Cap for enteral nutrition container, and method for manufacturing and using the cap.

Abstract

This disclosure relates to a cap device for enteral nutrition containers, and to a method for manufacturing and using a cap for enteral nutrition containers. [Solution] A package closure system comprising: a spout 141 extending from a package 131 and having a first connecting element 142; a cap having a flow path and configured to be directly and detachably connected to the first connecting element 142 and having a second connecting element; and an overcap 70 configured to close the flow path of the cap, wherein the second connecting element is configured to connect to the enteral line such that the cap positions the flow path from the spout 141 to the enteral line so as to indirectly connect the spout 141 to the enteral line by the flow path.

Description

Technical Field

[0001]

[0001] This disclosure generally relates to health and nutrition. More specifically, this disclosure relates to a cap device for an enteral nutrition container, as well as a method of manufacturing and a method of using a cap for an enteral nutrition container.

Background Art

[0002]

[0002] Delivery of nutritional compositions to mammals such as human patients who cannot orally ingest food or other forms of nutrition is often critically important. For example, enteral bottles and containers having a feeding tube that directly provides food to the gastrointestinal tract at a point below the mouth are often used to sustain life while a patient is unable to, or refuses to, orally ingest food. During treatment of acute medical conditions, bottles and containers, feeding tubes, and other artificial delivery systems and routes can be used temporarily. In the case of chronic medical conditions, such systems and routes can be used as part of a treatment plan that continues over the patient's lifetime. Regardless of the duration of use, these devices often provide the only means for a patient to receive nutritional supplementation.

[0003]

[0003] Common concerns regarding enteral nutrition supplementation of nutritional compositions are connection quality and leakage when connecting the container to the nutrition delivery device. Some nutritional compositions may be dual-use, and thus another common concern is providing a container that can be used for both oral ingestion and ingestion as enteral nutrition. A common method of delivering a nutritional composition to a patient is to pour the nutritional composition from the container into an open syringe attached to a feeding tube. Such a method can be difficult for children or patients with challenges related to fine motor skills. As a result, the nutritional composition may leak from the open syringe attached to the feeding tube.

Summary of the Invention

[0004]

[0004] This disclosure provides advantages and solutions to problems in existing techniques for connecting enteral containers to enteral nutrition tubes. In this regard, the cap may be configured to seal the container and may include an integrated connector configured to connect directly to an enteral nutrition tube. The cap may be configured to be removable for oral intake or to connect directly to an enteral nutrition tube. The methods and devices disclosed herein can provide an easy-to-use, multi-functional cap that can be used with a container.

[0005]

[0005] In one embodiment, the container may include pouches, Gualapack®, Doypack®, Smartflex packages, and / or other containers used to store food, food products, and / or beverages.

[0006]

[0006] In one embodiment, the container may have an integrated connector for direct connection to an enteral nutrition tube. The integrated connector may have an integrated or separate overcap for closing the container. The overcap may be detachably attached to the cap or permanently attached.

[0007]

[0007] In one embodiment, a container equipped with an integrated connector for direct connection to an enteral nutrition tube may eliminate the need for auxiliary medical devices such as adapters or dosing sets. Providing an integrated connector for direct connection to an enteral nutrition tube may be particularly advantageous when using nutritional compositions for bolus nutrition, for example, by eliminating syringes, adapters, and / or dosing sets that may be used with bolus nutrition.

[0008]

[0008] In one embodiment, a container equipped with an integrated connector for direct connection to an enteral nutrition tube can provide a tight connection with the nutrition tube, thereby preventing leakage and allowing the user to squeeze the container to apply pressure, resulting in faster fluid delivery than without pressure. The ability to squeeze the container can provide the additional benefit of supplying viscous nutritional compositions that may not be deliverable by conventional gravity-based delivery methods.

[0009]

[0009] In one embodiment, a container equipped with an integrated connector for direct connection to an enteral nutrition tube may also be equipped with a larger alternative spout, separate from or integrated with the integrated connector, which may be used for oral intake of nutritional compositions.

[0010]

[0010] In one embodiment, a container equipped with an integrated connector for direct connection to an enteral nutrition tube can be manufactured cost-effectively by being attached to a standard container.

[0011]

[0011] In one embodiment, the integrated connector is provided with a vent that allows the rigid container to be emptied.

[0012]

[0012] In one embodiment, the integrated connector is provided with a refill opening for refilling a container. The refill opening may be different from the opening configured to be attached to the enteral line and / or the opening configured to be attached to the container. For example, an integrated connector used in an application example for patient hydration may benefit from a second opening for refilling a container.

