WO2018166936A1

WO2018166936A1 - Closed enteral feeding system for drainage of gastric fluid

Info

Publication number: WO2018166936A1
Application number: PCT/EP2018/056001
Authority: WO
Inventors: Nicole Nadja HOLENWEG; SCARTAZZINI Felix ZÜRCHER; Ottilia Magdalena ROHRER; Nicolas ANDREY; Michael Reuben JEDWAB
Original assignee: Axium Mtech SA; Universität Bern
Priority date: 2017-03-16
Filing date: 2018-03-12
Publication date: 2018-09-20
Also published as: EP3595613A1

Abstract

A composition containing at least one of a nutrient or a medication can be administered to a patient through an enteral feeding tube, and the same enteral feeding tube can be used for active aspiration such as gastric fluid drainage. In an aspect, the gastric fluid can be aspirated with syringe, then a valve can be switched to empty the syringe into a container fluidly attached to the syringe, and after aspiration and collection of the gastric fluid are completed, the container can be discharged (e.g., thrown away) and/or the gastric fluid can be returned to the stomach.

Description

TITLE

CLOSED ENTERAL FEEDING SYSTEM FOR DRAINAGE OF GASTRIC FLUID

BACKGROUND

[0001] The present disclosure generally relates to a closed enteral feeding system. More specifically, the present disclosure is directed to a system comprising a tube through which enteral feeding, medication, and active aspiration (e.g., gastric fluid drainage) can be provided.

[0002] The human body derives its resources mainly from ingested food. However, in certain conditions patients may not be able to ingest sufficient amounts of food without help, for example hospitalized patients after surgery and/or in critical care conditions. Such patients may be unable or unwilling to accept oral feedings in sufficient amounts. For patients who have a functioning gastrointestinal tract but cannot ingest enough nutrients orally, enteral tube feedings are a valuable option to ensure proper nutrition that allows a quick recovery. Examples of indications for enteral nutrition include anorexia, protein undernutrition, liver failure, bowel preparation for surgery, closure of enterocutaneous fistulas, small-bowel adaptation after massive intestinal resection or in disorders that may cause malabsorption, inability to take oral feedings, trauma, and/or critical illness causing metabolic stress.

[0003] Enteral tube feedings can provide the required nourishment and/or medication in a medical flowable material, such as a fluid, through a patient feeding line of an enteral administration system that is connected to a container containing the medical flowable material. The system can use a feeding tube, such as a nasogastric or nasojejunal tube, to deposit the medical flowable material directly into the gastrointestinal tract at a point beyond the mouth, for example directly into the stomach, duodenum or jejunum.

[0004] However, accumulation of gas or liquid can result from enteral feeding and can cause excessive gastric pressure. Typically the body relieves such excess gastric pressure by expelling the accumulated gas or liquid through a burping response. However, upward expulsion of gastric fluid is highly undesirable during enteral feeding of flowable material into the gastrointestinal tract. [0005] The process of relieving excessive gastric pressure typically involves disconnecting the tube feed so that it can be replaced with a syringe or fluid collection bag. This process can lead to contamination, spillage, odor and at a minimum inconvenience.

SUMMARY

[0006] The present disclosure is generally directed to administering a composition containing at least one of a nutrient or a medication to a patient through an enteral feeding tube, and the same enteral feeding tube can be used for active aspiration such as gastric fluid drainage. Preferably, the gastric fluid can be aspirated with syringe, then a valve can be switched to empty the syringe into a container attached to a port of the syringe, the volume of the gastric fluid can be measured, and after aspiration and collection of the gastric fluid are completed, the container can be discharged (e.g., thrown away) and/or the gastric fluid can be reinfused into the stomach.

[0007] A closed system can facilitate the enteral feeding and the active aspiration. For example, the system can have at least three configurations that can be achieved without the need to add or remove components, namely a feeding configuration, an aspiration (e.g., gastric emptying) configuration, and a reinfusion configuration. One or more devices in the system can each be selectively moved between at least two orientations, and the selected orientation(s) of the one or more devices in the system can establish the desired configuration of the system.

[0008] Accordingly, in a preferred embodiment, the present disclosure provides a method comprising supplying a composition to a patient from a system comprising a first container. The system further comprises a first tube comprising a first end fiuidly connected to the first container, and the first tube comprises a second end fiuidly connected to a first three-way junction to which a first end of a second tube and a vessel are fiuidly connected. The second tube comprises a second end fiuidly connected to a second three-way junction to which a first end of a third tube and a second container are fiuidly connected. The third tube comprises a second end leading toward the patient.

[0009] In the preferred embodiment, the supplying of the composition comprises directing the composition from the first container in a first flow path comprising the first tube, the second tube and the third tube and leading into the gastrointestinal tract of the patient while blocking the composition from the vessel and the second container using one or more devices, for example one or more valves that can be positioned at a location selected from (i) the first three-way junction, (ii) the second three-way junction, and (iii) both the first and second three-way junctions.

[0010] Then the preferred embodiment of the method comprises withdrawing gastric fluid from the gastrointestinal tract of the patient into the vessel while the one or more devices block the composition from the second container and the vessel and block the gastric fluid from the first tube and the second container (e.g., by blocking the second container and the second end of the first tube). The withdrawing of the gastric fluid comprises using at least one of the one or more devices to establish a second flow path comprising the second tube and the third tube and leading into the vessel.

[0011] Then the preferred embodiment of the method comprises directing the gastric fluid in a third flow path from the vessel into the second container while the one or more devices block the gastric fluid from the first and third tubes and block the composition from the vessel and the second tube (e.g., by blocking the second end of the first tube and the first end of the third tube). The third flow path can comprise the second tube.

[0012] The method can further comprise reinfusion of the gastric fluid from the second container to the gastrointestinal tract of the patient, for example by directing the gastric fluid from the second container to the gastrointestinal tract or by directing the gastric fluid from the second container to the vessel and then to the gastrointestinal tract of the patient.

[0013] Other methods are provided herein, as well as the systems employed in the methods.

In yet another general embodiment, the present disclosure provides a method of selectively providing a composition to a patient and active gastric aspiration for the patient.

[0014] An advantage of one or more embodiments provided by the present disclosure is a closed enteral feeding system. This system can minimize or eliminate the odor, mess, and risk of contamination associated with a process of gastric emptying, measuring the withdrawn volume, and reinfusing the gastric fluid.

[0015] Another advantage of one or more embodiments provided by the present disclosure is to selectively switch between enteral feeding and gastric emptying without the need to remove the feeding bag.

[0016] Still another advantage of one or more embodiments provided by the present disclosure is a closed enteral feeding system that hygienically supplies medication and/or other interventions to the patient. [0017] Yet another advantage of one or more embodiments provided by the present disclosure is a system of enteral feeding and gastric emptying that is easy to use.

[0018] A further advantage of one or more embodiments provided by the present disclosure is an enteral feeding system with improved patient comfort.

[0019] Moreover, another advantage of one or more embodiments provided by the present disclosure is to allow measurement of gastric fluid using a syringe and/or graduated bag.

[0020] A further advantage of one or more embodiments provided by the present disclosure is an enteral feeding system that allows reinfusion of gastric fluids into the stomach, for example at different amounts according to patient clinical practice.

[0021] Additional features and advantages are described herein and will be apparent from the following Detailed Description and the Figures.

BRIEF DESCRIPTION OF THE FIGURES

[0022] FIG. 1 depicts a preferred embodiment of a system according to the present disclosure in a feeding configuration.

[0023] FIG. 2 depicts the preferred embodiment of the system in a gastric fluid withdrawal configuration.

[0024] FIG. 3 depicts the preferred embodiment of the system in a drainage container filling configuration.

[0025] FIG. 4 depicts the preferred embodiment of the system in a first reinfusion configuration.

[0026] FIG. 5 depicts the preferred embodiment of the system in a first stage of a second reinfusion configuration.

[0027] FIG. 6 depicts the preferred embodiment of the system in a second stage of a second reinfusion configuration.

[0028] FIG. 7 depicts a second embodiment of a system according to the present disclosure in a feeding configuration.

[0029] FIG. 8 depicts the second embodiment of the system in a gastric fluid withdrawal configuration.

[0030] FIG. 9 depicts the second embodiment of the system in a drainage container filling configuration. [0031] FIG. 10 depicts the second embodiment of the system in a first reinfusion configuration.

[0032] FIG. 11 depicts the second embodiment of the system in a first stage of a second reinfusion configuration.

[0033] FIG. 12 depicts the second embodiment of the system in a second stage of a second reinfusion configuration.

[0034] FIG. 13 depicts a third embodiment of a system according to the present disclosure in a feeding configuration.

[0035] FIG. 14 depicts the third embodiment of the system in a gastric fluid withdrawal configuration.

[0036] FIG. 15 depicts the third embodiment of the system in a drainage container filling configuration.

[0037] FIG. 16 depicts the third embodiment of the system in a first reinfusion configuration.

[0038] FIG. 17 depicts the third embodiment of the system in a first stage of a second reinfusion configuration.

[0039] FIG. 18 depicts the third embodiment of the system in a second stage of a second reinfusion configuration.

[0040] FIG. 19 depicts a fourth embodiment of a system according to the present disclosure in a feeding configuration.

[0041] FIG. 20 depicts the fourth embodiment of the system in a gastric fluid withdrawal configuration.

[0042] FIG. 21 depicts the fourth embodiment of the system in a drainage container filling configuration.

[0043] FIG. 22A is a schematic diagram of a configuration in which the system is connected to an upstream administration set.

[0044] FIG. 22B is a schematic diagram of a configuration in which the system is connected to a downstream administration set.

DETAILED DESCRIPTION

[0045] This disclosure is not limited to the particular apparatuses, methods, compositions, and experimental conditions described herein. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, as the scope of the present disclosure will be limited only to the appended claims.

[0046] The words "comprise," "comprises" and "comprising" are to be interpreted inclusively rather than exclusively. Likewise, the terms "include," "including" and "or" should all be construed to be inclusive, unless such a construction is clearly prohibited from the context.

