CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a PCT application, and claims priority to, and the benefit of, U.S. Provisional Application No. 62/640,346, filed March 8, 2018, titled“APPARATUS, DEVICE, METHOD, AND KIT FOR INFANT GAVAGE FEEDING,” which is incorporated herein by reference in its entirety.

BACKGROUND

1. Field of Invention

[0002] The present technology relates generally to infant gavage feeding and, more particularly, to an apparatus, device, methods, and kit that may include allowing a standard baby bottle readily to convert into a gavage feeding device for an infant.

2. Description of the Prior Art

[0003] Many babies struggle to breast or bottle feed, whether due to underdeveloped sucking and swallowing reflexes from being bom prematurely or being otherwise too small or weak; due to coordination difficulties; as a result of throat, esophagus, or bowel issues; or from lung or heart problems, any of which may make standard breast or bottle feeding difficult, or in some cases impossible. Without the ability to breast or bottle feed, these babies are at risk of

malnourishment absent other methods of feeding. Gavage feedings, using enteral feeding tubes, are often relied upon to supplement or replace breast or bottle feeding.

[0004] In some cases, babies may initially be bottle fed, but may require gavage feeding after a certain amount of milk or formula has been consumed orally. The process of switching from standard bottle feeding via a nipple to gavage feeding can be cumbersome, however, and can interrupt the flow and bonding of a feeding session. Currently, to achieve this difficult transition, any milk or formula remaining in the bottle is typically transferred from the original, standard bottle to another bottle and drawn up by a syringe from the secondary bottle, after which the syringe is attached to enteral tubing to deliver the milk directly to the baby’s stomach. This process is unwieldy, and often necessitates putting the baby down or enlisting the help of a second person, thereby disrupting the baby’s feeding experience.

[0005] Milk may also be wasted in the process, as a complete transfer of the remaining milk from the original bottle to the gavage feeding device is unlikely. This milk loss is wasteful and may create difficulties in tracking the exact volume of milk consumed by the baby. When gavage feeding, for example, there is a chance that when pouring the milk to gavage there might be spillage, resulting in loss of breast milk of unknown volume, particularly when a sole nurse or caregiver attempts to hold a wriggling baby during the bottle-to-gavage transfer process. To counteract this inevitable loss, many neonatal intensive care unit (NICU) facilities prepare more milk than needed, in order to compensate for breast milk that is wasted in the enteral tubing. Some mothers produce very small amounts of milk, such that any excess milk that is being made or wasted is likely detracting from the mother and baby's supply, or such that more donor milk is used than is necessary.

[0006] NICU facilities must also take into account that syringes, bottles, and pumps often do not have corresponding measurements. In some cases, if not measured correctly, any milk remaining in the enteral feeding tube at the completion of gavage feeding might be kept from the baby because, per the pump fluid measurements, the feeding may appear to be completed. As a result of this measuring inconsistency, the baby may have lost a portion of milk that was needed to meet total fluid nutritional requirements. With eight feeds per day, these repeated under- measurements could deprive the baby of substantial portions of necessary fluids and caloric needs.

SUMMARY

[0007] Applicant has recognized the difficulties noted above and that there is an unmet need for an apparatus, device, method, and kit to easily and efficiently convert a standard infant feeding bottle from nipple-delivered milk or formula feeding to gavage feeding, while avoiding the clumsiness and waste of typical transition methods. Applicant has also recognized that there is a need for an apparatus, device, method, and kit that easily adapts a universal infant feeding bottle into a gavage feeding device, without the need for additional parts or components, and without the need to purchase or utilize an entirely separate bottle. The present disclosure is directed to an apparatus, device, method, and kit for infant gavage feeding that provides an elegant solution to these previously unmet needs.

[0008] According to an embodiment, an infant gavage feeding apparatus may include an infant feeding bottle, a milk delivery component, a retaining ring, and a pressurizing component. In some embodiments, the infant feeding bottle can include a nipple portion removably secured to a top portion thereof. In some embodiments, the milk delivery component can include a frustoconical portion. An elongate tube portion can be connected to and extend outwardly and distally from the frustoconical portion. The elongate tube portion can be positioned to couple with an enteral feeding tube when positioned adjacent thereto. In some embodiments, the retaining ring can secure a base of the frustoconical portion of the milk delivery component to the top portion of the infant feeding bottle. The nipple portion of the infant feeding bottle can be removable from the top portion of the infant feeding bottle so as to allow attachment of the retaining ring to the infant feeding bottle. In some embodiments, the pressurizing component can be connected to the milk delivery component and positioned so as to increase a pressure within the infant feeding bottle and initiate a flow of milk from the infant feeding bottle into the enteral feeding tube via the milk delivery component when the pressurizing component is depressed.

