Device for detecting breast milk flow

Abstract

A new device for providing an indication to a nursing mother whether or not her baby is taking in breast milk during breastfeeding. Breast milk expressed from the mother's breast is delivered to the nipple of the device and flows through a transparent passageway portion of a nipple shield positioned in a position visible to the mother or a third party before the baby can suck from the nipple of the device. Thus, the device provides an indication that the baby is taking in breast milk from the mother's breast. Visibility of the passageway is achieved by routing the passageway through an area of ​​the device where the line of sight with the mother will not be obscured by the baby during breastfeeding, for example towards the periphery of the base of the device. The device passageway may also include a valve, and details of such valves are disclosed.

Description

[Technical field]

[0001] SUMMARY This disclosure describes techniques related to the field of detection of breast milk flow from a nursing mother, and in particular techniques for indicating the presence of that flow to the mother. [Background technology]

[0002] The desire to receive an indication of whether or not an infant is actually receiving breast milk during a feeding session often arises, especially during the first few weeks of infancy. Infants tend to suckle at the breast as a way of comfort, which may give the mother the impression that the infant is receiving breast milk when in fact they are not. Also, some mothers, especially before breastfeeding is established, may not produce enough milk so that a hungry infant may suckle for long periods of time without receiving an adequate supply of breast milk. Furthermore, some infants seem to fall asleep during feedings, and mothers may not realize that they are still breastfeeding. Various complex measurement systems have been proposed to give an indication of whether breast milk is being delivered to the infant. One approach used is weight subtraction, which is tedious, time-consuming and inaccurate. In this approach, the infant is weighed before and after feeding and the two weights are subtracted to calculate the breast milk consumption. Another approach is disclosed in the article "Breast Milk Flow Meter Apparatus and Method" by E. Kolberg et al., which tracks breast volume changes by computerized imaging of the breast before and after feeding. US Pat. No. 5,399,433, entitled "Breast Milk Flow Meter Apparatus and Method," discloses an approach in which a volumetric flow sensor is placed inside the silicone nipple cap where the infant sucks. Milk flow data from the sensor is converted to milk volume data that is displayed to the mother. Such systems generally require an electronic or electromechanical flow meter to be attached to the fluid flow path to measure the fluid flow. Several other systems have been proposed that use an electronic flow measurement module attached to the exterior of a breast milk collection device that fits the mother's breast to measure the milk flow. One such system is shown in US Pat. No. 5,399,433, entitled "Non-Invasive Breast Milk Monitoring" to LADrew, which has an electronic sensor to measure the milk flow. However, all of the above systems are expensive and complicated due to the electronic breast milk sensing unit, making them less suitable for low-cost and possibly disposable devices. Also, many mothers would be hesitant to use electronic devices on or near their infants, generally fearing the presence of electromagnetic radiation, and there is an additional risk that such externally attached parts may become dislodged from the device and somehow be ingested by the infant. A simpler device similar to a nipple shield is described in commonly owned US Patent No. 5,339,993, for "Apparatus and Method for Measuring Fluid Flow to an Infant", in which a portion of the main milk flow passes through a measurement flow path, and the length of milk collected in the measurement flow path after a feeding time provides a measure of the milk that has been removed through the main flow path. As the benefits of breastfeeding become more widely known, more mothers are breastfeeding than ever before, highlighting the need for a method to indicate an infant's breast milk intake. The disclosures of each publication mentioned in this section and other sections of the specification are each incorporated herein by reference in their entirety. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2006 / 054287 [Patent Document 2] US Patent Application Publication No. 2018 / 0147124 [Patent Document 3] U.S. Patent No. 7,896,835 [Non-patent literature]

[0004] [Non-Patent Document 1] SEJ Daly et al., “The Determination of Short-Term Breast Volume Changes and the Rate of Synthesis of Human Milk Using Computerized Breast Measurement”, Exp. Physiology, 77, 79-87 (1992) Summary of the Invention [Problem to be solved by the invention]

[0005] The present disclosure seeks to provide novel apparatus and methods that overcome at least some of the shortcomings of prior art systems and methods. [Means for solving the problem]

[0006] This disclosure describes a new exemplary device for providing a nursing mother with an indication as to whether or not her baby is taking in breast milk during a feeding session. The device is typically constructed of a flexible layer with a shape and design similar to currently available nipple shields, and the layout of the device's flow geometry is such that breast milk expressed from the mother's breast flows through a passageway with an area that provides an indication of breast milk flow before being delivered to the nipple of the device where the baby is sucking. The indicator portion of the passageway should be located in a position accessible to the mother or a helper. A simple way to realize the indicator portion of the passageway is to construct the portion of the passageway from a transparent or translucent material so that the flow of breast milk is visible to the mother, and this embodiment will be used below in describing the device, but is not intended to limit the flow indication to a visible indication. The passageway is located inside the device, located on the surface of the device, or otherwise attached to the device. Thus, the device provides an indication to the mother or a third party that the baby is taking in breast milk from the mother's breast. Another way to configure the device is to provide a small indicating container fluidly connected to the space for milk flow between the mother's breast and the nipple of the device, eliminating the need for the milk to pass through a passageway, with a portion of the milk flowing directly to the baby passing through a connection to the indicating container, where the presence or absence of milk is visible to the mother. Milk flow can also be indicated by using a mechanical protrusion in the milk flow path, where milk flow causes the mechanical protrusion to change direction, thereby indicating milk flow. In yet another embodiment, a small sealed container can be attached to the milk passageway, away from the baby and the mother's nipple, with a short connecting tube, and as the milk flows through the passageway as the baby sucks, it pushes along the connecting tube into the sealed container, where it can be easily seen.

[0007] The device is advantageously constructed of a flexible layer, typically having a shape and design similar to currently available nipple shields. The flexible layer is typically constructed of a material that is non-absorbent and non-irritating to the skin, such as silicone. Like the nipple shield, the flexible layer is configured to conformally fit a portion of the female breast, covering the areola and nipple, and has a central protrusion (hereinafter referred to as the device nipple) configured to be placed over the mother's nipple. This protrusion is so named because of its geometric shape when viewed from the outside, but also has the functional shape of a concave area or depression when viewed from the side of the mother's breast. This feature may generally be alternately referred to by a name related to its function from the inside of the device or a name related to its function from the outside of the device, depending on the context in which it is referenced, as will become clear below. However, this convention should not be understood as limiting such functional uses or relationships, and both terms or another descriptive name may be used alternatively. The protrusion / concave area may be configured as an integral part of the flexible layer, attached to the central area of ​​the flexible layer, or may be constructed of yet another material. The device may be provided in different shapes and different sizes to suit individual users, with the flexible layer conforming to the user's breasts during application of the device.

[0008] To provide an indication of whether the baby is ingesting breast milk during the feeding period, the device may have one or more passageways, which may have a circular cross section or any other suitable shape, to visually indicate the flow of breast milk, especially the surge of breast milk, which closely resembles the sucking pattern of the baby. The passageways are typically embedded inside the flexible layer so that the device may be formed from one piece, or formed on the surface of the flexible layer, or fixed on the surface and attached at their ends. The passageways have two openings, the first opening being an opening from the central concave region of the device, such that the opening faces the mother's breast when the device is worn. The second opening or openings of the passageways are also located in the central concave region of the device, but in the tip region of the protrusion, as openings to the outer surface of the flexible layer to face the baby during feeding. This opening to the outside should not be in fluid contact with the central concave hollow internal volume. Between the two openings, the passageway makes a detour radially outward from the central concave recessed region so that when the mother wears the device, a portion of the passageway is located in an area that is not visually obstructed by the baby's mouth and thus needs to be visible to the mother or third parties during use of the device. The flexible layer should be formed of a transparent or translucent material so that the fluid flow through the passageway is visible to the user. If not, at least a portion of the flexible layer in which the passageway is embedded should be constructed of a transparent or translucent material so that a portion of the passageway is visible during breastfeeding. In general, the second opening, which acts as the outlet opening, is located at the apex of the protuberance, which closely resembles the structure of the mother's nipple. The passageway may branch into multiple branches in the region of the second opening, so that the second "opening" may be constructed of multiple separate openings. This arrangement should allow the baby to suck more efficiently, since no part of the baby's tongue or lips will block the entire opening, as would be the case with a single opening. Similarly, the entrance of the passageway in the concave recess may have multiple openings. Additionally, the device may be provided with two or more parallel passageways to ensure sufficient milk flow is possible. This may be necessary, for example, where the passageways are formed within a thin, flexible layer of the device and therefore of restricted cross-section such that flow through a single passageway is restricted.At least one of the parallel passages requires an area where the mother can get a visual indication of the milk flow. For ease of explanation, any number of passages will be referred to below as a single passage, which is not intended to limit the application and should be understood to include multiple passages as recited in the claims.