[0047] Nevertheless, the devices and apparatuses disclosed herein may lack any element that is not specifically disclosed. Thus, a disclosure of an embodiment using the term "comprising" includes a disclosure of embodiments "consisting essentially of and "consisting of the components identified. Similarly, the methods disclosed herein may lack any step that is not specifically disclosed herein. Thus, a disclosure of an embodiment using the term "comprising" includes a disclosure of embodiments "consisting essentially of and "consisting of the steps identified.

[0048] The term "and/or" used in the context of "X and/or Y" should be interpreted as "X," or "Y," or "X and Y." Similarly, "at least one of X or Y" should be interpreted as "X," or "Y," or "X and Y." Where used herein, the terms "example" and "such as," particularly when followed by a listing of terms, are merely exemplary and illustrative and should not be deemed to be exclusive or comprehensive. Any embodiment disclosed herein can be combined with any other embodiment disclosed herein unless explicitly stated otherwise.

[0049] As used herein, "about," "approximately" and "substantially" are understood to refer to numbers in a range of numerals, for example the range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1% to +1 % of the referenced number, most preferably -0.1 % to +0.1% of the referenced number.

[0050] As used in this disclosure and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a component" or "the component" includes two or more components.

[0051] The terms "connect" and "attach" do not require direct connection or attachment and encompass connections and attachments that include one or more intermediate pieces that connect or attach the referenced components. "Fluidly connected" means that the referenced components can convey fluids (i.e., gases and liquids) between each other directly or by one or more intermediate pieces. This term does not mean that the fluidly connected components must convey fluids between each other in every mode of the system, but rather that the system can be selectively arranged in at least one mode in which the fluidly connected components convey fluids between each other. There may be other modes in which the fluidly connected components convey fluids between each other, for example if a particular valve orientation is employed.

[0052] As used herein, "reversibly movable" means that the referenced component can be moved relative to another component without damaging any of these components and without damaging a connector, if any, and preferably without requiring any tools. Similarly, "reversibly removable" means that the referenced component can be disconnected from another component and then reconnected to the other component without damaging any of these components and without damaging a connector, if any, and preferably without requiring any tools.

[0053] A "closed" enteral system is a system for which the entirety of the interior of the system is completely closed to the environment in which it is situated when all of the components are connected. For example, any openings in the system are preferably covered by a component of the system, and any removable components of the system are preferably reconnectable. The terms "block," "block," "close" and "closing" mean that the fluid cannot flow through the referenced component. For example, "blocking" a container means that fluid cannot enter the container, i.e., no opening is available in the system to provide fluid entry to the container. As another example, "blocking" an end of a tube means that fluid cannot exit the end of the tube into the immediately adjacent component. As yet another example, "blocking" a tube means that fluid cannot travel from one end of the tube to the other end of the tube.

[0054] As used herein, "configuration" refers to an arrangement of the closed enteral system. For example, as discussed in more detail later herein, the closed enteral system is capable of selectively establishing one of a plurality of fluid flow paths through the system, and each of the configurations of the system can establish one or more specific fluid flow paths. In some embodiments, the system can switch between configurations without the need to add or remove any components. In some embodiments, the system switches between configurations by a user selectively changing the orientation of one or more devices in the system. An "orientation" of a device refers to the alignment of the device relative to its adjacent components, e.g., pointing upward, pointing downward, pointing downstream, or pointing upstream. Changing the "orientation" of the device does not change its location within the system; i.e., the identity of the immediately upstream component and the identity of the immediately downstream component remains the same when the orientation of the device is changed.

[0055] Numerical adjectives, such as "first" and "second," are merely used to distinguish components. These numerical adjectives do not imply the presence of other components, a relative positioning, or any chronological implementation. In this regard, the presence of a "second tube" does not imply that a "first tube" is necessarily present. Further in this regard, a "second tube" can be used before, after, or simultaneously with any "first tube."

[0056] FIGS. 1-6 show a first and particularly preferred embodiment of a closed enteral feeding system 10 (hereafter "the system 10") that can be used to supply a composition 21 from a first container 20 to a patient. The composition 21 can be an enteral formula comprising at least one of a nutrient or a medication. Nevertheless, the composition 21 can be any liquid formula that can be delivered into a patient's digestive system from the system 10, for example in a clinical or intensive care unit (ICU) setting and/or a home. The first container 20 can be any container suitable for holding and dispensing the composition, such as an enteral feeding bag, and the present disclosure is not limited to a specific embodiment of the first container 20.

[0057] The system 10 can comprise a first tube 30, a second tube 40, and a third tube 50 that form a first flow path leading from the first container 20 to the patient. In various versions of the first embodiment of the system 10, the system 10 can be distal or proximal to an administration set. For example, in some versions, the first container 20 can be connected to the first tube 30 by an administration set. In some versions, the third tube 50 can be connected to the patient by an administration set.

[0058] The first tube 30 can be fluidly connected to the second tube 40, preferably at a first three-way junction. The first three-way junction has at least three openings and is not limited to only three openings, although a preferred embodiment of the first three-way junction does indeed have only three openings. The first tube 30 can comprise a first end 31 attached to and/or fluidly connected to the first container 20 and can comprise a second end 32 attached to and/or fluidly connected to a first end 41 of the second tube 40, for example at the first three-way junction. The first tube 30 can convey the composition 21 from the first container 20 to the second tube 40. The first end 31 of the first tube 30 can be directly attached to the first container 20 or can be attached to the first container 20 by a first intermediate connector 25. The first end 41 of the second tube 40 and/or the second end 32 of the first tube 30 can be removably attached to or integral with the first three-way junction.

[0059] The second end 32 of the first tube 30 can be fluidly connected to the first end 41 of the second tube 40 by a first valve 60, for example at the first three-way junction. In a preferred embodiment, the first valve 60 is a single valve that selectively moves between at least two orientations, each of the orientations forming a different flow path than the other orientation(s). For example, the first valve 60 can be an L-port valve that selectively closes one of three openings of the first valve 60 and fluidly connects the other two openings of the first valve 60. The first valve 60 is preferably a three-way valve, but instead can be a two-way valve if the system 10 also uses one or more clips, for example one clip or three clips.

[0060] A vessel 71 (e.g., a hollow cylinder, preferably provided by a syringe 70 and discussed in more detail hereafter) can be selectively fluidly connected to the second end 32 of the first tube 30 or the first end 41 of the second tube 40 by the first valve 60, e.g., at the first three-way junction.

[0061] The third tube 50 can comprise a first end 51 removably attached to or integral with a second three-way junction. For example, the second end 42 of the second tube 40 and/or the first end 51 of the third tube 50 can be removably attached to or integral with a second valve 65. In a preferred embodiment, the second valve 65 is a single valve that selectively moves between at least two orientations, each of the orientations forming a different flow path than the other orientation(s). For example, the second valve 65 can be an L-port valve that selectively closes one of three openings of the second valve 65 and fluidly connects the other two openings of the second valve 65. The second valve 65 is preferably a three-way valve, but instead can be a two- way valve if the system 10 also uses one or more clips, for example one clip or three clips.

[0062] The third tube 50 can comprise a second end 52 that can be attached to or integral with an enteral feeding tube, for example a nasogastric tube, a nasojejeunal tube, a naso- duodenal tube, an orogastric tube, or a percutaneous tube, and/or attached to an administration set. For example, the second end 52 of the third tube 50 can be directly attached to the enteral feeding tube or can be attached to the enteral feeding tube by a second intermediate connector 45. Alternatively or additionally, the third tube 50 itself can function as the enteral feeding tube.

[0063] As discussed in more detail hereafter, the second valve 65 can selectively direct gastric fluid from the patient into a second container 80 fluidly connected to the first end 51 of the third tube 50, for example at the second three-way junction. The second container 80 can be any container suitable for receiving and holding the gastric fluid, such as a collection bag (e.g., a bag made of a disposable material), and the present disclosure is not limited to a specific embodiment of the second container 80. In some versions of the first embodiment of the system 10, the second container 80 can be directly attached to or integral with the second three-way junction, e.g., with the second valve 65. In some versions of the first embodiment of the system 10, the second container 80 can be fluidly connected to the second three-way junction by a fourth tube 57. In an embodiment, a third intermediate connector 81 removably connects the second container 80 to the second valve 65 and/or the fourth tube 57. The second three-way junction has at least three openings and is not limited to only three openings, although a preferred embodiment of the second three-way junction does indeed have only three openings.

[0064] The syringe 70 can be upstream from the second container 80 (e.g., distal from the patient). In an embodiment, the syringe 70 can be removably attached to or integral with the first valve 60, e.g., a socket 61 of the first valve 60. The syringe 70 can have a plunger 72 that fits tightly in the vessel 71 and can be pulled or pushed inside the vessel 71 to respectively pull in or expel a liquid or gas through an orifice at an open end of the vessel 71; the open end can be attached to the first valve 60.

[0065] The first valve 60 preferably moves between at least two orientations, for example a first orientation in which the socket 61 is closed and the second end 32 of the first tube 30 and the first end 41 of the second tube 40 are in fluid communication, and a second orientation in which the second end 32 of the first tube 30 is closed and the first end 41 of the second tube 40 and the syringe 70 and are in fluid communication. In a preferred embodiment, the first valve 60 is moved between the first and second orientations by rotation of a stopcock provided by the first valve 60. For example, rotation of the stopcock in one direction (e.g., about 90 degrees) can move the first valve 60 from the first orientation to the second orientation, and rotation of the stopcock in the opposite direction (e.g., about 90 degrees) can move the first valve 60 from the second orientation to the first orientation.

[0066] The second valve 65 preferably moves between at least two orientations, for example a first orientation in which the second container 80 is closed and the second end 42 of the second tube 40 and the first end 51 of the third tube 50 are in fluid communication, and a second orientation in which the first end 51 of the third tube 50 is closed and the second end 42 of the second tube 50 and the second container 80 are in fluid communication. In a preferred embodiment, the second valve 65 is moved between the first and second orientations by rotation of a stopcock provided by the second valve 65. For example, rotation of the stopcock in one direction (e.g., about 90 degrees) can move the second valve 65 from the first orientation to the second orientation, and then rotation of the stopcock in the opposite direction (e.g., about 90 degrees) can move the second valve 65 from the second orientation to the first orientation.

