Patent Application
20190192843
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.
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.
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.
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,
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 L1 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
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
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 L1. 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 L1 as it'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,
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
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 L1 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
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.
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'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
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.
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.
| Number | Date | Country | |
|---|---|---|---|
| 62636924 | Mar 2018 | US | |
| 62108824 | Jan 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15009073 | Jan 2016 | US |
| Child | 16288377 | US | |
| Parent | 16223917 | Dec 2018 | US |
| Child | 15009073 | US | |
| Parent | 16154479 | Oct 2018 | US |
| Child | 16223917 | US |
