IL304104A - Nipple cleaning kit - Google Patents

Nipple cleaning kit

Info

Publication number
IL304104A
IL304104A IL304104A IL30410423A IL304104A IL 304104 A IL304104 A IL 304104A IL 304104 A IL304104 A IL 304104A IL 30410423 A IL30410423 A IL 30410423A IL 304104 A IL304104 A IL 304104A
Authority
IL
Israel
Prior art keywords
adapter
nipple shield
milk
shield device
cleaning
Prior art date
Application number
IL304104A
Other languages
Hebrew (he)
Inventor
Nahshon Alon
Richtman Amir
TRABELSI Adi
HADOMI Oded
KAN Adir
Original Assignee
Kaizen Bio Tech 2011 Ltd
Nahshon Alon
Richtman Amir
TRABELSI Adi
HADOMI Oded
KAN Adir
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kaizen Bio Tech 2011 Ltd, Nahshon Alon, Richtman Amir, TRABELSI Adi, HADOMI Oded, KAN Adir filed Critical Kaizen Bio Tech 2011 Ltd
Priority to IL304104A priority Critical patent/IL304104A/en
Priority to CN202421205560.6U priority patent/CN222383117U/en
Priority to PCT/IL2024/050633 priority patent/WO2025004046A1/en
Publication of IL304104A publication Critical patent/IL304104A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J11/00Teats
    • A61J11/0075Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J13/00Breast-nipple shields
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B08CLEANING
    • B08BCLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B9/00Cleaning hollow articles by methods or apparatus specially adapted thereto
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B08CLEANING
    • B08BCLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B9/00Cleaning hollow articles by methods or apparatus specially adapted thereto
    • B08B9/02Cleaning pipes or tubes or systems of pipes or tubes
    • B08B9/027Cleaning the internal surfaces; Removal of blockages
    • B08B9/032Cleaning the internal surfaces; Removal of blockages by the mechanical action of a moving fluid, e.g. by flushing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M2039/0009Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
    • A61M2039/0018Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation designed for flushing a line, e.g. by a by-pass

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Devices For Dispensing Beverages (AREA)
  • Measuring Volume Flow (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Description

NIPPLE CLEANING KIT FIELD The present disclosure describes technology related to the field of cleaning the inside bore of thin fluid transfer channels, especially for infant feeding nipples.
BACKGROUND It is well-known that when feeding babies it is important to keep all parts of their feeding equipment, such as the bottles and teats, sterile to reduce risk of infection. Before baby equipment can be sterilized they have to be thoroughly cleaned to remove any left-over residue from a previous feeding. Many parents breastfeed their babies and there are a range of devices that can help with any issues or difficulties that may arise from breastfeeding.
One such device is a nipple shield which provides real-time information to the mother regarding the flow of milk that the infant is taking. Such devices channel the milk flow from the mother’s breast to the infant’s mouth by means of narrow channels which direct the milk to a region away from the nipple region itself, where the flow becomes visible, and can be seen by the mother. One such device is shown in the published International Patent Application WO 2022/175833 entitled "Device for Flow Detection of Mother’s Milk", commonly owned by the present applicant. That publication shows both channels which run completely within the device, from the inside of the nipple tip through the display channel and to the outside surface of the nipple tip, for consumption by the infant. Other implementations show channels which direct the milk to and from an open end port where an external flow meter at the periphery of the device measures the flow.
However, unless the nipple shield is disposable, which is less favorably viewed today because of the need to conserve the world’s resources, including manufacturing resources, there exists a need to be able to thoroughly clean out the entire shield between feeding sessions, to ensure that it is clean before sterilization, to be safe for the child to use. It is difficult to thoroughly clean out milk residues from the passageways of such devices, by regular washing procedures, as the channels are small, capillary like tubes of considerable length, that cannot be opened to clean out.
Therefore, there exists a need to create a device that will enable the efficient cleaning of those narrow channels so that the nipple shield can be a reusable device that is safe for use by an infant.
The disclosures of each of the publications mentioned in this section and in other sections of the specification, are hereby incorporated by reference, each in its entirety.
SUMMARY The present disclosure attempts to provide novel systems and methods that overcome at least some of the disadvantages of prior art systems and methods. The present disclosure provides a novel device and method that enables the cleaning of narrow channels, such as those that are found in a nipple shield milk flow indication device, such as those described in the above referenced WO 2022/175833.