[0013]

[0013] In one embodiment, a cap is provided to be detachably connected to the spout of the container, and this cap does not have an overcap.

[0014]

[0014] In one embodiment, the integrated connector is provided separately from the container, and therefore the integrated connector can be used with containers known in the art and / or with the spouts of known containers.

[0015]

[0015] In another embodiment, a sealing ring is provided. The sealing ring may be configured to be positioned between the spout and the cap to maintain a tight connection between the spout and the cap of the container.

[0016]

[0016] The features and advantages described herein are not exhaustive, and many additional features and advantages will become apparent to those skilled in the art when considering the drawings and descriptions. Furthermore, it should be noted that the language used herein has been selected solely for readability and illustrative purposes and does not limit the scope of the subject matter of the invention. [Brief explanation of the drawing]

[0017] [Figure 1] A perspective view of one embodiment of the cap according to this disclosure is shown. [Figure 2] A lower diagram of one embodiment of the cap according to this disclosure is shown. [Figure 3] The upper and lower figures of one embodiment of the cap according to this disclosure are shown. [Figure 4] The upper and lower side views of one embodiment of the cap according to this disclosure are shown. [Figure 5] The upper and lower cutouts of one embodiment of the cap according to this disclosure are shown. [Figure 6] The image shows a cutaway view of the top of one embodiment of the cap according to this disclosure. [Figure 7] The image shows a side view of one embodiment of the upper part of one embodiment of the cap according to this disclosure. [Figure 8] An isometric view of the top of one embodiment of the cap according to this disclosure is shown. [Figure 9] This diagram shows a through-view of the upper cavity of one embodiment of the cap according to this disclosure. [Figure 10]An embodiment of a pouch, a cap, and an overcap in a connection configuration according to the present disclosure is shown. [Figure 11] An embodiment of a pouch, a cap, and an overcap with a spout in an assembled configuration according to the present disclosure is shown. [Figure 12] A detailed view of an embodiment of a thread of a spout of a pouch according to the present disclosure is shown. [Figure 13] An embodiment of a cap according to the present disclosure is shown. [Figure 14] An embodiment of a cap with a spike according to the present disclosure is shown.

Mode for Carrying Out the Invention

[0018]

[0031] Detailed embodiments of the device and method are disclosed herein. However, it should be understood that the disclosed embodiments are merely examples of the device and method and can be implemented in various forms. Therefore, the specific functional details disclosed herein should not be construed as limitations, but are merely representative examples for teaching those skilled in the art to adopt the present disclosure in various ways and form the basis of the claims.

[0019]

[0032] As used herein, "about," "approximately," and "substantially" refer to numbers within a numerical range, for example, within a range of -10% to +10% of the reference number, preferably within a range of -5% to +5% of the reference number, more preferably within a range of -1% to +1% of the reference number, and most preferably within a range of -0.1% to +0.1% of the reference number. All numerical ranges herein should be understood to include all integers or fractions within that range. Further, these numerical ranges should be construed to support claims directed to any number or subset of numbers within this range. For example, the disclosure of 1 to 10 should be construed to support ranges such as 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, etc.

[0020]

[0033] A preferred embodiment relates to a method and device for a cap or connector for connecting a container containing a nutritional composition to an enteral nutrition supply device, the cap or connector may also be used for oral intake of the nutritional composition.

[0021]

[0034] Figure 1 shows a general embodiment of the cap 10. The cap 10 may comprise an upper part 12 for connecting to an external receiving member and / or an overcap 70, as shown in Figures 10 and 11, and a lower part 11 for connecting to a container 131. Referring again to Figure 1, the external receiving member may be a male ENFit® connector. In one embodiment, a female ENFit® connector located on the upper part 12 of the cap 10 may be connected to a male ENFit® connector on the external receiving member. In an alternative embodiment (not shown in Figure 1), the external connector may be a female ENFit® connector, and the upper part 12 of the cap 10 may be configured as a male ENFit® connector for connecting to a female ENFit® connector on the external receiving member. The cap 10 may have an outer ridge 14 along the outer circumference of the lower part 11. The outer ridge 14 may be configured to assist the user when removing, manipulating, and / or attaching the cap to another system or device. For example, the cap 10 can be screwed onto nutritional products (e.g., flexible pouches, SmartFlex Bottles®, water bottles, Resource Junior® bottles, Infrasource® bottles, Tetra® bottles, other NHSc bottles, and / or other bottles known in the art). Although not shown in Figure 1, other features of the cap 10 may be provided, such as larger dimensions, and as part of the cap 10, expansions (i.e., wing portions for user grip) and / or textured surfaces may be provided.

