Patent Description:
A PEG (Percutaneous Endoscopic Gastronomy) is a fixture which is inserted into a patient's stomach which allows a feeding tube coming from a pump to be attached for feeding to commence. Some of the reasons why patients require a PEG are head trauma, stroke, collagen vascular disorder and cancers such as head, throat or oesophageal. Other reasons behind requiring enteral feeding can occur from needing to gain weight via a pre port option, which is used by people who can't get the required calories from their normal diet; neurological conditions such as motor neuron disease, brain tumour, Parkinson's disease or as a result of a brain injury. Surgical conditions such as preoperative or postoperative surgery, burns, or pancreatitis; a psychiatric issue like anorexia nervosa; or disorder such as cystic fibrosis may also require enteral feeding.

Some of the problems with current technology used in enteral feeding include the noise and vibrations of the pump used to deliver the liquid formula, the difficulty that users can experience when setting up the pump and, most importantly, the restriction to the persons mobility. Conventional feeding systems involve pumps which are battery or electronically powered. Noise and vibrations are produced which can be very disturbing, especially when trying to sleep at night. When feeding at home, patients are required to be lying down or seated, then the pump is placed on an IV type stand with the bag held higher over the pump. A single serving of approximately <NUM> to <NUM> can take from <NUM> to <NUM> hours to be administrated, but this is entirely dependent of the patient, as serving a feeding too fast can lead to stomach pains or vomiting, and releasing the formula too slow will have less effect and leave the patient tired and lacking in energy.

It is also necessary to have this setup beside their bed for night feeding. Slower feed rates are generally used at night for a longer release of food for the patient. Patients often find it difficult and irritating, when trying to sleep with the constant noise, vibration and also visual impact (lighting) of the pump.

When a patient is not at home they are required to use a special carry bag for the pump, formula, tubing and all other equipment needed. The conventional carry bag is approximately the same size of an average back pack. It allows the user to feed, while preforming some tasks but it is restrictive. Gravity is required to allow flow from a container for enteral fluid to a pump. The pump also requires an electricity supply and/or a battery pack. The units must also be programmed using a complex interface. The current portable systems are heavy and bulky which means that they are not very mobile and are not discrete.

<CIT> describes an existing portable enteral feeding apparatus.

The invention provides a portable enteral feeding apparatus for PEG feeding as set out in claim <NUM>, and optional features are set out in the dependent claims <NUM>-<NUM>.

The invention will be more clearly understood from the following description thereof, given by way of example only, in which:.

Referring to the drawings, there is illustrated an outlet port for a portable enteral feeding apparatus. The outlet port comprises a valve <NUM> and a housing or spout <NUM> for the valve <NUM>. In this case, the feeding apparatus comprises an expansile pouch <NUM> which has an expanded filled configuration and a collapsed configuration. In this case there is no mechanical means, such as a pump, to deliver the enteral feed from the pouch. The expansion of the expansile element, on filling, provides the sole force under which enteral fluid is delivered from the pouch.

The weldable spout has a self-sealing mechanism, used in filling and dispensing enteral feed from an elastomeric pouch. The valve seal mechanism is activated by pushing a spike through the valve seal. The spout comprises:.

The spout main body <NUM> can be made from any weldable thermoplastic, but is primarily made from Polyolefins, Polyethylene or Polypropylene.

The elastomeric valve <NUM> can be made from any elastomeric material but is primarily made from silicone of the range <NUM>-60A durometer.

The valve retainer ring <NUM> can be made from any thermoplastic, but is primarily made from Polyolefins, Polyethylene or Polypropylene.

<FIG> shows a cut section of the valve housing or spout <NUM> and the spike connector <NUM> in the process of being connected to each other. The spike member <NUM> is entering the high tolerance region <NUM> of the spout main body in this figure. There is an interference fit as the spike and the body mates. This interference fit between the spike and the body is in the order of <NUM> and is used to seal and prevent egress of food from the system while the spout/spike connector threads are in engagement and the spike is being pierced through the valve. In the event that the valve slit does not fully seal around the spike, the interference fit between the neck ID of the spout and the spike OD seal the food in the pouch.

The interference fit between the spike and the ID of the spout main body is an integral part of connecting the spout a feed set or given set. This applies to both cross fit and round spike connectors. The interference fit should be in the order of ≤<NUM>. In other words the ID of the spout main body should be -<NUM> < the diameter of the connector spike. This provides both an interference fit and a wiper seal effect as both are fitted together.