[0009] When the device is used, the flexible layer conforms to the woman's breast and the concave area, which is the device nipple, is placed over the mother's nipple. Usually, there is a cavity between the mother's nipple and the device nipple. During feeding, the baby sucks on the outside of the protrusion, i.e. the device nipple, which results in a negative pressure in the passageway. The negative pressure creates a vacuum in the passageway, drawing breast milk from the mother's nipple into the hollow concave space and the passageway, which helps to draw breast milk from the hollow concave space and the passageway to provide breast milk to the baby. The negative pressure forces the flexible layer to adhere to the mother's breast, thereby preventing breast milk from leaking outward from the concave space and the outer edge of the device, and also reduces air ingress from the outer edge and the generation of air bubbles in the breast milk flow.

[0010] Because the infant's mouth may block most of the flexible layer, the passageway must be positioned such that at least a portion of it is visible even when the center of the flexible layer is visually obstructed by the infant. The passageway is thus typically embedded in, attached to, or otherwise attached to the surface of the flexible layer in a location such that it extends around at least a portion of the peripheral region of the flexible layer, or in an area of ​​the flexible layer outside at least the concave well area, or through an exterior location such that it is visible during feeding times.

[0011] The passageway may advantageously be provided with a valve that opens at a predefined pressure to allow the flow of breast milk through the passageway in a direction from the central concave hollow opening towards the outlet opening at the tip of the device nipple to the baby. Some examples of such valves are provided in the detailed description section of this disclosure. Such a valve has the effect of helping to maintain a negative pressure in the passageway, and thus in the hollow concave area, when the baby stops sucking, thus ensuring a better attachment of the device to the mother's breast. The use of such a valve also reduces the sucking effort required by the baby, since between pauses in the baby's sucking, the baby does not need to generate the entire negative pressure required to draw breast milk from the concave space, which would otherwise be at atmospheric pressure, to the baby's mouth, but only from the negative pressure maintained in the concave space by the valve. The valve thus acts as a flow amplifier and may reduce the time required for feeding. The negative pressure maintained in the concave milk collection space may also assist the mother by inducing a better flow of breast milk from the mother's breast. The valves can be installed anywhere along the length of the passageway, providing a range of opening pressure models to suit the strength of sucking exhibited by the infant. Babies with more developed sucking abilities can advantageously use valves that open at higher absolute pressures. Alternatively, as an alternative consideration, the opening pressure can be selected to partially relieve the subatmospheric pressures generated by the infant's sucking without causing undue discomfort to the mother. The level selected can be chosen depending on the tolerable level of negative pressure applied to the mother's nipple. If deemed necessary or advantageous, two or more valves can be used along the flow path to control the flow rate. It should be made clear that references in this disclosure to opening or closing pressures relate to the absolute pressure difference across the valve at which the valve opens or closes, regardless of whether the valve is located in a negative pressure region, i.e., a partial vacuum region, or in a positive pressure region, i.e., above atmospheric pressure.

[0012] According to further exemplary embodiments of these flow indicating devices, two-way valves can also be used for this purpose, such two-way valves having the additional feature of operating to avoid excessive pressure on the mother's nipple from the baby's vigorous sucking, while at the same time maintaining a predetermined negative pressure within the device to keep the device attached to the mother's breast. The mechanism of this use is that when the baby stops sucking, if only a one-way valve was used, which closes when the baby stops sucking, the high negative pressure generated within the device would be maintained, thus continuing to apply negative pressure to the mother's nipple. The use of a two-way valve ensures that when the baby stops sucking and the high negative pressure generated by the baby within the device ceases, the reverse flow direction of the two-way valve allows air and / or milk to flow back into the passageway, but only up to the predetermined pressure at which the valve is designed to close. When the valve closes, this closure value of negative pressure is maintained, but it is less than the negative pressure generated by the baby, thereby reducing discomfort to the mother, but not all of the vacuum is released so the device remains attached to the mother's nipple.

[0013] All of the above breast milk detection devices according to various embodiments of the present disclosure have one common feature that distinguishes them from conventional devices such as devices for measuring milk flow, and that is that since the presently described devices only require the addition of one or more simple breast milk passageways to the nipple shield structure, these devices can be manufactured at low cost by conventional polymer manufacturing techniques without the need for additional mechanical or electronic components. This feature is very important because the device can be constructed as a single, compact, self-contained device with low enough manufacturing costs to be a single-use, disposable milk flow indicator. This is an important advantage over the aforementioned mechanical or electronic devices, allowing for more universal use of breast milk indicator devices for nursing mothers. Also, the construction as a single, integrated device avoids the risk of external parts becoming detached and potentially being swallowed by a nursing infant. Furthermore, a device without electronics, constructed only from inert polymeric materials, that can provide information regarding breast milk flow to an infant, should ease mothers' concerns regarding the operation of electronic devices in close proximity to young babies.

[0014] According to another aspect of the present disclosure, a novel method of manufacturing such a two-way differential pressure valve, self-actuating by pressure difference across the valve, is further described, where the opening pressure can be different for the two directions of flow. The valve uses a flexible diaphragm arranged along the direction of fluid flow, which has different flexibility for the two directions of flow. 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 and its freely movable inner or outer circumferential edge. The diaphragm is restrained between an inner post having an annular shoulder that restrains the inner edge of the diaphragm so that the diaphragm can only bend in one direction toward its outer edge, and an outer shoulder that restrains the outer edge of the diaphragm so that the diaphragm can only bend in the opposite direction toward its inner edge. Adjustment of the length of the free diameter of the bendable portion of the diaphragm allows adjustment of the pressure across the valve that causes the valve to open. A more complete description of the operation of the valve is shown in the detailed description section of Figures 5A-5E.

[0015] According to yet another embodiment of the present application, the described use of a valve to control the flow of breast milk out of the nipple hole allows for the provision of a new nipple shield device, which has the advantage of helping to ensure that the nipple shield stays in place on the mother's breast when the baby stops sucking. The valve allows for unimpeded flow of breast milk from the mother to the baby, but when the baby stops sucking, the valve closes to prevent air from flowing back through the nipple hole of the nipple shield, thereby releasing the vacuum holding the nipple shield in place and loosening the contact between the nipple shield and the mother's breast. Additionally, advantageously, the valve can have an opening pressure differential that still allows a certain amount of air to enter the nipple hole, reducing the negative pressure on the mother's nipple, making the negative pressure less uncomfortable for the mother, yet does not release all of the vacuum level in the device which would cause the device to become dislodged. For example, a nursing baby may apply negative sucking pressure at a first level, but once the baby stops or pauses, the valve allows air to enter to adjust the internal pressure on the mother's nipple to a less negative level that causes less discomfort to the mother. Additionally, the base of the nipple area of ​​the device may be reinforced, such as by using a thicker or stronger material, so that the base of the nipple remains more firmly attached to the mother's breast and is less prone to bending or lifting, thereby releasing the vacuum.

[0016] A further inventive addition to any of the devices described herein includes the use of a fluid dispenser integrated with a milk flow detector that can be advantageously used as a medication dispenser. As is well known, giving medication to an infant is difficult. The amount of medication given must be precise, and using a regular spoon or syringe to give medication to an infant is unreliable and inaccurate, as besides the challenge of getting the infant to take the dose, the infant may spit out part of the dose. According to this feature of the disclosure, a medication container reservoir is attached to the device and is fluidly connected to the breast milk passageway such that when the container is filled with the correct amount of medication, the flow of breast milk is mixed with the medication in a controlled manner depending on the flow rate of the medication from the container reservoir to the breast milk passageway. The infant then receives the entire dosage of the medication or other fluid desired to be given to the infant, mixed with the nursing breast milk such that even the taste of the medication is masked. The container reservoir may be removable to allow for easy filling. In addition to being applicable for incorporation into the milk flow detector of the present application, such features may also be incorporated into any other device that provides a flow path for breast milk to be ingested by an infant, such as the above-referenced U.S. Patent No. 5,399,633, which has a common inventor with the present application and is directed to an "Apparatus and Method for Measuring Fluid Flow to an Infant." Such features may also be incorporated into the improved nipple shield described above.

[0017] All of the above milk flow detectors are single-function, single devices for providing an indication to the mother that the infant is receiving a flow of breast milk. Additionally, added components are generally described as part of such single-use devices. In accordance with further implementations of the devices described herein, a novel multitasking nipple shield is described that can be used to perform many alternative functions related to various aspects of the needs of a breastfeeding mother. The nipple shield includes a versatile base unit that is attached to the mother's breast and transfers breast milk from the mother's nipple to the infant's mouth with a passageway that carries the breast milk to and from a remote location from the nipple. Any of a number of different operating heads can be attached to this remote location, with each type of head configured to perform its own dedicated function related to breast milk. The remote location includes a standardized pair of fluid flow connection terminals, with the various operating heads having matching standardized fluid flow connectors that can be attached to a remote connector on the nipple shield at the base. The nipple shield base unit is thus versatile, with the specific use of the device being determined by the head attached to the nipple shield's remote terminal. The heads can be fitted for various measurement or indication functions such as flow measurement, flow indication, drug addition, measurement of the infant's sucking pattern, milk quality analysis, detection of markers in breast milk indicative of maternal illness, and many other functional applications. In addition to the multitasking use of the overall device concept, another advantage of such devices is that the base nipple shield, with its flow paths and parts easily cleanable with a brush or machine, can be made for multiple use, while the more complex and therefore more difficult to clean head attachments can be single-use disposable units. However, it is feasible that head attachments can be made to be cleaned and reused, especially head attachments that incorporate electronic chips and are therefore somewhat expensive to be considered disposable attachments.

