Patent Publication Number: US-2019192843-A1

Title: Coupler for cleaning a feeding tube hub

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/636,924 filed Mar. 1, 2018, is a Continuation-in-Part application of U.S. Non-provisional patent application Ser. No. 15/009,073 filed Jan. 28, 2016, which claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/108,824 filed Jan. 28, 2015, is a Continuation-in-Part application of U.S. Non-provisional patent application Ser. No. 16/223,917 filed Dec. 18, 2018, and is a Continuation-in-Part application of U.S. Non-provisional patent application Ser. No. 16/154,479 filed Oct. 8, 2018, the entireties of which are hereby incorporated by reference for all purposes. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to the field of medical devices, and more particularly to cleaning devices and methods for use with fluid transfer connectors such as coupling connectors for enteral fluid containers. 
     BACKGROUND 
     Neonates and other healthcare patients are often administered fluids such as medications, nutritional fluids and supplements via enteral fluid delivery, commonly utilizing delivery systems including fluid containers, syringes, feeding tubes and other components. These components are often interconnected by connectors or couplings such as Luer connectors, or the more recently developed ENFit connector (ISO Standard 80369-3). 
     In some embodiments, these enteral connectors or couplings may include outer housing geometries with recesses or areas that could retain small quantities of unused feeding fluids that might allow for bacteria colonization or contain other potential contaminants. U.S. patent application Ser. No. 14/844,956, which is incorporated herein by reference, discloses a vented male ENFit enteral coupling or connector having a housing structure with drainage passages or vents to eliminate or reduce the likelihood of retaining feeding liquids or other contaminants in the outer housing. Cleaning tools as disclosed in U.S. Non-provisional patent application Ser. No. 15/009,073 filed Jan. 28, 2016, U.S. Provisional Patent Application Ser. No. 62/108,824 filed Jan. 28, 2015, and U.S. Provisional Patent Application Ser. No. 62/599,912 filed Dec. 18, 2017, the entireties of which are hereby incorporated by reference for all purposes, have been developed. In some cases, multiple manufacturing processes and molds are required to manufacture the cleaning tools which lead to higher costs. Improvements in the field are desirable, and it is to the provision of low-cost cleaning tools and methods thereof that the present invention is primarily directed. 
     SUMMARY 
     In example embodiments, the present invention provides a cleaning tool and methods thereof for cleaning a feeding tube hub. 
     In one aspect, the present invention relates to feeding tube hub plug for plugging a feeding tube hub. The feeding tube hub includes a male coupling defining a lumen extending therethrough, an outer collar and an annular space defined therebetween, the feeding tube hub plug includes a central plug member for plugging a lumen of a feeding tube hub and a body extending from the central plug member. In example embodiments, at least one opening or cutout is defined in the body such that the annular space is accessible without unplugging the central plug member from the lumen of the feeding tube hub. 
     In another aspect, the invention relates to a cleaning tool for cleaning a feeding tube hub including a brush member having a brush end and a grasping portion connected to the brush end, the brush member including a plurality of bristles. In example embodiments, the feeding tube hub includes a plug having one or more openings for receiving at least a portion of the cleaning tool to clean the feeding tube hub. 
     In still another aspect, the invention relates to a cleaning system for enteral feeding including a feeding tube hub plug and a cleaning tool. In example embodiments, the feeding tube hub plug includes a central plug member, a body extending from the central plug member, and at least one opening or cutout defined in the body. The cleaning tool includes an elongate member having a brush end and a grasping portion. The brush end includes a plurality of bristles extending therefrom. In example embodiments, at least a portion of the brush end is configured for passing through the at least one opening or cutout to access an annular space portion of the feeding tube hub. 
     In yet another aspect, the invention relates to a male to female coupling for attachment between a connector and a syringe. In example embodiments, the coupling is configured for coupling engagement between a male ENFit formatted coupling of a feeding tube connector and a female ENFit formatted coupling of a syringe. 
     In yet another aspect, the invention relates to method of cleaning a feeding tube hub including providing a feeding tube hub, the feeding tube hub being in communication with a lumen of a feeding tube and having a male coupling defining a lumen extending therethrough, an outer collar and an annular space defined therebetween; providing a cleaning tool; providing a feeding tube hub plug, the feeding tube hub plug having a plug member for sealing engagement with the lumen of the male coupling, a body extending from the plug member, and at least one opening or cutout defined in the body; attaching the plug member with the feeding tube hub to seal the lumen of the male coupling; inserting at least a portion of the cleaning tool within the at least one opening or cutout of the feeding tube plug hub such that at least a portion of the brush end is present within the annular space of the feeding tube hub; rotating the feeding tube hub plug relative to the feeding tube hub while the cleaning tool remains at least partially present within the annular space; and removing the cleaning tool from the at least one opening or cutout of the feeding tube hub plug. 