The presently described cleaning kit is designed to provide a strong flow of cleaning fluid that enters the apertures on the inside of the nipple shield and exits from the apertures on the outer surface of the nipple shield. The fluid should be a cleaning or sterilizing fluid but may be any other fluid that is suitable for such use.
The cleaning adapter has a structure, adapted to match the inner surface of the protrusion nipple part of a nipple shield flow indication device, and has a base surround and a tip. The base is adapted to sit against the base of the nipple shield flowmeter device, and the cone height is determined so that when the cone is inserted up to its base, the tip does not reach the feeding apertures in the tip, so that they are not blocked by the intruding cone device. The base surround also prevents cleaning fluid from splashing back over the user when the fluid is forced into the nipple shield.
The tapered shaped structure has a hollow central tube that runs from the base of the conically shaped structure up to the tip of the adapter and has two openings, one located at the base surface, and the other at the opposite end of the tube at the tip. According to an alternative implementation, the cleaning adapter has a structure that is adapted to fit over the outer surface of the nipple shield flow indication device. Such a cleaning adapter will then have an internal cone-like structure, adapted to match the outer surface shape of the nipple shield. Such a cleaning adapter also has a hollow central tube that runs from the outer top end of the adapter to the apex of the internal coned space of the adapter.
Other implementations show a cleaning adapter which can be used either internally or externally, by having to shaped nipple shield device interfaces, one at either end of the device, one of the interfaces having an external cone shape for insertion into the inner surface of a nipple shield device, and the other having an internal cone-like structure, matching the outer surface shape of the nipple shield device, and for fitting over the outer surface of the nipple shield device.
When in use, a syringe containing a cleaning solution is inserted into the central bore of the conically shaped structure and then the conically shaped structure with the attached syringe is either inserted into the inner space of the nipple structure, such that the tip of the conically shaped structure is close to, but does not block the apertures of the nipple shield, or it is placed over the nipple structure, according to the configuration of cleaning adapter used. Once the conically shaped structure is in place, a stream of the cleaning fluid is forced through the narrow milk flow passageway, cleaning out any milk residues from the previous feeding session. By this means, an efficient cleaning procedure can be performed without the need for brushes or probes that could damage the delicate nipple shield device, and especially its milk channels.
Alternatively, first the conically shaped structure is inserted into the inner space of the nipple structure or over the outer surface of the nipple device, and then the syringe containing cleaning fluid is attached to the central bore of the cleaning device.
There is thus provided in accordance with an exemplary implementation of the devices described in this disclosure, an appliance for cleaning at least one milk passage of a nipple shield milk measurement device, the at least one milk passage being connected either to at least one milk flow aperture disposed on an inner surface of the protrusion of the nipple shield device, or to at least one milk flow aperture disposed on an outer surface of the nipple shield device protrusion, the appliance comprising: (i) an elongated adapter, externally tapered along at least a part of its length from a broader base region to a narrower tip region, an outer surface of the tapered part of the adapter having a shape adapted to match the inner surface of the nipple shield device, such that the adapter can sit within the nipple shield device without significant leakage between the outer surface of the adapter and the inner surface of the nipple shield device; and (ii) an axial bore providing fluid connection between the base region and the tip of the tapered adapter, wherein the shape and the length of the adapter are such that when fully inserted into the nipple shield device, a space is left between the tip of the insert and the at least one milk flow aperture disposed on the inner surface of the nipple shield device.
In such an appliance, the elongated adapter may further comprise a surround rim located at the base region in a position that prevents spillage or splashing of any cleaning fluid leaking from between the outer surface the adapter and the inner surface of the nipple shield device. Additionally, the elongated adapter may further comprise a surround rim located at the base region in a position that is configured to limit the extent of entry of the adapter into the nipple shield device, such that a space is left between the tip of the insert and the at least one milk flow aperture disposed on the inner surface of the nipple shield device.
According to yet another implementation of the above described appliances, the axial bore may be of a size such that is can receive the ejection output opening of a syringe, such that when the adapter is positioned within the nipple shield device, cleaning fluid from the syringe can be flushed through at least one milk passage of the nipple shield device. Such an implementation may further comprising a Luer connection at the base end of the axial bore, such that the syringe can be connected to the elongated insert. Alternatively, the syringe may be an integral part of the appliance.