[0018] Although reference is made throughout this application and in the claims to the baby's mother being the provider of breast milk, it should be understood that this is the normal situation and the reference to the mother is not intended to exclude women other than the baby's mother, and the disclosure and claims are not intended to be construed as limited to mothers who use the device to breastfeed their infants.

[0019] Although the device described herein is most effectively used for feeding from the mother's breast, it can also be manufactured in a form that can be attached to a baby bottle, thus providing direct evidence of milk flow while the baby is drinking, rather than having to hold the bottle upright and interrupt the feeding to read the milk level on the bottle scale. This embodiment also allows for the use of opaque baby bottles.

[0020] Thus, in accordance with an exemplary embodiment of the device described in the present disclosure, there is provided a device configured to provide an indication of flow of breast milk from a female's breast to an infant, the device comprising: a flexible layer configured to conform to at least a portion of a female breast, the flexible layer comprising: (i) an inner surface configured to face the female breast and an outer surface; (ii) a protrusion disposed in a central region of the flexible layer and configured to be positioned over a nipple of the breast; (iii) at least one fluid communication passageway connecting an inner surface of the prongs with at least one opening in an outer surface of the tip region of the prongs, such that breast milk collected in a space between the nipple and the inner surface of the prongs can flow through the at least one passageway and out of the at least one opening in the tip region, at least one portion of the at least one passageway being positioned at a distance from the prongs such that during use of the device, at least one portion is positioned outside of an area where the baby's lips are expected to be during use of the device; and Includes.

[0021] In the above device, the at least one passageway may be embedded within the flexible layer, partially embedded within the flexible layer, disposed on an outer surface of the flexible layer, or partially separated from the flexible layer.

[0022] According to further embodiments, in any of the above devices, at least one portion of the at least one passageway is transparent or translucent so that the flow of breast milk in at least one portion of the at least one passageway is visible. The device may also include a sealed at least partially transparent container connected to at least one portion of the at least one passageway such that the breast milk passing through the at least one passageway is visible moving in a wave-like manner in the at least partially transparent container. Furthermore, at least one portion of the at least one passageway may include a mechanical element that is deflected in the flow of breast milk. Furthermore, at least one portion of the at least one passageway may have a characteristic that indicates the presence of a predetermined flow of breast milk in the at least one portion. Such a characteristic may be either a color change or an emitted sound.

[0023] In any of the above devices, the distance of at least one portion of at least one passageway from the protrusion may be at least 3 cm so that the at least one portion is visible outside the area where the mouth of an infant sucking on the protrusion is expected to be.

[0024] According to yet another embodiment, any of these devices may further include at least one valve disposed along the at least one passageway and configured to allow breast milk to flow only through the passageway from the space to the at least one opening in the tip region, in such a case, the at least one valve essentially closes when no suction is applied to the at least one opening in the tip region.

[0025] Any of the above devices may further include a container fluidly connected to the at least one passageway such that the fluid in the container can be delivered to the infant. The fluid may be a drug. Also, the fluid connection must be such that the contents of the fluid container are transferred to the flow of breast milk in the at least one passageway according to a predetermined flow rate.

[0026] Any of the above devices must be electronic-free, so that the electronic-free status of the device reduces the risk of electromagnetic radiation in the area of ​​the baby.

[0027] According to a further embodiment of the present disclosure there is further provided an apparatus for providing an indication of flow of breast milk from a breast, the apparatus being configured to be worn on at least a nipple region of a female breast, the apparatus comprising: (i) a layer of flexible material having a nipple-shaped projection having an inner surface and an outer surface, the inner surface configured to face the nipple area of ​​the female breast and the outer surface configured to face the mouth of the infant; (ii) at least one passageway formed in the flexible layer, the at least one passageway extending from a first location on an inner surface of the nipple-shaped projection to an outer surface of the flexible layer at or near an apex of the nipple-shaped projection; Including, At least one portion of the at least one passageway is configured to provide an indication of milk flow when an infant is sucking on the nipple-shaped protrusion.

[0028] In such a device, at least one portion of the passageway may be located in a region radially away from the nipple-shaped projection such that at least one portion of the passageway is outside of an area that may be obscured by the baby's lips. At least one portion of the at least one passageway may be transparent or translucent and located in a region radially away from the nipple-shaped projection such that the flow of breast milk is visible through the at least one portion. Furthermore, at least one portion of the at least one passageway may include a material that changes color when exposed to breast milk and is located in a region radially away from the nipple-shaped projection such that the flow of breast milk is visualized by such color change. As an alternative embodiment, at least one portion of the at least one passageway may include an element that emits a sound when a predetermined flow of breast milk is present within the at least one portion.

[0029] In yet another embodiment, any of the above devices may further include a ring formed around the base region of the nipple-shaped projection, the ring being less flexible than the flexible material layer so that the device more easily remains secured to the breast when the baby stops sucking. Also, the above devices should be free of electronic devices so that the risk of electromagnetic radiation in the area of ​​the baby is reduced.

[0030] According to yet another embodiment of the device of the present application, there is further provided a device adapted to be attached to at least the nipple region of a female breast, the device comprising: A flexible material layer having nipple-shaped projections, the flexible material layer having an inner surface configured to face the female breast and an outer surface configured to face the baby's mouth. and the flexible layer comprises: (i) at least one first passageway from an inner surface of the nipple-shaped projection to a location within an outer region of the flexible layer remote from the nipple-shaped projection, and at least one second passageway from a location within the outer region of the flexible layer remote from the nipple-shaped projection to an outer surface of the nipple-shaped projection at a location within a tip region of the nipple-shaped projection; (ii) a fluid connector port in a remote outer region of the flexible layer having a fluid connection opening arranged to connect to the first at least one passageway and the second at least one passageway; Including, The fluid connector port is configured to receive a head thereto that provides information regarding the milk supply passing from the woman's breast through the device to the baby.

[0031] In such a device, the head provides information regarding the amount of milk flowing from the woman's breast to the baby. The head may include a small flow sensor, or a reservoir connected by a channel to the path of the milk flow within the head so that a medication can be added to the milk flow, or a vacuum indicator so that the sucking level of the baby can be determined, or an analytical sensor so that the content of the milk can be determined. The head may also include a transmitting unit for transmitting the determined information to a remote device.

[0032] According to yet another embodiment of the present disclosure, there is provided a nipple shield for use by a breastfeeding woman, the nipple shield comprising: (i) a flexible layer configured to conform to at least a portion of a female's breast, the flexible layer having inner and outer surfaces and a raised region configured to be positioned over a nipple of the female's breast; (ii) at least one opening in the protruding region of the flexible layer such that at least one passageway is formed connecting the inner surface with the outer surface to permit the flow of breast milk from the woman's breast to an infant sucking on the nipple shield; (iii) a valve disposed in at least one passageway that permits the flow of breast milk from the woman's breast to the baby through the at least one passageway but restricts the flow of air or breast milk from the exterior to the interior; Includes.

[0033] In such nipple shields, each valve may have an opening pressure level that limits the inflow of air or breast milk to a predetermined subatmospheric pressure. Also, each valve may be configured to maintain a subatmospheric pressure in the space between the inner surface and the woman's breast. This subatmospheric pressure may be configured to allow the nipple shield to remain attached to the woman's breast when the baby stops sucking. Alternatively and in addition, the subatmospheric pressure may be configured to reduce the effort required for the baby to obtain breast milk or to induce a greater amount of breast milk from the woman's breast.

[0034] In further embodiments, such nipple shields may further include at least one element for indicating milk flow, each of the at least one element being disposed within the passageway to inform the nursing woman that breast milk is being provided to the infant. The nipple shield may further include a container fluidly connected to the passageway to enable fluid within the container to be provided to the infant. Any of the above nipple shields may further include 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 more easily remains secured to the woman's breast when the infant stops sucking.

[0035] According to yet another embodiment, there is provided a method for assisting a woman in feeding an infant, the method comprising: (i) applying a nipple shield device to the woman's breast, the nipple shield having at least one first opening facing the woman's nipple, the first opening being fluidly connected by a passageway to at least one second opening facing away from the woman's breast; (ii) allowing the infant to suck on the at least one second opening such that breast milk flows through the at least one first opening and out of the at least one second opening; Including, The nipple shield devices each include at least one valve positioned in one of the at least one passageway and allowing the flow of breast milk from the woman's breast to the baby but restricting the inflow of air or breast milk from the outside into the space between the nipple shield and the woman's breast.

