Enteral nutrition adapter and instructions for using the enteral nutrition adapter

Abstract

To provide an adapter for connecting a container of flowable material, such as enteral feed formula in a laminated paper container, to a feeding tube to enable bolus feeding.SOLUTION: The adapter can transfer the flowable material from the container by piercing the container and / or a cover of the container. The adapter can form a fluid-tight friction seal on the container. In some embodiments, the adapter has a reusable tube vent long enough to be positioned in the air gap of the container when the container is inverted by a user.SELECTED DRAWING: Figure 1

Description

【Technical Field】 【0001】 【0001】The present disclosure generally relates to an adapter for connecting a container of a fluid material, such as an enteral nutrition formula, to a supply tube to enable bolus feeding. The adapter can transfer the fluid material from the container by connecting to the neck portion of the container by piercing the container and / or the cover of the container, or additionally or alternatively, by covering and sealing the outside of the thread and / or neck portion with a flexible material. 【Background Art】 【0002】 【0002】Many people in hospitals or care facilities are unable to ingest food or medicine orally. These people typically receive enteral administration of a fluid material containing the necessary food and / or medicine. For example, an enteral administration set can be used to connect a patient supply line (e.g., a gastrostomy feeding tube) to a container that holds such a fluid medical or nutritional material. These fluid medical or nutritional materials are generally packed in flexible containers such as flexible pouches. For economic and other reasons, such pouches are inconvenient. 【0003】

[0003] In the food industry, containers such as Tetra Brik® and Tetra Prism® are used. These provide convenient, cost-effective, and lightweight cardboard containers for all kinds of injectable products, such as liquids. They come in a variety of sizes, e.g., 0.2 liters to 1.5 liters, or even larger. They are opaque and therefore perfect for enteral administration compositions that react to light, such as vitamin-containing compositions. With respect to medical fluids administered to patients, these fluids typically must be sterile. The containers can be sterilized and therefore can maintain freshness and nutritional value for several months without refrigeration or the addition of preservatives, even for the most perishable liquid foods. Finally, the containers can be sealed airtight in a sterile manner to prevent contaminants and / or oxygen from entering the container. Such containers can be advantageously used to contain pharmaceutical or nutritional compositions, such as enteral medical fluids or enteral nutrition fluids. 【0004】

[0004] However, existing enteral nutrition supply lines are not adapted to connect to existing containers, for example, to direct connections. As a result, medical compositions or nutritional compositions, such as fluids, are often injected into intermediate containers, such as syringes, and then connected to the supply line. Transferring to these intermediate containers is inconvenient for patients and healthcare workers and requires strength and dexterity. Furthermore, ensuring sterility during this process is difficult, and for example, transferring fluid materials carries the risk of leakage and exposure of the fluid material to the surroundings. [Overview of the project] 【0005】

[0005] The inventors have developed embodiments of adapters that are advantageous to adapters known at the time of the invention disclosed herein. These embodiments of adapters provide patients with easier and cleaner bolus delivery, for example, via a gastrostomy tube (G-tube). 【0006】

[0006] In a first embodiment, the present disclosure provides an adapter for fluidly connecting a syringe to a container for containing a composition (e.g., a laminated paper container), the syringe being connected to an enteral nutrition supply line. The adapter comprises a body having a lower end defining an opening and a spiked portion; a fluid outlet port extending from the upper end of the body, the upper end facing in the opposite direction to the lower end, the body comprising an internal chamber that fluidly connects the opening to the fluid outlet port, the fluid outlet port being configured to transfer a composition to a syringe connected to an enteral nutrition supply line; and one or more interface surfaces extending radially from the body, one or more of which optionally comprises ribs, the ribs being configured to create a gap between the syringe and the portion of the body between the ribs when the adapter is inserted into the syringe. Preferably, one or more interface surfaces provide a support for the container that is held independently within the syringe without user interference when the container is inverted. 【0007】

[0007] In one embodiment, the lower end portion is provided with a wall portion that forms a spike-like portion and also defines at least a part of the opening. 【0008】

[0008] In one embodiment, the opening is located in a plane positioned at an angle of 10 to 80 degrees with respect to at least one of (i) the side wall of the main body, or (ii) the longitudinal axis of the main body. 【0009】

[0009] In one embodiment, the main body is cylindrical. 【0010】

[0010] In one embodiment, at least a portion of the main body is transparent. 【0011】

[0011] In one embodiment, the enteral administration kit comprises an adapter and further comprises at least one of (i) a container for containing a composition, or (ii) a syringe. 【0012】

[0012] In one embodiment, the present disclosure provides a method for supplying enteral nutrition from a container (e.g., a laminated paper container), the container having a pre-formed hole leading to the inside of the container. The method includes the steps of connecting an adapter (e.g., a first embodiment of the adapter) to a container, the steps of which include a connecting step, which includes pushing the spiked portion of the adapter through a pre-formed hole in the container; inverting the container with the adapter attached, the steps of which optionally the adapter has one or more interface surfaces that provide a support for the container, which is held independently in a syringe without user interference when the container is inverted; inserting the end of the adapter opposite to the spiked portion into a syringe, the steps of which the steps of inserting the end of the adapter into the syringe result in the interior of the container being fluidly connected to the syringe through (i) the internal chamber of the adapter and (ii) the fluid outlet port at the end of the adapter inserted into the syringe; and guiding at least a portion of the composition in the container through the adapter and then through the syringe to an enteral nutrition supply line having a first end attached to the syringe, the second end of the enteral nutrition supply line being located in the patient. 【0013】

[0013] Preferably, the spike-shaped portion is larger than the pre-formed hole in at least one dimension, and the hole is expanded in at least one direction by pushing the spike-shaped portion of the adapter through the pre-formed hole. 【0014】

[0014] The method may include the step of applying pressure to at least one side surface of the container so as to guide at least a portion of the composition inside the container through the adapter. Pressure may be applied to two opposite side surfaces of the container by squeezing the container. 【0015】

[0015] In one embodiment, the step of introducing the composition in the container through the adapter is at least partially by gravity (for example, in some embodiments, entirely by gravity). 【0016】

[0016] In one embodiment, the adapter is connected to the container solely by friction fitting between the adapter and the expanded hole of the container, and the friction fitting forms a liquid-tight seal in the expanded hole. 【0017】

[0017] In one embodiment, the method includes the step of venting air through a gap between the body of the adapter and the inner surface of the syringe while the composition is guided through the adapter, the body of the adapter having a spiked portion, and the gap being formed by one or more interface surfaces extending from the body of the adapter, optionally one or more interface surfaces being selected from the group consisting of (i) vertical ribs extending from the body of the adapter and (ii) a sleeve surrounding the body of the adapter. 【0018】

[0018] In one embodiment, the method includes the step of engaging one or more stopping surfaces of the adapter with the container such that one or more stopping surfaces come into contact with the laminate paper, preventing the spike-shaped portion of the adapter from being pushed through a pre-formed hole in the container. 【0019】

[0019] In one embodiment, the adapter has at least one opening, and when the adapter is assembled to the container, at least one opening of the adapter is located inside the container and adjacent to a seal formed between the adapter and the container, and at least one opening allows the container and the adapter attached thereto to be inverted to substantially drain the container. The total area of ​​at least one opening of the adapter preferably includes an area of ​​at least 50% of the minimum flow path area of ​​the fluid port of the adapter to allow efficient gravity flow. The at least one opening preferably includes a portion (e.g., a smaller portion such as a portion with reduced width) that is at least 60% smaller than the total area of ​​at least one opening, closest to the seal to provide slow indicator leakage to the outside if the adapter is partially removed while inverted. 【0020】