[0022]

[0035] As a result, the cap 10 connects directly to the container 131 for the nutritional composition equipped with an enteral nutritional supply tube, without the use of an infusion set, administration set, or other adapter.

[0023]

[0036] The outer ridge 14 may be configured perpendicular to the plane defined by the minimum cross-sectional plane of the cap 10, as shown in Figure 1. Additionally or alternatively, the outer ridge 14 may be meshed, textured, and / or made of the same or different material as the rest of the cap 10. For example, the outer ridge 14 may be made of rubber.

[0024]

[0037] The cap 10 may have an upper connecting thread 13 extending from the upper part 12. The upper connecting thread 13 may be configured to be attached to an ENFit® connector. In one embodiment, the cap 10 does not have to have a connecting thread 13, and instead may have a clip connector, snap connector, plug connector, fitting connector, and / or other connector for connecting the cap 10 to an external receiving member. More or fewer connecting threads than the connecting thread 13 shown in Figure 1 may be manufactured, and / or different connecting threads than the connecting thread 13 may be manufactured. In one embodiment, the cap 10 may only partially conform to the ENFit® connector standard. For example, the cap 10 may have a bore size larger than the bore size provided in the ENFit® connector standard in order to reduce any flow restriction by the cap 10.

[0025]

[0038] The cap 10, and connecting components such as the overcap 70 shown in Figures 10 and 11, may be manufactured from materials including, but are not limited to, plastics, sustainable plastics, glass, metals, paper, fibers, cartons, edible materials (e.g., fibers, sugar, chew, etc.), and combinations thereof. The cap 10 may be configured to exhibit the temperature, pH, and / or other properties of the nutritional composition 132 shown in Figure 10, for example, by manufacturing the cap 10 from a material that corresponds to temperature and / or pH. The color of the cap 10 may correlate with the use of the nutritional composition 132, for example, the color of the cap may correlate with an embodiment of the nutritional composition 132 in which the nutritional composition 132 is optimized to meet specific nutritional requirements. The cap 10 may be manufactured from a flexible material, allowing the cap 10 to be used as a straw. The cap 10 may be manufactured from a transparent material, or may include a transparent section, to allow observation of the nutritional composition 132 flowing through the cap 10.

[0026]

[0039] Figure 2 shows a general view of the lower part 11 of the cap 10. The upper connecting thread 13 and the outer ridge 14 are shown. Figure 2 shows a lower receiving thread 21 that may be located within the lower cavity 22 of the cap 10. The lower receiving thread 21 may be configured to be attached to a container 131, thereby enabling engagement with the container 131, allowing the nutritional composition 132 to flow from the container 131 into the lower cavity 22 through the rest of the cap 10.

[0027]

[0040] Figure 3 shows an isometric view of the cap 10, which may generally include an upper part 12 with an upper connecting thread 13 and a lower part 11 with an outer ridge 14.

[0028]

[0041] Figure 4 shows a side view of a cap 10 which may generally include an upper part 12 with upper connecting threads 13 and a lower part 11 with an outer ridge 14. For reference, a centerline 41 passing through the midline of the generally cylindrical structure of the cap 10 is shown. The base 42 of the upper part may provide an interface between the upper part 12 and the lower part 11. The lower base 43 is shown and may be located on the distal end of the lower part 11 from the upper part 12.

[0029]

[0042] In one embodiment, the portion of the cap 10 between the upper base 42 and the ridge 14 may be elongated so as to be used as a straw and / or to facilitate user operation. Such an embodiment is more ergonomic and / or, if the cap 10 is manufactured from a transparent material, can provide better visibility of the material flowing through the cap 10.

[0030]

[0043] In one embodiment, the upper part 12 of the cap 10 may be retractable, that is, the upper part 12, which includes the second connecting element 13, may be partially or completely reversibly retractable into the cavity 22 of the lower part 11.

[0031]

[0044] Figure 5 shows a general cutaway view of the upper 12 and lower 11 of the cap 10. As shown, the cap 10 includes an upper cavity 51 that connects to the lower cavity 22, which is also shown in Figure 2. Referring again to Figure 5, the lower receiving thread 21 may extend into the inner circumference of the lower 11. The lower receiving thread 21 may also extend through the lower base 43 to assist the lower 11 (e.g., the lower receiving thread 21) when connecting to another connecting member.

