Abstract
A cleaning device is configured access and remove fluid from and dry a moat region defined by a hub of a medical connector, thereby minimizing the potential for bacterial growth in the hub. The cleaning device takes the form of an absorbent block which can be inserted into the moat by extending about a central male fitting and into a gap between the male fitting and the inner wall of a female hub of the medical connector. In a preferred embodiment of the invention, the block takes the form of a tubular cylinder particularly configured for use on ENFit medical connectors wherein the absorptive feature of the cleaning device can be employed alone or in combination with another cleaning tool used to first remove any existing dried and caked solution in the hub before removing residual cleaning fluid from the moat.
Claims
1. A method of removing fluid from within a medical connector including a female hub having an inner threaded wall and a central male fitting annularly spaced from the inner threaded wall by a moat region with a cleaning device including a body constituted by an absorbent material, said method comprising: inserting the body of the cleaning device within the moat region, with a hollow interior portion of the body receiving the central male fitting; and removing fluid from within the medical connector by absorbing the fluid from within the moat region with the absorbent material of the cleaning device.
2. The method of claim 1, wherein inserting the body of the cleaning device within the moat region includes linearly and non-rotatably pushing the body to a floor of the female hub.
3. The method of claim 1, further comprising expanding the body of the cleaning device within the female hub upon the absorbent material getting wet by absorbing the fluid.
4. The method of claim 1, further comprising automatically sealing the central male fitting with a plug of the cleaning device upon inserting the body of the cleaning device within the moat region.
5. The method of claim 1, further comprising softening a dried enteral feeding solution with a solvent or applying a disinfecting solution within the female hub by wetting the absorbent material of the cleaning device before inserting the body into the medical connector.
6. The method of claim 1, further comprising cleaning dried and/or caked solution in the moat region, prior to insertion of the absorbent material of the body into the moat region, with a tool provided as part of the cleaning device.
7. The method of claim 1, wherein the absorbent material of the cleaning device expands upon becoming wet such that the body extends radially outward between threads of the inner threaded wall.
8. The method of claim 1, further comprising using natural materials consisting of woven or non-woven cellulose or cotton, synthetic woven or non-woven fibers, or one or more absorbent polymers of the body to absorb the fluid.
9. The method of claim 1, wherein the body has a form of a tube or hollow cylinder for absorbing the fluid.
10. The method of claim 7, wherein the body of the cleaning device is linearly and non-rotatably inserted to a floor of the female hub.
11. The method of claim 10, wherein the body of the cleaning device is threadably withdrawn from within the female hub.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1 is a cross sectional view of the standard ENFit feeding tube connector.
(2) FIG. 2 is a cross sectional view of an absorbent cleaning device taking the form of a hollow cylinder or tube in accordance with a preferred embodiment of the invention.
(3) FIGS. 3 A to D show the use of the absorbent cleaning device with an ENFit feeding tube connector.
(4) FIG. 4 shows the expansion of the absorbent cleaning device into internal female threads of the ENFit feeding tube connector during use in fluid removal.
(5) FIGS. 5A and 5B show orientation and mechanical alteration of absorbent sheets of the cleaning device.
(6) FIGS. 6A-C show different finger grip styles for use on the cleaning device.
(7) FIG. 7 shows how a core may be incorporated into the cleaning device.
(8) FIG. 8 is a cross sectional view of a cleaning device embodiment constructed in accordance with the invention employing an integral core.
(9) FIG. 9 is a cross sectional view of a cleaning device embodiment with a separate core.
(10) FIG. 10 is a cross sectional view of a cleaning device embodiment with an integrated finger grip.
(11) FIG. 11 is a cross sectional view of a cleaning device with and end cap or sleeve finger grip.
(12) FIG. 12 is a cross sectional view of a cleaning device with and end cap or sleeve finger grip and an end plug.
(13) FIG. 13 is a cross sectional view of a cleaning device with an integrated stiffener at one end.
(14) FIG. 14 is a cross sectional view of a cleaning device with a hollow core stiffener.
(15) FIG. 15A-D show cross sectional views of cleaning devices with cores and fluid path plugs.
