Patent Application
20230364311
The present invention relates to medical devices. In particular, the present invention relates to apparatus and methods for supporting breastfeeding parents by allowing a baby to consume formula or breastmilk while latching on to the breast of the breastfeeding parent via a nipple shield with an incorporated feeding device.
Struggles with breastfeeding have long been a taboo subject and remain unspoken while at the same the pressure on women to breastfeed continues to increase. The benefits of breastmilk as well as the act of breastfeeding for mother and child are not in dispute. Breastfeeding helps mothers bond with the baby and allows the baby to take in important nutrients that have established health benefits. Breastfeeding also provides the benefit of bonding by enabling skin-to-skin contact.
Breastfeeding is particularly problematic for women who are either unable to produce enough or any milk or who are unable to properly latch the baby to their breast. This is also problematic for parents such as adoptive parents, women who have undergone mastectomies, same sex couples, or any other parental figures who desire to play a role in early bonding and feeding such as fathers.
Conventional devices which are designed to facilitate breastfeeding or to supplement milk intake by the infant during breastfeeding are inefficient and can require the help of at least one additional person such that use of these devices becomes impractical and inconvenient. Examples of some conventional products can include breast pumps, nipple shields, etc. Breast pumps assume that the mother has the ability to produce breast milk; however, these devices express breast milk into a bottle for later feeding forcing the mother to forego the skin-to-skin bonding experience with the baby. Nipple shields aide with babies who are unable to latch but also assume that the mother has the ability to produce enough breast milk to adequately nourish the child.
Other breastfeeding aide devices are impractical as they generally require the breastfeeding parent to insert a feeding tube into the baby's mouth while the baby either latches on through a nipple shield or simply sucks from the tube. However, the feeding tube typically has a tendency to fall out of the baby's mouth as it is not secured in any manner and any movement or tugging upon the tube tends to dislocate the feeding tube.
Accordingly, there is a need for a breastfeeding device which can either directly feed the baby during breastfeeding or supplement breastfeeding with the baby latched while allowing for direct skin-to-skin contact between the baby and the breastfeeding parent.
The devices and methods described combine as many benefits of breastfeeding as possible and also aides the mother in increasing her milk production while feeding formula or another fluid nutrient to the baby as a partial supplement to their own breast milk or even as a substitute while breastfeeding. Mothers may choose to feed expressed breastmilk if the baby does not latch and parents who cannot produce enough or any breast milk can feed the baby formula while still benefiting from the skin-to-skin bonding.
In one variation, the device can include a nipple shield which may attach to the breast or chest of the breastfeeding individual via a tacky substrate or an adhesive such as a reusable adhesive. A thin feeding tube through which the baby may receive either partial or complete feeding with either expressed breast milk and/or formula (or other fluid nutrient) may be incorporated within or upon the nipple shield and fluidly connect to a reservoir which holds the milk or formula and is designed to function in a handsfree manner. The reservoir may include a valve such as a unidirectional valve (e.g., duck-bill valve) that allows the reservoir to drain via the tube while preventing backflow or spillage and further removes any need to manually push or urge the milk or formula into the tube for baby to feed.
The nipple shield through which the feeding tube is incorporated may be configured to allow for the greatest areola exposure so that maximum areola stimulation from the sensation of suction by the baby can be achieved. The nipple shield may allow for the sensation of suction to also be felt by the nipple of the individual wearing the nipple shield and thereby promote milk production as provided by the suction.
One variation of the breastfeeding aid device may generally comprise a reservoir having a first opening, a flow selector positioned within the first opening, wherein the flow selector is configured to provide a predetermined flow rate from the reservoir, and a nipple shield configured to be positioned over a nipple of a subject such that the nipple is sealingly contained within a cavity defined by the nipple shield, the cavity having a channel fluidly coupled to the distal opening of the reservoir via the at least one fluid lumen and the cavity having at least one additional channel defined through a wall of the cavity. A suction force applied upon an exterior of the cavity may draw a fluid from within the reservoir and through the channel via the at least one fluid lumen and simultaneously creates a negative pressure within the cavity to stimulate the nipple of the subject.
