Breast pump assembly and method

Abstract

A system and method for pumping milk from a breast, wherein the milk is expressed from the breast under suction and the milk is discharged from the pumping mechanism to a collection container under positive pressure.

Description

[0001] This application is a divisional application of patent application number 201780010993.2, filed on February 9, 2017, entitled "Breast Pump Assembly and Method". Patent application 201780010993.2 is an application that entered the Chinese national phase of PCT international application PCT / US2017 / 017112. Technical Field

[0002] This disclosure generally relates to portable breast pump systems and methods for collecting breast milk from the breasts of lactating mothers. Background Technology

[0003] As more women recognize that breastfeeding is the best source of nutrition for infants and is also beneficial to the health of breastfeeding mothers, there is a growing demand for user-friendly, quiet, separate, and multifunctional breast pump solutions for use by breastfeeding mothers in various situations. This is especially true for working mothers who are away from home for 8 to 10 hours or more and need to pump breast milk to provide for their babies, but it is also a need in many other situations where mothers are away from the privacy of their home for extended periods, such as while shopping, dining out, or engaging in other activities.

[0004] While a variety of breast pumps are available, many are bulky and cumbersome, requiring numerous parts and components and making them difficult to transport. Manually driven breast pumps are cumbersome and inconvenient to use. Some electric breast pumps require an AC power source during use. Some systems are battery-powered, but battery power depletes quite quickly when an electric breast pump is operated continuously to maintain suction during milk extraction. Many available breast pumps are clearly visible to observers when used by the mother, and many also expose the mother's breasts during use.

[0005] There has been a long-standing need for a small, portable, self-powered, energy-efficient, wearable breast pump system that is easy to use, mimics natural breastfeeding, and is separate from the user's breast by not exposing it and being barely noticeable when worn.

[0006] Monitoring an infant's intake is useful to ensure they receive adequate nutrition. It is desirable to provide a breast pump system that easily and accurately monitors the volume of milk pumped by the system, allowing breastfeeding mothers to know how much milk has been expressed. It is also desirable to track the amount of milk pumped in each session, making it easy to know the amount of milk contained in any given milk collection container.

[0007] There has always been a need for an effective and easy-to-use breast pump system. This disclosure addresses these and other needs. Summary of the Invention

[0008] In short, this disclosure relates to a breast pump system or method. The system includes a breast contact structure and a collection or storage container or assembly, as well as a structure for delivering milk from the breast to the collection assembly. The method involves pumping milk from the breast and delivering the pumped milk to the collection assembly or storage container. In one particular aspect, the breast pump system responds in real time to optimize the pumping action of a particular user during a specific suction process.

[0009] According to one aspect of this disclosure, a system for pumping milk from a breast includes one or more of the following: a skin contact member or flange configured to form a seal with the breast; a conduit in fluid communication with and connected to the skin contact member; a drive mechanism configured to establish a vacuum distribution within the conduit; a housing; a milk collection container; and a non-transitory computer-readable medium storing instructions executable by a computing device to cause the computing device to perform functions associated with and guided by the instructions; wherein the housing includes compartments; wherein the skin contact member, the conduit, and the drive mechanism are housed within the compartments of the housing; wherein the milk collection container is positionable within the housing; and wherein the system is shaped and configured to conform to the contours of a user's breast.

[0010] In one or more embodiments, the system may include one or more of the following: a structure configured to guide fluid in, a squeeze protection structure, a flexible piping structure to achieve effective and predictable fluid pumping and generate a desired pressure distribution, and a cooperative structure for secure attachment and removal of fluid collection.

[0011] In various embodiments, the storage container can be specifically configured to prevent kinking and to improve durability and operability. The storage container can be designed to hold, contain, or retain milk or other fluids. Flow characteristics can be incorporated into the storage container in the form of a fan-shaped structure; valves and materials can be selected to facilitate the removal of air or gas; flaps and wings for operation can be provided; and structures suitable for removing milk from the collection assembly can be included.

[0012] In the various disclosed embodiments, the system defines a breast contour. A natural breast contour is intended to comfortably and conveniently fit the user's bra and present a natural appearance. Therefore, the contour is characterized by having a non-circular base. Furthermore, similar to a natural breast, the contour of the device or system is intended to define one or more asymmetrical curves and an off-center center of inertia. In one aspect, the system defines a breast enhancement system for improving the appearance of a user's breasts.

[0013] In at least one embodiment, the system is operated by an operational control system that tracks the internal pressure of the system against a known waveform. In this regard, the waveform may be a vacuum waveform indicating the pressure applied to the breast, and may be a sine wave or other desired or useful waveform that fluctuates between a vacuum of about 60 mmHg and a vacuum of about 120 mmHg to about 250 mmHg.

[0014] In one or more embodiments, the system includes a controller that enables real-time pressure control within the system.

[0015] In one or more embodiments, the system includes a controller that provides automatic compliance sensing and response.

[0016] In one or more embodiments, the system includes a non-contact pressure sensing device that accurately determines the internal pressure of the conduit without contacting the skin or the milk inside the conduit.

[0017] In one or more embodiments, the system includes one or more controllers that automatically detect one or more of milk discharge, overflow, and flow.

[0018] In one or more embodiments, the system is disabled when the flange is not in the operating position.

[0019] In one or more implementations, the system can be adapted to visualize user data and trends, as it involves volume (total volume from each breast) and the number of processes across several dimensions (daily, weekly, and monthly). Data and analysis can also be provided on the pumping process.

[0020] In at least one embodiment, the flange or skin contact member, conduit, drive mechanism, housing, and milk collection container are all contained within the bra cups. In other embodiments, the container need not be contained within the housing, and the pump need not be within the bra cups, but may be unsupported or self-supported, or may be unsupported or supported by other clothing, sleeveless vests, or straps surrounding the user's body.

[0021] In at least one embodiment, the system is battery powered and includes a battery housed in a compartment of the housing.

[0022] In at least one embodiment, the milk collection container includes a one-way valve that allows milk to flow into the milk collection container but prevents milk from flowing back from the milk collection container into the conduit. In one embodiment, the collection container or container assembly includes additional parts, valves, or fittings attached thereto and facilitates sealing with the container to establish a closed system. In one embodiment, the milk container may include a one-way valve that cannot be removed without impairing the function of the milk container or valve. The valve may take many shapes and types, including umbrella valves, duckbill valves, ball valves, or other valves. Moreover, in one or more embodiments, the container may be flexible or rigid, or disposable or reusable.

[0023] According to another aspect of this disclosure, a system for pumping milk from a breast includes one or more of the following: a flange or skin contact member configured to form a seal with the breast; a conduit fluidly communicating with and connected to the skin contact member; a drive mechanism configured to establish a vacuum distribution within the conduit by cyclic compression and allowing a portion of the conduit to depressurize; and a housing containing the conduit and the drive mechanism and supporting the skin contact member.

[0024] In at least one embodiment, the system further includes a milk collection container, wherein the milk collection container is in fluid communication with a conduit.

[0025] In at least one embodiment, the skin contact member includes: a breast contact portion configured and sized to fit and form a seal with a portion of the breast; and a nipple receiving portion extending from the breast contact portion.

[0026] According to another aspect of this disclosure, a method of operating a system for pumping breast milk includes one or more of the following: providing a system comprising: a skin contact member configured to form a seal with the breast; a conduit fluidly in communication with and connected to the skin contact member; a drive mechanism including a compression member configured to compress the conduit and allow decompression of the conduit in response to inward and outward movement of the compression member; a sensor; and a controller configured to control the operation of the drive mechanism; sealing the skin contact member to the breast; operating the drive mechanism to generate a predetermined pressure cycle within the conduit; monitoring at least one of the position and velocity of the compression member relative to the conduit via the controller; measuring or calculating the pressure within the conduit; and maintaining or changing the movement of the compression member as needed based on the calculated pressure and feedback of at least one of the force, position, and velocity of the compression member to ensure continued generation of the predetermined pressure cycle.

[0027] In at least one embodiment, the predetermined pressure cycle includes an extraction pressure cycle, and the controller increases the stroke distance of the compression member relative to the amount of milk entering the conduit to maintain the predetermined pressure during the extraction pressure cycle.

[0028] In at least one embodiment, the predetermined pressure cycle includes a latching cycle, wherein after determining that milk has entered the duct or after a predetermined time period, the controller operates the compression member to achieve a predetermined extraction pressure cycle, wherein the predetermined extraction cycle differs from the predetermined latching cycle in at least one of the following: maximum suction level, cycle frequency, or waveform shape. Furthermore, in one or more embodiments, the system includes a structure or function for recognizing when the user has completed pumping, or includes a structure or function that allows the user to easily end the pumping process by directly pausing and pulling the device away from the breast when a vacuum recognition is lost. Additionally, in one or more embodiments, the system may include an automatic purge function or an accelerometer used as gesture recognition, enabling the device to understand what the user is attempting to do.

[0029] According to another aspect of this disclosure, a system for pumping breast milk includes one or more of the following: a flange or skin contact member configured to form a seal with the breast; a conduit fluidly communicating with and connected to the skin contact member; a drive mechanism including a compression member configured to compress the conduit and allow decompression of the conduit in response to inward and outward movement of the compression member; a sensor; and a controller configured to control the operation of the drive mechanism; wherein, when the skin contact member is sealed to the breast, the controller operates the drive mechanism to generate a predetermined pressure cycle within the conduit, monitors at least one of the position and velocity of the compression member relative to the conduit, measures or calculates the pressure within the conduit based on signals received from the sensor, and maintains or changes the movement of the compression member as needed based on feedback from the calculated pressure and at least one of the force, position, and velocity of the compression member to ensure continued generation of the predetermined pressure cycle.

