Enteral nutrition container cap and methods of making and using same

Abstract

A package closure system may include a lid and a package outlet having a first connection unit, the lid configured to be removably connected to the package outlet using the first connection unit and including a second connection unit. The top cap may be configured to be removably connected to the cover using a second connection unit. A method for providing a nutritional composition from a container to the intestinal tract may include: removing a top cap from a cap configured to direct the nutritional composition through a channel within the cap, the cap removably connected to the container; sealingly connecting the cap to the intestinal tract; and applying pressure to the container to direct the nutritional composition from the container through the channel and into the intestinal tract.

Description

[0001] This application is a divisional application of the invention patent application with the application date of December 20, 2019, application number 201980084231.6, and invention name "Enteral nutrition container cover and method for preparing and using the cover". Background Art

[0002] The present disclosure relates generally to health and nutrition. More particularly, the present disclosure relates to an enteral nutrition container cover device and methods of making and using the enteral nutrition container cover.

[0003] It is often very important to deliver nutritional compositions to mammals (such as human patients) who are unable to take food or other forms of nutrition orally. For example, enteral bottles and containers with feeding tubes that deposit food directly into the gastrointestinal tract at a point below the mouth are often used to maintain life when the patient is unable or refuses to take food orally. Bottles and containers, feeding tubes, and other artificial delivery systems and approaches can be used temporarily during the treatment of acute medical conditions. For chronic medical conditions, such systems and approaches can be used as part of a treatment regimen that continues the remainder of the patient's life. Regardless of the duration of use, these devices often provide the only means for feeding the patient.

[0004] Common issues with enteral feeding of nutritional compositions are the quality of connection and spillage when connecting the container to the feeding device. Some nutritional compositions may be dual use, so another common issue is to provide a container that can be used for oral administration and as enteral nutrition intake. A common method of delivering a nutritional composition to a patient is to pour the nutritional composition from a container into an open syringe attached to a feeding tube. Such methods can be difficult for children or patients with challenges with fine motor skills. As a result, the nutritional composition may spill from the open syringe attached to the feeding tube. Summary of the invention

[0005] The present disclosure provides advantages and solutions to problems in the prior art for connecting an enteral container to an enteral feeding tube. In this regard, the cover can be configured to sealably close the container and can include an integrated connector configured to connect directly to an enteral feeding tube. The cover can be configured to be removed for oral administration or to provide a connection directly to an enteral feeding tube. The methods and devices disclosed herein can provide an easy-to-use, multifunctional cover that can be used with a container.

[0006] In embodiments, the container may include a bag, Smartflex packages and / or other containers for storing food, food products and / or beverages.

[0007] In an embodiment, the container may be provided with an integral connector for direct connection to an enteral feeding tube. The integral connector may include an integrated or separate top cap to close the container. The top cap may be removably or permanently attached to the lid.

[0008] In embodiments, a container provided with an integral connector for direct connection to an enteral feeding tube may eliminate the need for auxiliary medical devices such as adapters or feeding devices. Providing an integral connector for direct connection to an enteral feeding tube may be particularly advantageous when the nutritional composition is used for bolus feeding, for example, by eliminating syringes, adapters, and / or feeding devices that may be used with such feeding.

[0009] In an embodiment, a container provided with an integral connector for direct connection to an enteral feeding tube can provide a tight connection to the feeding tube that prevents spillage and allows the user to squeeze the container to apply pressure, thereby achieving faster fluid delivery than without the application of pressure. The ability to squeeze the container can provide the additional benefit of providing a viscous nutritional composition that may not be delivered by traditional gravity feeding methods.

[0010] In embodiments, a container provided with an integral connector for direct connection to an enteral feeding tube may also be provided with a larger alternative spout separate from or integral with the integral connector that may be used for oral nutritional compositions.

[0011] In an embodiment, a container provided with an integral connector for direct connection with an enteral feeding tube may provide for cost-effective manufacturing by attachment to a standard container.

[0012] In an embodiment, the integral connector is provided with a vent to allow emptying of the rigid container.

[0013] In an embodiment, the integrated connector is provided with a refill opening for refilling the container. The refill opening may be different from the opening configured to attach to the intestine and / or the opening configured to attach to the container. For example, an integrated connector for patient hydration applications may benefit from a second opening for refilling the container.