One variation for a method of aiding breastfeeding may generally comprise securing a nipple shield over a nipple of a subject such that the nipple is sealingly contained within a cavity defined by the nipple shield, receiving a suction force imparted upon an exterior of the cavity such that a fluid contained within a reservoir is drawn via a negative pressure through at least one fluid lumen fluidly coupled to the reservoir and through a channel defined within a wall of the cavity while the fluid is metered via a unidirectional valve positioned within the reservoir, and further receiving the suction force within the cavity such that the nipple of the subject is simultaneously stimulated.
The breastfeeding device allows individuals who may be challenged in breastfeeding or otherwise unable to breastfeed to experience the benefits of breastfeeding by enabling skin-to-skin bonding with the breastfeeding infant and encouraging the release of oxytocin while providing necessary nourishment to the infant. The device further enables the individual to feed the infant while handsfree and also allows for adjustment of the fluid flow rate of the milk or fluid by a flow limiting mechanism as well as by the action provided by the infant as well. Additionally, the nipple shield assembly may be adhered to the skin of the breastfeeding individual and may also provide for a differential nipple wall thickness which may enable the adjustable collapse of the crown or cavity of the nipple shield, as described in further detail.
In yet other variations, the couplings 22, 24 may be omitted and the fluid lumen 18 may form a continuous length for coupling directly to the fluid reservoir 32 either with the third coupling or connector 30 or without the coupling or connector 30 by directly integrating the fluid lumen 18 with the fluid reservoir 32.
The nipple shield assembly NS may be readily removed from the fluid reservoir assembly FR by disengaging the couplings 22, 24 from one another to enable the removal of either the fluid reservoir assembly FR and/or nipple shield assembly NS from the individual while other assembly may remain upon or secured to the individual.
The flow of the fluid dispensed from the fluid reservoir 32 may be actuated or initiated by the infant sucking upon the crown or cavity 14 of the nipple shield 12 such that a negative pressure is created within the interior of the crown or cavity 14. This negative pressure is formed throughout the length of the fluid lumen 18, 26 to draw the fluid within the fluid reservoir 32. To regulate the fluid flow, an adjustable clamping mechanism 28 such as a screw clamp, pinch clamp, roller clamp, etc. may be placed upon a portion of the second fluid lumen 26 to adjust or meter the flow of fluid exiting the fluid reservoir and passing through the second fluid lumen 26. Additionally, a valve 34 such as a unidirectional valve may be positioned within or along the fluid reservoir 32 to further meter the flow of fluid from the reservoir 32. As the infant sucks upon the crown or cavity 14, the negative pressure may draw the fluid from the reservoir 32 and the valve 34 may allow for the ambient air to pass through the valve 34 and into the reservoir 32 each time the infant sucks upon the nipple shield. Every time the infant ceases sucking, the valve 34 may remain in a closed configuration while maintaining a constant pressure within the reservoir 32 to prevent any further fluid from flowing out of the reservoir inadvertently thereby metering the fluid into boluses mimicking the natural flow of milk from the mother's breast.
The clamping mechanism 28 may also be adjusted to further meter the flow volume or flow rate of the fluid from the reservoir 32 during infant feeding. As the primary driver of the fluid release from the reservoir 32 is the degree of suction provided by the feeding infant, the clamping mechanism 28, valve 34, and/or collapsibility of the first fluid lumen 18, as described in further detail here, may provide for adjustability of the flow rate of the fluid from the reservoir 32.
The fluid lumen 18 may be attached, secured, or otherwise integrated along a portion 20 of the flange or brim 42 such that the terminal end of the fluid lumen 18 is fluidly coupled to at least one of the openings 16 along the crown or cavity 14 such that fluid from the fluid reservoir 32 may pass through the fluid lumen 18 and through the connected opening.
A separate adhesive layer 40 may be configured to adhere between a surface of the flange or brim 42 and against the skin of the individual such that the adhesive layer 40 encircles entirely around or partially around the nipple and seals the nipple shield 12 to the breast of the individual such that the crown or cavity 14 contains the nipple of the individual. The adhesive layer 40 may accordingly be configured into a shape which follows the flange or brim 42 of the nipple shield 12 while remaining open in a center portion to allow for insertion of the nipple into the crown or cavity 14. Hence, the adhesive layer 40 may take on any number of shapes such as a circular ring, ovular, rectangular, square, etc. Additionally, the adhesive layer 40 may be fabricated from any number of biologically compatible adhesives or tacky materials such as silicone so long as the layer 40 enables the nipple shield 12 to remain secured against the surface of the skin during breastfeeding and removed afterwards. Another variation may include an adhesive layer 40 which may be formed of a waxy or tacky substance, e.g., lanolin, which may be applied directly upon the breast prior to placing the nipple shield 12 upon the breast to form a temporary adhesive interface. Furthermore, the adhesive layer 40 may be removably attached to the nipple shield 12 for replacement or sterilization or the adhesive layer 40 may be formed as a permanent adhesive attached to the nipple shield 12.