[0030] These and other features of this disclosure will become apparent to those skilled in the art after reading the details of the systems and methods described more fully below. Attached Figure Description

[0031] Figure 1A A perspective view of a breast pump system according to an embodiment of the present disclosure is shown.

[0032] Figure 1B It is a description Figure 1A Rear view of the flange of the pump system.

[0033] Figure 2 It shows Figure 1A The front view of the system, where the shell has been removed.

[0034] Figure 3 Depicting Figure 1A The rear view of the system, where the flange has been removed.

[0035] Figure 4 yes Figure 1A A cross-sectional side view of the system.

[0036] Figure 5 yes Figure 1A An internal view of the system depicts the flexible conduits of the pump assembly.

[0037] Figure 6A yes Figure 1A The system's exploded diagram depicts the system's mechanical components.

[0038] Figure 6B -D depicts a view of an alternative shell structure.

[0039] Figure 6E -G depicts a view of yet another alternative to the shell structure.

[0040] Figure 6H This is a perspective view depicting the first approach to a system that includes a removable battery structure.

[0041] Figure 6I This is a perspective view depicting a second approach to a system that includes a removable battery structure.

[0042] Figure 6J This is a perspective view depicting a third approach to systems that include a removable battery structure.

[0043] Figure 7A It is a schematic diagram depicting the operating components of the system.

[0044] Figure 7B It is a diagram depicting the relationship between the position of the electric motor and the vacuum relative to time.

[0045] Figure 7C It is a diagram depicting the relationship between the position and volume of an electric motor.

[0046] Figure 8 This is a top view depicting one embodiment of the storage collection component of this disclosure.

[0047] Figure 9 It is a description Figure 8 A magnified view of the neck and valve of the storage collection component.

[0048] Figure 10 This is an enlarged view depicting the valve assembly of the storage and collection component.

[0049] Figure 11A It is a perspective view depicting the storage collection components connected to the system.

[0050] Figure 11B It is a perspective view depicting the first step of installing the assembled components.

[0051] Figure 11C This is a perspective view depicting the second step of installing the collection components.

[0052] Figure 11D This is a top view depicting the third installation step.

[0053] Figure 11E This shows yet another step in the collection component installation process.

[0054] Figure 12 It is a cross-sectional view depicting a part of the system.

[0055] Figure 13 It is a perspective view depicting the gate components of the system.

[0056] Figure 14 It is a cross-sectional view depicting the details of the door assembly.

[0057] Figure 15 Details of the door assembly are shown.

[0058] Figure 16 This is an enlarged view depicting the structure of the compression protection component.

[0059] Figure 17 This is an enlarged view depicting other structures of the crush protection assembly.

[0060] Figure 18 It is a perspective view depicting the flexible circuitry of the system.

[0061] Figure 19 It is a top view depicting the user interface components.

[0062] Figure 20 It is a bottom view that depicts further details of the user interface components.

[0063] Figure 21 The system's power access support structure is shown.

[0064] Figure 22-28 It describes various aspects of the remote user interface system.

[0065] Figure 29-41 Various other aspects of the remote user interface system are described. Detailed Implementation

[0066] Before describing the system and method, it should be understood that this disclosure is not limited to the specific embodiments described, and therefore changes are naturally possible. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting, as the scope of this disclosure is limited only by the appended claims.

[0067] Where a numerical range is provided, it should be understood that, unless the context explicitly specifies otherwise, each intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range is also specifically disclosed. Each smaller range between any stated or intermediate value within the range and any other stated or intermediate value within the range is included in this disclosure. The upper and lower limits of these smaller ranges may be independently included in or excluded from the range, and each smaller range that includes any one limitation, includes two limitations, or does not include any limitation is also included in this disclosure and is subject to the limitations specifically excluded from the stated range. Where a stated range includes one or two limitations, the range excluding one or both of the included limitations is also included in this disclosure.

[0068] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. While any methods and materials similar to or equivalent to those described herein may be used in the implementation or testing of this disclosure, preferred methods and materials are described hereafter. All disclosures referenced herein are incorporated by reference to disclose and describe methods and / or materials relating to the cited disclosures.

[0069] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless the context clearly indicates otherwise. Thus, for example, the stated “a sensor” includes a plurality of such sensors, and the stated “the pump” includes one or more pumps and their equivalents known to those skilled in the art, and so on.

[0070] The disclosures discussed herein are provided only because they were published prior to the filing date of this application. The publication dates provided may differ from the actual publication dates and may require separate verification.

[0071] Details of this system can be found in PCT applications PCT / US15 / 41257, PCT / US15 / 41271, PCT / US15 / 41277, and PCT / US15 / 41285, all filed on July 21, 2015, and PCT / US15 / 50340, filed on September 16, 2015, the entire contents of which are incorporated herein by reference.

[0072] Figure 1A-B is a perspective and rear view of a breast pump system 10 according to an embodiment of the present disclosure. The breast pump system 10 may include one or more, or a combination thereof, of the features or functions introduced or described below. The housing or outer shell 12 of the system 10 may be shaped and configured to conform to the contour of a user's breast, thus appearing more natural when worn under the user's clothing. As can be understood from the figures, the system may define a natural breast contour. The natural breast contour is designed to fit comfortably and conveniently into the user's bra and present a natural appearance. Therefore, the contour is characterized by having a non-circular base, unlike the base embodied in typical dome-shaped constructions. Extending from the base are curved surfaces with an asymmetrical pattern. Furthermore, like a natural breast, the contour of the device or system is designed to define one or more asymmetrical curves and an off-center center of inertia. A variety of natural breast shapes can be provided to suit the user's taste and needs. Opposite sides of the pump system 10 are constructed with flanges 14, the size and shape of which are designed to engage with the user's breast. The contour of the flanges 14 is adapted to comfortably fit a wide range of user body shapes and provide a structure for sealing engagement with breast tissue. In one particular embodiment, flange 14 may be formed of a generally rigid structure and, optionally or additionally, unlike a standard flange, flange 14 may lack sharp edges or lips that breast tissue may engage during use. In this respect, the flange includes a surface extending outward from the nipple-receiving portion of the flange to engage breast tissue, thereby providing an additional surface area for comfortable contact with the tissue. The flange can be designed in various ways to accommodate the user's nipple. One approach involves aligning a horizontal line formed within the flange structure slightly higher than the center, based on the principle that the mother's perspective is from above. This perspective allows the user to better align the breast with the horizontal line, thus better centering the nipple in the actual center of the nipple-receiving portion of the flange, thereby counteracting any aiming / alignment tendency associated with the centerline, because the user's perspective is from above the horizontal line, and also because the device pivots into place in some cases.

[0073] Figure 2 yes Figure 1A The front view of system 10 shows the housing or enclosure 12 removed, revealing the components originally covered by the housing 12 without obstruction. In particular, with the housing 12 removed, various electronic components are identifiable. System controllers are implemented in circuit board 15 communicating with flexible circuitry 16, each controller cooperating to connect to and control various electromechanical components of system 10. Control panel 17 communicates electronically with the controllers via flexible circuitry 16, enabling the user to turn the system on and off and change its operation. One or more motors 44, 46 are also provided and electronically controlled by the system to manipulate actuators operating on the conduit or flexible pipe 32 (described below) (see [link to documentation]). Figure 4 and Figure 5It includes a battery 48 to provide a rechargeable power source and is configured to be plugged into a power source for charging. Additionally, a pressure sensing element assembly 54 is provided, configured to provide the pressure sensing functionality described below. It can be designed, in at least one embodiment, that when the user is upright, the conduit or flexible tube 32 is oriented to run from bottom to top relative to the nipple of the breast.

[0074] Figure 3 The opposite sides of system 10 are shown, with flange 14 removed to show more details of the pumping function. Conduit or flexible tubing 32 (see...) Figure 4 -6) Includes a connector 33, typically spherical, sized and shaped to be detachably received in a recess 34 formed in the pump chassis 35. The connector 33 is designed to automatically engage with the moving motor blades without requiring user intervention or adjustment of components. The pump chassis 35 supports the electronic and electromechanical structures of the system 10 (see also...). Figure 2 The pump chassis 35 also provides space for a squeeze actuator 36, which is configured to move forward and retract toward and away from the conduit or flexible conduit 32, as further described below. Further pumping actions are achieved by engaging the conduit or flexible conduit 32 with the groove 34 via a compression and expansion member 38 (see [link to relevant documentation]). Figure 7A Further embossing is provided within the well formed in chassis 35, providing product and other information related to the breast pump. In this way, certain adhesive labels do not need to be applied to the breast pump structure.

[0075] Typically, real-time pressure control can be managed by the controller of system 10. The controller tracks the pressure and moves the pump motor in or out to influence the pressure in the selected direction. By vibrating the motor, the pump can be configured to pull the connector 33 of the conduit or flexible tubing structure 32 to increase its volume. If a vacuum exists in system 10, this vacuum can be increased as the volume of the tubing increases. Pushing the tubing reduces its volume. This, in turn, causes the vacuum level in the tubing to decrease, and if the vacuum level decreases sufficiently, a relative positive pressure can be generated. The pump controller applies these principles, senses the current pressure, and then gently pushes the compression member or impeller of the motor assembly in the direction where the desired pressure target is to be generated. By repeating this in real time, the system can create a controlled vacuum waveform that matches the waveform desired to be applied to the user's nipple.

