Patent Application
20250224263
The present disclosure describes technology related to the field of methods and systems for measuring and monitoring the quantity of milk delivered to an infant, and especially by a nursing mother to the infant.
The desire to determine how much of a nursing mother's milk a baby is actually taking in during a breastfeeding session often arises, especially in the first few weeks of an infant's life. Babies may be inclined to suck on a breast as a soothing mechanism, giving the mothers the impression that their babies are feeding, when in actual fact, they are not. Additionally, some mothers do not have an adequate milk supply, especially before breast-feeding has been well-established, and therefore a hungry infant may suckle on the breast for long periods of time, without receiving an adequate supply of milk. Additionally, some babies appear to fall asleep during nursing, and the mother may not realize that they are in fact still feeding. Similar requirements may also be required of an infant who is being bottle-fed, since, even though the exact quantity of milk being taken by the infant can be measured by weighing the bottle before and after feeding, or by viewing the graduations on the bottle, this measurement does not provide a real-time indication of the flow rate during the feeding itself, other than an estimation of the rate at which the milk level in the bottle moves downward during feeding, which is an approximate method.
Furthermore, besides the sum total of milk imbibed by the infant, and the rate of taking of the milk, there are other characteristics of the feeding session that simple present-day devices do not readily provide, such as feeding patterns encountered as a function of the time progress of the feed, which could provide beneficial and comparative information.
In order to give a measurement or at least an indication of the quantity of milk being supplied to a baby, various measurement systems have been proposed, some complex and requiring electronic measurement attachments, and some simple. One technique is disclosed in the article by S. E. J. Daly et al., entitled “The Determination of Short-Term Breast Volume Changes and the Rate of Synthesis of Human Milk Using Computerized Breast Measurement” published in Exp. Physiology, 77, 79-87 (1992). In this technique, changes in breast volume are traced by computerized imaging of the breast before and after feeding. International Patent Publication No. WO 2006/054287 for “Breast Milk Flow Meter Apparatus and Method” by E. Kolberg et al, disclose a technique in which a volumetric flow sensor is placed inside a silicon nipple cap through which the baby suckles. The milk flow data from the sensor is converted into milk volume data which is displayed to the mother. Such systems generally involve attaching electronic or electromechanical flow meters to a fluid flow passage in order to measure the fluid flow. There are several other systems proposed which use electronic flow measurement modules, attached externally to a milk collection device which fits over the mother's breast, to measure the milk flow. One such system is shown in International Patent Application Publication No. WO 2014/174508 for “Measurement of Nursed Breast Milk” to O. Melamed, which shows an external electronic measurement unit to measure the flow of milk through a mechanical flow meter. Likewise, in US Published Application No. 2018/0147124 for “Non-Intrusive Breast Milk Monitoring” to L. A. Drew, there is also shown an external electronic flow measurement and display unit.
A simpler, non-electronic device, resembling a nipple shield, has been described in U.S. Pat. No. 7,896,835 for “Apparatus and Method for Measuring Fluid Flow to a Suckling Baby”, commonly owned by the present applicant, in which a fraction of the main milk flow is passed through a measurement channel having a significantly higher resistance to fluid flow than the main milk flow channel, and the fluid flow into the measurement channel can be measured, such as by observing the length of the measurement channel that has filled with milk after the feeding session. Since the ratio of the fluid resistance of the two channels is known, the length of milk in the measurement channel can provide a measure of the quantity of milk drawn through the main channel.
In International Patent Publication WO/2022/175833, for “Device for Flow Detection of Mother's Milk”, also commonly owned by the present applicant and co-pending the present application, there is described a dedicated nipple shield device, which enables a simple indication to a nursing mother of the flow of milk from her infant during feeding, without the need for any electronic attachments. Additionally, that application also discloses a multi-task nipple shield device, that can be used for performing a number of alternative functions related to different aspects of a nursing mother's needs. The nipple shield device comprises a universal base unit which is fitted over the mother's breast, and which executes the transfer of the mother's milk from her nipple to the baby's mouth, by means of a passageway which conveys the milk to and from a location remote from the nipple. At this remote location, any of a number of different operational heads can be attached, each type of head being adapted to perform its own dedicated function or functions related to the milk. The remote location includes a standardized pair of fluid flow connection terminals, and the various operational heads have matching standardized fluid flow connectors that may be attached to the remote connectors on the base nipple shield. The base unit of the nipple shield is thus universal, and the particular use made of the device depends on the head attached to the remote terminals of the nipple shield. Heads, generally electronically operated, can be attached for various measurement or indicational functions, such as flow measurement, flow indication, medicine addition, measurement of the suction pattern of the baby, milk quality analysis, detection of markers in the milk indicating illness of the mother, and numerous other functional uses.
In International Patent Publication No. WO 2020/025337 to Coroflo Limited, for “Microsensor-based Breastfeeding Volume Measurement Device”, there is shown a differential pressure measurement module placed within the orifice in the nipple, through which the infant sucks milk, a first pressure sensor being positioned at the inlet port of the orifice, close to the mother's source of the milk, and a second pressure sensor close to the outlet port where the infant is sucking. The differential pressure calculated from measurements of the two sensors, gives an indication of the milk flow in the channel of the feeding orifice.