[0009] In some embodiments, the elongate tube portion of the milk delivery component can include a male luer fitting sized and shaped complementarily to a female luer fitting of the enteral feeding tube, such that a distal end of the elongate tube portion of the milk delivery component is insertable into a proximal end of the enteral feeding tube. In some embodiments, the enteral feeding tube can be selected from any of a nasogastric (NG) tube, an orogastric (OG) tube, a nasoduodenal (ND) tube, a nasojejunal (NJ) tube, a gastric or gastrostomy (G) tube, a gastrojejunal (GJ) tube, a transjejunal tube, and a jejunal (J) tube.

[0010] In some embodiments, the milk delivery component can further include a shoulder portion connected to and positioned between the base of the frustoconical portion and the retaining ring. The shoulder portion can be positioned to allow the flow of milk from the infant feeding bottle into the enteral feeding tube via the milk delivery component.

[0011] In some embodiments, the pressurizing component can include the shoulder portion, the shoulder portion having a depressible component positioned proximate to the base of the frustoconical portion of the milk delivery component.

[0012] In some embodiments, the pressurizing component can include a depressible component positioned between the retaining ring and the top portion of the infant feeding bottle. In some embodiments, the pressurizing component can be positioned such that tightening the retaining ring to the top portion of the infant feeding bottle can depress the depressible component of the pressurizing component and increase the pressure within the infant feeding bottle. [0013] The present disclosure also discloses embodiments directed to an infant gavage feeding device to transform an infant feeding bottle into an infant gavage feeding apparatus. In some embodiments, the device can include a milk delivery component and a pressurizing component. In some embodiments, the milk delivery component can include a frustoconical portion. An elongate tube portion can be connected to and extend outwardly and distally from the frustoconical portion. The elongate tube portion can be positioned to couple with an enteral feeding tube when positioned adjacent thereto. In some embodiments, the pressurizing component can be connected to the milk delivery component and positioned so as to increase a pressure inside an infant feeding bottle when the infant gavage feeding device is fluidly connected to the infant feeding bottle and so as to initiate a flow of milk from the infant feeding bottle into the enteral feeding tube via the milk delivery component when the pressurizing component is depressed.

[0014] In some embodiments, the infant gavage feeding device can further include a retaining ring to secure a base of the frustoconical portion of the milk delivery component to a top portion of the infant feeding bottle. A nipple portion of the infant feeding bottle can be removable from the top portion of the infant feeding bottle so as to allow attachment of the retaining ring to the infant feeding bottle. In some embodiments, the retaining ring can include a threaded component for connecting the retaining ring to the top portion of the infant feeding bottle so as to form a liquid-tight seal.

[0015] In some embodiments, the milk delivery component can further include a shoulder portion connected to and positioned between the base of the frustoconical portion and the retaining ring. The shoulder portion can be positioned to allow the flow of milk from the infant feeding bottle into the enteral feeding tube via the milk delivery component. [0016] In some embodiments, the pressurizing component can include the shoulder portion, and the shoulder portion can have a depressible component positioned proximate to the base of the frustoconical portion of the milk delivery component.

[0017] In some embodiments, the pressurizing component can include a depressible component positioned between the retaining ring and the top portion of the infant feeding bottle. In some embodiments, the pressurizing component can be positioned such that tightening the retaining ring to the top portion of the infant feeding bottle depresses the depressible component of the pressurizing component and increases the pressure within the infant feeding bottle.

[0018] In some embodiments, the pressurizing component can be formed of one or more of rubber, silicone, and latex.

[0019] The present disclosure further includes embodiments directed to a kit to transform an infant feeding bottle into an infant gavage feeding apparatus. In some embodiments, the kit can include a container and an infant gavage feeding device positioned in the container. In some embodiments, the infant gavage feeding device can include a milk delivery component, a retaining ring, and a pressurizing component. In some embodiments, the milk delivery component can include a frustoconical portion. An elongate tube portion can be connected to and can extend outwardly and distally from the frustoconical portion, and the elongate tube portion can be positioned to couple with an enteral feeding tube when positioned adjacent thereto. In some embodiments, the retaining ring can secure a base of the frustoconical portion of the milk delivery component to a top portion of the infant feeding bottle. A nipple portion of the infant feeding bottle can be removable from the top portion of the infant feeding bottle so as to allow attachment of the retaining ring to the infant feeding bottle. In some embodiments, the pressurizing component can be connected to the milk delivery component and positioned so as to increase a pressure inside an infant feeding bottle when the infant gavage feeding device is fluidly connected to the infant feeding bottle and so as to initiate a flow of milk from the infant feeding bottle into the enteral feeding tube via the milk delivery component when the pressurizing component is depressed.

[0020] In some embodiments, the kit further can include the enteral feeding tube positioned in the container. In some embodiments, the elongate tube portion of the milk delivery component can include a male luer fitting sized and shaped complementarily to a female luer fitting of the enteral feeding tube, such that a distal end of the elongate tube portion of the milk delivery component is insertable into a proximal end of the enteral feeding tube. In some embodiments, the enteral feeding tube can be selected from any of a nasogastric (NG) tube, an orogastric (OG) tube, a nasoduodenal (ND) tube, a nasojejunal (NJ) tube, a gastric or gastrostomy (G) tube, a gastrojejunal (GJ) tube, a transjejunal tube, and a jejunal (J) tube.

