Milk pumping and feeding system and method

Abstract

Methods and breast pump devices are provided for simultaneous pumping and feeding in a breastfeeding position and quantification of breast milk intake. The breast pump device includes a nipple shield for receiving a nipple, a housing having a throughput opening and a fluid path, the fluid path extending from the nipple shield to the throughput opening, and a negative pressure source. In some embodiments, the housing further includes a gate for controlling the amount of breast milk transferred to the infant. In some embodiments, the gate operates in response to the amount of breast milk transferred to the infant, thereby allowing quantification. In some embodiments, the amount of breast milk transferred is also recorded.

Description

[Background technology]

[0001] Although breastfeeding in the first 6 months of life is very beneficial for achieving optimal growth, development, and health of the child, and also provides many benefits to the mother, the majority of mothers report problems with breastfeeding within the first few days after birth. Many mothers report difficulty in establishing or understanding whether the infant is latching properly at the breast. Furthermore, many mothers also report problems with pain, such as cracked nipples, sores, and bleeding. Furthermore, many mothers are anxious about whether the infant is getting the right amount of breast milk or whether there is enough milk in the mother's milk. As a result, many mothers stop breastfeeding, even though they are fully willing to continue.

[0002] Breast pumps provide a solution to the difficulties of breastfeeding by mechanically extracting breast milk that can then be fed to the infant. However, the breast pumping process is time-consuming and interferes with a mother's ability to care for and bond with her newborn. Summary of the Invention

[0003] The present disclosure relates generally to breast pumps and quantification methods, and more particularly to breast pumps and quantification methods that enable simultaneous pumping and feeding and quantification of breast milk intake in a single feeding session.

[0004] Although breastfeeding in the first six months of life is highly beneficial for achieving optimal growth, development, and health, the majority of mothers report problems with breastfeeding within the first few days after birth. Breast pumps allow mothers to express breast milk, which the infant can then receive from a volume-labeled bottle, but currently available breast pumps do not allow a mother to simultaneously express breast milk and feed the expressed milk to her infant in the nursing position.

[0005] It would therefore be beneficial to provide a device that allows for simultaneous pumping and feeding in a breastfeeding position, even in the presence of obstacles such as difficulty in properly latching, the development of painful nipple sores or cracks, and concerns about whether adequate milk supply is in place. Providing this alternative feeding method is particularly important in the early postpartum period when the mother-infant dyad is establishing the bond of breastfeeding routines and rhythms, which is also the time when breastfeeding dropout rates are highest among mothers who wish to breastfeed. Furthermore, this device may be particularly beneficial for premature infants who are immunocompromised or unable to properly suck or latch until they are more mature. Simultaneous pumping and feeding with the same device allows the mother to care for the infant while pumping by being able to breastfeed or hold the infant as in natural feeding. The proximity of the infant when feeding from the device at the breast also allows for continued bonding and mimics the progression of breastfeeding, building intimacy between mother and infant for transition or implementation to breastfeeding. Furthermore, because breast milk is produced by positive feedback on the amount of breast milk removed from the breast (and not by the amount of milk consumed), simultaneous pumping and nursing facilitates removal of breast milk from the breast in amounts mediated by the infant's needs, thereby precisely regulating future milk production in the breast. In contrast, feeding the infant formula without pumping every time the infant needs it would falsely indicate a decreased need for milk production at the breast. Research has shown that milk removed from the breast during the first weeks postpartum is a concrete indication of the number of milk receptor sites created in the breast, which in turn affects the maximum amount of milk production over the following months. For this reason, facilitating the ease of milk removal from the breast during this period to feed the infant prepares the infant for optimal breast milk production.The ability to feed an infant while pumping also saves time by allowing a mother to feed her infant without first manually transferring the expressed or stored breast milk into a bottle for consumption at a time separate from the pumping process. Thus, to address this need, a device is provided that pumps breast milk and simultaneously makes the expressed breast milk available for consumption by the infant from a nipple attachment.

[0006] The embodiments of the present invention encompass a pumping and feeding system and method that provides controlled, measured dispensing and sensing of breast milk. Advantageously, such systems and methods are well suited for use with infants requiring intensive care, such as infants admitted to neonatal intensive care units (NICUs). According to some embodiments, the systems and methods are used to provide administered milk to infants in the NICU. For infants monitored in the NICU, it is important to know how much breast milk or formula they are receiving by oral feeding to manage weight gain. Infants in the NICU benefit greatly from quantified and facilitated pumping and feeding, as every drop of breast milk provides much-needed protection against diseases that can lead to serious complications, such as GI respiratory infections that can lead to surgical intervention. As an example, the American Academy of Pediatrics cites that the provision of human milk during a NICU stay reduces the risk of necrotizing enterocolitis by 77%. For this reason, NICU mothers are often most encouraged and motivated to express exclusively (exclusive expression refers to providing all nutrition through breast milk by pumping at 2-3 hourly intervals throughout the day and night). With a device that quantifies the amount of expressed breast milk dispensed to or ingested by the infant, the mother and medical team can continue to track the amount received without switching to a bottle or reading volumetric indications and manually calculating and recording feeding amounts. Furthermore, the lateral or pace-feeding position that the infant assumes to drink from the mother's expressed reservoir mimics facing the breast while lying or cross-holding, promoting safe swallowing for preterm infants. The lateral position allows milk to pool within the infant's cheeks, allowing the infant to swallow when ready. At gestational age, when the suck-swallow-breathe system may not be established, this prevents the infant from inadvertently aspirating or choking on milk in the reclining position often used for older infants.

[0007] In one aspect of the invention, the device is capable of both expressing milk and feeding the baby simultaneously from the same apparatus. The device may utilize negative pressure to induce the expression of milk from the breast. The device may comprise a housing comprising a nipple shield and a negative pressure source. The housing may further comprise a fluid path from the nipple shield for the breast to a nipple attachment for the baby. The housing may be sized and the nipple attachment oriented to allow the baby to take milk from the nipple attachment in a feeding position.

[0008] In another aspect of the invention, the device comprises a storage container for receiving excess breast milk not ingested by the infant during a feeding session. The breast milk storage container may comprise a standard thread for engaging with a nipple attachment to allow subsequent intake. Alternatively, the breast milk storage container may comprise an opening through which breast milk may be transferred into a bottle or breast milk storage bag to allow subsequent intake. By isolating breast milk exposed to the infant's saliva from the stored milk by the presence of a one-way valve or gate mechanism, a maximum safe storage time can be achieved for the stored milk, even if the infant is drinking at the same time. Storing milk while simultaneously meeting the nutritional needs of the infant also allows for a better controlled creation of a supply of milk to be used for future nutrition in the event that the mother weans the infant or ceases breastfeeding at the breast.

[0009] Furthermore, when the device is used to simultaneously express milk from a first breast and feed the baby, a second device can be used to express milk from the second breast into a breast milk storage container for subsequent intake.

[0010] It would also be beneficial to quantify the breast milk ingested by the infant and transmit and record that intake data for caregivers and health care providers. Instant quantification of breast milk ingested by the infant allows the mother to know if and how much breast milk the infant is receiving during a given feeding session and gestational age. This also allows for documentation of the breast milk transferred to the infant during each feeding session and for such data to be easily shared with health care providers. This quantification of the milk dispensed to the infant promotes the mother's confidence that the infant has received sufficient nutrition. Thus, to address this need, a device is provided that simultaneously pumps milk and makes the pumped breast milk available for intake by the infant from a nipple attachment, while quantifying the intake of breast milk.

[0011] In one aspect of the invention, the device includes an infrared sensor configured to quantify the breast milk transferred to the infant. The breast milk taken by the infant can be quantified by a series of built-in sensors that indicate whether a reserve breast milk receptacle or delivery tube of a defined volume is full or empty. The sensor can trigger a gate to allow more breast milk to be filled into the receptacle or delivery tube when empty, or to block the breast milk when full. Counting how many times a defined volume is filled can provide instant quantification of breast milk intake. This defined volume can range from about 0.1 mL to about 15 mL. Furthermore, the infrared sensor can transmit the quantification data to a personal device via a Bluetooth® connection for viewing by a caregiver or health care provider during the feeding session or at a later date. Embodiments of the invention also encompass systems and methods involving a device having a flexible compartment that collapses due to suction from the infant and a peristaltic pump to refill the flexible compartment, facilitating quantification of breast milk transferred to the infant. The collapse of the flexible compartment containing the small magnets is sensed by a Hall effect sensor, at which point a bolus of milk is pushed forward into the flexible compartment by the peristaltic motor. The number of rotations of the peristaltic motor and the inner diameter of the tubing being acted upon by peristalsis determine the amount of milk dispensed to the infant.

[0012] In another aspect of the invention, the device may embody a negative pressure source or may be compatible with commercially available negative pressure devices. According to some embodiments, the system and method may involve the use of the device to add, in whole or in addition, needed supplements, medications, or alternative nutrition such as formula to the expressed breast milk. This may be used to quantify food or other liquids while still in the feeding position, to fortify the breast milk with other ingredients such as formula or vitamins, or to add medications for ingestion alone or with other contents of the device. According to some embodiments, the system and method may involve the use of the device by any individual other than the mother (or individual producing the breast milk), such as a father or alternative caregiver. The other individual may dispense fluids to the infant, may assume a familiar feeding position and benefit from the associated bonding, and / or may also receive quantified amounts that can be recorded or shared through an application or other software for installation and execution on a computer, tablet, smartphone, or other electronic device.

[0013] In yet another aspect, embodiments of the present invention encompass a system for indicating an amount of feeding fluid dispensed to an individual. An exemplary system can include a chamber for storing the feeding fluid, a dosing mechanism for receiving the feeding fluid from the chamber and dispensing individual packets of the feeding fluid, each individual packet having an individual packet volume, a feeding device for receiving the feeding fluid dispensed by the dosing mechanism and allowing the feeding fluid to flow through an outlet of the feeding device to a mouth of the individual, a sensor assembly for determining when the feeding device is available to receive a new individual packet of feeding fluid dispensed from the dosing mechanism, and a counting mechanism for registering a count for each dispensing event performed by the dosing mechanism. In some cases, the system can include a processor for determining an amount of feeding fluid dispensed to the individual based on the individual packet volumes and the number of registered counts. In some cases, the dosing mechanism includes a peristaltic pump. In some cases, the sensor assembly includes a Hall effect sensor. In some cases, the system further includes a collapsible chamber for receiving the individual packets of feeding fluid dispensed by the dosing mechanism and allowing the individual packets of feeding fluid to flow toward the outlet of the feeding device. In some cases, the system further includes a magnet operatively associated with the collapsible chamber. In some cases, the sensor assembly determines that the peristaltic pump should dispense a new individual packet of the feed fluid when the magnet reaches a first distance away from the Hall effect sensor and determines that the peristaltic pump should pause when the magnet reaches a second distance away from the Hall effect sensor, the first distance being greater than the second distance. In some cases, the dosing mechanism includes a gate and a tube, the sensor assembly includes a full sensor and an empty sensor, the gate allows the passage of the feed fluid through the tube when the empty sensor indicates that the tube is empty of the feed fluid, and the gate prevents the passage of the feed fluid through the tube when the full sensor indicates that the tube is full of the feed fluid. In some cases, the dosing mechanism includes a first compressible chamber and a second compressible chamber, the first compressible chamber and the second compressible chamber alternately filling and dispensing the feed fluid.In some cases, the feeding device includes a first compressible chamber and a second compressible chamber, the first compressible chamber and the second compressible chamber alternately filling and dispensing the feeding fluid. In some cases, the system includes a first compressible chamber and a second compressible chamber, the first compressible chamber and the second compressible chamber alternately filling and dispensing the feeding fluid. In some cases, the system can further include a sensor, such as a capacitance sensor or an infrared sensor, configured to detect an amount of feeding fluid present in the chamber. In some cases, the system is configured to send a signal to cause additional feeding fluid to flow into the chamber based on the detected amount of feeding fluid.

[0014] In another aspect, an embodiment of the present invention encompasses a mobile computing device configured to display operational information of a fluid delivery system. An exemplary mobile computing device can include a screen, a processor, an electronic storage location operatively associated with the processor, and processor-executable code stored on the electronic storage location and embodied in a tangible, non-transitory computer-readable medium. The processor-executable code, when executed by the processor, can cause the processor to generate a graphical user interface on the screen, the graphical user interface including a display of feeding-fluid dispensed orally from the fluid delivery system to the individual. The display can be based on counts registered by a counting mechanism of the fluid delivery system, each count corresponding to an individual packet of feeding-fluid dispensed by a dosing mechanism of the fluid delivery system. In some cases, the display includes an amount of feeding-fluid dispensed from the fluid delivery system to the individual during a single feeding session. In some cases, the display includes an amount of feeding-fluid dispensed from the fluid delivery system to the individual during multiple feeding sessions. In some cases, the display includes a time indicator for the feeding sessions.

[0015] In another aspect, embodiments of the present invention encompass a method for indicating an amount of a feeding fluid dispensed to an individual. An exemplary method can include storing the feeding fluid in a chamber, receiving the feeding fluid from the chamber at a dosing mechanism, and dispensing individual packets of the feeding fluid from the dosing mechanism to a feeding device, each individual packet having an individual packet volume. The feeding device can make the feeding fluid available for oral ingestion by the individual. The method can also include using a sensor assembly to determine when the feeding device is available to receive a new individual packet of feeding fluid dispensed from the dosing mechanism. The method can further include using a counting mechanism to register a count for each dispense event performed by the dosing mechanism. In some cases, the method can include using a processor to determine an amount of feeding fluid dispensed to the individual based on the individual packet volumes and the number of registered counts. In some cases, the dosing mechanism can include a peristaltic pump. In some cases, the sensor assembly can include a Hall Effect sensor. In some cases, the method further includes receiving, at the collapsible chamber, the individual packet of feeding fluid dispensed by the dosing mechanism and directing the individual packet of feeding fluid from the collapsible chamber toward the feeding device. In some cases, the collapsible chamber is coupled to a magnet, and the sensor assembly determines that the peristaltic pump should dispense a new individual packet of feeding fluid when the magnet reaches a first distance away from the Hall effect sensor and determines that the peristaltic pump should pause when the magnet reaches a second distance away from the Hall effect sensor, the first distance being greater than the second distance. In some cases, the dosing mechanism includes a gate and a tube, and the sensor assembly includes a full sensor and an empty sensor, and the method further includes using the gate to allow passage of feeding fluid through the tube when the empty sensor indicates that the tube is empty of feeding fluid and using the gate to prevent passage of feeding fluid through the tube when the full sensor indicates that the tube is full of feeding fluid.In some examples, the dosing mechanism includes a first compressible chamber and a second compressible chamber, and the method further includes alternating between filling and dispensing the supply fluid by the first compressible chamber and the second compressible chamber. In some examples, the supply device includes a first compressible chamber and a second compressible chamber, and the method further includes alternating between filling and dispensing the supply fluid by the first compressible chamber and the second compressible chamber. In some examples, the system includes a first compressible chamber and a second compressible chamber, and the method further includes alternating between filling and dispensing the supply fluid by the first compressible chamber and the second compressible chamber. In some cases, the method further includes detecting an amount of supply fluid present in the chamber using a capacitance sensor and sending a signal to cause additional supply fluid to flow into the chamber based on the detected amount of supply fluid. In some cases, the method further includes detecting an amount of supply fluid present in the chamber using an infrared sensor, and sending a signal to cause additional supply fluid to flow into the chamber based on the detected amount of supply fluid. In some examples, the method may further include displaying, on a graphical user interface of a screen of the mobile computing device, an indication of the amount of feeding fluid being ingested by the infant. In some cases, the indication may include an amount of feeding fluid ingested by the infant during a single feeding session. In some cases, the indication may include an amount of feeding fluid ingested by the infant during multiple feeding sessions.

[0016] In yet another aspect, embodiments of the present invention encompass breast pump systems and methods for simultaneous pumping and feeding. An exemplary breast pump can include a breast flange for receiving a nipple, a housing having a throughput opening and a fluid path, the fluid path extending from the breast flange to the throughput opening, and a negative pressure source. In some cases, the housing further includes a negative pressure source. In some cases, the negative pressure source is external to the housing. In some cases, the breast pump further includes a nipple attachment. In some cases, the housing further includes a nipple attachment recess for receiving the nipple attachment. In some cases, the breast pump further includes a first check valve adjacent the negative pressure source and the nipple protector. In some cases, the breast pump further includes a second check valve adjacent the nipple protector and the priming chamber. In some cases, the breast pump further includes a third check valve adjacent the dosing tube and the nipple attachment. In some cases, the fluid pathway includes a priming chamber and a dosing tube, the dosing chamber having a first end, a second end, and an internal cavity. In some cases, the breast pump further includes a milk storage container having an opening. In some cases, the priming chamber includes an overflow opening configured to allow fluid to flow from the priming chamber through the opening in the milk storage container and into the milk storage container. In some cases, the fluid pathway has a first compartment adjacent to the nipple shield and a second compartment adjacent to the throughput opening. In some cases, the housing further includes a gate capable of preventing fluid flow between the first compartment of the fluid pathway and the second compartment of the fluid pathway. In some cases, the housing further includes a first sensor adjacent to the gate. In some cases, the housing further includes a second sensor adjacent to the throughput opening.

[0017] In another aspect, an embodiment of the invention encompasses a method for simultaneous pumping and feeding, comprising pumping breast milk from a breast using a breast pump having a nipple shield for receiving a nipple, a housing having a fluid pathway and a throughput opening, the fluid pathway extending from the nipple shield to the throughput opening, a negative pressure source, and a nipple attachment. The method may also include collecting breast milk in the fluid pathway and positioning an infant to receive the breast milk via the nipple attachment. Additionally, the method may include transferring the breast milk to the infant in discrete amounts. In some methods, the fluid pathway has a first compartment adjacent the nipple shield and a second compartment adjacent the throughput opening. In some methods, the housing may further include a gate capable of preventing fluid flow between the first compartment of the fluid pathway and the second compartment of the fluid pathway. In some methods, the gate is manually controlled. In some methods, the gate is electronically controlled. In some methods, the housing further includes a first sensor adjacent to the gate, the first sensor configured to close the gate when the second compartment of the fluid pathway is full and / or open the gate when the second compartment of the fluid pathway is not full. In some methods, the housing further includes a second sensor adjacent to the throughput opening, the second sensor configured to open the gate when the second compartment of the fluid pathway is empty.

[0018] In yet another aspect, an embodiment of the invention encompasses a method for simultaneous pumping and feeding, comprising pumping breast milk from a breast using a breast pump having a nipple shield for receiving a nipple, a housing, a throughput opening, a fluid pathway extending from the nipple shield to the throughput opening, the fluid pathway having a first compartment adjacent the nipple shield and a second compartment adjacent the throughput opening, the second compartment having a defined volume, and a gate capable of preventing fluid flow between the first compartment of the fluid pathway and the second compartment of the fluid pathway, a negative pressure source, and a nipple attachment. The method also includes collecting breast milk in the first compartment of the fluid pathway, opening the gate to allow breast milk to fill the second compartment of the fluid pathway, closing the gate when the second compartment of the fluid pathway is full, positioning the baby to receive breast milk via the nipple attachment, and recording a volume of breast milk intake. In some cases, the method also includes transmitting breast milk intake data to an external device. In some cases, the breast pump may also include a mechanism for sensing collapse of the bag using a Hall effect sensor system, which triggers the action of a peristaltic pump to dispense milk to the infant, allowing quantification. Optionally, the milk container can be used as part of the peristaltic pump by being a backing to provide back pressure to the peristaltic rollers. In some cases, the breast pump includes a collapsible compartment using a magnet / Hall effect and peristaltic tubing for oral dosing on demand. In some cases, the breast pump is configured to monitor the amount someone drinks on demand, down to very small amounts.