[0036] In this method, each valve has an opening pressure that limits the inflow of air or breast milk to a predetermined subatmospheric pressure. The valves can be configured to maintain a subatmospheric pressure in the space between the nipple shield and the woman's breast. This subatmospheric pressure can be configured to allow the nipple shield to remain attached to the woman's breast when the baby stops sucking. The subatmospheric pressure can also be configured to reduce the effort required for the baby to obtain breast milk and can be configured to induce a greater amount of breast milk from the woman's breast. Additionally, the method can be practiced by using a nipple shield device that includes an element for indicating breast milk flow, disposed between at least one passageway to inform the lactating woman that the baby is being fed breast milk.

[0037] According to yet another embodiment described herein, there is provided an apparatus configured to provide an indication of flow of breast milk from a female's breast to a nursing infant, the apparatus comprising: a flexible layer configured to conform to at least a portion of a female breast, the flexible layer comprising: (i) a dome-shaped portion configured to be placed over a nipple of a woman's breast, the dome-shaped portion being configured to define a space between the woman's nipple and an interior surface of the dome-shaped portion when the woman is wearing the device; (ii) at least one fluid communication passageway connecting a space defined within the dome-shaped portion with the at least one enclosed container, the at least one enclosed container being located in an area of ​​the device that is not expected to be obscured by a feeding infant's mouth by an exterior surface of the dome-shaped portion, such that breast milk traveling within the at least one enclosed container provides an indication of the flow of breast milk from the woman to the infant; and Includes.

[0038] In such devices, the at least one sealed container may be either transparent or translucent so that the movement of breast milk within the at least one sealed container is visible. This visual indication of the presence of breast milk within the at least one sealed container may be provided by a material that changes color upon contact with breast milk.

[0039] Such devices may also include a ring formed around a base region of the dome-shaped portion, the ring being less flexible than the flexible layer such that the device more easily remains secured to the woman's breast when the baby stops sucking. Such devices may also include a valve disposed in a region between the inner and outer surfaces of the dome-shaped portion, the valve being configured to allow the flow of breast milk from the woman's breast to the baby, but restrict the inflow of air or breast milk from the outside to the inner surface.

[0040] Any of the above devices must be electronic-free, thus reducing the risk of electromagnetic radiation in the area of ​​the baby due to the electronic-free status of the device.

[0041] In yet another embodiment described herein, a two-way valve is provided, the two-way valve comprising: (i) a body having an axial flow passage configured to permit fluid flow therethrough; (ii) a flexible diaphragm having an opening in its inner axial region, the diaphragm being disposed transverse to the intended flow axis of the valve; (iii) a first restraining element disposed in a first axial direction from a first side of the diaphragm and configured to limit bending motion of an inner region of the diaphragm in a first direction; (iv) a second restraining element disposed in a second axial direction from a second side of the diaphragm and configured to limit bending motion of a peripheral outer region of the diaphragm in a second direction; Includes.

[0042] Such a two-way valve further includes a post disposed within the axial flow passage of the body, to which a flexible diaphragm may be attached, the first constraining element being an enlarged portion of the post having an outer diameter greater than the outer diameter of the post, the flexible diaphragm being free to bend in a first direction only from a point beyond the outer diameter of the enlarged portion. In this valve, the second constraining element is a reduced portion of the body having an inner diameter less than the inner diameter of the axial flow passage of the body, the flexible diaphragm being free to bend in a second direction only from a point within the inner diameter of the reduced portion. Also, the distance between the outer diameter of the enlarged portion of the post and the outer peripheral edge of the flexible diaphragm may determine the opening pressure characteristic of the valve for a first axial flow. Furthermore, the distance between the inner diameter of the reduced portion of the body and the inner peripheral edge of the flexible diaphragm may determine the opening pressure characteristic of the valve for a second axial flow.

[0043] Another embodiment of the two-way valve comprises: (i) a body having an axial flow passage and a stepped surface formed at a concave first end; (ii) a post mounted within the axial flow passage of the valve body to define an annular flow passage within the axial flow passage of the valve body, the post having a widened tip defining a stepped shoulder, the stepped shoulder facing away from and longitudinally positioned adjacent the same axial region as the stepped surface of the concave first end of the valve body; (iii) a flexible diaphragm disposed between the stepped shoulder of the post and the stepped surface of the valve body and attached to the post across the annular flow passage; may include.

[0044] In such a two-way valve, the position of the flexible diaphragm may be such that fluid flow along the annular flow passage toward the concave first end of the valve body operates to generate a bending motion of the outer peripheral edge of the flexible diaphragm toward the concave first end, while fluid flow along the annular flow passage away from the concave first end of the valve body operates to generate a bending motion of the inner peripheral edge of the flexible diaphragm away from the concave first end. In such a two-way valve, for a given fluid flow, the degree of bending motion of the flexible diaphragm toward the concave first end may be determined by the radial distance between the step of the stepped shoulder of the central post and the outer peripheral edge of the flexible diaphragm. Also, the degree of bending motion of the flexible diaphragm away from the concave first end may be determined by the radial distance between the step of the stepped surface formed on the concave first end and the inner peripheral edge of the flexible diaphragm.

[0045] In any of these two-way valves, the choice of the length of the free diameter of the flexible portion of the diaphragm allows the adjustment of the pressure across the valve at which the valve opens. The opening of the valve can be self-actuated by the pressure difference across the valve. [Brief description of the drawings]

[0046] The present invention will be more fully understood and appreciated from the following detailed description taken in conjunction with the drawings, in which: [Figure 1] 1 shows a schematic isometric view of an exemplary device for displaying the flow of breast milk of a mother while feeding her baby; [Figure 2A] FIG. 2 is a plan view of the device shown in FIG. [Figure 2B] FIG. 2 is a plan view of a device similar to that of FIG. 1, but using a sealed cavity as an alternative method of illustrating milk flow. [Figure 2C] 13 illustrates the use of mechanical protrusions to indicate milk flow by deflecting in the flow. [Figure 2D] 1 shows an auxiliary storage container attached to the breast milk passage that is partially filled with breast milk and then partially emptied as the baby sucks and rests. [Diagram 3]FIG. 3 illustrates the addition of valves to passageways to improve the functionality of the device of FIGS. 1 and 2; [Figure 4A] 1 is a schematic diagram of a nipple shield incorporating a valve according to the present disclosure. [Figure 4A-4B] 4B and 4C show different examples of valve configurations for use in valved devices. [Fig. 4D-4E] Figures 4D and 4E show an additional enhancing feature of the nipple shield in the form of a belt so that the nipple shield can remain more securely attached to the mother's breast. [Figure 5A-5D] 5A-5D show an example of a novel differential pressure two-way valve design that may be used specifically in the present device. [Figure 5E] The types of opening characteristics that can be obtained from such a differential pressure two-way valve are shown below. [Figure 6A-6B] 6A and 6B show diagrammatically an embodiment of a drug dispenser of the device shown in FIGS. [Figure 7] FIG. 1 is a schematic exterior isometric view of an example base unit of a multi-tasking nipple shield of the present disclosure that can be used to perform a number of alternative functions related to different aspects of a nursing mother's needs. [Figure 8] FIG. 8 is an enlarged view of the outer tip region of the nipple projection of the device of FIG. 7. [Figure 9A-9B] 9A and 9B illustrate a method for facilitating the manufacture of the base unit of the multitasking nipple shield of FIGS. [Figure 10] 1 is a montage showing how the base unit of the multi-tasking nipple shield of the present disclosure can be used with the various mounting heads available for a variety of different tasks related to breastfeeding. [Figures 11A-11D] 11A-11D illustrate in greater detail an exemplary use of the multitasking nipple shield of FIGS. [Figure 12] FIG. 11 shows a schematic view of the appearance of a schematic embodiment of a breast milk measuring head connected to a base unit of the multitasking nipple shield of FIGS. 7 to 10; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] Reference is now made to Fig. 1, which illustrates generally a side and partial isometric view of an exemplary device 10 for visually indicating the flow of breast milk of a mother nursing an infant, constructed in accordance with the present disclosure. The device 10, in the form of a nipple shield, has a passageway for indicating the flow of breast milk and is shown worn over the woman's breast 11. During breastfeeding, the breast milk flowing through the passageway is visible to the mother or a third party, such as a lactation advisor, or its presence is indicated in a non-visual manner, thereby reassuring the mother that the infant is receiving a flow of breast milk from the mother's breast.