[0021] In some embodiments, the kit still further can include an infant gavage feeding device attachment component positioned in the container. The attachment component can have a clip to secure the infant gavage feeding device in an inverted orientation so as to allow hands-free feeding, and the infant gavage feeding device attachment component can be removably securable to one or more of: (a) the infant feeding bottle; and (b) the milk delivery component.

[0022] The present disclosure still further has embodiments directed to a method to operate an infant gavage feeding apparatus. In some embodiments, the method can include removing a nipple portion from a top portion of an infant feeding bottle. In some embodiments, the method can further include replacing the removed nipple portion with a milk delivery component. The milk delivery component can include a frustoconical portion, and an elongate tube portion can be connected to and extend outwardly and distally from the frustoconical portion. The elongate tube portion can be positioned to couple with an enteral feeding tube when positioned adjacent thereto. In some embodiments, the method further can include fluidly connecting a distal end of the elongate tube portion of the milk delivery component to a proximal end of the enteral feeding tube, and inverting the infant feeding bottle. In some embodiments, the method still further can include depressing a pressurizing component connected to the milk delivery component and positioned so as to increase a pressure within the infant feeding bottle and initiate a flow of milk from the infant feeding bottle into the enteral feeding tube via the milk delivery component when the pressurizing component is depressed.

[0023] In some embodiments, the step of removing the nipple portion from the infant feeding bottle can include removing the nipple portion from a retaining ring. The retaining ring, for example, can be positioned to connect the nipple portion to the top portion of the infant feeding bottle with a threaded component so as to form a liquid-tight seal. In some embodiments, the step of replacing the removed nipple portion with the milk delivery component can include inserting the milk delivery component into the retaining ring, and connecting the milk delivery component and the retaining ring to the top portion of the infant feeding bottle.

[0024] In some embodiments, the step of removing the nipple portion from the infant feeding bottle can include removing the nipple portion and a retaining ring positioned to connect the nipple portion to the infant feeding bottle from the top portion of the infant feeding bottle, and connecting the milk delivery component to the top portion of the infant feeding bottle.

[0025] In some embodiments, the step of fluidly connecting the distal end of the elongate tube portion of the milk delivery component to the proximal end of the enteral feeding tube can include inserting the distal end of the elongate tube portion of the milk delivery component into the proximal end of the enteral feeding tube. The distal end can include a male luer fitting, and the proximal end can include a female luer fitting sized and shaped complementarily to the male luer fitting so as to form a liquid-tight seal. In some embodiments, the enteral feeding tube can be selected from any of a nasogastric (NG) tube, an orogastric (OG) tube, a nasoduodenal (ND) tube, a nasojejunal (NJ) tube, a gastric or gastrostomy (G) tube, a gastrojejunal (GJ) tube, a transjejunal tube, and a jejunal (J) tube.

[0026] In some embodiments, the step of depressing the pressurizing component can include one or more of: (a) tightening a retaining ring positioned to connect the milk delivery component to the infant feeding bottle; and (b) depressing a depressible component positioned proximate to the milk delivery component.

[0027] Other aspects and features of the present disclosure will become apparent to those of ordinary skill in the art after reading the detailed description herein and the accompanying figures.

BRIEF DESCRIPTION OF DRAWINGS

[0028] Some of the features and benefits of the present disclosure having been stated, others will become apparent as the description proceeds when taken in conjunction with the accompanying drawings, in which:

[0029] FIG. 1 is a perspective view of an infant gavage feeding apparatus positioned adjacent to an enteral feeding tube, according to an embodiment.

[0030] FIG. 2A is a partial perspective view of an infant gavage feeding device coupled to an enteral feeding tube, according to an embodiment.

[0031] FIG. 2B is a partial rear perspective view of an infant gavage feeding device coupled to an enteral feeding tube, according to an embodiment. [0032] FIG. 3A is a partial perspective view of an infant gavage feeding device coupled to an enteral feeding tube, according to another embodiment.

[0033] FIG. 3B is an exploded partial perspective view of an infant gavage feeding device, a retaining ring, and an enteral feeding tube, according to an embodiment.

[0034] FIG. 3C is a partial rear perspective view of an infant gavage feeding device coupled to an enteral feeding tube, according to an embodiment.

[0035] FIG. 4 is perspective view of a kit to transform an infant feeding bottle into an infant gavage feeding apparatus, according to an embodiment.

[0036] FIG. 5 is a partial front elevational view of an infant gavage feeding device attachment component and an infant gavage feeding apparatus in use, according to an embodiment.

[0037] FIG. 6A is an exploded perspective view of a standard infant feeding bottle, according to an embodiment.

