Pump system for a breast pump, breast pump system and method for extracting milk

Abstract

A pump system for a breast pump, comprising a stepper motor; and a control unit configured to receive a user input setting, wherein the user input setting relates to a frequency, an amplitude and a pressure shape selected from a plurality of predetermined expression mode pressure shapes; determine an expression mode pressure profile based on the user input setting, wherein for a first expression mode pressure profile based on a user setting with a first pressure shape and a second expression mode pressure profile based on a user setting with a second pressure shape, the pressure at the air outlet as a function of time differs from each other in more and / or other ways than the scaling of the amplitude and / or time.

Description

[0001] This invention relates to the field of breast pumps for extracting milk from the nipple, particularly from the human breast. The invention particularly relates to pump systems, breast pump systems, cloud-based infrastructure, methods, and computer-readable instructions.

[0002] For newborns and toddlers, breast milk produced by their mothers is a tremendous source of nutrition, offering a wide range of short- and long-term benefits. However, for various reasons, it can be difficult to transfer milk directly from the mother's breast to the child. This can be due to situations such as the mother's milk production not being optimal (e.g., when the baby is premature), or the child not yet being able to successfully extract milk from the breast. Another common situation is when the mother cannot be with her child constantly, for example, because she has returned to work but still wishes to breastfeed. In those cases, a breast pump can be used to extract milk from the breast. The milk can then be stored for later feeding to the child.

[0003] Many different breast pumps are available. Typically, a breast pump subjectes the nipple to a pressure characteristic curve that varies over time (usually periodically), designed to mimic the sucking motion of a child. In most commercially available breast pumps, the pressure characteristic curve is largely determined by the type of breast pump used. Especially for portable pumps, vacuum pumps that release pressure very quickly are often used.

[0004] For example, US2018369463A1 describes a breast pump that includes a variable pressure generating unit.

[0005] WO 2022165200 A1 describes a vacuum motor device for facilitating the extraction of milk from a user's breast, the vacuum motor device comprising: a first chamber; a second chamber coupled to the first chamber; and a voice coil motor configured to allow air to flow into the second chamber and out of the first chamber during a milk extraction cycle to generate suction for extracting milk.

[0006] US2004158199A1 describes an apparatus for expressing milk from one or more breasts, the apparatus having at least one, and preferably two, extruders and a pump, wherein each of the extruders has a cup for fitting onto the breast and a cup outlet to which a vacuum generated by the pump can be connected.

[0007] Some available pumps allow users to change certain settings, typically the frequency (i.e., the length of a cycle) and the maximum pressure differential. For example, a higher frequency is used during the stimulation phase, and the frequency is reduced during the extraction or extrusion phase once the emulsion flow is activated. Some conventional systems also allow users to adjust the frequency or maximum pressure during the stimulation or extraction / extrusion phases. However, the shape of the pressure characteristic curve remains the same in known systems because the pressure characteristic curve is only used for scaling in time and / or amplitude.

[0008] The purpose of this invention is to overcome the shortcomings of the prior art, or at least to provide an alternative to the prior art. In particular, the purpose of this invention is to provide a pump system that allows users more choice in the shape of the pressure characteristic curve, especially when used with a portable breast pump.

[0009] This objective is achieved through a pump system in a breast pump used to extract milk from the nipple of a human breast, the pump system comprising, • At least one pressure outlet comprising at least one outlet membrane, wherein the pressure outlet is configured to be fluidly connected to a breast cup configured to be disposed on the breast (e.g., on / above the nipple). • A force unit configured to move at least one outlet membrane for controlling the pressure at an air outlet, wherein, optionally, the force unit includes a stepper motor configured to move in steps and to transmit motion to the outlet membrane with each step.

[0010] Optionally, the pump system includes a control unit configured to control a force unit, wherein the control unit is configured to: • Receive user input settings, where the user input settings involve selecting the frequency, amplitude, and pressure shape from multiple predetermined extrusion mode pressure shapes. • The extrusion mode pressure characteristic curve is determined based on user input settings, and the force unit is controlled based on the extrusion mode pressure characteristic curve.

[0011] In an embodiment, for a first extrusion mode pressure characteristic curve based on a user setting having a first pressure shape and a second extrusion mode pressure characteristic curve based on a user setting having a second pressure shape, the pressure at the air outlet, as a function of time, differs from each other in more and / or other ways than the amplitude and / or time being scaled.

[0012] In one embodiment, the control unit is configured to determine a stepping sequence for the stepper motor based on the extrusion mode pressure characteristic curve.

[0013] For example, both the first extrusion mode pressure characteristic curve and the second extrusion mode pressure characteristic curve can be based on user settings having a first frequency and a first amplitude (and are therefore identical for the first and second extrusion mode characteristic curves); the user settings on which the first extrusion mode pressure characteristic curve is based include a first pressure shape, and the user settings on which the second extrusion mode pressure characteristic curve is based include a second pressure shape (different from the first pressure shape, and both are selected from a plurality of predetermined extrusion mode pressure shapes). In such an embodiment, for the first extrusion mode pressure characteristic curve, the control unit is configured to determine a first step sequence for moving the stepper motor from the start of stepping to a first maximum step and back within a first time period, and for the second extrusion mode pressure characteristic curve, the control unit is configured to determine a second step sequence for moving the stepper motor from the start of stepping to the first maximum step and back within a first time period. Optionally, the difference between the first step sequence and the second step sequence lies in the size of the step and / or the speed of the step and / or the time period between subsequent steps and / or the direction of each step.

[0014] The present invention therefore relates in embodiments to a pump system for a breast pump. The breast pump can be used to extract milk from a human (female) breast. The pump system can, for example, be functionally connected to a breast cup. The breast cup may include a nipple receiving portion configured to be disposed on or around the nipple of the breast. The breast cup can be configured to subject the nipple to varying pressures, wherein the pump system is configured to generate such varying pressures. For example, the breast cup may include a diaphragm configured to move to subject the nipple to such varying pressures. The diaphragm can, for example, be fluidly connected to the pump system via a tube, wherein pressure changes in this fluid connection cause the diaphragm to move. The pump system can be configured to generate such pressure changes in this fluid connection. The diaphragm can be configured to seal the area around the nipple together with the nipple receiving portion of the breast cup.

[0015] The pump system includes at least one pressure outlet. The pressure outlet is fluidly connected to the breast cup. This allows the pump system to transmit pressure changes from the pressure outlet to the breast cup. The breast cup can then transmit these pressure changes to the nipple for milk extraction. The fluid connection between the pressure outlet and the breast cup can be achieved, for example, through a tube (e.g., made of a flexible material, such as a polymer). Air can be trapped in the tube to transmit pressure changes. However, it is also possible for the pressure outlet to be directly connected (e.g., without a tube) to the breast cup, for example, when the pump system and the breast cup are integrated with each other.

[0016] The air outlet can be located, for example, within the breast cup, where a change in air pressure occurs in response to movement of the outlet membrane. During use, the air outlet can be arranged, for example, close to the nipple to transmit the change in air pressure to the nipple.

[0017] An air outlet can be fluidly connected to a pressure outlet, for example, via a conduit. For instance, the air outlet can be configured to produce a pressure change that is approximately the same as the pressure change produced by the pressure outlet, albeit slightly later in time. This can be achieved, for example, by closing the conduit to maintain a fixed amount of air within it.

[0018] For the pressure characteristic curve of the first extrusion mode based on the user setting with the first pressure shape and the pressure characteristic curve of the second extrusion mode based on the user setting with the second pressure shape, the pressure at the air outlet as a function of time differs from each other in ways other than being scaled by amplitude and / or time and in other ways other than being scaled by amplitude and / or time.