[0048] The thin body of the device 10 is typically constructed from a flexible material, with an inner surface that faces the mother's breast 11 when worn, and an outer surface that is configured to face away from the mother, such that the outer surface faces the baby's lips and mouth 19 during breastfeeding. The flexible material may be silicone or other material that is non-absorbent and flexible enough for the mother to wear comfortably. The flexible material, or at least a portion of it, is typically transparent or translucent, for reasons explained below. As with currently available nipple shields, the device 10 covers at least the mother's nipple 12 when worn, and usually covers at least a large portion of the areola, if not the entire areola. The device can cover even more than the areola of the breast, and generally has a circular or oval shape, but can have another shape. The device 10 has a concave area that also appears as a dome-shaped protrusion 13 or "device nipple" according to its shape when viewed from the outside. This area is configured to be placed over the mother's nipple area. The maternal nipple area is understood to mean the maternal nipple 12, but can also include a portion of the area surrounding the maternal nipple. The device nipple 13 is typically formed such that when the device is worn, there is a cavity 14 formed between the device protrusion 13 and the maternal nipple 12. The concave area within the protrusion can be tunnel-shaped, similar to the area known as the "shield tunnel" of commercially available nipple shields. Alternatively, it may be hemispherical in shape, or more closely resemble the shape of the maternal nipple 12, as shown in the example of FIG. 1. The outer area of ​​the device surrounding the device nipple 13 is configured to conformally fit the female breast, such that the outer area remains near the female breast without a significant space between them. The approximate boundary area between the device protrusion 13 and the device outer area is indicated diagrammatically in FIG. 1 by a thin dashed line 18.

[0049] 1 includes a passageway 15 that connects the cavity region 14 with the exterior surface at the apex of the projection 13 and is routed such that at least a portion of the passageway is located at the exterior region of the device. The passageway can be formed within the thin, flexible material layer of the device, or can be formed in the surface of the thin, flexible material layer of the device, or can be a separate piece of tubing outside the thin, flexible layer that is connected to the device between the cavity end and the nipple end of the device.

[0050] During feeding, the device 10 is worn on the breast 11. The passage 15 has an inlet opening 16 communicating with the cavity 14 and an outlet opening 17 at the device nipple 13. The contour of the baby's lips 19 sucking on the device nipple is shown in dashed lines in FIG. 1. Due to the negative pressure created by the baby's sucking action on the device, or the mother's physiological response to the baby's tongue movements, breast milk is squeezed from the mother's breast into the cavity 14, drawn from the cavity 14 through the passage 15 and leaves the device through the outlet opening 17. All breast milk delivered to the baby therefore flows along the passage 15 as indicated by the arrows in FIG. 1. The device is intended to be worn with the inlet 16 of the passage at the bottom, so that breast milk collected by gravity at the bottom of the cavity 14 is efficiently collected. For this reason, the device can be configured with the cavity 14, which is the breast milk collection volume, concentrated in the lower area of ​​the space between the mother's nipple and the device nipple above the inlet opening 16 of the passage 15.

[0051] Reference is now made to FIG. 2A, a plan view of the device shown in FIG. 1, showing more clearly the path of the passageway 15. The reference numbers of the features in FIG. 2A are the same as those in FIG. 1. The passageway 15 is routed through an outward path from the cavity region 14 in the projection to the outer region of the device. This moves the passageway from the region under the sucking baby's lips 19 and mouth, which would be hidden from the mother's view, to an area where the mother or helper can see the flow of breast milk in the passageway without the view being obstructed by the baby's lips or mouth. The passageway can be directed radially outward toward the periphery of the device, as in the example shown in FIG. 2A. On its return path from the outer region of the device, the passageway re-enters the cavity while maintaining fluid isolation from the cavity, terminating at an outlet opening at the outer apex of the device nipple where breast milk is delivered to the baby.

[0052] The walls of the passageway are typically transparent or translucent so that when milk is flowing through the passageway, a person viewing the device receives an indication of whether milk is actually being drawn from the breast and fed to the infant. If the flexible material is not transparent or translucent, at least one portion of the flexible material surrounding the passageway in an area that is not expected to be obscured by the infant during feeding must be made of a transparent or translucent material. If the passageway is not formed in a flexible material, a portion of the tubing of the passageway itself must be transparent or translucent to indicate flow within the passageway. Instead of visual observation of the flow itself through the walls of the passageway, according to another exemplary embodiment, the passageway can be manufactured with an indicator material, such as a material that produces a color change when in contact with breast milk. Another embodiment can use features or protrusions within the passageway, such as reeds, flaps, or paddle wheels, that generate a sound when milk passes or flows through the passageway.

[0053] The simplest way to form the passageway is to form the passageway in the flexible layer, but the device can also be constructed with a tube that runs outside the flexible layer of the device, or attached to a surface of the device, usually the exterior surface, so as not to interfere with the airtightness of the device against the mother's breast. The passageway is typically tubular in shape so as to have a generally circular cross-section, although other cross-sections can be used without affecting the usefulness of the device.

[0054] Reference is now made to FIG. 2B, which shows an alternative construction of the milk flow detector 10 of FIG. 1. In this construction, the indicator passage does not require the entire or partial flow of breast milk to pass through it in order to indicate the presence of a flow of breast milk. In the embodiment shown in FIG. 2B, the passage of the device 10A takes the form of a short projection 15A that leads from its inlet opening 16 in the cavity 14 to a small, preferably transparent or translucent, enclosed volume 15B in which the breast milk collects. The baby's alternating sucking and relaxing actions cause the breast milk to at least partially enter and leave the enclosed indicator element 15B, or to splash into the enclosed indicator element 15B under the influence of alternating pressure fluctuations acting on the breast milk in the projection 15A. The mother can then see the breast milk entering and leaving the indicator chamber 15B, and thus know that the baby is getting his or her milk flow. The mother can learn to identify different characteristics of the way the breast milk splashes or enters and leaves the indicator chamber 15B, and to relate this to the rate at which the baby drinks the breast milk. The actual flow of breast milk from the mother's nipple to the baby's mouth 19 occurs through the nipple hole 17A of the device, just like in a normal nipple shield.

[0055] Reference is now made to Fig. 2C, which illustrates a further way in which the flow of breast milk through the passageway can be indicated. In the embodiment of Fig. 2A, it has been described above how features or protrusions within the passageway, such as reeds, flaps, or paddle wheels, can be used as sound-generating elements that emit a characteristic sound as breast milk passes or flows through the passageway. However, in addition to the auditory output generated by such elements, a physical visual indication of the presence of a flow of breast milk within the passageway can also be provided. Thus, for example, as shown diagrammatically in Fig. 2C, a flap 20 extending into the flow across the passageway 15 is deflected by the flow of breast milk onto its upstream face, and this deflection is clearly visible from outside the passageway.

[0056] Reference is now made to Fig. 2D, which illustrates yet another embodiment for providing an indication of the flow of breast milk through the passageway. In the embodiment shown diagrammatically in Fig. 2D, the passageway includes a small enclosed storage container 21 attached to the passageway 15 by means of a short connecting tube 22. Thus, as breast milk flows past the attached container connecting tube 22, it surges into the storage container 21, providing a visual indication of the flow of breast milk in the passageway. The visual indication is further accentuated because the baby sucks breast milk in pulses during every sucking period and rests between sucking movements. As a result, during sucking periods, the breast milk flowing along the passageway surges into the container, possibly only partially filling it, and then when the baby relaxes between his / her sucking movements, some of the breast milk in the container flows back into the passageway. This repeated wave of breast milk in and out of the container, possibly including bubbles generated in the waves, provides a good visual indication of the flow of breast milk as the baby sucks. In FIG. 2D, the reservoir is shown horizontally, however, it should be understood that the device can be used with the reservoir positioned in a vertical position so that breast milk can be clearly seen filling and draining from the reservoir.

[0057] Reference is now made to Fig. 3, which illustrates a further embodiment in which a valve 30 is attached to the passageway 15 to help maintain the negative pressure in the passageway and cavity so that the device remains attached to the mother's breast, as described in the overview section above. In Fig. 3, which illustrates a typical example of such an embodiment, the valve 30 is shown as a one-way valve, in this example in the form of a diaphragm or flap valve, which closes when no sucking is applied by the baby. In Fig. 3, which is a cross-sectional view, the flap valve 30 is shown as a circular diaphragm with a central opening 31 that opens when the forward flow of milk passes the flap valve 30, but closes when the flow of milk stops due to the baby ceasing to suck, thus maintaining the negative pressure in the passageway 15. However, it should be understood that any other form of valve could be used without affecting the functionality of the device. Similarly, the valve in Fig. 3 is attached to the device nipple 13 near the outlet 17 of the passageway, but could equally be formed anywhere else in the path of the passageway.

[0058] Reference is now made to FIG. 4A, which is a schematic diagram of a novel nipple shield 40 constructed in accordance with another exemplary embodiment of the present application. The nipple shield incorporates a valve 42. This improved nipple shield 40 is shown attached to the nipple 12 of the mother's breast using the nipple shield 40, and the baby receives milk through an opening 41, shown in this figure as a single opening, although there may be multiple openings, each with its own valve. When the baby stops sucking, the valve 42 closes, thereby preventing the inflow of air into any space between the nipple shield 40 and the mother's breast 12, thereby 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 could be any other type of valve that provides the required sealing of the nipple passageway 41. The use of such a valve in this nipple shield improves the ease of use of the nipple shield by ensuring the retention of the nipple shield to the mother's breast even when the baby pauses from his / her sucking action. Also, as described in the previous embodiment and in more detail below in relation to Figures 5A-5D, the valve can have a two-stage opening pattern such that the valve can be configured such that in the inflow direction, i.e., flow back from the baby to the mother's breast, a higher pressure difference is required to open the valve than is required to keep the valve open in the reverse outflow direction, this two-way valve allowing some air in before closing to enhance maternal comfort.