[0038] FIG. 6B is an exploded perspective view of an infant gavage feeding apparatus, according to an embodiment.

[0039] FIG. 6C is an exploded perspective view of an infant gavage feeding apparatus, according to another embodiment.

[0040] While the disclosure will be described in connection with the preferred embodiments, it will be understood that it is not intended to limit the disclosure to that embodiment. On the contrary, it is intended to cover all alternatives, modifications, and equivalents, as may be included within the spirit and scope of the disclosure as defined by the appended claims. PET ATT, ED DESCRIPTION

[0041] The method and system of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings in which embodiments are shown.

[0042] The present disclosure is directed to an infant gavage feeding apparatus, for example as illustrated in FIG. 1, according to an embodiment. The infant gavage feeding apparatus 100 may include an infant feeding bottle 105, a milk delivery component 115, a retaining ring 135, and a pressurizing component 140, according to an embodiment. The infant feeding bottle 105 may be a standard or universal infant feeding bottle, which may be compatible with a variety of infant feeding nipples, depending on individual infant ages, stages, and other physiological needs. As illustrated in the embodiment of FIG. 1, the nipple portion of the infant feeding bottle 105 has been removed from the top portion 110 of the infant feeding bottle 105 so as to allow for attachment of the retaining ring 135 and milk delivery component 115 to the top portion 110 of the infant feeding bottle 105.

[0043] As illustrated, the milk delivery component 115 can include a frustoconical portion 120, having an elongate tube portion 125 connected to and extending outwardly and distally from the frustoconical portion 120, and a cylindrical portion 122 connected to and extending outwardly and proximally from the frustoconical portion 120. The elongate tube portion 125 can be positioned to couple with an enteral feeding tube 130 when positioned adjacent thereto, in order to allow for gavage feeding of milk or formula from the infant feeding bottle 105, for example as illustrated in FIGS. 2 A and 2B. The angle at which the frustoconical portion 120 extends between the elongate tube portion 125 and the cylindrical portion 122 can be formed at any acute or obtuse angle sufficient to allow for passage of milk between the infant feeding bottle 105 and the enteral feeding tube 130, as will be readily understood by one of ordinary skill in the art. [0044] In some embodiments, the frustoconical portion 120, cylindrical portion 122, and elongate tube portion 125 of the milk delivery component 115 can be formed of plastic or some other suitable solid or semi-solid material to facilitate flow of milk or formula from the infant feeding bottle 105 to the enteral feeding tube 130, and to allow for secure coupling between the elongate tube portion 125 and the enteral feeding tube 130. In some embodiments, the milk delivery component 115 and/or the infant gavage feeding device 150 can be formed of bisphenol-a (BPA)-free plastic. Appropriate materials for formation of the milk delivery component 115 and the infant gavage feeding device 150 will be readily understood by one of ordinary skill in the art.

[0045] In some embodiments, the frustoconical portion 120, cylindrical portion 122, and elongate tube portion 125 of the milk delivery component 115 can be formed of molded plastic having varying diameters for each portion formed in a stepwise sequence, as illustrated. In other embodiments, the frustoconical portion 120, cylindrical portion 122, and elongate tube portion 125 of the milk delivery component 115 can be formed such that the transition between each segment is gradual or continuous. In other embodiments, the frustoconical portion 120, cylindrical portion 122, and elongate tube portion 125 can be formed as a single, continuous component, formed of the same molded plastic, rubber, silicone, or other appropriate material, as will be readily understood by one of ordinary skill in the art.

[0046] The infant gavage feeding apparatus 100 can also include a retaining ring 135 to secure a base of the cylindrical portion 122 of the milk delivery component 115 to the top portion 110 of the infant feeding bottle 105. In some embodiments, as illustrated in FIG. 6B, for example, the retaining ring 135 and milk delivery component 115 may be a single component, whereas in other embodiments, for example as illustrated in FIG. 6C, the retaining ring 137 and milk delivery component 315 may be separate components. In the latter case, according to some embodiments, the retaining ring 137 used with the nipple portion of the infant feeding bottle 105 may be reused with the milk delivery component 315, while in other embodiments a separate retaining ring 137 may be used.

[0047] As further illustrated in FIG. 1, the infant gavage feeding apparatus 100 may include a pressurizing component 140 connected to the milk delivery component 115 and positioned so as to increase a pressure within the infant feeding bottle 105 and initiate a flow of milk or formula from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115 when the pressurizing component 140 is depressed. In some embodiments, for example as illustrated in FIG. 2 A, the pressurizing component 140 may be positioned outside the retaining ring 135, and may allow for an increase in pressure in the infant feeding bottle 105 as a result of exerting downward force 207 on the pressurizing component 140. In other embodiments, for example as illustrated in FIG. 3B, the pressurizing component 440 may be positioned underneath the retaining ring 137, and may allow for pressurizing the infant feeding bottle 105 by rotating 307 the retaining ring 137 about the top portion 110 of the infant feeding bottle 105.