[0014] In an embodiment, a cap is provided for removably attaching to a spout of a container and the cap does not have a top cap.

[0015] In an embodiment, the integral connector is provided separately from the container so that the integral connector can be used with containers known in the art and / or spouts of known containers.

[0016] In an embodiment, a sealing ring is provided. The sealing ring can be configured to be placed between the spout and the cap of the container to maintain a tight connection between the spout and the cap.

[0017] The features and advantages described herein are not all inclusive, and in particular, many additional features and advantages will be apparent to those of ordinary skill in the art from the accompanying drawings and description. In addition, it should be noted that the language used in this specification is primarily selected for readability and instructional purposes and does not limit the scope of the subject matter of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A perspective view of an embodiment of a cover according to the present disclosure is shown.

[0019] Figure 2 Shown is a view of a lower portion of an embodiment of a cover according to the present disclosure.

[0020] Figure 3 Shown are views of an upper portion and a lower portion of an embodiment of a cover according to the present disclosure.

[0021] Figure 4 Shown are side views of upper and lower portions of an embodiment of a cover according to the present disclosure.

[0022] Figure 5 Cross-sectional views of upper and lower portions of an embodiment of a cover according to the present disclosure are shown.

[0023] Figure 6 A cross-sectional view of an upper portion of an embodiment of a cover according to the present disclosure is shown.

[0024] Figure 7 A side view of an embodiment of an upper portion of an embodiment of a cover according to the present disclosure is shown.

[0025] Figure 8 An isometric view of an upper portion of an embodiment of a cover according to the present disclosure is shown.

[0026] Fig. 9 A through cavity view of an upper portion of an embodiment of a cover according to the present disclosure is shown.

[0027] Fig.10 An embodiment of a bag, lid and top cap according to the present disclosure is shown in a connected configuration.

[0028] Fig.11 An embodiment of a bag with a spout, lid, and top cap in accordance with the present disclosure is shown in an assembled configuration.

[0029] Fig.12 Shown is a detail view of an embodiment of bag spout threads according to the present disclosure.

[0030] Fig.13An embodiment of a cover of the present disclosure is shown.

[0031] Fig.14 An embodiment of a cap provided with a piercing member according to the present disclosure is shown.

[0032] Fig.15 An embodiment of a cover is shown.

[0033] Fig.16 Another embodiment of a cover having an upper portion and a lower portion is shown. DETAILED DESCRIPTION

[0034] Detailed embodiments of the apparatus and method are disclosed herein. However, it should be understood that the embodiments disclosed herein are merely examples of apparatus and methods, which can be embodied in various forms. Therefore, the specific functional details disclosed herein should not be construed as limiting, but merely as a basis for claims to teach those skilled in the art to adopt the representative examples of the disclosure in various ways.

[0035] As used herein, "about", "approximately" and "substantially" should be understood to refer to numbers within a certain numerical range, such as within the range of -10% to +10% of the mentioned number, preferably -5% to +5% of the mentioned number, more preferably -1% to +1% of the mentioned number, and most preferably -0.1% to +0.1% of the mentioned number. All numerical ranges herein should be understood to include all integers or fractions within the range. In addition, these numerical ranges should be understood to provide support for claims involving any number or subset of numbers within the range. For example, the disclosure of 1 to 10 should be understood to support ranges of 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, etc.

[0036] Preferred embodiments are directed to methods and devices for attaching a cap or connector to a container containing a nutritional composition to an enteral feeding device, wherein the cap or connector may also be used for oral nutritional compositions.

[0037] Figure 1 1 and 2. An embodiment of a cover 10 is generally shown. The cover 10 may include an upper portion 12 for connecting to an outer receiving member and / or a top cap 70, such as Fig.10 and Fig.11 and a lower portion 11 for connection to a container 131. Figure 1 , the outer receiving member may be convex In an embodiment, a concave connector is positioned on the upper portion 12 of the cover 10 The connector is connectable to the male portion of the external receiving member. Connector. In an alternative embodiment ( Figure 1(not shown), the external connector may be concave connector, and the upper portion 12 of the cover 10 may be configured as a male Connector for connecting to the female end of an external receiving member Connector. The cap 10 may have an outer ridge 14 along the periphery of the lower portion 11. The outer ridge 14 may be configured to assist a user when removing, manipulating, and / or attaching the cap to other systems or devices. For example, the cap 10 may be screwed onto other devices containing nutritional products (e.g., flexible bags, SmartFlex Aquarius, Resources bottle, bottle, bottles, other NHSc bottles, and / or other bottles known in the art). Figure 1 Other features of the cover 10 may not be shown, but may be provided, for example, a larger size, extensions (ie, wings for gripping by a user), and / or a textured surface may be provided as part of the cover 10 .