     In yet another aspect, the invention relates to a plug for a feeding tube connector including a body, a central plug member, a syringe tip coupling and one or more channels extending through the body. In example embodiments, the central plug member extends from a first side of the body for plugging a lumen of a feeding tube hub. In example embodiments, the syringe tip coupling extends from a second side of the body and is configured for compatible engagement with a syringe tip of a syringe. In example embodiments, the one or more channels extending through the body are configured such that a cleaning fluid introduced within the syringe tip coupling flows through the body and within the annular space to clean the same. 
     In a further aspect, the present disclosure relates to a plug for plugging a feeding tube hub that has a male coupling defining a lumen extending therethrough, and an outer collar and an annular space defined therebetween. The plug includes a base configured for releasably covering at least a portion of an annular space defined in an outer collar of a feeding tube hub, and a plug insert extending from the base. The plug insert is configured for plugging a lumen of a feeding tube hub along a connection axis. At least one passageway extends through the base to provide access to the annular space defined in the outer collar of the feeding tube hub when the plug insert is plugging the lumen of the feeding tube hub. 
     In an additional aspect, the present disclosure relates to a coupler for cleaning a feeding tube hub comprising a male coupling defining a lumen extending therethrough, an outer collar and an annular space defined therebetween, the coupler comprising: a base configured for releasably covering at least a portion of an annular space defined in an outer collar of a feeding tube hub; a seal configured for removably sealing a lumen of a feeding tube hub; and a fluid conduit configured for receiving a volume of fluid from a fluid source and delivering the volume of fluid to the annular space in the outer collar of the feeding tube hub when the seal is sealing the feeding tube lumen. 
     In another aspect, the present disclosure relates to a coupling system comprising: a fluid delivery female ISO 80369-3 formatted coupling; a hub male ISO 80369-3 formatted coupling being separate from the fluid delivery female ISO-80369-3 formatted coupling; and a coupler comprising a female ISO 80369-3 formatted coupling and a male ISO 80369-3 formatted coupling, the coupler being separate from the fluid delivery female ISO 80369-3 formatted coupling and the hub male ISO 80369-3 formatted coupling, the coupler female ISO 80369-3 formatted coupling being removably coupled to the hub male ISO 80369-3 formatted coupling, and the coupler male ISO 80369-3 formatted coupling being removably coupled to the fluid delivery female ISO 80369-3 formatted coupling. 
     These and other aspects, features and advantages of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following brief description of the drawings and detailed description of example embodiments are explanatory of example embodiments of the invention, and are not restrictive of the invention, as claimed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a schematic diagram of a feeding tube hub plug plugged into a feeding tube hub with a cleaning tool inserted therein, according to an example embodiment of the present disclosure. 
         FIG. 2  is an exploded view of the feeding tube hub, feeding tube hub plug and cleaning tool shown in  FIG. 1 . 
         FIG. 3  is an isolated perspective view of the feeding tube hub plug shown in  FIGS. 1-2 . 
         FIG. 4  is a side view of the feeding tube hub plug shown in  FIG. 3 . 
         FIG. 5  is a top view of the feeding tube hub plug shown in  FIG. 3 . 
         FIGS. 6-13  are a plurality of top views of feeding tube hub plug schematic diagrams, according to additional example embodiments of the present disclosure, which can cooperatively function with the feeding tube hub and the cleaning tool shown in  FIGS. 1-2 . 
         FIG. 14  is a top perspective view of a schematic diagram of a feeding tube hub plug with a syringe tip connector, according to another example embodiment of the present disclosure. 
         FIG. 15  is a bottom perspective view of the feeding tube hub plug shown in  FIG. 14 . 
         FIG. 16  is a perspective view of a schematic diagram of a system including a feeding tube hub, a syringe and a male to female connector, according to another example embodiment of the present disclosure. 
         FIG. 17  is an exploded view of the system shown in  FIG. 16 . 
         FIG. 18  is an isolated front perspective view of the male to female connector shown in  FIGS. 16-17 . 
         FIG. 19  is a rear perspective view of the male to female connector shown in  FIG. 18 . 
         FIG. 20  is a perspective view of a schematic diagram of a male to female connector with clip connectors, according to another example embodiment of the present disclosure. 
         FIG. 21  is a front perspective view of a schematic diagram of a male to female connector and feeding tube hub plug, according to another example embodiment of the present disclosure. 
         FIG. 22  is a rear perspective view of the male to female connector and feeding tube hub plug shown in  FIG. 21 . 
         FIG. 23  is a front view of the male to female connector and feeding tube hub plug shown in  FIGS. 21-22 . 
         FIG. 24  is a rear view of the male to female connector and feeding tube hub plug shown in  FIGS. 21-22 . 