[0048] In the embodiment illustrated in FIG. 1, the pressurizing component 140 and cylindrical portion 122 may include a stepwise transition between a greater diameter of the pressurizing component 140 and a lesser diameter of the cylindrical portion 122. In other embodiments, the pressurizing component 140 and cylindrical portion 122 may share a single, continuous diameter, as will be readily understood by one having ordinary skill in the art.

[0049] As illustrated in FIG. 2 A, in some embodiments the elongate tube portion 125 of the milk delivery component 115 can include a male luer fitting 127 sized and shaped complementarily to a female luer fitting 132 of the enteral feeding tube 130. The complementary size and shape of the male luer fitting 127 and female luer fitting 132 can allow a distal end of the elongate tube portion 125 of the milk delivery component 115 to be inserted into a proximal end of the enteral feeding tube 130 to form a liquid-tight seal. By forming this seal, milk or formula can flow freely from the infant feeding bottle 105 into the enteral feeding tube 130 by gravity through the milk delivery component 115. In some embodiments, a removable cap can be positioned over the male luer fitting 127 to keep the milk delivery component 115 sealed prior to connection to the enteral feeding tube 130 and use.

[0050] In various embodiments, the enteral feeding tube 130 can be selected from any of a nasogastric (NG) tube, an orogastric (OG) tube, a nasoduodenal (ND) tube, a nasojejunal (NJ) tube, a gastric or gastrostomy (G) tube, a gastrojejunal (GJ) tube, a transjejunal tube, and a jejunal (J) tube, or any other enteral feeding tube as will be readily understood by one having ordinary skill in the art. In addition, in various embodiments the elongate tube portion 125 of the milk delivery component 115 may connect or couple to the enteral feeding tube 130 by any means understood and utilized in the art, such as by a threaded or snap connection, or by simple male-to-female insertion, among others, as will be readily understood by one having ordinary skill in the art.

[0051] As illustrated in FIG. 2 A, in some embodiments the milk delivery component 115 can include shoulder portion 145 connected to and positioned between the cylindrical portion 122 at the base of the frustoconical portion 120 and the retaining ring 135, so as to allow the flow of milk or formula from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115. By providing this sloped or angled transition between the infant feeding bottle 105 and the cylindrical portion 122 of the milk delivery component 115, backup or incomplete delivery of milk or formula can be avoided. The angle at which the cylindrical portion 122 meets the base of the frustoconical portion 120 to form the shoulder portion 145 can range between obtuse and acute, as will be readily understood by one having ordinary skill in the art, in order to facilitate milk flow.

[0052] In some embodiments, for example as illustrated in FIG. 2A, the pressurizing component 140 can be a component of the shoulder portion 145. For example, the shoulder portion 145 can have a depressible component positioned proximate to the cylindrical portion 122 at the base of the frustoconical portion 120 of the milk delivery component 115. The pressurizing component 140 can be formed of rubber, silicone, latex, or another appropriate flexible material, as will be readily understood by one of ordinary skill in the art, in order to allow the pressurizing component 140 to be depressed in a downward direction 207 towards the retaining ring 135. By applying downward pressure 207 to the pressurizing component 140, as illustrated, a pressure inside the infant feeding bottle 105 may be increased. This pressurization may be particularly useful to start, restart, or increase the flow of milk or formula from the infant feeding bottle 105 into the enteral feeding tube 130. In some instances, this pressurization may be necessary to facilitate the flow of thicker milk or formula, for example.

[0053] In other embodiments, for example as illustrated in FIGS. 3B and 3C, the pressurizing component 340 includes a depressible component positioned between the retaining ring 137 and the top portion 110 of the infant feeding bottle 105. In such embodiments, the pressurizing component 340 can be positioned such that tightening 307 the retaining ring 137 to the top portion 110 of the infant feeding bottle 105 - for example by rotating the retaining ring 137 to engage the threaded portion of the top portion 110 of the infant feeding bottle 105, according to some embodiments - depresses the depressible component of the pressurizing component 340 and increases the pressure within the infant feeding bottle 105. Also in such embodiments, the frustoconical portion 120, cylindrical portion 122, and elongate tube portion 125 of the milk delivery component 315 may be formed of a rigid or semi-rigid material, such as BPA-free plastic or another suitable material, as will be readily understood in the art. The pressurizing component 340, forming a ring at the base of the cylindrical portion 122 and positionable under the retaining ring 137, may be formed of a flexible, depressible material such as silicone, latex, or rubber, or any other suitable material as will be readily understood by one having ordinary skill in the art.

[0054] The present disclosure is also directed to an infant gavage feeding device to transform an infant feeding bottle 105 into an infant gavage feeding apparatus 100. In some embodiments, the infant gavage feeding device can be sterile prior to use, and can be positioned for single use, such that the infant gavage feeding device is disposable after use. In other embodiments, the infant gavage feeding device may be reusable.