[0067] In some embodiments, the second valve 65 moves between at least three orientations, for example the first and second orientations noted above and additionally a third orientation in which the second end 42 of the second tube 40 is closed and the first end 51 of the third tube 50 and the second container 80 are in fluid communication. In an embodiment, the second valve 65 is moved between the first, second and third orientations by rotation of a stopcock provided by the second valve 65 (e.g., in about 90 degree increments).

[0068] As shown in FIG. 1, the first embodiment of the system 10 can be in a feeding configuration. For example, the first valve 60 can be in the first orientation fiuidly connecting the second end 32 of the first tube 30 to the first end 41 of the second tube 40, preferably while closing the socket 61 , and the second valve 65 can be in the first orientation fiuidly connecting the second end 42 of the second tube 40 to the first end 51 of the third tube 50, preferably while closing the second container 80. In this arrangement, the composition 21 can flow from the first container 20 through the first tube 30, then through the first valve 60, then through the second tube 40, then through the second valve 65 and then through the third tube 50 to the patient, e.g., by gravity or a pump (first flow path, shown by the dashed arrow in this figure).

[0069] As shown in FIG. 2, the first embodiment of the system 10 can move from the feeding configuration to a gastric fluid withdrawal configuration. For example, the first valve 60 can be moved into the second orientation fiuidly connecting the first end 41 of the second tube 40 to the syringe 70 and closing the second end 32 of the first tube 30. Then the plunger 72 of the syringe 70 can be withdrawn from the vessel 71 to pull the gastric fluid through the third tube 50, then through the second valve 65, then through the second tube 40, and then through the first valve 60 into the vessel 71 of the syringe 70 (second flow path, shown by the dashed arrow in this figure).

[0070] In an embodiment, only a portion of the gastric fluid in the patient is removed by one pull of the plunger 72 (i.e., typically one pull of the plunger 72 will not completely empty the gastric fluid from the patient). The volume of the gastric fluid 85 withdrawn into the system 10 can be measured if desired, for example in the syringe 70 and/or the second container 80 using indicia 79 visible thereon.

[0071] As shown in FIG. 3, the first embodiment of the system 10 can move from the gastric fluid withdrawal configuration to a drainage container filling configuration, e.g., after the gastric fluid withdrawal configuration is used to withdraw a desired amount of the gastric fluid into the syringe 70 and/or after the system 10 has been in the gastric fluid withdrawal configuration for a desired time period. For example, after the gastric fluid has been pulled into the syringe 70, the second valve 65 can be moved into the second orientation closing the first end 51 of the third tube 50 and fluidly connecting the second end 42 of the second tube 40 and the second container 80. Then the plunger 72 of the syringe 70 can be pushed into the vessel 71 to direct the gastric fluid 85 from the vessel 71 of the syringe 70, then through the first valve 60, then through the second tube 40, then through the second valve 65 and into the second container 80 (third flow path, shown by the dashed arrow in this figure).

[0072] In an embodiment, the drainage container filling configuration shown in FIG. 3 can be used to block all flow through the system 10. For example, the third flow path depicted by the dashed arrow occurs when the plunger 72 of the syringe 70 is pushed into the vessel 71; if the system 10 is in the drainage container filling configuration and the plunger 72 is not pushed or pulled, then the system 10 can be static with flow therethrough blocked.

[0073] After the gastric fluid 85 has been directed from the syringe 70 into the second container 80, the first embodiment of the system 10 can be returned to the feeding configuration shown in FIG. 1. For example, moving the first valve 60 into the first orientation and moving the second valve 65 into the first orientation can arrange the first embodiment of the system 10 into the feeding configuration.

[0074] Alternatively, additional gastric fluid can be withdrawn by moving the first embodiment of the system 10 from the drainage container filling configuration shown in FIG. 3 back to the gastric fluid withdrawal configuration shown in FIG. 2. For example, moving the second valve 65 from the second orientation, which closes the first end 51 of the third tube 50, to the second orientation, which fluidly connects the third tube 50 to the syringe 70 via the second tube 40 and closes the second container 80, can arrange the system 10 into the gastric fluid withdrawal configuration. Then the additional gastric fluid can be withdrawn through the third tube 50, the second valve 65, the second tube 40 and the first valve 60 into the vessel 71 of the syringe 70 (second flow path, shown by the dashed arrow in FIG. 2). Then the additional gastric fluid can be directed into the second container 80 using the drainage container filling configuration shown in FIG. 3 (third flow path, shown by the dashed arrow in this figure). The system 10 can move back and forth between the gastric fluid withdrawal configuration and the drainage container filling configuration as many times as desired by the user, until a capacity of the second container 80 is reached, or preferably until the stomach of the patient has been emptied of gastric fluid. The volume of the withdrawn gastric fluid can be measured at any time in this process, for example at least at the end (e.g., the stomach of the patient has been emptied of gastric fluid), for example using the indicia 79 visible on the syringe 70 and/or the second container 80.

[0075] The second container 80 can be removed from the second valve 65, for example when the system 10 is positioned in one of the feeding configuration and the gastric fluid withdrawal configuration. For example, the second container 80 can be reversibly removed from the second valve 65 by removing the second container 80 from the third intermediate connector 81 and/or by removing the third intermediate connector 81 from the second valve 65. In some embodiments, a subsequent action can be selected from the group consisting of (i) discarding the second container 80 and attaching a new second container 80 to the second valve 65, (ii) dispensing at least a portion of the gastric fluid from the second container 80 and then reconnecting the second container 80 to the second valve 65, and (iii) completely removing the second container 80. The second container 80 can be reconnected to the second valve 65 by reconnecting the second container 80 to the third intermediate connector 81 and/or by reconnecting the third intermediate connector 81 to the second valve 65, for example when the system 10 is positioned in one of the feeding configuration or the gastric fluid withdrawal configuration.

[0076] Alternatively or additionally, the syringe 70 can be removed from the first valve 60. In an embodiment, the syringe 70 can be reversibly removed from the first valve 60 by removing the syringe 70 from the socket 61. In some embodiments, a subsequent action can be selected from the group consisting of (i) discarding the syringe 70 and attaching a new syringe 70 to the first valve 60, (ii) dispensing at least a portion of the gastric fluid from the syringe 70 and then reconnecting the syringe 70 to the first valve 60, and (iii) completely removing the syringe 70. The syringe 70 can be reconnected to the first valve 60 by reconnecting the syringe 70 to the socket 61.

[0077] As shown in FIG. 4, the first embodiment of the system 10 can move from one of the feeding configuration, the gastric fluid withdrawal configuration, and the drainage container filling configuration to a first reinfusion configuration, e.g., after the drainage container filling configuration is used to direct a desired amount of the gastric fluid into the second container 80 and/or after the system 10 has been in the drainage container filling configuration for a desired time period. For example, the second valve 65 can be moved into the third orientation closing the second end 42 of the second tube 40 and fluidly connecting the first end 51 of the third tube 50 and the second container 80. Then the gastric fluid 85 can be directed from the second container 80 through the second valve 65 and then through the third tube 50 into the gastrointestinal tract of the patient (fourth flow path, shown by the dashed arrow in this figure).

[0078] In the first reinfusion configuration, an embodiment of the second container 80 is at least partially flexible so that compression of the second container 80 can force the gastric fluid 85 from the second container 80 through the third tube 50 into the gastrointestinal tract of the patient. The first valve 60 can be in any orientation for the first reinfusion configuration, and the first reinfusion configuration does not require a specific orientation of the first valve 60.

[0079] A second reinfusion configuration of the first embodiment of the system 10 is shown in FIGS. 5 and 6. This reinfusion configuration is particularly advantageous if the second container 80 is rigid, although this reinfusion configuration can be employed even if the second container 80 is partially flexible.

[0080] In FIG. 5, a first stage of the second reinfusion configuration of the first embodiment of the system 10 is shown. The second valve 65 can be in the second orientation in which the first end 51 of the third tube 50 is blocked and the second container 80 is fluidly connected to the second end 42 of the second tube 40, and the first valve 60 can be in the second orientation in which the second end 31 of the first tube 30 is blocked and the vessel 71 is fluidly connected to the first end 41 of the second tube 40. As a result, the second tube 40 can fluidly connect the second container 80 and the vessel 71. Then the plunger 72 of the syringe 70 can be withdrawn from the vessel 71 to pull the gastric fluid 85 from the second container 80 through the second valve 65, then through the second tube 40, and then through the first valve 60 into the vessel 71 of the syringe 70 (fifth flow path, shown by the dashed arrow in this figure). [0081] In FIG. 6, a second stage of the second reinfusion configuration of the first embodiment of the system 10 is shown. The system 10 can be moved from the first stage to the second stage of the second reinfusion configuration by moving the second valve 65 from the second orientation to the first orientation in which the second container 80 is blocked and the second end 42 of the second tube 40 is fiuidly connected to the first end 51 of the third tube 50. As a result, the second tube 40 can fiuidly connect the third tube 50 and the vessel 71. Then the plunger 72 of the syringe 70 can be pushed into the vessel 71 to direct the gastric fluid from the vessel 71 through the first valve 60, then through the second tube 40, then through the second valve 65, then through the third tube 50 and then into the gastrointestinal tract of the patient (sixth flow path, shown by the dashed arrow in this figure). The user may perform reinfusion by alternating the first and second stages of the second reinfusion configuration as many times as needed or desired.

[0082] Referring again to FIGS. 1-6, in a preferred form of the first embodiment of the system 10, the first container 20 remains attached to the first tube 30 and/or the first intermediate connector 25 (i.e., the first container 20 is not removed therefrom) throughout movement of the system 10 from the feeding configuration to the gastric fluid withdrawal configuration to the drainage container filling configuration to the reinfusion configuration and back to the feeding configuration.

[0083] In some versions of the first embodiment of the system 10, the positions of the first container 20 and the second container 80 can be switched. Specifically, the first container 20 can be positioned where the second container 80 is shown in FIGS. 1-6 while the second container 80 can be positioned where the first container 20 is shown in FIGS. 1-6. Accordingly, the first container 20 and the second container 80 can switch positions without affecting the functionality of the first embodiment of the system 10.

