CN116867471A - Breast milk flow detection device - Google Patents
Breast milk flow detection device Download PDFInfo
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- CN116867471A CN116867471A CN202280012958.5A CN202280012958A CN116867471A CN 116867471 A CN116867471 A CN 116867471A CN 202280012958 A CN202280012958 A CN 202280012958A CN 116867471 A CN116867471 A CN 116867471A
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Abstract
A novel device for providing an indication to a nursing mother as to whether an infant is receiving milk during a breast-feeding session. Milk expressed from the mother's breast flows through a transparent channel portion of the nipple shield, which is provided in a position visible to the mother or third party, from which the infant can suck, before being supplied to the nipple of the device. Thus, the device provides an indication that the infant is receiving milk from the mother's breast. The visibility of the channel is achieved by arranging the channel through a region of the device which is unobstructed from the mother's view when feeding, for example towards the periphery of the base layer of the device. The device channel may also include a valve, and details of such a valve are disclosed.
Description
Technical Field
The present disclosure describes techniques related to the field of detecting milk flow from a nursing mother, particularly for indicating to the mother that milk flow is present.
Background
During breast feeding, there is often a desire to obtain an indication of whether the infant is actually sucking, especially in the first few weeks after birth. Infants may tend to suck the breast as a soothing mechanism, giving the mother the illusion that the infant is sucking on milk, not the fact. Moreover, some mothers do not have a sufficient supply of breast milk, particularly before breast feeding has been established, and therefore a starved infant may suck on the nipple for a long period of time without obtaining a sufficient supply of breast milk. In addition, some infants appear to fall asleep during lactation, and the mother may not be aware that they are still nursing.
To indicate whether an infant is taking breast milk, various complex measurement systems have been proposed. One technique employed in practice is weight-deduction (weight subtraction), which is cumbersome, time-consuming, and inaccurate. In this technique, milk consumption is calculated from the difference in body weight of the infant before and after lactation. Another technique is disclosed in the following documents: S.E.J.Daly et al, journal of experimental physiology, titled "computer mammography for determining short-term breast volume changes and rate of breast milk synthesis (The Determination of Short-Term Breast Volume Changes and the Rate of Synthesis of Human Milk Using Computerized Breast Measurement)" 77, 79-87 (1992). This technique tracks changes in breast volume by computer imaging of the breast before and after feeding. International patent publication WO 2006/054287 to kolberg et al discloses a technique, entitled "breast milk flow meter apparatus and method (Breast Milk Flow Meter Apparatus and Method)", which places a volumetric flow sensor in a silicon nipple cap through which a baby sucks on breast milk, and milk flow data from the sensor is converted to milk volumetric data and displayed to the mother. Such systems typically involve connecting an electronic or electromechanical flow meter to a fluid flow channel to measure fluid flow. Other systems have been proposed that use electronic flow measurement modules that are externally connected to a milk collection device that is mounted on the mother's breast to measure milk flow. U.S. published application No.2018/0147124 to l.drew et al discloses a system described above, entitled "Non-invasive breast milk monitoring (Non-Intrusive Breast Milk Monitoring"), which uses an electronic sensor to measure milk flow. However, due to the use of electronic milk sensing devices, all of the monitoring systems described above are expensive and complex, making them less suitable for low cost, single use devices. Likewise, many mothers hesitate to use electronic devices on or near the baby, often because they fear any electromagnetic radiation, and there is an additional risk that these externally connected components may become disconnected from the device and somehow ingested by the baby. Ownership generally belonging to the applicant's U.S. patent 7,896,835, "device and method for measuring fluid flow into a nursing baby (Apparatus and Method for Measuring Fluid Flow to a Suckling Baby)" describes a simple device resembling a nipple shield in which a portion of the primary milk flows through a measurement channel, and the length of milk collected in the measurement channel after a nursing period provides a measure of milk extracted through the primary channel. As the benefits of breast feeding are well known, more and more mothers began breast feeding than in the past, which highlights the need for a method to indicate milk intake by infants.
The present disclosure seeks to provide a novel apparatus and method that overcomes at least some of the disadvantages of prior art systems and methods.
The disclosure of each of the publications mentioned in this section and other sections of this specification are incorporated herein by reference in their entirety.
Disclosure of Invention
The present application describes a novel exemplary device for providing an indication to a nursing mother as to whether an infant is receiving milk during breast-feeding. The device is constructed of a flexible layer that is generally similar in shape and design to currently available nipple shields, and the arrangement of the flow geometry of the device is such that milk flowing from the mother's breast flows through a channel having a region that provides an indication of milk flow and then provides the milk to the nipple of the device from which the infant sucks. The indicator portion of the channel should be located where the mother or assistant can perceive. A simple way of realizing the indicator portion of the channel is to make it of a transparent or translucent material to enable the mother to see the milk flow, which will be used hereinafter when describing the device, but without any intention to limit the flow indication to a visible indication. The channels may be disposed within the device or on the device surface, or otherwise connected to the device. Thus, the device provides an indication to the mother or third party that the infant is ingesting milk from the mother's breast. Another way to construct the device is by providing a small indicator vessel in fluid connection with the milk flow space between the mother's breast and the nipple of the device, so that a portion of the milk flowing directly to the infant follows the connection to the indicator vessel where the mother can see if there is milk, thereby eliminating the need for milk to pass through the channel. Milk flow may also be indicated by using mechanical protrusions into the flow path of the milk, which causes the mechanical protrusions to change their direction, thereby indicating milk flow. In another embodiment, a small closed container may be connected to the milk channel at a location remote from the baby and mother's nipple by a short connecting tube, and milk is flushed along the connecting tube into the closed container as the baby sucks on the milk flowing in the channel, where it is readily visible.
The device is advantageously constructed of a flexible layer that generally has a shape and design similar to currently available nipple shields. The flexible layer is typically composed of a material that is non-absorbent and non-irritating to the skin, such as silicone or silicone gel. Like the nipple shield, the flexible layer is adapted to be conformably mounted to a portion of a female breast, covering the areola and nipple, with a protrusion therebetween, hereinafter also referred to as the device nipple, adapted to be positioned over the nipple of the mother. The protrusion is so named because of its geometry when seen from the outside, but it also has the functional form of a concave area or recess when seen from the side of the mother's breast. This feature may alternatively be referred to as either name, depending on the context in which it is referred to, typically in relation to a function from within the device, or in relation to a function from outside the device, as will be explained below. However, this convention should not be construed as limiting such functional use or relationship, and two terms or another descriptive designation may be used interchangeably. The raised/recessed area may be configured as an integral part of the flexible layer, or it may be attached in a central region of the flexible layer, and even be composed of another material. Devices of different shapes and different sizes may be provided to suit an individual user such that the flexible layer fits snugly over the user's breast during application of the device.
To indicate whether the infant is taking milk during feeding, the device may have one or more channels, which may have a circular cross-section or any other suitable shape, for visually displaying the flow of milk, in particular the milk gush mimicking the sucking pattern of the infant. The channel is typically embedded within the flexible layer so that the device may be formed from a single piece, or it may be formed on the surface of the flexible layer, or attached over the surface and attached at its ends. The channel has two openings, a first opening from a central concave region of the device such that when the device is worn, the opening faces the mother's breast. The second opening of the channel has one or more openings, also located in the central concave region of the device, but in the apex region of the protrusion, as an opening facing the outer surface of the flexible layer, such that it faces the infant during breast feeding. The opening to the outside should not be in fluid contact with the hollow interior space of the central concave hollow. Between the two openings, the channel forms a circuitous path radially outwards from the central concave recessed area, such that when the device is worn by the mother, a portion of the channel is located in an area that should not be visually obstructed by the baby's mouth and is thus visible to the mother or a third party during use of the device. The flexible layer should be formed of a transparent or translucent material so that the flow of fluid through the channel is visible to the user. If not, at least a portion of the flexible layer in which the channel is embedded should be composed of a transparent or translucent material such that a portion of the channel is visible during lactation. Typically, a second opening, which serves as an outlet orifice, is provided at the apex of the protuberance, mimicking the nipple structure of the mother. The channel may diverge into a plurality of branches in the region of the second opening, so that the second "opening" may consist of a plurality of individual holes. This arrangement should enable the infant to suck more effectively because no part of the infant's tongue or lips will block the entire opening, which may be the case with a single opening. Likewise, the inlet of the channel within the concave recess may have a plurality of openings. Furthermore, the device may be provided with more than one parallel channel to ensure that a sufficient milk flow is achieved. This may be necessary if: for example, when the channels are formed in a thin flexible layer of the device and thus have a limited cross section, the flow through a single channel will be limited. At least one of the parallel channels requires an area where the mother can obtain a visual indication of milk flow. For simplicity of description, any number of channels will be referred to hereinafter as a single channel, and thus should be understood to also include the case of multiple channels as claimed, and is not intended to limit the application.
When the device is in use, the flexible layer conformably fits to the woman's breast with the recessed area (which is the device nipple) positioned over the mother's nipple. There is typically a hollow space between the mother's nipple and the nipple of the device. During lactation, the infant sucks on the outside of the protuberance (device nipple), creating a negative pressure in the channel. The negative pressure creates a vacuum in the channel that helps draw milk from the mother's nipple into the hollow concave space and the channel, and draws milk from the hollow concave space and the channel to provide milk to the infant. The negative pressure forces the flexible layer to adhere to the mother's breast, thereby preventing milk from escaping outwardly from the concave space and the outer rim of the device, and also reducing air ingress through the outer rim and creating air bubbles in the milk flow.
Since the mouth of the baby may occlude a substantial portion of the flexible layer, the channel must be arranged in such a way that at least a portion of the channel is visible even though the central region of the flexible layer may be visually obstructed by the baby. Thus, the channel is typically embedded in or mounted on the surface of the flexible layer or otherwise attached to the flexible layer in a position such that it extends around at least a portion of the edge region of the flexible layer, or at least in a region of the flexible layer outside the concave recessed region, or through an external location such that it is visible during lactation.