[0059] The improved nipple shield can also incorporate a fluid delivery attachment, not shown in Figure 4A, but as described below in Figures 6A and 6B and associated paragraph

[0068] . This addition can be used with a simple device to allow accurate administration of medication to the baby whilst the baby is breastfed.

[0060] According to a further embodiment of the improved nipple shield described above in Figure 4A, by incorporating a flow indicating element in the short nipple passageway 41 of the device, the device can provide an indication to the mother that the baby is receiving breastfeeding that she would not otherwise be convinced of. The flow indicating element can be a sound emitting component, as such a component would provide that indication even if hidden in the baby's mouth.

[0061] Reference is now made to Figures 4B and 4C, which show, in schematic form, other exemplary forms of valves that may be used in any of the devices of the present application, whether a milk flow detector or a nipple shield incorporating a valve, according to the improvements presented herein. Figure 4B shows three different views of a ball valve that may be installed in the nipple of the valved nipple shield of the present disclosure, or at the outlet or anywhere along the entire length of the milk passage of the milk flow detector of the present disclosure. The ball 44 of this valve can move along a chamber 49. When the ball 44 rests on an opening 45 attached to the inner fluid side of the nipple hole, the ball 44 closes the opening 45, preventing air from flowing back into the device, thereby maintaining the device in contact with the mother's nipple. When the baby sucks on the nipple, the ball 44 is pushed out of the opening 45 by the milk flow, thereby allowing the baby access to the milk flow. The ball must be prevented from being swallowed by the baby, and in the embodiment of Figure 4B, this is achieved by a pair of tangs 43 that capture the ball in its cavity 49. Figure 4C shows an alternative valve in the form of a simple diaphragm valve 46 similar to that shown in cross section in Figure 4A, in which a flap 47 opens when milk flow occurs and returns to a closed position when milk flow stops. As previously mentioned, any suitable valve can be used in these embodiments.

[0062] Reference is now made to Figures 4D and 4E, which show further features of such a nipple shield 400. In such a nipple shield, a stronger band or ring is incorporated at the base of the nipple of the nipple shield to better hold it against the mother's nipple. In Figure 4D, a side cross-sectional view of the nipple region of the device is shown, showing the opening 403 in the nipple dome for the baby to suck on, and the thin flexible outer region 401 of the device for attachment to the mother's breast. At the junction 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, thereby helping the device to remain attached to the mother's nipple when the baby stops sucking. Such a reinforced band can be applied to any of the milk flow indicating devices of Figures 1 to 4A. Figure 4E shows a partial isometric view of the entire device from the direction marked 4E in Figure 4D to more clearly show the location of the reinforced band 402. Additionally, any of the devices described in this disclosure that incorporate a pressure regulating valve may benefit from such a reinforcing band or ring, as the maintenance of vacuum by the valve when the baby pauses from his / her sucking action is enhanced by the use of such a band or ring.

[0063] Reference is now made to Figures 5A-5D, which show an example of a novel two-way differential pressure valve 64 with different opening pressure characteristics in the two flow directions. The valve is self-actuating in the sense that its opening is determined by the pressure difference across the valve. Such a valve can be used in the present application and therefore its operation is described in the following paragraphs. However, it should be understood that such a valve can be used in any other application, whether liquid or gas flow control, and thus is not intended to be limited to the applications described herein, but has a wide range of applications throughout industry and medicine.

[0064] 5A and 5C show cutaway views of such an exemplary two-way valve, and 5B and 5D show isometric views of the two-way valve. As mentioned above, such a two-way valve is configured to allow essentially free flow of the mother's breast milk to the infant while at the same time allowing the inflow of air to the mother's nipple when the infant stops sucking, up to a predetermined negative pressure, in order to reduce the level of negative pressure acting on the mother's nipple. The opening pressure for the outward flow direction must occur at a lower operating pressure than the closing pressure for the inward flow direction. This allows the infant to feed with minimal hindrance after the valve opens for outward flow, while the backflow to reduce the level of negative pressure on the mother's nipple occurs at a higher differential pressure setting so that the device remains retained at the mother's breast.

[0065] The valve shown in Figures 5A to 5D is a two-way differential pressure valve that is self-actuated by the pressure difference across the valve, and the opening pressure can be different for the two flow directions. The valve uses a flexible diaphragm 51 that is confined in the flow passage of the valve between an outer shouldered step structure 53 of the valve body 54 and an inner stepped edge 55 of a bearing stand 50 mounted in the center of the valve, across the direction of fluid flow, where "inner" and "outer" refer to radial distances from the central axis of the valve. The flexible diaphragm 51 is positioned across the direction of fluid flow and has different flexibilities for the two flow directions. This difference in flexibility is created by providing different bending lengths of the diaphragm between the diaphragm's support point in the valve body 54 and its freely movable inner or outer circumferential edge. The diaphragm is restrained between an inner post 50 having an annular shoulder 55 which restrains the inner edge of the diaphragm so that the outer edge of the diaphragm can only bend in one direction away from the center post annular shoulder 55, and outer shoulders 52, 53 which restrain the outer edge of the diaphragm so that the diaphragm can only bend in the opposite direction away from the outer shoulders 52, 53. Adjustment of the length of the free radius of the bendable portion of the diaphragm allows control of the pressure across the valve that will cause the valve to open.

[0066] As shown in Figures 5A and 5B, when the baby sucks and creates a negative pressure, milk flow occurs as indicated by the upward arrow in Figure 5A. In this context, the terms "upward" and "downward" refer to the directions shown in the drawings and have no relation to absolute directions in space. The outer edge of the flexible diaphragm 51 lifts off its shouldered step structure 53, allowing milk to flow around its outer edge. The upward movement of the outer edge is limited by the inherent flexibility of the outer edge and the inner shoulder and step angle 55 of the central bearing stand 50 around which the outer edge bends, and milk flow occurs around the periphery of the bent diaphragm. On the other hand, when the baby stops sucking and milk flow stops, the negative pressure in the flow passage created by the baby's sucking causes the flexible diaphragm 51 to be pushed inward from its seat on the step structure 53 by the external air pressure and bend around the step angle 52 of the step structure. Any air or milk still in the valve passageway or in the baby's mouth will then enter the device by flowing between the central bearing platform 50 and the inwardly curved flexible diaphragm 51, as shown by the downward arrow in Figure 5C. The inward flow of air / milk will continue until the negative pressure in the device increases to a level that causes the diaphragm 51 to close, because the pressure differential across the valve is insufficient to keep the diaphragm 51 open.

[0067] The construction of the two-way valve shown in Figures 5A-5D is such that the pressure required to open the valve can be different in the two flow directions. This may be desirable because the pressure difference required to open the valve and allow milk to flow from the mother to the baby, as shown by the upward arrow in Figure 5A, must be low so as not to overly tax the baby's sucking effort. This pressure difference must generally be less than the pressure difference that would open the valve in the reverse direction, allowing air or milk to enter, as shown by the arrow in Figure 5C, to reduce the level of vacuum created in the milk flow path. This different opening pressure is achieved by the construction of the valve, which is configured so that the flexible diaphragm 51 has different flexibility in the two directions.

[0068] As is well known, the bending of a flexible diaphragm is caused by three factors: (a) Young's modulus of the diaphragm material, (b) the second moment of inertia in the bending direction, and (c) Free diameter of the membrane at its bending part is determined by. Because factors (a) and (b) are predetermined for a particular diaphragm material and shape, the difference in the degree of freedom of bending of the diaphragm is determined by the free bending diameter, as explained in paragraph

[0066] .

[0069] 5A, when the flow of breast milk is bending the diaphragm outward, the free radius of bending, or bending length D1, extends from the bending point at the corner 55 of the central bearing pedestal 50 to the outer edge of the diaphragm. Meanwhile, in FIG. 5C, when the inflow of air or breast milk is desired and the diaphragm is bending inward, the bending 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. Because the bending length D1 in the outward flow direction of FIG. 5A is longer than the bending length D2 in the inward flow direction of FIG. 5C, there is less resistance to bending for the outward flow than for the inward flow such that the valve opens and closes at a lower pressure differential in the outward flow direction than in the inward flow direction. However, it should be understood that the opening pressures can be configured to be equal or opposite, depending on the particular situation for which the two-way valve is designed, with the particular values ​​determined by the bending lengths D1 and D2 selected.

