of attaching the first body and the second body to clothing worn by the patient. 84. The method of claim 83, wherein the step of attaching the first body and the second body to clothing worn by the patient comprises releasably attaching the first body and the second body to a belt worn by the patient.

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