The channel may advantageously be provided with a valve that opens at a predetermined pressure, enabling milk to flow through the channel in a direction from the opening in the central concave hollow towards the outlet aperture in the apex of the nipple of the device to the infant. Several examples of such valves are provided in the detailed description section of this disclosure. Such a valve has the following effects: helping to maintain negative pressure within the channel and thus within the hollow concave region when the infant ceases sucking, thereby ensuring better adherence of the device to the mother's breast. Furthermore, the use of such a valve reduces the pumping effort required by the infant, since during pauses in the infant's sucking, the infant does not have to generate the full negative pressure required to pump milk from the concave space (which may be at atmospheric pressure without such a valve) to the infant's mouth, but only from the negative pressure maintained in the concave space by the valve. Thus, the valve acts as a flow amplifier and may reduce the time required for the feeding period. In addition, the negative pressure maintained in the concave milk collection space may assist the mother by inducing better flow of milk from the mother's breast. The valve may be mounted anywhere along the length of the passageway and may provide modes of various opening pressures to accommodate the sucking strength exhibited by the infant. Infants with more developed sucking capabilities can advantageously use valves that open at higher absolute pressures. On the other hand, the valve opening pressure may be selected, alternatively considered, to partially relieve the sub-atmospheric pressure created by the baby's sucking so that it does not cause excessive discomfort to the mother. The level selected may be selected based on the level of acceptance of negative pressure applied to her nipple by the mother. If deemed necessary or advantageous, more than one valve may be used along the channel to control flow. It should be clear that reference to an opening or closing pressure in this disclosure refers to the absolute pressure difference across the valve when the valve is open or closed, regardless of whether the valve is in a negative pressure region (i.e., a partial vacuum region) or a positive pressure region (i.e., a region above atmospheric pressure).
According to another exemplary embodiment of these flow indication devices, a bi-directional valve may also be used for this purpose, which is operable to avoid excessive pressure applied to the mother's nipple by the infant sucking vigorously, with the additional feature of maintaining a predetermined negative pressure within the device in order to keep the device attached to the mother's breast. The mechanism used is that if only a one-way valve is used, which closes when the baby stops sucking, the high negative pressure generated in the device will be maintained, thus continuing to apply negative pressure on the mother's nipple. The use of a bi-directional valve ensures that when the baby ceases to suck and the baby ceases to create negative pressure within the device, the reverse flow direction of the bi-directional valve allows air and/or milk to flow back into the channel, but only when the predetermined pressure at which the valve is designed to close is reached. Once the valve is closed, the negative pressure at this closed value is maintained, but less than that created by the infant, thereby alleviating the mother's discomfort, but not completely relieving the vacuum so that the device remains seated on the mother's nipple.
All of the above-described milk detection devices according to various embodiments of the present disclosure have one common feature that distinguishes them from previous devices (e.g., devices that measure milk flow), and that is, since the presently described devices involve only the addition of one or more simple milk channels to the nipple shield structure, they can be produced at low cost by conventional polymer production techniques without any additional mechanical or electronic components. This feature is very important because it enables the device to be constructed as a unitary and compact, self-contained device with sufficiently low manufacturing costs to be a single use disposable milk flow indicating device. This is a significant advantage over the mechanical or electronic devices described in the prior art and enables the nursing mother to use the milk indicating device more universally. Furthermore, the construction as a single integral device avoids the risk that external components may separate, while eliminating the concern that a nursing baby may ingest such separate components. In addition, an electronic device composed of only inert polymeric material capable of providing information about milk flow to the infant would alleviate the mother's concern about the operation of the electronic device so close to the infant.
According to another aspect of the application, a novel method of constructing such a bi-directional differential valve that is self-driven by a pressure differential across the valve, the opening pressure of which may be different for the two flow directions, is further described. The valve uses a flexible diaphragm disposed across the flow direction of the fluid, the flexible diaphragm having different flexibility for the two flow directions. This difference in flexibility is created by providing a different bending length of the diaphragm between the support point of the diaphragm in the valve body and its freely movable inner or outer periphery. The diaphragm is constrained between an inner post having an annular shoulder that constrains the inner edge of the diaphragm such that the diaphragm can flex in only one direction toward its outer edge and an outer shoulder that constrains the outer edge of the diaphragm such that the diaphragm can flex in only the other direction toward its inner edge. The adjustment of the length of the free diameter of the deflectable diaphragm portion enables adjustment of the pressure on the valve that results in opening of the valve. A more complete description of the operation of the valve is shown in the detailed description section of figures 5A to 5E.
According to a further embodiment of the application, the use of the described valve for controlling milk flow out of the nipple opening enables a new nipple shield arrangement to be provided, which has the advantage that it can help to ensure that the nipple shield remains in place on the mother's breast when the infant stops sucking. The valve enables unobstructed flow of milk from the mother to the infant, but when the infant stops sucking, the valve closes and prevents air from flowing back through the nipple opening of the nipple shield, which would release the vacuum holding the nipple shield in place if it were to flow back, making its contact with the mother's breast loose. The valve may additionally and advantageously have an opening pressure differential which still allows a certain amount of air to enter the nipple opening to reduce the negative pressure on the mother's nipple so that the mother's discomfort is reduced without releasing all vacuum levels within the device which would lead to detachment of the device. For example, a breast-fed infant may apply a first level of negative suction pressure, but once the infant stops or pauses, the valve may allow air to enter to adjust the internal pressure on the mother's nipple to a lower negative level, which reduces the feel of less comfort to the mother. In addition, the base of the nipple area of the device may be reinforced, for example by making the material thicker or stronger, so that the base of the nipple area remains more firmly attached to the mother's breast with a reduced tendency to bend and lift, which would result in the release of the vacuum.
Another inventive contribution to any of the devices described in the present application relates to the use of a fluid dispenser incorporated into a milk flow detector, which may be advantageously used as a medicament dispenser. It is well known that administration of drugs to infants is a challenge. The amount administered should be accurate and it is often unreliable and inaccurate to use a spoon or syringe to administer the drug to the infant, as in addition to the problem of the infant taking the dose, he/she may spit out a partial amount. According to a current feature of the present disclosure, the medicament container reservoir is fitted to the device and fluidly connected to the milk channel such that once the container has been filled with the correct dose of medicament, the flow of milk will mix with the medicament in a controlled manner, depending on the flow rate of medicament from the container reservoir to the milk channel. The infant will then receive all of the drug dose that was mixed with breast milk during breast feeding or any other fluid that it is desired to provide to the infant, so that even the taste of the drug will be masked. The container reservoir may be removable to facilitate filling. In addition to being suitable for incorporation into the milk flow detector of the present application, such features may be incorporated into any other device that provides a flow path for milk expressed by an infant, such as the above-referenced U.S. patent 7,896,835 having the inventor's common reference to the present application entitled "device and method for measuring liquid flow to a milk infant (Apparatus and Method for Measuring Fluid Flow to a Suckling Baby)". Furthermore, such features may also be incorporated into the improved nipple shield described above.
The milk flow detectors described above are all single function, unitary devices for providing an indication to the mother that the baby is receiving its milk flow. In addition, the added component parts are generally described as part/component of such a single application device. According to further embodiments of the device described in the present application, a new type of multi-functional nipple shield is described, which can be used to perform a number of alternative functions related to different aspects of the needs of a nursing mother. The nipple shield includes a universal base unit that fits over the mother's breast and delivers milk through a channel to a location remote from the nipple and from a location remote from the nipple to the baby's mouth. At this remote location, any of a number of different operating heads may be attached, each type of head being adapted to perform its own milk-related dedicated function. The remote location includes a standardized pair of fluid flow connection terminals and the various operating heads have mating standardized fluid flow connectors that can be attached to remote connectors on the base nipple shield. Thus, the base unit of the nipple shield is universal and the specific use of the device depends on the head of the remote terminal attached to the nipple shield. The head may be attached for various measurement or indication functions such as flow measurement, flow indication, drug addition, measurement of the baby's sucking pattern, milk quality analysis, detection of markers in milk that indicate maternal disease, and many other functional uses. In addition to the multi-task use of the overall device concept, another advantage of such devices is that the base nipple shield has channels and parts that are easy to use brush or machine clean, can be used multiple times, while the head attachment is more complex and thus more difficult to clean, can be a disposable unit that is disposable, but the head attachment can also be made so that they can be cleaned and reused is feasible, especially those with incorporated electronic chips, because of the somewhat high cost of making the disposable attachment.
Although throughout the present application and claims reference is made to the mother of an infant being a milk provider, which is the usual case, it should be understood that reference to a mother is not intended to exclude women other than the infant mother, and that the present disclosure and claims are not intended to be construed as limited to a mother breast feeding her infant using the device.
While the devices described in the present application are most useful for feeding from the mother's breast, they may also be produced in a form mounted on a milk bottle so that direct evidence of milk flow is obtained when the infant is fed, rather than interrupting the feeding phase to keep the bottle upright to read the milk level on the bottle scale. This embodiment also allows the use of opaque bottles.
Thus, according to an exemplary embodiment of the device described in the present disclosure, there is provided a device adapted to provide an indication of milk flow from a female breast to an infant, the device comprising:
a flexible layer adapted to fit over at least a portion of a female breast,
the flexible layer includes:
(i) An inner surface and an outer surface, the inner surface adapted to face the woman's breast;
(ii) A boss disposed in a central region of the flexible layer and adapted to be positioned over a nipple of the breast; and
(iii) At least one fluid communication pathway connecting the inner surface of the boss with at least one opening in the outer surface in an apex region of the boss such that milk collected in a space between the nipple and the inner surface of the boss can flow through the at least one pathway and out of the at least one opening in the apex region, at least a portion of at least one pathway being disposed at a distance from the protrusion such that during use of the device the at least one portion is disposed outside an area where an infant's lips are expected to be located during use of the device.