[0038] Thus, the cap 10 provides for direct connection of a container 131 for a nutritional composition to an enteral feeding tube without the use of a feeding set, feeding set, or other adapters.

[0039] The outer ridge 14 may be configured perpendicular to a plane defined by the smallest cross-sectional plane of the cover 10, such as Figure 1 Additionally or alternatively, the outer ridge 14 may be cross-hatched, textured, and / or comprised of the same or different material than the remainder of the cover 10. For example, the outer ridge 14 may be rubber.

[0040] The cap 10 may have an upper connecting thread 13 extending from the upper portion 12. The upper connecting thread 13 may be configured to attach to Connector. In an embodiment, the cap 10 may not be provided with connecting threads 13, and instead may be provided with clips, snaps, plugs, fittings and / or other connectors for connecting the cap 10 to an external receiving member. Figure 1 The connecting threads 13 shown may be more or fewer and / or different connecting threads. In an embodiment, the cover 10 may only partially conform to the Connector standard. For example, the cover 10 may have a A larger hole size is provided in the connector standard to reduce any flow restriction through the cap 10.

[0041] Fig.10 and Fig.11The lid 10 shown, as well as connecting components such as the top cap 70, can be made of materials including, but not limited to, plastic, sustainable plastic, glass, metal, paper, fiber, paper box, edible materials (e.g., fiber, sugar, chews, etc.), and combinations thereof. The lid 10 can be configured to indicate the temperature, pH, and / or other parameters of the nutritional composition 132, such as Fig.10 As shown; for example, by making the cover 10 from a material that is sensitive to temperature and / or pH. The color of the cover 10 can be related to the use of the nutritional composition 132; for example, the cover color can be related to an embodiment of the nutritional composition 132, wherein the nutritional composition 132 is optimized to meet specific nutritional needs. The cover 10 can be made of a flexible material so that the cover 10 can be used as a straw. The cover 10 can be made of a transparent material or can include a transparent section to enable observation of the nutritional composition 132 flowing through the cover 10.

[0042] Figure 2 There is generally shown a view of the lower portion 11 of the cap 10. The upper connecting threads 13 and the outer ridges 14 are shown. Figure 2 Shown are lower receiving threads 21 that may be positioned within lower cavity 22 of cap 10. Lower receiving threads 21 may be configured to attach to container 131, thereby engaging container 131 and allowing nutritional composition 132 to flow from container 131 into lower cavity 22 and through other portions of cap 10.

[0043] Figure 3 An isometric view of a cap 10 is generally shown and may include an upper portion 12 having upper connecting threads 13 and a lower portion 11 having an outer ridge 14 .

[0044] Figure 4 A side view of a cap 10 is generally shown, which may include an upper portion 12 having upper connecting threads 13 and a lower portion 11 having an outer ridge 14. A centerline 41 is shown for reference, passing through the midline of the generally cylindrical structure of the cap 10. An upper portion base 42 may provide an interface between the upper portion 12 and the lower portion 11. A lower portion base 43 is shown, which may be positioned on a distal end of the lower portion 11 from the upper portion 12.

[0045] In an embodiment, the portion of the lid 10 between the upper portion base 42 and the ridge 14 may be elongated to act as a straw and / or to be more easily manipulated by the user. Where the lid 10 is made of a transparent material, such an embodiment may provide better ergonomics and / or better visibility of material flowing through the lid 10.

[0046] In an embodiment, the upper portion 12 of the cover 10 may be retractable, ie, the upper portion 12 having the second connection unit 13 may be partially or completely reversibly retracted into the cavity 22 of the lower portion 11 .