[0055] In some embodiments, the infant gavage feeding device 150, 350 can include a milk delivery component 115, 315 and a pressurizing component 140, 340. According to some embodiments, the milk delivery component 115, 315 can include a frustoconical portion 120. An elongate tube portion 125 can be connected to and extend outwardly and distally from the frustoconical portion 120, and the elongate tube portion 125 can be positioned to couple with an enteral feeding tube 130 when positioned adjacent thereto. The infant gavage feeding device 150, 350 can also include a pressurizing component 140, 340 connected to the milk delivery component 115, 315 and positioned so as to increase a pressure inside an infant feeding bottle 105 when the infant gavage feeding device 150, 350 is fluidly connected to the infant feeding bottle 105 and so as to initiate a flow of milk from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115, 315 when the pressurizing component 140, 340 is depressed.

[0056] In some embodiments, for example as illustrated in FIG. 2A, the pressurizing component 140 of the infant gavage feeding device 150 can be positioned adjacent the cylindrical portion 122 at a base of the frustoconical portion 120, and can be used to increase pressure within the infant feeding bottle 105 by exerting pressure on the pressurizing component 140 in a downward direction 207, toward the retaining ring 135 positioned on an upper portion 110 of the infant feeding bottle 105.

[0057] In some embodiments, the infant gavage feeding device 150, 350 can further include a retaining ring 135, 137 to secure a base of the frustoconical portion 120 and cylindrical portion 122 of the milk delivery component 115 to a top portion 110 of the infant feeding bottle 105. In some embodiments, a nipple portion 675 of the infant feeding bottle 105 can be removable, for example as shown in FIG. 6 A, from the top portion 110 of the infant feeding bottle 105 so as to allow attachment of the retaining ring 135, 137 to the infant feeding bottle 105. In some embodiments, the retaining ring 135, 137 can include a threaded component for connecting the retaining ring 135, 137 to the infant feeding bottle 105 so as to form a liquid-tight seal. In other embodiments, various other attachment means between the retaining ring 135, 137 and the top portion 110 of the infant feeding bottle 105 may be utilized, such as a snap fitting or the like, as will be readily understood by one of ordinary skill in the art.

[0058] In the embodiments as illustrated in FIGS. 2 A and 2B, for example, the retaining ring 135 and the infant gavage feeding device 150, the latter of which includes the milk delivery component 115 and the pressurizing component 140, can be a single component. In such an embodiment, the pressurizing component 140 can connect the cylindrical portion 122 at the base of the frustoconical portion 120 of the milk delivery component 115 to the retaining ring 135.

[0059] In other embodiments, for example as illustrated in FIGS. 3A-C, the retaining ring 137 and the infant gavage feeding device 350, the latter of which includes the milk delivery component 315 and the pressurizing component 340, can be two separate components. In such an embodiment, the pressurizing component 340 can form a ring adjacent the cylindrical portion 122 at a base of the frustoconical portion 120 of the milk delivery component 315. The ring of the pressurizing component 340 can then be positioned under the retaining ring 137 in order to secure the infant gavage feeding device 350 to the top portion 110 of the infant feeding bottle 105. In some embodiments, the milk delivery component 315 can be inserted through an opening in the retaining ring 137 until the pressurizing component 340 is positioned under a top lip of the retaining ring 137. In other embodiments, the infant gavage feeding device 350 can be inserted upwardly through the opening in the retaining ring 137 until the pressurizing component 340 is positioned under and abutting the top lip of the retaining ring 137.

[0060] In some embodiments, the pressurizing component 340 can include a depressible component positioned between the retaining ring 137 and the top portion 110 of the infant feeding bottle 105. The pressurizing component 340 can be positioned such that rotating 307 the retaining ring 137 so as to tighten the retaining ring 137 to the top portion 110 of the infant feeding bottle 105 depresses the depressible component of the pressurizing component 340 and increases the pressure within the infant feeding bottle 105.

[0061] In the embodiments illustrated in FIGS. 1-2B, the milk delivery component 115 additionally can include a shoulder portion 145 connected to and positioned between the cylindrical portion 122 at the base of the frustoconical portion 120 and the retaining ring 135, the shoulder portion 145 positioned to allow the flow of milk from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115. In embodiments where the retaining ring 135 and infant gavage feeding device 150 are a single component, the pressurizing component 140 can include the shoulder portion 145, and the shoulder portion 145 can have a depressible component positioned proximate to the cylindrical portion 122 at the base of the frustoconical portion 120 of the milk delivery component 115. In embodiments where the retaining ring 137 and infant gavage feeding device 350 are separate components, the shoulder portion 145 can form the transition between the cylindrical portion 122 at the base of the frustoconical portion 120 and the pressurizing component 340 in some examples, while in other embodiments the cylindrical portion 122 may not transition with a shoulder portion into the pressurizing component 340, but rather may include a stepwise transition, for example as illustrated in FIG. 3 A, and as will be readily understood by one of ordinary skill in the art.