[0084] In some versions of the first embodiment of the system 10, the positions of the vessel 71 and the second container 80 can be switched. Specifically, the vessel 71 can be positioned where the second container 80 is shown in FIGS. 1-6 while the second container 80 can be positioned where the vessel 71 is shown in FIGS. 1-6. Accordingly, the vessel 71 and the second container 80 can switch positions without affecting the functionality of the first embodiment of the system 10. [0085] In some versions of the first embodiment of the system 10, the positions of the first container 20 and the vessel 71 can be switched. Specifically, the first container 20 can be positioned where the vessel 71 is shown in FIGS. 1-6 while the vessel 71 can be positioned where the first container 20 is shown in FIGS. 1-6. Accordingly, the first container 20 and the vessel 71 can switch positions without affecting the functionality of the first embodiment of the system 10.

[0086] FIGS. 7-12 show a second embodiment of the system 10 that can be used to supply the composition 21 from the first container 20 to a patient. In the second embodiment, the first tube 30 and the second tube 40 form a first flow path leading from the first container 20 to the patient. In various versions of the second embodiment of the system 10, the system 10 can be distal or proximal to an administration set. For example, in some versions, the first container 20 can be connected to the first tube 30 by an administration set. In some versions, the second tube 40 can be connected to the patient by an administration set. In the second embodiment of the system 10, the second tube 40 and the third tube 50 form a second flow path leading from the patient to the second container 80.

[0087] In the second embodiment of the system 10, the first tube 30, the second tube 40, and the third tube 50 can form a first three-way junction. The first tube 30, the second tube 40 and the third tube 50 are removably attached to or integral with the first three-way junction. The first three-way junction has at least three openings and is not limited to only three openings, although a preferred embodiment of the first three-way junction does indeed have only three openings.

[0088] The system 10 can comprise a clamp 35 that can selectively have an open position on the first tube 30 in which the first end 31 and the second end 32 of the first tube 30 are open to each other (e.g., the composition 21 can reach the second end 32 of the first tube 30 from the first container 20). The clamp can reversibly move on the first tube 30 between the open position and a blocking position in which the first tube 30 is blocked so that the first end 31 and the second end 32 of the first tube 30 are blocked from each other (e.g., the composition 21 cannot reach the second end 32 of the first tube 30). For example, the clamp 35 can have a first portion 36 having a diameter at least as large as the diameter of the first tube 30 so that the first tube 30 is open when circumscribed by the first portion 36 of the clamp 35. The clamp 35 can have a second portion 37 having a diameter substantially smaller than the diameter of the first tube 30 (e.g., a diameter that is about twice the thickness of the wall of the first tube 30) so that the first tube 30 is blocked when circumscribed by the second portion 37 of the clamp 35.

[0089] In a preferred form of the second embodiment, the clamp 35 slides on the first tube 30 in a direction perpendicular to the fluid flow to move between the open position in which the first portion 36 circumscribes the first tube 30 (e.g., the second portion 37 does not circumscribe the first tube 30) and the blocked position in which the second portion 37 circumscribes the first tube 30 (e.g., the first portion 36 does not circumscribe the first tube 30).

[0090] The clamp 35 in the second embodiment of the system 10 can be any device that can reversibly and selectively open or block the first tube 30, and the present disclosure is not limited to a specific embodiment of the clamp 35.

[0091] The second end 42 of the second tube 40 can be attached to or integral with an enteral feeding tube and/or an administration set, for example a nasogastric tube, a nasojejeunal tube, a naso-duodenal tube, an orogastric tube, or a percutaneous tube. For example, the second end 42 of the second tube 40 can be directly attached to the enteral feeding tube or can be attached to the enteral feeding tube by a second intermediate connector 45. Alternatively or additionally, the second tube 40 itself can function as the enteral feeding tube. In various embodiments, the system 10 can be distal or proximal to the administration set.

[0092] The first end 51 of the third tube 50 can be fiuidly connected to the second end 32 of the first tube 30 and/or the first end 41 of the second tube 40 at the first three-way junction. The first valve 60 can be positioned at the first three-way junction. In a preferred embodiment, the first valve 60 is a single valve that selectively moves between two orientations, each of the orientations forming a different flow path than the other orientation(s). For example, the first valve 60 can be an L-port valve that selectively closes one of three openings of the first valve 60 and fiuidly connects the other two openings of the first valve 60. The first valve 60 is preferably a three-way valve, but instead can be a two-way valve if the system 10 also uses one or more clips, for example one clip or three clips.

[0093] As discussed in more detail hereafter, the third tube 50 and the first valve 60 can selectively direct gastric fluid from the patient into the second container 80.

[0094] The third tube 50 can lead to a second three-way junction where the first valve 60 is preferably positioned. The second three-way junction has at least three openings and is not limited to only three openings, although a preferred embodiment of the second three-way junction does indeed have only three openings. The second container 80 can be removably attached to or integral with the first valve 60, for example by the third intermediate connector 81. In a preferred form of the second embodiment, the third intermediate connector 81 is bonded to the third tube 50 and/or the first valve 60 at the second three-way junction.

[0095] The syringe 70 can be removably attached to or integral with the first valve 60, e.g., the socket 61 of the first valve 60. The first valve 60 preferably moves between at least two orientations, for example a first orientation in which the second end 52 of the third tube 50 is closed and the syringe 70 and the second container 80 are in fluid communication, and a second orientation in which the second container 80 is closed and the second end 52 of the third tube 50 and the syringe 70 and are in fluid communication. In a preferred embodiment, the first valve 60 is moved between the first and second orientations by rotation of a stopcock provided by the first valve 60. For example, rotation of the stopcock in one direction (e.g., about 90 degrees) can move the first valve 60 from the first orientation to the second orientation, and rotation of the stopcock in the opposite direction (e.g., about 90 degrees) can move the first valve 60 from the second orientation to the first orientation.

[0096] In some embodiments, the first valve 60 moves between at least three orientations, for example the first and second orientations noted above and additionally a third orientation in which the socket 61 and/or the syringe 70 are closed and the second end 52 of the third tube 50 and the second container 80 are in fluid communication. In an embodiment, the first valve 60 is moved between the first, second and third orientations by rotation of a stopcock provided by the first valve 60 (e.g., in about 90 degree increments).

[0097] As shown in FIG. 7, the second embodiment of the system 10 can be in a feeding configuration. For example, the clamp 35 can be in the open position, and the first valve 60 can be in the first orientation closing the second end 52 of the third tube 50. In this arrangement, the composition 21 can flow from the first container 20 through the first tube 30 and the second tube 40 to the patient, e.g., by gravity or a pump (first flow path, shown by the dashed arrow in this figure).

[0098] As shown in FIG. 8, the second embodiment of the system 10 can move from the feeding configuration to a gastric fluid withdrawal configuration. For example, the clamp 35 can be moved to the blocked position. Then the first valve 60 can be moved into the second orientation fluidly connecting the second end 52 of the third tube 50 to the syringe 70 and closing the second container 80. Then the plunger 72 of the syringe 70 can be withdrawn from the vessel 71 to pull the gastric fluid through the second tube 40, then through the third tube 50, and then through the first valve 60 into the vessel 71 of the syringe 70 (second flow path, shown by the dashed arrow in this figure).

[0099] In an embodiment, only a portion of the gastric fluid in the patient is removed by one pull of the plunger 72 (i.e., typically one pull of the plunger 72 will not completely empty the gastric fluid from the patient). The volume of the gastric fluid 85 withdrawn into the system 10 can be measured if desired, for example in the syringe 70 and/or the second container 80 using indicia 79 visible thereon.

[00100] As shown in FIG. 9, the second embodiment of the system 10 can move from the gastric fluid withdrawal configuration to a drainage container filling configuration, e.g., after the gastric fluid withdrawal configuration is used to withdraw a desired amount of the gastric fluid into the syringe 70 and/or after the system 10 has been in the gastric fluid withdrawal configuration for a desired time period. For example, after the gastric fluid has been pulled into the syringe 70, the first valve 60 can be returned to the first orientation closing the second end 52 of the third tube 50 and fiuidly connecting the syringe 70 and the second container 80. Then the plunger 72 of the syringe 70 can be pushed into the vessel 71 to direct the gastric fluid 85 from the vessel 71 of the syringe 70 through the first valve 60 into the second container 80 (third flow path, shown by the dashed arrow in this figure).

[00101] After the gastric fluid 85 has been directed from the syringe 70 into the second container 80, the second embodiment of the system 10 can be returned to the feeding configuration shown in FIG. 7. For example, moving the clamp 35 to the open position, while the first valve 60 is in the first orientation closing the second end 52 of the third tube 50, can arrange the second embodiment of the system 10 into the feeding configuration.

[00102] Alternatively, additional gastric fluid can be withdrawn by moving the second embodiment of the system 10 from the drainage container filling configuration shown in FIG. 9 back to the gastric fluid withdrawal configuration shown in FIG. 8. For example, moving the first valve 60 from the first orientation, which closes the second end 52 of the third tube 50, to the second orientation, which fiuidly connects the second end 52 of the third tube 50 to the syringe 70 and closes the second container 80, while the clamp 35 is in the blocked position, can arrange the system 10 into the gastric fluid withdrawal configuration. Then the additional gastric fluid can be withdrawn through the second tube 40, the third tube 50 and the first valve 60 into the vessel 71 of the syringe 70 (second flow path, shown by the dashed arrow in this figure). Then the additional gastric fluid can be directed into the second container 80 using the drainage container filling configuration shown in FIG. 9 (third flow path, shown by the dashed arrow in this figure). The system 10 can move back and forth between the gastric fluid withdrawal configuration and the drainage container filling configuration as many times as desired by the user, until a capacity of the second container 80 is reached, or preferably until the stomach of the patient has been emptied of gastric fluid. The volume of the withdrawn gastric fluid can be measured at any time in this process, for example at least at the end (e.g., the stomach of the patient has been emptied of gastric fluid), for example using the indicia 79 visible on the syringe 70 and/or the second container 80.