In other variations, the fluid lumen 18 may instead be coupled directly to the flange or brim 42 of the nipple shield 12 itself and the flange or brim 42 may integrate or define a channel or fluid lumen through the flange or brim 42 to at least one of the openings 16 along the crown or cavity 14. Because the fluid lumen 18 is separate from the channel or fluid lumen integrated through the flange or brim 42, the fluid lumen 18 may be optionally decoupled from the flange or brim 42, e.g., for exchanging components or cleaning, etc.
The crown or cavity 14 may define one or more openings 16 along the raised surface of the nipple shield 12, as shown in the detailed top and partial cross-sectional side views of
An additional supplemental opening 52 may also be defined along the crown or cavity 14 but supplemental opening 52 may be fluidly coupled via fluid lumen 18 to the fluid reservoir 32.
In yet another variation as shown in
Another variation is illustrated in the partial cross-sectional side view of
While three openings 50 are shown defined through the interior cavity 60 and a single supplemental opening 52 is shown fluidly coupled to the fluid reservoir 32, these are intended as illustrative examples. Other variations may include any number of openings 50 which are greater than three or fewer than three or these openings 50 may be omitted entirely. Likewise, the single supplemental opening 52 may include more than one opening fluidly coupled to the fluid reservoir in other variations. Furthermore, additional supplemental openings 52 may be fluidly coupled to a single reservoir 32 or additional reservoirs which may hold the same or other supplemental fluids (e.g., medications, electrolytic fluids, etc.) which may be used in any number of combinations when feeding the infant.
The fluid lumen 18, fluid reservoir 32, and other components are positioned away from the face of the infant so as not to interfere with the breastfeeding process. The nipple shield 12 may also be configured for placement upon the breast and nipple in a predetermined orientation depending upon the positioning of the infant during breastfeeding. For instance, the supplemental opening 52 may be positioned relative to the infant so that the supplemental opening 52 is located along the lower side of the infant's mouth when feeding. This may help to ensure that the supplemental opening 52 remains fully patent as the infant latches upon the crown or cavity 14 and deforms the cavity. Hence, the nipple shield 12 may be placed upon the breast and nipple in a particular orientation depending on how the infant is positioned relative to the breast, e.g., lying down, reclined, etc. A orientation indicator 66 such as a line, image, or any marker may be located along the exterior of the crown 14 to indicate where the supplemental opening 52 is located so that the individual may orient the nipple shield 12 accordingly relative to the infant. The example shown in
Furthermore, the nipple shield 12 can be configured for use on either the left or right breast while in other configurations, one variation of the nipple shield 12 can be configured for the left breast while another variation of the nipple shield 12 can be configured for the right breast.
As the infant takes the crown or cavity 14 within their mouth, their natural inclination when latching for breastfeeding is to press down upon the nipple so that the nipple takes on an ovular or compressed configuration to conform to the mouth of the infant. An example is shown between the front views of
Each of the openings 16′ are shown to correspondingly compress such that the openings 50′ and supplemental opening 52′ are compressed into ovular configurations. To facilitate the reconfiguration of the crown 14, portions of the wall forming the crown 14 may be configured to have differing wall thicknesses.
While the crown or cavity 14 may be formed generally into a tapered structure shaped for insertion into the mouth of the infant, the structure may be varied in any number of ways to promote or stimulate primitive neonatal reflexes which may support breastfeeding. For example, the crown 14 may incorporate a cut-out along a portion of the structure. Alternatively, the crown 14 and/or flange or brim 42 of the nipple shield 12 may be contoured in various configurations to promote or stimulate the primitive neonatal reflexes of the infant.
Another optional feature of the device is shown schematically in
As described above, the flange or brim 42 of the nipple shield 12 may be configured to have a circumferential shape while other variations may have the flange or brim 42 partially removed.