In any of the above described appliances, the prevention of significant leakage between the outer surface of the adapter and the inner surface of the nipple shield device ensures the maintenance of pressure within the axial bore of the insert, such that the cleaning fluid is forced through the at least one of the milk passage.
Finally, there is further presented an appliance of any of the types described above, wherein the elongated adapter may further comprise an elongated hollow formed in the base region of the adapter, the elongated hollow being tapered along at least a part of its length, an inner surface of the tapered part of the elongated hollow having a shape adapted to match the outer surface of the nipple shield device, such that the elongated hollow of the insert can sit over the nipple shield device without significant fluid leakage between the inner surface of the tapered elongated hollow and the outer surface of the nipple shield device.
In accordance with yet another implementation of the devices of the present disclosure, there is further provided an appliance for cleaning at least one milk passage of a nipple shield milk measurement device, the at least one of the milk passage being connected either to at least one milk flow aperture disposed on an inner surface of the protrusion of the nipple shield device, or to at least one milk flow aperture disposed on an outer surface of the nipple shield device protrusion, the appliance comprising: (i) an elongated adapter, having a recess with an inner tapered profile along at least a part of its length, from a broader base region to a narrower tip region, the inner surface of the tapered part of the adapter having a shape adapted to match the outer surface of the nipple shield device, such that the adapter can sit over the nipple shield device without significant leakage between the inner surface of the adapter and the outer surface of the nipple shield device; and (ii) an axial bore providing fluid connection between the tip region of the recess and the outer tip of the elongated adapter, wherein the shape and the length of the recess of the elongated adapter are such that when fully mounted over the nipple shield device, a space is left between the at least one milk flow aperture disposed on the outer surface of the nipple shield device, and the narrower tip region of the recess of the adapter. According to yet another implementation of the last described appliance, the axial bore may be of a size such that is can receive the ejection output opening of a syringe, such that when the adapter is positioned over the nipple shield device, cleaning fluid from the syringe can be flushed through at least one milk passage of the nipple shield device. In such an implementation, the syringe may be an integral part of the appliance.
There is further provided in accordance with an exemplary implementation of the methods described in this disclosure, a method for cleaning at least one milk passage of a nipple shield milk measurement device, the at least one of the milk passage being connected either to at least one milk flow aperture disposed on an inner surface of the nipple shield device, or to at least one milk flow aperture disposed on an outer surface of the nipple shield device, the method comprising: (i) inserting a cleaning adapter into the inner space of the nipple shield device, the cleaning adapter comprising: (a) a shaped outer surface adapted to fit snugly into the inner space of the nipple shield device; (b) an axial bore from its outer end to its tip, the tip being adapted to be located at the inner end region of the nipple shield device; and (c) a base rim adapted to locate the cleaning adapter in such an axial position that the tip of the cleaning adapter is located at a predetermined distance from the inner surface of the nipple shield device; (ii) inserting a syringe containing a cleaning fluid into the outer end of the axial bore of the cleaning adapter; and (iii) activating the syringe to inject a stream of cleaning fluid under pressure into the at least one milk passage.
In such a method, the tip of the cleaning adapter may have a flattened shape.
Finally, any of the above described methods may comprise the additional step of connecting a fluid bridging connection piece to the remote end of a milk passage connected to at least one milk flow aperture disposed on the inner surface of the nipple shield device, and to the remote end of a milk passage connected to at least one milk flow aperture disposed on an outer surface of the nipple shield device, such that injecting a stream of cleaning fluid under pressure generates a flow of fluid through both the milk passages.
It is to be noted that although the nipple shield devices described in the above referenced WO 2022/175833 prior art publication, may be used for indication of milk flow, or measurement of milk flow, or, using the embodiments of Fig. 2, other measurements relating to the milk, in order to simplify nomenclature, throughout this disclosure, these devices are generically termed as nipple shield milk flow devices or milk measurement devices. It is however to be understood that this nomenclature is intended to cover any of the other functional uses of such devices.