In the above device, the at least one channel may be embedded in the flexible layer, or may be partially embedded in the flexible layer, or may be provided on an outer surface of the flexible layer, or may be partially separated from the flexible layer.
According to a further embodiment, in any of the above devices, at least a portion of the at least one channel is transparent or translucent such that the flow of milk in at least a portion of the at least one channel is visible. Furthermore, the device may comprise a closed at least partially transparent container connected to the at least a portion of the at least one channel such that milk passing through the at least one channel visually surges in the at least partially transparent container. Additionally, the at least a portion of the at least one channel may comprise a mechanical element that undergoes deflection in the milk flow. Even further, the at least a portion of the at least one channel may have a property that indicates when a predetermined milk flow is present within the at least a portion. Such an attribute may be a change in color or a sound emitted.
In any of the above devices, the distance of the at least a portion of the at least one channel from the boss may be at least 3cm such that the at least a portion is visible outside the area of the infant's mouth where sucking on the boss is expected.
According to a still further embodiment, any of these devices may further comprise at least one valve arranged along the at least one channel and adapted to enable milk to flow from the space only through the channel to the at least one opening in the apex region. In this case, the at least one valve is substantially closed when no suction is applied at the at least one opening in the apex region.
Any of the above devices may further comprise a container in fluid connection with the at least one channel such that fluid in the container may be provided to the infant. The fluid may be a medicament. Furthermore, the fluid connection should be passable such that the contents of the fluid container are transferred to the milk flow in the at least one passage according to a predetermined flow rate.
Any of the above devices should be electronics-free. Thus, the electronics-free state of the device reduces the risk of electromagnetic radiation in the infant area.
There is also provided, in accordance with another embodiment of the present invention, a device adapted to fit over at least a nipple area of a female breast for providing an indication of milk flow from the breast, the device comprising:
(i) A flexible material layer having a nipple-like projection with an inner surface adapted to face a nipple area of a female breast and an outer surface adapted to face a mouth of an infant; and
(ii) At least one channel formed within the flexible layer, the at least one channel passing from a first location on the inner surface of the nipple to the outer surface of the flexible layer at or near the apex of the nipple,
wherein at least a portion of the at least one channel is adapted to provide an indication of milk flow when the infant sucks on the nipple.
In such a device, at least a portion of the channel may be disposed in an area radially away from the nipple such that at least a portion of the channel is located outside an area where the baby's lips may obstruct it. In addition, the at least a portion of the at least one channel may be transparent or translucent and disposed in a region radially remote from the nipple such that milk flow is visible through the at least a portion. Furthermore, the at least a portion of the at least one channel may comprise a material that changes color when exposed to milk, and the at least a portion of the at least one channel is disposed in a region radially away from the nipple such that milk flow is visible through such a change in color. As an alternative embodiment, the at least part of the at least one channel may comprise an element that emits a sound when a predetermined milk flow is present in the at least part.
In yet another embodiment, any of the above devices may further comprise a loop formed around the base region of the nipple, the loop having a lower flexibility than the layer of flexible material, such that the device remains more easily affixed to the breast when the infant ceases sucking. Furthermore, the device should be electronics-free so that the risk of electromagnetic radiation in the infant area is reduced.
There is further provided, in accordance with yet another embodiment of the device of the present application, a device adapted to fit over at least a nipple area of a female breast, the device comprising:
a flexible material layer having a nipple having an inner surface adapted to face the female breast and an outer surface adapted to face the infant's mouth, the flexible layer comprising:
(i) At least one first channel leading from an inner surface of the nipple to a location remote from an outer region of the flexible layer of the nipple, and at least one second channel leading from a location remote from the outer region of the flexible layer of the nipple to an outer surface of the nipple, a location in an apex region of the nipple; and
(ii) A fluid connector port located in a distal outer region of the flexible layer having a fluid connection opening positioned such that the opening is connected to the at least one first channel and to the at least one second channel,
wherein the fluid connector port is configured for attaching a head to the fluid connector port, the head providing information related to milk supply transferred from the woman's breast to the infant through the device.
In such a device, the head provides information about the amount of milk flowing from the woman's breast to the infant. The head may include a miniature flow sensor, or a container connected by a channel to the path of the milk flow in the head, so that the drug can be added to the milk flow, or a vacuum indicator so that the sucking level of the infant can be determined, or an analytical sensor so that the composition of the milk can be determined. In addition, the header may include a transmission unit for transmitting the determined information to a remote device.
According to yet another embodiment of the present invention, there is provided a nipple shield for use by a lactating woman, comprising:
(i) A flexible layer adapted to fit over at least a portion of the female breast, the flexible layer having an inner surface and an outer surface, and a raised area adapted to be positioned over the nipple of the female breast;
(ii) At least one opening in the convex region of the flexible layer such that at least one channel connecting the inner surface with the outer surface is formed to enable milk to flow from the woman's breast to a baby sucking on the nipple shield; and
(iii) A valve disposed in the at least one channel, the valve allowing milk to flow from the woman's breast to the infant through the at least one channel, but restricting air or milk from flowing from the outside into the inner surface.
In such nipple shields, each valve may have an opening pressure level that limits the inflow of air or milk to a predetermined sub-atmospheric pressure (sub-atmospheric pressure). In addition, each valve may be adapted to maintain sub-atmospheric pressure in the space between the inner surface and the female breast. The sub-atmospheric pressure may be adapted to enable the nipple shield to remain attached to the woman's breast when the infant stops sucking. Alternatively and additionally, the sub-atmospheric pressure may be adapted to reduce the effort required by the infant to obtain milk, or it may be adapted to introduce/induce a greater amount of milk from the woman's breast.
In further embodiments, such a nipple shield may further comprise at least one element for indicating milk flow, each of the at least one element being disposed within the channel for communicating to a lactating female that the infant is receiving milk. The nipple shield may further comprise a container fluidly connected to the channel such that fluid within the container may be provided to the infant. Any of the above nipple shields may further comprise a loop formed around the base region of the concave region of the flexible layer, the loop having a lower flexibility than the flexible material layer, such that the nipple shield remains more easily attached to a woman's breast when the baby stops sucking.
According to yet another embodiment, there is provided a method for assisting a female nursing infant, the method comprising:
(i) Fitting a nipple shield device over the woman's breast, the nipple shield having at least one first opening facing the woman's nipple, the at least one first opening being fluidly connected by a channel to at least one second opening facing away from the woman's breast; and
(ii) Allowing the infant to suck on the at least one second opening such that milk flows from the at least one first opening and out of the at least one second opening,
Wherein the nipple shield apparatus includes at least one valve, each valve being disposed in one of the at least one channel, allowing milk to flow from the woman's breast to the infant, but restricting air or milk from flowing from the outside into the space between the nipple shield and the woman's breast.
In this method, each valve has an opening pressure that limits the inflow of air or milk to a predetermined sub-atmospheric pressure. The valve may be adapted to maintain sub-atmospheric pressure in the space between the nipple shield and the female breast. The sub-atmospheric pressure may be adapted to enable the nipple shield to remain attached to the woman's breast when the infant stops sucking. Furthermore, the sub-atmospheric pressure may be adapted to reduce the effort required by the infant to obtain milk, or it may introduce/induce/cause a greater amount of milk from the woman's breast. Furthermore, the method may be implemented by using a nipple shield device comprising an element for indicating the flow of milk, which element is arranged in at least one channel such that a lactating woman may be informed that an infant is being supplied with milk.
According to a further embodiment described in the present application there is provided a device adapted to provide an indication of milk flow from a female breast to a feeding infant, the device comprising:
A flexible layer adapted to fit over at least a portion of the woman's breast, the flexible layer comprising:
(i) A dome-shaped portion adapted to be positioned over a nipple of the female breast and shaped such that when the device is worn by the female, the dome-shaped portion forms a space between the female nipple and an inner surface of the dome-shaped portion; and
(ii) At least one fluid communication pathway connecting the space formed within the dome-shaped portion with at least one closed container disposed in an area of the device that is not expected to be obscured by a mouth of an infant fed at an outer surface of the dome-shaped portion such that milk moving within the at least one closed container provides an indication of a flow of milk from the woman to the infant.
In such a device, the at least one closed container may be transparent or translucent such that movement of milk in the at least one closed container is visible. Such visual indication of the presence of milk in the at least one closed container may be provided by a material that changes colour upon contact with milk.
Furthermore, such a device may also comprise a ring formed around the base region of the dome-shaped portion, the ring having a lower flexibility than the flexible layer, so that the device remains more easily attached to the woman's breast when the baby stops sucking. Such a device may further comprise a valve arranged in the area between the inner and outer surfaces of the dome-shaped member, which valve is adapted to allow milk to flow from the woman's breast to the baby, but to restrict air or milk from flowing from the outside to the inner surface.
Any of the above devices should be electronics-free. Thus, the electronics-free state of the device reduces the risk of electromagnetic radiation in the infant area.
In yet another embodiment described in the present disclosure, there is provided a two-way valve comprising:
(i) A valve body having an axial passage adapted to allow fluid flow therethrough,
(ii) A flexible diaphragm having a bore at an inner axial region thereof, the diaphragm being disposed across a desired flow axis of the valve,
(iii) A first constraining element disposed in a first axial direction from a first side of the septum and configured to limit bending movement of an interior region of the septum in the first direction, an
(iv) A second constraining element disposed in a second axial direction from a second side of the diaphragm and configured to limit bending movement of a peripheral outer region of the diaphragm in a second direction.
Such a bi-directional valve may further comprise a post disposed in the axial passage of the valve body, on which post a flexible diaphragm may be mounted, wherein the first restriction element is an enlarged section of the post having an outer diameter greater than an outer diameter of the post, the flexible diaphragm being free to flex in the first direction only from a point beyond the outer diameter. In this valve, the second restriction element may be a narrowed section of the valve body having an inner diameter smaller than an inner diameter of the axial passage of the valve body, the flexible diaphragm being free to flex in the second direction only from a point within the inner diameter. Furthermore, the distance between the outer diameter of the enlarged section of the post and the outer periphery of the flexible diaphragm may determine the opening pressure characteristic of the flow of the valve in the first axial direction. In addition, the distance between the inner diameter of the narrowed section of the valve body and the inner periphery of the flexible diaphragm may determine the opening pressure characteristics of the flow of the valve in the second axial direction.