[0020] In one embodiment, the method further includes the step of pausing the administration of enteral nutrition from the container to the patient, the pausing step of including the step of detaching the adapter from the container and / or the supply tube, the method further includes the step of covering the container and / or putting a lid on the adapter, the method further includes the step of refrigerating the container and then resuming the administration of enteral nutrition from the container to the patient. 【0021】

[0021] In one embodiment, the present disclosure provides a method for supplying enteral nutrition from a container, the container having a pre-formed hole into the interior of the container, the method comprising the steps of connecting an adapter (e.g., a first embodiment of the adapter) to the container, the steps of connecting the adapter to the container comprising pushing the spiked portion of the adapter through the pre-formed hole of the container, the spiked portion being larger in at least one dimension than the pre-formed hole, and pushing the spiked portion of the adapter through the pre-formed hole expands the hole in at least one direction, and the steps of inverting the container with the adapter attached, the steps of inverting the container so that at least a portion of the composition inside the container is guided through the adapter to an enteral nutrition supply line having a first end attached to the adapter, the second end of the enteral nutrition supply line being placed inside the patient. 【0022】

[0022] In one embodiment, the method includes the step of fluidly connecting the adapter to an enteral nutrition supply line before and / or after the step of connecting the adapter to a container. 【0023】

[0023] In a second embodiment, the Disclosure provides an adapter for fluidly connecting a syringe to a container for containing a composition (e.g., a laminated paper container), the syringe being connected to an enteral nutrition supply line. The adapter comprises a body having a lower end defining an opening, and a fluid outlet port extending outward from the upper end of the body, the upper end facing in the opposite direction from the lower end, the body comprising an internal chamber that fluidly connects the opening to the fluid outlet port, the fluid outlet port being configured to be sealed to an enteral nutrition supply line, and a vent tube extending outward from the upper end of the body at a different location from the fluid outlet port, the vent tube also extending inward through the internal chamber to a point beyond the lower end of the body, the lower end of the vent tube comprising an opening defining a first spike-like portion, and the lower end of the body defining a second spike-like portion. 【0024】

[0024] In one embodiment, the upper end of the ventilation tube is provided with a port configured to be connected to a cap and / or a flexible tube, and in some embodiments, a stylet can be inserted into the port before the container is inverted and then removed after the container is inverted. 【0025】

[0025] In one embodiment, the ventilation tube has a total length of approximately 1.5 to approximately 3.0 times the height of the main body. 【0026】

[0026] In one embodiment, the main body comprises at least one wall portion having an inner surface that defines at least a part of the internal chamber and an outer surface that is the outer surface of the main body. 【0027】

[0027] In one embodiment, the kit further comprises an adapter and a container for holding the composition. 【0028】 【0028】In one embodiment, the present disclosure provides a method of supplying enteral nutrition from a container (e.g., a laminated paper container), the container comprising a cover covering a hole pre-formed into the interior of the container. The method comprises connecting an adapter to the container, the adapter comprising a vent tube and a first spike provided by the vent tube, the step of connecting the adapter to the container comprising pushing the first spike of the adapter through the cover of the container so as to insert through the pre-formed hole, the step of connecting the adapter to the container comprising continuing to push the adapter so as to insert a second spike of the adapter through the pre-formed hole, the second spike being larger than the pre-formed hole in at least one dimension, and expanding the hole in at least one direction by pushing the second spike of the adapter through the pre-formed hole, a connecting step; and inverting the container with the adapter attached, wherein inverting the container guides at least a portion of the composition within the container through the adapter to an enteral nutrition supply line having a first end attached to the adapter, the second end of the enteral nutrition supply line being disposed within a patient, an inverting step. 【0029】 【0029】In one embodiment, the adapter is connected to the container only by a friction fit between the adapter and the expanded hole of the container, and the friction fit forms a liquid-tight seal at the expanded hole. 【0030】 【0030】In one embodiment, the method includes engaging one or more stop surfaces of an adapter with a container such that one or more stop surfaces contact the laminated paper and prevent the second spike-like portion of the adapter from being pushed through a pre-formed hole in the container. At the position of the adapter when one or more stop surfaces of the adapter contact the container, the end of the ventilation tube with the first spike-like portion can also be disposed within an air gap (e.g., the top space of the container) formed when the container is inverted. Additionally or alternatively, for example, the ventilation tube may be separately inserted to a position that partially or completely extends to the bottom of the container (e.g., in a modular embodiment of the adapter where the method may include attaching the adapter to the container and attaching the ventilation tube to the adapter as a separate step). In some embodiments, the ventilation tube can be partially inserted into the container such that ventilation occurs after a certain volume of liquid in the container has been removed by squeezing the container. 【0031】 【0031】Optionally, the adapter can include a chamber having a volume that increases the air gap when inverted, thereby minimizing the required length of the ventilation tube. 【0032】 【0032】In one embodiment, the method further includes closing the ventilation tube to prevent fluid from entering the ventilation tube prior to administration of the composition to the patient. 【0033】

[0033] In one embodiment, the present disclosure provides a method for supplying enteral nutrition from a container, the container comprising a neck portion having one or more threads surrounding a pre-formed hole in the container, the method comprising the steps of connecting an adapter to the container, the steps of connecting the components of the adapter to the container, thereby inserting a vent tube of the adapter into a pre-formed hole, the components being selected from the group consisting of (i) one or more threads on the adapter complementary to one or more threads on the container, (ii) a flexible material covering and sealing the outside of the neck portion of the container, and (iii) a combination thereof; and the steps of inverting the container with the adapter attached, the steps of inverting the container so that at least a portion of the composition inside the container is guided through the adapter to an enteral nutrition supply line having a first end attached to the adapter, the second end of the enteral nutrition supply line being placed inside the patient. 【0034】

[0034] Preferably, the lower end of the ventilation tube is separated from one or more complementary threads, and by connecting the adapter to the container, the lower end of the ventilation tube is positioned in the air gap (e.g., the top space of the container) that is formed when the container is inverted. 【0035】

[0035] The method may further include a step of blocking the vent tube to prevent fluid from entering the vent tube before administering the composition to the patient. 【0036】

[0036] The vent tube may optionally have a port at the end of the vent tube opposite the first spike-like portion. In one embodiment, a section of tubing may be connected to the vent tube (e.g., to a port), and may be transparent so that the fluid inside the vent tube can be visually observed. The tubing may include a cap, valve (e.g., a butterfly valve) or roller clamp for adjusting the vent hole and for measuring the flow. In one embodiment, such fluid may be contained by a fluid trap (e.g., in a flexible tube over the vent port). An air reservoir, such as a flexible sphere or flexible tube, may be used by the user to clean the vent tube with a certain volume of air if nutrients enter the vent hole. The vent passage can be blocked using a stylet until immediately before replenishment is started, thereby preventing fluid from inadvertently entering the vent passage. The stylet can be partially or completely removed to adjust the vent hole and / or to measure the flow. 【0037】

[0037] The advantages of one or more embodiments provided by the present disclosure are that the spike-like portion can be made sharp enough to puncture the foil of a container with moderate force without hazard to handling or shipping, can be made large enough to produce a suitable flow channel area, can be shaped to produce a foil flap regardless of the puncture location, can be made long enough to clean the opened foil flap, and can be made small enough to avoid the movement of the composition to the outside of the container, such as on any adhesive pad. 【0038】

[0038] Another advantage of one or more embodiments provided by this disclosure is an enteral nutrition adapter that can be easily connected to an enteral feeding tube. 【0039】