[0019] The pressure outlet may, for example, include at least one outlet membrane. The outlet membrane may, for example, fluidly close the pressure outlet on the pump side. The outlet membrane may be configured to be movable. For example, the outlet membrane may be made of a material that is deformable (e.g., under applied pressure). The outlet membrane may be made of a flexible material (e.g., a polymer). Movement of the outlet membrane (e.g., by deformation) generates pressure changes in the fluid connection with the breast cup.

[0020] In some embodiments, the pump system can be used to extract milk from a single human breast. In these embodiments, the pressure outlet may include a single outlet membrane.

[0021] In some embodiments, the pump system can be used to extract milk from multiple human breasts simultaneously, for example, from both breasts of the same mother. In these embodiments, it is possible that the pressure outlet includes a single outlet membrane fluidly connected to both breast cups. For example, the pressure outlet may include a first fluid connection to a first breast cup and a second fluid connection to a second breast cup, wherein movement of the single outlet membrane is configured to cause pressure changes in both fluid connections. It is possible that both the first and second fluid connections are connected to a separate pressure outlet connector, or it is possible that a single fluid connection branch enters both the first and second fluid connections (e.g., implemented by a Y-shaped conduit). However, it is also possible that the pressure outlet includes a first outlet membrane fluidly connected to the first breast cup and a second outlet membrane fluidly connected to the second breast cup.

[0022] The pump system also includes a force unit. The force unit is configured to generate / cause (and control) a pressure change at the pressure outlet, and thus transmit the pressure change to the breast cup. Specifically, the force unit can be configured to move at least one outlet membrane. By controlling the pressure change, for example by means of the outlet membrane, the force unit enables the pumping function of the pump system. The force unit may include, for example, a drive system, such as an (electric) motor.

[0023] Optionally, the force unit includes a stepper motor. A stepper motor is a motor that performs step-by-step motion. With each step, motion is transmitted to the outlet membrane. The stepping can be, for example, angular stepping, which can be converted into linear motion, which is transmitted to at least one outlet membrane. The stepper motor can be electrically driven, for example, by an electric motor (e.g., a brushless and / or DC motor).

[0024] The use of stepper motors in pump systems can be particularly advantageous. They provide a relatively compact drive system that allows for high precision and controllability. As explained in further detail below, the breast pump can be controlled according to different settings, for example, with different extrusion patterns, pressure profiles, frequencies, and / or amplitudes. Stepper motors allow for this flexibility. Furthermore, stepper motors can be used while producing very little noise. This can be advantageous, for example, when the mother uses the system close to a sleeping baby, or, for example, in an office setting, for use with a quiet environment. In other cases, the noise is less bothersome, and the mother can then choose a setting optimized to extract as much milk as possible as quickly as possible. Moreover, as explained in more detail below, stepper motors allow for a compact design of the pump system, which can be portable during use.

[0025] In one embodiment, the stepper motor is the main drive system for the force unit. In another embodiment, the stepper motor is the sole drive system for the force unit and / or the pump system.

[0026] Optionally, the pump system also includes a control unit. The control unit is configured to at least control the force unit. Therefore, the control unit can control the movement of the force unit, and thus control the pressure changes transmitted to the breast cup at the pressure outlet (e.g., because the movement of the outlet membrane is controlled). Therefore, the control unit is configured to control the pressure changes experienced by the nipple.

[0027] Optionally, the control unit is configured to control the force unit, for example, based on a pressure characteristic curve. During stimulation mode, the pressure characteristic curve can be a stimulation mode pressure characteristic curve. During extrusion mode, the pressure characteristic curve can be an extrusion mode pressure characteristic curve. The pressure characteristic curve represents the pressure experienced by the nipple. Typically, the nipple experiences substantially periodic pressure changes, which are reflected in the pressure characteristic curve. The pressure characteristic curve can be characterized by frequency (reflecting the length of the cycle), maximum pressure difference (reflecting the maximum negative pressure experienced by the nipple), and pressure shape. For example, within a cycle, the pressure shape reflects how the pressure evolves from the initial pressure to the maximum negative pressure and back. The pressure shape can be described by a mathematical function. Examples of pressure shapes are sine curves, polynomials, polynomial shapes and / or combinations of sine curve shapes, sequences of polynomial shapes, combinations of sine curve shapes with different frequencies, or sequences of sine curves with different frequencies and amplitudes. The pressure shape typically reflects the pressure (changes) exposed to the nipple. Therefore, pressure profile refers to the pressure changes generated at the breast cup (e.g., in the nipple receiving portion), for example, through the diaphragm of the breast cup (which is in turn controlled, for example, by the pressure outlet of the breast pump). To verify the pressure profile, for example, a pressure sensor can be placed in the breast receiving portion instead of the nipple when using the breast pump in the test environment.

[0028] Optionally, the control unit is configured to receive user input settings. These user input settings are provided by the user of the pump system. For example, this could be a mother applying the pump system to extract milk from her breasts, but in some cases, the user could be a professional assisting the mother (e.g., a nurse, midwife, or doctor). The user input settings relate to the desired pressure characteristic curve. Specifically, the user settings may relate to the frequency and / or amplitude and / or pressure shape of the pressure characteristic curve. While generally, the user settings will include information based on which the control unit is configured to determine the frequency, amplitude, and pressure shape, the user does not necessarily have to select all three individually. A single option selected by the user may, for example, reflect two or more of the frequency, amplitude, and pressure shape. It is also possible that the user does explicitly select the frequency, amplitude, or pressure shape, but this is derived from the user's input. For example, the user could input multiple factors such as: the baby's age; any related medical issues (e.g., nipple pain); and the time of day.

[0029] Optionally, a pressure shape can be selected from multiple predetermined extrusion mode pressure shapes (as part of the user input settings). Therefore, the user can choose between different extrusion mode pressure shapes. The pressure shape may include, for example, one or more of the following: a sine curve, a polynomial, a combination sequence of polynomial shapes and / or sine curve shapes, a sequence of polynomial shapes, a combination of sine curve shapes with different frequencies, or a sequence of sine curves with different frequencies and amplitudes.

[0030] As the pressure shape for the extrusion mode, this pressure shape will be applied to the pressure characteristic curve used during the extrusion mode. Typically, the breast pump first applies a stimulation mode. Similar to a child's sucking behavior, the stimulation mode applies a high-frequency pressure characteristic curve. This stimulates the breast to begin milk flow. Once the flow continues, the breast pump (as with a child) will switch to a lower-frequency pressure characteristic curve. This is the extrusion mode. Therefore, during this extrusion mode, the control unit allows the user to select between different pressure shapes. However, similar considerations can be applied in addition to or as alternatives to the stimulation mode. It is also possible that the control unit is configured to apply the same pressure shape to both the extrusion and stimulation modes.

[0031] Even with equal frequency and amplitude, different pressure shapes are distinct from one another. Therefore, different pressure shapes are not simply scaled versions of each other. Different mathematical functions can be used to describe different pressure shapes.

[0032] Specifically, the control unit is configured to determine an extrusion mode pressure characteristic curve based on user input settings. For a first extrusion mode pressure characteristic curve based on user settings having a first pressure shape and a second extrusion mode pressure characteristic curve based on user settings having a second pressure shape, the pressure at the air outlet, as a function of time, differs from each other in more and / or other ways than being scaled by amplitude and / or time.

[0033] In these embodiments, the control unit thus allows the user to select the pressure shape for the expression mode. This is impossible with traditional (portable) breast pumps, which are limited to a single pressure shape (especially when maintaining a constant frequency and amplitude). However, it has been found that some mothers respond better to certain pressures, while others respond better to other shapes. Furthermore, a mother's needs may change over time during breastfeeding. For example, at some times she may experience nipple pain and need a softer pressure shape, while at other times she may want to increase her output and need the pressure shape she finds most effective for milk extraction. This is a significant obstacle, as breast pumps can be a large investment (in a period when young parents typically have many expenses). Using these embodiments significantly reduces the risk of purchasing a breast pump that is not optimally suited to a particular mother.