Furthermore, since the protrusion in the center of the nipple shield milk flow device, having the shape and function of a nipple shield, is a major feature of the device, references to "the inside surface of", or "the outer surface of", or "inserted within" or "mounted over" the nipple shield milk flow device, or similar terms, are to be understood as relating to the protrusion itself of the device.
BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which: Fig.1 shows a schematic cross-sectional drawing of a first embodiment of a prior art milk flow indication device; Fig. 2 shows an isometric skeleton drawing of a second embodiment of a prior art milk flow indication device; Fig. 3A is a schematic drawing of a cleaning adapter designed to be used with a nipple shield milk measurement device, such as those shown in Figs. 1 and 2; Fig. 3B is a scale cross-sectional drawing of the cleaning adapter, showing typical dimensions and features; Fig. 3C is an image of the cleaning adapter of Figs. 3A and 3B in use, with the syringe attached to the cleaning adapter; Fig. 4A shows an alternative cleaning adapter designed to fit over the external surface of the nipple shield device; Fig. 4B shows an isometric sectioned drawing of the cleaning adapter of Fig. 4A; Fig. 4C is a cross-sectional schematic drawing of the external cleaning adaptors of Figs. 4A and 4B, mounted on a nipple shield device; Fig. 5A is a schematic drawing of a syringe attached to a cleaning adapter of Fig. 4C, for mounting on the outside of the shielding nipple; Fig. 5B is a schematic drawing of a syringe attached to a cleaning adapter of Fig. 4C, for mounting on the outside of the shielding nipple; Fig. 6 is an isometric skeleton drawing of an alternative cleaning adapter designed to be used with a nipple shield, such as those shown in Figs. 1 and 2; Fig. 7 is a schematic drawing of the cleaning adapter as shown in Fig. 6 being used in a different c configuration; and Fig. 8 is an isometric skeleton drawing of another alternative cleaning adapter to be used with a nipple shield such as the one shown in Fig. 2.
DETAILED DESCRIPTION Reference is first made to Figure 1 which illustrates a schematic cross-sectional drawing of a first embodiment of a prior art milk flow indication device 10, as shown in the above-mentioned International Patent Application WO 2022/175833. The milk flows from the mother’s breast 12 to the inside volume 14 of the nipple shield device 10, and through the long, narrow indicating passageway 15, to the outlet aperture 17 of the device, from which the infant can intake the milk through its lips 19. As can be seen from Fig. 1, efficient cleaning of the long narrow tube 15, is a difficult task.
Reference is now made to Figure 2 which illustrates an isometric skeleton drawing of a second embodiment of a prior art milk measurement device, as shown in the above-mentioned International Patent Application WO 2022/175833. This milk measurement device 70 differs from that shown in Fig. 1, in that the milk measurement is performed by an external replaceable measurement unit, which is connected to the nipple shield device at a fluid twin connector 78. Proceeding from the tip of the nipple shield protrusion 71, the milk flows from the inside volume of the nipple protrusion, via one or more exit apertures through passageway 72 to the output fluid connection port 76, where it is input to the external measurement unit, from which, milk flows back through input fluid connection port 77, back up passageway 73, and out of the tip of the nipple shield protrusion 71 via feed apertures 75 to the infant sucking on the device. The external measurement unit can be any of a number of modules for measuring flow, total supplied quantity, analysis of the milk, or any other function as described in the above referenced WO 2022/175833. In common with the embodiment of figure 1, the device of figure 2 also has a long and narrow milk flow path, but it differs in that the ends of the milk output channel 72 and the milk input channel 73 are open at the fluid connection port 76, such that a single flow cannot be used for cleaning both channels.
Reference is now made to Figure 3A which illustrates a schematic drawing of a cleaning adapter designed to be used with a nipple shield milk flow device, such as those shown in Figs. 1 or 2. As shown, the cleaning adapter 30 is generally cone shaped in order to fit inside the nipple shield protrusion, so that a flow of cleaning liquid under a positive pressure can be passed through the cleaning adapter 30 and into the milk flow channels in the nipple shield flow device, in order to clean out the milk flow channels. However, any other shape that may fit closely or snugly inside the nipple shield, to provide a sealed internal volume that will prevent significant leakage of the cleaning fluid under the pressure inside, may also be used.