A disadvantage common to all such systems which rely on measurement of the pressure drop as the milk flows through a measurement path having a significant fluid resistance, is that there is a considerable effort that must be exerted by the infant to obtain a good flow of milk. One of the reasons for the additional effort required by the infant in such nipples having a higher resistance flow path, is because the infant's sucking pattern is not a continuous application of negative sucking pressure applied to the nipple, but rather a pulsating series of separate sucking actions, typically at a rate of approximately 2 per second, in a sinusoidal-shaped pattern. This pulsating pattern of sucking is not to be confused with the breathing breaks, which the infant has to take every few seconds, those few seconds involving several such sucking cycles. This pattern of repetitive negative pressure pulses applied to the nipple results in an oscillatory flow of milk to and from the infant, since at every release of suction by the infant, part of the milk in the infant's mouth flows back through the nipple orifice to the volume surrounding the mother's breast, to be again taken in by the infant at the next sucking action of the cycle. As a result, part of the milk flows cyclically backwards and forwards through the nipple orifice, instead of being imbibed by the infant, and the net flow imbibed by the infant is only part of the milk moved by the infant during every sucking action of the cycle. This additional flow results in an unnecessary expenditure of energy by the infant, and hence, uncertainty on the part of the mother, as to whether the infant is receiving a sufficient quantity of milk during the feeding session. A more relevant potential problem for devices which do measure the flow of the milk consumed by an infant, is that if the flow of milk is not steady, or at least unidirectional, the constant changing of the flow may generate a noise problem for the measurement system, which would perform much more accurately if a steady flow of milk was available for the measurement.
As the benefits of breast-feeding become more widely known, more mothers are breast-feeding than in the past, highlighting the need for a simple but accurate device for measuring a baby's milk intake.
The disclosures of each of the publications mentioned in this section and in other sections of the specification, are hereby incorporated by reference, each in its entirety.
The present disclosure provides novel devices and methods that overcome at least some of the disadvantages of prior art systems and methods, for measurement of milk flow to a feeding infant. The presently described nipple devices have dome structures similar to commonly used nipple shields, having an internal milk collection volume between the dome structure and the mother's breast, from which the infant sucks milk through an orifice or orifices in the tip region of the nipple dome structure. The nipple devices use the fact that the flow to the infant through the nipple orifice or orifices, is proportional to the pressure difference between the milk expressed at the mother's breast, and the milk sucked by the infant at the output ends of the orifice or orifices, and the presently described nipple devices use novel structures in order to determine this pressure difference.
The nipple structures incorporate elements which provide a pressure differential measurement enabling the milk flow to be readily measured by a dedicated pressure sensor device. Such a pressure sensor device could be incorporated in a microelectronic chip mounted on the nipple device. The nipple device can be configured for use either as a nipple shield for measurement of milk flow from a mother's breast to the infant, or as the nipple cover for mounting on a feeding bottle.
According to a first implementation of these devices, the nipple device uses the principle that the flow of milk from the inside volume of the nipple device, whether mounted on a mother's breast or mounted on a feeding bottle, is proportional to the pressure difference generated by the nursing infant across the nipple orifice or orifices. The feeding orifice or orifices of the nipple connect the volume on the inside of the dome of the nipple device, with the outside of the dome of the nipple device, which the infant holds in its mouth. The pressure on the outer surface of the nipple dome, and hence at the outer end of the orifice channel or channels of the nipple device, is thus the negative pressure resulting from the sucking of the infant on the nipple dome. The pressure at the inner end of the orifice channel or channels, is equal to the pressure in the volume on the inside of the nipple dome, which, in the case of a nursing mother, is the volume between the mother's breast and the nipple device. In the case of the nipple device for use on a feeding bottle, the pressure on the inside will be that of the contents inside the bottle. The pressures both inside and outside of the flexible layer of the nipple device can vary between atmospheric pressure and a sub-atmospheric pressure, with the pressure in both of the volumes generally returning to the equilibrium atmospheric pressure when the baby pauses to breathe between several pulsating sucking actions. However, at any other instant of time, there will be a difference in pressure between the two ends of the orifice channel or channels, resulting from the infant's sucking, and since the system is always trying to get to a pressure equilibrium state, when the baby applies sub-pressure, the pressure in the baby's mouth and in the space between the nipple dome and the mother's nipple will tend to equalize. Therefore, milk will have to flow from the space between the nipple dome and the mother's breast, through the orifice(s) to the inside to the baby's mouth. Since the diameter of the orifice(s) is known, if the difference in pressure is known, the rate of flow of the milk can be determined. Even if the diameter of the orifice(s) is not known, a simple preliminary calibration procedure can be used to determine the relationship between the measured pressure to the flow rate of the milk through the orifice(s). Integration over time of those varying flow rates, will provide the total flow of milk passing through the orifice or orifices to the infant. The present application describes structures and methods which enable measurement of this pressure difference, and hence, the ability to measure the flow of milk from the mother to the infant.
In its simplest form, a nipple device of the type shown in the present disclosure requires a pair of pressure sensors (or a differential pressure sensor), whose inputs are connected by means of passageways respectively to the two regions of the milk flow whose pressures it is desired to measure. The pressure sensor(s) may be located at the outer peripheral edge of the base layer of the device, such that they are not obscured by the infant's mouth. Using the common nipple shield model, this can be achieved by forming the narrow passageways within the material of the nipple shield, with one of the passageways leading from an opening in the outer surface of the domed protrusion of the device, near its top end, such that it conveys the pressure generated within the mouth of the infant down the passageway to the first pressure sensor input, and the other of the passageways leading from an opening on the inside surface of the domed protrusion of the device, such that it conveys the pressure present within the inner volume of the domed protrusion, to the second pressure sensor input. This inner volume is the space where the milk expelled from the mother's breast collects, before being drawn through the feeding orifice(s) by the infant. So long as the resistance of the orifice(s) remains constant, the measured pressure difference thus provides an indication of the fluid flow rate of the milk from the mother to the infant. Since the passageways are hermetically sealed at their outer ends, there will be a minimal entry of milk into the passageways, the pressure at the milk flows being transferred by the trapped air layer in the passageways to the pressure sensor inputs. The presence of such a trapped air layer in the passageways is significant, since it provides a gaseous barrier to prevent the milk from contacting the pressure sensors themselves, which could cause malfunctions in the long term.