[0032]

[0045] Figure 6 shows a dimensioned cutout of the upper part 12 of the cap 10 in general, where the upper part 12 of the cap 10 is made to fit ENFit®. An upper cavity 51 is shown, which may extend through the upper part 12 along the centerline 41. The upper cavity 51 may be defined by an upper inner wall 62, having a diameter ΦD of the upper inner wall and an upper length above the base E. A discharge opening 61 may be provided at the distal end of the upper part 12 from the upper connecting thread 13. The discharge opening 61 may be defined by a diameter ΦU of the discharge opening.

[0033]

[0046] As shown in Figure 6, the diameter ΦU of the discharge opening may be smaller than the inner diameter ΦG of the upper base. In a configuration where the diameter ΦU of the discharge opening is smaller than the inner diameter ΦG of the upper base, the diameter ΦU of the discharge opening can create a flow limiting portion for the nutrient composition 132 flowing through the upper 12. At the interface between the inner diameter ΦG of the upper base and the diameter ΦU of the discharge opening, the chamfer angle T3 of the discharge opening may be configured to narrow the flow limiting portion in order to adjust the flow characteristics, such as flow velocity and / or turbulence. In one embodiment, the inner diameter ΦG of the upper base and the diameter ΦU of the discharge opening may be equal or approximately equal, so that there is no flow limiting portion and as a result the chamfer angle T3 of the discharge opening is 90° or about 90°.

[0034]

[0047] The upper part 12 may include an upper diameter ΦJ, the upper diameter ΦJ may correspond to the diameter of the outer wall of the upper part 12. In one embodiment, the upper connecting thread 13 extends beyond the upper diameter ΦJ. The upper connecting thread 13 may have an upper connecting thread diameter ΦH around the center line 41, and the upper diameter ΦJ is smaller than the upper connecting thread diameter ΦH.

[0035]

[0048] The upper connecting thread 13 may have a thread crown width M and a thread pitch width N, where the thread pitch width N is preferably at the widest point of the upper connecting thread 13. The upper connecting thread 13 may contact the upper 12 at its widest point. The upper connecting thread 13 may then taper towards its most distal portion, which may have a thread crown width M. In embodiments where the upper connecting thread 13 tapers towards a certain point, the thread crown width M may be zero or about 0. In one embodiment, the pitch thread width N and the thread crown width M may be equal or approximately equal, and as a result, the upper connecting thread 13 is not tapered (i.e., it is cut straight).

[0036]

[0049] In one embodiment, the relative ratios shown in Figure 6 may be varied to meet various user needs. For example, the upper length E above the base may be elongated to allow the cap 10 to be used as a straw and / or to facilitate user operation. In one embodiment, the upper diameter ΦJ may be further increased to allow the user to apply more torque to the cap 10 when screwing it into a device and / or component. In one embodiment, the diameter ΦD of the upper inner wall may be optimized for a desired flow rate through the cap 10. In one embodiment, dimensions including at least the thread crown width M, thread pitch width N, and the diameter ΦH of the upper connecting thread may be configured to connect to a particular device and / or component.

[0037]

[0050] In one embodiment, the cap 10 may include a foil strip and / or seal across the diameter ΦD of the upper inner wall. The foil strip and / or seal can signal to the user that the cap 10, container 131 and / or other structures have been tampered with. The foil strip and / or seal may also provide additional protection against leakage during shipping and / or handling of the container 131.

[0038]

[0051] Figure 7 shows a general side view of one embodiment of the upper part 12 of the cap 10. The upper part 12 is shown together with the upper connecting thread 13. The upper part 12 may generally be defined by a base width ΦW, a top width ΦF3, and a length R3 above the base. The upper part 12 may include a chamfered portion 73 at the end opposite the base 42 along the centerline 41, and the chamfered portion 73 may be defined by a chamfer height C.

[0039]

[0052] Figure 8 shows an isometric view of the upper part 12 of the cap 10, which is generally made to conform to ENFit®. The upper part 12 may include an upper connecting thread 13 that may extend radially outward from the center of the generally cylindrical structure of the upper part 12. The upper connecting thread 13 may be located in a plane offset from the plane defined by the upper base 42. Since the upper connecting thread 13 extends upward, the thread may terminate at an upper connecting thread end width X3. The upper connecting thread end width X3 may be provided to prevent misconnection of the cap 10. The configuration of the upper part 12 may include embodiments of the upper connecting thread end width X3 in which the upper connecting thread end width X3 is maximized, as the contact area provided by a longer embodiment of the upper connecting thread end width X3 may provide a larger sealing area.