[0039] A further advantage of one or more embodiments provided by the present disclosure is a ventilated membrane or ventilated material that prevents fluid from flowing out of the container, allows air to flow into the container, and is moldable at low cost. The ventilated membrane or ventilated material may be placed within the vent port and may be manufactured to be replaceable by the user, optionally, for the reuse of the adapter. 【0040】

[0040] A further advantage of one or more embodiments provided by the present disclosure is that the fluid flow can be controlled by mechanically controlling the airflow to the vent using caps, cams, tapered sections, limiting sections, pinch clamps, and / or roller clamps. Additionally, as the stylet is operated by the user (e.g., pulled out or rotated), portions of the stylet may be made smaller or tapered to further adjust the vent and measure the flow. 【0041】

[0041] Another advantage of one or more embodiments provided by the present disclosure is an adhesive pad for sealing the foil and / or carton of the enteral nutrition container by sealing the entire nutrition on the surface of the container, for example. 【0042】

[0042] Additional features and advantages are described herein. These will become apparent from the embodiments and drawings for carrying out the inventions hereafter. [Brief explanation of the drawing] 【0043】 [Figure 1] This is a side perspective view of a first embodiment of the adapter provided in this disclosure. [Figure 2A] This is a side view of the first embodiment of the adapter. [Figure 2B] This is a side view of the first embodiment of the adapter. [Figure 2C] This is a side view of the first embodiment of the adapter. [Figure 2D] This is a side cross-sectional view of the first embodiment of the adapter. [Figure 3A]This is a side perspective view of the first embodiment of the adapter. [Figure 3B] This is a side perspective view of the first embodiment of the adapter. [Figure 3C] This is a side perspective view of the first embodiment of the adapter. [Figure 3D] This is a side perspective view of the first embodiment of the adapter. [Figure 4] This is a top view of the first embodiment of the adapter, and it identifies the cross-section used in Figure 2D. [Figure 5] This is a top view of the container before it is used in the first embodiment of the adapter. [Figure 6A] This is a side view of a first embodiment of an adapter attached to a container. [Figure 6B] This is a side cross-sectional view of a first embodiment of an adapter attached to a container. [Figure 7] This is a top view of a first embodiment of an adapter attached to a container. [Figure 8] This is a side cross-sectional view of a first embodiment of an adapter attached to a container. [Figure 9] This is a top view comparing the profile of the spike-shaped portion of the first embodiment of the adapter with the holes in the container. [Figure 10] This is a top view of a syringe assembly having a first embodiment of an adapter attached to a container. [Figure 11] This is a side view of the assembly of a syringe and an adapter attached to a container, according to a first embodiment. [Figure 12] This is a side cross-sectional view of an assembly of a syringe and an adapter attached to a container, representing a first embodiment. [Figure 13] This is a side perspective view of one version of a first embodiment of an adapter for attachment to a syringe. [Figure 14] This figure shows a general version of a first embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port on a container. [Figure 15]This figure shows a general version of a first embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port on a container. [Figure 16] This figure shows a general version of a first embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port on a container. [Figure 17] This figure shows a general version of a first embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port on a container. [Figure 18] This figure shows a general version of a first embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port on a container. [Figure 19] This figure shows a general version of a first embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port on a container. [Figure 20] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 21] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 22] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 23] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 24] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 25] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 26] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 27] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 28] This is a diagram illustrating the first version of the second embodiment of the adapter in general terms. [Figure 29] This is a side view of a second version of a second embodiment of the adapter provided in this disclosure. [Figure 30] This is a side view of the second version of the second embodiment of the adapter. [Figure 31] This is a side perspective view of the second version of the second embodiment of the adapter. [Figure 32] This is a side perspective view of the second version of the second embodiment of the adapter. [Figure 33] This is a top view of the second version of the second embodiment of the adapter, and is a diagram that identifies the cross-section used in Figure 34. [Figure 34] This is a side cross-sectional view of a second version of the second embodiment of the adapter. [Figure 35A] This is a side view of a second version of a second embodiment of an adapter attached to a container. [Figure 35B] This is a side cross-sectional view of a second version of a second embodiment of an adapter attached to a container. [Figure 36] This is a top view of a second version of a second embodiment of an adapter attached to a container. [Figure 37] This is a side cross-sectional view of a second version of a second embodiment of an adapter attached to a container. [Figure 38] This is a top view comparing the profile of the spike-shaped portion of the second version of the second embodiment of the adapter with the holes in the container. [Figure 39] This figure shows a general variation of a second version of the second embodiment of the adapter, in which the adapter includes a leak indicator. [Figure 40] This figure shows a general variation of a second version of the second embodiment of the adapter, in which the adapter includes a leak indicator. [Figure 41] This figure shows a general variation of a second version of the second embodiment of the adapter, in which the adapter includes a leak indicator. [Figure 42]This figure shows a general variation of a second version of the second embodiment of the adapter, in which the adapter includes a leak indicator. [Figure 43] This figure shows in general another variation of the second version of the second embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port of the container. [Figure 44] This figure shows in general another variation of the second version of the second embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port of the container. [Figure 45] This figure shows in general another variation of the second version of the second embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port of the container. [Figure 46] This figure shows in general another variation of the second version of the second embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port of the container. [Figure 47] This figure shows in general another variation of the second version of the second embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port of the container. [Figure 48] This figure shows in general another variation of the second version of the second embodiment of the adapter, wherein the adapter includes one or more threads for a reversible connection to a threaded port of the container. [Figure 49] This diagram shows a general combination of the first and second embodiments of the adapter. [Modes for carrying out the invention] 【0044】

[0044] Definition 【0045】 The following are some definitions. However, definitions may also be found in the "Embodiments" section below, and the above heading "Definitions" does not mean that such disclosures in the "Embodiments" section are not definitions.

[0045] 【0046】When used in this disclosure and the appended claims, the singular forms "one," i.e., "a," "an," and "the," include multiple references unless otherwise indicated. Thus, for example, a reference to "a fluid" or "the fluid" includes two or more fluids.

[0046] 【0047】 The terms “comprise,” “comprises,” and “comprising” should be interpreted inclusively, not exclusively. Similarly, the terms “include,” “including,” and “or” should all be interpreted inclusively unless such an interpretation is clearly prevented by the context.

[0047] 【0048】 Nevertheless, the devices and apparatus disclosed herein may lack any elements not specifically disclosed. Accordingly, disclosures of embodiments using the term “comprising” include disclosures of embodiments that “consist essentially of” a specified component, and embodiments that “consist of” a specified component. Similarly, methods disclosed herein may not have any steps not specifically disclosed herein. Accordingly, disclosures of embodiments using the term “including” include disclosures of embodiments that “consist essentially of” a specified step, and embodiments that “consist of” a specified step.

[0048] 【0049】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". As used herein, the terms "example" and "such as" are merely illustrative and descriptive, and should not be considered exclusive or exhaustive, especially when followed by a list of terms. Unless otherwise stated, any embodiment disclosed herein may be combined with any other embodiment disclosed herein.

[0049] 【0050】 As used herein, “about” and “approximately” are understood to mean a number within a numerical range, for example, a range of -10% to +10% of the referenced number, preferably a range of -5% to +5% of the referenced number, more preferably a range of -1% to +1% of the referenced number, and most preferably a range of -0.1% to +0.1% of the referenced number.