According to another exemplary implementation of the devices and methods of the present disclosure, the material layer of the nipple dome region of the device of the present disclosure incorporates a pair of chambers embedded within the material layer. The use of only one pair of chambers is the simplest implementation, but similar measurement systems could also use more than a pair. These chambers may be disposed at any circumferential position of the nipple dome from which the infant sucks to obtain milk, but advantageously, though not necessarily, each may extend around opposite parts of the circumference of the nipple dome region of the device. The positions of the chambers relative to the centerline of the thickness of the layer of material of the nipple are configured to be different. One of the pair of chambers, herewithin known as the first chamber, is disposed closer to the outer surface of the layer of material of the nipple region of the device, than to the inner surface. The other of the pair of chambers, the second chamber, is disposed closer to the inner surface of the material layer of the nipple region of the device, than to the outer surface. The positioning of the chamber closer to one or the other surface of the nipple layer naturally results in a dividing wall between the chamber and the surface to which it is closer, that is thinner and hence more flexible, than the dividing wall between the chamber and the surface that it is further from. This thinner dividing wall could be considered to be a thin flexible membrane. Thus, each of the chambers has a thinner wall which will flex readily to changes in the pressure on its outer surface, and a thicker wall which can be considered to be a quasi-fixed wall which is regarded as not flexing under changes of the pressure in the volume outside of it. Once the outer wall of a chamber is regarded as being fixed because of the comparative rigidity of that rear wall, the application of an external pressure to the thin opposite wall of the chamber, whether above or below ambient pressure, results in a bowing motion of the thinner wall, either inwardly or outwardly, in accordance with the level of the applied outside pressure. The term “outer” used in this paragraph is intended to relate to the direction in which the thin wall is located relative to the material of the nipple, whether facing the mother's breast, or facing the real “outside” world relative to the mother, where the infant is located.
Thus, for instance, if the pressure outside of the nipple is less than the ambient pressure, such as is the normal situation when the infant is nursing, the thin wall of the chamber exposed to that lower pressure in the infant's mouth, will extend outwards, and the volume within the chamber will increase, and since the chamber is a closed volume, the pressures within it will decrease. Likewise, for the chamber with its thin wall facing towards the mother's breast, a reduced pressure within the volume of the domed nipple structure will cause the thin wall of that chamber to bow away from the wall and into the internal volume of the dome nipple structure, and since that chamber is also a closed body, the pressure within that chamber will decrease accordingly. Consequently, a differential pressure will be generated between the first and the second chambers, since the external sub-pressure generated by the sucking of the infant, causes the thinner outer wall of the first chamber to extend outwards more than the thinner wall between the second chamber and the inside of the nipple dome will extend inwards, resulting in a lower pressure within the first chamber than in the second chamber. This analysis makes the approximation that the rigidity of the thicker wall of each chamber is such that its motion under the influence of the pressure applied outside the thicker wall can be neglected in comparison to any motion of the thinner wall. This difference in pressures generated between the two chambers is proportional to the difference in pressures present between the outside surface of the nipple dome structure, and its inner volume. Since that difference in pressure is essentially equal to the difference in pressure across the milk flow orifice or orifices, and that difference in pressure determines the rate of flow of milk from within the nipple inner volume through the orifice or orifices to the infant's mouth on the outer surface, measurement of that pressure difference will therefore provide a measure of the milk flow to the infant.
An alternative way of viewing the interaction of the chambers with the ambient pressures present at the outer and inner surfaces of the nipple dome structure, is to consider the reduced pressure within the first chamber, generated because of the outward motion of the thin wall of the first chamber, as being proportional to the reduced pressure outside of the nipple dome. At the same time, for the second chamber located closer to the inner surface of the nipple dome structure, the pressure generated within that chamber, because of the inward motion of the thin wall of the second chamber, is proportional to the pressure within the inner volume of the nipple dome structure.
In an alternative structure to that described above, each chamber can be provided with one wall having a greater flexibility than its opposing wall, by manufacturing one of the walls of a more flexible material that that of the opposing wall. Such a structure will fulfill the requirements of the chambers of this application, but may not be so cost effective or simple to manufacture.
The above nipple devices have been described in their simplest form, which is also the most economical way of manufacturing the devices. In this basic implementation of the devices, which show how the differential pressure between these chambers can be used to provide information about the milk flow, there is only a single first chamber and a single second chamber. However, it is to be understood that the use of a single first chamber and a single second chamber is not intended to limit the devices, which could also function if either or both of the first and second chambers comprised more than a single chamber. The chambers have been thuswise claimed, as “at least a first chamber” and “at least a second chamber” respectively, in order to claim structures using multiple chambers for each pressure measurement, including structures which may have a different number of chambers for the pressure measurement on the inner space of the nipple dome structure, and the outer space, within the infant's mouth.
In order to measure the level of the differential pressure, one convenient method is to provide the nipple device with narrow passageways connecting the two chambers to a more remote region, such as the region at the periphery of the nipple base surround area, where a differential pressure measurement may be made between the two passageways. Alternatively, for multiple chambers for the inner and outer pressure measurements, it is to be understood that multiple passageways may be used for each input to the differential pressure sensor, and are intended to be thuswise claimed. That differential pressure measurement is then proportional to a measure of the milk flow passing through the orifice or orifices to the infant's mouth. Such a differential pressure measurement may be made by connecting the two fluid connections of a differential pressure sensor to the passageways from the first chamber and the second chamber. Many such pressure sensors are available, including miniature sensors only a few mm. in size, such that they do not involve a large encumbrance to the use of the nipple device. Such sensors may operate using a piezoresistive or a piezoelectric element, or a silicon-based microchip sensor, typically based on strain gauge technology, or any other physical phenomena, such as are used in many available commercial miniature pressure sensor elements. The output of the differential pressure gauge may be input to a readout monitor, which provides an output proportional to the milk flow. Calibration of the sensor is needed to convert its signal output to a reading which reflects the flow rate. The differential pressure measurement may even be transferred and analyzed by an external device, such as a smart phone.