[00103] The second container 80 can be removed from the first valve 60, preferably when the system 10 is positioned in one of the feeding configuration and the gastric fluid withdrawal configuration. For example, the second container 80 can be reversibly removed from the first valve 60 by removing the second container 80 from the third intermediate connector 81 and/or by removing the third intermediate connector 81 from the first valve 60. A subsequent action can be selected from the group consisting of (i) discarding the second container 80 and attaching a new second container 80 to the first valve 60, (ii) dispensing at least a portion of the gastric fluid from the second container 80 and then reconnecting the second container 80 to the first valve 60, and (iii) completely removing the second container 80. Then the second container 80 can be reconnected to the first valve 60, for example by reconnecting the second container 80 to the third intermediate connector 81 and/or by reconnecting the third intermediate connector 81 to the first valve 60, preferably when the system 10 is positioned in one of the feeding configuration and the gastric fluid withdrawal configuration.

[00104] Alternatively or additionally, the syringe 70 can be removed from the first valve 60. For example, the syringe 70 can be reversibly removed from the first valve 60 by removing the syringe 70 from the socket 61. In some embodiments, a subsequent action can be selected from the group consisting of (i) discarding the syringe 70 and attaching a new syringe 70 to the first valve 60, (ii) dispensing at least a portion of the gastric fluid from the syringe 70 and then reconnecting the syringe 70 to the first valve 60, and (iii) completely removing the syringe 70. The syringe 70 can be reconnected to the first valve 60 by reconnecting the syringe 70 to the socket 61.

[00105] As shown in FIG. 10, the second embodiment of the system 10 can move from one of the feeding configuration, the gastric fluid withdrawal configuration, and the drainage container filling configuration to a first reinfusion configuration, e.g., after the drainage container filling configuration to a reinfusion configuration is used to direct a desired amount of the gastric fluid into the second container 80 and/or after the system 10 has been in the drainage container filling configuration for a desired time period. For example, while the clamp 35 is in the blocked position, the first valve 60 can be moved into the third orientation closing the socket 61 and/or the syringe 70 and fluidly connecting the second end 52 of the third tube 50 and the second container 80. Then the gastric fluid 85 can be directed from the second container 80 through the first valve 60, then through the third tube 50 and then through the second tube 40 into the gastrointestinal tract of the patient (fourth flow path, shown by the dashed arrow in this figure).

[00106] For the first reinfusion configuration, the second container 80 can be at least partially flexible so that compression of the second container 80 can force the gastric fluid 85 from the second container 80 through the third tube 50 into the gastrointestinal tract of the patient.

[00107] A second reinfusion configuration of the second embodiment of the system 10 is shown in FIGS. 11 and 12. This reinfusion configuration is particularly advantageous if the second container 80 is rigid, although this reinfusion configuration can be employed even if the second container 80 is partially flexible.

[00108] In FIG. 11, a first stage of the second reinfusion configuration of the second embodiment of the system 10 is shown. The first valve 60 can be in the first orientation in which the second end 52 of the third tube 50 is blocked and the second container 80 is fluidly connected to the syringe 70. As a result, the first valve 60 can fluidly connect the second container 80 and the vessel 71. Then the plunger 72 of the syringe 70 can be withdrawn from the vessel 71 to pull the gastric fluid 85 from the second container 80 through the first valve 60 into the vessel 71 of the syringe 70 (fifth flow path, shown by the dashed arrow in this figure).

[00109] In FIG. 12, a second stage of the second reinfusion configuration of the second embodiment of the system 10 is shown. The system 10 can be moved from the first stage to the second stage of the second reinfusion configuration by moving the first valve 60 from the first orientation to the second orientation in which the second container 80 is blocked and the second end 52 of the third tube 50 is fiuidly connected to the syringe 70. As a result, the third tube 50 can fiuidly connect the second tube 40 and the vessel 71. Then the plunger 72 of the syringe 70 can be pushed into the vessel 71 to direct the gastric fluid from the vessel 71 through the first valve 60, then through the third tube 50, then through the second tube 40 and then into the gastrointestinal tract of the patient (sixth flow path, shown by the dashed arrow in this figure). The user may perform reinfusion by alternating the first and second stages of the second reinfusion configuration as many times as needed or desired.

[00110] Referring again to FIGS. 7-12, in a preferred form of the second embodiment of the system 10, the first container 20 remains attached to the first tube 30 and/or the first intermediate connector 25 (i.e., the first container 20 is not removed therefrom) throughout movement of the system 10 from the feeding configuration to the gastric fluid withdrawal configuration to the drainage container filling configuration to the reinfusion configuration and back to the feeding configuration.

[00111]

[00112] FIGS. 13-18 show a third embodiment of the system 10 that can be used to supply the composition 21 from the first container 20 to a patient. In the third embodiment of the system 10, the first tube 30, the second tube 40 and the third tube 50 can be connected together to form the first three-way junction as discussed above with respect to the second embodiment. In the third embodiment, the first valve 60 is preferably positioned at the first three-way junction (i.e., the intersection of the first tube 30, the second tube 40 and the third tube 50) instead of the second three-way junction.

[00113] The third embodiment of the system 10 preferably comprises a syringe tube 55 that fiuidly connects the syringe 70 to the second end 52 of the third tube 50 at the second three-way junction. The syringe tube 55 can be integral with or removably connected to the second three- way junction.

[00114] The system 10 can comprise the fourth tube 57, and the fourth tube 57 can extend from the second three-way junction to the third intermediate connector 81 and/or the second container 80. A first end 58 of the fourth tube 57 can be fiuidly connected to the syringe tube 55 and the third tube 50 at the second three-way junction. A second end 59 of the fourth tube 57 can be fiuidly connected to the third intermediate connector 81 and/or the second container 80. In the third embodiment of the system 10, the clamp 35 is preferably positioned on the fourth tube 57.

[00115] Further in this regard, the clamp 35 in the third embodiment of the system 10 can reversibly move on the fourth tube 57 between a blocked position in which the fourth tube 57 is blocked so that gastric fluid from the first valve 60 is directed to the syringe 70 and an open position in which the syringe 70 can direct the gastric fluid from the syringe 70 through the fourth tube 57 to the second container 80 when the first valve 60 closes the first end 51 of the third tube 50.

[00116] For example, in the third embodiment of the system 10 the first portion 36 of the clamp 35 can have a diameter at least as large as the diameter of the fourth tube 57 so that the fourth tube 57 is open when circumscribed by the first portion 36 of the clamp 35. The second portion 37 of the clamp 35 can have a diameter substantially smaller than the diameter of the fourth tube 57 (e.g., a diameter that is about twice the thickness of the wall of the fourth tube 57) so that the fourth tube 57 is blocked when circumscribed by the second portion 37 of the clamp 35. In a preferred form of the third embodiment of the system 10, the clamp 35 slides on the fourth tube 57 in a direction perpendicular to the fluid flow to move between the open position in which the first portion 36 circumscribes the fourth tube 57 (e.g., the second portion 37 does not circumscribe the fourth tube 57) and the blocked position in which the second portion 37 circumscribes the fourth tube 57 (e.g., the first portion 36 does not circumscribe the fourth tube 57).

[00117] The clamp 35 in the third embodiment can be any device that can reversibly and selectively open and block the fourth tube 57, and the present disclosure is not limited to a specific embodiment of the clamp 35.

[00118] In a preferred form of the third embodiment of the system 10, the first valve 60 is moved between a first orientation in which the first tube 30 is fiuidly connected to the second tube 40, and the first end 51 of the third tube 50 is blocked, and a second orientation in which the second tube 40 is fiuidly connected to the third tube 50, and the second end 32 of the first tube 30 is blocked. For example, the first valve 60 can be moved between the first and second positions by rotation of a stopcock provided by the first valve 60. For example, rotation of the stopcock in one direction (e.g., about 90 degrees) can move the first valve 60 from the first position to the second position, and rotation of the stopcock in the opposite direction (e.g., about 90 degrees) can move the first valve 60 from the second position to the first position.

[00119] As shown in FIG. 13, the third embodiment of the system 10 can be in a feeding configuration. For example, the first valve 60 can be in a first orientation closing the first end 51 of the third tube 50 and fiuidly connecting the second end 32 of the first tube 30 to the first end 41 of the second tube 40. In this arrangement, the composition 21 flows from the first container 20 through the first tube 30 and the second tube 40 to the patient, e.g., by gravity or a pump (first flow path, shown by the dashed arrow).

[00120] As shown in FIG. 14, the third embodiment of the system 10 can move from the feeding configuration to a gastric fluid withdrawal configuration. For example, the clamp 35 can be moved to the blocked position. Then the first valve 60 can be moved into the second position which closes the second end 32 of the first tube 30 while fiuidly connecting the first end 41 of the second tube 40 to the first end 51 of the third tube 50. Then the plunger 72 of the syringe 70 can be withdrawn from the vessel 71 to pull the gastric fluid through the second tube 40, then through the first valve 60, then through the third tube 50, and then through the syringe tube 55 into the vessel 71 of the syringe 70 (second flow path, shown by the dashed arrow). In an embodiment, only a portion of the gastric fluid in the patient is removed by one pull of the plunger 72 (i.e., typically one pull of the plunger 72 will not completely empty the gastric fluid from the patient). The volume of the gastric fluid 85 withdrawn into the system 10 can be measured if desired, for example in the syringe 70 and/or the second container 80 using indicia 79 visible thereon.

[00121] As shown in FIG. 15, the third embodiment of the system 10 can move from the gastric fluid withdrawal configuration to a drainage container filling configuration, e.g., after the gastric fluid withdrawal configuration is used to withdraw a desired amount of the gastric fluid into the syringe 70. For example, after the gastric fluid has been pulled into the syringe 70, the first valve 60 can be returned to the first orientation closing the first end 51 of the third tube 50, and the clamp 35 can be moved to the open position. The open position of the clamp 35 can fiuidly connect the syringe 70 and the second container 80 via the fourth tube 57 and optionally the third intermediate connector 81. Then the plunger 72 of the syringe 70 can be pushed into the vessel 71 to direct the gastric fluid 85 from the vessel 71 of the syringe 70 through the fourth tube 57 into the second container 80 (third flow path, shown by the dashed arrow). [00122] A preferred feature of the third embodiment of the system 10 is that the drainage container filling configuration can also function as the feeding configuration shown in FIG. 10. For example, as shown in FIG. 12, the composition 21 can flow from the first container 20 through the first tube 30 and the second tube 40 to the patient (first flow path) when the system 10 is still in the drainage container filling configuration (third flow path).