[0019] As disclosed herein, the breast pump system can include a nipple attachment that reduces the number of components by incorporating a one-way valve in the assembly. The embodiments of the systems and methods disclosed herein can provide multiple nipple shapes and sizes that allow the user to change the nipple assembly. The breast pump system can also include valves in the fluid path that operate to prevent backflow in multiple areas of the fluid path. Increasing the number of valves can prevent leakage upon disassembly. In some cases, the diaphragm separator used to create vacuum suction at the breast can be provided as two pieces (two smaller diaphragms that add up to the same volume). In some cases, the spout of the milk container can have a cap that allows ventilation and can close the container to prevent leakage. The cap can have three positions: (1) a position in which the milk container is closed, (2) a position in which the milk container is allowed to vent, and (3) a position in which the milk container is fully open and ready to pour the expressed milk into a bottle.

[0020] These and other embodiments are described in further detail in the following description taken in conjunction with the accompanying drawings. Particular embodiments of the disclosed devices, delivery systems, or methods are now described with reference to the drawings. In this detailed description, it is not intended to imply that any particular component, feature, or step is essential to the invention. [Brief description of the drawings]

[0021] [Figure 1] FIG. 1 shows a front view of a breastmilk pumping and feeding device according to some embodiments. [Diagram 2] 1 illustrates a housing configuration according to some embodiments. [Diagram 3] 1 illustrates a breast milk storage container configuration, according to some embodiments. [Figure 4]1 illustrates an internal configuration of a housing according to some embodiments. [Diagram 5] 1 illustrates an exploded view of the internal components of a housing according to some embodiments. [Figure 6] 1 shows a flowchart illustrating a method for quantifying breast milk transferred to an infant, according to some embodiments. [Figure 6A] 1 shows a flowchart illustrating a method for quantifying breast milk transferred to an infant, according to some embodiments. [Figure 7] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 8] 1 illustrates an exploded view of a breast pumping and feeding device according to some embodiments. [Figure 9] 1 shows an exploded view of the upper components of a breast pumping and feeding device according to some embodiments. [Figure 9A] 1 illustrates aspects of a backflow protector for a breast pumping and feeding device, according to some embodiments. [Figure 10] 1 shows an exploded view of the upper components of a breast pumping and feeding device according to some embodiments. [Figure 11] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 11A] 13A-13D show aspects of a grommet mechanism for a breast pumping and feeding device, according to some embodiments. [Figure 12A] 1 illustrates aspects of a nipple shield and associated components of a breast pumping and feeding device, according to some embodiments. [Figure 12B] 1 illustrates aspects of a nipple shield and associated components of a breast pumping and feeding device, according to some embodiments. [Figure 12C] 1 illustrates aspects of a nipple shield and associated components of a breast pumping and feeding device, according to some embodiments. [Figure 12D] 1 illustrates aspects of a nipple shield and associated components of a breast pumping and feeding device, according to some embodiments. [Figure 13A]1 illustrates aspects of a nipple shield and associated components of a breast pumping and feeding device, according to some embodiments. [Figure 13B] 1 illustrates aspects of a nipple shield and associated components of a breast pumping and feeding device, according to some embodiments. [Figure 14A] 13A-13D show aspects of a vent valve for a breast pumping and feeding device, according to some embodiments. [Figure 14B] 13A-13D show aspects of a vent valve for a breast pumping and feeding device, according to some embodiments. [Figure 15A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 15B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 15C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 16A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 16B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 17A] 1 illustrates aspects of a nipple attachment for a breast pumping and feeding device, according to some embodiments. [Figure 17B] 1 illustrates aspects of a nipple attachment for a breast pumping and feeding device, according to some embodiments. [Figure 17C] 1 illustrates aspects of a nipple attachment for a breast pumping and feeding device, according to some embodiments. [Figure 17D] 1 illustrates aspects of a nipple attachment for a breast pumping and feeding device, according to some embodiments. [Figure 18] 1 illustrates aspects of a graphic user interface according to some embodiments. [Figure 19] 1 illustrates aspects of a graphic user interface according to some embodiments. [Figure 20] 1 illustrates aspects of a computer system according to an embodiment of the present invention. [Figure 21A]1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21F] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21G] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 21H] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21I] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21J] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21K] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21L] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21M] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21N] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 21O] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 22A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 22B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 22C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 22D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 22E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 23A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 23B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 24A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 24B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 24C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 24D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 24E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 25A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 25B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 25C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 25D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 25E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 25F] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 26A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 26B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 26C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 26D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 27A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 27B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 27C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 27D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 27E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 28A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 28B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 28C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 29A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 29B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 29C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 30A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 30B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 31A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 31B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 31C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 32A]1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 32B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Diagram 33] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 34A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 34B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 34C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 34D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 34E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 35A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 35B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 35C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 35D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 36A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 36B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 36C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 36D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 37A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 37B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 37C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 37D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 38A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 38B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 38C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 38D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 38E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 38F] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 39A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 39B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 39C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 40A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 40B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 40C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 40D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 40E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 41A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 41B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 41C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 41D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 41E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig.41F] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 42A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 42B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 42C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig.42D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 42E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig.42F] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig.42G] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 43A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 43B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 43C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 44A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 44B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 44C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 45A]1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 45B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 46] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 47A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 47B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 47C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 47D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 48A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 48B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 49] 1 illustrates aspects of a method for breastfeeding, according to some embodiments. [Figure 50A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 50B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 50C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 50D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 51A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 51B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 51C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 51D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 52A]1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 52B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 53A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 53B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 54A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 54B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 54C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 54D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 55A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 55B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 55C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 55D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 56A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 56B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 56C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 56D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 57A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 57B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 57C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 57D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 58A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 58B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 58C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 59A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 59B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 59C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 59D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 60A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 60B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 60C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 60D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 61A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 61B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 61C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 62A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 62B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 62C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig.62D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 62E] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 63A] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 63B] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Figure 63C] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. [Fig. 63D] 1 illustrates aspects of a breast pumping and feeding device, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Particular embodiments of the disclosed devices and methods of use will now be described with reference to the drawings. In this detailed description, no intention is intended to imply that any particular component, feature, or step is essential to the invention.

[0023] It would be desirable to provide improved breast pump devices and methods that overcome some of the challenges of existing devices. For example, it would be desirable to provide a device that is capable of both pumping milk and feeding an infant simultaneously from the same device. Additionally, it would be desirable to provide a device that is capable of quantifying the amount of milk transferred to the infant, and transmitting and recording that intake data for caregivers and health care providers. The embodiments described herein address at least some of these challenges and advantages.

[0024] The devices and methods as disclosed herein provide a breast pump capable of pumping milk and simultaneously feeding an infant. A breast pump as described herein can be used in a hospital environment or at home. In some embodiments, a breast pump as provided herein can further quantify the amount of breast milk transferred to the infant. Although the specific description disclosed herein refers to dispensing a feeding fluid to an infant (e.g., a child under the age of one), it will be understood that embodiments of the invention encompass dispensing a feeding fluid to any breast-feeding child or any individual ingesting a feeding fluid.

[0025] In some embodiments, the system includes an integrated pump / feed / counting device having peristaltic pump, collapsible chamber, and counter features. In some embodiments, the system includes a peristaltic on-demand dosing bottle. In some embodiments, the system includes a feeding and pumping device. In some embodiments, the system includes a pneumatic counting mechanism.

[0026] In some instances, certain terms may be used interchangeably. For example, in some embodiments, the terms "feeding bag", "compressible chamber", "compressible bag", "collapsible chamber", "collapsible compartment", and "compressible compartment" may be used interchangeably. In some embodiments, a "milk pumping and feeding device" may refer to a "milk pumping, feeding and quantification device" or vice versa, depending, for example, on the combination of elements included within the device. In some embodiments, the terms "nipple ring", "nipple attachment", "smart nipple", and "nipple component" may be used interchangeably. In some embodiments, the terms "nipple shield" and "breast flange" may be used interchangeably. In some embodiments, the terms "nipple", "artificial nipple", and "feeding device" may be used interchangeably.

[0027] In some embodiments, a system for determining the amount of feeding fluid being transferred or dispensed to an infant includes elements such as a chamber for storing the feeding fluid, a dosing mechanism that receives individual packets of feeding fluid from the chamber (each individual packet having an individual packet volume), a compressible chamber or feeding bag that receives the individual packets of feeding fluid from the dosing mechanism, a nipple that receives the feeding fluid from the feeding bag and allows the feeding fluid to flow to the infant, a sensor that detects when the feeding bag is available to receive a new individual packet of feeding fluid from the dosing mechanism, and a counting mechanism that registers a count each time the dosing mechanism dispenses a new individual packet of feeding fluid into the feeding bag. In some embodiments, the system further includes a processor that determines the amount of feeding fluid being dispensed to the infant based on the individual packet volumes and the number of registered counts. In some embodiments, the sensor is not a flow sensor that reads the amount of milk flowing through the line. In some cases, the number of revolutions can be counted using manual counting methods and / or analog counting methods. In some embodiments, the number of revolutions of the peristaltic pump is counted using a Hall effect sensor. In some embodiments, the number of revolutions of the peristaltic pump can be counted by a magnetic encoder. Embodiments of the present invention encompass the use of any of a variety of counting mechanisms to count the number of revolutions (or partial revolutions) of the peristaltic pump that can cause the dispensing of a discrete volume of delivery fluid from the dosing mechanism.

[0028] FIG. 1 shows a front view of the housing 20 of the breast pumping and feeding device 10. The housing 20 can be made from molded plastic or a similar material. In some embodiments, the housing 20 includes a nipple attachment recess 24 and a throughput opening 25. The nipple attachment recess 24 can be about 1 mm to about 50 mm deep and can be circular, oval, or any other shape to accommodate nipple attachment components of various sizes (e.g., component 80 as shown in FIG. 4). The throughput opening 25 can be circular and sized to allow breast milk to exit the device 10. In some embodiments, the throughput opening 25 can be sized to accommodate a check valve (e.g., component 73 as shown in FIG. 4). In some embodiments, the breast pumping and feeding device 10 can be pre-configured with a breast milk storage container 30 in place. The breast milk storage container 30 can be positioned below or behind the nipple attachment recess 24. The breast milk storage container 30 can be made from food grade plastic, silicone, or a similar material. In some embodiments, the housing 20 further comprises a pump power button 21, a pump decrease button 22, and an increase button 23. The pump power button 21 can power a negative pressure source and can power sensors internal to the device. The decrease button 22 and the increase button 23 can control the level of negative pressure (e.g., when provided by the negative pressure source). The decrease button 22 and the increase button 23 can control the frequency of negative pressure (e.g., when provided by the negative pressure source).

[0029] FIG. 2 shows a perspective view of the housing 20. The housing 20 can be made of molded plastic or similar material. In some embodiments, the housing 20 includes a nipple attachment recess 24 and a throughput opening 25. The nipple attachment recess 24 can be about 1 mm to about 50 mm deep and can be circular, oval, or any other shape to accommodate nipple attachments of various sizes. The throughput opening 25 can be circular and sized to allow milk to exit the device 10. In some embodiments, the housing 20 further includes a pump power button 21, a pump decrease button 22, and an increase button 23. The pump power button 21 can power or be operably associated with a negative pressure source, and can power or be operably associated with one or more sensors within the breast pumping and feeding device. The decrease button 22 and the increase button 23 can control the level of negative pressure (e.g., as provided by the negative pressure source). The decrease button 22 and the increase button 23 can control the frequency of negative pressure (e.g., as provided by a negative pressure source). The housing 20 can have an outer profile 26 that is shaped to approximate a breast. The outer profile 26 can optionally include a soft or plush outer layer for interfacing with the baby. The housing 20 can further include a container cavity 27 that is sized and shaped to receive a breast milk storage container (e.g., component 30 as shown in FIG. 1).

[0030] FIG. 3 shows a perspective view of a breast milk storage container 30, according to some embodiments. The breast milk storage container 30 can be made of food grade plastic, silicone, or similar materials. The breast milk storage container 30 can be cylindrical, rectangular, or any other shape. The breast milk storage container 30 can include an opening 31 for receiving breast milk. The opening 31 can be circular, rectangular, or any other shape. The breast milk storage container 30 can further include one or more volume indicia 32 and a unit of measurement indicia 33. The unit of measurement indicia 33 can indicate ounces or milliliters, or another volume unit. The volume indicia 32 can be positioned to indicate, for example, one ounce of breast milk. The volume indicia 32 can be repeated, for example, to indicate additional ounces or volumes of breast milk. In some embodiments, the volume capacity of the breast milk storage container 30 can range from about 1 ounce to about 14 ounces.

[0031] FIG. 4 shows the internal configuration of the housing of the system 10A, according to some embodiments. The housing 20 can be made of molded plastic or similar material. In some embodiments, the housing 20 further comprises a pump power button 21, a pump decrease button (e.g., component 22 as shown in FIG. 1), and an increase button 23. The pump power button 21 can power or be operably associated with a negative pressure source 28, which can power or be operably associated with one or more sensors within the breast pumping and feeding device. The increase button 23 can control the level of negative pressure (e.g., when provided by the negative pressure source). The increase button 23 can control the frequency of negative pressure (e.g., when provided by the negative pressure source). The housing 20 can have an outer profile 26 that is shaped to approximate a breast. The outer profile 26 can optionally include a soft or plush outer layer for interfacing with the baby. The housing 20 can be pre-configured to have a breast milk storage container 30 in place. The breast milk storage container 30 may be made from food grade plastic, silicone, or similar materials.

[0032] The housing 20 may further comprise a nipple shield 40 for receiving the nipple 91 on the breast 90. The nipple shield 40 may be provided in a variety of funnel sizes to accommodate and support the varying nipple 91 sizes. The nipple shield 40 may create a seal around the nipple 91. Milk may flow or otherwise move or be expressed from the nipple 91 into an internal chamber 42 defined by the nipple shield. The nipple shield 40 may be snap-fitted into the housing 20 to allow the nipple shield 40 to be removed for cleaning. The housing 20 may further comprise a connection 50 to an external negative pressure source 28, a channel 53, a first check valve or flow control mechanism 51, and a second check valve or flow control mechanism 52. The channel 53 allows negative pressure to be applied to the first check valve 51 of the nipple attachment and the nipple attachment 40. In this manner, negative pressure may be created, regulated, or otherwise controlled within the internal chamber 42 of the nipple shield 40 by operation of the negative pressure source 28. The first check valve 51 may be positioned adjacent the channel 53 and the nipple shield 40. The first check valve 51 may be configured to prevent milk from migrating from the internal chamber 42 of the nipple shield 40 into the channel 53. In this manner, the breast pumping and feeding device may provide and / or control fluid communication between the negative pressure source 28 and the internal chamber 42 of the nipple shield 40 (e.g., when a seal exists between the nipple shield 40 and the skin at or near the nipple 91).

[0033] In some embodiments, the housing 20 may further comprise a priming chamber 60. In some cases, as further discussed elsewhere herein, the housing may not include a priming chamber. The second check valve 52 may be configured to only allow breast milk to flow from the internal chamber 42 of the nipple shield 40 into the priming chamber 60. The priming chamber 60 may be made of food grade plastic, silicone, or similar material. The priming chamber 60 may have a volume capacity of about 5 milliliters to about 30 milliliters. The priming chamber 60 may be cylindrical or any other shape and may be open at one end. The priming chamber 60 may further comprise a priming chamber cap 62. The priming chamber cap 62 may be configured to close the open end of the priming chamber 60 during use and may be detached from the priming chamber 60 after use to allow for cleaning. The housing 20 may further comprise a priming sensor 61 adjacent to the priming chamber 60. The priming sensor 61 may be configured to determine if a specified amount of breast milk is present in the priming chamber 60. The priming sensor 61 may be infrared, inductive, or of any other configuration. In this manner, the breast pumping and feeding device may provide and / or control fluid communication between the interior chamber 42 of the nipple shield 42 and the priming chamber 60 (e.g., when a seal exists between the nipple shield 40 and the skin at or near the nipple 91).

[0034] The housing 20 may include a dosing tube 70, a third check valve or flow control mechanism 73, and a nipple attachment 80. The dosing tube 70 may be made of food grade plastic, silicone, or similar materials. In some embodiments, such a tube 70 may be actuated using a peristaltic pump mechanism, as discussed elsewhere herein. The dosing tube 70 may be about 20 milliliters to about 70 millimeters in length. The dosing tube 70 may have a volume capacity of about 0.3 milliliters to about 5 milliliters. The dosing tube 70 may extend adjacent to or into the priming chamber 60, such that there may be a fluid pathway between the dosing tube 70 and the priming chamber 60. The dosing tube 70 may provide a fluid pathway from the priming chamber 60 to the third check valve 73. The dosing tube 70 may snap into the check valve 73. The dosing tube 70 may be removed from the housing 20 for cleaning. The check valve 73 may be configured to allow fluid to flow from the delivery tube 70 to the teat attachment 80 and to prevent fluid from flowing from the teat attachment 80 to the delivery tube 70. In this manner, the milking and feeding device may provide and / or control fluid communication between the priming chamber 60 and the delivery tube 70, as well as between the delivery tube 70 and the teat attachment 80. The teat attachment 80 may be sized and shaped to approximate the teat 91. The housing 20 may further comprise a gate 74, a full sensor 75, and an empty sensor 76. As discussed further elsewhere herein, in some embodiments, the housing may not include a full sensor and / or an empty sensor. The full sensor 75 may be configured to indicate whether the delivery tube 70 is full of fluid. The empty sensor 76 may be configured to indicate whether the delivery tube 70 is empty. Gate 74 may be configured to clamp dispensing tube 70 to prevent fluid flow unless empty sensor 76 indicates that dispensing tube 70 is empty.The full sensor 75 and empty sensor 76 may be infrared, inductive, or of any other configuration.

[0035] Thus, an embodiment of the present invention encompasses the use of a system 10A for determining an amount of feeding fluid being ingested by an infant, the system including a chamber for storing feeding fluid and a dispensing mechanism for receiving the feeding fluid from the chamber and dispensing individual packets of the feeding fluid, each individual packet having an individual packet volume. The system further includes a nipple for receiving the feeding fluid dispensed by the dispensing mechanism and allowing the feeding fluid to flow to the infant, and a sensor assembly for determining when the dispensing mechanism is ready to dispense a new individual packet of feeding fluid. Additionally, the system may include a counting mechanism for registering a count for each dispensing event performed by the dispensing mechanism, and a processor for determining an amount of feeding fluid being ingested by the infant based on the individual packet volumes and the number of registered counts.