Another embodiment of the two-way valve may include:
(i) A valve body having an axial passage and a stepped surface formed in a recessed first end,
(ii) A post mounted in the axial passage of the valve body forming an annular flow passage within the axial passage of the valve body, the post having a widened end forming a stepped shoulder facing in a direction opposite to that of the stepped surface of the recessed first end of the valve body and at a longitudinal position proximate to the same axial region as the stepped surface of the recessed first end of the valve body; and
(iii) A flexible diaphragm mounted on the post such that the flexible diaphragm is positioned between the stepped shoulder of the post and the stepped surface of the valve body and spans the annular flow passage.
In such a bi-directional valve, the position of the flexible diaphragm may be such that fluid flow along the annular channel toward the recessed first end of the valve body is operable to produce bending movement of the outer periphery of the flexible diaphragm toward the recessed first end, while fluid flow along the annular channel away from the recessed first end of the valve body is operable to produce bending movement of the inner periphery of the flexible diaphragm away from the recessed first end. In such a bi-directional valve, the extent of bending movement of the flexible diaphragm toward the recessed first end for a given fluid flow may depend on the radial distance between the step in the step shoulder of the center post and the outer periphery of the flexible diaphragm. In addition, the extent of bending movement of the flexible diaphragm away from the recessed first end may depend on a radial distance between a step of a step surface formed in the recessed first end and an inner periphery of the flexible diaphragm.
In any of these bi-directional valves, the length of the free diameter of the flexible portion of the diaphragm is selected to enable adjustment of the pressure on the valve when the valve is open. The opening of the valve may be self-driven by a pressure differential across the valve.
Drawings
The invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the accompanying drawings in which:
FIG. 1 schematically illustrates an isometric view of an exemplary device for displaying milk flow of a mother when breast-feeding an infant;
FIG. 2A is a plan view of the device shown in FIG. 1; FIG. 2B is a plan view of a device similar to that of FIG. 1, except that a closed chamber is used as an alternative method of indicating milk flow; FIG. 2C illustrates the use of mechanical protrusions to indicate milk flow by deflecting in the flow; fig. 2D shows an auxiliary container vessel attached to the milk channel, which is partially filled with milk and then partially emptied when the infant sucks and takes a rest; FIG. 3 shows the addition of a valve in the channel to improve the function of the device of FIGS. 1 and 2;
fig. 4A is a schematic view of a nipple shield incorporating a valve according to the present disclosure, while fig. 4B and 4C illustrate different examples of the structure of a valve used in a valve-mounted device, and fig. 4D and 4E illustrate additional stiffening features of the nipple shield in the form of a band to enable it to remain more securely affixed to a mother's breast;
Fig. 5A to 5D show one example of a novel differential bi-directional valve configuration which may be used in particular in the device of the present application, and fig. 5E shows the type of opening characteristics obtainable from such a differential bi-directional valve;
FIGS. 6A and 6B schematically illustrate a medication dispenser embodiment of the device of FIGS. 1 and 2;
FIG. 7 is a schematic exterior isometric view of one example of a base unit of the multi-functional nipple shield of the present disclosure that may be used to perform a number of alternative functions related to different aspects of the needs of a nursing mother;
FIG. 8 is an enlarged view of the outer tip region of the nipple bulge of the device of FIG. 7;
figures 9A and 9B illustrate a method of facilitating the manufacture of the base unit of the multi-functional nipple shield of figures 7 and 8;
FIG. 10 is a splice diagram showing how the base unit of the multi-functional nipple shield of the present disclosure can be used with various attachments that can be used for various different functions related to breast milk supply;
11A-11D illustrate in more detail an exemplary use of the multi-functional nipple shield of FIGS. 7-10; and
fig. 12 schematically shows an external view of an exemplary embodiment of a milk measuring head connected to the base unit of the multi-functional teat hood of fig. 7-10.
Detailed Description
Referring now to fig. 1, fig. 1 schematically illustrates a side view and a partial isometric view of an exemplary device 10 constructed in accordance with the present invention, the device 10 for visually displaying milk flow of a mother while an infant is nursing. The nipple shield 10 has a channel for indicating milk flow and is shown fitted over a woman's breast 11. During breast feeding, milk flowing through the channel is visible to the mother or a third party (e.g., a care-consultant), or the presence of milk is indicated by other means than visual means, thereby giving the mother confidence that the infant is receiving milk flow from her breast.
The thin body of the device 10 is typically constructed of a flexible material and has an inner surface that faces the mother's breast 11 when worn and an outer surface that is adapted to face away from the mother so that during breast feeding the outer surface faces the baby's lips and mouth 19. The flexible material may be silicone or any other material that is non-absorbent and flexible enough to be comfortably worn by the mother. The flexible material, or at least a portion thereof, is generally transparent or translucent for reasons to be explained below. Similar to the nipple shield available in the prior art, the device 10, when worn, covers at least the mother's nipple 12, typically at least a substantial portion, if not the entire areola. The device may cover a larger portion of the breast than the areola and generally has a circular or oval shape, but it may have other shapes as well. The device 10 has a concave region which, depending on its form when viewed from the outside, also appears as a dome-shaped protrusion 13 or "device nipple". The region is adapted to be positioned over a nipple area of the mother. The area of the mother's nipple is understood to mean the mother's nipple 12, but it may also include some areas around the mother's nipple. The nipple 13 of the device is typically formed such that when the device is worn, a cavity 14 is formed between the boss 13 of the device and the nipple 12 of the mother. The concave region within the boss may be tunnel-shaped, similar to the region of a commercially available nipple shield known as a "shield tunnel". It may also be hemispherical or may mimic the shape of the mother's nipple 12, as shown in the example of fig. 1. The outer region of the device surrounding the nipple 13 of the device is adapted to fit snugly over the woman's breast such that when the device is worn, the outer region remains close to the woman's breast without significant space therebetween. The approximate boundary area between the device boss 13 and the outer region of the device is schematically illustrated in fig. 1 by dashed line 18.
The exemplary embodiment of the device shown in fig. 1 comprises a channel 15 connecting the cavity region 14 with the outer surface at the apex of the boss 13 and arranged to enable at least a portion of the channel to be located in an outer region of the device. The channel may be formed in the thin flexible material layer of the device, or it may be formed on the surface of the thin flexible material layer of the device, or it may be a separate part of the tube outside the thin flexible layer and connected to the device between the lumen end and the nipple end of the device.
During breast feeding, the device 10 is mounted on a breast 11. The channel 15 has an inlet aperture 16 communicating with the chamber 14 and an outlet aperture 17 at the device connection 13. The contour of the baby's lips 19 sucked on the device nipple is shown in broken lines in fig. 1. Negative pressure generated by the sucking action of the infant on the device or the physiological response of the mother to the movement of the infant's tongue causes milk to be expressed from the mother's breast into the cavity 14 from where it is drawn through the channel 15 to exit the device through the outlet aperture 17. Thus, all milk supplied to the infant flows along the channel 15, as indicated by the arrows in fig. 1. The device is intended to be worn with the inlet of the channel 16 at the bottom so that milk that collects at the bottom of the cavity 14 by gravity will be effectively collected. To this end, the device may be configured with a cavity 14, which cavity 14 is a milk collection volume, concentrated above the inlet aperture 16 of the channel 15, at the bottom region of the space between the mother's nipple and the device nipple.
Referring now to fig. 2A, which is a plan view of the device of fig. 1, fig. 1 shows the path of the channel 15 more clearly. The numbering of the features in fig. 2A is the same as in fig. 1. The channel 15 is routed such that it extends in an outward path from the cavity region 14 in the projection into an outer region of the device. In this way, milk passes out from the lips 19 and the area under the mouth of the baby being sucked (where the mother cannot see the milk) into an area where the baby's lips or mouth do not obstruct its view and the mother or assistant can see the flow of milk in the channel. As in the example shown in fig. 2A, the channels may be directed radially outward toward the edge of the device. On its return path from the outer region of the device, the channel re-enters the cavity while remaining fluidly isolated from the cavity and terminating at an outlet orifice on the outside apex of the device nipple where milk is provided to the infant.
The walls of the channel are typically transparent or translucent so that as milk flows through the channel, the person observing the device receives an indication of whether milk is indeed expressed from the breast and supplied to the infant. In the case where the flexible material is not transparent or translucent, at least a portion of the flexible material surrounding the channel in an area that is not intended to be obscured by the infant during feeding should be made of a transparent or translucent material. If the channel is not formed within the flexible material, a portion of the tube of the channel itself should be transparent or translucent to show flow within the channel. As an alternative to visually observing the flow itself through the channel wall, according to other exemplary embodiments, the channel may be made of an indicator material that provides a color change upon contact with milk. Another embodiment may use features or protrusions in the channel, such as reeds, tabs, paddle wheels, which produce sound when milk flows through or passes through them.
Although the simplest way to form the channel is by forming the channel within a flexible layer, the device may also be constructed using a tube that either passes through the outside of the flexible layer of the device or is attached to its surface, typically the outer surface, so as not to interfere with the air tightness of the device relative to the mother's breast. The channel generally has the shape of a tube, so it has a generally circular cross section, but other cross sections may be used without affecting the utility of the device.
