ENTERAL FEEDING SYSTEM
20240261192 ยท 2024-08-08
Inventors
Cpc classification
A61J15/0026
HUMAN NECESSITIES
A61J1/1462
HUMAN NECESSITIES
A61J11/0005
HUMAN NECESSITIES
International classification
Abstract
A dispensing cap comprising a grasping body, a spout engaging bore and a dispensing coupling. The dispensing coupling has a dispensing cap coupled thereto through a tether. A pouch assembly is likewise disclosed, as is a process of enteral feeding with a pouch and a dispensing cap attachable to the spout. The dispensing cap can be provided and attached to a spout of a pouch (upon removal of a filling cap) wherein the dispensing cap may be provided in a sterilized bag or pouch prior to use. Methods and processes are likewise disclosed.
Claims
1.-20. (canceled)
21. A pouch assembly comprising: a pouch with a pouch body being flexible and defining a volume and a spout providing fluid communication with the volume; a dispensing cap coupled to the spout in fluid tight engagement, the dispensing cap comprising: a grasping body having an outer surface the grasping body having a lower end which is spaced apart from the pouch body; a spout engaging bore structurally configured to engage the spout; a spout engaging end extending from the bore and having an outlet opening that is in fluid communication with the spout, and in turn, the volume, the spout engaging end having an outer surface that is perpendicular to the spout engaging bore, and defining an outer rim; and a dispensing coupling extending from the spout engaging end, with the dispensing coupling being in fluid communication with the outlet opening, the dispensing coupling comprising an EnFit coupling; a flip-top cover positionable to overlie the dispensing coupling, the dispensing cover further comprising: a cap outer rim engaging the outer rim of the of the spout engaging end; a bore cover extending from an inner surface of the flip-top cover, structurally configured to engage a terminal end of the dispensing coupling; and a live hinge assembly having: a pair of spaced apart live hinge components, each having a first end coupled to the outer surface of the grasping body proximate the outer rim of the spout engaging end, and a second end coupled to the flip-top cover proximate the cap outer rim; and a limiting member positioned between each of the live hinge components, the limiting member having a first end coupled to the outer surface of the grasping body proximate the outer rim of the spout engaging end, and a second end coupled to the flip-top cover, whereupon a user can grasp the outer surface of the grasping body and while manipulating the flip-top cover between a first closed orientation and a second open orientation with a single hand spaced apart from the pouch body.
22. The pouch assembly of claim 21 further comprising an outer flange extending from the spout engaging end, and the flip-top cover includes an outer rim, wherein the outer flange and the outer rim interface in a closed configuration.
23. The pouch assembly of claim 21 further comprising a finger extending from the flip-top cover opposite the live hinge assembly, the finger facilitating movement of the flip-top cover about the live hinge-configuration.
24. The pouch assembly of claim 21 wherein the EnFit coupling further includes an elongated bore with an outer surface, the outer surface including a frustoconical portion extending from the spout engaging end and terminating at a beveled portion.
25. The pouch assembly of claim 21 wherein the pouch includes human breast milk.
26. The pouch assembly of claim 21 wherein the outward flange extends about the entirety of a perimeter of the outer surface of the spout engaging end.
27. The pouch assembly of claim 21 wherein the entirety of the outer surface of the spout engaging end within the perimeter comprises a planar configuration surrounding dispensing opening which is centrally located.
28. The pouch assembly of claim 21 wherein the dispensing cap is threadedly engaged to the spout of the pouch.
29. The pouch assembly of claim 21 wherein the pouch body is formed from a plurality of panels coupled together through at least one seal, with the spout having a base flange coupled to the plurality of panels about the at least one seal.
30. The pouch assembly of claim 21 wherein the spout includes a base flange with the base flange defining a footprint, wherein the outer surface of the grasping body extends beyond the footprint of the base flange of the spout.