[0034] Based on the pressure characteristic curve of the extrusion mode, the control unit controls the force unit. For example, the control unit controls when the force unit takes which steps and how fast those steps are taken. The control unit is configured, for example, to determine the step sequence of the stepper motor based on the pressure characteristic curve of the extrusion mode.

[0035] It will be understood that many different extrusion mode pressure characteristic curves are possible when amplitude, frequency, and pressure shape are selectable in the user settings. Specific features of these embodiments relate to a first extrusion mode pressure characteristic curve and a second extrusion mode pressure characteristic curve having the same frequency and amplitude but different pressure shapes. That is, for a first extrusion mode pressure characteristic curve having a first frequency, a first amplitude, and a first pressure shape, the control unit is configured to move the stepper motor from the start of stepping to a first maximum step and back in a first time period with a stepping sequence. For a second extrusion mode pressure characteristic curve having a first frequency, a first amplitude, and a second pressure shape, the control unit is configured to move the stepper motor from the start of stepping to a first maximum step and back in a second stepping sequence in a first time period.

[0036] The first step sequence differs from the second step sequence in stride length and / or the speed of the steps taken and / or the time period between subsequent steps and / or the direction of each step. For example, the first step sequence and the second step sequence differ from each other in stride length, speed of the steps taken, and time period between subsequent steps.

[0037] By applying different step sequences, it is possible to generate pressure characteristic curves of different shapes.

[0038] Optionally, when the control unit is configured to determine the extrusion mode pressure characteristic curve based on user input settings, the control unit is configured to determine the extrusion mode pressure characteristic curve as a periodic function. Optionally, the length of the period of the periodic function is based on frequency. Optionally, the minimum and / or maximum values ​​of the periodic function are based on amplitude. Optionally, the shape of the periodic function is based on pressure shape.

[0039] Optionally, the control unit is configured to determine a step sequence based on an extrusion mode pressure characteristic curve. For example, the control unit is configured to determine a first step sequence based on a first extrusion mode pressure characteristic curve, and / or a second step sequence based on a second extrusion mode pressure characteristic curve. For example, the extrusion mode pressure characteristic curve may represent a desired pressure characteristic curve at the nipple or at the pressure outlet. The control unit may apply a transfer function to determine the step sequence. For example, the transfer function may reflect how the stepping of the stepper motor affects the pressure at the nipple or pressure outlet, and / or the (inverse) transfer function may reflect how the pressure at the nipple or pressure outlet is affected by the stepping of the stepper motor. The transfer function may be determined theoretically, for example, based on how the stepper motor is connected to the outlet membrane. The transfer function may also be determined empirically, for example, by measuring the corresponding pressure (change) caused by the stepping of the stepper motor in a test environment.

[0040] Based on the extrusion pressure mode characteristic curve and, for example, the (inverse) transfer function, the control unit can be configured to determine the desired motion of the stepper motor. Based on the desired motion, the control unit can be configured to determine the step sequence. It is possible that the desired motion is continuous, while the stepper motor is configured to perform discrete step movements.

[0041] Optionally, the control unit is configured to determine the step sequence based on a weighted sum of polynomial terms, which may, for example, have different orders.

[0042] Optionally, the control unit is configured to determine, for example, amplitude scaling parameters, time scaling parameters, and / or time offset (also known as time shift) parameters for each polynomial term of the step sequence.

[0043] Optionally, the control unit can be configured to determine the amplitude scaling parameter based on the order of the polynomial terms. Thus, each polynomial term can be scaled according to its corresponding order. For example, the amplitude scaling parameter may include a numerical value that is raised to an exponent that is a function of (or equal to) the order of the polynomial term.

[0044] Optionally, the control unit is configured to determine the baseline scaling parameters for the step sequence.

[0045] For example, the control unit can be configured to derive the step sequence based on a weighted sum of the following polynomial terms:

[0046] Where, n s M is the step number, N is the maximum peak amplitude, N is the highest polynomial order (e.g., 5, 6, 7, or 8), i is the exponent of the i-th polynomial term (e.g., an integer included between 0 and 8), Pi is the polynomial coefficient, V is the amplitude scaling parameter, A is the time scaling parameter, B is the time offset parameter, and C is the time scaling parameter (e.g., C is a constant).

[0047] In this example, for instance, the polynomial coefficients (which may be different for each polynomial term) are multiplied by an amplitude scaling parameter, which is then raised to an exponent equal to the order of the polynomial term.

[0048] Each of the maximum peak amplitude, polynomial coefficients, amplitude scaling parameter, time scaling parameter, time offset parameter, and / or constant can be a real number.

[0049] For example, polynomial coefficients can be integers, such as positive or negative integers. One or more polynomial coefficients (e.g., polynomial coefficients where i is zero) can be equal to zero.

[0050] The control unit can be configured to derive polynomial terms (e.g., amplitude scaling parameters, time scaling parameters, and / or time offset parameters, etc.) of the step sequence based on the extrusion pressure mode characteristic curve (e.g., based on polynomial pressure shape).

[0051] Optionally, the control unit is configured to determine the step sequence based on a sine function.

[0052] Optionally, the control unit is configured to determine the amplitude scaling parameter, time scaling parameter, time offset parameter, and / or baseline scaling parameter of the sine function.

[0053] For example, the control unit can be configured to derive the step sequence based on the following sine function:

[0054] Where A is the amplitude scaling parameter, C is the time scaling parameter, D is the time offset parameter, and E is the baseline scaling parameter.

[0055] The control unit can be configured to derive parameters of the step sequence (e.g., amplitude scaling parameters, time scaling parameters, time offset parameters, and / or baseline scaling parameters) based on the extrusion pressure mode characteristic curve (e.g., based on polynomial pressure shape).

[0056] The control unit can be configured to determine the step sequence by normalizing and / or rounding the weighted sum of polynomial terms and / or sine functions.

[0057] Optionally, the control unit is configured to receive adjusted user settings during use. Optionally, the control unit is configured to enable adjustment of frequency and / or amplitude within each extrusion mode. For example, the adjusted user settings may relate to an adjusted frequency and / or an adjusted amplitude. Thus, the user can adjust the frequency or amplitude during use, for example, because of an excessive pressure differential. The control unit may be configured to determine an adjusted extrusion mode pressure characteristic curve with an adjusted frequency and / or an adjusted amplitude and / or an adjusted pressure shape based on the adjusted user settings, but optionally, the same pressure shape may be maintained. The control unit may, for example, be configured to determine the adjustment step sequence.

[0058] In embodiments, the stepper motor (and its motor driver) is configured to take multiple different steps. For example, the stepper motor is capable of taking at least two, three, or four different steps. For example, the stepper motor can be configured to take full steps and microsteps, where microsteps are smaller than full steps. For example, a full stepper motor can contain up to 256 microsteps. For example, the step size can be controlled by a motor driver, which can be (functionally) integrated into the stepper motor or control unit, for example. Optionally, when the stepper motor can take three or more different steps, at least three steps are multiples of each other. Optionally, when the stepper motor can take three or more different steps, at least three steps are not multiples of each other. Optionally, the stepper motor is configured to move in a single step within a single pressure characteristic curve. Therefore, when a pressure characteristic curve is selected, the step size remains the same.

[0059] In an embodiment, the plurality of predetermined extrusion mode pressure shapes include at least three or at least four different extrusion mode pressure shapes, each extrusion mode pressure shape being configured to produce a step sequence that is different from each other with equal amplitude and frequency.

[0060] In an embodiment, at least one of the plurality of predetermined extrusion pattern pressure shapes (e.g., a first pressure shape) is a sinusoidal shape.

[0061] Alternatively, the shape of the sine curve can be described by a sine function.

[0062] Optionally, the sine function includes amplitude scaling parameters, time scaling parameters, time offset parameters, and / or baseline scaling parameters.