[00123] Similarly to the discussion above with respect to the second embodiment of the system 10, the third embodiment of the system 10 can move back and forth between the gastric fluid withdrawal configuration and the drainage container filling configuration as many times as desired by the user, until a capacity of the second container 80 is reached, or preferably until the stomach of the patient has been emptied of gastric fluid. The volume of the withdrawn gastric fluid can be measured at any time in this process, for example least at the end (e.g., the stomach of the patient has been emptied of gastric fluid), for example using the indicia 79 visible on the syringe 70 and/or the second container 80.

[00124] The second container 80 can be removed from the fourth tube 57, preferably when the system 10 is positioned in one of the feeding configuration and the gastric fluid withdrawal configuration. For example, the second container 80 can be reversibly removed from the fourth tube 57 by removing the second container 80 from the third intermediate connector 81 and/or removing the third intermediate connector 81 from the fourth tube 57. A subsequent action can be selected from the group consisting of (i) discarding the second container 80 and attaching a new second container 80 to the fourth tube 57, (ii) dispensing at least a portion of the gastric fluid from the second container 80 and then reconnecting the second container 80 to the fourth tube 57, and (iii) completely removing the second container 80. Then the second container 80 can be reconnected to the fourth tube 57, for example by reconnecting the second container 80 to the third intermediate connector 81 and/or by reconnecting the third intermediate connector 81 to the fourth tube 57, preferably when the system 10 is positioned in one of the feeding configuration and the gastric fluid withdrawal configuration.

[00125] Alternatively or additionally, the syringe 70 can be removed from the second three- way junction. For example, the syringe 70 can be reversibly removed from the second three-way junction by removing the syringe 70 from the syringe tube 55. In some embodiments, a subsequent action can be selected from the group consisting of (i) discarding the syringe 70 and attaching a new syringe 70 to the second three-way junction, (ii) dispensing at least a portion of the gastric fluid from the syringe 70 and then reconnecting the syringe 70 to the second three- way junction, and (iii) completely removing the syringe 70. The syringe 70 can be reconnected to the second three-way junction, for example by reconnecting the syringe 70 to the syringe tube 55.

[00126] As shown in FIG. 16, the third embodiment of the system 10 can move from one of the feeding configuration, the gastric fluid withdrawal configuration, and the drainage container filling configuration to a first reinfusion configuration, e.g., after the drainage container filling configuration is used to direct a desired amount of the gastric fluid into the second container 80 and/or after the system 10 has been in the drainage container filling configuration for a desired time period. For example, the clamp 35 can be in the open position, and the first valve 60 can be moved into the second orientation blocking the second end 32 of the first tube 30 and fiuidly connecting the first end 51 of the third tube 50 and the first end 41 of the second tube 40. As a result, the fourth tube 57, the third tube 50 and the first valve 60 can fiuidly connect the second container 80 to the second tube 40. Then the gastric fluid 85 can be directed from the second container 80 through the fourth tube 57, then though the third tube 50, then through the first valve 60, and then through the second tube 40 into the gastrointestinal tract of the patient (fourth flow path, shown by the dashed arrow in this figure).

[00127] The second container 80 can be at least partially flexible so that compression of the second container 80 can force the gastric fluid 85 from the second container 80 through the fourth tube 57, the third tube 50, the first valve 60 and the second tube 40 into the gastrointestinal tract of the patient.

[00128] A second reinfusion configuration of the third embodiment of the system 10 is shown in FIGS. 17 and 18. This reinfusion configuration is particularly advantageous if the second container 80 is rigid, although this reinfusion configuration can be employed even if the second container 80 is partially flexible.

[00129] In FIG. 17, a first stage of the second reinfusion configuration of the third embodiment of the system 10 is shown. The first valve 60 can be in the first orientation in which the first end 52 of the third tube 50 is blocked, and the clamp 35 can be in the open position in which the second container 80 is fiuidly connected to the vessel 71 by the fourth tube 57. Then the plunger 72 of the syringe 70 can be withdrawn from the vessel 71 to pull the gastric fluid from the second container 80 through the fourth tube 57 into the vessel 71 of the syringe 70 (fifth flow path, shown by the dashed arrow in this figure).

[00130] In FIG. 18, a second stage of the second reinfusion configuration of the third embodiment of the system 10 is shown. The system 10 can be moved from the first stage to the second stage of the second reinfusion configuration by moving the first valve 60 from the first orientation to the second orientation in which the second end 32 of the first tube 30 is blocked and the first end 51 of the third tube 50 is fiuidly connected to the first end 41 of the second tube 40, while the clamp 35 is in the blocked position in which the second container 80 is closed. As a result, the third tube 50 and the first valve 60 can fiuidly connect the second tube 40 and the vessel 71. Then the plunger 72 of the syringe 70 can be pushed into the vessel 71 to direct the gastric fluid from the vessel 71 through the third tube 50, then through the first valve 60, then through the second tube 40 and then into the gastrointestinal tract of the patient (sixth flow path, shown by the dashed arrow in this figure). The user may perform reinfusion by alternating the first and second stages of the second reinfusion configuration as many times as needed or desired.

[00131] Referring again to FIGS. 13-18, in a preferred form of the third embodiment of the system 10, the first container 20 remains attached to the first tube 30 and/or the first intermediate connector 25 (i.e., the first container 20 is not removed therefrom) throughout movement from the feeding configuration to the gastric fluid withdrawal configuration to the drainage container filling configuration to the reinfusion configuration and back to the feeding configuration.

[00132]

[00133] FIGS. 19-21 show a fourth embodiment of the system 10 that can be used to supply the composition 21 from the first container 20 to a patient. The fourth embodiment can be configured similarly to the third embodiment, except a one-way valve 38 can replace the clamp 35. The one-way valve 38 can be any valve that only allows one direction of fluid flow (e.g., a check valve having a desired cracking pressure), and the present disclosure is not limited to a specific embodiment of the one-way valve 38. The one-way valve 38 can advantageously remove the need to move the clamp 35 between the blocked and open positions, such that fluid flow can be controlled solely by the first valve 60 and/or the syringe 70.

[00134] A preferred feature of the fourth embodiment of the system 10 is that the drainage container filling configuration can also function as the feeding configuration shown in FIG. 19. For example, as shown in FIG. 21, the composition 21 can flow from the first container 20 through the first tube 30, then through the first valve 60, and then through the second tube 40 to the patient (first flow path) when the system 10 is in the drainage container filling configuration (third flow path).

[00135] FIG. 22A generally illustrates a configuration in which the system 10 can be used; the first container 20 can be connected to an administration set 100 which in turn is connected to the system 10 which in turn is connected to a feeding tube 150 that leads to the patient 200. FIG. 22B generally illustrates another configuration in which the system 10 can be used; the first container 20 can be connected to the system 10 which in turn is connected to an administration set 100 which in turn is connected to a feeding tube 150 that leads to the patient 200. Any embodiment of the system 10, e.g., any of the first, second, third and fourth embodiments, can be used in the configuration shown in FIG. 22 A and the configuration shown in FIG. 22B.

[00136] In some embodiments, the system 10 and the administration set 100 are used with one or more extension lines 200 that can be one or more tubes that extend the length of the administration set 100. FIGS. 22A and 22B show the system 10 proximal to the patient from the one or more extension lines 200, but these figures are merely a non-limiting example, and the system 10 can be proximal from one or more of the extension lines 200 relative to the patient 200 and/or distal from one or more of the extension lines 200 relative to the patient 200.

[00137] In some embodiments, the administration set 100 comprises a medication port which can be a Y-port. The system 10 can be connected to the medication port; additionally or alternatively, one or more of the extension lines 200 can be connected to the medication port.

[00138] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

The invention is claimed as follows:

1. A method of providing a tube feed and gastric emptying in a closed system (10), the method comprising:

supplying a composition (21) to a patient from the system (10), the system (10) comprising a first container (20), the system (10) further comprising a first tube (30) comprising a first end (31) fluidly connected to the first container (20), the first tube (30) comprising a second end (32) fluidly connected to a first three-way junction to which a first end (41) of a second tube (40) and a vessel (71) are fluidly connected, the second tube (40) comprising a second end (42) fluidly connected to a second three-way junction to which a first end (51) of a third tube (50) and a second container (80) are fluidly connected, the supplying of the composition (21) comprising directing the composition (21) from the first container (20) in a first flow path comprising the first tube (30), the second tube (40) and the third tube (50) and leading into the gastrointestinal tract of the patient while one or more devices (60,65) block the composition (21) from the vessel (71) and the second container (80);

then withdrawing gastric fluid (85) in a second flow path from the gastrointestinal tract of the patient through the third tube (50) and the second tube (40) into the vessel (71) while at least one of the one or more devices (60,65) block the composition (21) from the vessel (71) and the second container (80) and block the gastric fluid (85) from the second container (80) and the first container (20), the withdrawing of the gastric fluid (85) comprising using at least one of the one or more devices (60,65) to establish the second flow path; and

then directing the gastric fluid (85) in a third flow path from the vessel (71) through the second tube (40) into the second container (80) while at least one of the one or more devices (60,65) block the gastric fluid (85) from the first and third tubes (30,50) and block the composition (21) from the vessel (71) and the second container (80).

2. The method of Claim 1, wherein the one or more devices (60,65) comprise a first valve (60) positioned at the first three-way junction.

3. The method of Claim 2, wherein:

a first orientation of the first valve (60) fluidly connects the second end (32) of the first tube (30) to the first end (41) of the second tube (40) and closes the vessel (71), the first valve (60) is in the first orientation for the first flow path, and

a second orientation of the first valve (60) fluidly connects the first end (41) of the second tube (40) to the vessel (71) and blocks the second end (32) of the first tube (30) , the first valve (60) is in the second orientation for the second and third flow paths.