[0076] The pump can slowly pull out the compression component or impeller until it reaches the predetermined target. If the impeller moves to the end of its range without generating the desired vacuum, the system is purged to create a greater vacuum potential. Purging is used to expel material from the system, thereby creating a strong vacuum potential. This is achieved by first closing the clamps on the conduit or flexible pipe, or by sealing the flexible pipe with baffles, barriers, etc., and then evacuating the flexible pipe, for example, by pushing the closed impeller. This forces the volume of the flexible pipe to decrease, and any fluid or air within that volume is also drawn out through a check valve and into a collection container. When the impeller retracts again, a higher vacuum can be generated because the contents of the pipe have been pre-purged. Once a higher vacuum is generated, the system can open the clamp valve, thereby applying the desired vacuum distribution to the breast and generating the desired pressure waveform.

[0077] When the system is filled with air, its compliance is very high, so that a large change in the motor position causes only a small change in vacuum. On the other hand, when the system is filled with fluid, a small change in the motor position causes a large change in vacuum. In one particular method, an encoder comprising multiple spaced magnets is associated with the motor. The magnets can be placed along the periphery of a generally disc-shaped encoder, with the orientation of the magnets parallel to the encoder's axis of rotation. One or more Hall effect sensors can be configured on circuit board 15 or as a surface mounted to circuit board 15 and positioned to read the movement and position of the magnets. In this way, the position of the motor can be determined and monitored. Therefore, configuring the system to be stable when the system responds and effective when it does not respond can be a challenge. One anticipated approach is to adjust the controller for a relatively rigid system and input a unitless quantity to move the motor in the desired direction, where the magnitude of the movement is modified according to the system output. Thus, if the system output is less than the desired output to achieve the pressure target, a cascaded controller can be created to increase the input waveform, and if the system output is greater than the desired output, the cascaded controller can be reduced. This can be done in real time by observing the relationship between the output and the input. In this way, the controller can continuously adjust the target waveform. The upper and lower waveforms can be controlled independently, which is beneficial for centering the waveform in an effective way and makes the system adjustment very accurate and fast.

[0078] The system can be further equipped with automatic milk dispensing detection. The pump can sense when it is full of liquid and respond accordingly by switching between pumping and dispensing when fluid begins to flow. In one approach, an algorithm incorporated into the system can be operated to examine the ratio of the maximum to minimum values ​​of a target wave in the pump and compare it to the pump's output. The result is a unitless but highly reliable sense of system compliance. This can be tuned to trigger an internal event when compliance exceeds certain known values ​​indicating that the system is full of fluid. Any other compliance measurement can be used in an equivalent manner.

[0079] In another method of milk let-down detection, it should be noted that pushing the air conduit does not generate the same force as pushing the fluid conduit. Tracking the force generated during purging can also be a good indicator of when the system is full of fluid. An event can be generated to track this event, such that when the purging force exceeds a certain known threshold, the system can be considered full of fluid rather than air. This method may involve less data tracking and fewer adjustments that vary with pump design or breast tissue. In another method, milk let-down detection can be based on tracking flow. That is, when flow begins, milk let-down must have already occurred, and the system can switch to pump suction when a small flow rate is collected. Furthermore, milk let-down can be tracked by looking at the relative rate of change of vacuum measured against the motor position. It should be noted that this relative rate of change is a compliance measurement. As the magnitude of this ratio increases, it can be concluded that the system is full of fluid.

[0080] Figure 4 A cross-section of a component of system 10 according to an embodiment of this disclosure is shown. Flexible conduit or duct 32 ( Figure 5 The smaller conduit 32S (isolated from the larger conduit 32S) includes a larger conduit portion 32L, the internal cross-sectional area of ​​which is larger than that of the smaller conduit portion 32S. The larger conduit portion 32L terminates at an opening sized for cleaning, and is typically sized to accommodate a little fingertip. Although both portions 32S and 32L are shown as tubular portions, this disclosure is not limited thereto, as one or both portions may be shaped in other ways. When shaped as a tube, the cross-section may be elliptical, square, other polyhedral shapes, asymmetrical shapes, or non-geometric shapes. Furthermore, the flexible conduit 32 may include an enlarged spherical portion 32B constructed near the end of the larger conduit portion 32L to help accommodate system hysteresis.

[0081] Figure 6A An exploded view of the structure and mechanical components of system 10 is depicted. A chassis 35 is constructed between housing 12 and flange 14. Notably, the chassis can be configured to snap-fit ​​into housing 12. Furthermore, in a preferred embodiment, chassis 35 directly or indirectly supports all pump components. In particular, PCB controller base 62 is supported by chassis 35 and is configured to connect to and support circuit board 15 (see also...). Figure 2The battery holder 64 is also supported by the chassis 35 and is sized and shaped to accommodate the rechargeable battery 48 assembly that powers the system 10. A cover jack 65 is also included to provide access to the battery assembly and to accommodate a power cord connector (not shown). The motor mount 66 and motor receiver structure 67 are also supported by the chassis 35 and are configured to house and support the system motor, which is battery powered and used to move actuators operating on the conduit or flexible conduit 32. The chassis 35 also supports the actuator bracket 69, as well as the pressure sensor bracket 70 and pressure sensor receiver 71. Furthermore, the user interface panel may include a button diaphragm 72 and a button diaphragm housing 73, which are supported on the housing 12 and positioned to engage with the flexible circuitry 16, which provides system control to the user.

[0082] To connect the conduit or flexible tubing assembly 32 to system 10, a flexible tubing ring 80 and a flexible tubing collar 82 are provided. The flexible tubing collar 82 is sized and shaped to be received into a groove 84 on a flange. A fluid container fitting 86 (shown isolated from the container) is sized and shaped to be received within the flexible tubing collar 82. A door assembly 90 is attached to flange 14 and configured to swing open and close to allow access to the interior of system 10 and to support a secure connection between fitting 86 and flexible tubing collar 82. Thus, it is contemplated that, in at least one embodiment, the collection or container assembly is supported and held in the attached state by frictional forces around the axis of the conduit against the collection or container assembly, and partly by the door assembly 90 (which can surround and hold the collection or container assembly in place). In alternative embodiments, the breast pump assembly may omit the door assembly entirely. Thus, the flange itself may include structures for holding the container assembly in place. Furthermore, the door assembly or other structures that are alternatives to the door assembly may be transparent, allowing direct observation of the container assembly.

[0083] In an alternative embodiment, the housing 14 is defined by an irregular shape, which includes the contours of the internal components and structures of the pump system that follow or mimic the design. Figure 6B In one particular method shown in -D, the outer surface of the housing 14 is characterized by an irregularly shaped notch 91, thereby providing an irregular shape to the outer surface. The notch 91 can be formed into various different shapes (see also...). Figure 6E-G). Various constructions of the individual bra cup skin or interface structure 98 are sized and shaped to fit the housing 14 and notch 91 to form a desired shape, such as the breast shape depicted in the figure. It should be noted that the breast pump system can operate with or without the bra cup skin or interface structure. Alignment and attachment structures or holes can be further provided to facilitate the fit between the interface structure 91 and the housing 14, and the interface structure can be available in a variety of colors, textures, and hardness to enhance or alter adhesion, softness to ensure a secure fit and external feel within the bra. Various other breast and other shapes can also be provided.

[0084] In yet another combination or individual implementation (see...) Figure 6H -J), the housing 14 may be adapted or configured to additionally or alternatively accommodate a replaceable battery. Here, the housing 14 includes recesses 91 of various other shapes, the recesses 91 being sized and shaped to accommodate a battery. In this method, the battery includes its own attachable housing 99, which mates with the recesses 91 of the housing 14, the housing 14 covering other pump suction structures. In one method, the mating features include a flat right-angled structure, and alignment and attachment holes and structures are also provided.

[0085] like Figure 7AAs schematically illustrated, latching, pumping, and extraction forces can be formed by two compression members 36 and 38, which are actively driven by motor drivers 44 and 46, respectively. Although more than two compression members and one or more drivers can be used, the currently preferred embodiment uses two compression members driven by two drivers, respectively, as shown. The system controller or system software and / or firmware controls the operation of the drivers in real time in response to predetermined latching and production targets or schemes detected by pressure sensors or pressure sensing element assemblies. The firmware can be programmed to approach such targets at various speeds, sometimes faster, sometimes slower, or more gently, thereby providing multiple levels of stimulation and extrusion. Thus, for example, a slower or faster approach can be used alternately to achieve latching, and there can be controls to determine the achieved latching level. Various levels of suction can also be present during extrusion. The pipe sections 32S and 32L can be closed or substantially closed by compression members 36 and 38, respectively. Furthermore, this active pumping member can be configured to engage with a conduit channel substantially perpendicular to the net flow of fluid or milk within the channel. Moreover, the compression zone of the conduit channel can be configured to open via a passive spring-loaded member located adjacent to the compression zone of the conduit channel, wherein the compression zone is opened via an auxiliary active support. When the system 10 is powered on, the compression member 36 opens and the compression member 38 begins to contract and retracts via its connection to a structure such as a ball connector for a conduit or flexible conduit 32, thereby gradually increasing the suction level within the conduit 32. When a predetermined maximum suction level is achieved (as confirmed by pressure readings obtained from a pressure sensor, as described below), the compression member 38 stops its travel in the current direction and remains in that position for a predetermined time when the operating mode of the system 10 has a predetermined time to maintain maximum suction (or moves slightly in the same direction to compensate for the reduction in suction when milk enters the system), or reverses direction and compresses the conduit 32L until a latching suction level is reached. If the maximum suction level is not reached before the compression member can fully retract during the first stroke, compression member 36 recompresses pipe 32S to seal the current vacuum level in the breast environment, and compression member 38 fully compresses pipe section 32L to expel more air from the system. Compression member 36 then reopens to fully open pipe section 32S, and the compression member performs another stroke, retracting again to create a greater suction level. This cycle continues until the maximum suction level is reached. It should be noted that in some cases the maximum suction level can be achieved in the first stroke, while in others multiple strokes may be required.