[0063] In an embodiment, at least one of a plurality of predetermined extrusion mode pressure shapes (e.g., a second pressure shape) is a shape determined by a polynomial having at least five factors (e.g., eight factors).

[0064] Alternatively, the shape of the polynomial can be described by a weighted sum of polynomial terms, which may, for example, have different orders.

[0065] Optionally, one or more polynomial terms of the polynomial function include amplitude scaling parameters, time scaling parameters, and / or time offset parameters.

[0066] In an embodiment, at least one of the multiple predetermined extrusion mode pressure shapes is a combination of polynomial shapes.

[0067] In an embodiment, at least one of the multiple predetermined extrusion mode pressure shapes is a combination of sinusoidal curve shapes.

[0068] In an embodiment, at least one of the multiple predetermined extrusion mode pressure shapes is a sequence of sinusoidal and polynomial shapes.

[0069] In an embodiment, at least one of the multiple predetermined extrusion mode pressure shapes is a combination of a sine curve shape and a polynomial shape.

[0070] In an embodiment, at least one of the multiple predetermined extrusion mode pressure shapes is a sequence of polynomial shapes.

[0071] In an embodiment, at least one of the multiple predetermined extrusion mode pressure shapes is a sequence of sinusoidal curve shapes.

[0072] In an embodiment, the first pressure shape has a pressure build-up section and a pressure release section, wherein, for example: • The pressure relief section occupies at least 40% of the first pressure shape over time; and / or • Wherein, the slope of the pressure relief section is equal to the slope of the pressure build-up section; and / or • The pressure build-up section and the pressure release section are mirror images of each other relative to the mirror line extending through the peak.

[0073] In an embodiment, at least one of a plurality of predetermined extrusion pattern pressure shapes has a pressure build-up section and a pressure release section, wherein the pressure release section has a first portion and a second portion with different slopes. In the first portion, the pressure is released more slowly than in the second portion. Optionally, in the second portion, the slope is similar in absolute value to the slope in the rise portion. Optionally, in this example, the pressure release section occupies more than 50% of the cycle (pressure shape in time).

[0074] In this embodiment, at least one of a plurality of predetermined extrusion pattern pressure shapes has a pressure build-up section and a pressure release section. The pressure release section has a steep slope when pressure is released rapidly. The pressure build-up section has a less steep slope as pressure is gradually built up. The pressure build-up section occupies most of the cycle (the pressure shape over time), for example, greater than 80%.

[0075] In this embodiment, at least one of the multiple predetermined extrusion mode pressure shapes has an aperiodic function with varying period and amplitude. When a user selects such a pressure characteristic curve in the user settings, the selected amplitude and frequency can be the average maximum amplitude and average frequency, respectively. Each single wave has a period, amplitude, pressure build-up segment, and pressure release segment. For a single wave, the wave is approximately mirrored near the moment when the amplitude has been reached. Therefore, the slope of the corresponding pressure build-up segment s is similar to the slope of the corresponding pressure release segment.

[0076] In this embodiment, at least one of the predetermined extrusion mode pressure shapes has a pressure build-up section and a pressure release section. For a single cycle, the wave is approximately mirrored near the moment when the amplitude has been reached. Therefore, the slope of the pressure build-up section is similar to the slope of the pressure release section. The fourth extrusion mode pressure characteristic curve has, for example, a sine curve shape.

[0077] In an embodiment, at least one of a plurality of predetermined extrusion mode pressure shapes has a pressure build-up section and a pressure release section. For a single cycle, the wave is approximately mirrored near the moment when the amplitude has been reached. Therefore, the slope of the pressure build-up section is similar to the slope of the pressure release section. The pressure shape may, for example, be convex. Optionally, the pressure shape has an extended time period between the pressure release section and the pressure build-up section in the next cycle.

[0078] In one embodiment, the pump system includes a user input module, such as a touchscreen or button, for receiving user input settings. Therefore, a user can provide user input settings by manipulating the user input module. The user input module can be configured to generate a user input signal based on the received user input settings and transmit that user input signal to the control unit.

[0079] In one embodiment, the pump system includes a communication terminal configured to receive user input settings wirelessly. The communication terminal can be configured to generate a user input signal based on the received user input settings and transmit the user input signal to a control unit. The communication terminal can, for example, employ any suitable wireless communication technology or protocol, such as Bluetooth, 4G, 5G, 6G, or Wi-Fi. The communication terminal can, for example, be configured to communicatively connect to a user equipment device (e.g., a mobile device, such as a smartphone, tablet, computer, or remote control). A user can provide user input settings on the user equipment device (e.g., via a mobile application), which are then transmitted to the communication terminal of the pump system. The communication terminal can also, for example, be configured to communicatively connect to a cloud-based system, which in turn can, for example, be configured to communicatively connect to the user equipment device. The user input settings are then entered by the user on the user equipment device, which transmits the user settings to the cloud-based system, which in turn transmits the user settings to the communication terminal.

[0080] In an embodiment, the control unit is further configured to control the force unit according to a stimulation mode prior to the extrusion mode. Applying a stimulation mode can facilitate the initiation of milk flow. During the stimulation mode, the control unit can be configured to apply a stimulation mode pressure characteristic curve. The stimulation mode pressure characteristic curve may have a stimulation frequency, stimulation amplitude, and stimulation pressure shape. Typically, the stimulation frequency can be relatively high. The stimulation frequency is generally higher than the frequency applied later in the extrusion mode pressure characteristic curve. Optionally, the stimulation pressure shape is the same as the pressure shape applied later in the extrusion mode pressure characteristic curve. Optionally, the stimulation pressure shape is different from the pressure shape applied later in the extrusion mode pressure characteristic curve.

[0081] Alternatively, the stimulation mode can be implemented similarly to any of the embodiments described herein with respect to the extrusion mode, with necessary modifications.

[0082] Optionally, the control unit is configured to receive stimulation user settings. Optionally, the stimulation user settings relate to stimulation frequency and / or stimulation amplitude. Optionally, the stimulation user settings also relate to stimulation pressure shape. For example, a stimulation pressure shape can be selected from multiple predetermined stimulation mode pressure shapes. The stimulation mode pressure shape can be, for example, similar to or the same as the extrusion mode pressure shape. Optionally, the control unit is configured to receive stimulation user settings while receiving user settings for the extrusion mode. Optionally, the user settings can relate to a single pressure shape that is applied to both the stimulation mode and the extrusion mode (i.e., only with different frequencies and / or amplitudes). However, it is also possible that the user settings allow the user to change the different pressure shapes used for the stimulation mode and the extrusion mode.

[0083] In an embodiment, the pump system includes a second pressure outlet configured to be connected to a second breast cup. The pump system is configured to provide varying pressure to the second breast cup. This allows, for example, a mother to extract milk from both breasts simultaneously. The second pressure outlet can be configured similarly to the first pressure outlet, for example, according to any embodiment described herein. For example, a force unit can be configured to control the pressure at both the pressure outlet and the second pressure outlet. The pressure at the second pressure outlet can be controlled, for example, by the same outlet membrane. It is also possible that the second pressure outlet includes a second outlet membrane. The force unit (e.g., by means of a stepper motor) can be configured to actuate the second outlet membrane, for example, simultaneously with the outlet membrane. The control unit can be configured, for example, to generate the same extrusion mode pressure characteristic curve in both breast cups. Optionally, the pressure changes generated by the pressure outlet and the second pressure outlet are in phase with each other. Optionally, the pressure changes generated by the pressure outlet and the second pressure outlet are out of phase with each other.

[0084] However, it should be noted that, in the embodiments, varying pressures can be generated at the two breast cups, each having a single pressure outlet. In those embodiments, the fluid connection can branch into two fluid connections, each connected to one of the breast cups.