[0047] Figure 5 A cross-sectional view of the upper portion 12 and the lower portion 11 of the cover 10 is generally shown. As shown, the cover 10 includes an upper cavity 51 connected to the lower cavity 22, also shown in FIG. Figure 2 See also Figure 5 , the lower receiving threads 21 may extend around the inner periphery of the lower portion 11. The lower receiving threads 21 may extend through the lower portion base 43 to help connect the lower portion 11 (eg, the lower receiving threads 21) to another connection member.

[0048] Figure 6 A dimensioned cross-sectional view of an upper portion 12 of a cover 10 is generally shown, wherein the upper portion 12 of the cover 10 is adapted to An upper cavity 51 is shown that can extend through the upper portion 12 along the centerline 41. The upper cavity 51 can be defined by an upper portion inner wall 62 and have an upper portion inner wall diameter and the upper portion portion length E above the base. The transmission opening 61 can be set at the distal end of the upper portion 12 from the upper connecting thread 13. The transmission opening 61 can be made of a transmission opening diameter limited.

[0049] like Figure 6 As shown, the transmission opening diameter Can be smaller than the inner diameter of the upper part of the base Diameter of the transmission opening Smaller than the inner diameter of the upper part base In the configuration, the transmission opening diameter A flow restriction may be formed for the nutritional composition 132 flowing through the upper portion 12. and transmission opening diameter In the interface between the upper and lower portions, the transfer opening chamfer T3 can be configured to adjust the flow restriction to adjust flow characteristics, such as flow rate and / or turbulence. and transmission opening diameter may be equal or approximately equal, thereby eliminating flow restriction and resulting in a transfer opening chamfer T3 of 90° or approximately 90°.

[0050] The upper portion 12 may include an upper portion diameter The upper portion diameter may correspond to the diameter of the outer wall of the upper portion 12. In an embodiment, the upper connecting thread 13 extends beyond the upper portion diameter. The upper connecting thread 13 may have an upper connecting thread diameter about the center line 41 The upper part diameter Smaller than the upper connection thread diameter

[0051] The upper connecting thread 13 may have a thread crest width M and a pitch width N, wherein the pitch width N is preferably the widest point of the upper connecting thread 13. The upper connecting thread 13 may contact the upper portion 12 at the widest point of the upper connecting thread 13. The upper connecting thread 13 may then taper to a distal-most portion of the upper connecting thread 13, which may have a thread crest width M. In an embodiment in which the upper connecting thread 13 tapers to a point, the thread crest width M may be zero or approximately zero. In an embodiment, the pitch width N and the thread crest width M may be equal or approximately equal, resulting in the upper connecting thread 13 being non-tapered (i.e., straight cut).

[0052] In an embodiment, the Figure 6 The relative proportions given in the figure can be adjusted to meet different user needs. For example, the upper portion length E above the base can be elongated to allow the lid 10 to be used as a straw and / or to be more easily manipulated by the user. In an embodiment, the upper portion diameter The inner wall diameter of the upper portion may be much larger to allow the user to apply more torque to the cap 10 when screwing the cap 10 into the device and / or component. It can be optimized for the desired flow rate through the cap 10. In an embodiment, at least the thread crest width M, the pitch width N and the upper connecting thread diameter are included. The size may be adapted for connection to a specific device and / or a specific component.

[0053] In an embodiment, the cover 10 may include a foil strip and / or a strip across the inner diameter of the upper portion. The foil strip and / or seal can signal to the user that the lid 10, container 131 and / or other structures have been breached. The foil strip and / or seal can also provide additional protection against leaks when shipping and / or handling the container 131.

[0054] Figure 7 A side view of an embodiment of an upper portion 12 of a cap 10 is generally shown. The upper portion 12 is shown with upper connecting threads 13. The upper portion 12 may generally be formed by a base width of Top Width The upper portion 12 may include a chamfer 73 at opposite ends of the base portion 42 along the centerline 41 , and the chamfer 73 may be defined by a chamfer height C.