(16) FIG. 16 is a cross section view of a cleaning device with a tool at one end.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
(17) With initial reference to FIG. 2, a cleaning device 9 constructed in accordance with a preferred embodiment of the invention takes the shape of a hollow cylinder or tube formed from a liquid absorbent material. More specifically, absorbent cleaning device 9 is made of a highly absorbent material and is sized according to the geometry of the ENFit connector to be cleaned. More generally, cleaner device 9 is structurally configured in size and shape to conform to the requisite medical connector hub, with the exemplary embodiments shown being configured for particular use with a known ENFit connector, such as that shown in FIG. 1. As will be detailed more fully below, cleaner device 9 functions to remove fluid from the inner surfaces of the ENFit feeding tube connector, including the inner wall, the female thread paths, the floor of the female hub and the outer surface of the tapered male fitting in the center of the female hub, leaving this moat region and its defining surfaces clean and dry.
(18) To accomplish the desired cleaning function, cleaning device 9 is long and narrow enough to fit within the geometry of the hub structure, and rigid enough to allow manipulation during the cleaning of all aspects of the hub. Further, cleaning device 9 is highly absorbent, with excellent wicking properties to remove all residual fluid from the hub, including from on and between the threads of the inside wall of the female hub. The cleaning device 9 may be formed from sheet material, die cut from a block of material, molded, or formed according to fabrication techniques particular to the material used. The absorbent materials may include natural materials such as woven or non-woven cellulose or cotton, or synthetic woven or non-woven fibers, or absorbent polymers such as poly vinyl acetate (PVA) or the like. Certainly, various absorbent materials having similar absorbent and other physical characteristics could be employed, such as for ease in fabrication, so long as the functionality in absorptive capability, stiffness and expansion upon wetting are maintained as detailed further below.
(19) FIGS. 3A-3D illustrate steps employed in using cleaning device 9 in absorbing fluids with the moat 7 of ENFit feeding tube connector 1. After disconnection of the ENFit tubing administration connector (not shown) from the ENFit feeding tube connector 1, cleaning device 9 is inserted into female hub 3. The cleaning device 9 fills the gap 7 between the inside wall 2 of the female hub 3 and the outer wall 5 of the tapered male fitting 4 as clearly shown in FIGS. 3B-3D, whereupon the highly absorbent material absorbs any fluid 10 that might remain in hub 3. Referring to FIG. 4, as the absorbent material of cleaning device 9 absorbs fluid 10 (labeled in FIG. 3), it will expand, filling the space 11 in moat 7 and wicking fluid from all portions of female hub 3, including between threads 8 along inner surface 2, floor 6 of hub 3, and walls 5 of tapered male fitting 4. Although cleaning device 9 is preferably configured to just be linearly and non-rotatably inserted to moat 7, if needed, such as if hub 3 contains a significant level of liquid which wets cleaning device 9 causing it to expand or cleaning device 9 is pre-wet prior to insertion, using a clockwise motion, the user can actually “screw” cleaning device 9 down to floor 6 of moat 7 to thoroughly clean threads 8. Regardless, the user can “unscrew”, i.e., threadably withdraw, the expanded cleaning device 9 when the fluid absorption/drying operation, i.e., cleaning, is completed.
(20) In one embodiment shown in FIG. 5A, an absorbent material 12, in the form of a sheet, is rolled into a hollow roll or cylinder (e.g., 1.750″ in length) in forming cleaning device 9, with an inner diameter (e.g., slightly greater than 0.220″) capable of passing over the tapered male fitting 4 in the center of the female hub 3 and an outer insertion diameter less than a diametric distance between the threads of hub 3. Again, upon the absorption of fluid and expansion, cleaning device 9 is configured to be compressed inside female hub 3. Multiple layers of absorbent material may be required, depending on the thickness of the material used, knowing that the roll of absorbent material must contact the inner walls 2, floor 6 and threads 8 of the female hub 3, as well as the outer wall 5 of the tapered male fitting 4, to provide thorough cleaning. The absorbent sheet 12 may also be rolled in a specific orientation according to the material used. For example, if an absorbent paper, e.g., cotton, is used, the absorbent sheet may be more easily rolled based on the grain direction 13 of the sheet. Additionally, the absorbent material may also be treated or mechanically altered to enhance rolling, such as by forming longitudinal ribs, either mechanically in the material, or by the addition of other materials, along the length of the rolled cylinder. For example, as illustrated in FIG. 5B, sheet 12 may be mechanically formed or treated, such as by creating mechanically formed polygon cross section shaped corrugations or flutes 14, to enhance both ease of rolling and the stiffness of the roll. In any case, with highly absorbent materials having rapid wicking capabilities employed in connection with the invention which may lose structural rigidity as they absorb fluid, the invention may employ a means to provide cleaning device 9 with structural integrity during use.