[0050] 【0051】 Numerical adjectives such as "first" and "second" are simply used to distinguish each element. These numerical adjectives do not imply the existence, relative positioning, or execution in any chronological order of other elements. In this regard, the existence of a "second" structure does not necessarily mean the existence of a "first" structure. Furthermore, in this regard, a "second" element can be acquired and / or used before, after, or simultaneously with any "first" element.

[0051] 【0052】The term “enteral composition” means a fluid composition that is formulated for ingestion by an individual, such as a human, and that delivers at least one nutrient or drug to that individual. Enteral compositions preferably have a viscosity of less than 150 cPs, more preferably less than 125 cPs, and most preferably less than 100 cPs. Enteral compositions typically contain at least one of proteins, lipids, and carbohydrates, and optionally contain one or more vitamins and minerals. The compositions of this disclosure, including many embodiments described herein, may consist of, or be essentially composed of, the elements disclosed herein, as well as any additional or optional components, components, or elements described herein or not that are useful in a diet.

[0052] 【0053】 The term “laminated paper container” means a container having one or more layers of paper or cardboard or other fibrous material coated on one side with a thermoplastic material such as polyethylene. The container may further comprise a layer of a barrier material, such as aluminum foil, which may be optionally coated with a thermoplastic layer on the surface of the laminated paper packaging material that is configured to come into contact with the composition. Non-limiting examples of containers are disclosed in U.S. Patent No. 6,223,924 and European Patent No. 1,088,765, both of which are incorporated herein by reference in their entirety. Other non-limiting examples include containers of type Tetra Brik®, Tetra Brik Aseptic®, Tetra Pak®, Tetra® Prisma, Tetra Recart®, Tetra Square®, Tetra Top®, Elopa®, Combiblok®, and Pure Pak®. The container may have a volume of approximately 0.125 liters to approximately 2 liters, preferably approximately 0.200 liters to approximately 1.0 liter, most preferably one of approximately 0.200 liters, approximately 0.250 liters, and approximately 1.0 liter.

[0053] 【0054】When used herein, directions such as "top," "bottom," "side," "vertical," and "horizontal" are based on the container in a stationary position (e.g., not inverted), where the stationary position is, specifically, where the container's opening is at the top of the container, components of a similar situation are at the "top," and the end of the container opposite the opening is at the "bottom," components of a similar situation are at the "bottom."

[0054] 【0055】 As used in this application, including in the attached claims, “kit” means that the specified components are physically associated with or contained in one or more containers and are considered to be a single unit for manufacture, delivery, distribution, sale, or use. Suitable containers for physically associating a kit include, but are not limited to, bags, boxes, cartons, bottles, packaging of any kind, design, or material, overlaps, shrink wraps, accompanying components (e.g., stapled, glued, etc.), or combinations thereof. A single package may be one or more containers containing the specified components and one or more containers that are physically associated with them, thereby being considered a single unit for manufacture, distribution, sale, or use.

[0055] 【0056】 Embodiment 【0057】 Embodiments of adapters disclosed herein preferably connect an enteral nutrition supply line (e.g., a G-tube) to a container (e.g., a laminated paper container). The adapter can guide an enteral composition contained in the container from the container to the enteral nutrition supply line. In a preferred embodiment, the adapter forms at least a temporary liquid-tight seal with the container so that the adapter prevents leakage of the composition when the composition is flowing from the adapter device, for example, when the user inverts the container so that the opening faces downward.

[0056] 【0058】A first embodiment provided by this disclosure is generally shown in Figures 1 to 19. In the first embodiment, the adapter 100 can connect an enteral nutrition supply line 112 to a container 114, preferably a laminated paper container. The container 114 may initially be sealed with a cover 120, such as aluminum foil, which can initially overlap and / or seal a pre-formed hole 140 in the container 114. To allow administration of a fluid, such as a composition 115 initially placed inside the container 114, for example, an enteral composition, the cover 120 can be opened by the adapter 100, establishing a passage from inside the container 114 through the adapter 100 to the enteral nutrition supply line 112. Thus, the adapter 100 may provide the container 114 with a spike-like portion 116 for forming an opening, such as a flap within the cover 120.

[0057] 【0059】 The cover 120 may be provided with a pull tab that can be removed from the rest of the container 114 before connecting the adapter 100 to the container 114. For example, the cover 120 can be peeled off from one or more surfaces of the container 114. However, the cover 120 is opened by the spiked portion 116, preferably by, for example, perforating and / or tearing the cover 120, thereby forming an opening in the cover 120. The disclosure is not limited to any particular embodiment of the spiked portion 116, and the spiked portion 116 may be any structure configured to open the cover 120 by, for example, perforating and / or tearing the cover 120.

[0058] 【0060】 The adapter 100 may include a body 118 that is preferably at least partially hollow, preferably by including an internal chamber 122. For example, the body 118 may have one or more wall portions, each having (i) an outer surface that is the outer surface of the body 118 and (ii) an inner surface that defines at least a portion of the internal chamber 122.

[0059] 【0061】The spike portion 116 may be part of the body 118, for example, the lower end portion 117 of the body 118 which also defines an opening into the internal chamber 122. Preferably, the spike portion 116 has a profile that is larger (i.e., larger in at least one dimension) than the hole 140 of the container 114 into which the spike portion 116 is inserted. For example, the opening defined by the lower end portion 117 of the body 118 may be in a plane that is at an angle to the side wall of the body 118 and / or the longitudinal axis of the body 118. As shown in Figure 9, preferably, the body 118 and / or the spike portion 116 have a cross section perpendicular to the longitudinal axis with a circumference larger (e.g., a larger radius) than the circumference of the hole 140 of the container 114. Referring again to Figures 1 to 19, the body 118 is shown as being generally cylindrical, but the body 118 may be of any shape, and this disclosure is not limited to a particular shape of body 118.

[0060] 【0062】 The opening at the lower end 117 of the main body 118 that forms the spike-shaped portion 116 is preferably in a plane at an angle of 10 to 80 degrees with respect to the side wall of the main body 118 and / or the longitudinal axis of the main body 118, more preferably at an angle of 20 to 70 degrees with respect to the side wall of the main body 118 and / or the longitudinal axis of the main body 118, and most preferably at an angle of 30 to 60 degrees with respect to the side wall of the main body 118 and / or the longitudinal axis of the main body 118.

[0061] 【0063】 The main body 118 may optionally include a drain slot 180, for example, a slot in the main body 118 extending upward from the lower end 117 of the main body 118. Additionally or alternatively, the main body 118 may optionally include a drain hole 181, for example, a hole extending through the main body 118 adjacent to the lower end 117 of the main body 118.

[0062] 【0064】The adapter 100 may further comprise one or more interface surfaces 182 extending axially from the body 118, for example, vertical ribs extending from the body 118 of the adapter 100, and / or a sleeve (e.g., a transparent sleeve) surrounding the body 118 of the adapter 100. One or more interface surfaces 182 may abut against the inner surface of the syringe 199 into which the adapter is at least partially inserted, as will be described in more detail herein. In this regard, the body 118 may be separated from the inner surface of the syringe 199 into which the adapter 100 is at least partially inserted to form a ventilation gap so that the syringe 199 can effectively drain. In one embodiment, one or more interface surfaces 182 may be tapered outward to provide a more secure fit when the syringe 199 has a larger diameter.

[0063] 【0065】 As the adapter 100 continues to be pushed into the container 114, one or more of the stop surfaces 183 can slide and come into contact with the upper surface of the container 114. Thus, the stop surfaces 183 can prevent the adapter 100 from being pushed further into the container 114.

