Patent Description:
The delivery of nutritional compositions to mammals, such as human patients, that cannot orally ingest food or other forms of nutrition is often of critical importance. For example, enteral bottles and containers having feeding tubes that deposit food directly into the gastrointestinal tract at a point below the mouth are often used to sustain life while a patient is unable, or refuses, to take food orally. Bottles and containers, feeding tubes and other artificial delivery systems and routes can be used temporarily during the treatment of acute medical conditions. For chronic medical conditions, such systems and routes can be used as part of a treatment regimen that lasts for the remainder of a patient's life. No matter the duration of use, these devices often provide the only means for feeding the patient.

Common concerns with the enteral feeding of nutritional compositions are connection quality and spillage when connecting a container to a feeding device. Some nutritional compositions may be dual use, so another common concern is to provide a container that may be used for consumption both orally and as enteral nutrition. A common method to deliver nutritional compositions to a patient is to pour the nutritional composition from a container into an open syringe attached to a feeding tube. Such methods may be difficult for children or patients with fine motor skills challenges. As a result, the nutritional composition may spill out of the open syringe attached to a feeding tube.

<CIT> discloses a connector device suitable for connecting an enteral administration set to a laminated paper packaging system comprising enterally administrable medical or nutritional food.

<CIT> discloses a syringe having a barrel and a non-luer tip that is not connectable to an intravenous device. The syringe has an enteral collar having a distal end and proximal end, the proximal end having a syringe engagement feature. The enteral collar is sized to permit an ENFit connection to an enteral device and prevent connection to a device having a luer connector.

The present disclosure provides advantages and solutions to problems in existing technologies for connecting enteral containers to enteral feeding tubes. A package closure system is provided according to claim <NUM>. A method for providing a nutritional composition is provided according to claim <NUM>.

Detailed embodiments of devices and methods are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of the devices and methods, which may be embodied in various forms. Therefore, specific functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims as a representative example for teaching one skilled in the art to variously employ the present disclosure.

As used herein, "about," "approximately" and "substantially" are understood to refer to numbers in a range of numerals, for example the range of -<NUM>% to +<NUM>% of the referenced number, preferably -<NUM>% to +<NUM>% of the referenced number, more preferably -<NUM>% to +<NUM>% of the referenced number, most preferably -<NUM>% to +<NUM>% of the referenced number. All numerical ranges herein should be understood to include all integers, whole or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from <NUM> to <NUM> should be construed as supporting a range of from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, from <NUM> to <NUM>, and so forth.

The preferred embodiments relate to a cap or connector methods and devices for connecting a container containing nutritional compositions to an enteral feeding device, where the cap or connector may also be used for oral ingestion of the nutritional compositions.

<FIG> generally illustrates an embodiment of a cap <NUM>. The cap <NUM> can comprise: an upper portion <NUM> for connecting to an external receiving member and/or an overcap <NUM> as shown in <FIG> and <FIG>; and a lower portion <NUM> for connecting to a container <NUM>. Referring back to <FIG>, the external receiving member may be a male ENFit® connector. In an embodiment a female ENFit® connector positioned on the upper portion <NUM> of the cap <NUM> may be connected to the male ENFit® connector of the external receiving member. In an alternative embodiment (not shown in <FIG>) the external connector may be a female ENFit® connector, and the upper portion <NUM> of the cap <NUM> may be configured as a male ENFit® connector, for connecting to the female ENFit ® connector of the external receiving member. The cap <NUM> may be provided with outer ridges <NUM> along an outer circumference of the lower portion <NUM>. The outer ridges <NUM> may be configured to assist a user when removing, manipulating and/or attaching the cap to other systems or devices. For example, the cap <NUM> may screw onto other devices containing nutritional product (e.g., a flexible pouch, a SmartFlex Bottle®, a water bottle, a Resource Junior® bottle, an Infrasource® bottle, Tetra® Bottle, other NHSc bottles, and/or other bottles known in the art). Although not shown in <FIG>, other features of the cap <NUM> may be provided, for example, larger dimensions, extensions (i.e., wings for grabbing by a user) and/or textured surfaces may be provided as part of the cap <NUM>.