[0070] Reference is now made to FIG. 5E, which is an exemplary graph showing the opening pressure characteristic obtained from a bidirectional self-actuating differential pressure valve as shown in FIGS. 5A-5D. The graph shows the flow-inducing characteristic of the valve in two opposite directions, one shown as a dotted line and the other as a solid line. The abscissa of the graph shows the elapsed time in nominal units, and the ordinate shows the flow-inducing characteristic of the valve, also in nominal units. Pressure is applied to the valve according to a sinusoidal periodic characteristic. In the direction where flow is easy, i.e., where the valve remains open until a low differential pressure across the valve, this characteristic is shown as a dotted line, and the flow ranges from 0 to 200 units as the pressure rises and falls from its minimum to its maximum value. In the direction where flow is more restricted, i.e., where a higher differential pressure is required to open the valve, this characteristic is shown as a solid line, and the valve remains closed until the pressure reaches a value that begins to provide flow at the 100 unit level, and remains open until the 200 unit level.

[0071] Reference is now made to Figures 6A and 6B, which show diagrammatically an exemplary embodiment of a drug dispenser for devices of the type shown in Figures 1 and 2. Figure 6A shows a cross-sectional / isometric view of the device, and Figure 6B shows a plan view. According to this novel feature of these devices, a drug container reservoir 60 is fluidly connected to the breast milk passage 15 by means of a connecting tube, such that when the container is filled with an appropriate amount of drug, the flow of breast milk is mixed with the drug in a controlled manner depending on the flow rate of the drug from the container reservoir to the breast milk passage. This flow rate can be controlled by a valve or can be determined by the viscosity of the drug and the fluid resistance of the connecting tube depending on the cross-sectional area and length of the connecting tube. The timing of adding the drug to the baby's breast milk can be determined by a stop valve in the connecting tube or an air inlet valve at the top of the container. The baby thus receives the entire drug dose or other liquid desired to be given to the baby, mixed at a desired rate with the breast milk being fed so that even the taste of the drug is masked. The container reservoir 60 is shown diagrammatically as a balloon-shaped volume, but it should be understood that it can have any form suitable for this purpose, such as a pre-filled vial, or a container with a closable lid. The container reservoir may be removable for easy refilling, or it may be attached to the milk flow detection device during manufacture as part of a single-use disposable device.

[0072] Reference is now made to FIG. 7, which is a schematic exterior isometric view of one example of a base unit of a multitasking nipple shield of the present disclosure that can be used to perform many alternative functions related to various aspects of a breastfeeding mother's needs. The base unit 70 includes a thin, flexible layer similar in shape to a conventional nipple shield and is configured to be worn by the mother on the breast. The central region has a protruding nipple volume 71 configured to conform to the mother's nipple. The nipple shield incorporates a pair of passageways 72, 73 embedded in the thin, flexible layer of the nipple shield, each passageway connecting a tip of the nipple volume to a separate location located in an area 75 accessible to the mother or a helper while the baby is sucking on the nipple of the device. One of these embedded passageways 72 is fluidly connected to an inner surface of the protruding nipple volume 71, while the other embedded passageway 73 is fluidly connected to an outer surface of the protruding nipple volume 71. A first of these passages 72 is configured to convey breast milk from an inner surface of the projecting nipple volume 71 in contact with breast milk discharged from the mother's nipple to a location 75 remote from the nipple protrusion, and the other of these passages 73 is configured to convey breast milk from that remote location 75 back to an outer surface of the projecting nipple volume 71 where it can be provided to a baby sucking on the outside of the device nipple. At the remote location, each passage terminates in a fluid connection pole 76, 77 of a fluid connector port 78, the two poles having known physical dimensions and spaced a known distance apart. The simplest and most cost-effective configuration is to use a pair of passages, but the device can also be configured with more than a pair of passages, as long as at least one passage is connected from the outer surface of the nipple protrusion to a fluid connection element at a remote location, and at least another passage is connected from the inner surface of the nipple protrusion to a fluid connection element at a remote location.

[0073] As further shown below in Figure 10, a number of different operating heads can be attached to the fluid connector port, with each head configured to perform a different function related to breast milk or breast milk flow. The nipple shield base unit 70 thus has universal application and the specific application of the device depends on the head attached to the nipple shield remote fluid port 78.

[0074] Reference is now made to Figure 8, which is an enlarged view of the outer tip region of the nipple projection of the device of Figure 7, showing how the passageways 72, 73 are connected to the inner surface of the nipple area 71 and the outer surface of the nipple area 71, respectively. As can be seen in Figure 8, the opening 82 of the first passageway 72 opens to the inner surface, and the opening 83 of the second passageway 73 opens to the outer surface. To provide low resistance to fluid flow, three openings are shown in each passageway, however, it should be understood that this is merely an exemplary embodiment and that any other number and configuration of openings that provides for adequate flow of breast milk may be used.

[0075] Reference is now made to Figures 9A and 9B, which illustrate a method for facilitating the manufacture of the base unit of the multitasking nipple shield of Figures 7 and 8. Because the properties required for the portion of the device containing the passageways are different from the properties required for the thin flexible layer of the nipple shield device, it is advantageous to manufacture the passageway portion separately from the nipple shield itself. Figure 9A illustrates a strip of material 90 containing molded passageways 72, 73 with a fluid connection port 78 at the distal end. Figure 9B illustrates a thin flexible body 91 of the nipple shield device with a shallow groove 92 formed in a portion of the thickness of the thin flexible body and having a shape configured to receive the strip of material 90 containing the molded passageways 72, 73. The tip region of the nipple region of the device has an opening formed in the tip region that connects to the inner surface of the nipple projection, the location of the opening coinciding with the opening of the first passageway 72 configured to convey breast milk from inside the nipple volume towards the distal fluid port 78.

[0076] Reference is now made to FIG. 10, which is a montage of how the base unit 70 of the multitasking nipple shield of the present disclosure may be used with various available attachment heads for a variety of different tasks related to a mother's breast milk supply. The attachment heads are configured to plug into a fluid connection port 78 located away from the nipple area 71 of the device. A number of different attachment heads are shown in FIG. 10. All heads have one common feature; that is, by connecting a head to the fluid connection port, a circuit is completed for the breast milk between passage 72 and passage 73 such that the baby can freely suckle from the mother's nipple and the breast milk can flow along first passage 72 to the head attached to fluid port 78 and back to the baby's mouth through passage 73. The flow indicating head 101 provides an indication to the mother that the baby is receiving a flow of breast milk through the nipple shield. The flow indicating head 101 may use any of the flow indicating functions described in the previous embodiments of the flow indicator device of the present disclosure. The flow measuring head 102 can provide a quantitative measurement of the amount of milk flowing from the mother to the baby, which can be based on the technology described in the aforementioned US Patent No. 5,339,933, commonly owned by the applicant, for "Apparatus and Method for Measuring Fluid Flow to an Infant", in which a portion of the main milk flow passes through a measurement channel, and the amount of milk collected in the measurement channel provides a measure of the milk drawn through the main channel. Alternatively, the head 102 can incorporate a microtechnology flow sensor in a loop formed in the head through which the main flow passes, and the output signal can be transmitted to a remote reader which indicates the flow rate, and which can be integrated to provide the amount of milk delivered. As the device is intended for home use, a transmission system communicating with, for example, a smartphone application is advantageous.

[0077] The head 103 for adding medicines to the infant's milk can incorporate a small medicine enclosure connected to the milk passage by a flow channel so that medicines can be added slowly to the infant's milk flow. In addition to the functions of the device previously described in this disclosure, the use of such a general purpose multitasking nipple shield allows the determination of many further measurements and characteristics. Thus, for example, a small chemical or spectroscopic analysis head 104 allows the measurement of the quality of the milk or its various components such as its fat level, pesticide content, and similar analyses. A further head 105 can be used to determine the sucking efficiency of the infant, for example by measuring the level of vacuum generated within the head, or the length of the sucking period compared to the infant's resting period, or other characteristics that characterize the infant's sucking ability. Also, the analysis of the breast milk with a disease detection head 106 including a micro-spectroscopic or biochemical analysis unit can provide advance warning of illnesses or diseases that may appear in the infant's milk supplied from the mother's breast. Such an analysis head may allow the device to detect breast cancer in the mother at an early stage. An advantage of the multi-tasking nipple shield device of Figure 10 is that all of the above suggested functions can be performed with their associated head attachments without interfering with the flow of milk delivered to the baby.

[0078] Reference is now made to Figures 11A-11D, which show in more detail an exemplary use of the multitasking nipple shield of Figures 7-10 for a flow display application with the head 101 of Figure 10. In Figure 11A, a multitasking nipple shield base unit 110 is shown with a flow display head unit 101 attached to a fluid port connection 114, with a nipple hole 111 in the tip area of ​​the nipple projection. The head 101 is shown to have a window area 113 which needs to be transparent to facilitate viewing the flow display in the attached display head 101. In Figure 11B, a side view of the base unit 110 with its attached head 101 is shown to show how the transparent observation window 113 is positioned away from the nipple area 111 for easy viewing by the nursing mother or helper.