[0064] 【0066】 In some embodiments, one or more interface surfaces 182 may comprise one or more stop surfaces 183. For example, an embodiment of one or more interface surfaces 182 comprising vertical ribs may have stop surfaces 183 at the lowest ends of the ribs. As another example, an embodiment of one or more interface surfaces 182 comprising sleeves may have stop surfaces 183 at the lowest ends of the sleeves. The one or more stop surfaces 183 may be part of the interface surface 182 (if present) or may be a separate structure.

[0065] 【0067】The portion of the main body 118 between the stop surface 183 and the opening at the lower end 117 can form a liquid-tight sealing and friction-retaining area 185 that engages with the side of the hole in the container 114. In one embodiment, the liquid-tight sealing and friction-retaining area 185 may optionally include a mechanical fixing member selected from the group consisting of one or more return portions, one or more raised portions, one or more gill structures, rubber material, and combinations thereof. In one embodiment, to help secure the adapter 100 to the container 114, a retaining member, such as an elastic band extending from the top surface 170 of the adapter 100 to the bottom of the container 114, can be applied to the top surface 170 of the adapter 100.

[0066] 【0068】 By positioning the adapter 100 such that one or more stop surfaces 183 abut against the container 114, the spike portion 116 can be pushed into the cover 120 and at least partially through the cover 120. This allows the spike portion 116 to form an opening in the cover 120 and / or container 114, thereby establishing a passage for the enteral composition 115 from inside the container 114 through the adapter 100 to the enteral nutrition supply line 112. In this regard, the body 118 may be provided with a fluid outlet port 121 on the upper surface 170 of the adapter 100, and the opening defined by the lower end 117 of the body 118 passes through the inside of the body 118 (e.g., through the internal chamber 122) to the fluid outlet port 121 (particularly shown in Figure 2D). The syringe 199 can fluidly connect the fluid outlet port 121 of the adapter 100 to the enteral nutrition supply line 112.

[0067] 【0069】The adapter 100 may optionally include a vent port 127 configured to allow air to enter the container 114 (e.g., by moving through an internal chamber 122) to compensate for the composition 115 leaving the container 114 through the adapter 100. The vent port 127 may include a filter that allows air to enter the container 114 from outside (e.g., through the internal chamber 122) while preventing the composition 115 from leaving the vent port 127. The filter preferably includes a bacterial filter configured to prevent contaminants such as bacteria from entering the container 114. This allows the filter to prevent contaminants from entering the enteral nutrition supply line 112. However, some embodiments of the adapter 100 do not include a vent, in which preferably, access to the container 114 is only through the passage formed by the internal chamber 122 and the fluid outlet port 121.

[0068] 【0070】 A non-limiting example of how the adapter 100 can be used is generally shown in Figures 5 to 12. The container 114 may have a hole 140. For example, the hole 140 can be cut into the body of the container 114 before the cover 120 is applied to the container 114. Additionally or alternatively, the container 114 may have a reduced thickness relative to the periphery of the container 114 and / or a portion defined by a cut in the container 114, and the spike-shaped portion 116 can form the hole 140 by positioning the adapter 100 (e.g., the stop surface 183) in contact with the container 114.

[0069] 【0071】The hole 140 may be of any preferred shape, for example, circular or rectangular, and any preferred dimensions may be, for example, about 0.3 cm to about 3.0 cm, preferably about 0.6 cm to about 2 cm, more preferably about 1.2 cm to about 1.5 cm, most preferably about 1.3 cm to about 1.4 cm, and may have a diameter of, for example, about 0.6 cm. The cover 120 may be removed before connecting the adapter 100, but preferably the spiked portion 116 opens the cover 120 and connects the adapter 100 to the container 114 by, for example, perforating and / or tearing the cover 120 (for example, so that the inside of the container 114 is exposed to the internal chamber 122 of the adapter 100).

[0070] 【0072】 For example, the adapter 100 can be pushed and / or screwed into the container 114 so that the spike-shaped portion 116 opens the cover 120 by perforating and / or tearing it, and is inserted into the hole 140. Inserting the spike-shaped portion 116 into the container 114 exposes the opening at the lower end 117 of the main body 118 to the inside of the container 114 so that the composition 115 can enter the internal chamber 122 (Figures 6A, 6B, and 8).

[0071] 【0073】 As shown in Figure 9, the spike portion 116 preferably has a profile that is larger (i.e., larger in at least one dimension) than the hole 140 of the container 114 into which the spike portion 116 is inserted. Thus, the hole 140 can be enlarged by the spike portion 116, and preferably a liquid-tight seal is also formed over the hole 140.

[0072] 【0074】The container 114 can be inverted by the user. As shown in Figures 10 to 12, the adapter 100 is inserted into the syringe 199, thereby allowing fluid communication between the inside of the container 114 and the enteral nutrition supply line 112 via the adapter 100 (for example, via the opening at the lower end 117 of the body 118, the internal chamber 122, and the fluid outlet port 121) and via the syringe 199. As shown in Figure 13, the adapter 100 may include a clip 150 that is reversibly attached to the syringe 199.

[0073] 【0075】 The composition 115 can be guided through the adapter 100 to the syringe 199 and then to the enteral nutrition line 112 by gravity and / or by applying pressure to the container 114, for example by squeezing the container 114 (e.g., without using a pump). The composition 115 can then be delivered to the patient through the enteral nutrition line 112.

[0074] 【0076】 Preferably, one or more parts of the adapter 100 (e.g., the main body 118) and / or the syringe 199 may be transparent so as to allow the user to observe the flow of the composition 115 into the adapter 100 and then into the syringe 199 before it enters the enteral nutrition line 112.

[0075] 【0077】In some embodiments, replenishment can be paused by detaching the adapter 100 from the container 114 or syringe 199, covering the container 114 or the adapter port 121, and storing the container 114 (e.g., refrigerating the container 114). Replenishment can then be resumed later by reconnecting the adapter 100 to the container 114 or syringe 199. Preferably, the adapter 100 is reusable, i.e., after cleaning the adapter 100, another container can be used for enteral administration using the same adapter 100. Furthermore in this regard, the frictional sealing achieved by the adapter 100 makes the adapter 100 reusable by minimizing (if any) loss of connectivity in containers such as laminated paper containers.

[0076] 【0078】 Figures 14 to 19 show a general version of one embodiment in which the adapter 100 has threads 119 on the body 118 that can be reversibly connected to corresponding threads on the container 114.

[0077] 【0079】 The first embodiment (e.g., adapter 100) can be used with minimal acquisition of motor skills, can visualize the flow, can provide a reliable flow, and can reduce spillage compared to known enteral administration methods, as a result of the features disclosed herein. Furthermore, adapter 100 can delay replenishment and allow for later termination without irreversible membrane occlusion. In addition, adapter 100 can form a friction fit with container 114, can use an interface with syringe 199, provides stability, and allows for one-handed use.

[0078] 【0080】A second embodiment provided by this disclosure is generally shown in Figures 20 to 48, but as previously stated herein, unless otherwise specified, any embodiment disclosed herein can be combined with any other embodiment disclosed herein. In the second embodiment, the adapter 200 may connect the enteral nutrition supply line 212 to a container 214, preferably a laminated paper container. The container 214 may initially be sealed with a cover 220, such as aluminum foil. To allow administration of a fluid, such as a composition 215 initially placed inside the container 214, for example, an enteral composition, the cover 220 can be opened by the adapter 200, establishing a passage from inside the container 214 through the adapter 200 to the enteral nutrition supply line 212.