[0055] Figure 8An isometric view of an upper portion 12 of a cover 10 is generally shown, the upper portion being adapted to Compatibility. The upper portion 12 may include an upper connection thread 13 that may extend radially outward from the center of the generally cylindrical structure of the upper portion 12. The upper connection thread 13 may be positioned in a plane offset from a plane defined by the upper portion base 42. When the upper connection thread 13 extends upward, the thread may terminate at an upper connection thread terminal edge width X3. The upper connection thread terminal edge width X3 may be provided to prevent misconnection of the cover 10. The configuration of the upper portion 12 may include an embodiment of the upper connection thread terminal edge width X3 in which the upper connection thread terminal edge width X3 is maximized, because the contact area provided by the longer embodiment of the upper connection thread terminal edge width X3 can provide a larger sealing area.

[0056] Fig. 9 A through cavity view of an upper portion 12 of an embodiment of the cover 10 is generally shown. Fig. 9 The view shown is a view generally along the centerline 41 and shows the upper cavity 51 defined by the upper portion inner wall 62. The upper cavity 51 may terminate into a transfer opening 61, which may provide a path into the lower cavity 22, such as Figure 2 As shown. Re-reference Fig. 9 The transmission opening 61 is shown as being generally circular, but may be other configurations, such as another geometric shape. The cross-section of the transmission opening 61 may also vary along the centerline 41 , for example, the diameter of the transmission opening 61 may increase and / or decrease along the centerline 41 .

[0057] The upper connecting thread 13 may protrude from a portion of the upper portion 12 defining the inner cavity 51. The upper connecting thread 13 is shown as having an upper connecting thread width γ that does not extend around the entire circumference of the upper portion 12. In an embodiment, the upper connecting thread width γ may extend more or less around the circumference of the upper portion 12. The edge of the upper connecting thread 13 may terminate with an upper connecting thread chamfer Z3. The upper connecting thread chamfer Z3 may be defined as the angle of: a first vector extending from a point defined by the centerline 41 in a plane perpendicular to the centerline 41; and a second vector defined by a position along the first vector, the second vector extending from the position.

[0058] Also shown is the upper connecting thread end edge width X3. The upper connecting thread end edge width X3 may be defined as a function of the thread pitch, thread depth, and the number of threads per unit distance along the centerline 41.

[0059] Fig.10 An embodiment of a container 131 is generally shown connected to the lid 10 with the top cap 70 capping the lid 10 in place.

[0060] exist Fig.10 In the preferred embodiment shown, the container 131 is shown as a bag, but may also include bags, containers, bottles, tubing, syringes, and / or any other container for holding and / or transporting the nutritional composition 132 and / or fluids. In embodiments where the nutritional composition container is deformable, such as when the container 131 is a bag, the user may squeeze the container 131 and / or apply pressure to the container to help move the nutritional composition 132 out of the container 131 and through the cap 10 or otherwise out of the container 131. In an embodiment, gravity is used to move the nutritional composition 132 out of the container 131 and through the cap 10 or otherwise out of the container 131. The configuration in which the container 131 is squeezed may remove the nutritional composition 132 from the bag more quickly than using conventional gravity feeding techniques. When the nutritional composition 132 is required to be used as a bolus, such as when a liquid bolus is required, the container 131 may be squeezable, and a tight connection between the container 131, the cap 10, and the patient line may help reduce spillage of the contents from the container 131.

[0061] The cap 10 connects directly to an enteral feeding tube (not shown) without the use of a feeding set, feeding set or other adapter.

[0062] In an embodiment, the cap 10 may be only partially threaded onto the container 131. The cap 10 and container 131 may be configured to be in a tamper-evident configuration, wherein a user may irreparably break a seal, plastic retainer, foil, or other mechanism that indicates that the package no longer has the original seal and / or is no longer sterile. In an embodiment, the cap 10 and / or the top cap 70 may be attached to the container 131 to break the tamper-evident seal.

[0063] although Fig.10 Not shown, but other features of the top cap 70 may be provided, for example, a larger size, extensions (ie, wings for gripping by a user), and / or a textured surface may be provided as part of the top cap 70.