[0086] When achieving maximum suction, the system can be designed and programmed such that the compression member 38 does not travel as far as possible in either direction to achieve the maximum and latch-up suction levels, thus allowing some reserve suction and pressure generation capacity. When the maximum suction level is reached and the pumping distribution can return to latch-up vacuum, the compression member 38 advances the compression conduit section 32L, thereby raising the vacuum in conduit 32. When latch-up suction vacuum is achieved, the compression member 36 closes conduit 32S again to ensure that latch-up vacuum is maintained relative to the breast, thereby maintaining sufficient suction. At this stage, the compression member 38 begins to move away again to increase the suction level back to maximum suction, and the compression member 36 opens to allow conduit 32S to open and allow the breast 2 to be exposed to maximum suction. Alternatively, the system can be programmed such that the compression member 38 cycles between the maximum suction level and the latch-up suction level without the compression member 36 closing during each cycle point, and the compression member 36 closing when the latch-up vacuum is exceeded.

[0087] When milk aspiration begins, compression members 36 and 38 can operate in the same manner as the latch, but in a manner that follows the aspiration waveform determined by a selected aspiration pump, which is determined in real time by system controls in response to a pressure measuring component or pressure sensing component. During this phase, any noise generated by the system's pumping action as milk or fluid flows through the pump mechanism is reduced. During the compression stroke of compression member 38, compression member 36 closes when the latch pressure / aspiration level is reached. The continued compression of compression member 38 increases the pressure in conduit 32 downstream of compression member 36 to generate positive pressure, which forces the contents (milk) of conduit portion 32L out of conduit portion 32L through a smaller conduit portion 32S2 downstream of 32L and through a check valve. The obtained positive pressure is sufficient to open the check valve for conveying milk out of conduit 32 and into a milk collection container. In one embodiment, the positive pressure is in the range of 20 mmHg to 40 mmHg, typically about 25 mmHg. During the reversal of the movement of the compression member 38, the compression member 36 opens when the suction level returns to the latch suction level, and the compression member 38 continues to open to increase the suction level to the maximum suction level.

[0088] This disclosure allows for the generation of a latching vacuum to seal the flange or skin contact member / breast 14 to the breast. The latching vacuum generated by the system is currently approximately 60 mmHg, but can be any value ranging from approximately 20 mmHg to approximately 100 mmHg. Once the system 10 has latched onto the breast via the skin contact member 14, the system then cycles between the latching vacuum and a target (also referred to as “peak” or “maximum”) suction level. Because the system 10 does not cycle down to 0 mmHg but maintains suction applied to the breast, the minimum end of the suction cycle is the latching suction level (e.g., approximately 60 mmHg), and the nipple contracts as little as with breast pump systems using the prior art. It has been observed that the nipple is drawn into the skin attachment member 10 in a manner similar to nipple formation during breastfeeding, provided an initial latch is achieved. Once the vacuum cycles between the latching vacuum level and the target vacuum level, the nipple exhibits significantly less back-and-forth movement during vacuum changes compared to systems using the prior art. During the use of this system, nipple movement (the distance between full extension and full retraction) is typically less than approximately 2 mm, and in some cases less than approximately 1 mm. Therefore, the latch provided by the system is not only more similar to natural breastfeeding, but the reduced nipple movement is also more similar to natural breastfeeding, as confirmed by the scientific literature. In one particular method, the system may employ ultrasound to observe nipple movement during pumping to ensure the desired nipple movement is achieved.

[0089] This significant reduction in nipple movement during the cycle arises from establishing a latch at the latch vacuum level, which then limits the range of vacuum oscillation between the latch vacuum (suction) and the peak vacuum (suction). Typically, the vacuum difference between the latch vacuum and the peak vacuum is less than 200 mmHg, and more typically less than 150 mmHg. In one example, a latch vacuum of 50 mmHg and a peak vacuum of 200 mmHg produce a vacuum difference of 150 mmHg.

[0090] Using this system to restrict nipple movement, as described, provides several benefits to the user. One benefit is less friction between the nipple side and the flange wall, significantly reducing the risk of irritation, skin damage, pain, swelling, etc. As a result, breastfeeding mothers experience significantly greater comfort using this system, and this benefit becomes increasingly apparent with repeated use. By maintaining at least one latch suction level at all times, this system provides a safer and more durable seal to the breast and significantly reduces the likelihood of air and / or milk leakage. The significantly less nipple movement provides the user with a more “natural” feel, more closely mimicking the sensation of breastfeeding an infant. Because the nipple travels less, this allows the skin contact member / flange 14 to be designed as a lower profile component, as its length can be shorter because it does not need to accommodate the greater length of nipple movement present in prior art systems. This allows the total amount of system 10 protruding from the breast to be less than in the prior art, as reducing the length of the skin contact member / flange 14 reduces the overall length of the system. Therefore, the distance from the nipple tip to the exposed end of the system housing is reduced.

[0091] The breast contact portion can be symmetrical about the nipple receiving portion; however, the nipple receiving portion can be offset. According to this disclosure, the skin contact member 14 is designed to reduce the internal volume of the nipple receiving portion, which is achieved by significantly reducing nipple movement during milk extraction using the system 10 including the skin contact member 14. The contour of the nipple receiving portion of the skin contact member 14 is designed to better match the natural shape of the nipple, thereby eliminating or significantly reducing dead space present around the nipple in prior art systems. The nipple receiving portion can be cylindrical in the portion adjacent to the breast contact portion, and then taper gradually in a conical shape. This design allows a portion of the areola to be received into the nipple receiving portion while limiting dead space. The diameter of all cross-sections of the nipple receiving portion is designed to be large enough to allow nipple expansion. The length of the nipple receiving portion can be about 23 mm, and can vary from about 22 mm to about 29 mm. The length of the nipple receiving portion is sufficient to allow the nipple to fill under vacuum while the distal end of the nipple does not contact the proximal end of the nipple receiving portion. In another approach, the size and / or shape of the nipple receptacle can be designed to mimic the anatomy of a breastfeeding child. In this regard, the nipple receptacle, in addition to the usual cylindrical shape, can be more specifically defined as a natural mouth shape or a roughly rectangular sheath with rounded corners and curved surfaces. Thus, the nipple of the breast forms a more natural breastfeeding shape through a naturally shaped nipple receptacle.

[0092] The inner contour 120 of flange 14 is designed for use in this system 10 and to maximize user comfort. The inner angle and generally flattened portion also help limit the forward movement of the breast tissue into the nipple receiving portion. The wider angle helps prevent breast tissue from pooling into the nipple receiving portion, resulting in less breast tissue being contained within it, making flange 14 more comfortable and providing more space for nipple filling than flanges of the prior art. By providing a wider angle, this also allows the overall system to be effectively shortened and allows the system to conform more flatly to the breast for improved comfort and appearance.

[0093] In one embodiment, the total system volume is approximately 24.0 cc. The total volume is calculated as the space within the nipple-receiving portion (not occupied by the nipple) and the pipe portions 32S, 32L, and 32S2, extending to the milk collection or container assembly. In this embodiment with a total system volume of approximately 24.0 cc, the active pump volume, i.e., the volume displacement achievable by compressing the pipe portion 32L from completely uncompressed to its compression limit by the compression member 38, is approximately 3.4 cc. When only air is present in the pipes 32 of system 10, pressure fluctuations are limited due to the compressibility of air, by moving the compression member 38 inward against the pipe portion 32L and outward away from the pipe portion. In this embodiment, the system is at a vacuum of -60 mmHg, and the full stroke of the compression member (from compressed to completely uncompressed pipe portion 32L) increases the vacuum to -160 mmHg. The ratio of pump suction volume to total system volume may be important in terms of the power and size of the pump system. In this embodiment, the pipe portion 32L is made of silicone. It has been recognized that reduced movement of the compression components during pumping allows for quieter operation of the pump motor and a quieter system overall. Furthermore, this system uses milk extruded as the system's hydraulic medium, and this medium is in direct contact with the user's breast, where a vacuum suctions the breast. Therefore, the system can use air suction for initial latching and pumping, and then switch to utilizing the extruded breast milk for pumping action or power.

[0094] During the milk-letting operation, system 10 operates to induce milk flow from the breast before suction, with a maximum suction target of up to 120 mmHg (typically, about 100 mmHg (-100 mmHg pressure)) to induce milk flow. The goal of milk-letting (or non-nutritive suction) is to stimulate the breast to express milk. The relatively shallow (small range of vacuum variation) and relatively fast pumping frequency during this phase means mimicking the initial sucking motion of a child at the breast. This is because during the milk-letting phase, the suction pressure is not allowed to exceed the maximum milk-letting suction of 100 mmHg or 120 mmHg, or any other value set for maximum milk-letting suction. Therefore, when the compression member 38 is pulled away from the conduit portion 32L, system 10 is designed to reach -100 mmHg (100 mmHg suction pressure) (or -120 mmHg, or any value set for maximum milk-letting suction) before the compression member 38 reaches a position where the conduit 32L is largely uncompressed.

[0095] During milk let-down (non-nutrition) periods, the system software and / or firmware transmit instructions to the system motor based on reads acquired and transmitted from the pressure sensing component, configuring the system to operate between -60 mmHg and -100 mmHg in one example. In this example, the compression member 38 can almost completely compress the tubing section 32L and then move away from the tubing section 32L to create a vacuum. A small amount of rebound through the tubing section 32L will achieve the maximum latching suction pressure of -100 mmHg, and the compression member 38 can circulate within a narrow range or band of near-full compression of the tubing section 32L relative to the tubing section 32L between -100 mmHg and -60 mmHg. As milk flows, this narrow band moves, at which point the tubing section 32L will be purged by full compression to expel the contents, thereby again gaining greater pumping capacity while the compression of the tubing section 32L is relatively smaller.