[0085] In this embodiment, the pump system is configured to be portable during use. Some possible features of a portable pump system during use are detailed below. It should be noted that such features can be made possible, for example, through various embodiments of the invention. In particular, the use of a stepper motor in the force unit allows for smaller size and / or lower weight and / or less energy consumption (allowing the use of batteries as a power source) compared to conventional systems, while achieving greater controllability of the pressure characteristic curve.

[0086] Advantageously, the pump system explained herein achieves a combination of frequency and (negative) pressure achievable with large hospital breast pumps, while remaining portable. Conventional breast pumps can be divided into two categories in terms of portability. Larger systems, for example, used in hospitals and sometimes rented out by (social)insurance companies, offer controllability but are clearly not portable. This limits their usability to mothers. On the other hand, conventional portable systems use less controllable pumping systems and therefore have several disadvantages in this respect. In the embodiments, the present invention can provide solutions to these problems.

[0087] For example, the pump system can be small enough to be comfortably carried during use. For example, the pump system may include a pump housing that includes at least a pressure outlet, a force unit, and a control unit, wherein the pump housing is, for example, less than 30 cm in the maximum direction, for example, less than 20 cm, for example, 15 cm or less. For example, the pump housing could be 25 cm × 20 cm × 15 cm, for example, less than 20 cm × 15 cm × 10 cm, for example, 15 cm × 12 cm × 6 cm or less. The pump housing can be, for example, generally beam-shaped or cuboid (although it will be understood that deviations in shape are possible, for example, for connectors, pressure outlets, buttons, rounded edges, etc.).

[0088] For example, the pump system can be lightweight enough to be comfortably carried during use. For example, the pump system can weigh less than 2 kg, for example, less than 1.5 kg, for example, less than 1 kg, for example, 700 g or less.

[0089] For example, the pump system may include a battery configured to provide (electrical) power to the power unit. Optionally, the battery may be configured to be rechargeable, for example, using a USB connection, such as USB-C or mini-USB.

[0090] For example, the pump system includes a carrying element. This carrying element allows the user to carry the pump system during use. For example, the carrying element may include a clip to allow the pump system to be attached to clothing, such as trousers. For example, the carrying element may include a strap that allows the pump system to be carried and supported by the shoulder (e.g., like a wallet). The pump housing may, for example, have a connecting ring for attaching the strap. For example, the carrying element may include a handle. Multiple carrying elements (e.g., a combination of two or more of the above) are also possible.

[0091] In this embodiment, the force unit is configured to provide varying pressure at the pressure outlet by changing its volume. For example, the force unit may be configured to actuate one or more outlet membranes. For example, the force unit may be configured to actuate a piston.

[0092] In one embodiment, the force unit includes a stepper motor, wherein, for example, the stepper motor is configured to move the outlet membrane.

[0093] In one embodiment, the pump system includes a motor shaft connected to a stepper motor, wherein the stepper motor is configured to cause linear movement of the motor shaft, and the motor shaft is configured to cause linear movement of at least one membrane. For example, the stepper motor may be configured to move in a rotational direction with each step. Rotational motion can be converted into linear motion. For example, the stepper motor may include a toothed wheel or cause gear movement in the rotational direction. The motor shaft may be toothed, wherein the teeth of the motor shaft interact with the teeth of the wheel. The wheel is configured to cause linear movement of the motor shaft by rotation. For example, the wheel may act as a pinion and the motor shaft may act as a rack. Because the steps of the stepper motor can be precisely controlled, the movement of the motor shaft can also be precisely controlled.

[0094] In this embodiment, the pump system includes a motor shaft connected to a stepper motor, which is rigidly connected to the outlet membrane. Therefore, the connection from the motor shaft (or the stepper motor itself) to the outlet membrane is rigid and not flexible. Thus, the connection is not accomplished by means of a belt or similar flexible element. This rigid connection ensures that accurate movement of the stepper motor results in accurate (and known / predictable) movement of the outlet membrane. This also allows for a more precise determination of the transfer function (how the movement of the stepper motor affects the pressure at the nipple), because there is a well-defined relationship between the movement of the stepper motor and the membrane.

[0095] In one embodiment, the pump system further includes a connecting element that is connected to the motor shaft and to at least one outlet membrane. Optionally, the connecting element is a rigid element. The connecting element transmits the motion of the motor shaft to the membrane.

[0096] In one embodiment, the pump system includes a clamping element (e.g., a clamping plate) and a clamping pair element (e.g., a clamping pair plate), the clamping element and the clamping pair element being configured to clamp a membrane between them, wherein the clamping element and the clamping pair element are configured to move by movement of a motor shaft.

[0097] In one embodiment, the pump system includes a pressure space (e.g., within a pressure space housing), the volume of which is determined by at least one outlet membrane. A pressure outlet is fluidly connected to the pressure space. The outlet membrane is configured to deform and / or move (when a stepper motor actuates). This changes the volume of the pressure space, allowing for varying pressure at the pressure outlet.

[0098] Optionally, the pressure space (and / or the pressure space housing, and / or the outlet membrane when in the end position) has a depth, a width, and a height, wherein the height is in a direction parallel to the longitudinal axis of the motor shaft, and the depth and width are both perpendicular to this longitudinal axis of the motor shaft (and therefore also perpendicular to the height), and the depth and width are perpendicular to each other. At least one of the depth and width is greater than the height, for example at least 2.5 times larger, for example at least 4 times larger. This allows for relatively large variations in the pressure space volume to accommodate relatively small movements of the motor shaft, which in turn allows for a compact design.

[0099] In embodiments where the pump system includes two outlet membranes, the connecting elements may include a first connector connected to the first outlet membrane and a second connector connected to the second membrane. For example, the first and second connectors may be symmetrical to each other, given a line of symmetry extending through the longitudinal central axis of the motor shaft.

[0100] In one embodiment, the pump system includes an initial position sensor configured to detect whether the stepper motor is in an initial position and generate an initial position signal, wherein a control unit is configured to receive the initial position signal. The initial position may, for example, be a rest position or zero position of the stepper motor (and motor shaft). The control unit may be configured to determine a stepping sequence as steps relative to the initial position. Optionally, the initial position sensor is a contact sensor. Optionally, a sensor pusher is attached to the motor shaft and configured to contact the contact sensor. Optionally, the control unit may be configured to control the stepper motor to pass through the initial position in each cycle of the extrusion mode pressure characteristic curve.

[0101] In this embodiment, the control unit is configured to apply feedforward control and / or open-loop control for controlling the force unit. Therefore, the control unit does not consider any feedback, meaning that additional sensors or similar components are not required. This is advantageous because it reduces cost and complexity compared to systems using one or more feedback signals (e.g., from pressure sensors). In particular, when using a stepper motor, the position of the motor shaft and thus the outlet membrane can be easily determined from the number of steps the stepper motor has taken.

[0102] In one embodiment, the pump system includes a pressure sensor configured to measure pressure at at least one pressure outlet, generate a pressure signal, and transmit the pressure signal to a control unit. In another embodiment, the pump system includes a pressure sensor configured to measure pressure, for example, at a breast cup (e.g., in a nipple receiving portion), generate a pressure signal, and transmit the pressure signal to a control unit. In these embodiments, a feedback signal is provided by means of the pressure signal, and the control unit can be configured to take this feedback signal into account when controlling the force unit.

[0103] In embodiments, the invention may relate to a breast pump system for extracting milk from the nipple of a human breast. The breast pump system may include a pump system according to any embodiment described herein. The breast pump system may optionally also include at least one breast cup.

[0104] Optionally, the breast pump system includes a connecting tube configured to connect at a first end to a breast cup and at a second end to a pressure outlet. The connecting tube fluidly connects the pressure outlet of the pump system to the breast cup. The connecting tube may be made of, for example, a flexible material (e.g., a polymer). The connecting tube may be, for example, transparent.

[0105] Optionally, the breast pump includes a combined / integrated system comprising a pump system and a breast cup. In these embodiments, a pressure outlet fluid can be connected to the breast cup without connecting tubing. Optionally, the pump system and / or breast cup are releasably connected to the combined system. This allows them to be removed, for example, for cleaning.