[0036] FIG. 5 shows an exploded view of the internal components of the housing, according to some embodiments. The housing 20 (e.g., as shown in FIG. 1) may include a nipple shield 40. The nipple shield 40 may be provided in a variety of funnel sizes. Furthermore, the nipple shield 40 may include an opening 41. The nipple shield 40 may have or define an internal chamber 42. The housing 20 (e.g., as shown in FIG. 1) may further include a channel 53, a first check valve 51, and a second check valve 52. The channel 53 allows negative pressure (e.g., from a negative pressure source 28) to be applied to the first check valve 51 of the nipple attachment and the nipple attachment 40. The first check valve 51 may be positioned adjacent to the channel 53 and the nipple shield 40. The first check valve 51 may be configured to prevent milk from migrating from the internal chamber 42 into the channel 53. The first check valve 51 can be configured to allow flow from the channel 53 into the internal chamber 42. In some embodiments, the housing 20 (e.g., as shown in FIG. 1) can further comprise a priming chamber 60. In some cases, as discussed elsewhere herein, the housing may not include a priming chamber. The second check valve 52 can be snap-fitted into the opening 41 of the nipple shield 40. The second check valve 52 can be configured to only allow breast milk to flow from the internal chamber 42 into the priming chamber 60. The second check valve 52 can be configured to prevent flow from the priming chamber 60 into the internal chamber 42. The priming chamber 60 can be made from food-grade plastic, silicone, or similar materials. The priming chamber 60 can replace or be referred to as a feeding bag and can have a volume capacity of 5 to 30 milliliters. The priming chamber 60 can be cylindrical or any other shape and can be open at one end. The priming chamber 60 may further include a priming chamber cap 62 .The priming chamber cap 62 can be configured to close the open end of the priming chamber 60 during use and can be removed from the priming chamber 60 after use to allow for cleaning. The housing 20 (e.g., as shown in FIG. 1) can further include a priming sensor 61 adjacent the priming chamber 60. The priming sensor 61 can be configured to determine whether a specified amount of breast milk is present in the priming chamber 60. The priming sensor 61 can be infrared, inductive, or of any other configuration. The priming chamber 60 can further include an overflow opening 64 to allow breast milk to overflow into a breast milk storage container (e.g., component 30 as shown in FIG. 1). In some embodiments, as discussed elsewhere herein, the priming chamber or feeding bag may not include such an overflow opening. The priming chamber 60 can further include a dosing tube opening 63.

[0037] The housing 20 (e.g., as shown in FIG. 1 ) may include a dosing tube 70, a third check valve 73, and a nipple attachment 80. The dosing tube 70 may be made of food grade plastic, silicone, or similar material. The dosing tube 70 may be about 20 millimeters to about 70 millimeters long. The dosing tube 70 may have a volume capacity of about 0.3 milliliters to about 5 milliliters. The dosing tube 70 may extend adjacent to or into the dosing tube opening 63 of the priming chamber 60. The dosing tube 70 may include an opening 71 to provide a fluid path from the priming chamber 60 to the third check valve 73. The dosing tube 70 may further include a bend 72 to accommodate the orientation of the third check valve 73. The dosing tube 70 may snap into the check valve 73. The dosing tube 70 may be removed from the housing 20 for cleaning. The check valve or flow control mechanism 73 can be configured to allow fluid to flow from the delivery tube 70 to the nipple attachment 80 and prevent fluid from flowing from the nipple attachment 80 to the delivery tube 70. The nipple attachment 80 can be sized and shaped to approximate a nipple. The nipple attachment 80 can include a distal exit port or opening 81. In some cases, the nipple attachment 80 can be referred to as a baby nipple, a baby nipple, or a bottle nipple. The housing 20 can further include a gate 74, a full sensor 75, and an empty sensor 76. The full sensor 75 can be configured to indicate whether the delivery tube 70 is full of fluid. The empty sensor 76 can be configured to indicate whether the delivery tube 70 is empty. In some cases, an air bubble sensor can be configured to provide an indication or notification to the device if liquid is present in the feeding bag or in the tube leading to the priming chamber. Gate 74 may be configured to clamp dispensing tube 70 to prevent fluid flow unless empty sensor 76 indicates that dispensing tube 70 is empty. Full sensor 75 and empty sensor 76 may be infrared, inductive, or of any other configuration.

[0038] FIG. 6 shows a flow chart illustrating a method 100 for quantifying breast milk transferred to an infant during simultaneous pumping and feeding, according to some embodiments. In a first step 101, a negative pressure source can apply negative pressure to the breast, resulting in a second step 102 of pumping breast milk from the breast. In a third step 104, breast milk can be collected in a priming chamber. As discussed elsewhere herein, in some cases, the device may not include a priming chamber, but instead may include a peristaltic tube and wheel mechanism. Furthermore, in some embodiments, breast milk can be collected in the priming chamber, and excess breast milk can be allowed to spill into a breast milk storage container. In a fourth step 106, a first sensor can detect if the priming chamber is full. The method 100 cannot proceed until a priming level is reached. Furthermore, the method 100 can proceed if a priming level is reached. In a fifth step 108, a second sensor can detect whether milk is present near the nipple attachment from which the baby receives it. If no milk is present near the nipple attachment, then in a sixth step 110, a gate opens to allow milk to flow from the priming chamber into the dosing tube. The fifth step 108 can be repeated until the second sensor detects that milk is present near the nipple attachment. In a seventh step 112, if milk is present near the nipple attachment, then a third sensor can detect whether the dosing tube is full. If the dosing tube is not full, then in an eighth step 114, a gate opens to allow milk to flow from the priming chamber into the dosing tube. In a ninth step 116, if the dosing tube is full, then the gate can be closed to prevent milk from leaving the priming chamber (e.g., into the dosing tube). In a tenth step 118, data is sent to a personal device (eg, a computer or smartphone) indicating that one unit of breast milk equivalent to the volume of the feeding tube has been transferred to the baby.

[0039] As discussed elsewhere herein, instead of using a dosing tube and a priming chamber, an embodiment of the breast pumping and feeding device can use a peristaltic pump mechanism. Additional aspects of such an embodiment can be further understood with reference to FIG. 6A. As shown in this flow chart, a method 100A for quantifying breast milk transferred to an infant during simultaneous pumping and feeding can include various steps. In a first step 101A, a negative pressure source or other mechanism can apply negative pressure to the breast, resulting in a second step 102A of expressing breast milk from the breast. In a third step 104A, breast milk can be collected. In a fourth step 106A, a first sensor can detect whether a priming level has been reached. The method 100A cannot proceed until the priming level has been reached. Furthermore, the method 100A can proceed if the priming level has been reached. In a fifth step 108A, a second sensor can detect whether a nipple ring component or a smart ring is attached to the device. If the nipple ring component is not attached to the device, the peristaltic pump is kept deactivated in a sixth step 110A. The fifth step 108A can be repeated until the second sensor detects that the nipple ring component is attached to the device. If there is milk near the nipple attachment in a seventh step 112A, a third sensor can detect if the feeding bag is full. If the feeding bag is not full, the peristaltic pump is activated in an eighth step 114A to facilitate the flow of milk into the feeding bag. If the feeding bag is full in a ninth step 116A, the peristaltic pump can be deactivated. In a tenth step 118A, data is sent to a personal device (e.g., computer or smartphone) to share intake data or that a certain amount of milk has been transferred to the baby.

[0040] 7 illustrates aspects of a breast pumping and feeding device 200, in accordance with an embodiment of the present invention. As shown therein, the device 200 is in an assembled configuration and includes an upper receptacle assembly 210 and a bottom housing assembly 220. The upper receptacle assembly 210 and the bottom housing assembly 220 are coupled together. As will be discussed further herein, the device 200 also includes a nipple attachment component 420. The bottom housing assembly 220 includes a curved surface 221 that is configured to resemble a demi-bra or lotus flower design.

[0041] 8A and 8B provide an exploded or unassembled view of the milk pumping and feeding device 200. As shown therein, the upper container assembly 210 includes a spout with a vent hole or opening 232, a container 234 (e.g., a transparent milk container), graduation markings 236, a nipple shield opening or opening 238 (e.g., into which a nipple shield may be snap-fitted or otherwise engaged or attached), and a negative pressure port 240 configured to engage a negative pressure source or to engage a conduit having a negative pressure source. In some cases, the negative pressure port 240 is configured to engage a pump flange housing. In some cases, the negative pressure port 240 is configured to be attached to the pump flange housing with a snap-fit ​​engagement. The port 240 may also operate as a port for a closed system vacuum flange. The upper container assembly 210 also includes a feeding tube connection mechanism 242 configured to be attached to or otherwise engaged with a feeding tube. In some cases, the feeding tube attachment mechanism 242 is a valve or port. In some cases, the feeding tube attachment mechanism 242 is a flexible valve. The upper container assembly 210 may also have a flat bottom surface 244 such that the upper container assembly 210 remains stable when placed or rests on a surface, such as a flat surface, for example, when the upper container assembly 210 is disengaged or separated from the bottom housing assembly 220. As further shown in FIG. 8, the bottom housing assembly 220 includes an electronics housing 252, a power button 254, a vacuum increase button 256 and a vacuum decrease button 258, and a baby "down" button 260. The electronics housing 252 may be configured to house sensors, pump hardware, and other components. As discussed elsewhere herein, the pump portion of the assembly may be the bottom portion in another embodiment. The bottom housing assembly 220 may also include a slit 262 configured to receive a feeding tube and / or nipple attachment. In some embodiments, as discussed elsewhere herein, the bottom housing assembly may not include a slit.The bottom housing assembly 220 generally provides a recess shaped or configured to receive the bottom portion 246 of the upper container assembly 210, for example in a nested arrangement. In some cases, the feeding tube connection mechanism 242 may be provided as a hole or opening that provides for fluid flow from a bottom or lower surface or surface 244 of the container 234.

[0042] FIG. 9 shows an additional embodiment of a breast pumping and feeding device including an upper container assembly 210 , a nipple shield 340 , a pump flange arrangement 350 having a pump flange tube 352 and a pump flange housing 354 , and a pump flange 360 ​​.

[0043] The upper container assembly 210 has a container 234 (e.g., a transparent milk container), a nipple shield opening or aperture 238 (e.g., into which a nipple shield 340 can be snap-fit ​​or otherwise engaged or attached), and a negative pressure port 240 configured to engage a negative pressure source or to engage a conduit having a negative pressure source. In some cases, the nipple shield 340 includes an engaging or snap-on rim 342 that mates with the nipple shield opening 238 of the container 234 (e.g., when a barrel 344 of the nipple shield 340 is positioned within the container 234). The nipple shield 340 may also include or be in fluid communication with a nipple shield negative pressure port 341, which engages with a distal end 351 of a pump flange tube 352. For example, the nipple shield negative pressure port 341 can be in fluid communication with the distal end 351 of the pump flange tube when both the port and the distal end 351 are disposed within the container 234 .

[0044] The reservoir negative pressure port 240 can be configured to engage a pump flange housing 354 of the pump flange mechanism 350. In some cases, the reservoir negative pressure port 240 and the pump flange housing 354 are configured to snap together. In some cases, the pump flange housing 354 is provided as a solid component. The pump flange 360 ​​can be flexible and can operate to prevent milk from entering the pump or negative pressure source 370. In some cases, the negative pressure source 370 can operate to provide a negative pressure to the barrel 344 or internal chamber of the nipple shield 340. The negative pressure in the barrel 344 or internal chamber of the nipple shield 340 can cause milk to be expressed from the breast into the barrel 344 or internal chamber, as described elsewhere herein.

[0045] When milk is placed in the barrel 344 or internal chamber of the nipple shield 340, the milk may flow through an exit port or opening 346 of the nipple shield 340, through the flow control mechanism 380, and into the interior of the container 234. In this manner, the nipple shield exit port 346 may act as an opening for releasing the milk. In some cases, the flow control mechanism 380 may be provided as a duckbill valve. The flow control mechanism 380 may operate to prevent backflow of milk, for example, to prevent milk from flowing from the container 234 into the internal chamber 343 or barrel 344 of the nipple shield 340.

[0046] The upper container assembly 210 can include a feeding tube attachment mechanism 242 configured to attach or otherwise engage with a feeding tube 410. In some cases, the feeding tube attachment mechanism 242 is a valve or port. Milk can flow from the container 234 through the feeding tube attachment mechanism 242 and into the feeding tube. In some cases, the feeding tube attachment mechanism 242 is provided as a flexible push-through port or opening for the feeding tube 410. As shown here, a nipple attachment 420 is coupled to the distal end of the feeding tube 410. In this manner, milk can flow from the feeding tube 410 through the nipple attachment mechanism 420 to the nursing baby. In some embodiments, the nipple attachment 420 can be shaped to resemble a nipple on a baby bottle.

[0047] In some embodiments, one or more features of the pump flange arrangement 350 and / or the pump flange 360 ​​can act as a backflow protector. FIG. 9A illustrates additional aspects of a backflow protector 950 for a breast pumping and feeding device, according to an embodiment of the present invention. The backflow protector includes a small case 952, a diaphragm or membrane 954, and a large case 954. In use, the diaphragm or membrane can be placed within the small case, and the large case can be placed over the diaphragm or membrane such that a seal is formed between the small case and the large case. In some embodiments, the backflow protector 950 can be referred to as a clamshell valve or a pump flange valve. The backflow protector can operate to ensure that steam or unwanted fluids do not reach the interior of the pump. As discussed further elsewhere herein, the clamshell can also be integrated within the body of the pump. The backflow protector 950 can operate to provide a barrier (e.g., which can be referred to as a media separation) between the pump 970 and the expressed breast milk. Relatedly, the backflow protector 950 can prevent breast milk from reaching the pump, and can help ensure that the expressed breast milk remains uncontaminated. Thus, breast milk can flow into the protector 950 and remain between the small case 952 and the diaphragm or membrane 954, without passing through the diaphragm or membrane 954 and entering the space between the diaphragm or membrane 954 and the large case 956. In some cases, one or more features of the backflow protector 950 (or, optionally, one or more features of the pump flange mechanism 350 and / or the pump flange 360 ​​shown in FIG. 9) may be referred to as a flexible clamshell, or a clamshell funnel and tube mechanism. In some cases, a clamshell may not be present. In some cases, a cavity may be present in the pump and may correspond to a clamshell.

[0048] FIG. 10 shows an additional embodiment of a breast pumping and feeding device including an upper container assembly 210 , a pump flange arrangement 350 having a pump flange tube 352 and a pump flange housing 354 , and a pump flange 360 ​​.

[0049] The upper container assembly 210 has a container 234 (e.g., a transparent milk container), a nipple shield opening or aperture 238 (e.g., into which a nipple shield may be snap-fit ​​or otherwise engaged or attached), and a negative pressure port 240 configured to engage a negative pressure source or to engage a conduit having a negative pressure source. In some cases, the nipple shield includes a mating or snap-on rim that mates with the nipple shield opening 238 of the container 234 (e.g., when the barrel of the nipple shield is positioned within the container 234). The nipple shield may also include or be in fluid communication with a nipple shield negative pressure port 341, which engages with a distal end 351 of a pump flange tube 352. For example, the nipple shield negative pressure port 341 can be in fluid communication with the distal end 351 of the pump flange tube when both the port and the distal end 351 are disposed within the container 234. In some cases, the nipple shield negative pressure port 341 can be referred to as a port for the pump flange tube, or a pump flange port.

[0050] The reservoir negative pressure port 240 can be configured to engage a pump flange housing 354 of the pump flange mechanism 350. In some cases, the reservoir negative pressure port 240 and the pump flange housing 354 are configured to snap together. In some cases, the pump flange housing 354 is provided as a solid component. The pump flange 360 ​​can be flexible and can operate to prevent milk from entering the pump or negative pressure source. In some cases, the negative pressure source can operate to provide negative pressure to the barrel or interior chamber of the nipple shield (e.g., via the nipple shield negative pressure port 341). The negative pressure in the nipple shield barrel or interior chamber can cause milk to be expressed from the breast into the barrel or interior chamber, as described elsewhere herein.

[0051] Once milk is placed within the barrel or interior chamber of the nipple shield, the milk can flow through an exit port or opening in the nipple shield, through the flow control mechanism, and into the interior of the container 234. In this manner, the nipple shield exit port can act as an opening for releasing the milk. In some cases, from the barrel or interior chamber, the milk can exit the nipple shield, pass through the flow control mechanism 380, and enter the interior of the container 234. In some cases, the flow control mechanism 380 is provided as a duckbill valve.

[0052] The upper container assembly 210 may include a feeding tube attachment mechanism 242 configured to be attached or otherwise engaged to the feeding tube 410. In some cases, the feeding tube attachment mechanism 242 is a valve or port. Milk may flow from the container 234 through the feeding tube attachment mechanism 242 and into the feeding tube 410. In some cases, the feeding tube attachment mechanism 242 is provided as a flexible push-through port or opening for the feeding tube 410. As shown here, a nipple attachment 420 is coupled to the distal end of the feeding tube 410. In this manner, milk may flow from the feeding tube 410 through the nipple attachment 420 to the nursing infant. The device may also include a flow control mechanism 430 disposed between the feeding tube 410 and the nipple attachment 420. The flow control mechanism 430 may be in fluid communication with both the feeding tube 410 and the nipple attachment 420 and may regulate the flow of fluid therebetween. In some cases, the flow control mechanism 430 is provided as a one-way valve (e.g., so that milk can flow from the feeding tube 410 to the nipple attachment 420, but cannot flow from the nipple attachment 420 to the feeding tube 410).

[0053] The upper container assembly 210 may also have a flat bottom surface 244 such that the upper container assembly 210 remains stable when placed or resting on a surface, such as a flat surface, for example, when the upper container assembly 210 is disengaged or separated from the bottom housing assembly.

[0054] 11 illustrates additional aspects of the milk pumping and feeding device 200, including the upper container assembly 210, the nipple shield 340, and the bottom housing assembly 220. The upper container assembly 210 has a container 234 (e.g., a transparent milk container), a nipple shield opening or aperture into which the nipple shield 340 can be snap-fitted or otherwise engaged or attached, and a negative pressure port configured to engage a negative pressure source or to engage a conduit having a negative pressure source. In some cases, the nipple shield 340 includes a mating or snap-on rim that mates with the nipple shield opening of the container 234 (e.g., when the barrel 344 of the nipple shield 340 is positioned within the container 234). The nipple shield 340 may also include or be in fluid communication with a nipple shield negative pressure port 341, which engages with the distal end of the pump flange tube. For example, the nipple shield negative pressure port 341 can be in fluid communication with the distal end of the pump flange tube when the port 341 and the distal end are both disposed within the container 234. In some cases, the nipple shield negative pressure port 341 may be referred to as a vacuum suction port for the pump flange tube. The bottom housing assembly 220 can include an electronics housing 252, which may be referred to as a hub.

[0055] In some cases, the negative pressure source may operate to provide negative pressure to the barrel 344 or internal chamber of the nipple shield 340. The negative pressure within the barrel 344 or internal chamber of the nipple shield 340 may cause milk to be expressed from the breast into the barrel 344 or internal chamber, as described elsewhere herein.

[0056] When milk is placed in the barrel 344 or internal chamber of the nipple shield 340, the milk may flow through an exit port or opening 346 of the nipple shield 340, through the flow control mechanism 380, and into the interior of the container 234. In this manner, the nipple shield exit port 346 may act as an opening for releasing the milk. In some cases, the flow control mechanism 380 may be provided as a duckbill valve. In some cases, the flow control mechanism 380 may be provided as a one-way valve. The flow control mechanism 380 may operate to prevent backflow of milk, for example, to prevent milk from flowing from the container 234 into the internal chamber 343 or barrel 344 of the nipple shield 340.