4. The method of Claim 3, comprising reinfusing at least a portion of the gastric fluid (85) from the second container (80) to the gastrointestinal tract of the patient by directing the gastric fluid (85) in a reinfusion flow path selected from the group consisting of:

(i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the third tube (50), while at least one of the one or more devices (60,65) block the second end (42) of the second tube (40), and

(ii) a fifth flow path leading from the second container (80) to the vessel (71) and comprising the second tube (40) and the first valve (60), while the first valve (60) is in the second orientation and at least one of the one or more devices (60,65) block the first end (51) of the third tube (50), and then a sixth flow path leading from the vessel (71) to the gastrointestinal tract of the patient and comprising the first valve (60), the second tube (40) and the third tube (50), while the first valve (60) is in the second orientation and at least one of the one or more devices (60,65) block the second container (80).

5. The method of Claim 3, comprising supplying an additional amount of the composition (21) to the patient from the first container (20) at a time subsequent to the directing of the gastric fluid (85) into the second container (80), the supplying of the additional amount of the composition (21) comprising moving the first valve (60) from the second orientation to the first orientation such that the additional amount of the composition (21) travels through the first flow path.

6. The method of Claim 5, wherein the supplying of the additional amount of the composition (21) to the patient comprises moving a second valve (65) positioned at the second three-way junction from an orientation fluidly connecting the second end (42) of the second tube (40) to the second container (80) and blocking the first end (51) of the third tube (50) to another orientation fiuidly connecting the first end (51) of the third tube (50) to the second end (42) of the second tube (40) and blocking the second container (80).

7. The method of Claim 3, wherein the one or more devices (60,65) comprise a second valve (65) positioned at the second three-way junction.

8. The method of Claim 7, wherein:

a first orientation of the second valve (65) fiuidly connects the second end (42) of the second tube (40) to the first end (51) of the third tube (50) and blocks the second container (80), the second valve (65) is in the first orientation for the first and second flow paths, and

a second orientation of the second valve (65) fiuidly connects the second end (42) of the second tube (40) to the second container (80) and blocks the first end (51) of the third tube (50), the second valve (65) is in the second orientation for the third fiow path.

9. The method of Claim 8, comprising reinfusing at least a portion of the gastric fluid (85) from the second container (80) to the gastrointestinal tract of the patient by directing the gastric fluid (85) in a reinfusion fiow path selected from the group consisting of:

(i) a fourth fiow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the third tube (50) and the second valve (65), while the second valve (65) is in a third orientation that blocks the second end (42) of the second tube (40) and fiuidly connects the second container (80) and the first end (51) of the third tube (50), and

(ii) a fifth flow path leading from the second container (80) to the vessel (71) and comprising the second valve (65), the second tube (40) and the first valve (60), while the second valve (65) is in the second orientation and the first valve (60) is in the second orientation, and then a sixth flow path leading from the vessel (71) to the gastrointestinal tract of the patient and comprising the first valve (60), the second tube (40), the second valve (65) and the third tube (50), while the second valve (65) is in the first orientation and the first valve (60) is in the second orientation.

10. The method of Claim 1, comprising performing a subsequent action selected from the group consisting of (i) disconnecting the second container (80) from the system (10), discarding the second container (80), and attaching a new second container (80) to the system (10), (ii) disconnecting the second container (80) from the system (10), dispensing at least a portion of the gastric fluid (85) from the second container (80), and then reconnecting the second container (80) to the system (10), (iii) completely disconnecting the second container (80) from the system (10), and (iv) reinfusing the gastric fluid (85) from the second container (80) to the gastrointestinal tract of the patient.

1 1. The method of Claim 10, comprising maintaining fluid connection of the first container (20) to the first end (31) of the first tube (30) throughout the supplying of the composition (21) to the patient from the first container (20), the withdrawing of the gastric fluid (85) from the gastrointestinal tract of the patient into the vessel (71), the directing of the gastric fluid (85) from the vessel (71) into the second container (80), and the subsequent action.

12. The method of Claim 1 , wherein the composition (21) is an enteral feeding formula comprising at least one of a nutrient or medication.

13. The method of Claim 1 , wherein the third tube (50) comprises or is fiuidly connected to an enteral feeding tube (150) selected from the group consisting of a nasogastric tube, a nasojejeunal tube, naso-duodenal tube, an orogastric tube, and a percutaneous tube.

14. The method of Claim 1 , wherein the system (10) comprises a syringe (70) that provides the vessel (71).

15. The method of Claim 1 , comprising measuring the gastric fluid (85) withdrawn from the gastrointestinal tract of the patient, using indicia on at least one of the vessel (71) or the second container (80).

16. A closed system (10) for providing a tube feed and allowing gastric emptying, the system (10) comprising:

a first container (20);

a first tube (30) comprising a first end (31) fiuidly connected to the first container (20); a first three-way junction to which a second end (32) of the first tube (30), a first end (41) of a second tube (40), and a vessel (71) are fiuidly connected; a second three-way junction to which a second end (42) of the second tube (40), a first end (51) of a third tube (50) and a second container (80) are fiuidly connected; and

one or more devices (60, 65) configured to selectively form a first flow path extending from the first container (20), the first flow path comprising the first tube (30), the second tube (40) and the third tube (50), leading to a second end (52) of the third tube (50), and blocking at least one first location selected from the group consisting of (i) the vessel (71) and (ii) the second container (80),

the one or more devices (60,65) configured to selectively form a second flow path extending from the second end (52) of the third tube (50), the second flow path comprising the third tube (50) and the second tube (40), leading into the vessel (71), and blocking at least one second location selected from the group consisting of (i) the first container (20) and (ii) the second container (80),

the one or more devices (60,65) configured to selectively form a third flow path extending from the vessel (71) into the second container (80) and blocking at least one third location selected from the group consisting of (i) the first end (51) of the third tube (50) and (ii) the first container (20).

17. The system of Claim 16, wherein the one or more devices (60,65) comprise a first valve (60) positioned at the first three-way junction.

18. The system of Claim 17, wherein:

a first orientation of the first valve (60) fiuidly connects the second end (32) of the first tube (30) to the first end (41) of the second tube (40) and closes the vessel (71), the first valve (60) is in the first orientation for the first flow path, and

a second orientation of the first valve (60) fiuidly connects the first end (41) of the second tube (40) to the vessel (71) and blocks the second end (32) of the first tube (30), the first valve (60) is in the second orientation for the second and third flow paths.

19. The system of Claim 18, wherein the one or more devices (60,65) are configured to selectively form a reinfusion flow path selected from the group consisting of: (i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the third tube (50), while at least one of the one or more devices (60,65) block the second end (42) of the second tube (40), and

20. The system of Claim 18, wherein the one or more devices (60,65) comprise a second valve (65) positioned at the second three-way junction.

21. The system of Claim 20, wherein:

a first orientation of the second valve (65) fluidly connects the second end (42) of the second tube (40) to the first end (51) of the third tube (50) and blocks the second container (80), the second valve (65) is in the first orientation for the first and second flow paths, and

a second orientation of the second valve (65) fluidly connects the second end (42) of the second tube (40) to the second container (80) and blocks the first end (51) of the third tube (50), the second valve (65) is in the second orientation for the third flow path.

22. The system of Claim 21 , wherein the one or more devices (60,65) are configured to selectively form a reinfusion flow path selected from the group consisting of:

(i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the third tube (50) and the second valve (65), while the second valve (65) is in a third orientation that blocks the second end (42) of the second tube (40) and fluidly connects the second container (80) and the first end (51) of the third tube (50), and

23. The system of Claim 16, wherein the third tube (50) comprises or is fluidly connected to an enteral feeding tube (150) selected from the group consisting of a nasogastric tube, a nasojejeunal tube, naso-duodenal tube, an orogastric tube, and a percutaneous tube.

24. The system of Claim 16, wherein the system (10) comprises a syringe (70) that provides the vessel (71).

25. A method of providing a tube feed and gastric emptying in a closed system (10), the method comprising:

supplying a composition (21) to a patient from a system (10) comprising a first container (20), the system (10) further comprising a first tube (30) comprising a first end (31) fluidly connected to the first container (20), the first tube (30) comprising a second end (32) fluidly connected to a first three-way junction to which a first end (41) of a second tube (40) and a first end (51) of a third tube (50) are fluidly connected, the third tube (50) comprising a second end (52) fluidly connected to a second three-way junction to which a vessel (71) and a second container (80) are fluidly connected, the supplying of the composition (21) comprising directing the composition (21) from the first container (20) in a first flow path comprising the first tube (30) and the second tube (40) and leading into the gastrointestinal tract of the patient while one or more devices (35,38,60) block the composition (21) from the vessel (71) and the second container (80) ;

then withdrawing gastric fluid (85) in a second flow path comprising the second tube (40) and the third tube (50) and leading from the gastrointestinal tract of the patient into the vessel (71) while at least one of the one or more device (35,38,60) block the composition (21) from the vessel (71) and the second container (80) and block the gastric fluid (85) from the second container (80) and the first container (20), the withdrawing of the gastric fluid (85) comprising using at least one of the one or more devices (60,65) to establish the second flow path; and

then directing the gastric fluid (85) in a third flow path from the vessel (71) into the second container (80) while at least one of the one or more devices (35,38,60) block the gastric fluid (85) from the first and second tubes (30,40) and block the composition (21) from the vessel (71) and the second container (80).

26. The method of Claim 25, wherein the one or more devices (35,38,60) comprise a first valve (60) positioned at the second three-way junction.

27. The method of Claim 26, wherein:

a first orientation of the first valve (60) fiuidly connects the vessel (71) to the second container (80) and blocks the second end (52) of the third tube (50), the first valve (60) is in the first orientation for the first and third flow paths, and

a second orientation of the first valve (60) fiuidly connects the second end (52) of the third tube (50) to the vessel (71) and blocks the second container (80), the first valve (60) is in the second orientation for the second flow path.

28. The method of Claim 27, wherein the one or more devices (35,60) comprise a clamp (35) on the first tube (30), the clamp (35) is in an open position on the first tube (30) for the first flow path, and the clamp (35) is in a blocking position on the first tube (30) for the second flow path.