The cap <NUM> thereby provides direct connection of a container <NUM> for a nutitional composition with an enteral line feeding tube, without the use of a giving set, administration set or other adaptor.

The outer ridges <NUM> may be configured perpendicularly to a plane defined by a smallest cross sectional plane of the cap <NUM>, as shown in <FIG>. Additionally or alternatively, the outer ridges <NUM> may be crosshatched, textured, and/or comprised of the same or different material as the rest of the cap <NUM>. For example, the outer ridges <NUM> may be rubber.

The cap <NUM> may be provided with upper connecting threads <NUM> extending from the upper portion <NUM>. The upper connecting threads <NUM> may be configured to attach to an ENFit® connector. In an embodiment, the cap <NUM> may not be provided with connecting threads <NUM>, and may instead be provided with a clip, snap, plug, fitting and/or other connector for connecting the cap <NUM> to an external receiving member. More or fewer and/or different connecting threads may be manufactured than the connecting threads <NUM> shown in <FIG>. In an embodiment, the cap <NUM> may only partially comply with ENFit® connector standards. For example, the cap <NUM> may be provided with a larger bore size than that provided in the ENFit® connector standards to reduce any flow restriction through the cap <NUM>.

The cap <NUM>, as well as connecting components such as the overcap <NUM>, shown in <FIG> and <FIG>, may be manufactured from materials including, but not limited to plastics, sustainable plastics, glass, metal, paper, fiber, carton, edible materials (e.g., fiber, sugar, chews, etc.) and combinations thereof. The cap <NUM> may be configured to indicate a temperature, a pH, and/or other parameter of a nutritional composition <NUM>, shown in <FIG>; for example, by manufacturing the cap <NUM> from a material responsive to the temperature and/or the pH. The color of the cap <NUM> may correlate to a use for the nutritional composition <NUM>; for example, a cap color may correlate to an embodiment of the nutritional composition <NUM> where the nutritional composition <NUM> is optimized to fulfill a specific nutritional requirement. The cap <NUM> may be manufactured from a flexible material, enabling the cap <NUM> to be used as a straw. The cap <NUM> may be manufactured from a transparent material or comprise a transparent section to enable the observation of the nutritional composition <NUM> flowing through the cap <NUM>.

<FIG> generally illustrates a view of the lower portion <NUM> of the cap <NUM>. The upper connecting threads <NUM> are shown, as well as the outer ridges <NUM>. <FIG> shows lower receiving threads <NUM>, which may be positioned within a lower cavity <NUM> of the cap <NUM>. The lower receiving threads <NUM> may be configured to attach to the container <NUM>, thereby engaging the container <NUM> and allowing the nutritional composition <NUM> to flow from the container <NUM>, into the lower cavity <NUM>, and through other portions of the cap <NUM>.

<FIG> generally illustrates an isometric view of the cap <NUM>, which may include: the upper portion <NUM> with the upper connecting threads <NUM>; and the lower portion <NUM> with the outer ridges <NUM>.

<FIG> generally illustrates a side view of the cap <NUM>, which may include: the upper portion <NUM> with the upper connecting threads <NUM>; and the lower portion <NUM> with the outer ridges <NUM>. A centerline <NUM> is shown for reference, which passes through a midline of the generally cylindrical structure of the cap <NUM>. An upper portion base <NUM> may provide an interface between the upper portion <NUM> and the lower portion <NUM>. A lower portion base <NUM> is shown, which can be positioned on the distal end of the lower portion <NUM> from the upper portion <NUM>.

In an embodiment, a portion of the cap <NUM> between the upper portion base <NUM> and the ridges <NUM> may be elongated to be used as a straw and/or to be more easily manipulated by a user. Such an embodiment may provide better ergonomics and/or better visibility to material flowing through the cap <NUM> if the cap <NUM> is manufactured from a transparent material.

In an embodiment, the upper portion <NUM> of the cap <NUM> may be retractable, i.e. the upper portion <NUM> with second connection element <NUM> may reversible retract, partially or fully, into the cavity <NUM> of lower portion <NUM>.