[0064] Fig.11 An embodiment of a container 131 is generally shown in an assembled configuration, the container being a bag having a spout 141 including bag spout threads 142, a cap 10, and a top cap 70. The bag spout threads 142 may be arranged circumferentially around the spout 141 and configured to receive the lower receiving threads 21 of the lower portion 11 of the cap 10. In an embodiment, the spout 141 may not be provided with connecting threads 142, but may be provided with clips, snaps, plugs, fittings, and / or other connectors for connecting the spout to a corresponding connector element of the lower portion 11 of the cap 10. Fig.11 The connecting threads 142 shown may include more, fewer and / or different connecting threads.

[0065] The top cap 70 may be configured to be connected by making the upper connecting thread 13 (such as Figures 1 to 7 10 ) is engaged with an upper receiving thread (not shown) of a top cap to be rotatably attached to the upper portion 12 of the cover 10 to be screwed into the upper portion 12 .

[0066] When the top cap 70 is placed on the upper portion 12, the center of the generally cylindrical shape of the top cap 70 can be aligned with the centerline 41 (e.g., as shown in FIG. Figure 4 The top cap 70 may be aligned with the upper portion 12 of the cover 10, and the top cap 70 may be aligned with the upper portion 12, for connecting the upper portion 12 to the top cap 70 using the upper connecting threads 13. In an embodiment, the upper connecting threads 13 may not be provided, and the top cap 70 may be assembled to the upper assembly using, for example, snaps, hooks, and / or friction couplings. In an embodiment, the top cap 70 may be a flip cover hinged from the upper portion 12 of the cover 10. In an embodiment, the top cap 70 may be a foil strip positioned across the upper portion 12 of the cover 10. In an embodiment, the top cap 70 may be configured so that it can be snapped off from the upper portion 12 of the cover 10, for example, the cover 10 and the top cap 70 may be prepared as a single unit having a weakened portion (such as a thinner material area, or a perforated area) at the interface of the top cap portion 70 and the upper portion 12 of the cover 10 to allow the top cap to be separated (snapped off) from the cover 10.

[0067] In an embodiment, a center plug may be included in the top cap 70. The center plug may extend from the closed end of the top cap 70 along the center line of the top cap toward the open end of the top cap 70. The center plug may help close the top cap 70 and / or attach the top cap to the upper portion 12 of the cover 10. The top portion 12 may have a foil strip and / or a cross-over inner wall diameter of the upper portion. (Upper part inner wall diameter exist Figure 6 In the embodiment of the seal of the embodiment of the invention, the center pin can be used to pierce the foil strip and / or the seal. In the upper part 12, the foil strip and / or the inner wall diameter of the upper part are provided. In embodiments of the invention in which the top cap 70 is provided, the top cap 70 may not be provided, as the sealing function of the top cap 70 may alternatively be provided by the foil strip and / or the seal.

[0068] The spout 141 may be configured to have a larger opening than the cap opening defined by the upper cavity 51 of the upper portion 12. The spout 141 may be configured for oral administration of a nutritional composition 132, while the cap may be configured to connect to a patient line, thus optionally requiring openings of different sizes for different uses.

[0069] In an embodiment, the spout 141 and / or the cap 10 may be sealed using a plastic, metal, foil or other seal. The seal may indicate whether the container 131 has been tampered with and / or provide additional sealing protection when shipping the container 131. The seal may be provided to ensure that the cap 10, the container 131 (e.g., bag) and / or the top cap 70 are sterile.

[0070] In an embodiment, the top cap 70, the lid 10, and the container 131 (e.g., a bag) are provided in a connection manner that still allows a user to screw and / or snap the top cap 70, the lid 10, and the container 131 to each other. For example, a retaining wire connecting the lid 10 to the top cap 70 and the container 131 may be provided. In an embodiment, the top cap 70 may be hinged from the lid 10. In an embodiment, the top cap 70, the lid 10, and the container 131 may all be connected to a connecting member that allows each of the top cap 70, the lid 10, and the container 131 to rotate in the connecting portion of the hinge member. This configuration can advantageously prevent the dislocation or engulfment of the lid 10, the top cap 70, and / or other components of the lid-top cap-container system.