Throughout the embodiments shown in this disclosure, as an alternative to a single differential pressure sensor, individual pressure sensors may be used, one on the end of each of the two passageways, each feeding their output signals to an electronic difference circuit, which then outputs the measured differential pressure. Likewise, in devices using more than two chambers, the differential pressure measurement may be obtained by measurement of the individual pressures between the ends of multiples of passageways, from each set of chambers. Thus, the pressure in the inner volume of the nipple dome obtained in several passageways from several chambers may be measured, and subtracted from that obtained from chambers measuring the pressure in the infant's mouth at the outer volume of the nipple dome, to provide the differential pressure, based on which the milk flow is determined. Consequently, the measurement of individual pressures, as claimed, is intended to cover pressures obtained from such combinations also.
There are a number of details of the structure of the nipple device which need to be observed, in order to provide accurate measurements of the milk flow. Since the accuracy with which the pressure within each chamber is measured, is dependent on the ordered motion of the thin wall under the effect of the pressure, it is important that any motion imparted to the shape of the nipple dome and hence of the chambers therewithin, by the reduced pressure of the infant's sucking, be reduced to a minimum. If the entire shape of the chambers were to become distorted by the sub-pressure of the infant's sucking, or by the physical motion of the tongue or lips of the infant, the motion of the thin wall, and thence the resulting change in volume of the chamber, would be undeterminable, and the pressure readings would be distorted accordingly. In order to prevent the pressure reading from being inaccurate because of this distortion of the shape of the nipple by the infant's sucking, the chambers may advantageously be positioned near the upper end of the dome of the nipple, where the material layer undergoes less distortion or change of shape, because of the increased inherent strength of the more closely curved region of the dome structure closer to the peak, as compared with the lower and less curved wall of the nipple dome structure. Alternatively, the upper region of the dome of the nipple can be artificially strengthened by using material or thickness providing more rigidity in that region. By those means, the chambers become more protected from externally induced mechanical distortions than otherwise. Furthermore, an analysis of the signals representing the pressures of both chambers, should enable determination as to whether the chamber membrane distortion is due to physical pressure of the tongue or lips of the infant, or if it is due to the real sub-pressure applied. The analysis of the feeding pattern will be able to remove such noises, and differentiate the effects of real pressure from other disturbances.
Additionally, distortion of the shape of the nipple could be directly caused by the lips of the infant, which contact the nipple further down on the walls of the nipple, rather than close to the peak of the dome of the nipple. Therefore, for chambers situated in the upper region of the nipple dome structure, or in a specifically strengthened region of the dome structure, the shape of the nipple at the measurement region is not disturbed by the infant's lips to the same extent as chamber situated further down the dome.
Since the use of an electronic measurement using the nipple device of the present disclosure enables measurement not only of the rate and quantity of milk taken by the infant, but also provides a real-time display of the pattern of the sucking and intake by the infant, this feature provides useful information to the mother regarding the progress of the feeding session, and of the tiredness of the infant.
A further advantage of the real-time determination of the sucking action of the infant is that the sucking sinusoidally-shaped tracking of the infant provides important information as to the health and strength of the baby, at least as far as its sucking ability goes, and comparison of that sinusoid measurement with normal standards provides an indication of the infant's development. Electronic data tracking of feeding sessions also enables the development of the infant to be readily followed over long periods.
As previously mentioned, the electronic nipple device of the present disclosure can also be used as a bottle nipple, thereby converting any bottle into a “smart bottle” in a very simple manner, at substantially lower cost than other methods of measurement of the quantity and rate of milk intake by an infant. The electronic nipple device is more accurate than any methods involving inspection of the level of the milk in the bottle as it goes down during the feeding session, besides the additional advantages available for the electronic nipple device of the present application, especially in the field of determining the temporally dependent pattern of the infant's feeding, and characteristics of the infant's feeding habits related thereto. The other advantages mentioned previously are also applicable to the “smart bottle” nipple, in that not only the quantity and rate of intake can be provided, but also the pattern of the infant's milk intake, and any clinical or development information obtained therefrom.
According to further implementations of the devices of the present application, in order to avoid effects of the mouth or tongue motions of the infant from interfering with the shape or form of the orifice or orifices, and hence with the magnitude of the flow resistance of the orifice or orifices, which would affect the accuracy of the differential pressure measurement, and hence the flow measurement, a number of structural improvements to the simple orifices used in prior devices, are proposed. According to a first implementation, the material in which the orifice or orifices are formed, is connected to the remainder of the dome nipple structure by means of a thinner, and hence more flexible, layer of the nipple material, which enables the region of the orifice(s) itself to remain stiffer than the region surrounding it, such that mechanical forces applied thereto by the infant may cause the orifice region to move or tilt, but will reduce the extent of deformation of the orifice or orifices themselves, thereby better maintaining the flow resistance of the orifice or orifices. This implementation effectively causes the orifice or orifices to “float” relative to the rest of the domed nipple structure, such that forces applied onto the upper extremity of the nipple structure are essentially not transferred to the structural form of the orifice or orifices themselves, or at least their effect on the orifice or orifices is reduced. In a similar manner, the region of the orifice or orifices can be made of a stiffer material than that of the rest of the nipple device, such that it does not undergo the same level of distortion when forces are applied to it, as it would if made of the same material.