<FIG> shows a cut section of the spout <NUM> and the spike connector <NUM> fully connected to each other. The spike connector comprises a spike <NUM> which is snap fitted to a cap <NUM> to allow the cap to be treaded on to the spout. When connected to the spout, a washer <NUM> is placed between the tip of the spout <NUM> and the spike <NUM>. The spout is made up of <NUM> components the spout body <NUM>, a silicone valve <NUM> and a valve retainer ring <NUM>. The valve <NUM> is held in place by the valve retainer ring <NUM> that is held by a slight ledge or protrusions from the spout body ID (not visible in drawing).

<FIG> shows a cut section of the spout <NUM> and the spike connector <NUM> in an exploded view. The image shows the spike <NUM>, the cap <NUM>, the poly foam washer <NUM>, the spout <NUM>, a silicone valve <NUM> and a valve retainer ring <NUM>.

<FIG> shows the food pod in its entirety when in use. The food pod has a surrounding membrane of foil <NUM>, an elastomeric membrane <NUM> which is connected to the spout <NUM> via a cable tie <NUM>. The arrows <NUM> show the direction of the fluid <NUM> which then passes through the spout <NUM> and the spike connector <NUM> and into the tubing <NUM> to be expelled to the patient.

The valve should withstand a pressure of ≥1psi.

<FIG> shows the pressure of the elastomer pouch <NUM> being released and shrinking as enteral food is delivered.

<FIG> shows the pressure of the pouch <NUM> fully released and the elastomer pouch <NUM> has returned to its original shape.

<FIG> shows the pouch <NUM> being connected to the base of the spout <NUM> by a cable tie <NUM>.

<FIG> shows the pouch <NUM> being connected to the spout <NUM> by a plastic fitment ring <NUM>.

<FIG> shows the pouch <NUM> being connected to the spout <NUM> by an o-ring <NUM>.

The spout main body has a fixation feature to aid attaching and securing the elastomeric pouch to the spout main body.

<FIG> shows one setup for closed filling of the pouch <NUM>. The nutritional feed packaging <NUM> is connected to a filling set <NUM> via a crossfit spike <NUM>. An ENFit Syringe <NUM> is connected to a stopcock <NUM>. In this image the nutritional feed is shown being pulled from the feed packaging <NUM> via the syringe <NUM> as a force is being pulled by the syringe as indicated by the arrow <NUM>. The stopcock <NUM> is set so that the flow only can enter the syringe <NUM>.

<FIG> shows the second step in the closed filling process. The syringe <NUM> is forced forward via the user indicated by the arrow <NUM>. The nutritional feed is then forced through the stopcock <NUM> and directly into the pouch <NUM> which then expands. The stopcock <NUM> has switched direction due to user interaction, directing the flow towards the pouch <NUM>.

<FIG> shows a filling spike <NUM>. The filling spike <NUM> is compatible with the tip of the syringe <NUM> tip. <FIG> shows the filling spike <NUM> connected to the syringe <NUM>.

<FIG> shows the filling process using the filling spike <NUM>. The user fills the syringe <NUM> with the filling spike <NUM> connected. The filling spike <NUM> is then inserted into a spout <NUM> (which is slightly modified to have a wider channel/ID). When connected, pressure <NUM> is then exerted in the syringe <NUM> which pushes the nutritional feed into the pouch <NUM>, forcing it to expand. <FIG> shows the pouch <NUM> partially filled.

<FIG> shows another connector <NUM> intended to be used with a cut section of the spike <NUM>.

<FIG> also shows another connector <NUM> intended to be used with a cut section of the spike <NUM>.

The valve may or may not have an incision to aid the valve in entry. The incision can be made of a single or many incisions, it may be partially or fully pierced. The incision is not limited to straight line incisions, it maybe half moon shaped.

<FIG> shows a single slit with smaller length.