Turning now to the fluid reservoir assembly FR,
Furthermore, because the fluid reservoir 32 does not need to be manually actuated to allow for the fluid to flow from the reservoir 32, the reservoir 32 may utilize the natural suction provided by the infant and may also take advantage of gravity to create a pressure head within the reservoir 32 by elevating the location of the fluid reservoir 32 relative to the infant. Hence, the fluid reservoir 32 may be positioned or secured to the individual at a location above the infant, such as the shoulder, chest, etc. such that the infant is located below the fluid reservoir 32. The height of the fluid reservoir 32 may vary or may be varied depending upon the infant and individual positioning during breastfeeding.
In another alternative variation, the fluid reservoir 32 may optionally incorporate a mechanism for increasing a pressure within the reservoir 32 to facilitate emptying of the reservoir 32 for infants who may need assistance with suction (e.g., premature infants). Mechanisms such as a plunger or pump may be used which can be actuated automatically or manually to pump air into the fluid reservoir 32 to increase the internal pressure. A pressure indicator may be optionally incorporated to monitor the pressure increase within the reservoir 32.
In yet another alternative variation, the fluid reservoir assembly FR may incorporate an alternative flow regulation mechanism, as shown in the perspective view of
The selector coupling or connector 72 may include a receiver body 80 which defines a receiving channel 84 into which the flow selector 74 may be inserted in a snug or fluid tight coupling. As the selector coupling or connector 72 may be fabricated from a soft material such as silicone, rubber, etc., the flow selector 74 may be slidingly inserted into the selector coupling or connector 72 such that the interior surface of the receiving channel 84 may conform against the outer surface of the flow selector 74 in a fluid tight seal. The interior of the receiving channel 84 may further define receiving grooves or channels 94′ which may receive each of the projections 94 along the exterior of the flow selector 74 in a corresponding manner. A distal surface of the receiver body 80 may further define a flow opening 86 selectively located over the distal surface such that when the flow selector 74 is inserted into the receiving channel 84, the projections 94 may urge or automatically align one of the openings of the flow selector 74 to the flow opening 86, as further shown in the perspective view of
During use, the flow selector 74 may be inserted, as shown by the directional arrow 98, into the receiving channel 84 and aligned by the projections 94 seating within the corresponding receiving grooves or channels 94′. The selector coupling or connector 72 may be secured to the opening of the fluid reservoir 70 and the coupling or connector 76 may be secured to the terminal end of the flow selector 74. The flow selector 74 may be rotated about its longitudinal axis, as indicated by the rotational arrow 96, by the user or another individual to select one of the appropriate openings 88, 90, 92 of the flow selector 74 for alignment with the flow opening 86. When rotated within the receiving channel 84, the flow selector 74 may provide a tactile indication of when the projections 94 become seated within their corresponding grooves or channels 94′ which may also provide a tactile indication that the selected opening 88, 90, 92 of the flow selector 74 is correspondingly aligned with the flow opening 86. By rotating the flow selector 74 accordingly, the flow rate from the flow reservoir 70 may be adjusted depending upon the feeding needs of the infant. For instance, aligning the first opening 88 with the largest diameter to the flow opening 86 may allow for the largest flow rate from the fluid reservoir 70 which aligning the third opening 92 with the smallest diameter to the flow opening 86 may allow for the smallest flow rate from the fluid reservoir 70.
A flow selector 74 having any number of openings defined through the body and any number of projections 94 may be used with a corresponding selector coupling or connector 72 in any combination with any of the fluid reservoirs, fluid lines, nipple shields, etc. described herein in any number of variations depending upon the desired combination of features and are within the scope of this disclosure.
Furthermore, with the fluid reservoir assembly FR secured and configured to function without manual actuation and the nipple shield assembly NS secured along the breast, the device may be fully operational in a handsfree manner where the individual M is able to maintain both hands free for handling the infant IN.
Each and every feature described may be used in any number of combinations as practicable. For instance, any variation of the fluid reservoir assembly FR described may be used with any variation of the nipple shield assembly NS including variations on the crown or cavity 14, nipple shield 12, orientation indicator 66, opening configurations, fluid reservoir assemblies, etc.
While illustrative examples are described above, it will be apparent to one skilled in the art that various changes and modifications may be made therein. Moreover, various apparatus or procedures described above are also intended to be utilized in combination with one another, as practicable. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.
This application claims the benefit of priority to U.S. Prov. App. 63/364,536 filed May 11, 2022, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63364536 | May 2022 | US |