     
    
    
     DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS 
     The present invention may be understood more readily by reference to the following detailed description of example embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein. 
     Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. 
     With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views,  FIGS. 1-2  show a feeding tube hub plug  10  for sealing a feeding tube hub or connector C along a connection axis L 1  according to example embodiments of the present invention. In example embodiments, the plug  10  comprises a plug member  12  or insert for sealing or plugging a lumen L of a coupling or connector M of the feeding tube connector C. In example embodiments, the feeding tube connector C is substantially related to U.S. patent application Ser. No. 14/844,956, which is incorporated herein by reference herein, and discloses a vented male ISO 80369-3 formatted ENFit enteral coupling or connector having a housing structure with drainage passages or vents to eliminate or reduce the likelihood of retaining feeding liquids or other contaminants in the outer housing. The plug  10  can have a tether  50  with an end ring  55  or fastener which secures to a grooved surface GS or recess on the connector C. The grooved surface GS can be a channel extending circumferentially around the connector C. The tether  50  can be flexible and can form a shape like a handle, as shown in  FIG. 1 , to allow a user to grasp and rotate the plug  10  about the connection axis L 1  with respect to the connector C. 
     According to example embodiments, an annular space A is defined between the connector M and a threaded inner surface of an outer collar OC, which may retain small quantities of unused feeding fluids that might allow for bacteria colonization or contain other potential contaminants. Accordingly, preferably the plug  10  as described herein allows for effectively cleaning the annular space A of the connector C while the lumen L of the connector M remains sealed by the plug member  12 . One or more openings (described further below) are defined in at least a portion of the plug  10  to provide access to the annular space A such that a brush or other cleaning member  80  can be inserted through one or more openings and within the annular space A to clean the same. 
     In example embodiments, the cleaning tool  80  comprises a generally elongate brush member comprising a brush end  82  and a grasping end  84 . The brush end  82  comprises a plurality of flexible (e.g., nylon) bristles extending radially from a rigid (e.g., stainless steel) post, and the grasping portion  84  comprises a rigid (e.g., plastic) shaft for controlling the actions of the brush end. Optionally, the cleaning tool  80  can be formed from other plastics, metals, natural materials, synthetic materials, and/or combinations thereof. In example embodiments, the brush end  82  generally extends along a linear path and is co-aligned with the grasping portion  84 . In other example embodiments, the brush end  82  can extend along a linear path that is angled relative to the grasping portion  84 , or for example, one or more portions of the brush end can extend along a non-linear path. 
     According to some example embodiments, the cleaning tool  80  can be wetted or coated with a liquid or cleaning solution or fluid prior to being inserted through the one or more openings. Optionally, a cleaning fluid can be provided within the annular space A prior to inserting the cleaning tool  80  therein to clean. According to one example embodiment, the cleaning fluid is contained within a container or other reservoir that is capable of discharging at least one fluid through the one or more openings  30  and within the annular space A. According to some example embodiments, a coupling or other connector can be provided on a portion of the base  20  (and in communication with the annular space A) such that a syringe or other container or dispensing means can be connected to the coupling for discharging the cleaning fluid within the annular space. Thereafter, the brush end  82  can be inserted through the one or more openings and cleaning can begin. According to additional example embodiments, the plug can further comprise a coupling for permitting a syringe or other device containing cleaning fluid to connect thereto for applying the cleaning fluid within the annular space. 
     After the feeding tube hub C is used for feeding a patient, the plug  10  is reconnected with the hub C such that the plug member  12  seals with the lumen L of the hub C. The brush end  82  of the cleaning tool  80  is then inserted within the opening  30  such that the brush end  82  generally occupies at least a portion of the annular space A. Then, with the brush end  82  occupying at least a portion of the annular space A and with the plug member  12  still being sealed with the lumen L, the entirety of the plug  10  and cleaning tool  80  are rotated about rotation about the connection axis L 1  with respect to the hub C (e.g., 360° of according to some example embodiments) to sweep any debris to the bottom of the hub. According to some example embodiments, after rotation of the plug  10  and cleaning tool  80 , the cleaning tool  80  is further inserted to pass through the annular space A and extend out of a bottom portion of the hub C, for example, wherein at least the brush end  82  extends through a vent feature that is generally provided at a bottom portion of the hub C. Thereafter, with the plug  10  remaining engaged with the hub C, the cleaning cool  80  is removed from the opening and discarded. According to some example embodiments, the cleaning tool  80  can be configured for multiple uses or cleanings, for example, wherein the entirety of the cleaning tool  80  or just a portion thereof can be cleaned and stored for additional cleanings. 