[0079] 【0081】 Therefore, the first version of the adapter 200 (Figures 20 to 28) may include short spike-like portions 316 on the container 214 for forming an opening such as a flap in the cover 220. The second version of the adapter 200 (Figures 29 to 48) may include short spike-like portions 316 and may further include long spike-like portions 216 on the container 214 for cooperatively forming an opening such as a flap in the cover 220.

[0080] 【0082】 The cover 220 may be provided with a pull tab that can be removed from the rest of the container 214 before connecting the adapter 200 to the container 214. For example, the cover 220 can be peeled off from one or more surfaces of the container 214. However, the first version of the adapter 200 (Figures 20-28) preferably opens the cover 220 by using short spike-like portions 316 to puncture and / or tear the cover 220, and then pushes the short spike-like portions 316 through the first opening to expand the first opening and form a second opening in the cover 220 that is larger than the first opening.

[0081] 【0083】In the first version of the adapter 200 (Figures 20 to 28), the short spike-like portion 316 can protrude from one or more plates 18 of the first version of the adapter 200, preferably one or more horizontal plates, for example, the first plate 18a. Each of the one or more plates 18 preferably has a generally rectangular or generally circular shape, but each of the one or more plates 18 may have any shape, and this disclosure is not limited to one or more plates 18 of a particular shape.

[0082] 【0084】 By positioning a first version of the adapter 200 (e.g., the lowest of one or more plates 18) so as to abut the container 214, the short spike-like portion 316 can be pressed into the cover 220 and at least partially through the cover 220. This allows the short spike-like portion 316 to form an opening in the cover 220, thereby establishing a passage for the composition 215 from inside the container 214 through the first version of the adapter 200 to the enteral nutrition supply line 12. In this regard, the first version of the adapter 200 may have a fluid inlet on the same side as the short spike-like portion 316 of one or more plates 18. The first version of the adapter 200 may have a fluid outlet port 221 on the opposite side of one or more plates 18, and the adapter 200 may have a bore extending through one or more plates 18 to fluidize the fluid inlet to the fluid outlet port 221. The dimensions of the bore may be adapted to the type and viscosity of the composition 215 (e.g., fluid) to be delivered contained in the container 214.

[0083] 【0085】 The enteral nutrition supply line 212 can be fluidly connected to the fluid outlet port 221 of the adapter 200. For example, the diameter of the inlet end of the enteral nutrition supply line 212 can be substantially the same as the diameter of the fluid outlet port 221, and the fluid outlet port 221 can be enclosed in a liquid-tight seal.

[0084] 【0086】A first version of the adapter 200 (Figures 20-28) may include a vent port 888 (connected to, for example, a vent tube 227) configured to allow air to enter the interior of the container 214 in order to compensate for the composition 215 that exits the container 214 through the adapter 200. The vent port 888 and / or the vent tube 227 may include a vent passage 228 extending (i) from the same side as the short spike-like portion 316 of one or more plates 18 to (ii) the opposite side of one or more plates 18 in order to allow air to enter the interior of the container 214 from the outside of the container 214.

[0085] 【0087】 The vent port 888 and / or vent tube 227 may include a filter positioned inside (i.e., within the vent passage 228) to allow air to enter the container 214 from outside the container 214 through the vent passage 228, while preventing the composition 215 from leaving through the vent passage 228. The filter preferably includes a bacterial filter configured to prevent contaminants such as bacteria from entering the container 214. This allows the filter to prevent contaminants from entering the enteral nutrition supply line 212.

[0086] 【0088】 In a first version embodiment of the adapter 200 (Figures 20-28), the adapter 200 includes an adhesive pad 232 configured to form a liquid-tight seal with the top surface and / or one or more sides of the container 214 when the adapter 200 is engaged with the container 214. The adhesive pad 232 can be connected to one or more plates 18, and at least a portion of the adhesive pad 232 may be parallel to and / or coplanar with at least a portion of one or more plates 18. Preferably, the adapter 200 is provided with a protective film covering the adhesive pad 232, which can be removed before use of the adapter 200.

[0087] 【0089】Therefore, a first version of the adapter 200 (Figures 20-28) can be used in a method of supplying enteral nutrition from a container 214, the container 214 having a pre-formed hole into the interior of the container, and the method is a step of connecting the first version of the adapter 200 to the container 214, the step of connecting the first version of the adapter 200 to the container 214, the step of pushing the short spike-like portion 316 of the adapter 200 through the pre-formed hole of the container 214, the short spike-like portion 316 being larger than the pre-formed hole in at least one dimension, and the adapter 200 through the pre-formed hole The method includes the steps of connecting, which involves pushing through the short spike-like portion 316 of the first version of the adapter 200 so that the hole is expanded in at least one direction, and inverting the container 214 with the first version of the adapter 200 attached so that at least a portion of the composition 215 in the container 214 is guided through the first version of the adapter 200 to an enteral nutrition supply line 212 having a first end attached to the first version of the adapter 200, the second end of the enteral nutrition supply line 212 being located in the patient. Preferably, this method includes the step of fluidizing the first version of the adapter 200 to the enteral nutrition supply line 212 before and / or after the step of connecting the first version of the adapter 200 to the container 214.

[0088] 【0090】 In a second version of the adapter 200 (Figures 29 to 48), preferably, the cover 220 is opened by, for example, perforating and / or tearing it with the long spike-like portion 216 to form a first opening in the cover 220, and then the short spike-like portion 316 is pushed through the first opening to expand the first opening and form a second opening in the cover 220 that is larger than the first opening.

[0089] 【0091】This disclosure is not limited to any particular embodiment of the long spike portion 216 and the short spike portion 316, and the long spike portion 216 and the short spike portion 316 may be any structure configured to open the cover 120, for example, by perforating and / or tearing the cover 220. Furthermore, “short” and “long” do not refer to any specific length, but rather to the relative lengths of the spike portions 216 and 316 to each other.

[0090] 【0092】 A second embodiment of the adapter 200 (for example, the first and / or second version) may comprise a body 218 which is preferably at least partially hollow, preferably by comprising an internal chamber 222. The ventilation tube 227 may extend through the internal chamber 222 either outward from the top surface 270 or inward from the top surface 270.

[0091] 【0093】 In the first version of the adapter 200 (Figures 20 to 28), the ventilation tube 227 preferably extends to a point adjacent to the short spike-like portion 316. In the second version of the adapter 200 (Figures 29 to 48), the ventilation tube 227 preferably extends beyond the short spike-like portion 316. Preferably, the total length of the ventilation tube 227 in the second version may be about 1.5 to about 3.0 times the length of the main body 218 in the longitudinal direction, and / or the ventilation tube 227 may have a length inside the container 214 that is about 0.5 to about 1.0 times the height of the container 214 (for example, about 0.5 to about 0.75 times the height of the container 214).

[0092] 【0094】 Furthermore, with respect to the second version of the adapter 200 (Figures 29 to 48), the lowest end of the ventilation tube 227 can terminate in the top space of the container 214 when the container 214 is inverted for fluid delivery, as shown in Figure 35B. The lowest end of the ventilation tube 227 can form a long spike-like portion 216.

[0093] 【0095】In a second embodiment of the adapter 200 (e.g., the first and / or second versions), the upper end of the ventilation tube 227 may optionally be provided with an indicator port configured to connect to a cap and / or flexible tube to indicate that the ventilation tube 227 has fluid in it and / or is blocked. In such embodiments, the ventilation tube 227 can be blocked and / or restricted using a stylet 999. Additionally or alternatively, the ventilation tube 227 can be blocked and / or restricted using a clamp and / or cap.