The cleaning adapter 30 has a base rim or surround 31, which defines the axial position of the cleaning adapter when it is inserted into the flow measurement device. At the opposite end of the cleaning adapter is the tip, which may advantageously have a flat plateau-like profile 32. Running axially through the length of the cleaning adapter is a bore 33, which is adapted to convey cleaning fluid from the base region to the tip region 32, where it can be forced into the milk passageways through the apertures on the inside surface of the nipple shield milk flow device, these apertures being shown in Figs. 1 and 2. In use, the cleaning fluid will be injected into the axial bore 33 by means of a syringe, to be shown in Fig. 3C hereinbelow, and which can apply a small positive pressure to the cleaning fluid to force it through the milk flow passageways.
This method of use now explains the function of the base rim 31, and of the optional but advantageous flat-topped tip surface 32 of the cleaning adapter. In order to ensure that there is a clear path for the cleaning fluid to pass from the axial bore into the entrance aperture or apertures of the milk channel, it is important that the tip of the cleaning adapter does not come into contact with the apertures themselves, which would cause an impedance or even blockage to the flow of the cleaning fluid from the axial bore into the milk channels. To avoid this, the base rim seats against a reference surface in the bottom region of the nipple shield device, and the known length of the cleaning adapter thereby accurately defines the axial position of the top surface of the cleaning adapter relative to the inner top surface of the nipple device, which should be a small distance from the milk exit apertures. The flat-topped tip also participates in the task of keeping a clear space at the tip of the cleaning adapter to enable a clear flow for the cleaning fluid, by keeping a clear space between the flat tip surface 32 and the rounded inside surface of the nipple device.
The base rim also has the secondary purpose of preventing cleaning fluid from escaping from around the edges of the conical insert if it does not form a good seal with the inside volume of the nipple shield device.
Reference is now made to Fig. 3B which is a scale cross-sectional drawing of the cleaning adapter, showing typical dimensions and features. The numbered features are the same as those shown in Fig. 3A, with the addition of a Luer connection flange 34 at the bottom end of the axial bore 33, so that the syringe containing the cleaning fluid may be locked in place to the cleaning adapter. The Luer connector may alternatively be a non-lockable version.
Reference is now made to Fig. 3C which is an image of the complete nipple cleaning kit in use, showing how the syringe 35 is to be attached to the cleaning adapter 30. The syringe should have an injection end which matches the inner profile of the axial bore 33 of the cleaning adapter 30. A soft rubber or polymer end may be used to ensure a leak-proof connection. Alternatively, syringe 35 may be incorporated as a single piece with the cleaning adapter 30.
Cleaning adapter 30 is inserted inside the nipple shield milk flow device, such as of the type shown in Figs. 1 or 2, or another type of nipple shield flowmeter device, and the syringe 35, charged with a cleaning solution, is attached to the cleaning adapter 30 by inserting the tip of the syringe 36 into the lower end of the axial bore 33 of the cleaning adapter. When the syringe plunger 37 is actuated, the cleaning fluid is forced under pressure through the axial bore 33 of the cleaning adapter 30, and, in the case of the prior art embodiment of Fig. 1, through the apertures 16 on the inner surface of the nipple shield, then through the entire length of the milk flow channel 15 and out of the apertures 17 on the outer surface of the nipple shield, thus cleaning out the milk flow channels.
Reference is now made to Fig. 4A, which shows an alternative cleaning adapter 40 designed to be used with a nipple shield milk flow device such as that shown in Figs. 1 and 2. This cleaning adaptor differs from that of Fig. 3A and 3B in that this cleaning adapter 40 is designed to fit over the external surface of the nipple shield device. In order to ensure as leak-proof a seal as possible, cleaning adapter 40 has a hollow internal base section that will be clearly shown as item 41 in Fig. 4B, shaped such that it can fit snugly over the outer surface of the nipple structure. Running axially through the length of the cleaning adapter is a bore 43, and a syringe, such as that shown in Fig. 3C, can be attached to the end of bore 43 to inject cleaning fluid from the tip region of the cleaning adapter to the base region, where it can be forced into the milk passageways through the apertures on the outside surface of the nipple shield milk flow device, these apertures being shown in Figs. and 2.