[0040]

[0053] Figure 9 shows a general through-view of the upper cavity 12 of one embodiment of the cap 10. The diagram shown in Figure 9 is a view from roughly below the center line 41 and shows the upper cavity 51 defined by the upper inner wall 62. The upper cavity 51 may terminate into the discharge opening 61 and provide a path to the lower cavity 22, as shown in Figure 2. Referring again to Figure 9, the discharge opening 61 is shown as generally circular, but it may have other configurations, e.g., other geometric shapes. The cross-section of the discharge opening 61 may also vary along the center line 41; for example, the diameter of the discharge opening 61 may increase and / or decrease along the center line 41.

[0041]

[0054] The upper connecting thread 13 may protrude from the portion of the upper 12 that defines the inner cavity 51. The upper connecting thread 13 is shown along with the width γ of the upper connecting thread, which does not extend around the entire circumference of the upper 12. In one embodiment, the width γ of the upper connecting thread may extend around more or less of the circumference of the upper 12. The edge of the upper connecting thread 13 may terminate at a chamfer angle Z3 of the upper connecting thread. The chamfer angle Z3 of the upper connecting thread can be defined as the angle between a first vector extending from a point defined by the center line 41 in a plane perpendicular to the center line 41, and a second vector defined by a trajectory along the first vector and extending along that trajectory.

[0042]

[0055] The end edge width X3 of the upper connecting thread is also shown. The end edge width X3 of the upper connecting thread can be defined as a function of the thread pitch, thread depth, and number of threads per unit distance along the center line 41.

[0043]

[0056] Figure 10 shows, in general terms, one embodiment of a container 131 connected to a cap 10, with an overcap 70 placed in a fixed position over the cap 10.

[0044]

[0057] The container 131 is shown as a pouch in the preferred embodiment shown in Figure 10, but may also include bags, containers, bottles, lines, syringes, and / or any other containers used to hold and / or transfer the nutritional composition 132 and / or fluid. In embodiments in which the container for the nutritional composition is deformable, for example, if the container 131 is a pouch, the user may squeeze the container 131 and / or apply pressure to the container 131 to assist in moving the nutritional composition 132 out of the container 131 through the cap 10 or otherwise out of the container 131. In one embodiment, gravity may be used to move the nutritional composition 132 out of the container 131 through the cap 10 or otherwise out of the container 131. The configuration in which the container 131 is squeezed allows the nutritional composition 132 to be moved out of the pouch more quickly than using conventional gravity-based feeding techniques. If the nutritional composition 132 is required to be used as a bolus, for example, a liquid bolus, the container 131 may be compressible, and a tight connection between the container 131, the cap 10, and the patient's line is advantageous in that it reduces leakage of the contents from the container 131.

[0045]

[0058] Cap 10 connects directly to the nutritional tubing (not shown) of the enteral line without the use of an infusion set, administration set, or other adapters.

[0046]

[0059] In one embodiment, the cap 10 may be partially screwed onto the container 131. The cap 10 and container 131 may consist of a tamper-evident configuration in which the user irreparably destroys a seal, a plastic retainer, foil, or other mechanism indicating that the package no longer has its original seal and / or is no longer sterile. In one embodiment, the cap 10 and / or overcap 70 may be attached to the container 131 in such a way as to destroy the tamper-evident seal.

[0047]

[0060] Although not shown in Figure 10, other features of the overcap 70 may be provided, such as larger dimensions, and the overcap 70 may include extensions (i.e., wing portions for the user to grasp) and / or textured surfaces.

[0048]

[0061] Figure 11 shows one embodiment of a container 131, a cap 10, and an overcap 70, which are a pouch with a spout 141, in a general assembled configuration, wherein the spout has a spout thread 142 on the pouch. The spout thread 142 on the pouch is circumferentially configured around the spout 141 and may be configured to receive a lower receiving thread 21 on the lower part 11 of the cap 10. In one embodiment, the spout 141 does not have to have a connecting thread 142, and instead may have a clip connector, a snap connector, a plug connector, a fitting connector, and / or other connectors to connect the spout to a corresponding connector element on the lower part 11 of the cap 10. More or fewer connecting threads than the connecting thread 142 shown in Figure 11 may be manufactured, and / or different connecting threads may be manufactured.