[0071] Fig.12 A detailed cross-sectional view of a container spout thread 142 of an embodiment of a spout 141 is generally shown. The container spout thread 142 can be defined by a spout thread crest width 151. In an embodiment, the spout thread crest width 151 can be zero or approximately zero, which results in threads that converge at a point. The container spout thread 142 can be defined by an upper spout thread half angle 153 and a lower spout thread half angle 152. The upper spout thread half angle 153 and the lower spout thread half angle 152 can be defined by the angle of the upper portion or the lower portion of the thread teeth of the container spout thread 142 relative to a plane substantially perpendicular to the centerline of the substantially cylindrical embodiment of the spout 141. In an embodiment, the upper spout thread half angle 153 and the lower spout thread half angle 152 are equal or approximately equal. In an embodiment, the upper spout thread half angle 153 and the lower spout thread half angle 152 are not equal or approximately equal.

[0072] In an embodiment, the method for connecting the container 131 to the intestine may include removing the top cap 70 from the cover 10, wherein the cover 10 is configured to allow the nutritional composition 132 to flow through the cover 10. "Removable" means that the user can remove the top cap 70 from the cover 10 without using tools and without damaging the top cap 70 and the cover 10.

[0073] The cap 10 can be removably connected to the container 131 and then sealingly connected to the intestine. "Removably connected" means that the user can remove the cap 10 from the container 131 without using tools and without damaging the cap 10 and the container 131.

[0074] Pressure may be applied to the container 131 to cause the nutritional composition 132 in the container 131 to flow through the cap 10 and into the intestine. The nutritional composition 132 may be refilled into the container 131 through the refill opening in the cap 10 and / or through the spout 141. In an embodiment, when the top cap 70 is connected to the cap 10 before the cap 10 is sealingly connected to the intestine, it may be necessary to break the seal. The method may include disconnecting the cap 10 from the intestine. The method may include resealing the cap 10 by reconnecting the top cap 70 to the cap 10.

[0075] Fig.13 An embodiment of a lid 10 having an upper portion 12 is shown. In an embodiment, the lid 10 can be configured to be connected to a container other than the container 131. For example, in accordance with Fig.13 In the embodiment of the present invention, the upper portion 12 of the cover 10 can have a Smartflex cover connection 201. The Smartflex cover connection 201 can be configured to connect to the Smartflex The diameter of the Smartflex cover connection 201 may be larger than the diameter of the upper portion 12. In such embodiments, an intermediate portion 203 may be provided. The intermediate portion 203 may be configured to provide a connection between the relatively larger diameter of the Smartflex cover connection 201 and the relatively smaller diameter of the upper portion 12. In an embodiment, the diameter of the Smartflex cover connection 201 may be closer to the diameter of the upper portion 12, for example within about 10%. In such embodiments, the intermediate portion 203 may not be provided, and the Smartflex cover connection 201 may be directly connected to the upper portion 12.

[0076] In an embodiment, the Smartflex cover connection 201 may have a ridge 202. The ridge 202 may be configured to be perpendicular to a plane defined by the largest cross-sectional plane of the Smartflex cover connection 201, such as Fig.13 Additionally or alternatively, the ridges 202 may be cross-hatched, textured, and / or constructed of the same or different material than the rest of the Smartflex cover connection 201. For example, the ridges 202 may be rubber.

[0077] Fig.14 An embodiment of the upper part 12 including an upper cavity 51 is shown. Fig.14In an embodiment of the present invention, the upper portion base 42 is configured to be connected to the piercing member 210. The upper portion base 42 can be configured to be connected to the lower portion 11 and the piercing member 210. In such embodiments, the lower receiving thread 21 can be configured to be connected to a nozzle, such as nozzle 141, and allow the piercing member 210 to enter the nozzle 141. In an embodiment where the nozzle 141 is sealed, the piercing member 210 can be configured to break the seal by piercing the seal when the piercing member 210 enters the nozzle 141.

[0078] The piercing member 210 may be provided with a piercing member cavity 211. The piercing member cavity 211 may be connected to the transmission opening 61. Fig.14 As shown, the diameter of the piercing member cavity 211 corresponds to the diameter of the transfer opening 61 and can reduce any flow restriction between the transfer opening 61 and the piercing member cavity 210. In an embodiment, the lower portion 11 is connected to the spout 141 so that the nutritional composition 132 in the container 131 flows from the container 131 into the piercing member cavity 211, through the transfer opening 61 and into the upper cavity 51.