Referring to <FIG>, there is illustrated a portable enteral feeding apparatus <NUM> according to the invention. The apparatus <NUM> for PEG feeding comprise a pouch <NUM> which defines a reservoir for enteral feed. The pouch <NUM> has an outlet <NUM> for delivery of enteral feed from the pouch. An outlet spout <NUM> has a pouch spigot <NUM> for connection to the pouch outlet <NUM> and a connector spigot <NUM> which is adapted for mounting of a connector shaft. A valve <NUM> is mounted to the spout. The connector spigot <NUM> has mounting means for mounting a connector shaft <NUM> of a PEG feeding system. The spout is configured so that when the connector shaft <NUM> extends through the valve <NUM>, the connector shaft <NUM> can be secured to the spout. However, there is an interlock to prevent fixing of the connector shaft <NUM> to the connector spigot <NUM> if the connector shaft is not extended through the valve <NUM>. This ensures that there can be no flow from the pouch unless the connector is correctly connected to the spout.

In this case the connector spigot comprises a plurality of grooves and the interlock comprises an end stop in at least one of the grooves.

Referring in particular to <FIG> the connector spigot <NUM> comprises four grooves, each groove being <NUM>° circumferentially spaced-apart from an adjacent groove, two of the grooves which are spaced-apart by <NUM>° have end stops. The two longer grooves are <NUM>, <NUM> and the two shorter grooves are <NUM>. The shorter grooves <NUM> have end stops <NUM>, <NUM>.

The connector shaft <NUM> in this case is an ENFit cross connector shaft having two long ribs <NUM>, <NUM> and two shorter ribs <NUM>, <NUM>. The two longer ribs <NUM>, <NUM> have leading edges which penetrate through a slit in the valve <NUM>. The shorter ribs <NUM>, <NUM> engage against the end stops <NUM>, <NUM> in this configuration as illustrated particularly in <FIG> and <FIG>. The connector shaft <NUM> has a channel <NUM> through which enteral fluid can flow when the connector shaft is in the correctly aligned configuration.

If the connector shaft <NUM> is turned though <NUM>°, the longer ribs <NUM>, <NUM> will be aligned with the short grooves <NUM> and the leading edges of the long ribs <NUM>, <NUM> will be prevented from advancing any further by the end stops <NUM>, <NUM> as illustrated particularly in <FIG> and <FIG>. This interlock prevents fixing of the connector shaft <NUM> to the connector spigot <NUM> and thereby ensures that there can be no flow in this incorrect configuration.

The connector spigot <NUM> of the spout <NUM> has screw threads <NUM> which engage with corresponding screw threads on a cap <NUM> of the connector. The cap <NUM> is attached to the connector shaft <NUM> by snap fitting. The cap <NUM> is adapted to screw onto the connector spigot <NUM>. However, the screw threads <NUM> are positioned so that the cap <NUM> will only engage when the connector shaft <NUM> has extended through the valve <NUM>. In this way a further interlock is provided to prevent operation of the device if the connector shaft is not correctly inserted.

The spout <NUM> comprises a receiver, in this case a ledge <NUM>, against which the valve <NUM> is engaged. A retaining ring <NUM> is snap-fitted into the spout to retain the valve <NUM> position.

In this case the valve <NUM> is a single slit zero seal valve which may be of a suitable elastomeric material such as silicone with a durometer in the range of <NUM> to 60A.

The mounting of the valve <NUM> allows the valve to flex during penetration and removal of the Crossfit spike. This ensures that a seal is maintained and that no leakage occurs.

<FIG> are views of a cut-section of the spout <NUM> showing a cap, weld spout <NUM>, silicone valve <NUM> and retaining ring <NUM>.

<FIG> is a cut section of the spout <NUM> connected to an ISO18250-<NUM> Crossfit spike <NUM>. This view shows the valve <NUM> being opened allowing fluid to pass through the tubing set.

<FIG> and <FIG> are views of the assembled spout and the Crossfit spike <NUM> aligned correctly as per <FIG>.

<FIG> is an enlarged view of part of <FIG>. This shows the detail around the end stop/blockers <NUM>, <NUM>. The end stops <NUM> prevent the Crossfit spike <NUM> passing through the valve <NUM>.

<FIG> also shows Crossfit spike <NUM> being inserted in the incorrect position. The end stops <NUM>, <NUM> prevent the spike going any further and damaging the valve <NUM>. The end stops <NUM>, <NUM> are placed at a distance that does not allow the threads on the Crossfit spike to <NUM> connect with the threads on the spout. This ensures that no torque can be generated to break through the end stops <NUM>, <NUM>.