[0106] In one embodiment, the breast pump system also includes a milk container configured to receive milk extracted from the breast, wherein the milk container is optionally incorporated into a breast cup.

[0107] In one embodiment, the system also includes a mobile application. The mobile application may be configured to execute on a user equipment device (e.g., a smartphone, tablet, smartwatch, or computer). The mobile application is configured to communicatively connect (e.g., via a communication terminal) to the control unit of the pump system. The mobile application may be configured, for example, to transmit user settings to the control unit, wherein the user can provide user settings on the user equipment device. The mobile application may be configured, for example, to present data to the user. The mobile application may execute, for example, using non-transitory computer-readable instructions.

[0108] In one embodiment, the system also includes a cloud-based infrastructure configured to communicatively connect to the pump system's control unit and / or local user equipment device, and includes, for example, at least one server with a processing unit. The cloud-based infrastructure may be configured, for example, to communicate via internet communications (e.g., Wi-Fi, 3G, 4G, or 5G).

[0109] This invention also relates to one or more methods. Although these methods can be performed using a pump system according to the invention, neither the pump system nor the methods are limited thereto. Features described herein with reference to the pump system have the same meaning relative to the method, unless otherwise expressly defined. Features described with reference to the pump system can be applied to the method with necessary modifications to achieve similar advantages, and vice versa.

[0110] One or more objects of the present invention can be achieved by a method for extracting milk from a human breast, wherein the method includes the step of using a pump system or breast pump according to any of the embodiments described herein. Optionally, the method further includes the step of using a force unit of the pump system to generate varying pressure at the nipple.

[0111] One or more objects of the present invention can be achieved by a method for extracting milk from a human breast, the method optionally including the step of subjecting the breast to a first extrusion mode pressure characteristic curve and / or a second extrusion mode pressure characteristic curve using a pump system according to any embodiment of the embodiments described herein. Optionally, the method includes the step of receiving user input settings and determining the extrusion mode pressure characteristic curves based thereon.

[0112] One or more objects of the present invention can be achieved by a method for controlling a pump system for a breast pump (optionally according to any embodiment of the embodiments described herein), wherein the method includes the steps of receiving user input settings and determining a pressure characteristic curve of an extrusion mode based thereon.

[0113] In the embodiments, any method described herein is a non-therapeutic method. For example, the method may be used by a mother who cannot always be with her child, for example, because she works but still wishes to breastfeed her child. For example, in these embodiments, the method is not intended to overcome the fact that the mother has a medical problem.

[0114] In embodiments, the present invention relates to (non-transitory) computer-readable instructions configured to cause a control unit of a pump system (e.g., according to any embodiment described herein) to perform a method according to any embodiment described herein.

[0115] Exemplary embodiments of the invention are described using the accompanying drawings. It should be understood that these drawings are merely examples of how the invention can be implemented and are in no way intended to be construed as limiting the scope of the invention and the claims. Along the drawings, the same features are indicated by the same reference numerals. In the drawings:

[0116] Figures 1a-1c The schematic diagram shows the housing of a pump system used in a breast pump;

[0117] Figures 2a-2d A schematic diagram illustrates the pump system;

[0118] Figures 3a-3e The schematic map illustrates the pressure characteristic curves of extrusion modes with different pressure shapes.

[0119] Figure 4 The schematic diagram illustrates the working principle of the control unit of the pump system.

[0120] Figures 1a-1c The schematic diagram shows the housing 10 of the pump system 30 for the breast pump 1. Figure 1a The figure shows the top surface 10a, the first side surface 10b, and the second side surface 10c. Figure 1b The third side surface 10d, the fourth side surface 10e, and the bottom surface 10f are shown. Figure 1c In the diagram, the bottom surface 10f is not shown to make the pump system 30 visible.

[0121] A pressure outlet 21 is provided in the first side surface 10b. A tube (not shown) can be connected to the pressure outlet 21 by arranging the pressure outlet 21 in the open end of the tube. The opposite end of the tube can be connected to a breast cup. The breast cup can be placed on the nipple of a human breast. The pump system 30 can provide varying pressure at the pressure outlet 21, which is transmitted to the breast cup via the tube. The breast cup can then subject the nipple to varying pressure, which will result in the extraction of milk from the breast (provided, of course, the breast is from a lactating mother).

[0122] Figure 1a A further schematic diagram illustrates a screen 11 that can be provided within the housing 10. The screen 10 can present information to a user (e.g., a mother). This information may relate, for example, whether the pump system 30 is on / activated, the settings of the pump system 30, battery status, etc. However, other methods of transmitting information to the user are also conceivable, such as by means of (LED) lighting. Several buttons 12, 13, 14, 15 allow the user to provide user settings to the pump system. User settings may relate, for example, to activating the pump system 30, and also to desired operating settings for the pump system 30, for example, related to pressure characteristic curves generated under varying pressure. Figure 1b The figure shows several ports 16, 17, and 18 disposed in the housing, which may be used, for example, for charging the battery and / or for data connectivity.

[0123] Figures 1a-1c The diagram shows that the housing 10 has a generally beam-shaped form, although some corners are rounded. The bottom surface 10f can be used to mount the housing 10 on a supporting surface, such as a table. However, the pump system 30 (and therefore the housing 10) is also portable during use. This allows the user to move around and perform normal activities while pumping. The breast pump 1 may, for example, have a weight of 700g and dimensions of 15 cm × 12 cm × 6 cm.

[0124] Figure 1cA pump system 30 is illustrated. In the example shown, the pump system 30 includes a stepper motor 31. The stepper motor 31 performs stepping motion, which allows for good controllability. The rotation of the stepper motor 31 at each step is transmitted to a motor shaft 32, which moves in a linear direction at each step. Although not explicitly shown in the figures, it will be understood that the stepper motor 31 and the motor shaft 32 include teeth that interact with each other to convert the rotational motion of the stepper motor 31 into linear motion of the motor shaft 32.

[0125] The linear motion of the motor shaft 32 is in a direction parallel to the longitudinal central axis of the motor shaft 32. Figure 1c In the view shown, the movement is towards the left and right sides. Figure 1c In the configuration shown, the motor shaft 32 is in its original position, which is the leftmost position. It can be seen that there is space in the housing 10 for moving the motor shaft 32 to the right side. The motor shaft 32 is connected to the pressure space 20, and the pressure outlet 21 is also connected to this pressure space. The pressure space 20 is confined within the pressure space housing 22.

[0126] Figures 2a-2d The schematic diagram shows the pump system 30. Figure 2a An isometric view is shown. Figure 2b A side view is shown. Figure 2c Another view is shown, and Figure 2d A pump system 30 without a pressure space housing 22 is shown.

[0127] exist Figure 2c As can be seen, the motor shaft 32 is connected to the connecting element 33 at the end section. The connecting element 33 is then connected to the clamping plate 34. The clamping plate 34 is connected to the clamping pair plate 35. Figure 2d The membrane 25 is clamped between the clamping plate 34 and the clamping pair 35. The movement of the motor shaft 32 will thus be transmitted to the membrane 25 via the connecting element 33, the clamping plate 34 and the clamping pair 35.

[0128] A membrane 25 is disposed within a pressure space housing 22. The pressure housing 22 includes a membrane movement section 23 having a shape adapted to fit the membrane 25. The space within the membrane movement section 23 between the membrane 25 and the pressure outlet 21 is sealed by the membrane 25. Therefore, the available space for air within this space is defined by the position of the membrane 25. As the membrane 25 moves via the motor shaft 32, this available space for air becomes larger or smaller. This affects the pressure within this space and at the pressure outlet 21, allowing for varying pressures.

[0129] The membrane 25 is made of a flexible material (e.g., a polymer). This allows the membrane 25 to deform during the movement of the motor shaft 32. This deformation can facilitate changing the available space while also keeping the space sealed to prevent air from entering or escaping.