[0079] Reference is now made to Figs. 11C and 11D, which show two alternative schematic embodiments of the flow indicator head 101, in a larger scale, in order to show the details of the head structure. The two different figures show different ways in which an indication of the flow of breast milk can be generated. In Fig. 11C, a flow indicator head 101C is shown that uses the method of indicating flow as shown in Fig. 2A. The flow of breast milk coming from the breast milk collection volume in the nipple projection area through a passage in the base unit 110 is directed around a transparent or semi-transparent loop of tube 115 in the observation window 113, and then returns from the observation head to the passage in the base unit to return to the nipple hole where the baby can suck. The mother can thus directly see the flow of breast milk inside the observation window. In Fig. 11C, an alternative flow indicator head 101D is shown that uses the structure shown in Fig. 2D. In this embodiment, the indicating breast milk chamber 116 is fluidly connected at a junction in the indicating head unit 101D to a passage that carries breast milk from the base unit to the base unit. As the milk flows through the passages in the head, some of the milk enters the enclosed chamber 116 where it can be viewed through an observation window, providing a visual indication of the flow of milk in the passages. In particular, as an infant repeatedly sucks at the mother's breast, the milk intermittently passes through the passages and enters the milk chamber 116 in waves (surges) that are synchronized with the infant's sucking action. These repeated waves of milk 117 entering and leaving the milk chamber 116 provide a good visual indication of the flow of milk as the infant sucks.

[0080] Reference is now made to FIG. 12, which shows a schematic view of a schematic embodiment of a breast milk measuring head 102 connected to a base unit 110 of a multitasking nipple shield. The head can operate using the same inventive concept as described in the above-mentioned US Pat. No. 5,399,992. The structure of such a head unit includes two flow paths for breast milk (not shown in FIG. 12), the first flow path providing the main passage of breast milk for the infant having a substantially lower resistance to the fluid flow of the breast milk than the second flow path. The second flow path is connected in parallel with the first flow path and has a substantially higher resistance to the flow of breast milk than the first flow path. As a result, the breast milk flows into the second flow path at a substantially slower rate than the main flow path, and the position reached by the advancing front of the breast milk is a measure of the total amount of breast milk that has passed the quantitative measuring head 102. The position of the front of the breast milk filling can be determined relative to a graduation 121 on the head, which can be calibrated according to the total amount of breast milk ingested by the infant. As an alternative embodiment, a micro flow meter can be used to measure the flow rate of breast milk in the measurement head 102, with the measurement tip providing an output signal of flow rate, or by integrating the flow rate, to measure the total amount of breast milk ingested by the baby.

[0081] The exemplary embodiments are provided so that the disclosure will be complete and the scope will be fully conveyed to those skilled in the art. Many specific details, such as examples of specific components, devices, and methods, are described so that the embodiments of the present disclosure are fully understood. It will be apparent to those skilled in the art that it is not necessary to employ specific details, and that the exemplary embodiments can be embodied in many different forms, none of which should be construed as limiting the scope of the present disclosure. It will also be apparent to those skilled in the art that the present invention is not limited by what has been particularly shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not in the prior art and that would occur to those skilled in the art upon reading the above description.

Claims

1. 1. An apparatus configured to indicate flow of breast milk from a woman's breast to a baby, comprising: a flexible layer configured to conform to at least a portion of the female's breast; The flexible layer comprises: an inner surface configured to face the female's breast and an outer surface; a nipple-shaped protrusion disposed in a central region of the flexible layer and adapted to be placed over a nipple of the breast; at least one fluid communication passageway connecting an inner surface of the protrusion with at least one opening in an outer surface of the tip region of the protrusion, such that breast milk collected in a space between the nipple and the inner surface of the protrusion can flow through the passageway and out of the at least one opening in the tip region, at least a portion of the passageway being located in an area radially away from the protrusion and outside of an area where the baby's lips are expected to be when the device is in use, to physically indicate the flow of breast milk when the baby is sucking on the protrusion; An apparatus comprising:

2. The device of claim 1 , wherein the passageway is embedded within the flexible layer, partially embedded within the flexible layer, disposed on an exterior surface of the flexible layer, or partially separated from the flexible layer.

3. 3. The device of claim 1 or 2, wherein at least a portion of the passageway is transparent or translucent to allow the flow of breast milk in at least a portion of the passageway to be visible.

4. 10. The device of claim 1, further comprising a sealed and at least partially transparent container fluidly connected to at least a portion of said passageway such that breast milk passing through said passageway is visible rippling within said at least partially transparent container.

5. The device of claim 1 , wherein at least a portion of the passageway includes a mechanical element that flexes in the flow of breast milk.

6. 6. The device of claim 1, wherein at least a portion of the passageway has a characteristic indicative of the presence of a predetermined breast milk flow in said at least a portion.

7. The device of claim 6 , wherein the characteristic is either a change in color or an emitted sound.

8. 8. A device as claimed in any one of claims 1 to 7, wherein the radial distance of at least a portion of the passage from the tip of the protrusion is at least 3 cm such that the at least a portion is visible outside the area expected to be the mouth of an infant sucking on the protrusion.

9. 9. The device of claim 1, further comprising at least one valve disposed along the passageway and configured to allow breast milk to flow through the passageway from the space only to at least one opening in the tip region.

10. 10. The device of claim 9, wherein the at least one valve is essentially closed when no suction is being applied to the at least one opening in the tip region.

11. An apparatus as described in any one of claims 1 to 10, further comprising a container fluidly connected to the passage so that fluid in the container can be supplied to the infant.

12. The device of claim 11 , wherein the fluid is a drug.

13. 13. Apparatus according to claim 11 or 12, wherein the fluid connection is such that the contents of the fluid container are transferred to the flow of breast milk in the passage according to a predetermined flow rate.

14. 14. The device of claim 1, wherein the device is free of electronics.

15. 15. The device of claim 14, wherein the electronics-free state of the device reduces electromagnetic radiation hazards in the area of ​​the infant.

16. 1. A device for indicating flow of breast milk from a female breast to a baby, the device being adapted to be worn on at least the nipple area of ​​the breast of the female, comprising: a layer of flexible material having a nipple-shaped projection having an inner surface and an outer surface, the inner surface configured to face the nipple area of ​​the female breast and the outer surface configured to face the mouth of the infant; a passageway formed in or partially embedded within the flexible layer, the passageway connecting a first location on the inner surface of the nipple-shaped projection with at least one opening in the outer surface of the flexible layer at or near the tip of the nipple-shaped projection; Including, At least a portion of the passageway is disposed in an area radially spaced from the nipple-shaped projection so as to indicate a flow of breast milk when the baby is sucking on the nipple-shaped projection.

17. The device described in claim 16, wherein the area radially away from the nipple-shaped protrusion is such that at least a portion of the passage is not obscured by the lips of the infant sucking on the nipple-shaped protrusion.

18. 17. The device of claim 16, wherein at least a portion of the passageway is transparent or translucent such that the flow of the breast milk is visible through said at least a portion.

19. 17. The device of claim 16, wherein at least a portion of the passageway comprises a material that changes color when exposed to breast milk, such color change allowing visualization of the flow of the breast milk.

20. 17. The device of claim 16, wherein at least a portion of the passageway includes an element that emits a sound when a predetermined flow of breast milk is present in the at least a portion of the passageway.

21. 21. A device as claimed in any one of claims 16 to 20, further comprising a ring formed around a base region of the nipple-shaped projection, the ring being less flexible than the flexible material layer so that the device more easily remains secured to the breast when the baby stops sucking.

22. 22. The device of any one of claims 16 to 21, wherein the device is free of electronics.

23. An apparatus as described in any one of claims 16 to 22, wherein at least a portion of the passageway includes a sealed, at least partially transparent container fluidly connected to the passageway such that breast milk passing through the passageway is visible rippling within the at least partially transparent container.

24. The apparatus of claim 16, wherein at least a portion of the passageway includes a mechanical element that deflects in the flow of breast milk.

25. An apparatus as described in any one of claims 16 to 24, wherein the radial distance of at least a portion of the passage from the tip of the protrusion is at least 3 cm such that at least a portion of the passage is not obscured by the lips of the infant sucking on the nipple-shaped protrusion.

26. An apparatus as described in any one of claims 16 to 25, further comprising at least one valve disposed along the passage and configured to allow breast milk to flow through the passage only in a direction from a location on the inner surface of the nipple-shaped protrusion toward at least one opening in the tip region.

27. ​​The device described in claim 26, wherein the at least one valve is essentially closed when suction is not being applied to at least one opening in the tip region.

28. An apparatus as described in any one of claims 16 to 27, further comprising a container fluidly connected to the passage so that fluid in the container can be supplied to the infant during breastfeeding.

29. The device of claim 28, wherein the fluid is a drug.

30. An apparatus as described in any one of claims 16 to 27, wherein at least a portion of the passage is positioned on the outer edge of the apparatus toward the periphery of the base.

31. An apparatus as described in any one of claims 16 to 30, wherein the apparatus is configured to indicate the flow of breast milk without the use of electronic circuitry.

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