<FIG> is a detailed view of <FIG> on the spike <NUM> and the interaction with the end stops <NUM>, <NUM>.

<FIG> shows an isometric view of the assembled spout <NUM> and spike <NUM> being aligned incorrectly.

<FIG> shows an isometric view of the assembled spout <NUM>.

<FIG> are plan views from above and below of the assembled spout <NUM>.

<FIG> illustrates the spout <NUM> sealed to a pouch laminate. The spout has side wings <NUM> to which the pouch laminate is welded. Air vents <NUM> are provided to evacuate the space between the expansile pouch and the foil during filling.

<FIG> is a cut section detail of the retaining ring <NUM> interacting with the snapfit of the spout <NUM>.

The guides <NUM> for placement of a securing mechanism such as cable ties <NUM> to retain the pouch are also shown.

The interlock arrangement ensures that the Crossfit spike can only penetrate the valve when the spike and the valve are correctly aligned. This is important as it ensures that a seal is maintained when the Crossfit spike is inserted through the single slit valve. Backflow is prevented. The valve seal also wipes feed from the spike as it is withdrawn.

An enteral feeding pouch is described in our <CIT>. A docking station for use with an enteral feeding apparatus is described in our <CIT>.

<FIG> shows a cut-section of an assembled spout <NUM> with a shorter extrude below the wings <NUM>. This spout does not have placement for a securing mechanism resulting in a shorter extrude.

<FIG> shows the same spout as pictured in <FIG> in an isometric view. An air vent is not used in this particular spout.

<FIG> shows a cut-section of a spout sealed to a laminate packaging <NUM>. This demonstrates that the spout <NUM> can be used with conventional packaging <NUM>.

<FIG> shows an exploded view of the assembled spout, retaining ring <NUM>, silicone valve <NUM>, cable ties <NUM> (x2), elastomer <NUM> and foil pouch.

<FIG> shows a front view of a giving set (delivery tube) with ISO18250-<NUM> Crossfit connector <NUM>.

<FIG> shows the filling set with ISO18250-<NUM> Crossfit spikes <NUM> on either end.

<FIG> shows an ISO80369-<NUM> syringe <NUM>.

<FIG> shows an image of a universal adapter <NUM> used to connect some feed bottle types to an ISO18250-<NUM> system.

Claim 1:
A portable enteral feeding apparatus comprising:
a pouch (<NUM>) which defines a reservoir for enteral fluid and having an outlet for delivery of enteral fluid from the pouch;
an outlet spout (<NUM>) having a pouch spigot (<NUM>) connected to the pouch outlet and a connector spigot (<NUM>);
a valve (<NUM>) mounted to the spout;
the connector spigot having mounting means (<NUM>) for mounting a connector shaft of a PEG feeding system to the connector spigot when a connector shaft is extended through the valve; and
an interlock (<NUM>, <NUM>) to prevent fixing of a connector shaft to the connector spigot if a connector shaft is not extended through the valve,
wherein:
the spout comprises a valve receiver for the valve,
characterized in that,
the valve is a slit valve (<NUM>) comprising an elastomeric material,
said receiver comprises a ledge (<NUM>) for engagement with the valve (<NUM>), and against which the valve (<NUM>) is engaged, and a retaining ring (<NUM>) is snap-fitted into the spout to retain the valve (<NUM>) position,
the apparatus further comprises a connector having a distal shaft (<NUM>) and proximal mounting features (<NUM>) for connection to a feeding tube, the distal shaft having connector formations which are adapted to engage with the connector spigot (<NUM>), and said distal shaft is a cross connector shaft (<NUM>-<NUM>), and the connector spigot (<NUM>) has screw threads (<NUM>) which engage with corresponding screw threads on a cap (<NUM>) of the connector, in which the connector spigot screw thread (<NUM>) is adapted for engagement with the connector cap (<NUM>) only when said distal shaft (<NUM>) extends through the valve (<NUM>),
the pouch comprises an expansile element (<NUM>) having an expanded filled configuration and a collapsed configuration, and the pouch spigot (<NUM>) is adapted
for mounting the outlet of the expansile element to the pouch spigot, and
the pouch spigot comprises a mounting feature such as a groove to which the expansile element is mounted, and the pouch (<NUM>) is connected to the spout (<NUM>) by a plastics fitment ring (<NUM>) or a cable tie.