[0057] The upper container assembly 210 may include a feeding tube attachment mechanism 242 configured to attach or otherwise engage with the feeding tube 410. In some cases, the feeding tube attachment mechanism 242 is a valve or port. Milk may flow from the container 234 through the feeding tube attachment mechanism 242 and into the feeding tube 410. In some cases, the feeding tube attachment mechanism 242 is provided as a flexible push-through port or opening for the feeding tube 410. As shown here, a nipple attachment 420 is coupled to the distal end of the feeding tube 410. In this manner, milk may flow from the feeding tube 410, through the nipple attachment 420, and to the nursing infant (e.g., via a distal exit port or opening 421 of the nipple attachment 420). In some cases, the device 200 may include a flow control mechanism 430 in fluid communication with and disposed between the feeding tube 410 and the nipple attachment 420. The flow control mechanism 430 can regulate the flow of fluid between the feeding tube 410 and the nipple attachment 420. In some cases, the flow control mechanism 430 is provided as a one-way flow valve (e.g., so that milk can flow from the feeding tube 410 to the nipple attachment 420, but not from the nipple attachment 420 to the feeding tube 410). In some cases, the flow control mechanism 430 is provided as a duckbill valve.

[0058] The bottom housing assembly 220 may include a first sensor 292, which may be a priming sensor. The bottom housing assembly 220 may also include an electronic solenoid valve or gate 294, a second sensor 296 or a "full sensor," and a third sensor 298 or an "empty sensor."

[0059] In the embodiment shown here, the device 200 is configured to be able to mount or position the milk container 234 around the breast of the user. Furthermore, the device 200 can be configured to allow all of the milk that the mother pumps to be available to the baby, so that excess milk from one point in the session is not made available if the baby changes his or her drinking rate or is faster than pumping during the session. The device 200 offers a simple design with few compartments and parts for assembly and cleaning. In operation, when the milk container 234 is filled, the milk inside the container is positioned approximately around the breast and at a sufficient height so that all of the milk can exit the bottom of the container 234 (e.g., via the feeding tube attachment 242) and reach the baby's mouth (e.g., via the nipple attachment 420), thus allowing the container 234 to function as both a milk storage compartment and a supply source.

[0060] The device 200 also provides visibility of the nipple during milk expression. The clear plastic container 234 allows the mother to look down at her breast and nipple and see if the nipple is being sucked directly through the barrel 344 of the nipple shield 340, or if it is being pulled to the side, potentially causing a less than optimal milk flow. The device 200 also allows the mother to see if a flow has started and how much milk is flowing (a gush may result from a dozen or so streams, or only one or two). Knowing this gives the mother a sense of whether she should reposition or increase or decrease the suction (e.g., using the vacuum increase button 256 or vacuum decrease button 258 as shown in FIG. 8) to get the best milk flow.

[0061] According to some embodiments, the device 200 includes two assemblies: a transparent top container or upper container assembly 210 that interfaces with the breast (e.g., via a nipple shield 340), and a bottom housing or bottom housing assembly 220 that houses the electronics for counting and providing suction (milk) to the breast. The bottom housing assembly 220 can include an electronics housing 252. The transparent top milk container or upper container assembly 210 can be lowered and snap-fit ​​into the bottom housing assembly 220 or electronics housing 252.

[0062] The milk container 234 may be provided as a clear plastic container that interfaces with the breast (e.g., via a nipple shield 340) to receive milk being vacuumed from the breast. With respect to the milk pathway, milk exits the nipple, is expressed into the nipple shield's internal chamber 343 and / or barrel 344, and flows downward from the nipple shield 340 through a flow control mechanism 380, which may be provided as a duckbill, one-way valve, into the container 234. The expressed milk may not touch the breast as it fills the container 234, but does occupy a physical space around the breast. Once the milk fills the container 234 to a certain level, e.g., 30 mL (1 oz), a first sensor 292, which may be an infrared "priming" sensor facing the underside of the milk container 234, may trigger an indicator (e.g., a light or a beep) that indicates the milk is ready for the baby to drink. In some cases, the level of milk in the container 234 that triggers the indicator has a value within a range of about 0.89 mL (about 0.03 oz) to about 51.8 mL (about 1.75 oz).

[0063] At that point, a "baby feed" button as shown in Figure 8 or a "down" button 260 to the baby can be pressed to allow milk to flow through a flexible transparent tube 410 towards the baby nipple 420. The baby nipple 420, which the baby sucks on, can include a non-leaking air hole 422 and a flow control mechanism 430 (e.g. an internal one-way flow duckbill valve) to prevent backflow into the milk in the milk container 234. Alternatively, referring to Figure 14, an air vent valve can be provided elsewhere along the flexible tube, such as in the form of a one-way y-valve, which can draw air into the tube so the baby does not have to resist the vacuum of the straw chamber to drink.

[0064] Referring again to FIG. 11, the milk capacity of the container 234 can be about 8 oz. In some cases, the milk capacity of the container 234 can have a value within a range of about 4 oz to about 10 oz. In some cases, the container 234 can have one or more volume indicia (such as, for example, the volume indicia 32 shown in FIG. 3). In some cases, the volume indicia can provide an indication of fluid increments (e.g., 1 oz increments). In some cases, the container 234 can be made available in a range of different sizes or volume capacities, which can be made available in graduated increments, for example, 1 oz increments. In some embodiments, the container 234 can include a spout having a vent hole or opening 232. As shown here, the hole 232 can be positioned toward the top of the container 234. In some cases, the hole 232 is a sealable hole. The hole 232 can be opened to allow milk to be poured from the container 234 into another container, bottle, milk storage bag, etc. The sealable hole 232 can also feature a small vent hole that remains open at all times or that optionally remains open (e.g., can be in an open or closed position) to allow air to exit the container 234 as milk enters the container 234 and replaces the air.

[0065] Once the feeding and / or pumping of additional milk is completed, the baby feeding button (e.g., button 260 shown in FIG. 8 on the bottom assembly) can be pressed again to stop the flow of milk to the nipple, and the pump power button (e.g., button 254 shown in FIG. 8) can be pressed to stop the negative pressure. The baby can be removed from the device 200, the device 200 can be removed from the breast, and the transparent milk container apparatus or upper container assembly 210 can be separated from the bottom housing assembly 220.

[0066] 11, the milk pumping and feeding device 200 is also configured for easy disassembly. For example, the upper container assembly 210 can be decoupled or separated from the bottom housing assembly 220. In some cases, such separation can be accomplished by pulling the upper container assembly 210 and the bottom housing assembly 220 away from each other. The bottom housing assembly 220 can also include a slit 262 (see also FIG. 8) configured to receive the feeding tube 410 and / or nipple attachment 420, such that when the upper container assembly 210 and the bottom housing assembly 220 are separated from each other, the bottle nipple attachment 420 and the tube assembly 415 (which can include the tube 410 and the flow control mechanism 430) can be moved in an upward direction relative to the bottom housing assembly 220 through the slit 262. As discussed further elsewhere herein, in some cases, the bottom housing may not have a slit. In some cases, the bottom housing may have a cavity instead of a slit. In some cases, the baby nipple attachment 420 and tube assembly 415 can be removed from the bottom of the bottom housing assembly 220 for cleaning (e.g., by removing the tube 410 from the feeding tube connection mechanism 242), and the flexible rubber hole through which the tube protruded will tighten back on itself, forming a seal.

[0067] As further discussed elsewhere herein, in some embodiments, certain aspects of the tube assembly 415, for example, may provide a peristaltic mechanism that compresses the feeding tube 410, thereby facilitating the flow of milk to the nipple attachment 420, thereby allowing the baby to drink. In some embodiments, the sensor 296 and / or the sensor 298 may operate to detect whether milk is present and indicate to the mother or user that the device is ready to provide milk to the baby. In some embodiments, the tube assembly 415 may provide an assembly through which milk can pass through a dosing tube that is connected to a priming chamber. In some embodiments, the nipple shield 340 to which the breast interfaces may provide a breast flange from which milk can be expressed.

[0068] FIG. 11A illustrates an embodiment of an exemplary grommet mechanism 241 that can be optionally used with or as part of a feeding tube connection mechanism. As shown, the grommet mechanism 241 includes an opening or hole 243 that can be configured to receive a feeding tube. When a feeding tube is inserted through the opening 243, the sides or edges of the opening 243 can flex to form a seal with the tube. When the tube is removed or not positioned within the opening 243, the sides or edges of the opening can effectively form a seal that prevents or inhibits fluid flow or movement through the opening. In some cases, the grommet mechanism 241 can be provided as a rubber grommet. In some cases, the grommet mechanism 241 provides a self-tightening seal with a push-through opening 243 that is configured to receive a feeding tube. The grommet mechanism 241 can be positioned within a hole in the bottom or underside of the container, or otherwise through the bottom or underside of the container.

[0069] Referring again to Figure 11, the clear plastic receptacle 234 can then be placed on a surface or the rubber spout 232 on top can be opened to allow milk to be poured from the receptacle 234 into another receptacle or destination. Once the milk has been poured from the container 234, the negative pressure components, such as the flexible clamshell and / or clamshell funnel / tube (which may include one or more features of the pump flange mechanism 350 and / or pump flange 360, as shown in Figure 9, or one or more features of the backflow protector 950 of Figure 9A), can be removed for cleaning. The breast-interfacing nipple protector 340 can then be separated from the rear of the milk container 234, both for cleaning, and the flow control mechanism or duckbill valve 380 can be removed.

[0070] The breast pumping and feeding device 200 may also include a counting mechanism, which may be disposed, for example, within the bottom housing assembly 220. In some cases, the counting mechanism may include one or more sensors (e.g., sensor 61, sensor 75, and / or sensor 76 shown in Figures 4 and 5, or sensor 296 and / or sensor 298 shown in Figure 11) configured to quantify the milk transferred to the infant. In some cases, such a sensor may be an infrared sensor. In some cases, the milk ingested by the infant can be quantified by a series of built-in sensors (e.g., sensors 61, 75, and / or 76 shown in Figs. 4 and 5, or sensors 296 and / or 298 shown in Fig. 11) that indicate whether a predefined volume reserve milk receptacle (e.g., priming chamber 60 shown in Figs. 4 and 5) or a delivery tube (e.g., tube 70 shown in Figs. 4 and 5, or tube 410 shown in Figs. 9, 10, and 11) is full or empty. These sensors can trigger the receptacle or delivery tube to allow more milk to be filled if empty, or to shut off the milk if full. Counting how many times a defined volume has been filled can provide an immediate quantification of milk intake. In some cases, the defined volume can range from about 0.1 mL to about 15 mL.

[0071] In the embodiment shown in Figure 11, a substantial portion of the feeding tube 410 is configured to be disposed in a horizontal orientation when the device is in operation. Without being bound to any particular theory, it is believed that surface tension on a limited inner diameter (ID) of the tube 410 interfacing with the sensor can provide an amount of flow force or momentum such that gravity is not required for milk to flow into the tube 410. As mentioned elsewhere herein, the physical sensor for identifying the presence of milk can be an infrared sensor (e.g., identifying a physical color difference caused by milk) or the sensor can be a capacitance sensor (e.g., identifying the proximity of a liquid).

[0072] In some cases, a capacitance sensor of the system can be configured to detect the amount of supply fluid present in the chamber, and in some cases, capacitance can be used to measure when the chamber is pre-full and when it is empty, and to signal for additional fluid to enter the chamber.

[0073] In some cases, a pumping and feeding device may not include a counting mechanism. For example, a pumping and feeding device without a counting mechanism may be configured to allow a baby to drink continuously, and therefore only a small amount of storage is required. In some cases, a pumping and feeding device without a counting mechanism may be configured to allow for a smaller frame.

[0074] In some cases, the pumping and feeding device may not include a reservoir or may include a small reservoir. For example, the pumping and feeding device may be provided in a smaller configuration with a reservoir containing only 30-89 mL (1-3 oz) of milk, barely enough to consistently provide a primed amount for the infant to drink. In some cases, such a device may include a counting mechanism and an external pump, and thus its primary purpose is the direct delivery and counting of milk ingested by the infant. The pump may also sense fullness via infrared or capacitance, stopping pumping when it reaches maximum capacity, then shutting off, and turning back on when it falls below another threshold.

[0075] The breast pumping and feeding device 200 can be configured to provide a vacuum path to facilitate milk flow. In some cases, the housing of the device can house a pump mechanism or negative pressure source. For example, the pump mechanism can include a motor. The pump mechanism can operate to provide negative pressure to a clamshell flexible valve that fits over a hard clamshell feature on the side of the milk container. This flexible valve can operate to ensure that milk, condensation, or other moisture from the milk container 234 is not drawn into the electronics housing 252. In some cases, the flexible valve can be drawn toward the electronics housing 252 to provide the amount of negative pressure needed to draw milk from the breast through the hard matching clamshell part and tubing leading to the central nipple shield 340. The location of the suction source in the clear top container 234 can be located in various locations, such as the side, rear, or lower area of ​​the container 234. In some cases, the nipple shield negative pressure port 341 of the nipple shield 340, which interfaces with the vacuum, is desirably positioned in the top half of the container 234 to avoid drawing in excess milk, and optionally includes shielding features to prevent milk from being squirted directly into the port 341. To increase or decrease suction, plus (+) and minus (-) buttons (see, e.g., FIG. 8) on the housing can be pressed, and the sound increases or decreases accordingly. If the sound stops despite pressing the button, then maximum or minimum suction has been reached. In some cases, the breast pumping and feeding device may not include a built-in pump, which may reduce the cost of the device. Such an embodiment may also not include pump software built into the bottom housing. In some cases, the breast pumping and feeding device may be configured for use with an off-the-shelf pump. For example, the device may include an external breast pump port on the clear container 234 with mating parts that interface with the tubing of various commercially available pumps, allowing suction to be provided by any pump the mother has on hand.

[0076] 12A and 12B show an embodiment of a proximal pump flange assembly 1200 of a breast pumping and feeding device. The proximal pump flange assembly 1200 can be coupled to or used with a nipple shield 1240. The proximal pump flange assembly 1200 can be operable to mediate suction to the breast and can be attached to or disposed adjacent to the nipple shield 1240. As shown here, the proximal pump flange assembly 1200 includes a pump flange housing 1210 and an internal pump flange 1220. In some cases, the pump flange housing 1210 is a solid pump flange housing. In some cases, the internal pump flange 1220 is a flexible internal pump flange. The nipple shield 1240 includes a rim 1242 configured to engage a nipple shield opening or aperture of a container, such as a transparent milk container. In some cases, the rim 1242 engages the container with a snap-fit ​​connection. Aspects of the nipple protector-container coupling can be further understood with reference to Figure 9. The proximal pump flange assembly 1200 can be configured to be in operative fluid association with a negative pressure source. In some cases, the proximal pump flange assembly 1200 can include one or more features of a backflow protector (e.g., as shown in Figure 9A). In this sense, aspects of the proximal pump flange assembly can operate as a diaphragm valve, helping to facilitate the application of negative pressure to the user.

[0077] Milk disposed within the barrel 1244 or internal chamber of the nipple shield 1240 can flow out or through an outlet port or opening 1246 of the nipple shield 1240, as indicated by milk discharge pathway 1248. In this sense, the outlet port 1246 provides an opening for the discharge of milk from the nipple shield. As shown here, the outlet port 1246 can include a rim 1247. In some cases, the rim 1247 is configured to be releasably attached to a duckbill valve or other flow control mechanism. The duckbill valve or other flow control mechanism (see, e.g., element 380 in FIG. 11 ) can operate to prevent backflow into the pump suction.

[0078] The top view of Figure 12C and the front view of Figure 12D show additional aspects of the proximal pump flange assembly 1200 of the breast pumping and feeding device. As shown here, the proximal pump flange assembly 1200 includes a vacuum transfer path 1260 to the nipple.

[0079] 13A and 13B show aspects of a nipple shield or breast flange 1340 and a distal pump flange mechanism 1350, according to an embodiment of the present invention. The nipple shield 1340 can include a rim 1341 (e.g., a milk-container interacting rim) configured to engage with a nipple shield opening or aperture of a container, such as a transparent milk container. As shown here, the distal pump flange mechanism 1350 can include a pump flange tube 1352, a pump flange housing 1354, and a pump flange 1360. In some cases, the pump flange 1360 can be a flexible pump flange. The pump flange 1360 can interface with the pump housing. The nipple shield 1340 can include a vacuum hole or aperture 1342, and a tube 1370 can provide fluid communication between the pump flange tube 1352 and the aperture or port 1342 via the tube 1370. As shown here, the opening 1342, tube 1370, and distal pump flange mechanism 1350 are generally positioned toward the side of the nipple shield 1340, rather than toward the top of the nipple shield. In this way, the attachment between the nipple shield 1340 and the pump flange mechanism 1350 does not impede the mother's view of the nipple while pumping. It may be beneficial for the mother to view the nipple within the nipple shield 1340, to ensure that the nipple and / or milk is positioned or moving straight down the nipple shield barrel 1344 (e.g., to maximize flow), and / or to ensure that the milk or colostrum flows and is successfully removed. Thus, the location of the port 1342 may be positioned such that the pump flange tube leading to the pump flange housing is positioned toward the side, rear, or other location that does not impede the user's view of the nipple. As discussed elsewhere herein, the nipple shield 1340 may include an outlet opening 1346 for expelling milk. In some cases, the outlet opening 1346 may be attached to a duckbill valve or other flow control mechanism.As shown here, the outlet opening or port 1346 is angled slightly back toward the user to minimize the depth of the pumping and feeding device. In some cases, the opening or port 1346 may be smaller and not angled (e.g., extending straight down from the barrel 1344).

[0080] Thus, the nipple shield may have a connection point or port for a one-way valve, such as a duckbill valve, such that the port is oriented straight down (as shown in Figures 12A and 12B) or angled (as shown in Figure 13A). The angled version may allow for a smaller frame.

[0081] As shown in Figures 12C and 12D, the nipple protector 1240 may also have a vacuum port (e.g., including a vapor barrier) in fluid communication with the vacuum transfer path 1260. In this case, the vapor barrier is in an upward position relative to the front end of the nipple protector. As shown in Figure 13A, the nipple protector 1340 may also have a vacuum port 1342 including a vapor barrier. In this case, the vapor barrier is in a lateral position relative to the front end of the nipple protector. In some cases, the location of the vapor barrier may be anterior relative to the front end of the nipple protector. In some cases, the nipple protector 1340 may include one or more features of a backflow protector (e.g., as shown in Figure 9A) or may be operatively associated with one or more features of a backflow protector. In this sense, aspects of the nipple protector may operate as or in concert with a diaphragm valve to facilitate application of user negative pressure.

[0082] As shown in Figures 9, 10, and 11, the milk pumping and feeding device may include a feeding tube 410 through which milk can flow (e.g., via a nipple attachment 420) to a nursing infant. In some cases, a vent valve, such as in the form of a one-way y-valve, may be provided at a location along the flexible tube or feeding tube 410, which may draw air into the tube 410 so that the infant does not have to resist the vacuum of the straw chamber to drink. The side view of Figure 14A and the cross-sectional view of Figure 14B show aspects of an exemplary vent valve 1410, according to an embodiment of the present invention. In some cases, the vent valve may be placed on the tube 410 after the container and the first solenoid valve (e.g., electronic solenoid valve or gate 294 shown in Figure 11), which may introduce air into the system so that milk can be flushed out of the tube 410. In some cases, the tube 410 may be collapsible. In some cases, the tube 410 may include, operate as, or be operatively associated with a crush counting mechanism. Milk may enter one end of the vent valve 1410 and exit the other end, as shown in Figures 14A and 14B. According to some embodiments, air is introduced to allow milk to flow out of the tube if the solenoid does not allow milk to flow in and there is a vacuum in the line.