According to yet another implementation, the inner side of the domed nipple structure can comprise a thicker region having a number of channels within the thickness of that region, these channels leading to the region around the inner orifice opening, such that the mother's milk can flow to the orifice or orifices in the event that the mother's nipple is in close contact with the inner side of the domed structure, and may otherwise block the orifice or orifices.
In order to avoid any of the above-mentioned interference with the measurement of the milk flow at the orifice(s), according to yet another embodiment of the present disclosure, the milk flow itself, instead of flowing directly from the inner side of the domed nipple structure, through the orifice(s) to the infant's mouth, can be conveyed by means of a fluid transfer passageway, to a location near the outer edge of the device, distant from the protruding domed nipple structure, where a constriction is formed in the flow path, and this constriction acts as the fluid flow resistor across which the differential pressure is measured. After flowing through the flow resistor, the milk is conveyed back through a second fluid transfer passageway, to the outer side of the dome nipple structure through an orifice or orifices, and into the mouth of the infant. In this embodiment, the orifice or orifices do not then have any function as the fluid flow resistor of the device, but act merely as the delivery of the milk to the infant from the nipple device. The passageways may be implemented as more than one passageway in each direction, in order to minimize the resistance to the milk flow between the domed nipple structure and the flow resistor. Pressure sensors are installed either at, or in, the end regions of the hydraulic flow resistor, in order to measure the differential pressure across the resistor, and from this differential pressure, the milk flow rate can be determined. The use of a fluid flow resister at a position remote from the feeding orifice(s) thus enables an accurate measure of the flow rate to be obtained, essentially independently of any interference by the infant with the flow emerging from the feeding orifice or orifices.
As in previously described implementations, contact between the milk flow and the pressure sensors can be prevented by use of a trapped air layer in the passageways between the milk flow itself and the pressure sensors. According to another method of preventing milk from contracting the pressure sensors themselves, a pair of pressure transfer chambers can be used, one for the milk flowing into the flow resistor, and one for the milk flowing out of the flow resistor. Each of the chambers has a flexible diaphragm dividing each chamber into two separate sub-chambers. The first pair of sub-chambers are in contact with the milk, one on the input side and the other on the output side of the flow resistor, while the second pair of sub-chambers are in contact with the pressure sensors themselves, one for the pressure on the input side of the flow resistor and the other for the pressure on the output side of the flow resistor. The flexible diaphragms flex in accordance with the pressure applied to them by the milk flow sub-chambers, thus act as a pressure transfer mechanism, transferring those pressures to the pressure sensors, in the second pair of sub-chambers. Since the milk is prevented by the flexible diaphragms from flowing into the second pair of sub-chambers, the pressure sensors are therefore protected from contact with the milk itself, but do sense the fluid pressures of the milk flow by means of the extension of the flexible diaphragms.
The above mentioned International Patent Publication WO2022/175833 for “Device for Flow Detection of Mother's Milk”, there is shown in
The above mentioned devices have been described assuming that the flow of milk to the infant is continuous, and without taking into account any pulsating flow pattern of milk through the nipple orifice or orifices, to the infant. The present application also describes a further novel feature of feeding nipples, which provides a steadier flow of milk to the infant, and reduces the effort required by the infant to feed through the nipple, and which then enables every feeding session to be less strenuous to the infant, and with less anxiety to the mother. This feature can be advantageously applied to the measurement nipples so far described hereinabove, but can also be applied to improve nipples of any type in which the feeding orifices are of limited fluid conductance, such as those nipples in which the pressure drop across the orifice is necessary to enable the determination of the flow through the orifice(s), These improved nipples include a partial area of the nipple protrusion surface which is intended to be within the mouth of the infant, having a greater flexibility than that of the remainder of the nipple. This flexible region can be most readily formed by making the partial area of thinner material or of more pliable material than the rest of the nipple area. The flexible region then acts as a pressure equalizer for the action of the infant's sucking, as will be explained hereinbelow.
With prior art nipples, as the infant sucks, a negative pressure is generated within the infant's mouth, and this negative pressure is transferred to the inside volume of the nipple protrusion, from where, milk accumulated in the space between the mother's breast and the nipple's inside surface, is withdrawn. The flow of milk from the mother to the infant arises because the negative pressure in the infant's mouth generated by the infant's sucking has a higher level of negative pressure, i.e. a more negative absolute pressure, than the negative pressure in that inner volume. In the periods of time between the infant's cyclic sucking actions, the infant releases the sub-pressure in its mouth, and the intra-mouth pressure returns essentially to atmospheric pressure, and since the pressure in the inner space of the nipple is then lower than that in the infant's mouth, milk flows back from the infant's mouth into the accumulation of milk in the inner volume of the nipple. The amount of milk flowing back is proportional to the difference in pressure between the baby's mouth, now closer to atmospheric pressure between sucks, and the inside space of the nipple. In the now described nipples of the present disclosure, the flexible membrane region acts to reduce this difference in pressure by flexing to follow the changes in differential pressure between the infant's mouth and the internal nipple space. Thus, while the infant is in the sucking portion of the pulsating feeding process, the flexible membrane moves outward in the direction of the milk flow towards the lower pressure of the infant's mouth. But when the infant relaxes sucking, the flexible membrane bulges inwards towards the mother's breast, since the relaxation of the infant's sucking results in the pressure in the infant's mouth cavity rising towards atmospheric pressure, generating a higher absolute pressure than in the mother's inner space. This inward membrane movement thereby effectively reduces the volume of the space between the nipple and the mother's breast, resulting in the reduction of the extent of the negative pressure (i.e. raising the absolute pressure) of the accumulated milk therein, and thus reducing the differential pressure across the nipple orifice, and hence reducing the backward flow of milk from the infant to the inside volume of the nipple. The rise in pressure on the mother's side, towards the pressure on the infant's side, occurs more rapidly than would be obtained without the flexible membrane, when the tendency to equalization of the two pressures would be dependent on the rate of flow of the milk though the feeding orifice(s).