<FIG> generally illustrates a cutaway view of the upper portion <NUM> and the lower portion <NUM> of the cap <NUM>. As shown, the cap <NUM> includes an upper cavity <NUM> that connects to the lower cavity <NUM>, also shown in <FIG>. Referring back to <FIG>, the lower receiving threads <NUM> may extend around an inner circumference of the lower portion <NUM>. The lower receiving threads <NUM> may extend through the lower portion base <NUM> to aid the lower portion <NUM> (e.g., the lower receiving threads <NUM>) in connecting to another connection member.

<FIG> generally illustrates a dimensioned cutaway view of the upper portion <NUM> of the cap <NUM>, wherein the upper portion <NUM> of the cap <NUM> is adapted for ENFit® compatibility. The upper cavity <NUM> is shown, which may extend through the upper portion <NUM> along the centerline <NUM>. The upper cavity <NUM> may be defined by an upper portion inner wall <NUM>, and have an upper portion inner wall diameter ØD and an upper portion length above base E. A transmission opening <NUM> may be provided at a distal end of the upper portion <NUM> from the upper connecting threads <NUM>. The transmission opening <NUM> may be defined by a transmission opening diameter ØU.

As shown in <FIG>, the transmission opening diameter ØU may be smaller than an upper portion base inner diameter ØG. In a configuration where the transmission opening diameter ØU is smaller than the upper portion base inner diameter ØG, the transmission opening diameter ØU may create a flow restriction for the nutritional composition <NUM> flowing through the upper portion <NUM>. In an interface between the upper portion base inner diameter ØG and the transmission opening diameter ØU, a transmission opening chamfer angle T3 may be configured to throttle the flow restriction to adjust flow characteristics, for example flow speed and/or turbulence. In an embodiment, the upper portion base inner diameter ØG and the transmission opening diameter ØU may be equal or about equal, therefore eliminating the flow restriction and resulting in the transmission opening chamfer angle T3 being <NUM>° or about <NUM>°.

The upper portion <NUM> may comprise an upper portion diameter ØJ, which may correspond to a diameter of the outer walls of the upper portion <NUM>. In an embodiment, the upper connecting threads <NUM> extend beyond the upper portion diameter ØJ. The upper connecting threads <NUM> may have an upper connecting threads diameter ØH around the centerline <NUM>, where the upper portion diameter ØJ is smaller than the upper connecting threads diameter ØH.

The upper connecting threads <NUM> may have a thread crest width M and a thread pitch width N, where the thread pitch width N is preferably a widest point of the upper connecting threads <NUM>. The upper connecting threads <NUM> may contact the upper portion <NUM> at the widest point of the upper connecting threads <NUM>. The upper connecting threads <NUM> may then taper to the most distal portion of the upper connecting threads <NUM>, which may have the thread crest width M. In an embodiment where the upper connecting threads <NUM> taper to a point, the thread crest width M may be zero or about zero. In an embodiment, the pitch thread width N and the thread crest width M may be equal or about equal, resulting in the upper connecting threads <NUM> being un-tapered (i.e., straight-cut).

In an embodiment, the relative proportions given in <FIG> may be varied to meet different user needs. For example, the upper portion length above base E may be elongated to allow the cap <NUM> to be used as a straw and/or more easily manipulated by a user. In an embodiment, the upper portion diameter ØJ may be much larger to allow a user to apply more torque to the cap <NUM> when screwing the cap <NUM> into a device and/or a component. In an embodiment, the upper portion inner wall diameter ØD may be optimized for a desired flow rate though the cap <NUM>. In an embodiment, the dimensions including at least the thread crest width M, the thread pitch width N and the upper connecting threads diameter ØH may be adapted for connecting to a specific device and/or a specific component.

In an embodiment, the cap <NUM> may include a strip of foil and/or a seal across the upper portion inner wall diameter ØD. The strip of foil and/or the seal can signal to a user that the cap <NUM>, the container <NUM>, and/or other structure has been tampered with. The strip of foil and/or the seal may also provide added protection against leaks when shipping and/or handling the container <NUM>.

<FIG> generally illustrates a side view of an embodiment of the upper portion <NUM> of the cap <NUM>. The upper portion <NUM> is shown with upper connecting threads <NUM>. The upper portion <NUM> may generally be defined by a base width ØW, a top width ØF3 and a length above base R3. The upper portion <NUM> may include chamfers <NUM> at an opposite end from the base portion <NUM> along the centerline <NUM>, and the chamfers <NUM> may be defined by a chamfer height C.