[0049]

[0062] The overcap 70 may be configured to screw into the upper part 12 by engaging the upper connecting threads 13 with the upper receiving threads of an overcap (not shown) that is rotatably mounted to the upper part 12 of the cap 10 (as shown in detail in Figures 1 to 7).

[0050]

[0063] When the overcap 70 is positioned on top 12, the generally cylindrical center of the overcap 70 can be aligned with the center line 41, as shown in Figure 4, for example, so that the overcap 70 is aligned with the top 12 to connect the top 12 to the overcap 70 using the upper connecting threads 13. In one embodiment, the upper connecting threads 13 may not be provided, and the overcap 70 may be fitted to the upper assembly using, for example, snaps, hooks, and / or friction couplings. In one embodiment, the overcap 70 may be a flip-top cap that is hinged to the top 12 of the cap 10. In one embodiment, the overcap 70 may be a foil strip positioned over the entire top 12 of the cap 10. In one embodiment, the overcap 70 may be configured to snap off from the upper part 12 of the cap 10. For example, the cap 10 and the overcap portion 70 may be manufactured as a single element having a weak portion (such as a zone of thinner material or a perforated zone) at the interface between the overcap portion 70 and the upper part 12 of the cap 10, so that the overcap 70 can be separated (snap off) from the cap 10.

[0051]

[0064] In one embodiment, the overcap 70 may include a central peg. The central peg may extend from the closed end of the overcap 70 along the centerline of the overcap toward the open end of the overcap 70. The central peg may assist in closing and / or securing the overcap 70 to the upper part 12 of the cap 10. In embodiments where the upper part 12 has a foil strip and / or seal over the diameter ΦD of the inner wall of the upper part (the diameter ΦD of the inner wall of the upper part is indicated in Figure 6), the central peg can be used to puncture the foil strip and / or seal. In embodiments where the upper part 12 has a foil strip and / or seal over the diameter ΦD of the inner wall of the upper part, the overcap 70 may not be provided, since the sealing function of the overcap 70 may be provided by the foil strip and / or seal instead.

[0052]

[0065] The spout 141 may be configured to have an opening larger than the opening of the cap defined by the upper cavity 51 of the upper part 12. The spout 141 may be configured for oral intake of the nutritional composition 132, and the cap may be configured to connect to a patient's line, and thus, optionally, different sized openings are required for different uses.

[0053]

[0066] In one embodiment, the spout 141 and / or cap 10 may be sealed using plastic, metal, foil, or other seals. The seals may indicate whether the container 131 has been tampered with if tampering has occurred, and / or whether additional sealing protection is provided at the time of shipment of the container 131. The seals may be provided to ensure that the cap 10, the container 131 (e.g., a pouch), and / or the overcap 70 are sterile.

[0054]

[0067] In one embodiment, the overcap 70, cap 10, and container 131 (e.g., a pouch) can be provided in a connection configuration that still allows the user to screw and / or snap the overcap 70, cap 10, and container 131 together. For example, a retaining line may be provided connecting the cap 10 to the overcap 70 and container 131. In one embodiment, the overcap 70 may be hinged to the cap 10. In one embodiment, the overcap 70, cap 10, and container 131 may all be connected to a connecting member that allows each of the overcap 70, cap 10, and container 131 to rotate within the connecting portion of the hinged connecting member. Such a configuration can advantageously prevent misplacement or ingestion of the cap 10, overcap 70, and / or other components of the cap-overcap-container system.

[0055]

[0068] Figure 12 shows a detailed cutaway view of the threads 142 of the spout of a container in one embodiment of the spout 141. The threads 142 of the spout may be defined by the spout's thread crest width 151. In one embodiment, the spout's thread crest width 151 may be zero or about zero, resulting in threads that converge to a single point. The threads 142 of the spout may be defined by the upper thread half-angle 153 and the lower thread half-angle 152. The upper thread half-angle 153 and the lower thread half-angle 152 may be defined by the upper or lower angle of the threads 142 of the spout from a plane substantially perpendicular to the centerline of a substantially cylindrical embodiment of the spout 141. In one embodiment, the upper thread half-angle 153 and the lower thread half-angle 152 are equal or approximately equal. In one embodiment, the upper thread half-angle 153 of the spout and the lower thread half-angle 152 of the spout are not equal or nearly equal.