An alternative, and more graphic way of viewing this step is to regard the inward bulging membrane as enlarging the volume available for the milk in the infant's mouth, thereby making more room to contain the milk which the infant did not swallow, rather than it returning to the mother's side of the nipple. Once the infant again applies suction, the membrane reverses its bulging profile, and moves in an outward direction, since there is now a more negative pressure on the infant's side of the membrane. The differential pressure across the orifice therefore increases and the resulting flow of milk to the infant then continues. The result of the membrane oscillatory motion is thus to reduce the differential pressure across the orifice when the infant is relaxed in the non-sucking phase of the sucking cycle, and to increase or to maintain the differential pressure across the orifice when the infant begins a sucking action again, such that the net effect of the membrane is to increase the net flow of milk from the mother to the infant, and to reduce the extent of the reverse flow of milk from the infant's mouth back to the inner space of the nipple protrusion. This then achieves the double advantage of reducing the effort required by the infant to nurse, and to smooth out the net flow pattern of the milk from the mother to the infant, thereby reducing the “noise” of the differential pressure measurement necessary to determine the milk flow rate.
The above described methods of providing easier feeding for the infant, and for generally reducing the pulsating nature of the infant feeding process, have been described using one or more areas of the nipple region as the flexible membrane to generate the desired effects arising from changes in the comparative volumes available on either side of the nipple protrusion, as the membrane flexes to and fro with the infant's sucking pattern. In the same way, according to a further embodiment of the devices described in this disclosure, it is possible to achieve the same changes in volume between the mother's and the infant's side of the nipple protrusion, when the infant is feeding, by manufacturing the entire nipple protrusion, of a material having substantially higher flexibility than is accepted in the field. Currently available infant nipples, or flow measurement devices based on infant nipple devices, use a flexible material having a hardness in the region of 50 Shore A, or even somewhat less flexible, in order to provide good resistance of the nipple material to the infant's jaw motions, especially with older infants, and hence good wear qualities and long life to the nipple. According to the presently proposed nipple devices, the entire nipple protrusion is formed of a silicone or other flexible layer having a hardness of 40 Shore A, or even less, such as 35 Shore A or even as flexible as 30 Shore A. This provides less resistance of the nipple protrusion to the changes in pressure generated by the sucking or relaxing of the infant feeding, and hence easier feeding and less pulsation. It may also be advantageous to manufacture the entire nipple device of such a more flexible material, in order to reduce manufacturing costs.
The size of the feeding orifice or orifices should be a compromise between being sufficiently small so that the differential pressure between the two ends of the orifice(s) is sufficiently high for the milk flows expected, to enable accurate measurement by the pressure sensors, yet not so small that the orifice(s) represents such a resistance to the flow of milk to the infant, that the infant cannot feed comfortably. The optimum size or sizes can either be measured experimentally or determined from the size of the orifice or orifices used in nipples in general use. However, it is to be understood that the need to measure the differential pressure does place additional constraints on the upper size of the nipple orifice(s).
In practice, the membrane section can be positioned in any part of the nipple protrusion, whether within the region around the orifice in the dome, or on the upper side wall of the nipple protrusion, on condition that it is situated within the infant's mouth when in use. The area of the pressure sensitive membrane is limited by the need to maintain sufficient strength that the membrane does not rupture when strained beyond the limit for which it was designed.
The entire nipple device can be manufactured in a very low cost and high volume manner, by any suitable polymer forming process. The differential pressure sensing device and its controller can be formed on a single microelectronic substrate, such that the electronic readout unit will not take up an appreciable amount of space on or adjacent to the nipple device.
Since the operation of the devices described in the present application, involve negative or sub-atmospheric pressures generated by the sucking action of the infant, and transferred to the mother's nipple, in order to avoid any lack of clarity about the level of these negative pressures, reference to raising or lowering the negative pressure is understood to mean raising or lowering the extent of the negative pressure, even though the pressures are negative. Thus, for example, a term such as “lowering the negative pressure” is not taken in this disclosure to mean making the absolute level of the negative pressure even lower, but rather that the extent of the negative pressure as expressed in the negative level of the pressure, is lowered, which means raising the absolute pressure.
Although reference is made throughout this application to the mother of the infant as being the supplier of the milk, and is also thuswise claimed, this being the usual situation, it is to be understood that references to the mother are not intended to exclude a woman providing the milk other than the infant's mother, and the disclosure and the claims are not intended to be interpreted as limited to a mother using the device to breast-feed her baby.
Additionally, the orifice through which the infant sucks the milk from the inner volume of the dome of the nipple structure, may be a single opening, or several openings, and reference in this disclosure and in the claims to “an orifice” or to “the orifice”, is intended to be interpreted as the total passageway for milk from inside the nipple to the infant's mouth, whether through a single orifice or through more than one orifice.
Furthermore, it is recognized that a differential pressure measurement can be performed either by use of a dedicated differential pressure sensor, or by two separate pressure sensors with a subtraction circuit to provide an output proportional to the difference in pressure between them. Consequently, in this disclosure, and as claimed, any mention of a differential pressure measurement, or a differential pressure sensor, is intended to include measurements performed either by a single differential measurement probe, or by two separate pressure measurement probes.