(21) As illustrated in FIGS. 6 A-C, the rolled cleaning device 9 may be prevented from unrolling using components such as a tape or label 15 (FIG. 6A), a sleeve or band 16 (FIG. 6B) or an end cap 17 (FIG. 6C), all of which may be used as a finger rest to prevent the user's fingers from becoming wet as liquid is wicked into the material during use. These components may also be used in conjunction with each other to secure the absorbent material and prevent unrolling, while also providing a finger rest. As in FIGS. 6A and 6B, the finger rest may be located toward the middle of the cleaning device 9 if a two ended cleaner is desired, or at the end of the cleaning device 9 for a single ended cleaner, as in FIG. 6C. The finger rest may be secured to the absorbent material using various methods, such as with a pressure sensitive adhesive or a hot melt adhesive, by deforming the finger rest material by mechanical staking, or by melting the finger rest using heat or ultrasound to bond it to the absorbent material.
(22) In other embodiments designed for enhanced strength, a core element may be used, either alone or in combination with other strength enhancing arrangement described herein. Such a core element may be formed by using the absorbent material itself, or through the addition of another component or components. In one embodiment shown in FIG. 7, a core element 18 may be created by rolling enough additional absorbent material to fill at least a portion the hollow center of the absorbent cylinder, while still allowing clearance at the ends of the cylinder to accommodate the length of the tapered male fitting 4, or a secondary roll of either absorbent or non-absorbent material may be incorporated into the absorbent cylinder 9. In another embodiment shown in FIG. 8, the absorbent material is molded, formed or cut into a shape with varying thicknesses to create a unitary core region 19 providing increased structural integrity while still accommodating the length of the tapered male fitting 4. In a still further embodiment as shown in FIG. 9, a rigid or semi-rigid material is incorporated into the lumen (not labeled) of the cleaning device 9 to act as a core element 20. For example, a solid or hollow core element 20 of molded or extruded material could be incorporated into the outer body of cleaning device 9 during the rolling process to provide structural rigidity. Further, this core element may be used to facilitate rolling through the use of a longitudinal slot or groove 21 which accommodates the leading edge of the absorbent sheet.
(23) In accordance with another aspect of the invention, with particular reference to FIG. 10, a tape or other semi-rigid material 22 may be incorporated into a roll of absorbent material to provide structural rigidity to the wall of the rolled cleaning device 9. For example, a pressure sensitive tape 22 could be applied to a sheet of the absorbent material and incorporated into cleaning device 9 as it is rolled. To prevent unrolling, an additional portion of tape 22 may extend beyond the edge of the absorbent material, while being used to secure a loose end of tape 22 to itself. In a manner analogous to that discussed above with particular reference to FIG. 6B, multiple layers of tape 22 could be used to provide different amounts of rigidity, while also acting as a finger grip.
(24) At this point, it should be noted that, in connection with the arrangement of FIG. 6B, the incorporation of rigid or semi-rigid band 16 can also establish an additional way to improve the structural integrity around the exterior of the cleaning device. Band 16 could be in the form of an extruded or molded component, and may be a unitary component or formed from two or more components. That is, band 16 would provide enhanced structural rigidity and keep the absorbent cleaning device 9 from unrolling, while still acting as the finger grip to protect the user's fingers from becoming wet during use. Just as referenced above, band 16 could be secured to the absorbent material with adhesive, with heat or ultrasonic welding, heat staked, or by a mechanical means such as structures in a molded component to grip the absorbent material to prevent band 16 from sliding off the body of cleaning device 9. It should be further recognized that the referenced embodiment of FIG. 6C can establish another arrangement for providing structural integrity, while keeping the cleaning device from unrolling. That is, end cap 17 fastened to one end of the body of cleaning device 9 adds to the overall structural integrity. End cap 17 can have a closed or open end. In the case of a closed end cap 17, the body of cleaning device 9 is inserted into cap 17. An adhesive, such as hot melt glue, can be used to secure the body in end cap 17. Alternatively, end cap 17 could be molded with the body and incorporate structures to grip the absorbent material to prevent the body of cleaning device 9 from sliding out of end cap 17. Again, additional methods could be used to secure end cap 17 to the body of cleaning device 9, such as mechanical staking, welding or the like.