[0056]

[0069] In one embodiment, a method for connecting the container 131 to an enteral line may include the step of removing the overcap 70 from the cap 10, the cap 10 being configured to allow the nutritional composition 132 to flow through it. "Removing" means that the user can remove the overcap 70 from the cap 10 without using any instruments and without damaging the overcap 70 or the cap 10.

[0057]

[0070] The cap 10 can be detachably connected to the container 131 and then sealed and connected to the enteral line. "Detachably connected" means that the user can remove the cap 10 from the container 131 without using any instruments and without damaging the cap 10 or the container 131.

[0058]

[0071] Pressure can be applied to the container 131 to allow the nutritional composition 132 inside the container 131 to flow through the cap 10 into the enteral line. The nutritional composition 132 can be refilled into the container 131 through the refill opening of the cap 10 and / or through the spout 141. In one embodiment, when an overcap 70 is connected to the cap 10, the seal may have to be broken before the cap 10 can be sealed and connected to the enteral line. The method may include a step of disconnecting the cap 10 from the enteral line. The method may also include a step of resealing the cap 10 by reconnecting the overcap 70 to the cap 10.

[0059]

[0072] Figure 13 shows one embodiment of a cap 10 having an upper part 12. In one embodiment, the cap 10 may be configured to connect to a container other than the container 131. For example, in the embodiment according to Figure 13, the upper part 12 of the cap 10 may have a Smartflex cap connector 201. The Smartflex cap connector 201 may be configured to connect to the spout of a Smartflex Bottle®. The diameter of the Smartflex cap connector 201 may be larger than the diameter of the upper part 12. In such an embodiment, an intermediate portion 203 may be provided. The intermediate portion 203 may be configured to connect the relatively small diameter of the upper part 12 with the relatively large diameter of the Smartflex cap connector 201. In one embodiment, the diameter of the Smartflex cap connector 201 may be close to the diameter of the upper part 12, for example, within about 10%. In such an embodiment, the intermediate portion 203 may not be provided, and the Smartflex cap connector 201 can be connected directly to the upper part 12.

[0060]

[0073] In one embodiment, the Smartflex cap connector 201 may include a ridge 202. The ridge 202 may be configured perpendicular to the plane defined by the maximum cross-sectional plane of the Smartflex cap connector 201, as shown in Figure 13. Additionally or alternatively, the ridge 202 may be mesh-like, textured, and / or made of the same or different material as the rest of the Smartflex cap connector 201. For example, the ridge 202 may be rubber.

[0061]

[0074] Figure 14 shows one embodiment of the upper part 12 having an upper cavity 51. In the embodiment according to Figure 14, the upper base 42 is configured to connect to the spike 210. The upper base 42 may be configured to connect to the lower part 11 and the spike 210. In such embodiments, the lower receiving thread 21 may be configured to connect to a spout, for example, a spout 141, allowing the spike 210 to enter the spout 141. In embodiments where the spout 141 is sealed, the spike 210 may be configured to break the seal by perforating the seal when the spike 210 enters the spout 141.

[0062]

[0075] The spike 210 may include a spike cavity 211. The spike cavity 211 may be connected to a discharge opening 61. As shown in Figure 14, the diameter of the spike cavity 211 corresponds to the diameter of the discharge opening 61, which can reduce any flow limit between the discharge opening 61 and the spike cavity 210. In one embodiment, the lower part 11 is connected to a spout 141 so that the nutritional composition 132 in the container 131 enters the spike cavity 211 from the container 131 and flows through the discharge opening 61 to the upper cavity 51.

[0063]

[0076] Figure 15 shows one embodiment of the cap 10. In the embodiment shown in Figure 15, a second cap 100 is inserted between the cap 10 and a container 131 (not shown). In the embodiment shown in Figure 15, the upper part 12 of the second cap 100 includes an ENPlus® (cross) port connector (indicated as 210), and the upper part 12 of the first cap 10 includes an ENFit® connector (indicated as 211). In the embodiment shown in Figure 15, the lower part of the cap 10 includes a first threaded connection portion located within an inner wall type section defining a proximal cavity. This first threaded connection portion is configured to connect to a further threaded portion (indicated as 13) located outside the upper part of the cap 100. In one embodiment, the arrangement of caps 10 and 100 may be reversed.