[0096] System 10 responds to pressure changes within pipe 32 caused by milk entering pipe 32. (See again) Figure 7A Compression elements 36 and 38 are operatively connected to actuators 44 and 46, respectively, for independent but coordinated actuation and retraction of actuators 44 and 46. When an electric actuator is used, battery 48 is electrically connected to actuators 44 and 46, as well as controller 52 and pressure sensor 54, and provides the power required to operate actuators 44 and 46 to drive the compression and retraction of compression elements 36 and 38.

[0097] Sensor 54 provides feedback to controller 52 to control the pump suction cycle to achieve and / or maintain a desired vacuum level. Sensor 54 is preferably a force-measuring sensor that provides data for calculating system pressure, but it can also be a pressure, flow, temperature, proximity, motion sensor, or other sensor capable of providing information that can be used to monitor the safety and function of the pump mechanism of system 10. As shown, sensor 54 is a non-contact sensor, meaning it is not in fluid communication with the milk or vacuum space of system 10.

[0098] As described above, the conduit or flexible conduit 32 is positioned to be operatively connected to the electric motor. A sensor 54, in the form of a force-measuring element sensor, is provided on the opposite side of the flexible conduit 32. The positioning of the electric motor is tracked, and the force on the conduit 34 is evaluated to determine the internal vacuum. By employing machine learning or supervised learning regression techniques, the system 10 can be trained to interpret the motor positioning and conduit strain (as well as the motor speed or pump setting), while compensating for noise and hysteresis, to achieve the pressure / vacuum level. More specifically, any mathematical regression of the neural network system or data can be incorporated into the system firmware, allowing the sensor input to be translated into a pressure / vacuum level. In this regard, the system 10 may include or communicate with a non-transient computer-readable medium storing instructions executable by the system's computing device or external to the system, causing the computing device to perform functions associated with and guided by the firmware.

[0099] To train the neural network, a large amount of data was generated from accurate vacuum readings and strain gauge readings. All data was sent to software for post-processing. Data acquired during normal pump flow rates was determined to be best suited for training the system 10. For example, data could be collected when the flow rate was 2-3 ml / min, and when the system pumped slowly at each pressure target. This method ensures that the motor moves relatively uniformly throughout its entire stroke cycle, and that noise associated with high flow rates is not incorporated into the calculations. Highly controlled settings were also used to generate data to produce unbiased data. Furthermore, system accuracy was improved when a specific generated neural network was used for a specific pressure range. Special code was used to isolate the data from different pumping limits in the training data, and only that data was used to generate the neural network later when the pump reached the same limit.

[0100] Now for reference Figure 8-10This illustrates one embodiment of a collection or container assembly 60. In one particular embodiment, the collection or container assembly 60 may be formed from two 2.5-3.0 mil sheets of material, which may be band-welded or otherwise joined together along the periphery 92 of the assembly, and the size of the collection or container assembly 60 may be designed to hold up to 4.5 ounces or 8 ounces of liquid. In particular, the collection or container assembly 60 may be pre-formed to optimize or maximize space within the pump system and flange. For transport, the collection or container assembly may be vacuum-stretched to flatten or thin it for packaging or handling. The body of the collection or container assembly is generally bladder-shaped and includes a generally asymmetrical elliptical central opening 93 formed by an internal seal. In one particular approach, the body may additionally include a triangular gusset to provide greater volume. A pair of wings 94 extend into the central opening 93 and are configured to handle and facilitate the positioning of the collection or container assembly 60 within the pump system 10. A narrow neck 95 is centrally positioned and extends longitudinally away from the central opening 93. The neck 95 includes a tab portion 96 providing a gripping and removal mechanism, and may also include one or more slits or tearable elements 97 configured to aid in tearing open the container 90. Further notches are designed to facilitate tearing the package assembly. Alternatively, in an alternative embodiment, the collection or container assembly 90 may be resealable and reusable, may include larger or smaller openings, or include a nozzle configuration for dispensing contents. A nozzle may also be attached to a fitting or valve of the collection assembly for easy dispensing. Such a nozzle may further include a mechanism to temporarily or permanently disable the valve or fitting. The valve of the collection or container assembly may also be reused with a second or subsequent collection or container assembly and thus can be removed from the container assembly.

[0101] Furthermore, in one particular embodiment, the collection or container assembly 90 may be made of polyethylene, may be BPA-free, and is a food-grade material. Assembly 90 should be freeze-resistant without tearing and able to withstand temperatures ranging from approximately 0 to 80 degrees Celsius. Additionally, the tensile strength may be 2300-2900 psi, and the tear strength may be 440-600 psi, with a maximum water vapor transmission rate of approximately 0.5 g / 100 in. 2 / 24h, oxygen transfer rate is approximately 150cc / 100in 2 / 24h. In alternative embodiments, the material of the collection or container assembly can be, for example, Gore-tex or Tyvek fabric. This alternative material allows for venting. Therefore, non-enclosed or unsealed systems are also contemplated. In this specific aspect, other vents or other methods for venting the system can be incorporated into one or more embodiments. Thus, the container assembly can be designed to be automatically or actively ventilated during or after use of the pump system. In one approach, a pressure valve can be incorporated into the system and configured to activate upon reaching certain system pressures, and the valve can be designed to act as a fluid barrier, allowing only air to escape but not fluid.

[0102] The system is intended to be configured to pump into a sealed collection or container assembly 60, or to pump into a sealed collection and container assembly 60 including an integral valve, or other airtight collection or container assembly 60, or a combination thereof. In this specific aspect, the system may alternatively or additionally be closed and never vented to the atmosphere, and / or the system suction is reduced only by the flow of milk into the system. Thus, in at least one method, milk or fluid pumped through the system is not exposed to fresh outside air from the environment once it enters the collection or container assembly. Therefore, the direction of the pump system or a person has virtually no effect on system operation (i.e., no spillage). The collection or container assembly may include rigid or flexible sealing elements, such as rings or gaskets, in which the pump or container valve is pushed in or screwed in and sealed. The collection or container assembly may also include openings or holes or structures that are penetrated to seal the container assembly around the member entering therein. Furthermore, a series of disposable and durable combinations of container 101 and valve fitting 102 arrangements are envisioned, such that one or both of container 101 and fitting 102 are disposable or reusable. Additionally, the container can be configured to be located inside or outside the pump housing.

[0103] Fitting 102 can be implemented as a valve, such as umbrella valve assembly 103 or other type of one-way valve fluidly connected to storage container 101. The fitting can also be implemented in many alternative ways and can be integrally formed with the container, either additionally or alternatively. For example, in one anticipated approach, the fitting and / or valve can be formed as part of the container, rather than being defined as a separate component attached to the container. However, as... Figure 8-10As shown, the tail 104 of the umbrella valve 103 can be used to disable the valve when desired, such as by rotating the tail 104 and bringing it against the valve body to remove gas. Additionally, the valve includes a generally cylindrical portion with a diameter of approximately 0.585 inches, extending from a flat base 104 with a width of approximately 0.875 inches. The flat base 104 is trapped and sealed between two pieces of container material, and the flat base 104 includes a tail 106. The tail 106 is used to ensure flow through the neck of the container assembly 60, particularly when the tail 106 is inserted into the pump assembly (see [link to relevant documentation]). Figure 11A The tail 106 has a narrow and elongated shape to allow flow around the tail. That is, when the container assembly is attached to the breast pump body, the tail 106 maintains flow through the neck even when the neck is folded. The valve 103 prevents milk backflow into the flexible conduit 32 and facilitates maintaining the suction (vacuum) level in the flexible conduit 32. In other embodiments, other features may be provided or constructed in the valve to allow low pressure or otherwise overcome the valve to expel air. This approach may include protrusions attached to or associated with the valve such that when the protrusion is pushed against the collection or container assembly, the edge of the valve translates, thereby disrupting the internal seal of the valve. Additionally, a small piece may be attached to the valve structure and constructed within the container assembly. Dragging the small piece through the layers of the container assembly causes the edge of the valve to be released and disrupts the valve seal.

[0104] In at least one embodiment, valve 103 opens to allow flow into milk collection container 60 at a pressure of approximately 25 mmHg. Valve 103 may be configured and designed such that fluid flow is allowed through valve 103 when the pressure in conduit or flexible conduit 32 is positive (e.g., approximately 25 mmHg, or some other pre-designed “crack pressure”). The operation of the compression element cycles between increasing the vacuum as the compression element moves away from the flexible conduit 32 and decreasing the vacuum as the compression element compresses the flexible conduit 32, but generally the vacuum should not be increased to a predetermined maximum value. As the compression elements 36, 38 compress the flexible conduit 32, the pressure in system 10 rises and reaches a minimum suction level (e.g., a latching suction level, such as -60 mmHg, -30 mmHg, or some other predetermined latching suction level), in which case the compression member (squeeze valve) 36 seals portion 32S, thereby maintaining minimum suction (latching suction) of the breast. The continuous compression of the compression section 32L by the compression member 38 continues to increase the pressure downstream of the compression member 36 until the crack pressure (e.g., 25 mmHg or some other predetermined positive crack pressure) is reached, which will open the valve 103. The compression elements 36, 38 continue to compress the flexible conduit 32, pumping fluid (milk) through the valve 103 and into the collection container assembly 60, until the compression element 38 reaches the end of its journey. The end of the journey of the compression element 38 relative to the section 32L can be predetermined, or it can be calculated in real time by the controller 52 using feedback from the pressure sensor 54 and feedback from the actuator of the compression element 38. Based on the feedback from the actuator of the compression element 38, the feedback controller 52 can calculate the relative position of the compression element 38 during its journey. The compression member 36 remains closed throughout the process, as it is used to seal the conduit 32 for the entire period of time during which the compression element 38 pumps milk into the collection container assembly 60. As the compression elements 36, 38 reverse and pull away from the flexible conduit 32, they begin to circulate again.