     The plug  10  can preferably be configured as desired to permit accessibility of the cleaning tool  80  within the annular space A and with the plug member  12  sealing the lumen L of the connector M of the feeding tube hub C. In example embodiments illustrated in  FIGS. 3-5 , the plug  10  as described herein comprises the plug member  12  or insert, a body  20  from which the plug member  12  extends, and one or more openings  30  or passageways, channels or access openings (described further below) for permitting the cleaning tool  80  to access the annular space A of the feeding tube hub C to clean the same. In example embodiments, the plug  10  can further comprise a grasping portion  40  or handle (e.g., for grasping to install/remove the plug  10  to/from the feeding tube hub C), the tether  50 , and the retaining ring  55 , for example, for generally tethering the plug  10  to the feeding tube hub C. In use, the tether  50  can be grasped and function as a handle to rotate the plug  10  with respect to the feeding tube hub C. 
     The body  20  can have a generally planar geometry with a circumferential edge  22  interrupted by the geometry of the openings  30 . The body  20  can have a collar or skirt  14  that can extend generally downwardly, while being interrupted by the openings  30  or cutouts as shown particularly in  FIGS. 3-4 , leaving gaps in the collar for additional insertion of the brush  80 . The plug  10  is capable of being attached and removed from the hub C while the cleaning tool is occupying the annular space A. 
       FIGS. 6-13  illustrate example designs of plugs which can effectively function as the plug ( 10 ) described in  FIGS. 1-5 . The plugs illustrated in  FIGS. 6-13  can include similar geometries to the plug ( 10 ) in  FIGS. 1-2 , including having the plug member  12  for insertion within the lumen L of the connector M of the feeding tube hub C.  FIG. 6  illustrates a plug  10   a  with a single cylindrical opening  30   a  or aperture extending through a portion of a body  20   a  or base, for example, generally centered on one side of a grasping portion  40   a  or handle. The body  20   a  can be a planar disc having a generally circumferential periphery  22   a  and be connected by a tether  50   a . As described above, in use the brush end  82  of the cleaning tool  80  is inserted through the opening  30   a  to clean the annular space A of the connector C. 
       FIG. 7  illustrates a plug  10   b  design with a similar body  20   b , circumferential periphery  22   b , grasping portion  40   b  and tether  50   b . The plug  10   b  includes an opening  30   b  that defines a curved or arcuate path that is formed through a portion of the body  20   b  along one side of the grasping portion  40   b . The opening  30   b  can have an elongated semi-circular geometry and generally follow the curvilinear shape of the outer circumference  22   b . As described above, in use the brush end  82  of the cleaning tool  80  is inserted through the opening  30   b  to clean the annular space A of the connector C. The elongated shape of the opening  30   b  allows for the orientation and position of the brush end  82  to be changed during use. 
       FIG. 8  illustrates a plug  10   c  design with a similar body  20   c , circumferential periphery  22   c , grasping portion  40   c  and tether  50   c . The plug  10   c  includes an opening  30   c  defining a generally elongate channel from a portion of the body to an outer periphery portion  22   c  thereof. As described above, in use the brush end  82  of the cleaning tool  80  is inserted through the opening  30   c  to clean the annular space A of the connector C. As shown, a portion of the channel  30   c  that is defined near the grasping portion  40   c  is generally rounded, for example and according to some example embodiments to provide for seating against an outer surface of the grasping portion  84  of the cleaning tool  80 . 
       FIG. 9  illustrates a plug  10   d  design with a similar body  20   d , circumferential periphery  22   d , grasping portion  40   d  and tether  50   d . The plug  10   d  includes a pair of opposingly oriented openings  30   d  that define a curved or arcuate path that is formed through a portion of the body  20   d  along both sides of the grasping portion  40   d . The openings  30   d  can have an elongated semi-circular geometry and generally follow the curvilinear shape of the outer circumference  22   c . As described above, in use the brush end  82  of the cleaning tool  80  is inserted through the openings  30   d  to clean the annular space A of the connector C. The elongated shape of the openings  30   d  allow for the orientation and position of the brush end  82  to be changed during use. 
       FIG. 10  illustrates a plug  10   e  design with a similar body  20   e , circumferential periphery  22   e , grasping portion  40   e  and tether  50   e . The plug  10   e  includes a pair of opposingly oriented openings  30   e  in the form of notches or generally rectangular or polygonal openings formed through the body  20   e  and mirrored about an axis aligned with the grasping portion  40   e . As described above, in use the brush end  82  of the cleaning tool  80  is inserted through the openings  30   e  to clean the annular space A of the connector C. The shape of the openings  30   e  allow for the orientation and position of the brush end  82  to be changed during use. 