<FIG> generally illustrates an isometric view of the upper portion <NUM> of the cap <NUM>, adapted for ENFit® compatibility. The upper portion <NUM> may include upper connecting threads <NUM>, which may extend radially outward from the center of the generally cylindrical structure of the upper portion <NUM>. The upper connection threads <NUM> may be positioned in a plane offset from a plane defined by the upper portion base <NUM>. As the upper connecting threads <NUM> extend upward, the threads may terminate at an upper connecting thread terminus edge width X3. The upper connecting thread terminus edge width X3 may be provided to prevent misconnection of the cap <NUM>. A configuration of the upper portion <NUM> may comprise an embodiment of the upper connecting thread terminus edge width X3 where the upper connecting thread terminus edge width X3 is maximized because the contact area provided by a longer embodiment of the upper connecting thread terminus edge width X3 may provide a larger sealing area.

<FIG> generally illustrates a through-cavity view of the upper portion <NUM> of an embodiment of the cap <NUM>. The view shown in <FIG> is a view generally down the centerline <NUM> and shows the upper cavity <NUM> defined by the upper portion inner wall <NUM>. The upper cavity <NUM> may terminate into the transmission opening <NUM>, which may provide a path into the lower cavity <NUM>, as shown in <FIG>. Referring back to <FIG>, the transmission opening <NUM> is shown as generally circular, but may be other configurations, for example another geometric shape. The transmission opening <NUM> may also vary in cross section along the centerline <NUM>, for example the transmission opening <NUM> may increase and/or decrease in diameter along the centerline <NUM>.

The upper connecting threads <NUM> may protrude from a part of the upper portion <NUM> that defines the inner cavity <NUM>. The upper connecting threads <NUM> are shown with an upper connecting thread width γ which does not extend around the entire circumference of the upper portion <NUM>. In an embodiment, the upper connecting thread width γ may extend around more or less of the circumference of the upper portion <NUM>. An edge of the upper connecting threads <NUM> may terminate at an upper connecting thread chamfer angle Z3. The upper connecting thread chamfer angle Z3 may be defined as an angle from: a first vector extending from a point defined by the centerline <NUM> in a plane perpendicular to the centerline <NUM>; and a second vector defined from a locus along the first vector, the second vector extending from the locus.

The upper connecting thread terminus edge width X3 is also shown. The upper connecting thread terminus edge width X3 may be defined as a function of a thread pitch, a thread depth, and a number of threads per unit of distance along the centerline <NUM>.

<FIG> generally illustrates an embodiment of a container <NUM> connected to the cap <NUM> and with the overcap <NUM> in place capping the cap <NUM>.

The container <NUM> is shown as a pouch in the preferred embodiment depicted in <FIG>, but may also comprise a bag, container, bottle, line,, and/or any other container used to hold and/or transport the nutritional composition <NUM> and/or fluid. Since the container of nutritional composition is deformable, for example when the container <NUM> is a pouch, a user may squeeze and/or apply pressure to the container <NUM> to assist in moving the nutritional composition <NUM> from the container <NUM> and through the cap <NUM> or otherwise out of the container <NUM>. In an example not according to claim <NUM>, gravity is used to move the nutritional composition <NUM> from the container <NUM> and through the cap <NUM> or otherwise out of the container <NUM>. A configuration where the container <NUM> is squeezed may move the nutritional composition <NUM> from the pouch more quickly than using conventional, gravity fed techniques. When the nutritional composition <NUM> is required for use as a bolus, for example when a bolus of liquid is required, the container <NUM> may be squeezable and tight connections between the container <NUM>, cap <NUM>, and a patient line are advantageous in reducing spillage of the contents from the container <NUM>.

The cap <NUM> connects directly to an enteral line feeding tube (not shown), without the use of a giving set, administration set or other adaptor.