[0105] As milk enters the system, the suction level decreases (pressure increases). Feedback from pressure monitoring by pressure sensor 54 provides input to a feedback loop, which adjusts the position of compression member 38 to maintain a desired vacuum (pressure) within the conduit or flexible conduit 32 by compensating for pressure changes that cause variations in the amount of milk within the flexible conduit 32. For example, for a relatively large amount of milk in the conduit, this would require a relatively short stroke of compression member 38 to achieve latching pressure. Since a shorter stroke of compression member 38 takes less time, this can be achieved by either slowing down the movement of compression member 38 to achieve the same pumping timing cycle or increasing the cycle frequency.

[0106] The system 10, equipped with a non-contact pressure sensor 54, will include loading a collection or container assembly 60 into the system 10 (see [link]). Figure 11A -E). In the first step ( Figure 11B In this process, flange 14 is removed from its engagement with the rest of system 10. Attached to the flange is a conduit or flexible pipe 32. A central opening 93 is positioned above the central protrusion of flange 14 and flexible pipe 32. Next, the user can clamp wing 94 under flexible pipe 32. Figure 11C Then, the collection or container assembly 60 is inserted into the flange 14. The fitting 102 is placed within the collar 82 of the flexible tube 32 (see...). Figure 11A and 11E In some embodiments, the collection or container assembly 60 may have helpful labels, icons, or notifications. For example, a milk drop icon may be printed on the collection or container assembly 60 in an enlarged size to indicate the degree of container filling, and a "this side up" message may be included to help the user properly install the collection or container assembly 60. Furthermore, the container assembly 60 includes multiple surfaces away from a storage area where printing or handwriting can be performed. For example, wings 94 and pull tabs 96 may be used as handwriting or printing surfaces. Similar labels or messages (e.g., "Thank you, Mom" ​​messages) may be included on the collar 84 or other portions of the flexible conduit 32 to help properly orient the flexible conduit relative to the flange 14. It should be appreciated that the collection or container assembly may also be placed in alternative locations. For example, the collection or container assembly may be constructed around the nipple of the breast. In this regard, the container assembly itself may form the desired flange or breast contact structure within its core structure. In one particular approach, the container assembly may also include a surface area facing the breast more above the nipple than below it.

[0107] It is conceivable that the door assembly 90 is used to provide a continuous profile of the flange 14 to engage the user's breast and support the engagement of the collection or container assembly 60 with the system 10. Therefore, the door assembly 90 can be configured to pivot relative to the flange 14 and can be used to close the system 10 when the pump is snapped shut. In this way, the fitting 102 and the container pack 101 are securely clamped between the collar 82 of the conduit or flexible tubing 32 and the door assembly 90, while the cylindrical portion of the fitting 102 is received within the collar 82. The collar 82 can also provide rigidity to the flexible tubing 32, allowing it to be loaded into the flange 14 and providing circumferential support when the fitting 102 is inserted. Ribs or O-rings can be provided on the inner surface of the flexible tubing to facilitate a seal with the fitting 102 and can have a radius of approximately 0.64 mm. In one embodiment, the inner diameter of the flexible conduit between the ribs may be approximately 14.6 ± 0.17 mm, while the outer diameter of the fitting 102 may be approximately 14.8 ± 0.17 mm, in order to form an interference fit, accompanied by a force of approximately 1-2.51 bs.

[0108] like Figure 12 and 13 As best shown, the door assembly 90 also includes a pair of spaced-apart and curved guide arms 105. The profile of the arms 105 is designed to guide the door assembly 90 as it closes and approaches the curved handrails 107. In this way, as the door assembly 90 rotates toward the conduit or flexible conduit 32, the latch 109 of the door assembly 90 first moves away from and then over the handrails 107 and positions itself behind them, thereby providing a secure engagement of the flange 14 with the package assembly 60 when the latch 109 is loaded into the system 10 (see [link to system 10]). Figure 11C ).like Figure 8 and 9 As best shown, fitting 102 includes a fan-shaped portion 110, which facilitates this secure engagement and alleviates excessive stress placed on the package assembly by resisting kinking when fitting 102 is securely installed within the system. The door assembly may also include one or more ribs 111. Figure 15 Rib 111 engages fitting 102 and provides direct support for it.

[0109] Now for reference Figure 16-18 This illustrates a method for preventing squeezing via a movable portion of the pump system 10. One or more magnets 118 may be attached to the flange 14. A corresponding sensor 119 (such as a Hall effect sensor) may be attached to the flexible circuitry 16 mounted to the mounting bracket 120 (see also...). Figure 3 System 10 can be configured to allow the motor to be activated only when the sensor detects the magnet 118. This way, the pumping action of the system, particularly the compression components, will not move until the flange 14 is properly connected to the housing 12, thus preventing any squeezing or engagement of these components with the user. Alternatively, mechanical or electronic switches or RFID technology, or optical sensors or sonar technology, can be incorporated into the system to provide the desired security, ensuring that the system will not operate unless all components (i.e., flanges, conduits, and memory) are fully connected.

[0110] In another approach, system 10 may include firmware for tracking system pressure on the force-sensing element. Here, the motor blades can be arranged and controlled by the firmware to move outward by 0.5 mm or some defined distance, and the pressure on the force-sensing element can be observed to check for proper installation of the conduit or flexible tubing. If the observed pressure is not as expected, such as no pressure, the motor is not allowed to move inward for pumping. A similar technique can be used to test proper installation of the collection container. After the motor extends, the extruder can seal the flexible tubing. Once the motor is withdrawn, vacuum is only measured if the package is properly installed to seal the tubing on the container side to prevent air from filling it.

[0111] It has also been recognized that pump systems may require fluid ingress protection. Therefore, it is anticipated that various gaskets can be incorporated within the system structure. One specific location for the gasket is the interface between the chassis and the housing, and thus, specially designed gaskets are constructed around the perimeter of the chassis along the portion used to engage the housing. In this regard, a 0.3 mm interference fit is envisioned between the gasket and the housing. Furthermore, the gasket can be constructed close to moving receiver structures, such as force-sensing elements, sensors, and motors, to help prevent fluid ingress.

[0112] Once the flange or skin contact member 14 is placed on the body / pump housing 34, the pump power can be connected. Now refer to Figures 19-20 An enlarged view of the user interface panel is shown, as described above, which includes a button membrane 72 and a button membrane housing 73, both supported on the housing 12 and arranged to engage with a flexible circuit that provides system control to the user. Here, the membrane 72 serves as a light guide. Light emission, intensity, and button deflection force are configured for convenient and efficient interaction with the user. Thus, pressing the power button 130 activates the pump system 10 by interacting with a switch 131 configured on the flexible circuit 16 (see...). Figure 18 It should be noted that additional switches 132 may be provided on the flexible circuit, aligned with other envisioned system control buttons included on the flexible membrane 72. If the system 10 requires an external power source or battery for charging, access to supporting electronic components is obtained through a cover jack 65 constructed within the housing 12. Figure 21 ).

[0113] When the pump system 10 is powered on, the controller 52 reads the force on the pressure sensor 54, with the pressure sensor acting as the pressure sensor 54. This is the load measured by the pressure sensor before the skin contact member 14 is applied to the breast; therefore, in one approach, the pressure in the catheter or flexible conduit 32 is atmospheric pressure. The controller 52 then calibrates the system such that the preloaded force or position, or the measured load or strain, is equal to atmospheric pressure. Based on neural networks or computer learning, the load or strain detected at the flexible conduit 32 during operation of the breast pump system 10 when attached to the breast can be converted into pressure readings in the system 10.

[0114] System 10 can calculate the volume of milk pumped into the system or the volume collected in the milk collection container assembly 60. Knowing the dimensions of the conduit or flexible conduit 32 downstream of the compression member 36 when the conduit portion 32S is sealed, the total volume capacity of system 10 downstream of the compression member 36 can be calculated. (See again...) Figure 7AThe position of the compression member 38 relative to the conduit 32 is tracked (e.g., by always knowing the position of the driver 46), indicating the volume change in the conduit 32. As the pumping process proceeds, milk is pumped / purged into the milk collection container when the compression member 36 closes the small conduit section 32S at the compression position. When the compression member 36 has closed the conduit section 32S, the positional change of the compression member 38 used to perform the purging of milk from the flexible conduit 32 into the milk collection container 60 is used to calculate the volume change in the conduit 32 downstream of the compression member 36, which is equal to the volume of milk pushed into the milk collection container 60.

[0115] Specifically, under one algorithm, as fluid enters system 10, it is identified that the motor must move further and further outward to generate a latching vacuum. As the latching vacuum is generated, tracking this movement and the rate of change of position of the compression or blade components is one method of measuring flow rate. For example, the slope of the line associated with tracking the blade position for latching vacuum is proportional to the flow rate. After adjusting steps to correlate this relationship, the flow rate can be easily calculated from the slope of the line.

[0116] Using another method, the number of purgings can be tracked when the system is full for flow measurement purposes. As mentioned above, it is possible to determine when system 10 is purging fluid and purging air because the force of purging fluid is much higher than that of purging air. Therefore, by counting the number of purgings containing fluid and knowing the purging volume of each purging, flow calculations can be performed without significant system adjustments or calibrations, thus avoiding the misinterpretation of slow air leaks with flow. Leaks can also be detected by the following algorithm: shutting off the compression member, then shutting off the pump compression or paddle member, and then pulling the pump compression member outward to create a vacuum. By then holding the pump compression member in that position and confirming that the vacuum is maintained, it is possible to determine whether a leak exists in system 10.