(25) In the case of an opened end cap as in FIG. 11, an open ended cap or sleeve 23 is provided at one end of the body for cleaning device 9. Open cap/sleeve 23 can be molded and incorporate structures 24 to grip the absorbent material to prevent the body of cleaning device 9 from sliding out of cap/sleeve 23, or the cap/sleeve 23 could be secured in various other ways, including being mechanically staked to the absorbent material, alone, or in conjunction with, heat or ultrasonic welding. An additional arrangement is shown in FIG. 12 for securing an open cap/sleeve 25 to the body of cleaning device 9 wherein an end plug 26 is used in conjunction with cap/sleeve 25. In this case, cap/sleeve 25 is placed over the body of cleaning device 9, and end plug 26 is inserted into the lumen of cleaning device 9, capturing the absorbent material between cap/sleeve 25 and end plug 26. End plug 26 can secured mechanically through the use of structures 27 to grip the absorbent material, via an interference press fit, or by being sealed to the cap/sleeve 25 using heat, ultrasound, or adhesive. The structures 27 could alternatively be located on cap/sleeve 25 (as in a manner similar to structures 24 of FIG. 11), or end plug 26 could be smooth or feature complementary elements to structures 27. The open ended cap/sleeve 25 and end plug 26 could also be combined into a singular component with similar features which could be placed over or around the end of cleaner device 9.
(26) In some cases it may be desirable to wet the absorbent material of the cleaning device before it is inserted into the connector to provide a solvent to soften dried or partially dried enteral feeding solution during cleaning, or to apply a disinfecting solution. As mentioned above, the wetting may decrease the structural integrity of the body and make the cleaner device difficult to insert into the connector. To accommodate wet use, the cylinder can be fabricated from multiple materials, with at least one material providing absorbency and at least one other material providing structural rigidity. FIGS. 13 and 14 illustrate exemplary embodiments wherein a structural element is added to one end of cleaning device 9 to give it more rigidity at that end. In the embodiment of FIG. 13, a strip of semi-rigid material or tape 28 is incorporated within the hollow body of cleaner device 9 to reinforce a wettable end 29 or, as in the embodiment of FIG. 14, a hollow core 30 is positioned in the lumen of cleaning device 9 at wettable end 29. In either case, the stiffening material still allow cleaning device 9 to fit over the male fitting of a medical connector. The tape or semi-rigid material 28 of FIG. 13 or the hollow core 30 of FIG. 14 could have fenestrations or cutouts to allow absorbent material to be exposed to the surfaces of the female hub of the connector, while still providing increased rigidity.
(27) During a cleaning operation, it may be desirable to plug the end of the tapered male fitting of the medical connector to prevent liquid from entering the fluid path of the feeding tube and, subsequently, the patient, such as the patient's gastrointestinal tract. To address this concern, a plug may be created by incorporating a core into the cleaning device, with the core being shaped to have a geometry configured to occlude the lumen of the tapered male fitting when the cleaning device is applied to female hub. With initial reference to FIG. 15A, a core 31, having one or more core ends 32 and shown as a separate component from the body of cleaner device 9, is constructed from a conformable material such as an elastomeric polymer. Alternatively, as in the embodiment of FIG. 15C, a core 33, having one or more core ends 34, is created by filling a hollow interior of cleaning device 9 with absorbent material. The absorbent core 33 can be created in various ways, such as by rolling an appropriately sized and shaped piece of absorbent material into a structure such that core 33 and core ends 34 are formed during the rolling process, or alternatively core 33 could be formed using a separate piece of absorbent material incorporated as an integral part of the body of cleaning device 9. In either case, during use, pressure exerted by the user while cleaning the medical connector causes the core end 32 or 34 to press against, and conform to, the tapered male fitting 4, thus sealing the lumen as shown in FIG. 15B and FIG. 15D.
(28) There are times when a solution, such as an enteral solution, could dry and cake in the moat. As discussed above, brushes are currently used to remove these accumulations. However, in accordance with the invention, provisions are made to integrate a tool into one end of the cleaning device to facilitate removal of the dried material. FIG. 16 illustrates an exemplary embodiment wherein a supplemental molded or fabricated tool 35 is incorporated into a molded core or end cap, and secured to the upper end portion of cleaning device 9, such as through the use of adhesive, heat seal or ultrasound. Alternatively, the tool 36 could be formed integral with the body of the cleaning device 9 or by deforming an end cap or sleeve using a controlled heat or ultrasonic welding process either during or after attachment of the cap or sleeve to the upper end portion of cleaning device 9.
(29) Although described with reference to preferred embodiments of the invention, it should be readily understood that various changes and/or modifications can be made to the invention without departing from the spirit thereof. Certainly, the skilled person will appreciate that the hub cleaning device described herein is not limited to use with an ENFit enteral feeding tube connector, but rather can be readily configured for use with a wide range of medical connectors including a moat region which is difficult to readily access for necessary cleaning purposes. In general, the invention is only intended to be limited by the scope of the following claims.