Referring now to fig. 2B, an alternative construction of the milk flow detector 10 of fig. 1 is shown wherein the indicator pathway is capable of indicating the presence of milk flow without having all or even only a portion of the milk flow directly through it. In the embodiment shown in fig. 2B, the passage of the device 10A takes the form of a short branch 15A leading from its inlet aperture 16 in the cavity 14 to a small enclosed volume 15B, preferably transparent or translucent, in which enclosed volume 15B milk can be collected. The action of the infant alternately sucking and relaxing causes milk to enter and leave the closure indicator element 15B at least in part, or to splash in the closure indicator element 15B under the influence of alternating pressure fluctuations acting on the milk in the branch 15A. The mother can then see the milk entering and leaving the indicator chamber 15B and can thus learn that the baby is getting his or her milk flow. The mother may learn different features that distinguish the manner in which milk splashes in indicator chamber 15B or into indicator chamber 15B and out of indicator chamber 15B and correlate that appearance to the rate at which the infant draws milk. The actual flow of milk from the mother's nipple to the baby's mouth 19 occurs through the nipple opening 17A of the device, as in any conventional nipple shield.
Referring now to fig. 2C, another method by which milk flow through a channel may be indicated is shown. In the embodiment of fig. 2A, it was mentioned above how a feature or protrusion in the channel (such as a reed, or a tab, or a paddle wheel) may be used as a sound generating element that emits a characteristic sound when milk flows through or past it. However, in addition to the audible output produced by such elements, a physical visual indication of the presence of milk flow in the channel may also be provided. Thus, for example, as schematically shown in fig. 2C, the fins 20 extending into the flow through the channel 15 are deflected by the milk flow onto their upstream surfaces, and the deflection is clearly visible from the outside of the channel.
Referring now to fig. 2D, yet another embodiment for providing an indication of milk flow through a channel is shown. In the embodiment schematically shown in fig. 2D, the channel comprises a small closed container 21 attached to the channel 15 by a short connecting tube 22. Thus, as milk flows through the attached container connection tube 22, milk floods into the container vessel 21, providing a visual indication of milk flow in the pathway. The visual indication is even more strongly emphasized because the infant draws milk in pulses during each sucking period and rests between sucking actions. Thus, during the sucking period, milk flowing along the channel floods into the container, possibly only partially filling the container, and then a portion of the milk in the container flows back into the channel when the infant relaxes between his/her pumping actions. This constant surge of milk into and out of the container (which may include bubbles generated in the surge) provides a good visual indication of milk flow as the infant sucks. In fig. 2D the container vessel is shown as horizontal, but it will be appreciated that the device may be used such that the container is in an upright position so that filling and emptying of milk from the container vessel is clearly seen.
Referring now to fig. 3, another embodiment is shown in which a valve 30 is fitted into the channel 15 to help maintain negative pressure in the channel and cavity so that the device remains attached to the mother's breast, as explained in the summary section above. In fig. 3, which shows a typical example of such an embodiment, the valve 30 is shown in this example as a one-way valve in the form of a diaphragm valve or flap valve, which closes when the infant is not applying suction. In fig. 3, which is a cross-sectional view, the flap valve 30 is shown as a circular diaphragm with a central aperture 31, the central aperture 31 being open when milk flow forward through it, but the central aperture 31 being closed when milk flow ceases as the baby ceases sucking, and thus maintaining a negative pressure within the channel 15. However, it should be understood that any other form of valve may be used without affecting the function of the device. Similarly, although the valve in fig. 3 is fitted near the outlet 17 of the channel, it could equally be formed at any other point in the path of the channel at the device nipple 13.
Referring now to fig. 4A, fig. 4A is a schematic illustration of a novel nipple shield 40 constructed in accordance with another exemplary embodiment of the application. The joint boot includes a valve 42. The improved nipple shield 40 is shown mounted on the nipple 12 of the mother's breast in which it is used, and the infant receives the mother's milk through an opening 41, which opening 41 is shown as a single opening in the figure, but there may be more than one opening, each with its own valve. When the infant stops sucking, the valve 42 closes, preventing air from flowing into any space between the nipple shield 40 and the mother's breast 12, helping to ensure that the nipple shield remains secured to the mother's breast. The valve 42 is shown as a simple diaphragm or flap valve, but may be any other type of valve that will provide the desired sealing of the joint channel 41. The use of such a valve in the nipple shield improves the ease of use of the nipple shield by ensuring that the nipple shield is attached to the mother's breast even when the infant pauses from his/her sucking action. Furthermore, as described in the previous embodiments, and as will be described more fully below in connection with fig. 5A-5D, the valve may have a two-stage opening mode, such that the valve may be adapted to open in the inflow direction, i.e. the reflux in the direction from the infant to the mother's breast, requiring a higher pressure differential than is required to keep the valve open in the reverse outflow direction. The bi-directional valve allows some air to flow in before closing to increase the comfort of the mother.
Additionally, the improved nipple shield may also incorporate a fluid dispensing fitment, not shown in FIG. 4A, but as described below in FIGS. 6A and 6B and related paragraph [0068 ]. This improvement can be used in a simple device to enable accurate dispensing of the medicament to the infant while the infant is nursing.
According to another embodiment of the improved nipple shield described above in fig. 4A, the incorporation of a flow indicator element 41 in the short nipple tunnel of the device enables the device to provide an indication to the mother that the infant is being provided with milk, which she would otherwise be unable to determine. The flow indication element may be a sound emitting component, as such a component will provide an indication of it even if hidden in the mouth of the infant.
Referring now to fig. 4B and 4C, fig. 4B and 4C schematically illustrate other exemplary forms of valves, whether milk flow sensing devices or nipple shields incorporating valves, that may be used in any of the devices of the present application in accordance with the improvements presented in the present application. Fig. 4B shows three different views of a ball valve 48, the ball valve 48 may be mounted at the nipple of the valved nipple shield of the present disclosure, or at the outlet or somewhere along the length of the milk channel of the milk flow detection device of the present disclosure. The ball 44 of the valve is movable along the chamber 49. When the ball 44 is positioned over the opening 45 attached to the inner fluid side of the nipple opening, the hole 45 can be closed and air is prevented from flowing back into the device, thereby maintaining its contact with the mother's nipple. As the infant sucks on the nipple, the ball 44 is pushed away from the aperture 45 by the milk flow, thereby enabling the infant to obtain the milk flow. The ball must be prevented from being ingested by the infant, which is accomplished in the embodiment of fig. 4B by a pair of tangs 43 which hold the ball within its cavity 49. Fig. 4C shows an alternative valve in the form of a simple diaphragm valve 46, similar to the valve shown in cross section in fig. 4A, in which the flap 47 is open when milk flow occurs, but the flap 47 returns to the closed position when milk flow ceases. As previously mentioned, any suitable valve may be used in these embodiments.
Referring now to fig. 4D and 4E, fig. 4D and 4E illustrate another feature of such a nipple shield 400, wherein a higher strength band or ring is built into the base of the nipple shield so that it is more securely held on the mother's nipple. In fig. 4D, a side cross-sectional view of the nipple area of the device is shown, showing the opening 403 in the nipple dome for the baby to suck, and the thin flexible outer area 401 of the device for mounting on the mother's breast. At the juncture of the thin flexible outer region and the nipple dome, a circular band 402 of thicker or less flexible material is formed, which reduces the ability of the device to bend or lift off the mother's nipple, helping to keep the device attached to the mother's nipple when the infant stops sucking. Such reinforcement bands may also be applied to any of the milk flow indicating devices of fig. 1-4A. Fig. 4E shows a partial isometric view of the entire device from the direction labeled 4E in fig. 4D to more clearly show the location of reinforcing strip 402. Furthermore, any of the devices described in this disclosure that incorporate a pressure regulating valve may benefit from such a stiffening band or ring, as the maintenance of the vacuum by the valve is enhanced by the use of the above-described band or ring when the infant pauses due to his/her sucking action.
Referring now to fig. 5A-5D, one example of a novel bi-directional differential valve 64 is shown having different cracking pressure characteristics in both flow directions. The valve is self-driven in the sense that the opening of the valve is determined by the pressure differential applied across the valve. Such a valve may be used in the device of the present application and its operation is therefore described in the following paragraphs. However, it should be understood that such a valve may be used in any other application, whether for liquid flow control or gas flow control, and thus is not intended to be limited to the applications described herein, with wide range of applications throughout the industry and medicine.
Fig. 5A and 5C show cross-sectional views of such an exemplary bi-directional valve, while fig. 5B and 5D are isometric views of the bi-directional valve. As mentioned above, such a bi-directional valve is adapted to allow the mother's milk to flow substantially freely to the baby while allowing air to flow into the mother's nipple when the baby ceases to suck, to a predetermined negative pressure, so as to reduce the level of negative pressure acting on the mother's nipple. The valve opening pressure in the outward flow direction should occur at a lower operating pressure than the valve closing pressure in the inward flow direction. In this way, once the valve is opened to flow outwardly, the infant can suck with minimal obstruction, while the reverse flow for reducing the negative pressure level on the mother's nipple occurs at a higher pressure differential setting so that the device remains on the mother's breast.
The valves shown in fig. 5A to 5D are bi-directional differential valves, self-driven by the pressure differential across the valve, and the opening pressure may be different for the two flow directions. The valve uses a flexible diaphragm 51, the flexible diaphragm 51 being constrained in the valve flow path, transversely to the direction of fluid flow, between an outer shoulder step 53 of the valve body 54 and an inner step edge 55 of the base 50 mounted in the centre of the valve, wherein "inner" and "outer" are related to the radial distance from the central axis of the valve. The flexible membrane 51 is arranged across the flow direction of the fluid and has different flexibility for both flow directions. This difference in flexibility is created by providing different bending lengths of the diaphragm between the support point of the diaphragm in the valve body 54 and its freely movable inner or outer periphery. The diaphragm is constrained between an inner post 50 and outer shoulders 52, 53, the inner post 50 having an annular shoulder 55 that constrains the inner edge of the diaphragm such that the outer edge of the diaphragm can flex only in one direction away from the central post annular shoulder 55, the outer shoulders 52, 53 constraining the outer edge of the diaphragm, e.g. the diaphragm can flex only in the other direction away from the outer shoulders 52, 53. The adjustment of the length of the free diameter of the deflectable diaphragm portion enables control of the pressure on the valve causing the valve to open.