[0094] 【0096】 In the second version of adapter 200 (Figures 29-48), the ventilation tube 227 may have a reduced profile to reduce the force puncturing the cover 220 with the long spike-like portion 216. The ventilation tube 227 may have a reduced internal cross-section at the long spike-like portion 216 to minimize the entry of fluid into the ventilation tube 227.

[0095] 【0097】 In some embodiments, the adapter 200 may be modular. For example, the ventilation tube 227 may be a separate component from the main body 218, and the ventilation tube 227 can be inserted through the main body 218 of the adapter 200 independently of the connection of the adapter 200 to the container 214.

[0096] 【0098】In a second embodiment of the adapter 200 (e.g., the first and / or second version), the short spike portion 316 may be part of the main body 218, for example, the lower end 217 of the main body 218 which also defines an opening into the internal chamber 122. The short spike portion 316 preferably has a profile that is larger (i.e., larger in at least one dimension) than the pre-formed hole 240 of the container 214 into which the short spike portion 316 is inserted. For example, the opening defined by the lower end 217 of the main body 218 may be in the side wall of the main body 218 and / or in a plane at an angle to the longitudinal axis of the main body 218. Preferably, the main body 218 and / or the short spike portion 316 have a cross-section perpendicular to the longitudinal axis with a circumference larger (e.g., a larger radius) than the circumference of the hole 240 of the container 214. Although the body 218 is shown to be generally cylindrical, the body 218 may have any shape, and this disclosure is not limited to a specific shape of body 218.

[0097] 【0099】 In a second embodiment of the adapter 200 (for example, the first and / or second version), the opening at the lower end 217 of the main body 218, which forms the short spike-like portion 316, is preferably in a plane at an angle of 10 to 80 degrees with respect to the side wall of the main body 218 and / or the longitudinal axis of the main body 218, more preferably at an angle of 20 to 70 degrees with respect to the side wall of the main body 218 and / or the longitudinal axis of the main body 218, and most preferably at an angle of 30 to 60 degrees with respect to the side wall of the main body 218 and / or the longitudinal axis of the main body 218.

[0098] 【0100】 Similarly, in the second version of the adapter 200 (Figures 29 to 48), the opening at the lower end of the ventilation tube 227 forming the long spike-like portion 216 is preferably in a plane at an angle of 10 to 80 degrees with respect to the side wall of the body 218 and / or the longitudinal axis of the body 218, more preferably at an angle of 20 to 70 degrees with respect to the side wall of the body 218 and / or the longitudinal axis of the body 218, and most preferably at an angle of 30 to 60 degrees with respect to the side wall of the body 218 and / or the longitudinal axis of the body 218.

[0099] 【0101】 In a second embodiment of the adapter 200 (e.g., the first and / or second version), the vent tube 227 may be configured to allow air to enter the container 214 in order to compensate for the composition 215 that exits the container 214 through the adapter 200. The vent tube 227 may include a filter that allows air to enter the container 214 from the outside, while preventing the composition 215 from exiting through the vent tube 227. The filter preferably includes a bacterial filter configured to prevent contaminants such as bacteria from entering the container 214. This allows the filter to prevent contaminants from entering the enteral nutrition supply line 212.

[0100] 【0102】 In a second version, the ventilation tube 227 may have a ventilation port 888 at the end of the ventilation tube 227 opposite to the long spike-like section 216, for example. In one embodiment, a section of tubing may be connected to the ventilation port 888 (for example, connected to the ventilation tube 227) and may be transparent so that the fluid inside the ventilation tube 227 can be visually observed, and the tubing may include a cap, valve (e.g., a butterfly valve) or roller clamp to adjust the vent and measure the flow. The ventilation passage can be blocked using a stylet 999 until just before replenishment is started, thereby preventing fluid from inadvertently entering the ventilation passage.

[0101] 【0103】 In a second embodiment of the adapter 200 (for example, the first and / or second version), the body 218 may optionally include a drain slot 280, for example, a slot in the body 218 extending upward from the lower end 217 of the body 218. Additionally or alternatively, the body 218 may optionally include a drain hole 281, for example, a hole extending through the body 218 adjacent to the lower end 217 of the body 218.

[0102] 【0104】In a second version of the adapter 200 (Figures 29 to 48), the adapter 200 may further comprise one or more interface surfaces 282 extending axially from the body 218, for example, vertical ribs extending from the body 218 of the adapter 200, and / or sleeves surrounding the body 218 of the adapter 200. The adapter 200 may also comprise one or more stop surfaces 283 that can slide and contact the upper surface of the container 214 as the adapter 200 continues to be pushed into the container 214. The one or more stop surfaces 283 may be part of the interface surfaces 282 (if present) or may be separate structures. The stop surfaces 283 can prevent the adapter 200 from being pushed further into the container 214.

[0103] 【0105】 For example, an embodiment of one or more interface surfaces 282 having vertical ribs may have a stop surface 283 at the lowest end of the ribs. Another example is an embodiment of one or more interface surfaces 282 including a sleeve which may have a stop surface 283 at the lowest end of the sleeve. Yet another example is that the stop surface 283 may be an annular rim extending from the body 218.

[0104] 【0106】 The portion of the main body 218 between the stop surface 283 and the opening at the lower end 217 can form a liquid-tight sealing and friction-retaining area 285 that engages with the side of the hole in the container 214. In one embodiment, the liquid-tight sealing and friction-retaining area 285 may optionally include a mechanical fixing member selected from the group consisting of one or more fins, one or more protrusions, one or more gill structures, rubber material, and combinations thereof. In one embodiment, to assist in securing the adapter 200 to the container 214, a retaining member, such as an elastic band extending from the top surface 270 of the adapter 200 to the bottom of the container 214, can be applied to the top surface 270 of the adapter 200.

[0105] 【0107】By positioning the adapter 200 such that one or more stop surfaces 283 abut against the container 214, the first spike portion 216 and the second spike portion 316 are pushed into the cover 220 and can pass through the cover 220 at least partially. This allows the first spike portion 216 and the second spike portion 316 to form an opening in the cover 220 and / or container 214, thereby establishing a passage for the enteral composition 215 from inside the container 214 through the adapter 200 to the enteral nutrition supply line 212. In this regard, the body 218 may be provided with a fluid outlet port 221 on the upper surface 270 of the adapter 200, and the opening defined by the lower end 217 of the body 218 passes through the inside of the body 218 (for example, through the internal chamber 222) to the fluid outlet port 221 (particularly shown in Figure 37). The internal chamber 222 can optionally have a volume that increases the air gap when inverted, thereby minimizing the required length of the ventilation tube 227.

[0106] 【0108】 The fluid outlet port 221 of the adapter 200 can be fluidly connected to the enteral nutrition supply line 212. For example, the diameter of the inlet end of the enteral nutrition supply line 212 can be substantially the same as the diameter of the fluid outlet port 221, and the fluid outlet port 221 can be enclosed in a liquid-tight seal.

[0107] 【0109】 A non-limiting example of how to use the second version of adapter 200 is generally shown in Figures 35A to 37. The container 214 may be provided with a hole 240. For example, the hole 240 can be cut into the body of the container 214 before the cover 120 is applied to the container 214. Additionally or alternatively, the container 214 may have a reduced thickness relative to the periphery of the container 214 and / or a portion defined by a cut in the container 214, and the hole 240 can be formed by positioning the adapter 214 (e.g., one or more stop surfaces 183) in contact with the container 214, with the first spike-like portion 216 and the second spike-like portion 316.