       FIG. 11  illustrates a plug  10   f  design with a similar body  20   f , circumferential periphery  22   f , grasping portion  40   f  and tether  50   f . The plug  10   f  includes a pair of opposingly oriented openings  30   f  that define a geometry that is formed through a portion of the body  20   f  along both sides of the grasping portion  40   f .  FIG. 8  is generally similar to the plug ( 10   d ) of  FIG. 9 , however, the interior radiused sidewall of the openings  30   f  or channels is removed to be substantially aligned with the extension of the grasping portion  40   f , and thus the openings  30   f  are larger in size to provide greater flexibility in orientation and movement of the brush ends  82  of the cleaning tool  80  during use. 
       FIG. 12  illustrates a plug  10   g  design with a similar body  20   g , circumferential periphery  22   g , grasping portion  40   g  and tether  50   g .  FIG. 12  show a plurality of positionally separated openings  30   g , for example four cylindrical openings or apertures extending through a portion of the body  20   g , which can be shaped and positioned as desired to provide a variety of access positions for the brush end  82  of the cleaning tool  80 . In example embodiments, the openings  30   g  are shaped to be substantially cylindrical in shape, however, other embodiments can comprise other shaped openings as desired, for example, oval, elliptical, rectangular, polygonal, or other desired shapes. According to one example embodiment, one or more spaced-apart openings  30   g  can be formed through the body  20   g  as desired, for example, to define a linear array of openings. According to one example embodiment, the one or more openings are substantially aligned with the annular space A. 
       FIG. 13  illustrates a plug  10   h  design with a similar body  20   h , circumferential periphery  22   h , grasping portion  40   h  and tether  50   h . The plug  10   h  includes an opening  10   h  that is an entire front portion removed, for example, to define a large cutout portion from the base  22   h.    
       FIGS. 14-15  show a plug  100  according to another example embodiment of the present invention. In example embodiments, the plug  100  is generally similar to the plug  10  as described above, for example, comprising a plug member  112 , a body  120 , a collar  122  or skirt having one or more cutouts  124  defined therethrough, one or more passageways or access openings  134  for permitting the brush member  82  to access the annular space A of the feeding tube connector C when the plug  112  is sealingly engaged with the lumen L. The plug  100  further includes a syringe tip coupling  140  or collar configured for receiving engagement with a syringe tip of a syringe. The plug  100  can also have a gripping portion  142  or handle to operate similarly to the gripping portion ( 40 ) described above. The illustrated gripping portion  142  can comprise a pair of co-planar flanges extending from the syringe tip coupling  140 . 
     In example embodiments, one or more openings, jets or channels  130  extend through the body  120  to permit cleaning fluid that is introduced within the syringe tip coupling  140  to be discharged or jetted within the annular space A of the feeding tube connector C. The channels  130  are spaced apart from each outer and generally surround the plug member  112  to define a circular array of about six generally cylindrical openings  130 . The openings  130  are positioned to each fit within the open receiving area of the syringe tip coupling  140 , so that fluid received into the syringe tip coupling flows uninterruptedly through the openings. In alternate embodiments, more or less than six of the openings can be provided as desired. 
     According to one example embodiment, the channels  130  are positioned and oriented to direct the cleaning fluid outwards (e.g., generally away from the plug member  112 ) and in either of a clockwise or counter-clockwise direction away from the connection axis L 1 . In example embodiments, the channels  130  are configured to assist the cleaning fluid in flowing not only through the annular space A, but also around the annular space A and within the threaded portion of the collar of the connector C. For example, the channels  130  preferably provide a jetting system for cleaning the feeding tube connector C such that the cleaning fluid effectively spirals or generally moves along a helical path with respect to the connection axis L 1  as it&#39;s passed through the annular space A. In alternate example embodiments, the one or more channels  130  can be sized, positioned and oriented as desired, for example, so as to maximize the effectiveness of the cleaning fluid in removing and cleaning out any unwanted debris, bacteria, or other undesirables within the annular space A. As also described above, the brush member  82  can be introduced within the cutout  134  to occupy at least a portion of the annular space A to clean the same. 
     According to another example embodiment, the present invention relates to a male to female coupling or hub connector. As depicted,  FIGS. 16-20  show a male to female coupling or hub connector  200  according to an example embodiment of the present invention. In example embodiments, the hub connector  200  comprises a first end  212  and a second end  214 , wherein the first end  212  comprises a male ISO 80369-3 ENFit compatible or formatted coupling and the second end  214  comprises a female ISO 80369-3 ENFit compatible or formatted coupling. In example embodiments, the male to female coupling  200  is coupled between the above-described feeding tube hub or connector C and a syringe S with a female ISO 80369-3 ENFit compatible coupling SC. For example, the male ISO 80369-3 EN Fit formatted coupling on the first end  212  of the coupling  200  is configured for compatible engagement with the female coupling SC of the syringe S and the female ISO 80369-3 ENFit formatted coupling on the second end  214  of the coupling is configured for compatible engagement with a male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C. In example embodiments, the feeding tube connector C can be vented. U.S. patent application Ser. No. 14/844,956 is incorporated herein by reference and discloses a vented male ISO 80369-3 EN Fit enteral coupling or connector having a housing structure with drainage passages or vents to eliminate or reduce the likelihood of retaining feeding liquids or other contaminants in the outer housing. 