[0130] The connection between the stepper motor 31 and the diaphragm 25 is formed by rigid elements 32, 33, 34, and 35, which do not deform (at least not noticeably under the stresses applied during normal operation of the system 30). This rigid connection allows for precise movement of the diaphragm 25, as the movement of the motor shaft 32 is practically equal to the movement of the diaphragm 25. Furthermore, the elimination of numerous intermediate components (unlike known systems that use belts or various gears between the motor and the diaphragm) allows for the manufacture of a compact motor system. This compact motor system allows for a smaller housing, which is beneficial for portability during use.

[0131] Pressure space 20 is composed of depth ( Figure 2b (in the vertical direction), width ( Figure 2b In the direction perpendicular to the paper) and height ( Figure 2b The width is greater than the height, by at least 2.5 times. This allows for a relatively large change in the volume of the pressure space for relatively small movements of the motor shaft 32, which in turn allows for a compact design.

[0132] exist Figure 2b In the diagram, the initial position sensor 42 is visible. The initial position sensor 42 is configured to detect when the stepper motor 31 is in its initial position, and therefore the motor shaft 32 is in its initial position (as shown in the figure). In the example shown, the sensor actuator 41 is connected to the motor shaft 32 and moves with it. The sensor actuator 42 has a protrusion that extends vertically downward away from the motor shaft 32 (in the figure). Figure 2b (In the middle). When the stepper motor 31 and motor shaft 32 are in their initial positions, the protrusion of the sensor pusher 42 contacts (and presses) the initial position sensor 42. The initial position sensor 42 is a contact sensor in this case, configured to generate an initial position signal indicating that the protrusion of the sensor pusher is pressing the initial position sensor 42. Based on the initial position signal, it can be detected that the stepper motor 31 is in its initial position.

[0133] The pump system 30 shown in the above figures is advantageous for various reasons. First, the design can be very compact and lightweight, making it possible to carry the pump system 30 during use. This is advantageous because it allows the mother to perform other activities while pumping breast milk. The housing 10 may be provided with carrying elements, such as a handle or connecting ring for attaching a strap. With such a strap, the mother can carry the housing like a purse. Second, the stepper motor 31 and its connection to the membrane 25 allow for a high degree of controllability. This controllability, in particular, allows the user to select between different pressure characteristic curves. In this case, the pressure characteristic curve can be characterized, for example, by frequency, amplitude, and pressure shape. However, conventional (portable) pump systems only allow for adaptation of frequency and amplitude, while the system shown also allows for adaptation of pressure shape.

[0134] Figures 3a-3e Examples of pressure characteristic curves with different pressure shapes possible for a pump system are shown. These graphs illustrate curves of different pressures applied to the breast. Therefore, pressure can be measured at the nipple, for example, within the nipple receiving portion of the breast cup. The horizontal axis in these graphs represents time (T), and the vertical axis represents negative pressure (P). Although the pressure is generally depicted as positive in these graphs, it will be understood that negative pressure is generally applied to the breast to simulate a child's sucking motion. Therefore, the pressure can be considered as the opposite of what is shown in these graphs.

[0135] Figures 3a-3e The pressure characteristic curves shown are expression mode pressure characteristic curves. They are configured for use during the expression mode of breast pump 1. Typically, a stimulation mode pressure characteristic curve is first applied to the breast to activate milk flow. The frequency of the stimulation mode pressure characteristic curve is usually high. Then, the expression mode pressure characteristic curve is applied to extract milk from the breast. Alternatively, the stimulation mode pressure characteristic curve may apply the same pressure shape as the illustrated stimulation mode pressure characteristic curve, but at a higher frequency.

[0136] Figure 3a The diagram illustrates a characteristic curve 101 for a first extrusion mode, which is a periodic function with a period 102 and an amplitude 103. The frequency of the periodic function is the reciprocal of the period. The function has a pressure build-up segment 104 and a pressure release segment 105. The pressure release segment has a first portion 105a and a second portion 105b with different slopes. In the first portion 105a, the pressure is released more slowly than in the second portion 105b. In the second portion 105b, the slope is similar in absolute value to the slope in the rising portion 104. In this example, the pressure release segment occupies more than 50% of the period (pressure shape over time). Figure 3aThe pressure in the first extrusion mode characteristic curve 101, which is a function of time, can be described by a sequence of polynomials.

[0137] Figure 3b The diagram illustrates the characteristic curve 111 of the second extrusion mode, which is a periodic function with a period 112 and an amplitude 113. The frequency of the periodic function is the reciprocal of the period. This function has a pressure build-up segment 114 and a pressure release segment 115. The pressure release segment 115 has a steep slope when the pressure is released rapidly. As the pressure gradually builds up, the pressure build-up segment 114 has a gentle slope. In this example, the pressure build-up segment occupies most of the period (the pressure shape over time), even exceeding 80%. Figure 3b The pressure in the second extrusion mode characteristic curve 111, which is a function of time, can be described by a sequence of sine and polynomial functions, such as a sine-building segment and a polynomial-releasing segment, or by a sequence of polynomial functions, some of which can be approximated by a sine function.

[0138] Figure 3c The figure illustrates the characteristic curve 121 of the third extrusion mode, which is a non-periodic function with varying periods 122a and 122b and amplitudes 123a and 123b. Since children do not utilize perfectly periodic pressure characteristic curves, this extrusion characteristic curve simulates a child's sucking behavior. When a user selects this type of pressure characteristic curve in the user settings, the selected amplitude and frequency can be the average maximum amplitude and average frequency, respectively. Each single wave has periods 122a and 122b, amplitudes 123a and 123b, pressure build-up segments 124a and 124b, and pressure release segments 125a and 125b. For a single wave, it can be seen that the wave is approximately mirror-image near the moment when amplitudes 123a and 123b have been reached. Therefore, the slopes of the corresponding pressure build-up segments 124a and 124b are similar to the slopes of the corresponding pressure release segments 125a and 125b. Figure 3c The pressure in the third extrusion mode characteristic curve 121, which is a function of time, can be described by a combination of polynomial functions and sine functions or by a sequence of polynomial functions (some of which can be approximated by sine functions).

[0139] Figure 3d The figure illustrates the characteristic curve 131 of the fourth extrusion mode, which is a periodic function with a period of 132 (the reciprocal of the frequency) and an amplitude of 133. The pressure characteristic curve has a pressure build-up segment 134 and a pressure release segment 135. For a single period, it can be seen that the wave is approximately mirror-image near the moment when the amplitude 133 has been reached. Therefore, the slope of the pressure build-up segment 134 is similar to the slope of the pressure release segment 135. The pressure characteristic curve 131 of the fourth extrusion mode has a sinusoidal shape. It can be described by a sine or cosine function. Figure 3dThe pressure as a function of time is the characteristic curve 131 of the fourth extrusion mode.

[0140] Figure 3e The diagram illustrates the characteristic curve 141 of the fifth extrusion mode, which is a periodic function with a period 142 (the reciprocal of the frequency) and an amplitude 143. The pressure characteristic curve has a pressure build-up segment 144 and a pressure release segment 145. For a single cycle, it can be seen that near the moment when the amplitude 143 has been reached, the wave is approximately mirror-image. Therefore, the slope of the pressure build-up segment 144 is similar to the slope of the pressure release segment 145. The pressure shape is convex, and this pressure shape has an extended time period 146 between the pressure release segment 145 and the pressure build-up segment 144 in the next cycle. Figure 3e The fifth extrusion mode characteristic curve 141 can be described by a sequence of sine and polynomial functions, including, for example, sine building and releasing segments and polynomial time periods between consecutive sine segments. In some examples, the fifth extrusion mode characteristic curve 141 can also be described by a sequence of polynomial functions, some of which can approximate sine functions.