31. The pouch assembly of claim 21 wherein the grasping body has a substantially cylindrical configuration.
32. The pouch assembly of claim 21 wherein the upper surface includes a plurality of openings extending therethrough.
33. A dispensing cap structurally configured for attachment to a spout of a pouch assembly, the dispensing cap comprising: a grasping body having an outer surface the grasping body having a lower end which is spaced apart from the pouch body; a spout engaging bore structurally configured to engage the spout; a spout engaging end extending from the bore and having an outlet opening that is in fluid communication with the spout, and in turn, the volume, the spout engaging end having an outer surface that is perpendicular to the spout engaging bore, and defining an outer rim; and a dispensing coupling extending from the spout engaging end, with the dispensing coupling being in fluid communication with the outlet opening, the dispensing coupling comprising an EnFit coupling; a flip-top cover positionable to overlie the dispensing coupling, the dispensing cover further comprising: a cap outer rim engaging the outer rim of the of the spout engaging end; a bore cover extending from an inner surface of the flip-top cover, structurally configured to engage a terminal end of the dispensing coupling; and a live hinge assembly having: a pair of spaced apart live hinge components, each having a first end coupled to the outer surface of the grasping body proximate the outer rim of the spout engaging end, and a second end coupled to the flip-top cover proximate the cap outer rim; and a limiting member positioned between each of the live hinge components, the limiting member having a first end coupled to the outer surface of the grasping body proximate the outer rim of the spout engaging end, and a second end coupled to the flip-top cover, whereupon a user can grasp the outer surface of the grasping body and while manipulating the flip-top cover between a first closed orientation and a second open orientation with a single hand spaced apart from the pouch body.
34. The dispensing cap of claim 13 further comprising an outer flange extending from the spout engaging end, and the flip-top cover includes an outer rim, wherein the outer flange and the outer rim interface in a closed configuration.
35. The dispensing cap of claim 13 further comprising a finger extending from the flip-top cover opposite the live hinge assembly, the finger facilitating movement of the flip-top cover about the live hinge-configuration.
36. The dispensing cap of claim 13 wherein the EnFit coupling further includes an elongated bore with an outer surface, the outer surface including a frustoconical portion extending from the spout engaging end and terminating at a beveled portion.
37. The dispensing cap of claim 13 wherein the outward flange extends about the entirety of a perimeter of the outer surface of the spout engaging end.
38. The dispensing cap of claim 13 wherein the entirety of the outer surface of the spout engaging end within the perimeter comprises a planar configuration surrounding dispensing opening which is centrally located.
39. The dispensing cap of claim 13 wherein the grasping body has a substantially cylindrical configuration.
40. The dispensing cap of claim 13 wherein the upper surface includes a plurality of openings extending therethrough.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] The disclosure will now be described with reference to the drawings wherein:
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DETAILED DESCRIPTION OF THE DISCLOSURE
[0078] While this disclosure is susceptible of embodiment in many different forms, there is shown in the drawings and described herein in detail a specific embodiment(s) with the understanding that the present disclosure is to be considered as an exemplification and is not intended to be limited to the embodiment(s) illustrated.
[0079] It will be understood that like or analogous elements and/or components, referred to herein, may be identified throughout the drawings by like reference characters. In addition, it will be understood that the drawings are merely schematic representations of the invention, and some of the components may have been distorted from actual scale for purposes of pictorial clarity.
[0080] Referring now to the drawings and in particular to
[0081] With further reference to
[0082] In greater detail, the spout 110 includes base flange 112 and upstanding spout body 114. The spout 110 generally comprises a rigid polymer member that is sealed to the panels or the seams of the pouch body. In the configuration shown, the spout comprises a fin seal spout which is coupled to the pouch between opposing panels in line with a seam. Other spouts are likewise contemplated, including spouts which include, for example bag flanges that are sealingly attached to an inner or outer surface of one or more of the panels.
[0083] While not limited to use therewith, some such pouches are disclosed in U.S. Pat. No. 9,751,677 B2 issued to Fiere et al. Other such pouches are sold by ScholleIPN Corporation of Northlake, Illinois under the name CleanPouch, CleanPouchAseptic. The foregoing are solely illustrative and not to be deemed limiting, as other pouches and containers are contemplated for use. Other containers contemplated for use comprise pillow-type containers.
[0084] With reference to
[0085] Referring again to
[0086] The spout engaging end 15 comprises inner surface 40, outer surface 42, inner depending flange 44, slot engaging flange 46 and outlet opening 48. The spout engaging end, in the configuration shown, comprises a substantially planar member that is generally perpendicular to a central axis of the spout, having an inner surface 40 and an outer surface 42. An outlet opening 48 is centrally located and extends through the spout engaging end 15. In the configuration shown, the outlet opening is generally centered about the central axis of the spout, as a single opening. Of course, variations are contemplated, including in location as well as number and shape of the opening.
[0087] The inner depending flange 44 includes an inner surface 50 and an outer surface 52. The outer surface 52 interfaces with the upstanding spout body about the upper opening 116. In some configurations, the interface may comprise a sealed engagement therebetween. To assist with the cooperation between components, the lower end of the outer surface may be chamfered to facilitate engagement and to minimize obstruction therebetween.
[0088] The slot engaging flange 46 depends from the inner surface 40 of the spout engaging end 15. The slot engaging flange interfaces with (and may sealingly engage) the circumferential slot 120 of the spout 110. It will be understood that the slot engaging flange may be slightly angled radially outwardly so that engagement with the circumferential slot 120 pushes the slot engaging flange 46 in a radially outward direction so as to facilitate slightly biased engagement and to provide enhanced sealing therebetween.