[0062] The present disclosure is also directed to a kit configured to transform an infant feeding bottle into an infant gavage feeding apparatus. In some embodiments, for example as illustrated in FIG. 4, the kit 400 can include a container 455 and an infant gavage feeding device 150 positioned in the container. The container 455 may take the form of a box or carton; molded plastic, cardboard, or felt form; envelope; or the like, as will be readily understood by one having ordinary skill in the art. In some embodiments, the container 455 can be positioned to maintain the contents of the container 455 in a sterile condition prior to use. Although described and illustrated in FIG. 4 with respect to an infant gavage feeding device 150, in which the milk delivery component 115, pressurizing component 140, and retaining ring 135 are a single component, in other embodiments the kit 400 can include an infant gavage feeding device 350, in which the milk delivery component 315 and pressurizing component 340 are separate from the retaining ring 137, as discussed above. In the latter embodiments, the kit 400 may or may not include the retaining ring 137.

[0063] As discussed above, the infant gavage feeding device 150 can include a milk delivery component 115, a retaining ring 135, and a pressurizing component 140, according to the illustrated embodiment. The milk delivery component 115 can include a frustoconical portion 120, with an elongate tube portion 125 connecting to and extending outwardly and distally from the frustoconical portion 120. The elongate tube portion 125 can be positioned to couple with an enteral feeding tube 130 when positioned adjacent thereto. The retaining ring 135 can secure a base of the frustoconical portion 120 to a top portion 110 of the infant feeding bottle 105. A nipple portion of the infant feeding bottle 105 can be removable from the top portion 110 of the infant feeding bottle 105 so as to allow attachment of the retaining ring 135 to the infant feeding bottle 105. The pressurizing component 140 can be connected to the milk delivery component 115 and positioned so as to increase a pressure inside the infant feeding bottle 105 when the infant gavage feeding device 150 is fluidly connected to the infant feeding bottle 105 and so as to initiate a flow of milk from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115 when the pressurizing component 140 is depressed.

[0064] In some embodiments, the kit 400 can further include an enteral feeding tube 130 positioned in the container 455. As previously discussed, the elongate tube portion 125 of the milk delivery component 115 can include a male luer fitting 127 sized and shaped complementarily to a female luer fitting 132 of the enteral feeding tube 130, such that a distal end of the elongate tube portion 125 of the milk delivery component 115 is insertable into a proximal end of the enteral feeding tube 130. In some embodiments, the kit 400 can additionally include a removable cap to cover the male luer fitting 127 of the milk delivery component 115 when not in use so as to maintain sterility. In some embodiments, the enteral feeding tube 130 can be selected from any of a nasogastric (NG) tube, an orogastric (OG) tube, a nasoduodenal (ND) tube, a nasojejunal (NJ) tube, a gastric or gastrostomy (G) tube, a gastrojejunal (GJ) tube, a transjejunal tube, and a jejunal (J) tube.

[0065] In some embodiments, the kit 400 can further include an infant gavage feeding device attachment component 565 positioned in the container 455, the attachment component 565 having a clip 570 to secure the infant gavage feeding device 150 in an inverted orientation so as to allow for hands-free feeding. As illustrated in the embodiment of FIG. 5, the infant gavage feeding device attachment component 565 can be removably securable to the infant feeding bottle 105, or in alternate embodiments can be removably securable to the infant gavage feeding device 150, or in still other embodiments can be removably securable to both the infant feeding bottle 105 and the infant gavage feeding device 150. As illustrated, the infant gavage feeding device attachment component 565 can include one or more full or partial ring structures to encircle and removably secure the infant feeding bottle 105 and/or infant gavage feeding device 150. In other embodiments, various other removable attachment means are contemplated, as will be readily understood by one of ordinary skill in the art.

[0066] In the illustrated embodiment, the infant gavage feeding device attachment component 565 is secured to the shirt or other portion of a user 560 by a clip 570 or other suitable attachment component, such that the infant gavage feeding device 150 and infant feeding bottle 105 are suspended in an inverted orientation to allow for hands-free feeding. Although illustrated as a clip 570, in other embodiments the infant gavage feeding device attachment component 565 may be secured to a user 560 or to a stationary object, such as a piece of furniture of medical stand, by any appropriate means, as will be readily understood by one having ordinary skill in the art.

[0067] The present disclosure is also directed to a method to operate an infant gavage feeding apparatus 100. In some embodiments, the method can include removing a nipple portion 675 from a top portion 110 of an infant feeding bottle 105, as illustrated in FIG. 6A, and replacing the removed nipple portion 675 with a milk delivery component 115, 315, as illustrated in FIGS. 6B and 6C, respectively. As illustrated in FIG. 6 A, removing the nipple portion 675 can include releasing the retaining ring 137 from the top portion 110 of the infant feeding bottle 105, for example by rotating the retaining ring 137 on a threaded portion of the top portion 110 of the infant feeding bottle 105. In other embodiments, the retaining ring 137 may be removed from the infant feeding bottle 105 by any other acceptable means, such as by unsnapping or the like, as will be readily understood by one of ordinary skill in the art.