[0083] 14B, the vent valve 1410 may include two male connectors 1412, 1414 on either side for rubber tubing through which milk enters and leaves, and a second inlet 1416 on the top that allows air to enter in one direction. The vent valve 1410 may be plastic and is fitted with a rubber duckbill or similar one-way valve 1418 that is normally closed but will expand open if there is negative pressure inside the valve or tubing.

[0084] 15A, 15B, and 15C show aspects of an exemplary breast pumping and feeding device 1500, according to an embodiment of the present invention. As shown, the device 1500 includes an upper container assembly 1510 having a feeding tube connection mechanism 1542 configured to attach to or otherwise engage a feeding tube. In some cases, the feeding tube connection mechanism 1542 is a barbed connector. The device also includes a bottom housing assembly 1520.

[0085] Aspects of an exemplary breast pumping and feeding device 1600 are shown in Figure 16A (side view) and Figure 16B (front view). As shown therein, the device 1600 includes an upper receptacle assembly 1610 having or in fluid communication with a nipple attachment 1614. The device also includes a bottom housing assembly 1620. In some embodiments, the upper receptacle assembly 1610 can be configured to store or contain milk or other fluids. The device 1600 can also include a breast flange 1625.

[0086] Figure 17A shows a side view of a teat attachment part 1710 according to an embodiment of the invention. Figure 17B shows a cross-sectional view of a teat attachment part 1710 according to an embodiment of the invention. Figure 17C shows a rear view of a teat attachment part 1710 according to an embodiment of the invention. Figure 17D shows a front view of a teat attachment part 1710 according to an embodiment of the invention.

[0087] FIG. 18 illustrates aspects of a mobile computing device 1800 having a display screen 1810 with a graphical user interface 1820. This embodiment supports the use of a single pumping and feeding device. As shown, the user interface 1820 includes a menu feature 1822, an electronics housing battery charging feature 1824, a milk chamber volume feature 1826 (green color may indicate "primed"), a pumping time feature 1828 (e.g., may indicate the amount of time pumped out of 60 minutes), and an intake feature 1830 (e.g., may indicate the amount of fluid consumed by the baby). The intake feature 1830 may include one or more colored rings. Each ring may indicate an incremental amount of fluid consumed (e.g., 30 mL (1 ounce)). In some cases, the fill of the color may indicate a fraction of the incremental amount (e.g., fraction of a milliliter (ounce)). The user interface 1820 may also include a usage feature 1832. In some cases, the usage feature 1832 may display any of a variety of types of information, including history, graphs, and data about the amount of milk pumped, the amount drunk, the number of pumps, and trends.

[0088] FIG. 19 illustrates aspects of a mobile computing device 1900 having a display screen 1910 with a graphical user interface 1920. This embodiment corresponds to the use of a dual pumping and feeding device. As shown here, the user interface 1920 includes a menu feature 1922, a right indicator 1924 (e.g., indicating the right breast), a left indicator 1926 (e.g., indicating the left breast), a right intake feature 1928, and a left intake feature 1930. The intake features 1928, 1930 may include one or more expanding colored rings. Each ring may indicate an incremental amount of fluid ingested (e.g., 30 mL (1 ounce)). In some cases, the fill of the color may indicate a fraction of the incremental amount (e.g., fractions of a milliliter (ounce)).

[0089] In some embodiments, a computing device, such as a mobile computing device, can be programmed with an application (app) for use in operating and / or displaying information regarding the status or operation of one or more pumping and feeding devices. The app can be configured as an Android app or an iOS app and can receive data, for example via Bluetooth, from the electronics housing of one or two breast pumps that the user is using. The app can cause the computing device to display the amount of milk the baby is drinking (e.g., to an accuracy of 1-5 mL, ±1-3 mL range). The computing device can also only display whether the baby is drinking or not, and can provide the amount with further details. The computing device can display the amount of time pumping has been ongoing and the battery power of the pumping and feeding device. The computing device can display the amount of milk pumped or provide a place to enter extra milk pumped. The computing device can also display the feeding volume and / or history of the milk volume, such as a graph, along with some analysis by time and day.

[0090] The mobile computing device may include a personal device such as a phone or tablet. The app may display a start page on the computing device that visually features one device paired by Bluetooth (e.g., FIG. 18) or two devices paired by Bluetooth (e.g., FIG. 19) and their capabilities. Clicking on any of the visuals provides either more information about that capability or the ability to control the device via a screen.

[0091] In some embodiments, a mobile computing device for displaying operational information regarding an infant fluid feeding system may include features such as a screen, a processor, an electronic storage location operatively associated with the processor, and processor executable code stored on the electronic storage location and embodied in a tangible, non-transitory computer readable medium. The processor executable code, when executed by the processor, may cause the processor to generate a graphical user interface on the screen. The graphical user interface may include a display of feeding fluid ingested by an infant from the infant fluid feeding system. In some cases, the display includes an amount of feeding fluid ingested by an infant from the infant fluid feeding system during a single feeding session. In some cases, the display includes an amount of feeding fluid ingested by an infant from the infant fluid feeding system over multiple feeding sessions. In some cases, the display includes a time indicator for the feeding session. In some cases, the fluid feeding system may have a companion phone application that connects to the system via Bluetooth. An estimate of the amount of milk consumed by the infant can be tracked on the device and displayed on the phone application, which also stores the feeding data from each individual pumping session. This allows mothers to track how much milk their infants have consumed over time. This also allows a new set of automated data to be collected about when and how much mothers are feeding their children, how many mothers are using assistive devices to feed, how old they are, and which infant / mother dyads may be using other forms of breastfeeding support. Correlating this with user-provided demographic data such as maternal age, geographic location, etc., provides market knowledge for serving mothers.

[0092] Embodiments of the present invention encompass an associated computer program product for informing a user of operational aspects of a breast pumping and / or feeding system. The computer program product may be embodied on a non-transitory tangible computer readable medium and may include computer executable code for generating a graphical user interface on a screen of a mobile computing device, the graphical user interface including a display of feeding fluid taken by an infant from the infant fluid feeding system. In some cases, the display includes an amount of feeding fluid taken by an infant from the infant fluid feeding system during a single feeding session. In some cases, the display includes an amount of feeding fluid taken by an infant from the infant fluid feeding system over multiple feeding sessions. In some cases, the display includes a time indicator for the feeding session.

[0093] For the battery symbol (e.g., feature 1824 in FIG. 18), color shading can indicate the relative amount of charge remaining in the rechargeable electronic device housing. Clicking on feature 1824 can provide an integer percentage value out of 100 and the time remaining before charging is required.

[0094] For the container symbol (e.g., feature 1826), color shading may indicate the relative amount of milk currently in the milk container. Green may indicate that the container is primed, or that there is enough present for the baby to begin drinking. No color may mean that there is less than the "primed amount" needed to allow the baby to begin drinking. Clicking on feature 1826 may provide an estimate in milliliters (ounces), displayed as a whole number, such as "~1 oz (30 milliliters)," and a verbal or audio indication that the container is primed, such as "Ready to drain."

[0095] With respect to the concentric ring symbol (e.g., features 1830, 1926, or 1930), one or more concentric rings may indicate the amount of milk the infant has taken from one or more pumping and feeding devices. In some embodiments, one may start with only one unshaded circle, representing the possibility of drinking 30 mL (1 oz). The shading within the circle may indicate the relative amount of milk drunk within that range of ounces. Once the full 30 mL (1 oz) has been drunk, the circle may be fully shaded. If more than 30 mL (1 oz) has been drunk, a new concentric ring may appear and the circle may become shaded with the relative amount as the infant drinks. The amount each concentric circle represents may be defined as an amount different than 30 mL (1 oz) or may change depending on the age of the infant, since newborns may only drink a few mL at a time and 6 month old infants may drink more than 237 mL (8 oz). Clicking on the image (eg, 1830, 1926, or 1930) can provide the numerical amount of milk drunk in ounces and (if less than an ounce) mL.

[0096] With respect to the clock symbol (e.g., feature 1828 in FIG. 18), the clock symbol indicates via color shading the amount of time the breastpump has been pumping milk at the breast relative to 60 minutes. Clicking on the symbol (e.g., 1828) can provide a numerical amount of time in minutes, such as "17 minutes," that the breastpump has been pumping milk at the breast.

[0097] With regard to the graph symbol (e.g., feature 1832 in FIG. 18), clicking on the graph symbol can lead to other pages containing collated data and / or graphical information based on data collected by the breast pump. Other pages may have a history of pumping frequency or volume by date via graphs or tables. Other pages may have visuals, tables, or graphs of volume drunk, number of pumps, number of drinks over various time periods such as days, weeks, months, or years. The app can be configured to give the mobile computing device the ability to export any of these analyses and share them with other apps on the phone or computing device. Using weight, height, and head circumference data that had been entered into the app, any of the mentioned parameters can be shown compared to averages from other mother-infant dyads, or even national or WHO standards.

[0098] With respect to the breast pump device symbol 1829, clicking on the breast pump device symbol can lead to a control page or function. In this case, the same controls that are available on the physical device (e.g., pumping and feeding device) are available to operate. For example, the breast pump can be turned on and off via a power button, the strength of the vacuum suction on the breast can be adjusted up or down, and draining of the baby can be started or stopped by clicking or unclicking a drain button. There may also be a button to adjust the frequency of the vacuum suction. In some embodiments, clicking on the device symbol 1829 will lead to a page or pop-up of controls for that device (e.g., power on / off, strength, frequency, draining, etc.).

[0099] With respect to the menu symbols (e.g., feature 1822 or feature 1922), clicking on the menu symbol may lead to other features of the app, such as "Resources," "Profile," "Help," or "Contact Us," or "Contact Us." "Resources" may be a portal with more information for new or breastfeeding mothers, and "Profile" may allow the user to select any infant profile (if the device is being used for multiple children) or view information entered about the infant, such as birth date, weight, height, head circumference, diaper changes, sleep schedule, etc. "Help" or "Contact Us" may result in a lead-up to live chat, questions, FAQs, or inquiry information. "Contact Us" may lead to a portal to contact other mothers using the app, including finding or chatting with mothers in the user's area.

[0100] 20 illustrates aspects of an exemplary computer system or device 2000 configured for use with any of the breast pumping and feeding devices disclosed herein and / or for use as a computing device (e.g., a mobile computing device) in accordance with embodiments of the present invention. Examples of computer system or device 2000 may include enterprise servers, blade servers, desktop computers, laptop computers, tablet computers, personal digital assistants, smartphones, any combination thereof, and / or any other type of machine configured to perform computations. Any computing device encompassed by embodiments of the present invention may be configured to exhibit similar characteristics as computer system 2000, in whole or at least in part.

[0101] The computer system 2000 of Figure 20 is shown to include hardware elements that may be electrically coupled (or communicate in other manners as appropriate) via a bus 2002. The hardware elements may include a processing unit having one or more processors 2004, including but not limited to one or more general purpose processors and / or one or more special purpose processors (digital signal processing chips, graphics acceleration processors, etc.), one or more input devices 2006, which may include but are not limited to a remote control, mouse, keyboard, keypad, touch screen, etc., and one or more output devices 2008, which may include but are not limited to a presentation device (e.g., controller screen, display screen), printer, etc.

[0102] The computer system 2000 may further include (and / or be in communication with) one or more non-transitory storage devices 2010, which may include, but are not limited to, local and / or network-accessible storage devices, and / or solid-state storage devices, such as, but not limited to, disk drives, drive arrays, optical storage devices, random access memory and / or read-only memory, which may be programmable, flash-updateable, etc. Such storage devices may be configured to implement any suitable data store, including, but not limited to, various file systems, database structures, etc.

[0103] The computer system 2000 may also include a communications subsystem 2012, which may include, but is not limited to, wireless communication devices and / or chipsets such as modems, network cards (wireless and / or wired), infrared communication devices, Bluetooth devices, 802.11 devices, WiFi devices, WiMax devices, cellular communication facilities such as GSM (Global System for Mobile Communications), W-CDMA (Wideband Code Division Multiple Access), LTE (Long Term Evolution), etc. The communications subsystem 2012 may enable data to be exchanged with networks (such as those described below, to name a few), other computer systems, controllers, and / or any other devices described herein. In many embodiments, the computer system 2000 may further include a working memory 2014, which may include random access memory and / or read-only memory devices as described above.

[0104] Computer system 2000 may also comprise software elements shown as currently residing in working memory 2014, including other code, such as an operating system 2016, device drivers, executable libraries, and / or one or more application programs 2018, which may comprise computer programs provided by various embodiments and / or may be designed to implement methods and / or configure systems provided by other embodiments as described herein. By way of example, one or more procedures and / or system components described with respect to the method(s) discussed herein may be implemented as code and / or instructions executable by a computer (and / or a processor therein), and in one aspect, such code and / or instructions may then be used to configure and / or adapt a general-purpose computer (or other device) to perform one or more operations in accordance with the described methods.

[0105] A set of these instructions and / or code may be stored on a non-transitory computer-readable storage medium, such as the storage device(s) 2010 described above. In some cases, the storage medium may be incorporated within a computer system, such as computer system 2000. In other embodiments, the storage medium may be separate from the computer system (e.g., a removable medium such as a flash memory) and / or may be provided as an installation package, whereby the storage medium may be used to program, configure, and / or adapt a general-purpose computer to the stored instructions / code. These instructions may take the form of executable code that is executable by computer system 2000 and / or may take the form of source and / or installable code that takes the form of executable code when compiled and / or installed on computer system 2000 (e.g., using any of a variety of commonly available compilers, installation programs, compression / decompression utilities, etc.).

[0106] It will be apparent that substantial modifications can be made according to specific requirements. For example, customized hardware might also be used and / or particular elements might be implemented as hardware, software (including portable software such as applets), or both. Furthermore, connection to other computing devices, such as network I / O devices, might also be used.

[0107] As mentioned elsewhere herein, in one aspect, some embodiments may employ a computer system (such as computer system 2000) to perform methods according to various embodiments of the present disclosure. According to a set of embodiments, some or all of the steps of such methods are performed by computer system 2000 in response to processor 2004 executing one or more sequences of one or more instructions contained in working memory 2014 (which may also be embedded in other code, such as operating system 2016 and / or application program 2018). Such instructions may also be read into working memory 2014 from another computer-readable medium, such as one or more of storage devices 2010. By way of example only, executing a sequence of instructions contained in working memory 2014 may cause processor 2004 to perform one or more steps of the methods described herein.

[0108] The terms "machine-readable medium" and "computer-readable medium" as used herein may refer to any non-transitory medium that participates in providing data that causes a machine to operate in a specific manner. In an embodiment implemented using computer system 2000, various computer-readable media may participate in providing instructions / code to processor 2004 for execution and / or may be used to store and / or carry such instructions / code. In many implementations, computer-readable media are physical and / or tangible storage media. Such media may take the form of non-volatile or volatile media. Non-volatile media may include, for example, optical and / or magnetic disks, such as storage device 2010. Volatile media may include, but is not limited to, dynamic memory, such as working memory 2014.

[0109] Exemplary forms of physical and / or tangible computer readable media include floppy disks, flexible disks, hard disks, magnetic tape or any other magnetic medium, compact disks, any other optical medium, any other memory chips or cartridges such as ROM, RAM, or any other medium from which a computer can read instructions and / or code. Various forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to the processor 2004 for execution. By way of example, the instructions may initially be carried on a magnetic and / or optical disk of a remote computer. The remote computer may load the instructions into its dynamic memory and send the instructions as signals over a transmission medium to be received and / or executed by the computer system 2000.

[0110] The communications subsystem 2012 (and / or components thereof) may generally receive signals, and the bus 2002 may then convey the signals (and / or data, instructions, etc. carried by the signals) to the working memory 2014, from which the processor 2004 retrieves and executes the instructions. The instructions received by the working memory 2014 may optionally be stored on the non-transitory storage device 2010 before or after execution by the processor 2004.

[0111] Moreover, it should be appreciated that components of computer system 2000 may be distributed across a network. For example, some processing may be performed using a first processor at one location, while other processing may be performed by another processor remote from the first processor. Other components of computer system 2000 may be similarly distributed. Thus, computer system 2000 may be interpreted as a distributed computing system that performs processing at multiple locations. In some examples, computer system 2000 may also be interpreted as a single computing device, such as a separate laptop, desktop computer, etc., depending on the context.

[0112] The processor may be a hardware processor, such as a central processing unit (CPU), a graphic processing unit (GPU), or a general-purpose processing unit. The processor may also be any suitable integrated circuit, such as a computing platform or microprocessor, a logic device, etc. Although the present disclosure is described with reference to a processor, other types of integrated circuits and logic devices are also applicable. The processor or machine may not be limited by data computing capabilities. The processor or machine may perform 512-bit, 256-bit, 128-bit, 64-bit, 32-bit, or 16-bit data operations.

[0113] Each of the calculations or operations discussed herein can be performed using a computer or other processor having hardware, software, and / or firmware. The various method steps can be performed by modules, which may comprise any of a wide variety of digital and / or analog data processing hardware and / or software configured to perform the method steps described herein. The modules include data processing hardware, optionally adapted to perform one or more of these steps by having appropriate machine programming code associated therewith, where modules relating to two or more steps (or parts of two or more steps) are integrated within a single processor board or separated within different processor boards in any of a wide variety of integrated and / or distributed processing architectures. These methods and systems will often employ tangible media embodying machine-readable code having instructions for performing the method steps described herein. All features of the described systems and devices are applicable to the described methods, mutatis mutandis, and vice versa. Suitable tangible media may include memory (including volatile and / or non-volatile memory), storage media (e.g., magnetic recording such as on a floppy disk, hard disk, tape, or optical memory such as a CD, CD-R / W, CD-ROM, DVD, or any other digital or analog storage medium), etc. Although exemplary embodiments have been described in some detail by way of example and for clarity of understanding, those skilled in the art will recognize that various modifications, adaptations, and variations may be employed.

[0114] According to some embodiments, machine-readable code instructions for and / or data generated or used by the pumping and feeding devices and / or computing devices (which may include smartphones or other mobile computing devices) may be stored on or executed by any of a variety of computing modalities, including, but not limited to, a personal computer, a server (e.g., a hosted and / or privately owned server), an internet connection, cloud hosting, cloud-based storage, etc. According to some embodiments, data acquired by the pumping and feeding devices may be associated with the mobile computing device (e.g., a smartphone) via data exchange technology (e.g., Bluetooth) and then relayed via the cloud to a secure server (e.g., a server accessed over the internet and the software, services, and / or databases running on those servers).