[0117] In addition to calculating the volume of milk purged in each purge cycle, the system (via controller 52) can sum the volumes from all purge cycles to calculate the total volume entering the pump or the volume pushed into the milk collection container 60 during the milk aspiration process. This volume can be stored with a unique identifier provided to the milk container so that system 10 records how much milk is stored in each milk collection container 60. This information can also be timestamped so that the user knows the time and date of milk collection for each milk collection container. Other statistics can be calculated, including but not limited to: the average volume for each aspiration process, the total volume aspirated for any given date, the average daily milk aspiration volume, etc. Any and all of this data can be exported to an external computer, either manually or automatically, when the computer is within range of system 10 for wireless communication or when the computer is connected to the system via a wired connection. Alternatively, any and all of this data can also be uploaded to a cloud service, either manually or automatically, wirelessly or via a wired connection over the Internet.

[0118] In a preferred method, the volume aspirated from the breast pump is calculated by constructing a map of the motor position relative to the volume at a specific vacuum level (e.g., -60 mmHg), as such a vacuum level is reliable, predictable, and repeatable. To establish this relationship, various known flow rates are generated within the breast pump, and the motor position at -60 mmHg is identified and stored as data. A script is then used to extract this data to construct the relationship between the motor and the volumetric scale. Specifically, as... Figure 7B As shown, line M represents the relationship between motor position and time, and line V represents the relationship between vacuum and time. Input this data into the script to obtain a volume-time graph. The script checks the indication of the number of purgings and discards the data, except for the start and end of the first cleaning in the cycle between purgings (by...). Figure 7B The spike S in the text represents the peak. The time is adjusted so that the relative time of the selected data replaces the absolute time. The script also filters out data that is significantly higher or lower than -60 mmHg. The relative time is then converted to volume, as the motor location becomes a volume difference over the relative time span. This data can be plotted as a line (see...). Figure 7CThe area below the line represents volume. The script is represented as a line with a specific slope, and the output is represented as a sixth-order equation. This sixth-order equation is incorporated into the codebase and used in real time to convert the measured motor position into volume during pumping at approximately -60 mmHg. Therefore, calculus is ultimately used for this volume calculation, where the motor position is integrated with respect to volume between two points to determine the volume difference. At certain flow levels, an adjustment factor can be multiplied by the calculated volume when comparing the calculated flow rate to real-world experiments, for example, to accommodate flow rates shortly before and after purging, or to accommodate flow rates above 15 ml / min. Additionally, based on empirical observation, mathematical constants are incorporated into the volume calculation when the pump is filled with air. The determination of whether the pump is filled with air can be achieved by observing the operating intensity of the motor; it is known that the motor must operate at a greater intensity to create the vacuum change when the system is filled with air than when the system is filled with fluid.

[0119] When calculating the volume of milk pumped from system 10, as described, it is necessary to distinguish any air pumped by the system from the milk pumped by the system and from the pumped milk and air mixture. When the milk pumping / suction process is initiated, air is present in conduit 32, and this initial volume of air needs to be pumped into the milk collection container 60 to prepare the pumping system 10. Again, the difference between pumping air and pumping milk can be identified by relating the pressure change to the amount of movement of the compression member 38 required to produce the pressure change. For example, a greater positional change or more total travel of the compression member 38 is required to produce the same pressure change when air is in the conduit than when the conduit 32 is full of milk. Therefore, a relatively large movement of the compression member accompanied by a relatively small pressure change indicates the presence of air in the conduit 32. This pressure difference can also be detected when the compression member 36 opens (i.e., without closing conduit section 32S) and the compression member 38 contracts, thus increasing the vacuum pressure.

[0120] When the user completes the pumping phase of drawing milk from the breast, and a significant amount of milk remains in the tubing 32, it is useful and efficient to purge the milk from the tubing 32 into the milk collection container 60. The aspiration termination phase can be performed based on a predetermined aspiration phase time, a predetermined amount of milk already pumped, manual cessation of the aspiration phase by the operator, or some other predetermined value achieved after the aspiration has been performed. The direction of the pumping stroke of the compression member 38 is reversed, and the compression member 38 operates in the opposite direction to reduce suction within the tubing 32 and optionally generate a small positive pressure within the tubing 32 to facilitate removal of the system 10 from the breast. Alternatively, suction can be reduced to a level where there is still slight suction, allowing the user to still pull the system 10 from the breast to detach it. Preferably, the vacuum is reduced to 0 mmHg or a very small positive pressure to allow the system 10 to automatically detach from the breast. The termination pressure value for stopping the decompression by reverse pumping can be in the range of approximately -20 mmHg (weak vacuum) to +50 mmHg (e.g., the valve-to-container crack pressure). During this process, the compression member 36 does not close the tubing section 32S, but keeps it open. This reverse pumping can be initiated automatically or by the user. The process continues until the seal between the system 10 and the breast is broken, which is detected by the controller via sensor 54. Once exposure of the tubing 32 to atmospheric pressure is detected, the pumping direction reverses again, pumping the milk in the tubing 32 under positive pressure and driving the milk from the tubing 32 into the container 60. If, by chance, the system 10 accidentally or otherwise reseals to the breast during purge pumping, the system 10 can automatically shut down when it senses a renewed vacuum pressure near the flange or breast / skin contact member 14.

[0121] System 10 can be configured to distinguish whether it has been attached to the user's left or right breast. This is useful for tracking the milk volume output of each breast per process and the total milk volume output of each breast throughout the day. When using two pump systems, data tracking for each breast can remain accurate even if one of the pump systems 10 was attached to the right breast in a previous process and is attached to the left breast in the current process. In one embodiment, the pump system 10 can determine its current position (i.e., left or right breast) by receiving a signal from another pump system already attached to another breast. This determines the relative left and right position of the two pump systems 10, allowing each system 10 to accurately record whether milk was drawn from the right or left breast. This identification is automatic, requires no user input, and also reduces the burden on the user, who would otherwise need to record which pump system 10 is placed on which breast and maintain that order in each consecutive pumping process. Labels for the left and right pumps are also envisioned, for example, by placing markings on the system housing or cap socket (e.g., near the power connector).

[0122] Various methods for assessing milk volume can be incorporated into a pump system. Certain methods are described in co-pending international application No. PCT / US15 / 50340, the entire contents of which are incorporated herein by reference. Another method for assessing expressed milk volume involves placing one or more disposable data collection devices on the mother or child. One specific method involves creating a boundary on the breast skin and using a reference to conveniently measure changes in the boundary dimensions. This change in dimensions is then correlated with milk production to obtain the expressed or pumped milk volume. The crib or cradle may also include sensors and communication hardware that communicate with the pump system to assess and manage milk consumption and demand, as well as infant health.

[0123] System 10 can calculate the pressure during operation in any of the above-described manner. The suction (pressure) level can be varied as desired, and a control loop is provided by continuous or repeated pressure measurements / calculations, with feedback from sensor 54 to controller 52. This control loop can be used to adjust the position and / or speed of compression members 38 to change the suction pressure to a desired level, or to maintain the desired suction pressure in real time. Therefore, controller 52 can control the position and speed of compression members 36, 38 to achieve any desired vacuum pressure pumping distribution and provide automatic real-time adjustment to maintain the desired vacuum pressure within the system. A real-time response to maintain flow rate is also envisioned. This can be implemented independently or in conjunction with real-time monitoring and pressure regulation.

[0124] Controller 52 tracks the position of compression member 38 relative to pipe 32L, such as by recording the position of drive 46 or shaft (the interconnection between drive 46 and compression member 38), and calculates (or looks up) pressure based on data received from sensor 54. The system controller or firmware is programmed with or retains this information (which correlates the values ​​detected by the system sensors with drive position and speed, and system pressure). Therefore, changes in the position and / or speed of compression member 38 by controller 52 can be controlled by the resulting changes in the calculated or looked-up pressure relative to the pressure being sought. As described above, system 10 can be trained to account for motor positioning and pipe strain (and motor speed or pump settings) while compensating for noise and hysteresis to achieve the pressure / vacuum level using machine learning or supervised learning regression techniques. More specifically, neural network systems or other mathematical regressions can be incorporated into the system firmware so that sensor inputs can be translated into pressure / vacuum levels. Therefore, controller 52 can control compression member 36 in a similar manner, but the control of member 36 is more focused on position control because compression member 36 needs to completely close the tubing portion 32S when maintaining latch suction on the breast / nipple. However, the closure is timed and performed at a defined latch pressure, which is determined based on data received by sensor 54.

[0125] Now for reference Figure 22-28 This presents various aspects of remote control and data collection methods. In at least one envisioned embodiment, system 10 can be configured to communicate with a server, remote computer, smartphone, or other device, such as via signals, such as via Wi-Fi, Bluetooth, Bluetooth Low Energy (BTLE), radio frequency identification (RFID), near field communication (NFC), etc. Specifically, one or more chips can be integrated into the controller of pumping system 10 (via wired and / or wireless, preferably wireless) and can be configured to communicate with an external computer. The controller and / or external computer communicate with sensors / chips that indicate when the system is in use and can track usage. For example, by tracking usage time and / or the number of uses or even pump cycle counts, the controller or external computer can prompt the user when to replace parts or report usage. In this way, for each milk collection container used by system 10 to draw milk, information such as the date and time of drawing, the volume drawn, etc., can be recorded and stored. Therefore, system 10 can register individual milk collection containers, allowing the user to easily identify when milk was collected from each container, the volume in each container, etc. A breast pump system can record the volume of milk in any given container during pumping. The recorded data can be automatically or manually sent to an external computer and / or to the internet. Therefore, user data and trends can be collected, stored, and analyzed, as these are related to volume (total volume from each breast) and the number of processes across several dimensions (daily, weekly, or monthly). Consequently, data and analysis about the pumping process can be provided to the user.