The above described nipple devices have been shown in their simplest form, which is also the most economical way of manufacturing the devices, in the sense that, in the basic implementation of the devices, there is only a single flexible membrane for providing the pressure compensation to overcome the tendency for milk to return to the mother's side of the nipple structure. However, it is to be understood that the use of a single flexible membrane is not intended to limit the devices, which could also function if more than one flexible membrane were to be used, provided that they were both positioned in locations that would be essentially within the infant's mouth during feeding. The flexible membrane has thuswise been claimed, as “at least one region of the material of the nipple device, . . . having a higher flexibility than the remaining parts of the nipple device” or “at least one area of the domed protrusion . . . ”. Such claim language, or language similar thereto, is intended to also include claim structures using more than one flexible membrane for providing the reverse milk flow compensation. Furthermore, the term “a single flexible membrane”, may in some embodiments, be understood to relate to the whole of the nipple protrusion of the device.
There is thus provided in accordance with an exemplary implementation of the devices described in this disclosure, a device for monitoring a flow of milk drawn by an infant during feeding, the device comprising:
In such a nipple device, the differential pressure between the first pressure sensor and the second pressure sensor enables determination of the flow of milk from within the inner volume of the domed protrusion to the at least one position in the outer surface of the domed protrusion. Additionally, the first and second sensors may be incorporated in a differential pressure module. This differential pressure module may comprise a subtraction circuit operating between the outputs of the pressure sensors.
In any of the nipple devices described above, the connection between the first at least one passageway and the second at least one passageway has a constricted bore to generate increased fluid flow resistance to the flow of milk therethrough. Furthermore, the milk flow to the infant is determined from the differential pressure measured between the pressure sensors, using a known relationship. The output of the pressure measuring devices also enables the pattern of the infant's ingestion of milk to be determined. Additionally, the base layer of the nipple device may be shaped to be mounted on the breast of a mother providing milk to the infant, or it may be adapted to be mounted on a feeding bottle. Furthermore, the region of the base layer remote from the domed protrusion may be a peripheral region of the base layer of the nipple device.
According to further implementations of the devices of this disclosure, in any of the above described devices, the pressure sensors or the differential pressure module may be located in a separate head adapted to be attached to the periphery of the nipple device through fluid flow ports. In such a case, the separate head may comprise either a display for showing the level of the flow of milk, or a wireless facility for transmitting the flow rate to a remote receiver.
In addition, in any of those above described nipple devices, each of the first and the second at least one passageway is connected to a chamber having a flexible diaphragm dividing its internal volume into two hermetically closed compartments, and the pressure transfer between each of the first and the second at least one passageway and its associated pressure sensor is performed across the flexible diaphragm. In such a device, the first at least one passageway may be connected to a first of its two hermetically closed compartments, and the first pressure sensor may be connected to the second of the two hermetically closed compartments. The second of the two hermetically closed compartments may be filled with a liquid.
In yet further implementations of the nipple devices of the present disclosure, the diameter of the passageways may be selected to be sufficiently small that milk entering the passageway at the pressure generated in the device, does not mix with air already in the passageway. Optimally, the passageway has an internal diameter not exceeding 4 mm.
In accordance with yet further implementations of the presently described devices, there is also provided a nipple device to feed an infant, comprising:
In such a nipple device, the at least one higher flexibility area flexes inwards or outwards of the domed protrusion region in accordance with a differential pressure between the two opposite sides of the at least one higher flexibility area. Also, the at least one higher flexibility area is located within an area which is adapted to be within the infant's mouth when feeding. Furthermore, the at least one higher flexibility area may be located either in the region of the at least one orifice, or in a position in the wall of the domed protrusion region of the nipple device. Also, the flexing of the at least one higher flexibility area is adapted to reduce a change in the differential pressure between the opposite sides of the at least one higher flexibility area, by reducing the volume of that side of the flexible membrane having the lower pressure and increasing the volume of that side of the flexible membrane having the higher pressure.
The inward flexing of the flexible membrane when the infant relaxes a sucking action, may be adapted to reduce the extent of reverse flow of milk from the mouth of the infant to the inner space of the domed nipple protrusion by the process of enlarging the volume available to the infant for keeping milk within his/her mouth. Alternatively, the outward flexing of the flexible membrane when the infant begins a sucking action, may be adapted to increase the extent of flow of milk from the inner space of the domed nipple protrusion to the mouth of the infant, by enlarging the volume of the inner space of the domed nipple protrusion. Also, the differential pressure sensor unit may be pre-calibrated, such that the differential pressure measured is related to the milk flow through the at least one orifice of the nipple device.
According to yet another implementation of these nipple devices, the differential pressure sensor unit may comprise at least one of:
In any such devices, the base layer of the nipple device may be adapted to be mounted on a breast of a mother providing milk to the infant, or it may be adapted to be mounted on a feeding bottle. Furthermore, advantageously, the at least one differential pressure sensor unit may located in a peripheral region of the base layer of the nipple device.
In accordance with yet further implementations of the presently described devices, there is also provided a nipple device to feed an infant, comprising:
There is further provided according to further embodiments described in this application, a device to monitor a flow of milk drawn by an infant during feeding, the device comprising:
Furthermore, the differential pressure measurement unit may be pre-calibrated such that the differential pressure measured is related to the milk flow through the at least one orifice of the device. The differential pressure measured may also determine the milk flow in real time. Additionally or alternatively, the differential pressure measured may be used to determine the feeding pattern of the infant as a function of time.
In any of these embodiments, the first and the second chambers may be disposed at different circumferential positions in the domed nipple region of the device. At least one of the first walls having increased flexibility is in the form of a thin membrane. Furthermore, at least one of the chambers may be disposed in a region of the domed nipple region having higher rigidity than other regions of the domed nipple region, such that the at least one chamber is more resistant to physical disturbance by the infant. The higher rigidity of the region of the domed nipple device may result from the at least one chamber being formed in a material having stiffer properties than other regions of the domed nipple device.