Reference is now made to Figure 4B which shows an isometric sectioned drawing of the cleaning adapter 40 of Fig. 4A, showing the internal hollow 41, shaped to fit snuggly over the outer surface profile of the nipple shield device with which it is to be used. The cleaning adapter 40 is constructed so that the inner surface of the adapter does not block the apertures of the nipple shield, when mounted thereon, such as by designing the length and shape of the conical internal hollow 41 such that when it sits firmly on the nipple shield device, a space remains between the tip of the nipple shield device and the top face 44 of the hollowed internal space 41. Alternatively or additionally, the hollow internal space 41, as measured from the base face 42, which is meant to rest on the surround part of the nipple shield device, to the top face 44 of the hollowed internal space 41, may be made longer that the length of the protrusion of the nipple shield device on which it is intended to be mounted.
Reference is now made to Fig. 4C which is a cross sectional schematic drawing of the external cleaning adaptor 40 of Figs. 4A and 4B, mounted on a nipple shield device 46, ready for the cleaning action to the milk aperture(s) 45 and their associated milk flow tubes, by fluid injected into the central bore 43 by a syringe. Though for simplicity in the drawing of Fig. 4C, the aperture(s) 45 are shown as passing through to the internal space of the nipple shield device, in practice, for the nipple shield devices of Figs. 1 and 2, they are connected to long and narrow milk channels, for the cleaning of which, the presently described cleaning adapters are advantageously intended. Fig. 4C clearly shows how the seal between the nipple shield device and the internal hollow can be achieved by manufacturing the slope of the internal conical surface 47 to match the shape of the outer surface of the nipple shield device, such that a snug fit is obtained.
Referring back now to Figs. 4A, 4B and 4C, and according to a further implementation of the cleaning adapters of the present disclosure, they can be constructed such that a single adapter can be used to clean from the inside space of the nipple shield milk flow device, as shown in Figs. 3A and 3B, or from the outside of the nipple shield milk flow device, as shown in Fig. 4A to Fig. 4C. This dual purpose adapter can be understood by noting that in the adapters shown in Figs. 4A to 4C, the upper outer end of the adapter has been formed with a conically shaped outer surface 48, which can serve as the mating surface of an internal cleaning adapter, such as those shown in Figs. 3A and 3B.
Such dual purpose cleaning adaptors are useful for cleaning the milk channels of the nipple shield milk flow devices as shown in Fig. 2. In such nipple shield devices, there are separate milk channels to and from the periphery of the device, one 72 from the mother, from apertures opening into the internal surface of the nipple device protrusion, and the other to the infant, opening into the feed aperture(s) 75 in the external surface of the nipple device. So long as the peripheral ends of the milk channels are not connected, their cleaning has to be performed both from the inside and the outside of the nipple shield device. Therefore cleaning adapter 40 has to be used twice, both in a position within the inner surface of the nipple shield, which allows cleaning of the milk flow channel 72 and in a second position, over the outer surface of the nipple shield to allow milk flow channel to be cleaned.
Reference is now made to Figs. 5A and 5B, which show the way in which the syringe 35 may be connected to the dual purpose cleaning adapter 40 of Figs. 4A to 4C. In Fig. 5A, the syringe is shown attached to the outer end of the dual purpose cleaning adapter, such that the adapter can be fitted over the outer surface of the feeding nipple of the nipple shield device, in order to clean milk passages leading to the feed aperture(s) for the baby. In Fig. 5B, the syringe is shown attached to the other end of the dual purpose cleaning adapter, such that it can be inserted into the inner conical hollow, for cleaning milk passages used for transferring the milk from the mother.
Reference is now made to Fig. 6 and Fig. 7, which illustrate how the dual purpose cleaning adapter of Figs. 4A to 4C can be used in cleaning a nipple shield milk flow device 70 having two separate milk flow channels, such as that shown in Fig. 2. Fig. 6 shows the cleaning adapter 40 fitted on the outside of the nipple shield device 70, for cleaning milk channels to the infant terminating on the outer surface of the device, while Fig. 7 shows the cleaning adapter 40 fitted on the inside of the nipple shield device 70, for cleaning milk channels from the mother starting at the inner surface of the device.