     In example embodiments, rather than using a cleaning tool or other cleaning method for eliminating any small quantities of unused feeding fluids that might allow for bacteria colonization or contain other potential contaminants (e.g., within recesses or areas that could retain feeding fluids), the male to female coupling  200  preferably provides for a disposable solution, or for example, a solution for substantially eliminating the likelihood that unused feeding fluids would be likely to overflow within one or more portions of the feeding tube connector. For example, the male to female coupling  200  provides an intermediate conduit between the syringe female ISO 80369-3 ENFit formatted coupling and the male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C. Thus, after a desirable quantity of feeding fluids or other fluids have been dispensed from the syringe S, through the coupling  200 , and through the feeding tube connector C (and further through the feeding tube FT to be delivered to the patient), the components thereof can be disconnected in a way whereby substantially all of the feeding fluid, if not the entirety of the feeding fluid, is prevented from overflowing or entering within one or more recesses or areas of the feeding tube connector C, for example, such that the feeding tube connector (or portions thereof) need not be cleaned after use. For example, rather than using a cleaning device such as U.S. patent application Ser. No. 15/009,073 (the entirety thereof incorporated herein by reference), the male to female coupling  200  can be provided as an intermediate coupling between the syringe S and the feeding tube connector C. 
     According to one example embodiment, after feeding when it is desired to disconnect the syringe S from the feeding tube connector C, and with the male to female coupling  200  connected therebetween, the second end  214  of the male to female coupling  200  is disconnected from the male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C (with the male ISO 80369-3 ENFit formatted coupling of the first end  212  remaining engaged with the female ISO 80369-3 ENFit formatted coupling of the syringe S). Preferably, the unused feeding fluids remain within the conduit of the male to female coupling  200  such that feeding fluids are prevented from overflowing or exiting from the conduit of the male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C and within one or more recesses or areas of the feeding tube connector C. According to another example embodiment, with the male to female coupling  200  connected therebetween, the first end  212  of the male to female coupling  200  is disconnected from the female ISO 80369-3 ENFit formatted coupling of the syringe S (with the female ISO 80369-3 ENFit formatted coupling of the second end  214  remaining engaged with the male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C). The second end  214  of the male to female coupling  200  can then be disconnected from the feeding tube connector C. 
     In example embodiments, the conduit extending therebetween the syringe S and the feeding tube FT can comprise a vacuum or generally become pressurized, for example, such that the initial disconnection between two of the three components (syringe, coupler  200 , connector C) generally relieve the vacuum or pressure present, and wherein relieving the vacuum or pressure generally causes at least some unused or residual feeding fluids to overflow or generally become exposed to the atmosphere, some of which can enter into one or more recesses or areas of the components. Thus, example embodiments of the present invention preferably provide for redirecting or repositioning the location whereby unused feeding fluids are exposed or overflow, thereby preventing any unused feeding fluids from overflowing within one or more recesses or areas of the feeding tube connector C, and thus maintaining a clean and aseptic connector C such that a cleaning tool is not needed. 
     An outer collar portion of first end  212  the coupling  100  can comprise one or more surface features  218  or other recesses, indentions, projections or other features such that an enhanced gripping surface can be provided to assist a user in attachment/detachment of the coupling  200  from the connector C or syringe S. According to one example embodiment, the outer collar portion comprises a disc-like flange (not shown) or other outwardly-protruding member, for example, to ensure the coupling  200  is not a choking hazard and, for example, to comply with 16 CFR § 1501.4. 