As shown in fig. 5A and 5B, when the infant sucks and creates a negative pressure, milk flow occurs, as indicated by the upwardly directed arrows in fig. 5A. In this regard, the terms "upward" and "downward" refer to directions shown in the drawings, and are independent of absolute directions in space. The outer edge of the flexible diaphragm 51 is lifted from its shoulder step structure 53 to enable milk to flow around its outer edge. Its upward movement is limited by its inherent flexibility and the internal shoulder and step angle 55 of the center base 50, which flexes around the center base 50 and milk flow occurs around the perimeter of the flexing membrane. On the other hand, when the baby ceases sucking and the flow of milk ceases, the negative pressure within the flow channel created by the baby's sucking causes the flexible diaphragm 51 to be pushed inwardly by the external air pressure from its seat on the stepped structure 53, flexing around the stepped corner 52 of the structure. Air or milk still in the valve passage or baby's mouth then enters the device by flowing between the central base 50 and the internally curved diaphragm 51, as indicated by the downwardly directed arrow in fig. 5C. The inward flow of air/milk continues until the negative pressure in the device rises to a level where the diaphragm 51 is closed, as the pressure differential across the valve is insufficient to keep it open.
The configuration of the bi-directional valve shown in fig. 5A-5D allows the pressure required to open the flow of the valve to be different for the two flow directions. This may be desirable because the pressure differential (shown by the upward arrow in fig. 5A) required to open the valve and enable milk to flow from the mother to the infant should be low so as not to place an excessive burden on the infant's sucking effort. This pressure differential should generally be less than when the valve is opened in the opposite direction, where air or milk is allowed in, as indicated by the arrows in fig. 5C, to reduce the level of vacuum formed within the milk flow channel. This opening pressure difference is achieved by the structure of the valve. Which are arranged such that the ease of deflection of the flexible membrane 51 is different in both directions.
It is well known that the bending of a flexible diaphragm depends on three factors:
(a) Young's modulus of the separator material;
(b) A second moment of inertia in the bending direction; and
(c) Free diameter of the curved portion of the membrane.
Factors (a) and (b) are predefined for a particular diaphragm material and shape, and thus the difference in the bending degrees of freedom of the diaphragm depends on the free diameter of the bending, as will now be explained herein.
Referring now to fig. 5A, when milk flow causes the diaphragm to flex outwardly, the free diameter or flex length D1 of the flex extends from the flex point at the corner 55 of the center base 50 to the outer edge of the diaphragm. On the other hand, in fig. 5C, when air or milk inflow is required and the diaphragm is bent inward, the bent length D2 extends from the bending point at the corner 52 of the stepped shoulder 53 of the valve body to the inner edge of the diaphragm. Since the bending length D1 of the outward flow direction of fig. 5A is longer than the bending length D2 of the inward flow direction of fig. 5C, the bending resistance of the outward flow is smaller than the bending resistance of the inward flow, so that the valve opens and closes with a lower pressure difference in the outward flow direction than in the inward flow direction. However, it should be appreciated that the opening pressures may be arranged equal or even opposite depending on the specifics of the two-way valve design, with the specifics being determined by the selected bending lengths D1 and D2.
Referring now to fig. 5E, fig. 5E is an exemplary graph illustrating opening pressure characteristics that may be obtained from the bi-directional self-driven differential valve shown in fig. 5A-5D. In this figure, the flow conductance characteristics of the valve in two opposite directions are shown, one shown by the dashed line and the other by the solid line. The abscissa of the graph shows elapsed time in nominal units, while the ordinate also shows valve flow conductance characteristics in nominal units. Pressure is applied to the valve according to a sinusoidal periodic characteristic. This characteristic is shown by the dashed line in the direction of easier flow, i.e. the direction in which the valve remains open at a lower pressure difference across the valve, the flow being in the range of 0 to 200 units as the pressure rises and falls from its minimum value to its maximum value. In the more restricted flow direction, i.e. the direction in which a higher pressure difference is required to open the valve, this characteristic is shown by the solid line, the valve remains closed until the pressure reaches a value at which to start providing 100 units of flow and remains open until 200 units of level.
Referring now to fig. 6A and 6B, an exemplary medicament dispenser embodiment for a device of the type shown in fig. 1 and 2 is schematically illustrated. Fig. 6A shows a cross-section/side view of the device, while fig. 6B shows a plan view. According to this new feature of these devices, the medicament container reservoir 60 is fluidly connected to the milk channel 15 by means of a connecting tube, so that once the container has been filled with the correct amount of medicament, the flow of milk will mix with the medicament in a controlled manner, depending on the flow rate of medicament from the container reservoir to the milk channel. The flow rate may be controlled by a valve or may be determined by the fluid resistance of the connection tube (according to the cross-sectional area and length of the connection tube) and the viscosity of the medicament. The timing of the addition of the drug to the infant milk may be determined by a shut-off valve in the connection tube or by an air inlet valve in the top of the container. Thus, the infant will receive the full dose of the drug or any other liquid desired to be provided to the infant during breast-feeding, mixed with the breast milk, and at the desired rate, even such that the taste of the drug is masked. The container reservoir 60 is schematically shown as a balloon-shaped volume, but it will be appreciated that it may have any suitable form for this purpose, such as a prefilled vial or a container with a closable lid. The container reservoir may be detachable for refilling, or it may be attached to the milk flow detection device during manufacture as part of a single use disposable device.
Referring now to fig. 7, fig. 7 is a schematic external isometric view of one example of a base unit of the multi-functional nipple shield of the present invention that may be used to perform a number of alternative functions related to different aspects desired by a nursing mother. The base unit 70 comprises a thin flexible layer, which is shaped to correspond to a conventional nipple shield, and is adapted to be fitted by the mother on her breast. The central region has a protruding nipple volume 71 adapted to fit over the mother's nipple. The nipple shield includes a pair of channels 72, 73 embedded in a thin flexible layer of the shield, each connecting the tip of the nipple volume to a remote location disposed in an area 75, which area 75 is visible to the mother or assistant as the baby sucks on the nipple of the device. One of these embedded channels 72 is fluidly connected to the inner surface of the protruding nipple volume 71 and the other embedded channel 73 is fluidly connected to the outer surface of the protruding nipple volume 71. A first one 72 of these channels is adapted to convey milk from the inner surface of the protruding nipple volume 71 to a location 75 remote from the nipple, where the milk contacts milk expelled from the mother's nipple, and another one 73 of these channels is adapted to convey milk from this remote location 75 back to the outer surface of the protruding nipple volume 71, where the milk can be supplied to an infant sucking outside the nipple of the device. At the remote location, each channel terminates in a fluid connection rod 76, 77 of a fluid connector port 78, the two rods having known physical dimensions and being spaced apart by a known distance. While the simplest and most cost effective configuration is to use a pair of passages, the device may also be configured with more than one pair of passages, so long as at least one of the passages connects from the outer surface of the nipple projection to the fluid connection element at the remote location and at least another passage connects from the inner surface of the nipple projection to the fluid connection element at the remote location.
A plurality of different operating heads, each adapted to perform a separate function related to milk or milk flow, may be attached to the fluid connector ports, as will be further shown in fig. 10 below. Thus, the base unit 70 of the nipple shield has a general purpose, and the particular use of the device depends on the head of the remote fluid port 78 attached to the nipple shield.
Referring now to fig. 8, fig. 8 is an enlarged view of the outer tip region of the nipple of the device shown in fig. 7, showing how the channels 72, 73 connect to the inner surface of nipple area 71 and the outer surface of nipple area 71, respectively. As shown in fig. 8, the holes 82 of the first channels 72 are open to the inner surface, and the holes 83 of the second channels 73 are open to the outer surface. Three holes are shown in each channel to provide low resistance to fluid flow, but it should be understood that this is an exemplary embodiment only and that any other number and form of holes that provide suitable milk flow may be used.
Referring now to fig. 9A and 9B, a method of facilitating manufacture of the base unit of the multi-functional nipple shield of fig. 7 and 8 is illustrated. Since the properties required for the sections of the device comprising the channel are different from those required for the thin flexible layer of the nipple shield device, it is advantageous to manufacture the channel sections separately from the channel sections of the nipple shield itself. Fig. 9A shows a strip section of material 90 containing molded channels 72, 73 with the fluid connection port 78 at the distal end. Fig. 9B shows a thin flexible body 91 of a nipple shield apparatus wherein a shallow channel 92 is formed in a portion of the thickness of the thin flexible body, having a shape adapted to receive a strip portion 90 of material containing molded channels 72, 73. The tip region of the nipple area of the device has a hole formed therein that connects to the inner surface of the nipple, the position of the hole matching the hole in the first channel 72, the first channel 72 being adapted to deliver milk from the interior of the nipple volume towards the fluid port 78 at a remote location.
Referring now to fig. 10, which is a splice diagram, there is shown how the base unit 70 of the multi-functional nipple shield of the present disclosure can be used with various attachments that can be used for various different tasks related to breast milk supply. The attachment head is adapted to be inserted into a fluid connection port 78 located away from the nipple area 71 of the device. A number of different attachment points are shown in fig. 10. All heads have a common feature that the connection of the head to the fluid connection port completes a milk circuit between channels 72 and 73 so that the baby can freely express milk from the mother's nipple, with milk flowing along first channel 72 to the head attached at fluid port 78 and returning to the baby's mouth through channel 73. The flow indication head 101 provides an indication to the mother that the infant is receiving milk flow through the nipple shield. The flow indication head 101 may use any of the flow indication features described in the previous embodiments of the flow indicator device of the present disclosure. The flow measurement head 102 is capable of quantitatively measuring the amount of milk flowing from the mother to the baby, which may be based on the previously mentioned commonly owned U.S. patent 7,896,835 entitled "device and method for measuring liquid flow to a baby in milk" (Apparatus and Method for Measuring Fluid Flow to a Suckling Baby), wherein a portion of the primary milk flow passes through a measurement channel, wherein the amount of milk collected in the measurement channel provides a measure of the milk extracted through the primary channel. Alternatively, the head 102 may incorporate a micro-technology flow sensor in a loop formed in the head through which the primary flow passes, and the output signal may be transmitted to a remote reader that displays the flow rate, and the flow rate may be integrated to provide the amount of milk delivered. Since the device is intended for home use, a transmission system in communication with e.g. a smartphone application would be advantageous.