Additionally, in any of these above mentioned devices the differential pressure measurement unit may comprise two pressure sensors with a subtraction circuit operating on the outputs of the two pressure sensors. It may also comprise a microelectronic chip mounted on the device. A control unit may be used, adapted to convert the output of the differential pressure measurement unit to a measure of the milk flow through the device to the infant. The control unit may be adapted to convert the output of the differential pressure measurement unit to determine the feeding pattern of the infant.
The base layer of any of the above described nipple devices may be connected to the flexible layer that is adapted to be mounted on the breast of a mother providing milk to the infant. Alternatively, it may be adapted to be mounted on a feeding bottle. Also, the differential pressure measurement unit may be transferred to a remote system to be displayed or analyzed.
Furthermore, the first chamber may comprise multiple first chambers and the second chamber may comprise multiple second chambers, the device further comprising multiple passageways to connect the multiple first chamber to a first input of the differential pressure measurement unit, and multiple passageways to connect the multiple second chamber to a second input of the differential pressure measurement unit.
According to yet another implementation of such devices, there is disclosed a nipple shield device to determine milk flow drawn by an infant during feeding, the nipple shield device comprising:
According to a last implementation of devices of this disclosure, to feed an infant, such devise may comprise:
In such a device, the region of the domed protrusion region surrounding the at least one orifice may have a higher flexibility than remaining regions of the domed protrusion region. In such a case, the domed protrusion region surrounding the at least one orifice may have either a thinner thickness or different elastic properties from the remaining regions of the domed protrusion region. Additionally, the inner side of the domed protrusion region surrounding at least one orifice may comprise a region of thickness greater than that of the remaining area, the region having a number of channels within the thickness of that region, these channels leading to the region around the inner orifice opening. Additionally, at least one orifice may has a first inner opening whose ends are fluidly connected to the differential pressure measurement module, and a second outer opening having a larger diameter.
Finally, it is to be understood that references to a differential pressure module or unit or the like, for measurement of the difference between the fluid pressures across the fluid flow resistor, may be understood to relate to separate pressure sensors or to both pressure sensors built into a single unit, but necessarily involving two separate pressure measurements. The terms may thus have been used interchangeably, but should be understood to relate to the same type of measurement.
The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
Reference is first made to
In its simplest implementation, the method shown in the schematic device of
Reference is now made to
Reference is now made to
More complex controllers could be used for outputting a real-time signal proportional to the flow rate such that information can be collected regarding the nature of the infant's feeding habits, the change in feeding action during a feeding session, and, by integrating the signal, the total amount of milk taken by the infant during the whole feeding session. Alternatively, and advantageously, the pressure measurement chip or the control unit can be adapted to transmit its measurements to a remote smart device, such as a mobile phone, where the data can be analyzed and presented. This has the advantage that the control unit 31 can be made much more compact and simpler, since its only function is to export the differential pressure readings to an external control system, where all of the calculations can be executed relating to the milk flow rate, milk quantity or the nature of the feeding process. Furthermore, it has the advantage that the mother or another party can readily read the results of the measurement in real time on a device separate from the nipple device itself. Furthermore, the chip or the control unit or both can be manufactured such that they are transferable from nipple device to nipple device, so that the user only needs one chip or control unit with its electronics, which can be used for many successive nipples.
The nipple device is advantageously formed of a thin layer of flexible material 12, such as a silicone compound, or another suitable flexible polymer, and has a base section 11 from which the dome region 10 extends. The example device shown in
The device shown in
The chambers differ from each other in that they are not equally positioned relative to the centerline of the thickness of the flexible layer in the dome region, as will be more clearly shown in the cross-sectional view of
The chambers have been described (as will be shown more clearly in
The device operation has been explained with the chambers 14 close to the orifice or orifices, such that they are located within the mouth of the infant during the feeding session. Since the infant may distort the flexible layer of the dome structure by physical squeezing or pushing of the flexible layer, and this may distort the motion of the membrane-like wall, and hence the pressure level generated within the chamber, the chambers should be located in a region having a higher rigidity than other parts of the nipple dome, so that they are less disturbed by physical forces. As previously stated, the position in the curved upper part of the dome of the nipple has more resistance to distortion than the lower parts of the dome. An increased resistance to distortion can also be achieved by making the material in the upper part of the nipple dome with a higher rigidity than elsewhere on the dome, either by using a stiffer material in that region, or by making the flexible layer thicker in that region. It is of course to be understood that this increased rigidity relates to the thicker wall of the chamber and not to the membrane-like wall, which should maintain the desired flexibility to respond sufficiently to the variable pressure applied to it.
Reference is now made to
As previously stated, the forward and backward flow of milk through the nipple orifice, caused by the pulsating nature of the infant's sucking, generates a noise level which renders the differential pressure measurement more difficult to perform accurately, and also increases the effort required by the infant to feed from the mother. Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
Reference to
Reference is now made to
The difference between
It is to be emphasized that even though the flexible membrane have been shown applied in
Reference is now made to
In the same way that the infant's tongue may block the feeding orifice from its outer end, the tip of the mother's nipple may inadvertently block the feeding orifice from its inner end. Reference is now made to
Reference is now made to
This location of the fluid flow resistor, in the base peripheral region of the device, is an advantageous alternative to using the feeding orifice as the fluid flow resistor with the problems generated thereby, and measuring the pressure drop across the orifice by means of pressure transferring passageways leading to the outer edge of the device base layer, and measuring the differential pressure at that location.
Reference is now made to
Reference is now made to
Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details have been set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. Furthermore, it is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.
| Number | Date | Country | Kind |
|---|---|---|---|
| 291920 | Apr 2022 | IL | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2023/050356 | 4/3/2023 | WO |