[0115] According to some embodiments, the pumping and feeding device can be configured to provide paced feeding. The lateral position, where the baby is fed from a bottle-like device but facing the breast, can mimic breastfeeding and allow the user to hold and feed the bottle as if they were breastfeeding naturally (e.g., getting used to the breastfeeding position, bonding with the baby, etc.). Furthermore, the lateral position can allow for paced feeding, meaning that the baby has the initiative to draw milk from the bottle as they do at the breast, rather than experiencing a continuous strong downward flow. This method (paced feeding, or lateral feeding) is used as a technique in NICUs, where babies may have poor swallowing and sucking control and may not be able to regulate the flow of milk to avoid choking. The lateral position instead allows milk to pool in the cheeks, which allows the baby to swallow when ready. Furthermore, paced feeding is often recommended for mothers and infants who have breast difficulties but wish to pursue breastfeeding. When the bottle is held horizontally to the floor (and the infant is in either an upright sitting or lying position) rather than tilted downwards, the infant must determine when milk is entering the mouth by drawing from a bottle that is not dripping but is filled to just below the nipple slit. This further reinforces the infant's expectation that milk needs to be drawn in order to drink, and also helps develop the sucking muscles necessary for sucking directly at the breast.

[0116] 21A-21D show aspects of an exemplary milk pumping and feeding device 2100, according to an embodiment of the present invention. As shown therein, the milk pumping and feeding device 2100 is in an assembled configuration and includes an upper container assembly 2110 and a bottom housing assembly 2120. The upper container assembly 2110 and the bottom housing assembly 2120 are coupled together. In some cases, the upper container assembly 2110 can be referred to as or can include a milk storage container. In some cases, the bottom housing assembly 2120 can be referred to as or can include a pump housing front. As discussed further herein, the device 2100 also includes a nipple attachment or nipple component 2114. The bottom housing assembly 2120 can be operable to house electronics and / or other mechanisms of the device 2100. The upper container assembly 2110 can be operable to contain and / or store milk or other liquids. In some cases, the upper container assembly 2110 can include a milk storage container spout 2191. As shown in FIG. 21D, a breast flange 2125 can be incorporated into the milk container or upper container assembly 2110, and the entire milk container can be attached to the bottom housing assembly 2120. In some cases, the feeding device or system 2100 can include a nipple ring component 2181. In some cases, the feeding device or system 2100 can include a pump housing rear 2171. In some cases, the feeding device or system 2100 can include a pump diaphragm 2173. In some cases, the feeding device or system 2100 can include a container click stop switch 2175. As shown in FIG. 21E, the milk container component or upper container assembly 2110 and the nipple component or nipple attachment 2114 can be removed from the main pump body or bottom housing assembly 2120. As shown in FIG. 21F, milk or liquid can be transferred from the milk container or upper container assembly 2110 to the teat attachment 2114 via the action of a peristaltic pump wheel mechanism 2127.

[0117] As shown in FIG. 21G-1-21G-3, the nipple attachment or assembly 2114 (which may also be referred to as or included as part of a nipple component subassembly) may be connected to the milk container or upper container assembly 2110 via a small tube 2144 driven by a peristaltic pump wheel 2138. In some cases, the tube 2144 is part of the container subassembly 2155. The peristaltic tube 2144 may provide fluid communication between the container 2110 and the nipple 2114. In some cases, the wheel mechanism 2138 is part of the pump housing subassembly 2165. In some cases, the bottom housing assembly 2120 may be part of the pump housing subassembly 2165. The diaphragm 2119 of the upper container assembly 2110 operates to create a negative pressure on the breast, causing milk or fluid to be expressed. Milk or fluid can be stored around the breast flange 2125 and backflow can be prevented via the action of a one-way valve such as a duckbill valve 2126. As shown here, the pump housing subassembly 2165 can include a cavity 2166 into which the nipple component subassembly 2114 is inserted.

[0118] As shown in the side cross-sectional view provided by FIG. 21H, a breast pumping and feeding device 2100A, which may be provided as or include a system for determining the amount of feeding fluid being ingested by an infant, may include a chamber or container 2110A for storing feeding fluid. The system 2100 may also include a breast flange 2002A, a pump diaphragm 2004A, and a one-way valve, such as a duckbill valve 2006A (e.g. for the flange), connecting the breast flange 2002A with the container 2110A and providing fluid communication therebetween. Additionally, the system 2100A has a dosing mechanism 2112A, which may include a peristaltic pump wheel mechanism. As shown here, the dosing mechanism 2112A may receive feeding fluid from the chamber or container 2110A and may dispense individual packets of feeding fluid, for example into or towards the nipple 2114A, for ingestion by the infant. For example, the peristaltic pump wheel can create a peristaltic action to move fluid from the container 2110A towards the nipple 2114A. Each individual packet of feeding fluid can have an individual packet volume. Thus, the nipple 2114A can receive the feeding fluid dispensed by the dosing mechanism 2112A and allow the feeding fluid to flow to the infant. The system 2100A can also include a sensor assembly or Hall effect sensor 2102A (relevant aspects of which are further shown in Figures 21N and 21O) operative to determine when the compressible chamber 2118A is ready to receive a new individual packet of feeding fluid. Furthermore, the system 2100A can include a counting mechanism 2104A operative to register a count for each dispense event performed by the dosing mechanism 2112A. In some embodiments, the counting mechanism is attached to an axle that drives the peristaltic wheel 2112A. In some embodiments, the counting mechanism can include, for example, a Hall effect sensor or a magnetic encoder. The number of revolutions of the peristaltic pump can be counted by a Hall effect sensor to determine the amount of fluid made available to the infant.In some embodiments, the number of revolutions of the peristaltic pump can be counted by a magnetic encoder. Embodiments of the present invention encompass the use of any of a variety of counting mechanisms for counting the number of revolutions (or partial revolutions) of the peristaltic pump. In the embodiments provided herein, the system 2100A includes a fluid connection 2116A (e.g., a right-angled return angle connection piece) that attaches to the container 2110A and the intake of the dosing mechanism (e.g., peristaltic tubing, peristaltic pump wheel) to provide fluid communication therebetween. In some cases, the fluid connection 2116A does not include a plug. As discussed elsewhere herein, the system 2100A can also include a processor that determines the amount of feeding fluid being ingested by the infant based on the individual packet volumes and the number of registered counts.

[0119] As mentioned above, the dosing mechanism 2112A may include a peristaltic pump. The sensor assembly may include a Hall effect sensor. Additionally, the system 2110A may include a collapsible feeding bag 2118A that receives the individual packets of feeding fluid dispensed by the dosing mechanism 2112A and directs the individual packets of feeding fluid towards the nipple 2114A. The collapsible chamber 2118A may operate to hold milk to be made available to the infant. In some cases, the feeding fluid travels from the feeding bag 2118A to the nipple 2114 via a one-way duckbill valve 2122A (e.g., for the nipple). The valve 2112A may operate to ensure that milk flows in one direction to the infant and / or to ensure that air does not enter the feeding bag 2118A and falsely indicate that the compressible chamber contains fluid. As shown here, the system 2100A can also include a fluid connection 2132A (e.g., a fluid connection through a plug) that is attached to the peristaltic tube and serves to provide fluid communication with the nipple 2114A. In some cases, the system 2100A can also include a container click-stop switch component 2142A that operates to hold the container 2110A in place once the container 2110A is inserted. In some cases, the system 2100A can include a magnet operatively associated with the collapsible feeding bag 2118A. The sensor assembly can be operable to determine that the collapsible chamber is available to fill or receive a feeding fluid (or the peristaltic pump is ready to start) when the magnet reaches a first distance away from the Hall effect sensor, and that the peristaltic pump is ready to pause (or stop) when the magnet reaches a second distance away from the Hall effect sensor, the first distance being greater than the second distance. Thus, embodiments of the present invention encompass systems and methods for sensing bag collapse using Hall effect sensors, which can trigger the movement of a peristaltic pump that forces milk to the baby and can allow quantification of the dispensed milk.Optionally, the milk container can be used as part of a peristaltic pump by being a backing to provide counter pressure to the peristaltic rollers. In some cases, the collapsible compartment can work with a magnet / Hall effect and a peristaltic tube for oral administration on demand.

[0120] Combining a peristaltic pump with a sensor assembly can provide several advantages, including ease of use and the ability to allow the infant to initiate the feeding action. In some embodiments, isolating the sensor from the milk path allows for easier cleaning since the sensor does not need to come into contact with the milk. In some embodiments, the sensor is passive, allowing the infant to initiate the refilling of the bag. Relatedly, embodiments disclosed herein provide a compressible feeding bottle that automatically refills when the infant finishes drinking, rather than a pump that pumps milk to the infant through a straw (and may engage a flow sensor). Thus, the exemplary embodiments create a more natural feeding action for the infant. Furthermore, embodiments disclosed herein provide systems and methods that may not require venting, for example, through the use of a compressible feeding bag, which also provides an easy way for the infant to aspirate without opposing a closed volume that would require an air source. Even with a separate vent source to move the fluid (so the baby is not forced to drink as from a pinched straw), such venting may require another check valve in the system. Furthermore, the embodiments disclosed herein do not rely on gravity. In contrast to sensor and filling methods that require the milk to be dripped where the sensor detects, the peristaltic pump pumping embodiments disclosed herein can provide pumping to the baby reservoir, moving the milk from the bottom of the milk container (so that no milk is wasted) to a location closer to the mother's anatomical nipple, regardless of the size or configuration of the milk container. Furthermore, the embodiments disclosed herein can provide improved accuracy. For example, the peristaltic pump can deliver highly accurate liquid packets to the baby, which can be easily calculated by the rotation of the peristaltic pump, without touching the fluid the baby drinks. Furthermore, the embodiments of the present invention can provide the ability to increase the rate of drinking. For example, the magnet / bag combination may operate independently of the peristaltic pump and may behave in response to an infant alone.Since the magnet / bag can indicate any amount of contraction, if it is returned to its original state near the Hall effect sensor, it will indicate fullness and no decision needs to be made by the device as to how much milk to deliver. If the milk bag or feeding bag is in any state other than full, the peristaltic pump can continue to dispense packets of milk until the bag is full. This allows for real-time or on-demand response to the baby's actions. The feeding bag or compartment does not need to wait to refill (as in the chamber + empty / full infrared reading configuration) to record a bolus of milk and then dispense it to the baby. Furthermore, embodiments of the present invention provide improved operability with respect to the strength of the baby's suction. For example, a surprising advantage of this method is that in the case of the Hall effect sensor and magnet configuration, the sensor can also operate to detect the amount of contraction the baby is exerting on the bag. This can indicate differences in suction strength / completeness from one baby to another, or based on the baby's age, or sucking skill practice. This may also allow progress to be monitored and to detect or analyze which feeding practices result in better sucking or intake of milk. Correlations may also be understood between the distance of contraction (sucking strength) and the amount of milk the infant takes in or weight gain, etc. Furthermore, embodiments of the present invention provide improved operation with respect to providing an easily usable system for infants with latching problems. For example, in infants with latching or efficient sucking problems, drinking from a small flexible chamber as disclosed herein allows the infant to take in the feeding fluid with less effort. Furthermore, embodiments of the present invention provide improved configurations for continuous drinking. In some other non-vented drinking systems, the infant may need to open his / her mouth to allow air back into the system. This may interrupt the infant's continuous drinking as they would normally do at the breast.If there were an air hole in the bulge, air would need to flow through the milk, which would entrain the milk and provide more air into the baby's GI system. With the peristaltic mechanism and flexible magnetic bag as disclosed herein, there is no need to introduce air into the chamber to create a continuous drinking flow.

[0121] FIG. 21H provides a cross-sectional view of the assembled device 2100. As shown in the partial cross-sectional view of FIG. 21I, milk or fluid from the upper bin assembly 2110 can be forced into the tube 2111. The peristaltic wheel mechanism 2127 can rotate and operate to pump the milk or fluid coming from the upper bin assembly 2110 through the tube 2111 and into the nipple assembly or attachment 2114. The milk or fluid can rise up the tube and can be stored in the feeding bag 2113. The baby can suck on the nipple attachment 2114, which facilitates the transfer of milk or fluid from the feeding bag 2113 to the baby. According to some embodiments, the baby can suck on the nipple attachment, which collapses the feeding bag including the magnet. When the magnet moves away from the Hall effect sensor inside the housing, the peristaltic pump is activated to refill the feeding bag. When the magnet moves back near the Hall effect sensor (e.g., due to an expansion of the feeding bag 2113), the peristaltic pump will stop pumping milk into the feeding bag. In that pattern, the baby is provided with milk or fluid on demand, and the amount of fluid dispensed is determined by multiplying the resulting revolutions of the peristaltic motor by the amount of fluid passing in one revolution. The check valve 2128 can operate to prevent or inhibit milk or fluid from re-entering the feeding bag 2113 after it has been sucked out, and can also operate to prevent air from outside the nipple device from entering the feeding bag and falsely indicating it is full of milk if the baby's mouth does not form a vacuum around the nipple. In some embodiments, the feeding bag 2113 shrinks as the baby drinks from the nipple. As the feeding bag 2113 shrinks, a sensor is triggered to activate the peristaltic wheel mechanism 2127 to pump more fluid into the nipple assembly or fitting 2114. The sensor counts the number of rotations of the peristaltic wheel mechanism 2127, thereby allowing the volume of fluid passing through to be counted. Figure 21J shows an embodiment of the device 2100 without the peristaltic tube of the peristaltic pump wheel mechanism 2127.FIG. 21K shows an aspect of the device 2100 with the peristaltic tube 2127A of the peristaltic pump wheel mechanism 2127. FIG. 21L provides an exploded view of the nipple attachment or assembly 2114. FIG. 21M provides an exploded view of the upper container assembly 2110. As described herein, embodiments of the present invention encompass systems and methods for quantification of dispensed fluid. Such technology may involve a bag + Hall effect sensor + peristaltic pump and may be a modification of a two-bag system as also disclosed herein. Embodiments also encompass systems and methods involving accurate monitoring of the amount someone drinks on demand, down to very small amounts. Such embodiments provide excellent application for the small amounts consumed by preterm or full-term infants, but may also be applied to oral administration or monitoring of oral intake by any child, adult, or elderly person. Thus, the device may be configured to provide on-demand monitoring of fluid intake, which may involve quantification technology as disclosed elsewhere herein.

[0122] 21N and 21O show the operation of a feeding bag according to an embodiment of the present invention. As shown in FIG. 21N, when the feeding bag or compressible chamber 2110N is in a "full" configuration or position (e.g., completely filled with feeding fluid such as milk), the magnet 2120N is pushed toward or positioned close to the Hall effect sensor 2130N. In some embodiments, when the feeding bag 2110N is fully filled, the magnet 2120N will be pushed as close as possible to the Hall effect sensor 2130N. As shown here, the magnet 2120N can be embedded in the feeding bag 2110N and sensed by the Hall effect sensor 2130N. The Hall effect sensor 2130N can be positioned outside the feeding bag 2110N along the axis of the magnet 2120N. As shown in FIG. 21O, when the feeding bag or compressible chamber 2110N is compressed, the magnet 2120N is positioned farther away from the Hall effect sensor 2130N. In some cases, when the feeding bag 2110N is in an "empty" configuration or position (e.g., empty of feeding fluid such as milk), the magnet 2120N is positioned as far away from the Hall effect sensor 2130N as possible. The feeding bag 2110N can be crushed (e.g., via the folds 2140N) to create a fully compressed geometry. As discussed elsewhere herein, the crushing or compression of the feeding bag 2110N can provide an indication that some milk has been ingested (e.g., by the infant) and that the feeding bag 2110N can then accept additional milk. According to some embodiments, the peristaltic dose is less than the negative volumetric contraction of the feeding bag, so at least one more packet can be provided.

[0123] 22A-22E show aspects of a milk pumping and feeding device 2200, according to an embodiment of the present invention. As shown therein, the system 2200 can include a cavity 2210 into which a teat component subassembly can be inserted, and a fluid connection point or hole 2220 into which the teat component can be connected to a fluid connection tube. The system 2200 can also include a milk container alignment feature 2230. Additionally, the system 2200 can include a cutout 2240 for a ball bearing that accommodates a peristaltic wheel assembly, a barb 2250 that connects an air pump to the diaphragm cavity, and a junction point 2260 between the front and rear housings.

[0124] 23A and 23B show aspects of a breast pumping and feeding device 2300, according to an embodiment of the present invention. As shown, the system 2300, or pump subassembly thereof, can include a rear pump housing 2310, a top pump housing 2320, a front pump housing 2340, an air pump mounting bracket 2350, a barb 2360 for connecting the air pump to the diaphragm cavity, and a peristaltic motor mounting bracket 2370.

[0125] 24A-24E show aspects of a breast pumping and feeding device 2400, according to an embodiment of the present invention. As shown therein, the system 2400, or pump subassembly thereof, can include a pump housing front 2410 and alignment features 2420 within the cavity that allow a user to properly insert the nipple subassembly.

[0126] 25A-25F show aspects of a milk pumping and feeding device according to an embodiment of the present invention. As shown therein, the system, or receptacle click switch 2500 thereof, can include a receptacle click stop switch component 2510, a circular cutout 2520 to guide the user to press in the correct contact point, a peg 2530 to allow insertion of the switch during assembly of the device and rotation when inserted into the upper pump housing, a living hinge 2540 to create a spring action mechanism on the switch, and a click mechanism angled surface 2550 configured to constrain movement of the milk receptacle component when attached to the upper pump housing.

[0127] 26A-26D show aspects of a rear pump housing 2610 of a breast pumping and feeding device, according to an embodiment of the present invention. 27A-27E show aspects of a pump housing top 2710 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the pump housing top 2710 can include a bracket 2720 for connecting the pump housing top to other pump housing components, a bracket 2730 for securing a peristaltic pump motor in place, a bracket 2740 for securing an air pump in place, tracks 2750 for aligning a container upon insertion, top features 2760 that allow for assembly of a peristaltic motor pump within the top housing component, and container alignment features 2770.

[0128] 28A-C show aspects of a container subassembly 2810 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the container subassembly 2810 can include a diaphragm 2820 that contracts into a cavity to create a negative pressure that facilitates suction at the breast. The container subassembly 2810 can also include a container alignment feature 2830 that clicks into an alignment feature on the top of the pump housing, and an alignment feature 2840 for a fluid connection assembly that is inserted onto the milk container. Additionally, the container subassembly 2810 can include a spout cap 2850 for the milk container. The container subassembly 2810 can also include a breast flange seal 2860 around the edge of the milk container, allowing the axis of the user's nipple to be aligned with the axis 2870 of the diaphragm. The container subassembly 2810 can further include a peg 2880 on the side of the container that can slide into a track system on the top pump housing.

[0129] 29A-29C show aspects of a container subassembly 2910 of a milk pumping and feeding device, according to an embodiment of the present invention. As shown here, the container subassembly 2910 can include a fluid connection tube 2920 that can be inserted into the bottom of the milk container, and a piercing plug 2930 that can be attached to the front of the milk storage container and connects with a teat component at the front of the device. The container subassembly 2910 can also include a one-way duckbill valve 2940 that allows milk to pass from the breast flange to the container, but not vice versa. Additionally, the container subassembly 2910 can include a cutout 2950 in the bottom of the milk container that allows the fluid connection to be compressed by a peristaltic wheel, thereby creating a pumping action.

[0130] 30A and 30B provide exploded and cross-sectional views, respectively, of the container subassembly 3010. As shown, the container subassembly 3010 includes a spout cap 3020, a breast flange 3022, a duckbill valve 3024, a flange seal 3026, a milk container 3028, and a diaphragm pump 3030. The breast flange 3022 can be curved to accommodate the natural anatomy of the breast and has a constriction point 3023 to facilitate expression. The duckbill valve 3024 can be a one-way valve that fits within the breast flange 3022 to create a seal for suction. The milk container 3028 can have a cutout 3029 in its base that allows the fluid connection components to be compressed. The diaphragm pump 3030 can have a ridge 3031 that can allow for linear compression and / or collapsibility.