[0108] 【0110】The hole 240 may be of any preferred shape, for example, circular or rectangular, and any preferred dimensions may be, for example, about 0.3 cm to about 3.0 cm, preferably about 0.6 cm to about 2 cm, more preferably about 1.2 cm to about 1.5 cm, most preferably about 1.3 cm to about 1.4 cm, and may have a diameter of, for example, about 0.6 cm. The cover 220 may be removed before connecting the adapter 200, but preferably the long spike-like portion 216 opens the cover 220, for example by perforating and / or tearing the cover 220, and the short spike-like portion 316 further opens the cover 220 so that the adapter 200 can be connected to the container 214 (for example, so that the inside of the container 214 is exposed to the internal chamber 222 of the adapter 200).

[0109] 【0111】 For example, the adapter 200 can be pushed and / or screwed into the container 214 so that the long spike portion 216 opens the cover 220 and is inserted into the hole 240 by perforating and / or tearing the cover 220, and then the short spike portion 316 tears the cover 220 and is inserted into the hole 240. Insertion of the first spike portion 216 and the second spike portion 316 into the container 214 allows the opening of the lower end 217 of the main body 218 to be exposed to the inside of the container 214 so that the composition 215 can enter the internal chamber 222 (Figures 35A, 35B and 36).

[0110] 【0112】 As shown in Figure 38, the short spike portion 316 preferably has a profile that is larger (i.e., larger in at least one dimension) than the pre-formed hole 240 of the container 214 into which the short spike portion 316 is inserted. Thus, the short spike portion 316 can enlarge the hole 240, and preferably also form a liquid-tight seal in the hole 240.

[0111] 【0113】The container 214 can be inverted by the user. As shown in Figures 35A to 38, the adapter 200 can be used to fluidly communicate the inside of the container 114 with the enteral nutrition supply line 212 via the adapter 200 (for example, via the opening at the lower end 217 of the main body 218, the internal chamber 222, and the fluid outlet port 221).

[0112] 【0114】 The composition 215 can be guided through the adapter 200 to the enteral nutrition line 212 by gravity and / or by applying pressure to the container 214, for example by compressing the container 214 (e.g., without using a pump). The composition 215 can then be delivered to the patient through the enteral nutrition line 212.

[0113] 【0115】 The ventilation tube 227 is preferably long enough to be positioned within the air gap of the container 214 when the container 214 is inverted by the user (Figure 35B). In this regard, the internal chamber 222, when filled, preferably increases the volume of the air gap and minimizes the amount of fluid entering the ventilation tube 227.

[0114] 【0116】 Preferably, one or more parts of the adapter 200 (e.g., the main body 218) may be transparent so as to allow the user to observe the flow of the composition 215 entering the adapter 200 before it enters the enteral nutrition supply line 212.

[0115] 【0117】In some embodiments, replenishment can be paused by detaching the adapter 200 from the container 214 or replenishment tube 212, covering the container 214 or adapter 200, and storing the container 214 (e.g., refrigerating the container 214). Replenishment can then be resumed later by reconnecting the adapter 200 to the container 214 or replenishment tube 212. Preferably, the adapter 200 is reusable, i.e., after cleaning the adapter 200, another container can be used for enteral administration using the same adapter 200. Furthermore in this regard, the frictional sealing achieved by the adapter 200 makes the adapter 200 reusable by minimizing (if any) loss of connectivity in containers such as laminated paper containers. Nevertheless, in some embodiments, the adapter 200 may be a single-use device that is discarded after application to the container 214.

[0116] 【0118】 A second embodiment (e.g., adapter 200) can be used with minimal acquisition of motor skills, visualize the flow, provide a reliable flow, and avoid the cost of adhesives or filters, as a result of the features disclosed herein. Furthermore, adapter 200 can delay replenishment and terminate later without irreversible membrane blockage.

[0117] 【0119】 Figures 39 to 42 show a general version of one version of a second embodiment in which the adapter 200 has a leak indicator 284, for example, a slot extending from a drain hole 281. Figures 43 to 48 show a general embodiment in which the adapter 200 has threads 219 on a body 218 that can be reversibly connected to corresponding threads on a container 214.

[0118] 【0120】In one aspect of the present disclosure shown in Figure 49, the first embodiment 100 and the second embodiment 200 can be combined. In this regard, the body 218 may include an upper portion 10 having one or more of the following: a fluid outlet port 121 (e.g., fluid outlet port 121), a ventilation port 27 (e.g., ventilation port 127), and one or more plate ventilation ports 18 (e.g., a first plate 18a).

[0119] 【0121】 Various embodiments of the adapters disclosed herein (e.g., the first and second embodiments, their respective versions, and combinations thereof) may be made from plastic or polymer materials, including but not limited to polyolefins, such as polypropylene or polyethylene, and may be manufactured by molding techniques, for example, by injection molding. The adapter 10 is preferably made from a material having low permeability to oxygen. Furthermore, the adapter 10 may be sterilizable by, for example, ethylene oxide (ETO), gamma rays, beta rays, peroxides, or one or more of any other suitable chemicals known to those skilled in the art, and may be retort-processable or sterilizable.

[0120] 【0122】 Various changes and modifications to the currently 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 subject matter of the invention and without impairing the intended advantages. Therefore, such changes and modifications are intended to be covered by the appended claims.

Claims

[Claim 1] An adapter for supplying enteral nutrition from a container, A main body having a lower end that defines an opening, A single fluid outlet port extending outward from the upper end of the main body, wherein the upper end faces in the opposite direction to the lower end, and the main body comprises an internal chamber that fluidly connects the opening to the fluid outlet port. The device comprises a ventilation passage extending outward from the upper end of the body at a location different from the fluid outlet port, the ventilation passage also extending inward through the internal chamber to a point beyond the lower end of the body, the lower end of the ventilation passage including an opening defining a first spike-like portion, and the lower end of the body defining a second spike-like portion. The upper end of the ventilation tube having the ventilation passage also includes an indicator port configured to be connected to a cap and / or a flexible tube to indicate the presence of fluid in the ventilation passage and / or that the ventilation passage is blocked, in the adapter. [Claim 2] The adapter according to claim 1, comprising a stylet configured to block and / or restrict the ventilation passage. [Claim 3] The adapter according to claim 1, comprising a clamp and / or cap configured to block and / or restrict the ventilation passage. [Claim 4] The adapter according to claim 1, wherein the ventilation tube has a total length of 1.5 to 3.0 times the height of the main body. [Claim 5] The adapter according to claim 1, wherein the ventilation tube has a length inside the container that is 0.5 to 1.0 times the height of the container. [Claim 6] The adapter according to claim 1, wherein the main body comprises at least one wall portion having an inner surface that defines at least a part of the internal chamber and an outer surface that is the outer surface of the main body. [Claim 7] The adapter according to claim 1, wherein the main body comprises at least one of (a) a drain slot extending from the opening at the lower end of the main body, or (b) a drain hole in the main body adjacent to the lower end of the main body. [Claim 8] The adapter according to claim 7, wherein the main body further comprises a leakage indicator which is a slot extending from the drain hole. [Claim 9] The adapter according to claim 1, wherein the fluid outlet port is configured to be sealed and attached to an enteral nutrition supply line. [Claim 10] The adapter according to claim 1, wherein the adapter comprises one or more interface surfaces extending radially from the main body. [Claim 11] The adapter according to claim 10, wherein the one or more interface surfaces comprises a plurality of ribs, each configured to create a gap between the syringe and the portion of the main body between the ribs when the adapter is inserted into the syringe. [Claim 12] A kit comprising the adapter according to claim 1, further comprising the container for containing the composition.

Images