[0126] In a specific method, at least the process start time, process end time, and total volume of milk extracted from the breast can be stored and tracked. For example, a process can be defined as the start of a latch and can continue with a pause of up to 5 minutes. Therefore, a pause exceeding 5 minutes can be defined as the end of the previous process. A language protocol is generated to enable bidirectional communication between an external device or program and the breast pump. That is, both the pump and the external device can create, understand, and respond to specific messages. Furthermore, real-time data and historical data can be processed differently, and their data streams can be maintained separately. Real-time updates are generated and stored in the pump, and can be retrieved by an external device (e.g., activated by an up or down button or a volume update). Thus, this real-time data can be reflected on and updated on the external device's screen. Historical data is stored within the pump as a stream, and the pump can communicate with this stream to extract or act upon it. An internal pump memory (such as an in-chip disk or other internal flash memory) communicates with the pump to write process data to an internal history log. For example, at the end of a process, the pump writes the process data to its internal history log. An external device will then query for the presence of any data, and if the pump indicates the presence of data, the external device will download that history data to update its non-real-time view screen. The external device can also make the same query after a prolonged period and then download multiple sets of process data, and can also query during the process. In one particular implementation, data from up to 600 processes can be stored.

[0127] In one or more embodiments, the system may additionally or further include a structure configured to perform an active pause mode or include functionality operating as an active pause mode, which allows the system to maintain latch vacuum while remaining virtually silent (especially at no / low flow rates). Such a system is quieter than pump mode but ensures that the system does not dislodge from the breast. The active pause mode can be used when the mother needs to interact with others and does not want them to hear the pump, or for other reasons, she may not be ready to remove the device but also does not want active pumping.

[0128] The remote user interface 140 on the external device can take many forms. The pump system can also be personalized, such as by naming one or more pumps ( Figure 22 You can create a user profile for a child and link it to the child's date of birth. Figure 23 Additional details, such as the child's age when the system is first used, can be collected to generate age-related analyses. This allows for tracking of the pump's performance in relation to the child's growth. Reminders can be input into the system. Figure 24This allows users to focus on matters other than breast pumping. Notifications can be set for pumping time or volume, and both metrics, along with battery life, can be tracked and reflected on a remote computer. Figure 25-28 Easy-to-understand and convenient graphics are envisioned for expressing status, such as curved hemispherical strips 150 reflecting the volume pumped by each pump system; the same information is also shown in digital form 152. Timing countdowns and information from one or more previous processes can also be displayed graphically for effective communication with the user. Remote initiation of new processes is also available to the user.

[0129] Whether provided as an application (App) on a mobile phone, computer, or other computing device, the remote user interface 140 may also include specific user control functions, as well as various related easy-to-understand displays (see...). Figure 29-41 ).like Figure 29 As shown, in one or more methods, the amount of milk pumped is tracked daily, and the user is given the option to set a process tracker daily. The amount pumped is also tracked by the breast. The user can set one or more times and volumes of pumping the breast for one or more pumping sessions. For example ( Figures 30-31 Users can set volume targets in various increments (such as 0.1 ounces). These settings can be set, saved, or canceled. Figure 32 As shown, the user can then control whether the pump aspirates from one or both breasts, and the system then begins to track the volume aspirated (see [link]). Figure 33 As the pump draws in ( Figure 34 The easily readable curved strip reflects the volume pumped from each breast; the strip thickens as more volume is pumped. Users can adjust the suction level of one or both pumps attached to the breast. Figures 35-36 This coordinates the desired pumping action. After reflecting changes in the suction level, the user can return the system to tracking the volume pumped from the breast ( Figure 37 It also provides an indication of the remaining volume to be pumped. Once the pumping target, such as the target volume ( Figure 38 The user interface will then indicate that the process is complete. Afterward, an updated settings tracker will be presented, which has the ability to set further pumping timing schedules. Figure 39 Then, the user can select an option to describe the pump suction overview or pump suction history (see...). Figure 40 and 41 The user interface can provide data including bar charts and numerical data to display pumping time and number of procedures by day and by breast. Additionally, the size of the circle can indicate the relative amount pumped by date, and the color can represent the breast.

[0130] The pump system may also include a power management system for power saving. In one aspect, the pump system can be characterized as having multiple modules or threads, each running a separate program. Each thread (such as fifteen to twenty different threads) is designed to operate in a power-saving manner. That is, each thread is controlled to find and find its own maximum and minimum power-required mode.

[0131] The pump system can be further configured such that the power management system includes power gradations that encompass various levels at which threads seek to achieve maximum and minimum required power. In one approach, the levels may include one or more of hibernation, standby, standby with LEDs, and active. Hibernation can be characterized as a deep sleep state, and standby can be defined as a level where the system runs computer chips and performs calculations but not external components. Standby with LEDs can simply mean the involvement of LEDs, and active can mean that external components (such as motors and sensors) are operating. Therefore, the power system can operate such that a query is sent to each thread to inquire about the thread's current state and its minimum required mode. The power system then loops through each thread, setting the power level to the required maximum and minimum power levels so that each thread can operate normally.

[0132] In further implementations and methods, the pump system may alternatively or additionally include built-in components or a computer or function-based application to alleviate the user's life stress, enable the user to better care for the health of the breastfeeding infant, maximize the user's mobility and freedom, and support all aspects of being or acting as a parent. In these respects, the pump system architecture and functionality may include one or more of the following: highlighting pain points, physical condition, sleep, pain relief, and postpartum issues; tracking sleep; sensing and tracking the infant's vital signs and movements; monitoring the health status of the mother as caregiver; and / or providing education, guidance, or instruction on methods of moving and carrying the infant, fertility, subsequent infant needs, maternal health, ultrasound, and fertility. The pump system may also include app integration with smart bottles, smart scales, etc., to facilitate the management of the infant's overall health and nutrition. App updates regarding stimulation and milk production, and pumping timing based on this information, such as suggestions to start pumping, may also be provided. The system architecture and functionality may also involve updating the pumping distribution according to the infant's age and needs, developing pumping functions that increase milk production, improve efficiency or comfort, or better mimic the infant's pumping ability. Data can be stored in the cloud for analysis, and additional features can be provided to modify speed and alternate between custom patterns and distributions. Additional or multiple sizes of flanges and packages or container components can be provided to the user, as well as night pump functionality or programs, including automated processes with start and stop.

[0133] Inventory management is provided as a further function, integrated into the structure of the pump system. Associatedly, container components may include scannable structures or structures that communicate with the inventory management system (e.g., via barcodes, RFID chips). Furthermore, operational communication structures may be provided, allowing users to communicate with and / or transfer data between a baby center platform storing data, thereby facilitating effective management of infant nutrition, and connections may be established for automated communication with milk banks and donation centers. Additionally, a caregiver data-sharing system may be included within the functionality and structure of the pump system. Textual information is added to other forms and methods for conveying this important and useful information.

[0134] While this disclosure has been described with reference to specific embodiments thereof, those skilled in the art will understand that various changes and substitutions may be made without departing from the true spirit and scope of this disclosure. Furthermore, numerous modifications may be made to adapt specific circumstances, materials, material composition, processes, process steps, or steps to the purpose, spirit, and scope of this disclosure. All such modifications are intended to fall within the scope of this disclosure.

Claims

1. A method of processing data associated with a breast pumping system, comprising: generating and storing real-time data from operating the breast pumping system; generating and storing historical data from operating the breast pumping system; and keeping the real-time data stream separate from the historical data stream, wherein there is two-way communication between an external device or program and the breast pump, and / or the breast pump writes process data to its internal history log and / or the external device, wherein the real-time data can be reflected on and update the screen of the external device, and the external device will download the historical data for updating its non-real-time view screen, wherein the breast pumping system is configured to employ air suction on the breast for initial latching and pumping, then switch to utilizing expressed breast milk for pumping action or power, and wherein the breast pumping system includes an active pause mode that allows the breast pumping system to remain silent while maintaining a latching vacuum to accommodate use scenarios where the user needs to interact with others or does not wish to actively pump.

2. The method of claim 1, wherein the historical data is stored in the breast pumping system.

3. The method of claim 1, comprising storing process data, wherein a process is defined as the start of latching and can last up to and through a 5-minute pause.

4. A system for processing data associated with a breast pumping system, comprising: a controller for generating and storing real-time data from operating the breast pumping system; wherein historical data is stored and generated by operating the breast pumping system, and the real-time data stream is kept separate from the historical data stream, wherein there is two-way communication between an external device or program and the breast pump, and / or the breast pump writes process data to its internal history log and / or the external device, wherein the real-time data can be reflected on and update the screen of the external device, and the external device will download the historical data for updating its non-real-time view screen, wherein the breast pumping system is configured to employ air suction on the breast for initial latching and pumping, then switch to utilizing expressed breast milk for pumping action or power, and wherein the breast pumping system includes an active pause mode that allows the breast pumping system to remain silent while maintaining a latching vacuum to accommodate use scenarios where the user needs to interact with others or does not wish to actively pump.

5. The system of claim 4, wherein the historical data is stored in the breast pumping system.

6. The system of claim 4, wherein process data is stored, wherein a process is defined as the start of latching and can last up to and through a 5-minute pause.

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