The head 103 for adding a drug to the infant's milk feed may incorporate a small drug housing connected to the milk channel by a channel so that the drug may be slowly added to the infant's milk flow. In addition to the functionality of the device previously described in this disclosure, the use of such a universal multi-task nipple shield enables a plurality of additional measurements and features to be determined. Thus, for example, the microchemical or spectroscopic analysis head 104 may enable the quality of milk or its various components, such as its fat level or pesticide content, and similar analyses. The other head 105 may be used to determine the sucking efficiency of the infant, for example by measuring the level of vacuum created within the head, or the length of the sucking period compared to the rest period of the infant, or other characteristics that characterize the sucking ability of the infant. In addition, analysis of breast milk in the disease detection head 106 (which would include a microscopic spectral or biochemical analysis unit) may provide a pre-warning of disease or illness, which may be manifested in milk delivered from the mother's breast to the infant. Such an analysis head may have the function of detecting breast cancer of the mother early using the device. An advantage of the multi-task nipple shield apparatus of fig. 10 is that all of the above suggested functions can be performed with its associated head attachment without interfering with the flow of milk provided to the infant.
Referring now to fig. 11A-11D, an exemplary use of the multi-functional nipple shield of fig. 7-10 is shown in more detail for a flow indication application using the head 101 of fig. 10. In fig. 11A, the base unit 110 of the multi-functional nipple shield is shown with nipple opening 111 in the apex region of the nipple and the flow indicator head unit 101 attached at the fluid port connection 114. The head 101 is shown with a window area 113, the window area 113 should be transparent in order to facilitate viewing of the flow indication within the attached indication head 101. In fig. 11B, a side view of the base unit 110 with its attachment head 101 is shown to illustrate the manner in which the transparent viewing window 113 is positioned away from the nipple area 111 so that it can be easily viewed by a nursing mother or assistant.
Referring now to fig. 11C and 11D, two alternative exemplary embodiments of the flow-indicating head 101 are schematically shown in greater scale to illustrate details of the head structure. Two different figures show alternative ways in which an indication of milk flow may be produced. In fig. 11C, a flow indicating head 101C is shown, using the method of indicating flow as shown in fig. 2A. Milk flow from the milk collection volume within the nipple area through the channel in the base unit 110 is directed around the transparent or translucent ring of tubes 115 within the viewing window 113 and then back from the viewing head into the channel of the base unit to return to the nipple opening on which the infant can suck. Thus, the mother can directly observe milk flow within the observation window. In fig. 11D, another flow indicating head 101D is shown, using the structure shown in fig. 2D. In this embodiment, the indicator milk chamber 116 is fluidly connected to a channel that delivers milk from the base unit at a junction within the indicator head unit 101D and back to the base unit. As milk flows through the channel in the head, a portion of the milk enters the enclosed chamber 116, where the milk can be observed through the viewing window in the enclosed chamber 116, providing a visual indication of the flow of milk in the channel. In particular, as the infant repeatedly sucks on the mother's breast, milk passes down the channel in a jet, and enters the milk chamber 116 in a surge that is synchronized with the sucking action of the infant. These constant surges of milk 117 into and out of the milk chamber 116 provide a good visual indication of milk flow as the infant sucks.
Referring now to fig. 12, an external view of an exemplary embodiment of the milk measurement head 102 is schematically shown, the milk measurement head 102 being connected to the base unit 110 of the multi-functional nipple shield. The head may operate using the same inventive concepts as described in the above-referenced U.S. patent No.7,896,835. The structure of such a head unit comprises two flow paths for milk (not shown in fig. 12), the first flow path providing the baby with a main channel of milk, which has a much lower resistance to the fluid flow of milk than the second flow path. The second flow path is connected in parallel with the first flow path and has a substantially higher milk flow resistance than the first flow path. Thus, milk flows into the second flow path at a significantly slower rate than in the main path, and the position reached by the advancing front surface of milk is a measure of the total amount of milk that has passed through the quantitative measurement head 102. The position of the front of the milk filling may be determined relative to the scale 121 on the head, which may be calibrated according to the total amount of milk expressed by the infant. Alternatively, a micro-flow meter may be used to measure the flow rate of milk in the measurement head 102, an output signal of the flow rate may be provided by a measurement chip, or the total amount of milk consumed by the infant may be obtained by integrating the flow rate.
The exemplary embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, in order to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to one skilled in the art that the exemplary embodiments may be embodied in many different forms without the specific details, and should not be construed as limiting the scope of the disclosure. Furthermore, those skilled in the art will appreciate 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 the various features described hereinabove as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.
Claims (63)
1. A device adapted to provide an indication of milk flow from a female breast to an infant, the device comprising:
a flexible layer adapted to fit over at least a portion of a female breast, the flexible layer comprising:
an inner surface and an outer surface, the inner surface adapted to face the female breast;
a boss disposed in a central region of the flexible layer and adapted to be positioned over a nipple of the breast; and
At least one fluid communication channel connecting the inner surface of the boss with at least one opening in the outer surface of the apex region of the boss such that milk collected in the space between the nipple and the inner surface of the boss can flow through the at least one channel and out of the at least one opening in the apex region, at least a portion of the at least one channel being maintained at a distance from the boss such that during use of the device, the at least a portion is outside of an area in which infant lips are expected to be located during use of the device.
2. The device of claim 1, wherein the at least one channel is embedded in the flexible layer, or at least partially embedded in the flexible layer, or disposed on an outer surface of the flexible layer, or partially detached from the flexible layer.
3. The device of any one of the preceding claims, wherein at least a portion of at least one channel is transparent or translucent such that milk flow is visible in at least a portion of at least one channel.
4. The device of claim 1, further comprising a closed at least partially transparent container in communication with at least a portion of the at least one channel, such that milk passing through the at least one channel is visually infused into the at least partially transparent container.
5. The apparatus of claim, wherein at least a portion of the at least one channel comprises a mechanical element that deflects in milk flow.
6. The device of any one of the preceding claims, wherein at least a portion of the at least one channel has a characteristic that indicates when a predetermined milk flow is present within the at least one portion.
7. The apparatus of claim 6, wherein the characteristic is a change in color or an emitted sound.
8. The device of any of the preceding claims, wherein at least a portion of the at least one channel is separated from the boss by a distance of at least 3cm such that the at least a portion is visible outside an area where the infant's mouth is expected to suck on the boss.
9. The device of any one of the preceding claims, further comprising at least one valve disposed on the at least one channel and configured to enable milk to flow through the channel only from the space to the at least one opening in the apex region.
10. The device of claim 9, wherein the at least one valve is substantially closed when no suction is applied at the at least one opening in the apex region.
11. The device of any one of the preceding claims, further comprising a container in fluid communication with at least one channel, such that fluid in the container may be provided to an infant.
12. The device of claim 11, wherein the fluid is a pharmaceutical agent.
13. The device of any one of claims 11 and 12, wherein the fluid communication is passable such that the contents of the fluid container are transferred into the milk flow in the at least one channel at a predetermined flow rate.
14. The apparatus of any one of the preceding claims, wherein the apparatus is electronics-free.
15. The device according to claim 11, wherein the electronics-free status of the device reduces the risk of electromagnetic radiation in the infant area.
16. A device adapted to fit at least a nipple area of a female breast for providing an indication of milk flow from the breast, the device comprising:
a flexible material layer having a nipple having an inner surface adapted to face a female breast and an outer surface adapted to face a baby's mouth; and
At least one channel formed in the flexible layer passing from a first location on the inner surface of the nipple to at or near the apex of the nipple on the outer surface of the flexible layer,
wherein at least a portion of the at least one channel is configured to provide an indication of milk flow when the infant sucks on the nipple.
17. The device of claim 16, wherein the at least a portion of the channel is located in an area radially away from the nipple such that the at least a portion of the channel is located outside an area that the lips of the infant will cover.
18. The device of claim 16, wherein the at least a portion of the channel is transparent or translucent and is located radially away from the nipple such that the flow of milk is visible through the at least a portion.
19. The device of claim 16, wherein the at least a portion of the at least one channel comprises a material that changes color when exposed to milk, the material being disposed radially away from the nipple such that flow of the milk is visible through such change in color.
20. The apparatus of claim 16, wherein said at least a portion of said at least one channel comprises an element that emits sound when a predetermined milk flow is present within said at least a portion.
21. The device of any one of claims 16 to 20, further comprising a ring formed around the base region of the nipple, the ring having a lower flexibility than the flexible material layer, such that the device is easier to maintain attached to the breast when the infant stops sucking.
22. The apparatus of any one of claims 16-21, wherein the apparatus is electronics-free.
23. A device adapted to fit at least a nipple area of a female breast, the device comprising:
a flexible material layer having a nipple-like projection with an inner surface adapted to face a nipple area of a female breast and an outer surface adapted to face a baby's mouth, the flexible layer comprising:
at least one first channel leading from an inner surface of the nipple to a location remote from an outer region of the flexible layer of the nipple, and at least one second channel leading from a location remote from the outer region of the flexible layer of the nipple to an outer surface of the nipple, a location in an apex region of the nipple; and
A fluid connector port located in a distal outer region of the flexible layer having a fluid connection opening positioned such that the opening is connected to the at least one first channel and to the at least one second channel,
wherein the fluid connector port is configured to connect to a head that provides information related to the supply of milk transferred from the female breast to the infant through the device.