[0131] 31A-31C show aspects of a nipple component subassembly 3110 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown therein, the nipple component subassembly 3110 may include a feeding bag 3112 extending beyond the rear of the nipple component, a fluid connection point 3114 connecting a fluid path to the nipple component subassembly, a nipple ring component having a front portion 3118 that clicks into the front portion of the pump housing, and a nipple 3120 made of soft silicone and forming a seal with the front portion of the nipple ring component. The rear portion 3122 of the nipple ring component may connect with the front portion of the nipple ring component. The nipple 3120 may be symmetrical and may not require alignment by the user when inserted into the nipple ring subassembly.

[0132] 32A and 32B show aspects of a nipple component subassembly 3210 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the nipple component subassembly 3210 can have a rounded rear portion 3222 that mates with a rounded cavity in the pump subassembly, and an alignment feature 3224 in the rear of the nipple ring component that allows for secure alignment of the nipple component subassembly within the pump housing. A feeding bag component 3230 can be overmolded into the rear of the nipple ring component. A one-way duckbill valve 3240 can be compressed by the nipple and the rear of the nipple ring component. A fluid pathway connection 3250 can transfer breast milk from a container to the feeding bag.

[0133] 33 shows aspects of a nipple component subassembly 3310 of a milk pumping and feeding device, according to an embodiment of the present invention. As shown therein, the nipple component subassembly 3310 can have a nipple ring component (first rear portion) 3320, a feeding bag component 3340, a nipple ring component (second rear portion) 3350, a nipple ring component (front portion) 3360, and a nipple component 3370.

[0134] Figures 34A-E show aspects of a nipple ring component (front) 3410 of a milk pumping and feeding device, according to an embodiment of the present invention. As shown here, the nipple ring component (front) 3410 can have a front portion 3420, one or more retention features 3430 that allow the rear component of the nipple ring to be inserted into the front component, a lip 3450 on the front nipple ring that allows a seal to be created on the nipple, and a retention feature 3460.

[0135] Figures 35A-D show aspects of a nipple component 3510 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the nipple component 3510 has a circular profile 3520 that is well suited for a baby to breastfeed. The rounded and convex side profile 3530 is well suited for a baby to breastfeed. A lip feature 3540 on the nipple allows a seal to be created by the front component of the nipple ring.

[0136] 36A-36D show aspects of a valve, such as a one-way duckbill valve 3610, of a breast pumping and feeding device, in accordance with an embodiment of the present invention. As shown here, the one-way duckbill valve 3610 has a slit opening 3620 that allows fluid to pass in only one direction. A one-way valve, such as the duckbill valve 3610, also has a rear cutout 3630 that has a shape that allows fluid to travel from the fluid connection path to the feeding bag. Fluid can pass through the duckbill valve, but the vacuum created by peristaltic action does not allow fluid to pass back through the valve.

[0137] 37A-37D show aspects of a nipple ring component (second rear portion) 3710 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the nipple ring component (second rear portion) 3710 includes one or more alignment features 3720 for a one-way valve, such as a duckbill valve, that allow a user to insert the duckbill valve in a desired orientation, an opening 3730 for a feeding bag component, and an opening 3740 for a fluid pathway connection component.

[0138] 38A-38F show aspects of a nipple ring component (first rear portion) 3810 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the nipple ring component (first rear portion) 3810 includes a fluid pathway connection 3820 on its rear surface, as well as a protrusion 3830 on its rear surface that serves as a feature for aligning the nipple assembly within the pump housing cavity. Additionally, the nipple ring component (first rear portion) 3810 includes an opening 3840 for a feeding bag component, an opening 3850 for a fluid pathway connection component, one or more channels 3860 on its rear surface that allow the subassembly to be aligned as desired within the nipple cavity on the pump housing, and one or more alignment features 3870 that secure the nipple rear component within the front component.

[0139] 39A-39C show aspects of a nursing bag component 3910 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the nursing bag component 3910 includes a sloped profile 3920 to allow for easy insertion into the pump housing cavity, a lip feature 3930 to allow for overmolding, rib features 3940 on the interior of the nursing bag to ensure compression of the component along a linear axis, and a top portion 3950 that is thicker than the rest of the nursing bag body to allow for a magnet to be molded into place.

[0140] 40A-40E show aspects of a solenoid valve component 4010 of a breast pumping and feeding device, in accordance with an embodiment of the present invention. As shown here, the solenoid valve component 4010 includes a barb 4020 that allows connection to an air pump, thereby allowing vacuum pressure to be released periodically.

[0141] 41A-41F show aspects of a peristaltic pump motor 4110 of a breast pumping and feeding device, according to an embodiment of the present invention. As shown here, the peristaltic pump motor 4110 includes a motor shaft 4120 that can be plugged directly into a peristaltic wheel support component.

[0142] 42A-42G show aspects of an air pump motor 4210 of a breast pumping and feeding device, in accordance with an embodiment of the present invention. As shown here, the air pump motor 4210 includes a connection mechanism 4220 that allows the air pump to connect via tubing to a barb feature on a cavity in the front pump housing.

[0143] 43A-C show aspects of a peristaltic wheel support component 4310 of a milk pumping and feeding device, according to an embodiment of the present invention. As shown here, the peristaltic wheel support component 4310 includes one or more holes 4320 for aligning and connecting the individual peristaltic roller components (e.g., four in total), a hole 4330 for inserting the shaft of a peristaltic motor therein, and one or more protrusions 4340 that allow for alignment within a friction reducing ball bearing or bushing.

[0144] 44A-C show aspects of a peristaltic wheel roller 4410 of a milk pumping and feeding device, according to an embodiment of the present invention. As shown here, the peristaltic wheel roller 4410 includes a peristaltic roller 4420 that is connected to a peristaltic wheel support component via a ball bearing (or bushing component) and a dowel pin element. In some cases, this connection is via a bushing mechanism. In some cases, this connection includes a lubricating material. The peristaltic wheel roller 4410 can have a circular profile 4430 that creates minimal friction when compressing the peristaltic tube.

[0145] 45A and 45B show aspects of a ball detent component 4510 of a breast pumping and feeding device, in accordance with an embodiment of the present invention. As shown here, the ball detent component 4510 includes a spring-loaded ball detent mechanism 4520 that allows for alignment and locking of the component in place.

[0146] 46 illustrates aspects of a quick count bottle system 4600, according to an embodiment of the present invention. As shown, the quick count bottle system 4600 can include a bottle nipple 4610, a one-way valve assembly 4620, a fluid meter housing (top portion) 4630, a delivery volume display 4640, a power on / off button 4650, a fluid container 4660, an electronic fluid meter 4670, and a battery indicator light 4680. In some cases, the quick count bottle system 4600 may not include a delivery volume display. Relatedly, in some embodiments, the delivery volume display can be displayed on a personal device (e.g., a tablet or smartphone).

[0147] 47A-47D show aspects of a quick count bottle system 4700, according to an embodiment of the present invention. As shown therein, the quick count bottle system 4700 can include a flexible bottle nipple 4710 and an inner ring 4712 for restricting the fluid path, which mates with a one-way valve 4714 mounted within a plate-like housing 4716. The system 4700 also includes a fluid meter housing 4720 having a flexible diaphragm 4722 with a magnet 4724 embedded therein, which has an expanded configuration during negative pressure due to suction. The housing 4720 also includes a fluid path 4726 from a container so that fluid can enter the fluid meter housing. Additionally, the housing 4720 includes a fluid exit point or conduit 4728, so that fluid can be available at the top of the flexible diaphragm after being pushed by the peristaltic rollers. The system 4700 also includes an electronic fluid meter 4740 having a Hall effect sensor 4742, a peristaltic roller 4744, and other operating mechanisms such as a battery indicator light, a fluid dispensing display, a power on / off button, a battery, a charging port, and a motor. The system 4700 further includes a fluid container 4750 having threads 4752 that mate with the fluid meter housing.

[0148] 48A and 48B show a single aspect of an instant count bottle system 4800, according to an embodiment of the present invention. As shown here, such a single aspect of the system 4800 can include a fluid meter housing 4810, and an electronic fluid meter 4830. Additionally, the system 4800 can include a fluid outlet or conduit 4840 providing a path to the nipple, a fluid inlet or conduit 4850 providing a path from the fluid container, and a peristaltic tube or sheath 4860 that holds or defines the fluid path, such that a peristaltic roller 4870 can propel fluid (e.g., in the direction indicated by arrow A) through the tube 4860.

[0149] FIG. 49 illustrates an aspect of a method 4900 of operation for a feeding device such as a fast-counting bottle. Step 4910 may include filling the bottle with fluid. Step 4920 may include detecting whether a nipple ring component is attached. If the nipple ring component is not attached, the method may include keeping the peristaltic pump disabled, as shown in step 4930. If the nipple ring is attached, the method may include detecting whether the feeding bag is full, as shown in step 4940. If the feeding bag is full, the method may include activating the peristaltic pump, as shown by step 4950, and sharing intake data, as shown by step 4970. If the feeding bag is not full, the method may include deactivating the peristaltic pump, as shown by step 4960, and sharing intake data, as shown by step 4970. After sharing the intake data, the method may include detecting whether the feeding bag is full, as indicated by step 4940.

[0150] 50A-50D show a single embodiment of a feeding system 5000 with a counting sensor chip according to an embodiment of the present invention. As shown here, such a single embodiment of the system 5000 can include a flange 5010 as shown in the rear view of FIG. 50A. As shown in the front view of FIG. 50B, a nipple 5020 can be attached to the front of a container 5030 to allow the baby to drink. The container 5030 can hold expressed milk. The breast flange 5010 can create a constriction against the mother's breast and can be connected to an external pump source. A milk counting sensor 5040 can be inserted between the container and the baby's nipple to track the flow of expressed milk into the baby's mouth.

[0151] Figures 51A-51D show a single aspect of a breastfeeding system 5100, according to an embodiment of the present invention. A nipple side view is provided in Figure 50B, and a flange side view is provided in Figure 50D.

[0152] Figures 52A and 52B show an isolated aspect of a expressed milk flow sensor 5210 according to an embodiment of the present invention. Figure 52A provides a side view of the sensor 5210 and Figure 52B provides a front view of the sensor 5210. Figures 53A and 53B show an isolated aspect of a container 5310 according to an embodiment of the present invention. Figure 53A shows an opening 5320 on the container to which a baby nipple can be attached. Figure 53B provides a side view of the container 5310 without a sensor, flange, or baby nipple attached.

[0153] Figures 54A-54D show aspects of an integrated teat assembly 5410 according to an embodiment of the present invention. As shown in the breastpump assembly embodiment shown in Figure 54B, the teat 5420 can be integrated into the side of the container and there are no sensors to track the intake of expressed milk. As shown in the breastpump assembly embodiment shown in Figure 54D, a flange 5430 can be attached within the milk container.

[0154] 55A-55D show aspects of a manual expression breast pump assembly 5500 according to an embodiment of the present invention. As shown here, the overmolded component 5510 of the assembly can be constructed of soft plastic and can have a shape that follows the curvature of the container to appear to be one continuous shape. As shown in FIG. 55C, the overmolded component 5510 can be overmolded or integrated into the container, which can allow the mother to press the soft plastic portion to create a vacuum to manually express breast milk. As shown in FIG. 55D, the breast pump assembly can utilize a milk flow sensor 5520 as disclosed elsewhere herein and can also include a teat 5540 as disclosed elsewhere herein. The teat 5540 and / or the sensor 5520 can be removable. The flange 5530 can be attached to the milk container and can have other flange features as disclosed elsewhere herein.

[0155] Figures 56A-56D show aspects of a container 5610, according to an embodiment of the present invention. Figure 56A provides a view of the container 5610 without the softer integrated plastic parts, nor the flange and baby nipple components. As shown in Figure 56C, the nipple and milk counting sensor can both be removed.

[0156] 57A-57D show aspects of an infrared (IR) sensor breast pump assembly 5700, according to an embodiment of the present invention. As shown in FIG. 57D, the IR sensor 5710 can take the form of a ring around the interior of the flange component and can track the amount of milk stored in the container (separate from the sensor 5720 that tracks how much the baby has taken in). The sensor 5720 is a milk flow sensor. In some embodiments, the baby teat 5730 can have teat features as disclosed elsewhere herein. In some embodiments, the teat 5730 and the sensor 5720 can be detachable.

[0157] Figures 58A-C show aspects of an infrared (IR) sensor 5810, according to an embodiment of the present invention. As shown in the rear view of Figure 58A, the sensor can have a ring shape to allow for easy fitting inside the breast flange. As shown in the front view of Figure 58B, the sensor can have one or more infrared light sources 5820. As the milk in the container fills up, the milk covers each of the infrared light sources one by one, which communicate with the phone via Bluetooth to signal the mother how much milk has been stored in the container.

[0158] 59A-59D show aspects of a capacitance sensor breast pump assembly 5900 according to an embodiment of the present invention. As shown in the rear view of the container shown in FIG. 59A, the assembly can include the container and the capacitance sensor, the breast flange is not shown here. As shown in FIG. 59B, the capacitance sensor 5910 can be provided as a thin component that appears to wrap around the side of the container. The capacitance sensor 5910 can be in the form of a sticker and can be used on the container to sense how much breast milk has been stored in the container. As shown in FIG. 59C, a component 5920 that fits on the back of the container has an opening to allow the flange to be inserted therethrough. As shown in FIG. 59D, the capacitance sensor can be powered by a component 5930 that fits on the back of the container that provides power to the sensor and interprets and transmits the data to a phone via Bluetooth.

[0159] Figures 60A-60D show additional aspects of a capacitance sensor breast pump assembly 6000, according to an embodiment of the present invention. Typically, the capacitance sensor is attached to the container. Figure 60B shows the capacitance sensor 6010 removed. Figure 60C shows the container without the capacitance sensor. A cutout 6020 on the side of the container can be a connection point for a rear component that provides power to the capacitance sensor present on the container.

[0160] 61A-61C show an embodiment of a rear ring component 6110 that plugs into the container and provides power to the capacitive sensor. The component 6110 can include a protrusion 6120, which can be a plug mechanism or site of electrical connection, where the rear ring component interacts with the container.

[0161] Figures 62A-E show aspects of a pumping feature, according to an embodiment of the present invention. As shown in Figure 62A, the pumping feature includes an air pump 6210 that pumps air into a chamber 6220. The chamber holds a bag 6222 as shown in Figure 62A. Referring again to Figure 62A, milk is drawn into the bag by negative pressure created by the pump, starting at an inlet 6230. The bag is connected to a milk inlet and also to a milk outlet 6240. A solenoid valve 6250 serves to release air from the chamber, with the default position being closed. Blocking points A and B hold a vacuum in the line from the inlet to the outlet.

[0162] As shown in FIG. 62B, an air pump can force air into the chamber, which compresses a bag 6222 within the chamber, as indicated by the dashed line. As shown in Figure 62C, blocking point A is released, allowing milk to flow into the bag through the inlet. The bag expands to a quiescent state with the release of the solenoid valve (relieving pressure), allowing milk to be drawn into the bag through the inlet.

[0163] As shown in Fig. 62D, an air pump can compress the bag by pumping air into the chamber. Blockage point A can close when air is pumped into the chamber. Blockage point B can open when air is pumped into the chamber, allowing milk from the bag to be pumped through the outlet. Milk can fill the outlet chamber.

[0164] As shown in FIG. 62E, the air pump can be turned off and cut-off points A and B can close the lines to store and keep the milk in the outlet chamber. In some cases, embodiments may involve systems and methods for counting without the need for venting. In some examples, such embodiments may involve the use of two vent bags and a switch. In some examples, such embodiments may involve the use of a peristaltic mechanism and one bag. In some examples, such embodiments may involve a counting bottle.

[0165] In some counting bottle embodiments, on-demand drinking from the mouth of an infant (or adult) triggers the collapse of a chamber containing a magnet on a distal end, which indicates the distance of the magnet from a Hall effect sensor as the chamber collapses. The indicated collapse triggers peristaltic action to send a bolus of milk into the chamber until the chamber is at its maximum size. The number of revolutions of the peristaltic pump is counted by another Hall effect sensor, which determines the amount of fluid made available to the infant. In some embodiments, the number of revolutions of the peristaltic pump can be counted by a magnetic encoder. Embodiments of the invention encompass the use of any of a variety of counting mechanisms to count the number of revolutions (or partial revolutions) of the peristaltic pump. With respect to the counting bottle, the source of milk can be a bottle that can be held by hand, the fluid can be any fluid, and the amount of fluid actively ingested can be displayed directly on the bottle or on a connected device. This counting bottle may be used to feed infants of any age, or may be attached to a larger bottle with a straw guide to accurately monitor drinking for adults. It may be particularly beneficial for infants born prematurely, as intake is monitored in mL. It may also be used to administer oral amounts of fluids or medications for any person.

[0166] Some system and method embodiments may involve an alternating compression approach. Exemplary breast pumps disclosed herein may provide alternating compression during suction. This is based on the concept that a baby acts on the breast in two ways during effective breastfeeding: (a) by distorting the tongue into a bowl shape, creating a local vacuum under the nipple, and (b) by releasing the bowl and compressing the areola with the tongue between the tongue and the hard palate (roof of the mouth). This alternating method of two actions draws and expresses milk from the breast. A traditional vacuum breast pump acts like the first action, while "manual expression" of milk functions like the second action. Embodiments of the present invention include methods involving providing pressure to the areola by filling with air, and incorporating compression mechanically within the vacuum device, including distorting flanges, etc. Thus, embodiments include implementing alternating compression on the areola / breast within a breast pump device as disclosed herein. Such techniques may result in more effective milking and require less milking time. In some cases, the feeding system may include a first compressible chamber and a second compressible chamber, which may alternately fill and dispense a feeding fluid throughout a feeding process or event. In some cases, the two compressible chambers may alternately fill and dispense. Relatedly, the feeding system may provide a fluid path extending from a nipple shield to a throughput opening, the fluid path having two compartments adjacent to the throughput opening, both of which have a defined volume, which alternately fill with fluid and dispense fluid to the throughput opening. FIGS. 63A-D show aspects of an embodiment of a counting method in which two compressible chambers alternately provide milk. As shown in FIG. 63A, in a first step, a switch 6320 may be closed and a compressible bag A may be filled with a feeding fluid. In a second step, switch 6320 is opened, compressible bag A is compressed or crushed, and supply fluid flows into compressible bag B, as shown in FIG. 63B.As shown in Figure 63C, in a third step, switch 6320 is closed and compressible bag A returns to a neutral position or configuration and the infant can drink or receive feeding fluid from compressible bag B. As shown in Figure 63D, in a fourth step, switch 6320 is closed and compressible bag B is compressed or crushed as the infant drinks or receives feeding fluid from it. Both compressible bag A and compressible bag B can have magnets embedded within them allowing their position or configuration to be measured or detected using a sensor such as a Hall effect sensor.

[0167] Some system and method embodiments may involve configurations that include multiple counters connected to negative pressure sources at different locations. An exemplary embodiment may include two counters / feeders / collectors (one on each breast) connected around a central remote vacuum source that can be positioned anywhere (e.g., between the breasts, on the top half of each breast, on the shoulder or behind the neck, or away from the body, etc.). Each counter / feeder / collector may have its own remote negative pressure source.