[0089] The dispensing coupling 16 is shown as comprising outer surface 62 and elongated bore 60 extending therethrough. The outer surface 62 may include a frustoconical portion 64 and a beveled portion 66 at the upper end thereof to facilitate engagement with an outside device. In the configuration shown, the cross-sectional area of the elongated bore 60 is larger than the cross-sectional area of the outlet opening 48. In other configurations, the two can be matched or can have an alternate relationship. It will be understood that one such a dispensing coupling is known as the EnFit coupling of an EnFit connection system. In the particular configuration shown, the EnFit coupling comprises a male connection system. Such connectors are covered, for example, under ISO 80369, and more particularly, under ISO 80369-3, the entire contents of the standards is hereby incorporated by reference in its entirety. It will be understood that couplings other than the EnFit that, preferably, may be utilized for enteral feeding are likewise contemplated, and that the disclosure is not limited only to such couplings as the EnFit.
[0090] In other configurations, such as the configuration of
[0091] With reference to
[0092] As can be appreciated from
[0093] In still other configurations, and with reference to
[0094] In operation, to, for example, fee an infant enterally, a user is provided with a container, such as a pouch, having breast milk, formula or other nutrients, for example. Advantageously, in the pouch configuration disclosed above, such filling may have been accomplished aseptically. In other configurations, a retort process may have been utilized post fill, for example. It will be understood that while the process is particularly useful as a system in an aseptic fill environment, the process is not limited thereto.
[0095] First, in the aseptic environment, typically, the pouch or container will have a first cap installed at the time of filling, and, the dispensing cap 10 can be provided in a separate sterilized package. The user can remove the dispensing cap 10 from the sterilized package. Once removed, the user can remove the cap that is covering the pouch 100. Once removed, the user can apply the dispensing cap 10 to the pouch 100. The user can connect the dispensing cover 18 to the dispensing coupling prior to fitting the dispensing cap to the pouch to minimize the possibility of squeezing or otherwise disrupting the pouch which may cause the loss of some of the contents through the spout. In the case of the flip-top cover, the cover can be in the closed orientation prior to and during the attachment thereof to the spout.
[0096] Preferably, to attach the dispensing cap and to remove the other cap, the user can grasp and retain the spout, and to allow the remainder of the pouch body to be free from contact and/or grasping.
[0097] Once the dispensing cap has been attached to the spout, the user can couple the dispensing coupling to an outside structure. For example, and with reference to
[0098] The syringe can be drawn to fill the volume of the pouch. Such a syringe may be filled with anywhere between 2 ml and 35 ml, for example, while more or less fill is contemplated. At the same time, the pouch volume can be reduced through the pulling of fluid, or thorough careful compression of the pouch. In some configurations, the pouch can remain right side up (with the spout above the pouch body) or can be flipped upside down, so that the pouch body is above the spout. Other configurations between these are likewise contemplated.
[0099] Once the desired amount has been dispensed into the syringe, the user can disconnect the syringe. The user can then apply the dispensing cover 18 over the elongated bore of the dispensing coupling 16.
[0100] In other configurations, a feeding tube having an EnFit coupling, for example (and without limitation), can be directly attached to, for example, the dispensing cap, an example of which is shown in
[0101] In any such instance, once completed, the user can disconnect a syringe, a feeding tube or another structure from the dispensing cap 18 and the dispensing cover can be reapplied to seal the volume of the pouch. The pouch can then be stored in, for example, a refrigerator, if desired, without the fear of losing product through the spout. Additionally, as the pouch volume can be reduced during dispensing, the ingress of air or other fluids from the outside can be limited, thereby further reducing the possibility of introducing microbes or pathogens into the volume of the pouch.
[0102] While the system is utilizeable with other types of containers, the use thereof with pouches, bags or other containers which can change in volume has the advantage of minimizing the ingress of fluids and gasses during the dispensing process.
[0103] It will be understood that the different types of dispensing couplings, the different types of dispensing covers and the different types of tethers can be varied between the different configurations and interchanged to form a number of different variations. In addition, the pouch of the present disclosure may be replaced with a differently configured package, including, but not limited to a flexible package or the like. Furthermore, the particular fluids that are contained within the pouch can be varied, and those that are disclosed are merely disclosed as exemplary and are not intended to be limiting.