     According to another example embodiment illustrated in  FIG. 20 , a male to female coupling  300  can be provided with a receiving collar  316  that has one or more delectably resilient fingers or clips  320  or anchors provided for secondary engagement with the feeding tube connector C. As illustrated, the clips  320  extend between a fixed end and a deflecting free anchor end. The male to female coupling  300  includes the same structure as the male to female coupling  200  illustrated above, including the identical male ISO 80369-3 ENFit formatted coupling of the first end  212  and the female ISO 80369-3 ENFit formatted coupling of the second end  214 . As illustrated, the receiving collar  316  extends about and around the female ISO 80369-3 ENFit formatted coupling of the second end  214 . The receiving collar  316  can have an internal diameter that is greater than the outer diameter of the outer collar OC (see  FIG. 2 ) of the connector C in order to receive the outer collar OC therein. The pair of oppositely opposed clips  320  (comprising end protrusions extending inwardly) are provided at the second end  314  of the coupling  300 , for example, such that when the female ISO 80369-3 ENFit formatted coupling of the second end  214  is fully engaged with the male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C, the clips  320  generally releasably engage or anchor to an outer portion of the feeding tube connector C, for example, wherein the protrusions or projections engage with a grooved surface GS (see  FIG. 2 ) formed along an outer body portion of the feeding tube connector C. Thus, in example embodiments, the coupling  300  preferably provides for a dual engagement or locking feature wherein a first engagement is provided between lugs of the female ISO 80369-3 ENFit coupling of the coupling  300  and the threaded collar of the feeding tube connector C, and a second engagement is provided between the clips  320  and an outer portion of the feeding tube connector C. Optionally, other clips or other complementary coupling features can be provided as desired, for example, such that an additional engagement can be provided therebetween. In some example embodiments, the clips  320  can be configured for removable engagement wherein a user can press or actuate portions thereof to release the clips from engagement with the feeding tube connector C. 
     Optionally, the clips  320  can be configured to permanently engage with the feeding tube connector C. According to another example embodiment, the clips or other engagement features can be provided such that axial displacement along the connection axis L 1  between the coupling  300  and the feeding tube connector C causes the clips  320  or other coupling features to disengage with the feeding tube connector. In some example embodiments, the outer sleeve or collar  316  of the coupling  300  can comprise a channel for complementary engagement with one or more protrusions formed along an outer periphery portion of the feeding tube connector C. 
     According to some example embodiments, the male to female coupling is configured such that engagement of a female coupling with the male coupling of the male to female coupling causes permanent engagement therebetween. For example, according to example embodiments, the male to female coupler comprises a mechanism which can cause permanent engagement with compatible couplings during its first engagement therewith. Thus, according to some example embodiments, the mechanism aids in preventing syringe re-use and/or extension set re-use. 
     According to another example embodiment, the syringe S and/or coupling  200  can comprise a lumen extension tip, or for example, a low-dose tip comprising a small diameter lumen, for example, such that the overflow of unused feeding fluids is further reduced (if not entirely eliminated) and wherein the volume of the conduit is reduced to a volume that is substantially similar to the volume of the conduit when the syringe is connected directly to the feeding tube connector. For example, the syringe S can comprise a lumen extension tip SLDT and the coupling  200  can comprise a lumen extension tip, both of which are configured to occupy at least a portion of the conduit of the male ISO 80369-3 ENFit formatted couplings, thereby reducing the volume of the conduit. U.S. patent application Ser. No. 15/210,282 filed Jul. 14, 2016 and U.S. patent application Ser. No. 15/659,323 disclose syringes and couplings/connectors comprising lumen extension tips, the entirety of which is incorporated by reference herein in its entirety. 
     According to another example embodiment, the male to female coupling  200  can also comprise a tethered plug such as plug ( 10 ) in  FIGS. 1-5  coupled thereto, for example, to comply with 16 CFR § 1501.4 (e.g., not entirely fitting within the test cylinder specified by § 1501.4) and to provide for plugging the lumen or conduit of the male ISO 80369-3 ENFit formatted coupling of the feeding tube connector C. 
     Optionally, according to some example embodiments, one or more of the clips ( 320 ) can provide for removable or permanent engagement with the female ISO 80369-3 ENFit formatted coupling of the syringe S, for example, wherein the outer threaded collar of the second end  214  of the couplings described herein can be modified to provide for dual-action attachment and removal with the female ISO 80369-3 ENFit formatted coupling of the syringe. Optionally, the outer collar of the feeding tube connector C can similarly comprise a modified or clipped collar with a similar structure to the collar  316  and clips  320  herein described. U.S. patent application Ser. No. 15/454,761, U.S. patent application Ser. No. 15/078,674, U.S. patent application Ser. No. 15/185,583, U.S. patent application Ser. No. 14/844,922, U.S. Design Patent Application Serial No. 29/521,665, and U.S. Design Patent Application Serial No. 29/533,173 are incorporated herein by reference and disclose various clipped, snap-on and dual-action attachment and removal mechanisms for replacement with the outer coaxial connection collars of the male to female couplings  200 ,  300  and/or the feeding tube connector C. 
       FIGS. 21-24  illustrates a plug  400  for plugging the lumen L of a feeding tube connector C (see  FIGS. 1-2 ) according to additional example embodiments of the present invention. For example, the plug  400  can be generally tethered to the feeding tube connector C, similarly to the embodiment shown in  FIGS. 1-2 , and connectable to the coupling M of the feeding tube connector C while sealing the lumen L thereof and permitting a syringe S or other device containing a cleaning fluid to connect and output the cleaning fluid through one or more openings such that the cleaning fluid passes through the annular space A of the connector C to clean or flush the same. In example embodiments, the plug  400  comprises a first coupling end  402  for coupling engagement with the feeding tube connector C and a second coupling end  404  for coupling engagement with a syringe tip ST of the syringe S. According to one example embodiment, the syringe S comprises an oral syringe having a standard oral syringe tip. 