[0064]

[0077] Figure 16 shows another embodiment of the cap 10 comprising an upper part 12 and a lower part 11. In one embodiment, the upper part 12 of the cap 10 may include one or more additional connection ports / connection elements in addition to a connection element configured to connect directly to an enteral line. For example, in the embodiment according to Figure 16, the upper part 12 of the cap 10 includes a connection element indicated as 211, configured to connect directly to an enteral line, and a second connection element indicated as 210, configured as an ENPlus® (cross) port connector for connecting to a dosing set or infusion set. The second connection element or connection port may be configured as another type of connector or port, and may be used as an alternative means of connecting a pouch / bottle to a nutritional supplement tube, or as a port that allows the introduction of a syringe or tube for adding a drug or additive to a nutritional composition, for example, or as a port for introducing water to flush the system.

[0065]

[0078] In one embodiment, a method for manufacturing a cap for a container may include the step of forming a cap having a cylindrical section having a proximal end and a distal end; a proximal cavity having an inlet opening located within the proximal end of the cylindrical section; a distal cavity having an outlet opening located within the distal end of the cylindrical section; a dispensing portion located between the proximal and distal cavities; a first threaded connector located on the inner circumference of a wall-shaped section defining the proximal cavity; and a second threaded connector located on the outer circumference of the distal end of the cylindrical section. This method may include injection molding and / or extrusion molding.

[0066]

[0079] A method for manufacturing a package closure system may include the steps of molding a package outlet having a first connecting element, a cap having a second connecting element configured to be detachably connected to the package outlet using the first connecting element, and an ENFit® connector and / or overcap configured to be detachably connected to the cap using the second connecting element. In one embodiment, the overcap configured to be detachably connected to the ENFit® connector and / or cap may be optional.

[0067]

[0080] It should be understood that various changes and modifications to the embodiments described herein will be obvious 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. Furthermore, these embodiments are not limited to the exact details of the methods or configurations described above, and therefore these embodiments are intended to be covered within the scope of this disclosure. Furthermore, unless otherwise specified, any use of terms such as “first,” “second,” etc., does not indicate any order or importance, but rather, terms such as “first,” “second,” etc., are used simply to distinguish one element from another.

Claims

1. A package (131) containing a nutritional composition (132), A spout (141) extending from the package and equipped with a first connecting element (142), A cap (10) having flow channels (22, 51) and configured to be directly and detachably connected to the first connecting element, and comprising a second connecting element (13), An overcap (70) configured to close the flow path of the cap, A package closing system comprising, The second connecting element is configured to connect to the enteral line such that the cap indirectly connects the spout to the enteral line through the flow path, and the flow path leads from the spout to the enteral line. The aforementioned second connection element is a connector compliant with ISO 80369-3, The aforementioned overcap is The overcap is provided with a central peg that extends from the closed end of the overcap along the centerline of the overcap toward the open end of the overcap. The cap is connected by a hinge, and / or It is connected to the cap by a retaining line. A package closing system having one or more of the following:

2. The first connecting element comprises a first screw-type connecting element (142), The second connecting element comprises a second screw-type connecting element (13). The system according to claim 1.

3. The cap is configured to be detachable from the spout. The overcap is configured to be separable from the cap, When the cap is separated from the spout and the overcap is separated from the cap, the overcap, the cap, and the spout maintain a physical connection. The system according to claim 1 or 2.

4. With additional features to prevent tampering, The tamper-evident element is configured to break when the cap is separated from the spout. The system according to any one of claims 1 to 3.

5. The aforementioned cap is an integrated connector. The system according to any one of claims 1 to 4.

6. The aforementioned flow path comprises an upper cavity (51) and a lower cavity (22), The flow limiting unit is located within the flow path and between the upper cavity and the lower cavity. The flow limiting section restricts the flow through the upper cavity in order to adjust the flow characteristics. The system according to any one of claims 1 to 5.

7. The foil strip is configured to seal the flow path of the cap. The system according to any one of claims 1 to 6.

8. The foil strip is configured to seal the spout (141). The system according to any one of claims 1 to 7.

9. The aforementioned cap comprises an upper part (12) and a lower part (11), The upper part comprises one or more additional connecting elements in addition to the second connecting element. The system according to any one of claims 1 to 8.

10. The aforementioned overcap is equipped with wings for the user to grasp, The system according to any one of claims 1 to 9.

11. The aforementioned cap comprises an upper part (12) and a lower part (11), The second connecting element comprises a screw-type connecting element, The overcap includes an upper receiving screw configured to be screwed onto the upper part of the cap by engaging with the screw-type connecting element (13). The system according to any one of claims 1 to 10.

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