Reference is now made to Fig. 8, which shows an alternative method of cleaning the milk channels of the nipple shield device of Fig. 2, which differs from the methods shown hereinabove, in that both milk channels are cleaned simultaneously. Fig. 8 is a skeleton drawing of an adapter attachment 80 that can be used for that purpose. Adapter attachment 80 is designed to connect to the output fluid connection port 76 and the input fluid connection port 77 of the nipple shield device of Fig. 2. Adapter attachment 80 has a bifurcated channel structure, with the single input 81 of the bifurcation adapted to enable a syringe containing cleaning fluid to be attached. The two output lines of the junction 82, 83, are the lines connected to the fluid connection ports 76, 77 of the nipple shield device. Once the adapter attachment 80 and syringe are in place, ejection of cleaning fluid from the syringe results in the cleaning fluid flowing simultaneously through both of the milk channels 72, 73 of the nipple shield device of Fig. 2, the cleaning fluid that passes through milk flow channel 72 exiting the channel at apertures 74 - located on the inner surface of the nipple shield, and the cleaning fluid that passes through milk flow channel 73 exiting the channel at apertures 75, located on the outer surface of the nipple shield.
According to yet a further method of cleaning both milk channels 72, 73, in one procedure, it is also possible to use either the internal cleaning adaptor of Figs. 3A to 3C, or the external or dual purpose cleaning adaptor of Fig. 4A to 4C to flush cleaning fluid down one of the milk channels 72, 73, with a bridging connector (not shown) attached to the output ports 76, 77 such that the cleaning fluid exits from one port, passes through the bridging connection canal, and reenters the second port to flush out the second of the milk channels. The bridging connector looks exactly like the adapter attachment 80 of Fig. 8, except that lines 82 and 83 are simply joined together as a fluid connection path, without any junction attached thereto.
Alternatively, the cleaning procedure may be performed with the pressure measurement module still attached to the nipple shield device, though this may not be recommended, in case the cleaning fluid affects any sensors in the flow path inside the measurement module.
As already indicated with regards to cleaning adapter 30, also with regard to cleaning adapter 40 and the adapter attachment 80, the syringe 35 can either be a separate component of the cleaning kit or it can be an incorporated as a single piece with any of the cleaning adapters or attachments (30, 40 or 80).
Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. Furthermore, it is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and sub-combinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.

Claims (14)

1. CLAIMS
2. We claim: 1. An appliance for cleaning at least one milk passage of a nipple shield milk measurement device, the at least one of the milk passage being connected either to at least one milk flow aperture disposed on an inner surface of the protrusion of the nipple shield device, or to at least one milk flow aperture disposed on an outer surface of the nipple shield device protrusion, the appliance comprising: an elongated adapter, externally tapered along at least a part of its length from a broader base region to a narrower tip region, an outer surface of the tapered part of the adapter having a shape adapted to match the inner surface of the nipple shield device, such that the adapter can sit within the nipple shield device without significant leakage between the outer surface of the adapter and the inner surface of the nipple shield device; and an axial bore providing fluid connection between the base region and the tip of the tapered adapter, wherein the shape and the length of the adapter are such that when fully inserted into the nipple shield device, a space is left between the tip of the elongated adapter and the at least one milk flow aperture disposed on the inner surface of the nipple shield device. 2. An appliance according to claim 1 wherein the elongated adapter further comprises a surround rim located at the base region in a position that prevents splashing of any cleaning fluid leaking from between the outer surface the adapter and the inner surface of the nipple shield device.
3. An appliance according to claim 1 wherein the elongated adapter further comprises a surround rim located at the base region in a position that is configured to limit the extent of entry of the adapter into the nipple shield device, such that a space is left between the tip of the adapter and the at least one milk flow aperture disposed on the inner surface of the nipple shield device.
4. An appliance according to any of the previous claims, wherein the axial bore is of a size such that is can receive the ejection output opening of a syringe, such that when the adapter is positioned within the nipple shield device, cleaning fluid from the syringe can be flushed through at least one milk passage of the nipple shield device.
5. An appliance according to claim 4, further comprising a Luer connection or Luer lock connection at the base end of the axial bore, such that the syringe can be connected to the elongated adapter.
6. An appliance according to claim 4 wherein the syringe is an integral part of the appliance.
7. An appliance according to any of the previous claims, wherein the prevention of significant leakage between the outer surface of the adapter and the inner surface of the nipple shield device ensures the maintenance of pressure within the axial bore of the adapter, such that the cleaning fluid is forced through the at least one of the milk passage.