[0079] Fig.15 An embodiment of the cover 10 is shown. Fig.15 In the embodiment shown, the second cover 100 is inserted between the cover 10 and the container 131 (not shown). Fig.15 In the embodiment shown, the upper portion 12 of the second cover 100 includes (cross) port connector (shown as 210), and the upper portion 12 of the first cover 10 includes Connector (shown as 211). Fig.15 In the illustrated embodiment, the lower portion of the cap 10 includes a first threaded connection portion positioned in the inner wall section defining the proximal cavity. The first threaded connection portion is configured to connect with another threaded portion (shown as 13) on the exterior of the upper portion of the cap 100. In an embodiment, the order of the caps 10 and 100 can be reversed.

[0080] Fig.16 Another embodiment of a cover 10 having an upper portion 12 and a lower portion 11 is shown. In an embodiment, the upper portion 12 of the cover 10 may include one or more additional connection ports / connection units in addition to the connection unit configured for direct connection to the intestine. Fig.16 In the embodiment, the upper portion 12 of the cover 10 includes a connection unit shown as 211 and a second connection unit shown as 210, which is configured to be directly connected to the intestine, and the second connection unit is configured to (Cross) port connector for connection with a feeding device or a supply device. Alternatively, the second connection unit or connection port can be configured as another type of connector or port and can be used as an alternative means for connecting a bag / bottle to a feeding tube or, for example, as a port allowing the introduction of a syringe or tube to add drugs or additives to the nutritional composition or for the introduction of water to flush the system.

[0081] In an embodiment, a method of preparing a cap for a container may include forming the following items: a cap having a cylindrical section including a proximal end and a distal end; a proximal cavity including an inlet opening positioned within the proximal end of the cylindrical section; a distal cavity including an outlet opening positioned within the distal end of the cylindrical section; a transmission portion positioned between the proximal cavity and the distal cavity; a first threaded connection positioned around an inner periphery of a wall section defining the proximal cavity; and a second threaded connection positioned around an outer periphery of the distal end of the cylindrical section. The method may include injection molding and / or extrusion.

[0082] A method of manufacturing a package closure system may include molding the following: a package outlet including a first connection unit; a cover configured to be removably connected to the package outlet using the first connection unit and including a second connection unit; and A connector and / or a top cap configured to be removably connected to the cover using a second connection unit. In an embodiment, the connector and / or the top cap configured to be removably connected to the cover The connector and / or top cap are optional.

[0083] It should be understood that the various changes and modifications made to the embodiments described herein will be apparent to those skilled in the art. These changes and modifications may be made without departing from the essence and scope of the subject matter of the present invention and without diminishing its expected advantages. Therefore, such changes and modifications are intended to be covered by the appended claims. In addition, the various embodiments of the present invention are therefore not limited to the precise details of the above-mentioned methods or structures, because such variations and modifications are intended to be included within the scope of the present invention. In addition, unless otherwise specified, any use of the terms "first", "second", etc. does not indicate any order or importance, but the terms "first", "second", etc. are only used to distinguish one unit from another unit.

Claims

1. A package closure system, the package closure system comprising: a deformable package [131] containing a nutritional composition [132]; and A cover [10] comprising an upper portion and a lower portion, wherein the upper portion is configured to be connected to an enteral feeding tube and the lower portion is configured to be connected to the packaging Connector.

2. The package closure system of claim 1, wherein: A connecting thread [13] extends from the upper portion and is configured to attach to the Connector.

3. The package closure system of claim 2, further comprising a top cap [70] configured to close the package.

4. The package closure system of claim 3, wherein: The top cap is configured such that it can be snapped off the upper portion.

5. The package closure system of claim 4, wherein: The top cap is a single unit having a weakened portion at the interface of the top cap and the upper portion.

6. A package closure system according to any one of claims 1 to 5, wherein: The cover has a Larger hole sizes available in connector standards.

7. A package closure system according to any one of the preceding claims, wherein: The deformable packaging is a bag.

8. A package closure system according to any one of the preceding claims, wherein: The cover also includes an outer ridge along an outer periphery of the lower portion.

9. A package closure system according to any one of the preceding claims, wherein: The cover also includes wings for grasping by a user.

10. A package closure system according to any one of the preceding claims, wherein the lid is configured to be connected to a male Connector.

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