     In example embodiments, the first coupling end  402  comprises an ISO 80369-3 formatted coupling for providing for coupling engagement with the connector M of the feeding tube connector C. In example embodiments, the first coupling end  402  defines a reservoir  410  that is to be occupied by the connector M, and a plug member  412  is generally centrally-positioned therein for providing sealing engagement with the lumen L of the connector M. One or more channels, jets or openings  430  are defined generally near the plug member  412  and communicate with the second coupling end  404 . In example embodiments, the second coupling end  404  comprises an inner syringe coupling  420  (e.g., for coupling engagement with the syringe tip ST) and an outer collar portion  422  generally surrounding the syringe coupling  420 . In example embodiments, the one or more openings  430  are configured to communicate between the syringe coupling  420  and the reservoir of the first coupling end  402 . An opening or conduit  432  is provided on a portion of the first coupling end  602 . The one or more openings  430  can be fluidly connected to the conduit(s)  432  through a circular array of six channels formed through the body, each of the channels extending generally outwards away from the central plug member and in one of either the clockwise or counter-clockwise directions. The cleaning fluid passing through the channels spirals or generally moves along a helical path as it&#39;s passed through the annular space from the openings  430  to the exit from the conduit(s)  432 . 
     In example embodiments, the conduit  432  provides a path such that the cleaning fluid passing through the one or more openings  430  is guided or directed to flow within the annular space A and along the one or more threads defined along an internal portion of the collar of the feeding tube connector C. For example, with the connector M generally occupying most of the reservoir  410  of the first coupling end  402  and with the plug member  412  sealingly engaging the lumen L of the connector M, any cleaning fluid introduced within the syringe coupling  420  flows through the one or more openings  430  and within the reservoir  410 . However, as the connector M is occupying a substantial amount of the reservoir  410  (and generally sealingly engaged therewith), the cleaning fluid therein is prevented from flowing out of the reservoir  410 , but instead takes the path of least resistance and further flows through the conduits  432  and within the annular space A and along the threads of the collar of the feeding tube connector C. According to one example embodiment, one conduit  432  is formed through first coupling end  402 . In alternate example embodiments, two or more conduits can be formed through the first coupling end  402 . 
     An additional embodiment can include elements of the plug structure similar to the plug ( 10 ) (described in  FIGS. 1-5 ) and elements of the coupling ( 200 ,  400 ) structure in  FIGS. 16-19, 23-24 . Such a combination of these above-described embodiments can be determined for enablement without explicit illustration. Similarly to the above-described plug ( 10 ), this additional plug comprises a plug member, a body from which the plug member extends, and a tether extending from the body. Also, a skirt or outer flange can be formed along an outer periphery portion of the body, for example, which generally abut an end portion of the connector C when the plug is sealingly engaged with the lumen L of the connector M. Additionally, a side of the body that is generally opposite the side comprising the plug member comprises a syringe tip coupling similar to the first end ( 212 ) of the coupling ( 200 ) described in  FIGS. 16-19 , and one or more wings or gripping portions generally extending outwardly from the syringe tip coupling. As similarly described above, one or more openings, similar to openings ( 430 ) in  FIG. 23-24 , are formed through the body to provide a path for cleaning fluid to flow through the plug and within the annular space A of the connector C to clean the same. The opening can be positioned and formed through the body such that cleaning fluid introduced in the syringe tip coupling flows through the body and exits at a position spaced away from the plug member to further flow within the annular space A and along the threads of the collar of the feeding tube connector C. Similarly to the plug ( 10 ) described above, one or more reduced surface area void sections or cutouts can be defined within portions of the body such that a brush or cleaning tool  80  can pass therethrough to occupy one or more portions of the annular space to clean the same. 
     In example embodiments, the body can include a skirt extending about at least a portion of the periphery thereof. In example embodiments, at least a portion of the skirt comprises one or more reduced surface area passageways or cutouts. In example embodiments, the body comprises a single cutout for permitting the brush  80  (and brush end  82 ) access within the annular space A. As similarly described above, while the brush member  82  is at least partially occupying the annular space A and with the plug member sealed with the lumen L, the plug can be rotated in either of the clockwise or counter-clockwise directions such that the brush member  82  can access and clean the entirety of the surfaces defining the annular space A. 
     According to example embodiments, some of the plugs as described herein can provide both access within the annular space A and the introduction of a cleaning fluid within the annular space, both of which can be accomplished while the lumen L of the connector M remains sealed. 
     While the invention has been described with reference to example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.