In an embodiment, the cap <NUM> may only be partially screwed onto the container <NUM>. The cap <NUM> and the container <NUM> may be configured in a tamper-evident configuration, where a user may irreparably break a seal, plastic retainer, foil, or other mechanism that shows that a package no longer has the original seal and/or is no longer sterile. In an embodiment, the cap <NUM> and/or the overcap <NUM> may be attached to the container <NUM> to break the tamper evident seal.

Although not shown in <FIG>, other features of the overcap <NUM> may be provided, for example, larger dimensions, extensions (i.e., wings for grabbing by a user) and/or textured surfaces may be provided as part of the overcap <NUM>.

<FIG> generally illustrates an embodiment of the container <NUM> that is a pouch with a spout <NUM> comprising pouch spout threads <NUM>, the cap <NUM>, and the overcap <NUM> in an assembly configuration. The pouch spout threads <NUM> may be configured circumferentially about the spout <NUM> and configured to receive the lower receiving threads <NUM> of the lower portion <NUM> of the cap <NUM>. In an embodiment, the spout <NUM> may not be provided with connecting threads <NUM>, and may instead be provided with a clip, snap, plug, fitting and/or other connector for connecting the spout to a corresponding connector element of the lower portion <NUM> of the cap <NUM>. More or fewer and/or different connecting threads may be manufactured than the connecting threads <NUM> shown in <FIG>.

The overcap <NUM> may be configured to screw into the upper portion <NUM> by engaging the upper connecting threads <NUM> (as shown in detail in <FIG>) with upper receiving threads of the overcap (not shown) to be rotatably attached to the upper portion <NUM> of the cap <NUM>.

When the overcap <NUM> is placed over the upper portion <NUM>, a center of the generally cylindrical shape of the overcap <NUM> may be aligned with the centerline <NUM>, for example the centerline <NUM> as shown in <FIG>, to align the overcap <NUM> with the upper portion <NUM> for connecting the upper portion <NUM> to the overcap <NUM> using the upper connecting threads <NUM>. In an embodiment, the upper connecting threads <NUM> may not be provided, and the overcap <NUM> may fit onto the upper assembly using, for example, a snap, a hook, and/or a friction coupling. In an embodiment, the overcap <NUM> may be a flip-top cap hinged from the upper portion <NUM> of the cap <NUM>. In an embodiment, the overcap <NUM> may be a foil strip positioned across the upper portion <NUM> of the cap <NUM>. In an embodiment the overcap <NUM> may be configured such that it can be snapped off the upper portion <NUM> of the cap <NUM>, for example the cap <NUM> and overcap <NUM> may be produced as a single element with a weakend portion (such as a zone of thinner material, or a perforated zone) at the interface of the overcap portion <NUM> and the upper portion <NUM> of the cap <NUM>, to allow the overcap to be separated (snapped off) from the cap <NUM>.

In an embodiment, a central peg may be included in the overcap <NUM>. The central peg may extend from a closed end of the overcap <NUM> along a centerline of the overcap toward an open end of the overcap <NUM>. The central peg may aid in closing and/or affixing the overcap <NUM> to the upper portion <NUM> of the cap <NUM>. In an embodiment where the upper portion <NUM> has the strip of foil and/or the seal across the upper portion inner wall diameter ØD (the upper portion inner wall diameter ØD is labeled in <FIG>), the central peg may be used to puncture the strip of foil and/or the seal. In an embodiment where the upper portion <NUM> has the strip of foil and/or the seal across the upper portion inner wall diameter ØD, the overcap <NUM> may not be provided because the sealing function of the overcap <NUM> may instead be provided by the strip of foil and/or the seal.

The spout <NUM> may be configured with a larger opening than the opening of the cap defined by the upper cavity <NUM> of the upper portion <NUM>. The spout <NUM> may be configured for oral consumption of the nutritional composition <NUM>, while the cap may be configured to be connected to a patient line, thus optionally requiring different sized openings for different uses.

In an embodiment, the spout <NUM> and or the cap <NUM> may be sealed using a plastic, metal, foil, or other seal. The seal may indicate whether the container <NUM> was tampered with if tampering should occur and/or to provided additional sealing protection when shipping the container <NUM>. The seal may be provided to ensure the cap <NUM>, the container <NUM> (e.g., a pouch), and/or the overcap <NUM> are sterile.