24. The device of claim 23, wherein the head provides information regarding the amount of milk flowing from a female breast to an infant.
25. The device of claim 24, wherein the head comprises a miniature flow sensor.
26. The device of claim 23, wherein the head comprises a container connected by a channel to a path of milk flow in the head such that a drug can be added to the milk flow.
27. The device of claim 23, wherein the head includes a vacuum indicator enabling a determination of the baby's suction level.
28. The device of claim 23, wherein the head includes an analytical sensor enabling the determination of the milk content.
29. An apparatus device according to any one of claims 23 to 28, wherein the header comprises a transmission unit for transmitting the determined information to a remote device.
30. A nipple shield for use by a lactating female, comprising:
a flexible layer adapted to fit over at least a portion of the female breast, the flexible layer having an inner surface and an outer surface, and a raised area adapted to be positioned over the nipple of the female breast;
at least one opening in the convex region of the flexible layer such that at least one channel connecting the inner surface with the outer surface is formed to enable milk to flow from the woman's breast to a baby sucking on the nipple shield; and
a valve disposed in the at least one channel, the valve allowing milk to flow from the woman's breast to the infant through the at least one channel, but restricting air or milk from flowing from the outside into the inner surface.
31. The nipple shield of claim 30, wherein each valve has an opening pressure level that limits the inflow of air or milk to a predetermined sub-atmospheric pressure.
32. The nipple shield of claim 30, wherein each valve is adapted to maintain sub-atmospheric pressure in a space between the inner surface and the woman's breast.
33. The nipple shield of any one of claims 31 and 32, wherein the sub-atmospheric pressure is adapted to enable the nipple shield to remain attached to a woman's breast when the infant stops sucking.
34. The nipple shield of any one of claims 31 and 32, wherein the sub-atmospheric pressure is adapted to reduce the effort required by the infant to obtain milk.
35. The nipple shield of any one of claims 31 and 32, wherein the sub-atmospheric pressure is adapted to induce a greater amount of milk from the woman's breast.
36. The nipple shield of any one of claims 30 to 35, further comprising at least one element for indicating milk flow, each of the at least one element being disposed within the channel such that a lactating female infant can be notified that milk is being supplied.
37. The nipple shield of any one of claims 30 to 36, further comprising a container fluidly connected to the channel, such that fluid within the container can be provided to an infant.
38. The nipple shield of any one of claims 30 to 37, further comprising a ring formed around a base region of the recessed region of the flexible layer, the ring having a lower flexibility than the flexible material layer, such that the nipple shield remains more easily affixed to the woman's breast when the baby ceases sucking.
39. A method for assisting a female nursing infant, the method comprising:
fitting a nipple shield device over the woman's breast, the nipple shield having at least one first opening facing the woman's nipple, the at least one first opening being fluidly connected by a channel to at least one second opening facing away from the woman's breast; and
allowing the infant to suck on the at least one second opening such that milk flows from the at least one first opening and out of the at least one second opening,
wherein the nipple shield apparatus includes at least one valve, each valve being disposed in one of the at least one channel, allowing milk to flow from the woman's breast to the infant, but restricting air or milk from flowing from the outside into the space between the nipple shield and the woman's breast.
40. The method of claim 39, wherein each valve has an opening pressure that limits the inflow of air or milk to a predetermined sub-atmospheric pressure.
41. The method of claim 39, wherein the valve is adapted to maintain sub-atmospheric/sub-atmospheric pressure in the space between the nipple shield and the woman's breast.
42. The method of any one of claims 40 and 41, wherein the sub-atmospheric pressure is adapted to enable the nipple shield to remain attached to the woman's breast when the infant stops sucking.
43. The method of any one of claims 39 and 40, wherein the sub-atmospheric pressure is adapted to reduce the effort required by the infant to obtain milk.
44. The method of any one of claims 40 and 41, wherein the sub-atmospheric pressure is adapted to cause a greater amount of milk from the woman's breast.
45. The method according to any one of claims 39 to 44, wherein the nipple shield device further comprises an element for indicating milk flow, the element being arranged in at least one channel enabling notification to a lactating female infant that milk is being supplied.
46. A device adapted to provide an indication of milk flow from a female breast to a feeding infant, the device comprising:
a flexible layer adapted to fit over at least a portion of the woman's breast, the flexible layer comprising:
a dome-shaped portion adapted to be positioned over a nipple of the female breast and shaped such that when the device is worn by the female, the dome-shaped portion forms a space between the female nipple and an inner surface of the dome-shaped portion; and
at least one fluid communication pathway connecting the space formed within the dome-shaped portion with at least one closed container disposed in an area of the device that is not expected to be obscured by a mouth of an infant fed at an outer surface of the dome-shaped portion such that milk moving within the at least one closed container provides an indication of a flow of milk from the woman to the infant.
47. The apparatus of claim 46, wherein the at least one closed container is transparent or translucent such that movement of milk in the at least one closed container is visible.
48. The device of claim 47, wherein the visual indication of the presence of milk in the at least one closed container is provided by a material that changes color upon contact with milk.
49. The device of any one of claims 46 to 48, further comprising a ring formed around a base region of the dome-shaped portion, the ring having a lower flexibility than the flexible layer, such that the device remains more easily affixed to the woman's breast when the baby ceases sucking.
50. The device of any one of claims 46 to 49, further comprising a valve disposed in a region between the inner and outer surfaces of the dome-shaped member, the valve being adapted to allow milk to flow from the female breast to the infant, but to restrict air or milk from flowing from the outside into the inner surface.
51. The apparatus of any one of claims 46 to 50, wherein the apparatus is electronics-free.
52. The apparatus of claim 51, wherein the electronics-free state of the apparatus reduces the risk of electromagnetic radiation in the infant's area.
53. A two-way valve, the two-way valve comprising:
A valve body having an axial passage adapted to allow fluid flow therethrough;
a flexible diaphragm having a bore at an inner axial region thereof, the diaphragm disposed across an intended flow axis of the valve;
a first constraining element disposed in a first axial direction from a first side of the septum and configured to limit bending movement of an interior region of the septum in the first direction, an
A second constraining element disposed in a second axial direction from a second side of the diaphragm and configured to limit bending movement of a peripheral outer region of the diaphragm in a second direction.
54. The two-way valve of claim 53, further comprising a post disposed in the axial passage of the valve body, the flexible diaphragm mounted on the post, wherein the first restriction element is an enlarged section of the post having an outer diameter greater than an outer diameter of the post, the flexible diaphragm being free to flex in a first direction only from a point beyond the outer diameter.
55. The two-way valve according to any one of claims 53 and 54 wherein the second restriction element is a narrowed section of the valve body having an inner diameter less than an inner diameter of the axial passage of the body, the flexible diaphragm being free to flex in the second direction only from a point within the inner diameter.
56. The two-way valve of claim 54, wherein a distance between an outer diameter of the enlarged section of the stem and an outer periphery of the flexible diaphragm determines an opening pressure characteristic of the flow of the valve in the first axial direction.
57. The two-way valve of claim 55, wherein a distance between an inner diameter of the narrowed section of the valve body and the inner periphery of the flexible diaphragm determines an opening pressure characteristic of flow of the valve in the second axial direction.
58. A two-way valve, the two-way valve comprising:
a valve body having an axial passage and a stepped surface formed in a recessed first end;
a post mounted in the axial passage of the valve body forming an annular flow passage within the axial passage of the valve body, the post having a widened end forming a stepped shoulder facing in a direction opposite to that of the stepped surface of the recessed first end of the valve body and at a longitudinal position proximate to the same axial region as the stepped surface of the recessed first end of the valve body; and
a flexible diaphragm mounted on the post such that the flexible diaphragm is positioned between the stepped shoulder of the post and the stepped surface of the valve body and spans the annular flow passage.
59. The two-way valve of claim 58, wherein the position of the flexible diaphragm is such that fluid flow along the annular channel toward the recessed first end of the valve body is operable to produce bending movement of the outer periphery of the flexible diaphragm toward the recessed first end, and fluid flow along the annular channel away from the recessed first end of the valve body is operable to produce bending movement of the inner periphery of the flexible diaphragm away from the recessed first end.
60. The two-way valve of claim 59, wherein for a given fluid flow, the extent of bending movement of the flexible diaphragm toward the recessed first end is dependent on a radial distance between a step in the step shoulder of the center post and an outer periphery of the flexible diaphragm.
61. The two-way valve of claim 59, wherein, for the given fluid flow, the extent of bending movement of the flexible diaphragm away from the recessed first end is dependent on a radial distance between a step of the step surface formed in the recessed first end and an inner periphery of the flexible diaphragm.
62. The two-way valve according to any one of claims 59 to 61 wherein the length of the free diameter of the flexible portion of the diaphragm is selected such that the pressure on the valve when the valve is open can be adjusted.
63. The two-way valve according to any one of claims 59 to 62 wherein the opening of the valve is self-driven by a pressure differential across the valve.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IL280929 | 2021-02-16 | ||
| US202163223616P | 2021-07-20 | 2021-07-20 | |
| US63/223616 | 2021-07-20 | ||
| PCT/IB2022/051373 WO2022175833A1 (en) | 2021-02-16 | 2022-02-16 | Device for flow detection of mother's milk |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN116867471A true CN116867471A (en) | 2023-10-10 |
Family
ID=88223850
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280012958.5A Pending CN116867471A (en) | 2021-02-16 | 2022-02-16 | Breast milk flow detection device |
Country Status (2)
| Country | Link |
|---|---|
| JP (1) | JP2024512237A (en) |
| CN (1) | CN116867471A (en) |
-
2022
- 2022-02-16 CN CN202280012958.5A patent/CN116867471A/en active Pending
- 2022-02-16 JP JP2023549620A patent/JP2024512237A/en active Pending
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| Publication number | Publication date |
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| JP2024512237A (en) | 2024-03-19 |
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