29. The method of Claim 28, comprising reinfusing at least a portion of the gastric fluid (85) from the second container (80) to the gastrointestinal tract of the patient by directing the gastric fluid (85) in a reinfusion flow path selected from the group consisting of:

(i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the first valve (60), the third tube (50) and the second tube (40), while the first valve (60) is in a third orientation blocking the vessel (71) and fiuidly connecting the second container (80) and the second end (52) of the third tube (50), and the clamp (35) is in a blocking position on the first tube (30), and

(ii) a fifth flow path leading from the second container (80) to the vessel (71) and comprising the first valve (60), while the first valve (60) is in the first orientation, and then a sixth flow path leading from the vessel (71) to the gastrointestinal tract of the patient and comprising the first valve (60), the third tube (50) and the second tube (40), while the first valve (60) is in the second orientation and the clamp (35) is in a blocking position on the first tube (30).

30. The method of Claim 28, comprising supplying an additional amount of the composition (21) to the patient from the first container (20) at a time subsequent to the directing of the gastric fluid (85) into the second container (80), the supplying of the additional amount of the composition (21) comprising moving the first valve (60) from the second orientation to the first orientation while the clamp (35) is in the open position on the first tube (30) such that the additional amount of the composition (21) travels through the first flow path.

31. The method of Claim 25, wherein the one or more valves comprise a first valve (60) positioned at the first three-way junction.

32. The method of Claim 31 , wherein:

a first orientation of the first valve (60) fluidly connects the first tube (40) to the second tube (40) and blocks the first end (12) of the third tube (50), the first valve (60) is in the first orientation for the first and third flow paths, and

a second orientation of the first valve (60) fluidly connects the first end (51) of the third tube (50) to the first end (41) of the second tube (40) and blocks the second end (32) of the first tube (30), the first valve (60) is in the second orientation for the second flow path.

33. The method of Claim 32, wherein a first end (58) of a fourth tube (57) is fluidly connected to the second three-way junction, and a second end (59) of the fourth tube (57) is fluidly connected to the second container (80).

34. The method of Claim 33, wherein the one or more devices (35,38,60) comprise a clamp (35) on the fourth tube (57), the clamp (35) is in a blocking position on the fourth tube (57) for the second flow path, and the clamp (35) is in an open position on the fourth tube (57) for the third flow path.

35. The method of Claim 34, comprising reinfusing at least a portion of the gastric fluid (85) from the second container (80) to the gastrointestinal tract of the patient by directing the gastric fluid (85) in a reinfusion flow path selected from the group consisting of: (i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the fourth tube (57), the third tube (50), the first valve (60) and the second tube (40), while the first valve (60) is in the second orientation and the clamp (35) is in the open position on the first tube (30), and

(ii) a fifth flow path leading from the second container (80) to the vessel (71) and comprising the fourth tube (57), while the first valve (60) is in the first orientation and the clamp (35) is in the open position on the fourth tube (57), and then a sixth flow path leading from the vessel (71) to the gastrointestinal tract of the patient and comprising the third tube (50), the first valve (60) and the second tube (40), while the first valve (60) is in the second orientation and the clamp (35) is in the blocking position on the fourth tube (57).

36. The method of Claim 33, wherein the one or more devices (35,38,60) comprise a one-way valve (38) in the fourth tube, the one-way valve (38) blocks the second container (80) from the gastric fluid (85) in the second flow path.

37. The method of Claim 27, comprising supplying an additional amount of the composition (21) to the patient from the first container (20) at a time subsequent to the directing of the gastric fluid (85) into the second container (80), the supplying of the additional amount of the composition (21) comprising moving the first valve (60) into the first orientation such that the additional amount of the composition (21) travels through the first flow path.

38. The method of Claim 25, comprising performing a subsequent action selected from the group consisting of (i) disconnecting the second container (80) from the system (10), discarding the second container (80), and attaching a new second container (80) to the system (10), (ii) disconnecting the second container (80) from the system (10), dispensing at least a portion of the gastric fluid (85) from the second container (80), and then reconnecting the second container (80) to the system (10), (iii) completely disconnecting the second container (80) from the system (10) and (iv) reinfusing at least a portion of the gastric fluid (85) from the second container (80) through the system (10) back into the patient while maintaining connection of the second container (80) to the system (10) for the entirety of a time period that at least extends from the withdrawing of the gastric fluid (85) from the gastrointestinal tract of the patient to completion of the reinfusing back into the patient.

39. The method of Claim 38, comprising maintaining connection of the first container (20) to the first end (31) of the first tube (30) throughout the supplying of the composition (21) to the patient from the first container (20), the withdrawing of the gastric fluid (85) from the gastrointestinal tract of the patient into the vessel (71), the directing of the gastric fluid (85) from the vessel (71) into the second container (80), and the subsequent action.

40. The method of Claim 25, wherein the composition (21) is an enteral feeding formula comprising at least one of a nutrient or medication.

41. The method of Claim 25, wherein the second tube (40) comprises or is fiuidly connected to an enteral feeding tube selected from the group consisting of a nasogastric tube, a nasojejeunal tube, naso-duodenal tube, an orogastric tube, and a percutaneous tube.

42. The method of Claim 25, wherein the system (10) comprises a syringe (70) that provides the vessel (71).

43. The method of Claim 25, comprising measuring the gastric fluid (85) withdrawn from the gastrointestinal tract of the patient, using indicia on at least one of the vessel (71) or the second container (80).

44. A closed system (10) for providing a tube feed and gastric emptying, the system (10) comprising:

a first container (20);

a first tube (30) comprising a first end (31) fiuidly connected to the first container (20); a first three-way junction to which a second end (32) of the first tube (30), a first end (41) of a second tube (40), and a first end (51) of a third tube (50) are fiuidly connected;

a second three-way junction to which a second end (52) of the third tube (50), a vessel (71) and a second container (80) are fiuidly connected; and

one or more devices (35,38,60) configured to selectively form a first flow path extending from the first container (20), the first flow path comprising the first tube (30) and the second tube (40), leading to the second end (42) of the second tube (40), and blocking at least one first location selected from the group consisting of (i) the vessel (71) and (ii) the second container (80),

the one or more devices (35,38,60) configured to selectively form a second flow path extending from the second end (42) of the second tube (40), the second flow path comprising the second tube (40) and the third tube (50), leading into the vessel (71), and blocking at least one second location selected from the group consisting of (i) the first container (20) and (ii) the second container (80),

the one or more devices (35,38,60) configured to selectively form a third flow path extending from the vessel (71) into the second container (80) and blocking the first container (20).

45. The system (10) of Claim 44, wherein the one or more devices (35,38,60) comprise a first valve (60) positioned at the second three-way junction.

46. The system (10) of Claim 45, wherein:

a first orientation of the first valve (60) fluidly connects the vessel (71) to the second container (80) and blocks the second end (52) of the third tube (50), the first valve (60) is in the first orientation for the first and third flow paths, and

a second orientation of the first valve (60) fluidly connects the second end (52) of the third tube (50) to the vessel (71) and blocks the second container (80).

47. The system (10) of Claim 46, wherein the one or more devices (35,60) comprise a clamp (35) on the first tube (30), the clamp (35) is in an open position on the first tube (30) for the first flow path, and the clamp (35) is in a blocking position on the first tube (30) for the second flow path.

48. The system (10) of Claim 47, wherein the one or more devices (35,38,60) are configured to selectively establish a reinfusion flow path selected from the group consisting of:

(i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the first valve (60), the third tube (50) and the second tube (40), while the first valve (60) is in a third orientation blocking the vessel (71) and fluidly connecting the second container (80) and the second end (52) of the third tube (50), and the clamp (35) is in a blocking position on the first tube (30), and

49. The system (10) of Claim 44, wherein the one or more valves (60,65) comprise a first valve (60) positioned at the first three-way junction.

50. The system (10) of Claim 49, wherein:

51. The system (10) of Claim 50, further comprising a fourth tube (57) having a first end (58) fluidly connected to the second three-way junction, and a second (59) end of the fourth tube (50) is fluidly connected to the second container (80) (50).

52. The system (10) of Claim 51 , wherein the one or more devices (35,38,60) comprise a clamp (35) on the fourth tube (57), the clamp (35) is in a blocking position on the fourth tube (57) for the second flow path, and the clamp (35) is in an open position on the fourth tube (57) for the third flow path.

53. The system (10) of Claim 52, wherein the one or more devices (35,38,60) are configured to selectively establish a reinfusion flow path selected from the group consisting of: (i) a fourth flow path leading from the second container (80) to the gastrointestinal tract of the patient and comprising the fourth tube (57), the third tube (50), the first valve (60) and the second tube (40), while the first valve (60) is in the second orientation and the clamp (35) is in the open position on the first tube (30), and

54. The system (10) of Claim 44, wherein the second tube (40) comprises or is fiuidly connected to an enteral feeding tube selected from the group consisting of a nasogastric tube, a nasojejeunal tube, naso-duodenal tube, an orogastric tube, and a percutaneous tube.

55. The system (10) of Claim 44, comprising a syringe (70) that provides the vessel

(71).

56. A method of selectively providing a composition (21) to a patient and active gastric aspiration for the patient using the system of Claim 16 or the system of Claim 44, the method comprising attaching the first container (20) that holds the composition (21) to the first end (31) of the first tube (30) directly or by an intermediate connector (25).

57. The method of Claim 56, wherein the system (10) is fiuidly connected to an administration set (100) in at least one arrangement selected from the group consisting of (i) the system (10) positioned distal from the administration set (100) relative to the patient (200), (ii) the system (10) positioned proximal from the administration set (100) relative to the patient (200), (iii) the system (10) fiuidly connected to the administration set (100) by one or more extension lines (200) and (iv) the system (10) fiuidly connected to the administration set (100) by a medication port of the administration set (100).

58. A method of selectively providing a composition (21) to a patient and active gastric aspiration for the patient using the system of Claim 16 or the system of Claim 44, the method comprising attaching the second container (80) that receives gastric fluid (85) from the patient to the system (10) directly or by an intermediate connector (81).

59. The method of Claim 58, wherein the system (10) is fluidly connected to an administration set (100) in at least one arrangement selected from the group consisting of (i) the system (10) positioned distal from the administration set (100) relative to the patient (200), (ii) the system (10) positioned proximal from the administration set (100) relative to the patient (200), (iii) the system (10) fluidly connected to the administration set (100) by one or more extension lines (200) and (iv) the system (10) fluidly connected to the administration set (100) by a medication port of the administration set (100).