In an embodiment, the overcap <NUM>, the cap <NUM>, and the container <NUM> (e.g., a pouch) are provided in a connected manner which may still allow for a user to screw and/or snap the overcap <NUM>, the cap <NUM>, and the container <NUM> to each other. For example, a retaining line may be provided that connects the cap <NUM> to the overcap <NUM> and the container <NUM>. In an embodiment, the overcap <NUM> may be hinged from the cap <NUM>. In an embodiment, the overcap <NUM>, the cap <NUM>, and the container <NUM> may all be connected to a connecting member that allows each of the overcap <NUM>, the cap <NUM>, and the container <NUM> to rotate in a connecting portion of the hinged member. Such a configuration may advantageously prevent misplacing or swallowing of the cap <NUM>, overcap <NUM>, and/or other components of a cap-overcap-container system.

<FIG> generally illustrates a detailed cutaway view of the container spout threads <NUM> of an embodiment of the spout <NUM>. The container spout threads <NUM> may be defined by a spout thread crest width <NUM>. In an embodiment, the spout thread crest width <NUM> may be zero or about zero, which results in a thread that comes to a point. The container spout threads <NUM> may be defined by an upper spout thread half angle <NUM> and a lower spout thread half angle <NUM>. The upper and lower spout thread half angles <NUM> and <NUM> may be defined by an angle of an upper or lower portion of a container spout thread <NUM> thread tooth from a plane substantially perpendicular to a centerline of a substantially cylindrical embodiment of the spout <NUM>. In an embodiment, the upper spout thread half angle <NUM> and the lower spout thread half angle <NUM> are equal or about equal. In an embodiment, the upper spout thread half angle <NUM> and the lower spout thread half angle <NUM> are not equal or about equal.

In an embodiment, a method for connecting the container <NUM> to an enteral line may include removing the overcap <NUM> from the cap <NUM>, where the cap <NUM> is configured to flow the nutritional composition <NUM> through the cap <NUM>. "Removing" means that a user can remove the overcap <NUM> from the cap <NUM> without using tools and without damaging the overcap <NUM> and the cap <NUM>.

The cap <NUM> may be removably connected to the container <NUM> and then connected sealingly to the enteral line. "Removably connected" means that that a user can remove the cap <NUM> from the container <NUM> without using tools and without damaging the cap <NUM> and the container <NUM>.

A pressure may be applied to the container <NUM> to flow the nutritional composition <NUM> in the container <NUM> through the cap <NUM> and into the enteral line. The nutritional composition <NUM> may be refilled in the container <NUM> through a refilling opening in the cap <NUM> and/or through the spout <NUM>. In an embodiment, a seal may be required to be broken when the overcap <NUM> is connected to the cap <NUM> prior to connecting the cap <NUM> sealingly to the enteral line. The method may include disconnecting the cap <NUM> from the enteral line. The method may include resealing the cap <NUM> by reconnecting the overcap <NUM> to the cap <NUM>.

<FIG> illustrates an embodiment of the cap <NUM> with the upper portion <NUM>. In an embodiment, the cap <NUM> may be configured to connect to containers other than the container <NUM>. For example, in the embodiment according to <FIG>, the upper portion <NUM> of the cap <NUM> may be provided with a Smartflex cap connection <NUM>. The Smartflex cap connection <NUM> may be configured to connect to a spout of a Smartflex Bottle®. A diameter of the Smartflex cap connection <NUM> may be larger than a diameter of the upper portion <NUM>. In such an embodiment, a middle portion <NUM> may be provided. The middle portion <NUM> may be configured to provide a connection between the relatively large diameter of the Smartflex cap connection <NUM> with the relatively small diameter of the upper portion <NUM>. In an embodiment, the diameter of the Smartflex cap connection <NUM> may be closer to the diameter of the upper portion <NUM>, for example within about <NUM>%. In such an embodiment, the middle portion <NUM> may not be provided, and the Smartflex cap connection <NUM> may connect directly to the upper portion <NUM>.