[0104] For example, and as shown in
[0105] In one configuration which is meant to be illustrative and not limiting, the dispensing cap configuration includes grasping body 12 having a spout engaging bore 14 and a spout engaging end 15, as well as an auxiliary coupling 230 and a nipple assembly 222. As set forth in other configurations, the grasping body provides a user the structure by which to grasp and retain the dispensing cap. In the configuration of
[0106] The outer wall 206 is spaced apart from the inner wall, and is coupled thereto by way of the annular wall 208. The annular wall 208 includes upper surface 214. The outer wall, in the configuration shown, corresponds in configuration to the depending wall 280 or the nipple assembly so that the two substantially match from a standpoint of diameter. Of course, variations are contemplated, however, such a configuration allows for selectively grasping one or both of the structures simultaneously as desired.
[0107] It is preferred that the grasping body is molded along with the spout engaging bore and the spout engaging end. In the configuration shown, the spout engaging bore substantially matches previously described configurations set forth above. The spout engaging end, in the configuration shown terminates the spout engaging bore. The nipple assembly provides an alternative dispensing coupling which is attached to the grasping body through the auxiliary coupling.
[0108] In the configuration shown, the auxiliary coupling is formed together with the grasping body 12 and includes upstanding wall 230. In the configuration, the upstanding wall 230 is substantially parallel to the inner wall and the outer wall of the annular hoop and perpendicular to the annular wall. The upstanding wall extends upwardly away from the upper surface 214 of the annular wall in a direction opposite of the inner and outer walls of the annular hoop. The upstanding wall 230 includes lower end 232, upper end 234, which defines an upper rim, inner surface 236 and outer surface 238.
[0109] The nipple assembly 222 is shown in
[0110] The retention ring 260 includes upper wall 262, and depending wall 280. As will be understood, the retention ring is threaded onto the upstanding wall so as to sandwich the nipple member, and in particular the base flange 242 of the nipple member, therebetween. The upper wall 262 of the retention ring 260 includes central opening 264, outer perimeter 266, upper surface 268, lower surface 270. The lower surface includes lower nub 272 which further facilitates the sealing of the nipple member. The depending wall 280 includes inner surface 282, outer surface 286 and lower end 189. The inner surface 282 includes threads that matingly engage the threads of the outer surface of the upstanding wall 230. The outer surface 286 includes grasping ribs 288 which facilitate grasping and manipulating of the retention ring by a user. The retention ring may comprise a molded polymer that is resilient (and may be from a polymer that is similar, identical to, or distinct from the polymer from which the dispensing cap is formed). Typically, the nipple member is of a more flexible and compressible material so as to be elastically deformable between the retention ring and the upstanding wall.
[0111] It will be understood that while an opening is shown at the spout engagement end, in some configurations, another dispensing coupling 16 (such as the outlet surface or outer shell of the configurations of
[0112] It will further be understood that such nipple assemblies can be single use/disposable such that after use, the entire pouch with the nipple assembly may be tossed or discarded.
[0113] In other configurations, it is further contemplated that an all-in-one solution of a spout may be provided wherein the desired dispensing coupling is on the dispensing cap and the dispensing cap is provided at the time of filling. In such configurations, a pressure fit seal 315 may be applied and a dispensing cover can be tethered to the dispensing cap, and a break away seal 317 can be applied over the cap to body interface, which seal can be frangible and can be broken in a number of different manners. One such configuration is shown in
[0114] Another such configuration, showing a flip top with a flat finger coupling is shown in
[0115] Among other advantages and features, the foregoing disclosure provides a substantially closed system and can enhance aseptic technique by protecting contents and facilitating aseptic transfer when filling syringes from the pouch which may be filled in an aseptic configuration. Furthermore, the configuration allows for the dispensing of fluid from a single container. The enteral feeding system of the present disclosure when utilized in the manners disclosed follows to the ADA and ASPEN guidelines on aseptic handling of human breast milk. Furthermore, it is contemplated that the dispensing caps protect contents and facilitate closed system aseptic transfer when filling syringes. In the configurations disclosed, the dispensing cap can be covered with the dispensing cap so as to provide a cost effective, easy fluid transfer system, especially as compared to conventional manners of transfer and extraction which may utilize multiple straws, for example.
[0116] It will further be understood that the at least some of the disclosure is directed to limit or eliminate breast milk exposure to air, which can be highly problematic with the use of conventional simple open style containers. As is known in the art, ambient air exposure, which can be common with standard screw style lids and bottles, can contribute to the oxidation of milk lipids and an accelerated rate of bacteria colonization within the fluid.
[0117] The foregoing description merely explains and illustrates the disclosure and the disclosure is not limited thereto except insofar as the appended claims are so limited, as those skilled in the art who have the disclosure before them will be able to make modifications without departing from the scope of the disclosure.