[0068] Once the nipple portion 675 has been removed, the milk delivery component 115, 315 can be replaced on the top portion 110 of the infant feeding bottle 105. The milk delivery component 115, 315 can include a frustoconical portion 120 and an elongate tube portion 125 connected to and extending outwardly and distally from the frustoconical portion 120. The elongate tube portion 125 can be positioned to couple with an enteral feeding tube 130 when positioned adjacent thereto.

[0069] The method can further include fluidly connecting a distal end of the elongate tube portion 125 of the milk delivery component 115, 315 to a proximal end of the enteral feeding tube 130, for example as illustrated in the embodiments according to FIGS. 2 and 3A. The method can further include inverting the infant feeding bottle 105 and depressing a pressurizing component 140, 340 connected to the milk delivery component 115, 315 so as to increase a pressure within the infant feeding bottle 105 and initiate a flow of milk from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115, 315 when the pressurizing component 140, 340 is depressed.

[0070] In some embodiments, for example as illustrated in FIG. 6C, removing the nipple portion 675 from the infant feeding bottle can include removing the nipple portion 675 from the retaining ring 137. The retaining ring 137 can be positioned to connect the nipple portion 675 to the top portion 110 of the infant feeding bottle 105 with a threaded component so as to form a liquid-tight seal. The step of replacing the removed nipple portion 675 with the milk delivery component 315 can additionally include inserting the milk delivery component 315 into the retaining ring 137, either through the top or bottom of the retaining ring 137, as previously discussed, and connecting the milk delivery component 315 and the retaining ring 137 to the top portion 110 of the infant feeding bottle 105.

[0071] In other embodiments, for example as illustrated in FIG. 6B, removing the nipple portion 675 from the infant feeding bottle 105 can include removing the nipple portion 675 and the retaining ring 137 positioned to connect the nipple portion 675 to the infant feeding bottle 105 from the top portion 110 of the infant feeding bottle 105, and connecting the milk delivery component 115, attached to retaining ring 135, to the top portion 110 of the infant feeding bottle 105.

[0072] In some embodiments, the step of fluidly connecting the distal end of the elongate tube portion 125 of the milk delivery component 115, 315 to the proximal end of the enteral feeding tube 130 can include inserting the distal end of the elongate tube portion 125 of the milk delivery component 115, 315 into the proximal end of the enteral feeding tube 130. In some embodiments, as described above, the distal end of the enteral feeding tube 130 can include a male luer fitting 127, and the proximal end of the enteral feeding tube 130 can include a female luer fitting 132 sized and shaped complementarily to the male luer fitting 127 so as to form a liquid-tight seal. In some embodiments, a removable cap can be positioned on the distal end of the male luer fitting 127 when the milk delivery component 115, 315 is not in use, so as to maintain sterility, and can be removed in order to couple the male luer fitting 127 to the female luer fitting 132 of the enteral feeding tube 130. In some embodiments, the enteral feeding tube can be selected from any of a nasogastric (NG) tube, an orogastric (OG) tube, a nasoduodenal (ND) tube, a nasojejunal (NJ) tube, a gastric or gastrostomy (G) tube, a gastrojejunal (GJ) tube, a transjejunal tube, and a jejunal (J) tube.

[0073] In some embodiments, for example as illustrated in the embodiment of FIG. 2A, the step of depressing the pressurizing component 140 can include depressing 207 a depressible component positioned proximate to the milk delivery component 115. In other embodiments, for example as illustrated in the embodiment of FIG. 3B, the step of depressing the pressurizing component 340 can include tightening 307 the retaining ring 137 positioned to connect the milk delivery component 315 to the infant feeding bottle 105. In either embodiment, depressing the pressurizing component 140, 340 can increase a pressure within the infant feeding bottle 105 in order to start, restart, or increase the flow of milk or formula from the infant feeding bottle 105 into the enteral feeding tube 130 via the milk delivery component 115, 315. This may be particularly beneficial for thicker milk or formula.

[0074] This application is a PCT application, and claims priority to, and the benefit of, U.S. Provisional Application No. 62/640,346, filed March 8, 2018, titled“APPARATUS, DEVICE, METHOD, AND KIT FOR INFANT GAVAGE FEEDING,” which is incorporated herein by reference in its entirety. [0075] The present disclosure described herein, therefore, is well adapted to carry out the objects and attain the ends and advantages mentioned, as well as others inherent therein. While a presently preferred embodiment of the disclosure has been given for purposes of disclosure, numerous changes exist in the details of procedures for accomplishing the desired results. These and other similar modifications will readily suggest themselves to those skilled in the art, and are intended to be encompassed within the spirit of the present disclosure disclosed herein and the scope of the appended claims.