In an embodiment, the Smartflex cap connection <NUM> may be provided with ridges <NUM>. The ridges <NUM> may be configured perpendicularly to a plane defined by a largest cross sectional plane of the Smartflex cap connection <NUM>, as shown in <FIG>. Additionally or alternatively, the ridges <NUM> may be crosshatched, textured, and/or comprised of the same or different material as the rest of the Smartflex cap connection <NUM>. For example, the ridges <NUM> may be rubber.

<FIG> illustrates an embodiment of the upper portion <NUM> comprising the upper cavity <NUM>. In the embodiment according to <FIG>, the upper portion base <NUM> is configured to be connected to a spike <NUM>. The upper portion base <NUM> may be configured to connect to the lower portion <NUM> and the spike <NUM>. In such an embodiment, the lower receiving threads <NUM> may be configured to connect to a spout, for example the spout <NUM>, and allow for the spike <NUM> to enter the spout <NUM>. In an embodiment where the spout <NUM> is sealed, the spike <NUM> may be configured to break the seal by piercing the seal when the spike <NUM> enters the spout <NUM>.

The spike <NUM> may be provided with a spike cavity <NUM>. The spike cavity <NUM> may be connected to the transmission opening <NUM>. As shown in <FIG>, a diameter of the spike cavity <NUM> corresponds to a diameter of the transmission opening <NUM> and may reduce any flow restriction between the transmission opening <NUM> and the spike cavity <NUM>. In an embodiment, the lower portion <NUM> is connected to the spout <NUM> such that the nutritional composition <NUM> in the container <NUM> flows from the container <NUM>, into the spike cavity <NUM>, through the transmission opening <NUM> and into the upper cavity <NUM>.

<FIG> illustrates an embodiment of the cap <NUM>. In the embodiment illustrated in Fugure <NUM> a second cap <NUM> is be inserted between the cap <NUM> and the container <NUM> (not shown). In the embodiment illustrated in <FIG> the upper portion <NUM> of the second cap <NUM> includes an ENPlus® (cross) port connector (shown as <NUM>) and the upper portion <NUM> of the first cap <NUM> includes an ENFit® connector (shown as <NUM>). In the embodiment illustrated in <FIG> the lower portion of the cap <NUM> comprises a first threaded connection portion positioned in an inner walled section defining a prximal cavity. This frst threaded connection portion being confirgured for connection with a further threaded portion (shown as <NUM>) on the exterior of the upper portion of the cap <NUM>. In an embodiment, the sequence of the caps <NUM> and <NUM> may be inversed.

<FIG> illustrates another embodiment of the cap <NUM> with the upper portion <NUM> and lower portion <NUM>. In an embodiment the upper portion <NUM> of the cap <NUM> may include one or more further connection ports / connection elements in addition to the connection element configured for direct connection to the enteral line. For example, in the embodiment according to <FIG>, the upper portion <NUM> of the cap <NUM> includes a connection element, shown as <NUM>, configured for direct connection to an enteral line and a second connection element, shown as <NUM>, configured as an ENPlus® (cross) port connector, for connection with an administration set or giving set. The second connection element or connection port may alternatively be configured as another type of connector or port, and may be used as an alternative means to connect the pouch/bottle to a feeding tube, or, for example, as a port allowing introduction of a syringe or tube for addition of a medicament or additive to the nutritional composition, or for introducing water to flush the system.

In an embodiment, a method of making a cap for a container may comprise forming: the cap to have a cylindrical section comprising a proximal end and a distal end; a proximal cavity comprising an inlet opening positioned within the proximal end of the cylindrical section; a distal cavity comprising 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 circumference of a walled section defining the proximal cavity; and a second threaded connection positioned around an outer circumference of the distal end of the cylindrical section. The method can comprise injection molding and/or extrusion.

Claim 1:
A package closure system comprising:
a deformable package [<NUM>] housing a nutritional composition [<NUM>];
a spout [<NUM>] extending from the package, the spout comprising a first connection element [<NUM>]; and
a cap [<NUM>] comprising a channel [<NUM>, <NUM>], configured to removably connect directly to the first connection element, and comprising a second connection element [<NUM>], the second connection element configured to connect to an enteral line to position the channel leading from the spout to the enteral line such that the cap indirectly connects the spout to the enteral line by the channel, wherein the second connection element is an ENFit® connector.