8. An appliance according to any of the previous claims, wherein the elongated adapter further comprises an elongated hollow formed in the base region of the adapter, the elongated hollow being tapered along at least a part of its length, an inner surface of the tapered part of the elongated hollow having a shape adapted to match the outer surface of the nipple shield device, such that the elongated hollow of the adapter can sit over the nipple shield device without significant fluid leakage between the inner surface of the tapered elongated hollow and the outer surface of the nipple shield device.
9. An appliance for cleaning at least one milk passage of a nipple shield milk measurement device, the at least one of the milk passage being connected either to at least one milk flow aperture disposed on an inner surface of the protrusion of the nipple shield device, or to at least one milk flow aperture disposed on an outer surface of the nipple shield device protrusion, the appliance comprising: an elongated adapter, having a recess with an inner tapered profile along at least a part of its length, from a broader base region to a narrower tip region, the inner surface of the tapered part of the adapter having a shape adapted to match the outer surface of the nipple shield device, such that the adapter can sit over the nipple shield device without significant leakage between the inner surface of the adapter and the outer surface of the nipple shield device; and an axial bore providing fluid connection between the tip region of the recess and the outer tip of the elongated adapter, wherein the shape and the length of the elongated adapter are such that when fully mounted over the nipple shield device, a space is left between the at least one milk flow aperture disposed on the outer surface of the nipple shield device, and the narrower tip region of the recess of the adapter.
10. An appliance for cleaning at least one milk passage of a nipple shield milk measurement device according to claim 9, wherein the axial bore is of a size such that is can receive the ejection output opening of a syringe, such that when the adapter is positioned over the nipple shield device, cleaning fluid from the syringe can be flushed through at least one milk passage of the nipple shield device.
11. An appliance for cleaning at least one milk passage of a nipple shield milk measurement device according to claim 10, wherein the syringe is an integral part of the appliance.
12. A method for cleaning at least one milk passage of a nipple shield milk measurement device, the at least one of the milk passage being connected either to at least one milk flow aperture disposed on an inner surface of the nipple shield device, or to at least one milk flow aperture disposed on an outer surface of the nipple shield device, the method comprising: inserting a cleaning adapter into the inner space of the nipple shield device, the cleaning adapter comprising: a shaped outer surface adapted to fit snugly into the inner space of the nipple shield device; an axial bore from its outer end to its tip, the tip being adapted to be located at the inner end region of the nipple shield device; and a base rim adapted to locate the cleaning adapter in such an axial position that the tip of the cleaning adapter is located at a predetermined distance from the inner surface of the nipple shield device; inserting a syringe containing a cleaning fluid into the outer end of the axial bore of the cleaning adapter; and activating the syringe to inject a stream of cleaning fluid under pressure into the at least one milk passage.
13. The method of claim 12 wherein the tip of the cleaning adapter has a flattened shape.
14. The method of either of claim 12 and 13, comprising the additional step of connecting a fluid bridging connection piece to the remote end of a milk passage connected to at least one milk flow aperture disposed on the inner surface of the nipple shield device, and to the remote end of a milk passage connected to at least one milk flow aperture disposed on an outer surface of the nipple shield device, such that injecting a stream of cleaning fluid under pressure generates a flow of fluid through both the milk passages.
IL304104A 2023-06-27 2023-06-27 Nipple cleaning kit IL304104A (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
IL304104A IL304104A (en) 2023-06-27 2023-06-27 Nipple cleaning kit
CN202421205560.6U CN222383117U (en) 2023-06-27 2024-05-30 Appliance for cleaning at least one milk channel of a nipple shield milk measuring device
PCT/IL2024/050633 WO2025004046A1 (en) 2023-06-27 2024-06-27 Nipple cleaning kit

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IL304104A IL304104A (en) 2023-06-27 2023-06-27 Nipple cleaning kit

Publications (1)

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IL304104A true IL304104A (en) 2025-01-01

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WO (1) WO2025004046A1 (en)

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WO2022175833A1 (en) * 2021-02-16 2022-08-25 Kaizen Bio-Tech (2011) Ltd. Device for flow detection of mother's milk

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