[0168] Some system and method embodiments may involve configurations that include massage features. Exemplary embodiments may include a device or components thereof that can be worn as a bra that is worn over the top half of the breast or elsewhere. Some embodiments may have massage features that are intended to provide a massage to the breast for better milk expression. This may or may not be by exogenous sensation, triggered by a motor contained within the device, or it may be a separate massage / vibration that can be controlled independently.

[0169] Some system and method embodiments may involve configurations including an inverted milk bag for an infant nipple. An exemplary embodiment may involve a milk bag with a magnet that collapses as the infant drinks, and that functions in an inverted fashion such that the bag is flat like a diaphragm component at rest and then expands into the nipple cavity as the infant sucks.

[0170] Some system and method embodiments may involve configurations that include a pace / breast mode. Exemplary embodiments provide the ability to select settings on the pump or computer application that cap the pace of milk delivered to the infant nipple milk bag to mimic the pace at which the infant may extract milk from the breast. The purpose may be to prevent the infant from receiving milk at a faster pace than normal breastfeeding and becoming accustomed to this pace, either rejecting the breast in the future, or receiving too much milk too quickly and choking or becoming overfed.

[0171] Some system and method embodiments may involve configurations that include a pacifier mode. Exemplary embodiments allow the nursing function to be intentionally shut off by the mother to create a pacifier from the nipple attachment by disabling the peristaltic motor. By way of example, this function may be used to promote sleep, to limit intake, or to allow the infant to engage in non-nutritive sucking, which may aid the infant's digestion by triggering peristalsis of the GI tract.

[0172] Embodiments of the systems and methods disclosed herein can be used to add other fluids, such as formula, vitamins, medications, and water, that are typically administered to infants via bottles, droppers, or syringes, either alone or in combination with breast milk.

[0173] Some system and method embodiments may involve configurations that include an infant nipple device. An exemplary embodiment may include a magnet and Hall effect that indicates the distance of the compressible compartment from a non-stationary position, and may be used separately or in conjunction with the device to determine the relative suction power of the infant's mouth.

[0174] An embodiment of the present invention can incorporate a check valve action, such as a one-way valve inside the infant nipple device, that prevents air from entering the compressible feeding chamber and falsely indicating that no additional milk is needed by not compressing the bag. For feeding and / or tracking embodiments, the device can include a companion phone application that connects to the device via Bluetooth. An estimate of the amount of milk ingested by the infant can be tracked on the device and displayed on the phone application, which can also store feeding data from each individual pumping session. This allows mothers to track how much milk their infants have had over a period of time. This also allows a new set of automated data to be collected about when and how much mothers are feeding their children, how many mothers are using assistive devices to feed, how old they are, and which infant / mother dyads may be using other forms of breastfeeding support. Correlating this with user provided demographic data such as maternal age, geographic location, etc. provides market knowledge to serve mothers. In some embodiments, the device can pump milk from the mother's breast and simultaneously allow the mother to feed her infant in a breastfeeding position with the freshly expressed breast milk. This feeding is performed via a nipple attached to the breast pump and is performed automatically in response to the infant sucking on the nipple. In some cases, the mother can also manually turn off the feeding function if selected. In some embodiments, the device can use an infant-driven feeding mechanism. Relatedly, in some embodiments, the device makes milk available for the infant to drink only if the infant is sucking on the nipple attachment as if it were a breast. In some cases, an integrated sensor can operate to make milk available to the infant only if expressed breast milk is present and will not push air out if milk is not available.In that way, the device can operate as a "low colic" system that provides little air to the infant. The embodiments disclosed herein can incorporate various feeding mechanism features. For example, with regard to the peristaltic pump, expressed breast milk can be transferred from the milk container to the nipple attachment via a peristaltic pump mechanism acting on a tube. This mechanism allows milk to be hygienically transferred from the milk container to the nipple attachment only when the infant demands milk. With regard to the dosing tube and priming chamber feature, expressed breast milk can be transferred from the milk container to the nipple attachment via a series of priming chambers and dosing tubes. The priming chamber can hold expressed breast milk and transfer it to the nipple attachment via a dosing tube controlled by a series of valves and sensors. With regard to the compressible bag feature, expressed milk can be transferred from the milk container to the nipple attachment via a compressible bag that draws expressed milk from the milk chamber to the nipple attachment via suction actuated by a vacuum pump. Such a compressible bag may have a series of cut-off points that allow a suction mechanism to draw milk from the container into the bag and then push the milk from the bag into the nipple attachment. With regard to storage, the device may operate to store milk in a container that is kept uncontaminated by the baby's saliva, thus maintaining a longer CDC recommended shelf life. This may be accomplished by the action of a one-way valve in the baby's nipple. For example, a one-way valve in the nipple may prevent the baby from transferring contaminated milk (that was in the baby's mouth) back into the nipple attachment. With regard to peristaltic action, the one-way flow of the peristaltic motor action may further inhibit the flow of milk back into the tank. With regard to liquid sensing, the device may include a sensor or a series of sensors that track the amount of expressed breast milk that is accumulating in the milk container. This sensor may provide readings by indicating the presence or absence of milk at various heights along the milk container that correspond to ounces of milk present when the milk container is full.With regard to pumping, the device uses a pumping mechanism to create a vacuum at the breast, causing breast milk to be pumped and stored in a milk container. The user can control the intensity and speed of pumping using physical buttons on the device or by the user's mobile device. With regard to wearable embodiments, the entire device can be wearable and used by placing it in a pumping bra that is worn directly over the breast. The nipple attachment can be positioned on the device such that it can protrude from an opening in the pumping bra.

[0175] According to some embodiments, on-demand suction by the baby at the bottle-like teat automatically drives the flow of additional milk made available to the baby. The foregoing description, while containing numerous details regarding certain preferred embodiments, should not be construed as limiting the scope of the invention, but rather as providing exemplification of preferred embodiments.

[0176]

[0013] Embodiments of the present invention include kits having a breast pumping and feeding device as disclosed herein. In some embodiments, the kits include one or more breast pumping and feeding devices, along with instructions for using the device(s), e.g., according to any of the methods disclosed herein.

[0177] Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, those skilled in the art will recognize that certain changes, modifications, alternative configurations, and / or equivalents may be practiced or adopted as desired and within the scope of the appended claims. Moreover, each document provided herein is incorporated by reference in its entirety to the same extent as if each document was individually incorporated by reference. In relation thereto, all publications, patents, patent applications, academic papers, books, technical literature, etc. mentioned herein are incorporated by reference to the same extent as if each individual publication, patent, patent application, academic paper, book, technical literature, etc. was specifically and individually indicated to be incorporated by reference.

Claims

1. 1. A system for indicating an amount of a delivery fluid dispensed to an individual, comprising: a chamber for storing a supply fluid; a dosing mechanism for receiving the supply fluid from the chamber and dispensing individual packets of the supply fluid, each individual packet having an individual packet volume; a collapsible chamber for receiving the individual packets of delivery fluid dispensed by the dosing mechanism; a feeding device having a nipple interior, the feeding device receiving feeding fluid from the collapsible chamber and allowing feeding fluid to flow from the nipple interior through an outlet of the feeding device to the individual's mouth; a check valve disposed between the collapsible chamber and an interior of the teat, the check valve allowing fluid to flow from the collapsible chamber to the interior of the teat and preventing fluid to flow from the interior of the teat to the collapsible chamber; a sensor assembly for determining when the collapsible chamber is available to receive a new individual packet of delivery fluid to be dispensed from the dosing mechanism; a counting mechanism that registers a count for each dispense event performed by the dosing mechanism; A system including:

2. The system of claim 1 further comprising a processor that determines an amount of supply fluid to be dispensed to the individual based on the individual packet volume and the number of registered counts.

3. 10. The system of claim 1, wherein the dosing mechanism comprises a peristaltic pump, the sensor assembly comprises a Hall effect sensor, and the system further comprises: a magnet operatively associated with the collapsible chamber; The system, wherein the sensor assembly determines that the peristaltic pump should dispense a new individual packet of supply fluid when the magnet reaches a first distance away from the Hall effect sensor, and determines that the peristaltic pump should pause when the magnet reaches a second distance away from the Hall effect sensor, the first distance being greater than the second distance.

4. 2. The system of claim 1, wherein the dosing mechanism includes a gate and a tube, and the sensor assembly includes a full sensor and an empty sensor, the gate allowing passage of supply fluid through the tube when the empty sensor indicates that the tube is empty of supply fluid, and the gate preventing passage of supply fluid through the tube when the full sensor indicates that the tube is full of supply fluid.

5. 2. The system of claim 1, wherein the dosing mechanism includes a first compressible chamber and a second compressible chamber, the first compressible chamber and the second compressible chamber alternately filling and dispensing a supply fluid.

6. 10. The system of claim 1, further comprising a sensor selected from the group consisting of a capacitance sensor and an infrared sensor, the sensor configured to detect an amount of supply fluid present in the chamber, the system configured to send a signal to cause additional supply fluid to flow into the chamber based on the detected amount of supply fluid.

7. The system of claim 1 further includes a breast flange in fluid communication with the chamber, the breast flange defining a breast flange axis, the feeder defining a feeder axis, the breast flange axis being aligned with or above the feeder axis.

8. The system of claim 1 further includes a breast flange fluidly connected to the chamber, the dosing mechanism including a peristaltic wheel, the center of the peristaltic wheel being positioned rearward of a front portion of the breast flange and forward of a rear portion of the breast flange.

9. The system described in claim 1 further includes a breast flange fluidly connected to the chamber, the chamber being located within a housing, and the supply device being attached to the housing and positioned below the breast flange.

10. The system of claim 9, wherein the supply device is removable from the housing.

11. The system of claim 1, wherein the administration mechanism includes a peristaltic pump having a peristaltic tube, at least a portion of the tube being positioned below and within the nipple of the feeding device.

12. 1. A method for indicating an amount of a delivery fluid dispensed to an individual, comprising: storing a supply fluid in a chamber; Receiving a supply of fluid from the chamber in a dosing mechanism; Dispensing individual packets of a supply fluid from the dosing mechanism, each individual packet having an individual packet volume; receiving, in a collapsible chamber, the individual packets of delivery fluid dispensed by the dosing mechanism; allowing the individual packets of feeding fluid to flow from the collapsible chamber through a check valve to an interior of a teat of a feeding device, the check valve allowing fluid flow from the collapsible chamber to the interior of the teat and preventing fluid flow from the interior of the teat to the collapsible chamber; determining when the collapsible chamber is available to receive a new individual packet of delivery fluid dispensed from the dosing mechanism using a sensor assembly; registering a count for each dispense event performed by said dispensing mechanism using a counting mechanism; The method includes:

13. 13. The method of claim 12, further comprising using a processor to determine an amount of supply fluid to dispense to the individual based on the individual packet volume and the number of registered counts.

14. 13. The method of claim 12, wherein the dosing mechanism comprises a peristaltic pump and the sensor assembly comprises a Hall effect sensor; The method, wherein the collapsible chamber is coupled to a magnet, and the sensor assembly determines that the peristaltic pump should dispense a new individual packet of supply fluid when the magnet reaches a first distance away from the Hall effect sensor, and determines that the peristaltic pump should pause when the magnet reaches a second distance away from the Hall effect sensor, the first distance being greater than the second distance.

15. 13. The method of claim 12, wherein the dispensing mechanism includes a gate and a tube, and the sensor assembly includes a full sensor and an empty sensor, the method further comprising: using the gate to allow passage of supply fluid through the tube when the empty sensor indicates that the tube is empty of supply fluid; and using the gate to prevent passage of supply fluid through the tube when the full sensor indicates that the tube is full of supply fluid.

16. 13. The method of claim 12, wherein the dosing mechanism includes a first compressible chamber and a second compressible chamber, the method further including alternating filling and dispensing of a supply fluid by the first compressible chamber and the second compressible chamber.

17. The method of claim 12 further comprises: detecting an amount of supply fluid present in the chamber using a capacitance sensor; and sending a signal to cause additional supply fluid to flow into the chamber based on the detected amount of supply fluid.

18. The method of claim 12 further comprises: detecting an amount of dispense fluid present in the chamber using an infrared sensor; sending a signal to cause additional supply fluid to flow into the chamber based on the detected amount of supply fluid; The method includes:

19. The method of claim 12 , further comprising displaying, on a graphical user interface of a screen of a mobile computing device, an indication of the amount of supply fluid ingested by the individual.

20. 20. The method of claim 19, wherein the indication includes an amount of feeding fluid ingested by the individual during a single breastfeeding session.

21. 20. The method of claim 19, wherein the indication includes an amount of feeding fluid ingested by the individual during multiple breastfeeding sessions.

22. The method of claim 12 further comprises engaging a breast flange with the breast of a nursing mother, the breast flange being in fluid communication with the chamber and defining a breast flange axis, the feeder defining a feeder axis, the breast flange axis being aligned with or above the feeder axis.

23. The method of claim 12 further comprises engaging a breast flange with the breast of a nursing mother, the breast flange being fluidly connected to the chamber, and the dosing mechanism comprising a peristaltic wheel, the center of the peristaltic wheel being positioned rearward of a front portion of the breast flange and forward of a rearward portion of the breast flange.

24. The method of claim 12 further comprises engaging a breast flange with the breast of a nursing mother, the chamber being located within a housing, and the delivery device being attached to the housing and positioned below the breast flange.

25. The method of claim 24, wherein the supply device is removable from the housing.

26. The method of claim 12, wherein the administration mechanism includes a peristaltic pump having a peristaltic tube, at least a portion of the tube being positioned below and within the nipple of the feeding device.

27. A milk pumping and feeding system comprising: a negative pressure source configured to express breast milk from the breast; a chamber configured to store the expressed breast milk; a dosing mechanism for receiving the expressed breast milk from the chamber and dispensing individual packets of the expressed breast milk, each individual packet having an individual packet volume; a collapsible chamber for receiving the individual packets of expressed breast milk dispensed by the dosing mechanism; a feeding device having a nipple interior for receiving expressed breast milk from the collapsible chamber and for allowing the expressed breast milk to pass from the nipple interior through an outlet of the feeding device to the baby's mouth; a sensor assembly that determines when the collapsible chamber is available to receive a new individual packet of expressed breast milk to be dispensed from the dosing mechanism; A system including:

28. The system described in claim 27 further includes a check valve disposed between the collapsible chamber and the interior of the nipple, the check valve allowing fluid flow from the collapsible chamber to the interior of the nipple and preventing fluid flow from the interior of the nipple to the collapsible chamber.

29. The system of claim 27, further comprising a counting mechanism that registers a count for each dispensing event performed by the administration mechanism.

30. The system of claim 27 further includes a breast flange in fluid communication with the chamber, the breast flange defining a breast flange axis, the feeder defining a feeder axis, the breast flange axis being aligned with or above the feeder axis.

31. The system of claim 27 further includes a breast flange fluidly connected to the chamber, the dosing mechanism including a pump, the center of the pump being positioned rearward of a forward portion of the breast flange and forward of a rearward portion of the breast flange.

32. The system described in claim 27 further includes a breast flange fluidly connected to the chamber, the chamber being located within a housing, and the supply device being attached to the housing and positioned below the breast flange.

33. The system of claim 32, wherein the supply device is removable from the housing.

34. The system of claim 27, wherein the administration mechanism includes a peristaltic pump having a peristaltic tubing, at least a portion of the tubing being positioned below and within the nipple of the delivery device.

35. The system of claim 27, wherein the dosing mechanism includes a gate and a tube, and the sensor assembly includes a full sensor and an empty sensor, the gate allowing the passage of expressed breast milk through the tube when the empty sensor indicates that the tube is empty of expressed breast milk, and the gate preventing the passage of milk through the tube when the full sensor indicates that the tube is full of expressed breast milk.

36. The system of claim 27, wherein the dosing mechanism includes a peristaltic pump, the sensor assembly includes a Hall effect sensor, and the system further includes a magnet operatively associated with the collapsible chamber, the sensor assembly determining that the peristaltic pump should dispense the new individual packet of supply fluid when the magnet reaches a first distance away from the Hall effect sensor and determining that the peristaltic pump should pause when the magnet reaches a second distance away from the Hall effect sensor, the first distance being greater than the second distance.

37. A method for expressing breast milk and feeding the breast, comprising: contacting the milk pumping and feeding system with the breast; expressing breast milk from the breast using a negative pressure source of the pumping and feeding system; storing the expressed breast milk in a chamber of the pumping and feeding system; receiving expressed breast milk from the chamber in a dosing mechanism of the milk pumping and feeding system; dispensing individual packets of expressed breast milk from the dosing mechanism, each individual packet having an individual packet volume; receiving the individual packets of expressed breast milk dispensed by the dosing mechanism in a collapsible chamber of the pumping and feeding system; allowing the individual packets of expressed breast milk to flow from the collapsible chamber into a nipple interior of a feeding device of the milk pumping and feeding system; allowing expressed breast milk to flow from within the nipple through an outlet of the feeding device to the baby's mouth; determining, using a sensor assembly of the milk pumping and feeding system, when the collapsible chamber is available to receive a new individual packet of milk dispensed from the dosing mechanism; The method includes:

38. The method of claim 37, wherein allowing the flow of expressed breast milk from inside the nipple to the infant's mouth includes allowing the individual packets of expressed breast milk to flow from the collapsible chamber through a check valve to the inside of the nipple of the feeding device, the check valve allowing fluid flow from the collapsible chamber to the inside of the nipple and preventing fluid flow from the inside of the nipple to the collapsible chamber.

39. The method of claim 37 further comprising using a counting mechanism of the milking and feeding system to register a count for each dispensing event performed by the dosing mechanism.

40. The method of claim 37, wherein contacting the milking and feeding system with the breast includes engaging a breast flange of the milking and feeding system with the breast, the breast flange being in fluid communication with the chamber and defining a breast flange axis, and the feeding device defining a feeding device axis, the breast flange axis being aligned with or above the feeding device axis.

41. The method of claim 37, wherein contacting the milking and feeding system with the breast includes engaging a breast flange of the milking and feeding system with the breast, the breast flange being fluidly connected to the chamber, and the dosing mechanism includes a pump, the center of the pump being located rearward of a front portion of the breast flange and forward of a rear portion of the breast flange.

42. The method of claim 37, wherein contacting the milking and feeding system with the breast includes engaging a breast flange of the milking and feeding system with the breast, the chamber being located within a housing of the milking and feeding system, and the delivery device being attached to the housing and positioned below the breast flange.

43. The method of claim 42, wherein the supply device is removable from the housing.

44. The method of claim 37, wherein the administration mechanism includes a peristaltic pump having a peristaltic tube, at least a portion of the tube being positioned below and within the nipple of the delivery device.

45. The method of claim 37, wherein the dosing mechanism includes a gate and a tube, and the sensor assembly includes a full sensor and an empty sensor, the method further comprising: using the gate to allow passage of expressed breast milk through the tube when the empty sensor indicates that the tube is empty of expressed breast milk; using the gate to prevent passage of milk through the tube when the fullness sensor indicates that the tube is full of expressed breast milk; The method includes:

46. The method of claim 37, wherein the dosing mechanism includes a peristaltic pump, the sensor assembly includes a Hall effect sensor, the collapsible chamber is coupled to a magnet, and the sensor assembly determines that the peristaltic pump should dispense the new individual packet of expressed breast milk and that the peristaltic pump should pause when the magnet reaches a first distance away from the Hall effect sensor.

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