[0141] Figure 4 The schematic diagram illustrates the operation of the control unit 201. The control unit 201 can be arranged in a housing as shown in the previous figure and is configured to control the pump system by controlling the stepper motor 31.

[0142] Control unit 201 can be implemented according to any suitable embodiment, as many types of control units are known. Control unit 201 includes memory 202 for storing data, such as historical data, computer-readable instructions, user input settings, control settings for stepper motor 31, pressure characteristic curves, pressure shapes, etc. Control unit 201 includes processing units for performing processing steps and / or calculations.

[0143] Control unit 201 is configured to receive user input settings. The user can provide these user input settings in various ways. For example, the user can press one of buttons 12, 13, 14, 15 to generate respective user input signals 12a, 13a, 14a, 15a transmitted to control unit 101. Buttons 12, 13, 14, 15 may be part of a user input module. Control unit 201 may also include a communication terminal 201.1, configured to receive user input settings via wireless communication signal 211a. The user can provide user input settings, for example, on a mobile application 211, which transmits the user input settings to control unit 201. Although... Figure 4 The figure shows a wireless communication signal 201.1 directly to the control unit 201. However, in practice, a cloud-based system that is functionally arranged between the mobile application 211 and the control unit 201 can also be used.

[0144] User input settings may involve the desired frequency and amplitude (i.e., maximum pressure). Alternatively, user input settings may involve the user's desired pressure profile. The user may, for example, select from several predetermined extrusion mode pressure profiles. These several may include, for example, […]. Figures 3a-3e Two or more pressure shapes are shown. It has been found that some pressure shapes work well for some mothers, while others work well for others (e.g., in terms of milk output and / or comfort). Even for a single mother, the optimal pressure shape can depend on varying factors and therefore varies. Allowing users to choose between different pressure shapes ensures that a suitable pressure shape can be found.

[0145] Control unit 201 determines the extrusion mode pressure characteristic curve based on user input settings. This can be achieved, for example, by scaling the baseline pressure characteristic curve used for the selected pressure shape based on the selected frequency and / or amplitude. Control unit 201 then generates a control signal 201a based on the determined extrusion mode pressure characteristic curve to control the stepper motor's stepping. Control signal 201a ensures that stepper motor 31 moves in a step sequence from the start of stepping to the maximum step and back. The stepping sequence depends on the pressure shape, the maximum step depends on the amplitude, and the speed at which the stepping sequence is executed depends on the frequency.

[0146] It will be understood that even when the same frequency and the same amplitude are chosen for two different pressure profiles, this will result in different step sequences. Within any step sequence, the control unit is free to determine the step size, the speed at which one or more steps are taken, the direction of the steps, and / or the time period between subsequent steps. Therefore, two different step sequences can also differ from each other in step size and / or the speed at which steps are taken and / or the time period between subsequent steps and / or the direction of the steps.

[0147] The desired extrusion pattern pressure characteristic curve reflects the pressure at the breast. When determining the step sequence based on this, the control unit 201 can consider a transfer function (or its inverse function). The transfer function reflects how the movement of the motor shaft 32 affects the pressure at the breast. This can depend on the breast cup, but a general model can also be implemented if the type of breast cup is unknown.

[0148] The control unit 201 is also configured to receive a raw position signal 42a from the raw position sensor 42. Based on this, the stepper motor 31 can be confirmed to be in its raw position. For example, any step taken in a step sequence can be determined relative to the raw position. The position of the stepper motor 31, the motor shaft 32, and therefore the diaphragm can be accurately known by tracking the steps taken. Accurate control of pressure at the breast can be achieved without feedback from additional sensors or the like.

[0149] Detailed embodiments of the invention have been described herein as needed; however, it should be understood that the disclosed embodiments are merely examples of the invention, and these examples may be implemented in different ways. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as the basis of the claims and as a representative basis for teaching those skilled in the art to practice the invention in various ways with virtually any suitable detailed structure. Not all described objectives need to be achieved with specific embodiments.

[0150] Furthermore, the terminology and expressions used herein are not intended to limit the invention, but rather to provide an understandable description of the invention. Unless otherwise specified, the terms “a,” “an,” or “one” as used herein refer to one or more. The terms “a multiple of,” “a plurality,” or “several” refer to two or more. The terms “comprise,” “include,” “comprising,” and “having” have open-ended meanings and do not exclude the presence of additional elements. Reference numerals in the claims should not be construed as limiting the invention.

[0151] The fact that certain technical features are described only in different dependent claims still allows for the possibility of using combinations of these technical measures advantageously.

[0152] A single processor or other unit may perform the functions of the different components mentioned in the specification and claims. For example, in practice, the functions of the processing unit or control unit or a single processing unit or control unit described herein may be distributed across multiple components, optionally physically separated from each other. Any communication between components may be wired or wireless by known methods.

[0153] Actions performed by the control unit can be implemented as programs, such as computer programs and software applications. Programs can be executed using computer-readable instructions. Programs may include subroutines, functions, procedures, object methods, object implementations, executable applications, source code, object code, shared libraries / dynamically loaded libraries, and / or other sets of instructions designed to execute on a computer system.

[0154] Computer programs or computer-readable instructions may be stored and / or distributed on suitable media, such as optical storage media or solid-state media equipped with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunications systems.

Claims

1. A pump system (30) for a breast pump used to extract milk from human breasts, the pump system comprising: • At least one pressure outlet (21), the at least one pressure outlet comprising at least one outlet membrane (25), wherein the pressure outlet (21) is configured to be fluidly connected to a breast cup, the breast cup being configured to be disposed on the breast. • A force unit configured to move the at least one outlet membrane (25) for controlling the pressure at the air outlet, wherein the force unit includes a stepper motor (31) configured to move in steps and to transmit motion to the outlet membrane (25) with each step. • A control unit configured to control the force unit, wherein the control unit is configured to: • Receive user input settings, wherein the user input settings relate to the frequency, amplitude, and pressure shape selected from a plurality of predetermined extrusion mode pressure shapes. • The extrusion mode pressure characteristic curve is determined based on the user input settings, and the force unit is controlled based on the extrusion mode pressure characteristic curve, wherein: • For the pressure characteristic curve of the first extrusion mode based on the user setting with a first pressure shape and the pressure characteristic curve of the second extrusion mode based on the user setting with a second pressure shape, the pressure at the air outlet, as a function of time, differs from each other in more and / or other ways than the amplitude and / or time being scaled.

2. The pump system (30) according to claim 1, wherein, The control unit is configured to determine a stepping sequence for the stepper motor (31) based on the extrusion mode pressure characteristic curve, wherein, • Both the first extrusion mode pressure characteristic curve and the second extrusion mode pressure characteristic curve are based on user settings with a first frequency and a first amplitude; • For the pressure characteristic curve of the first extrusion mode, the control unit is configured to determine a first step sequence for causing the stepper motor (31) to move from the start of stepping motion to the first maximum step and back within a first time period. • For the pressure characteristic curve of the second extrusion mode, the control unit is configured to determine a second step sequence for causing the stepper motor (31) to move from the initial stepping motion to the first maximum step and back within the first time period. The first step sequence differs from the second step sequence in one or more of the following aspects: stride length, speed of the steps taken, time period between subsequent steps, and direction of each step in the step sequence.

3. The pump system (30) according to claim 1, wherein, The stepper motor (31) is configured to employ multiple different strides.

4. The pump system (30) according to any one of the preceding claims, wherein, The plurality of predetermined extrusion mode pressure shapes include at least four different extrusion mode pressure shapes, each of which is configured to produce a step sequence that is different from each other with equal amplitude and frequency.

5. The pump system (30) according to any one of the preceding claims, wherein, The first pressure shape is a sinusoidal curve shape, and wherein, The second pressure shape is a shape determined by a polynomial having at least five factors.

6. The pump system (30) according to any one of the preceding claims, wherein, The first pressure shape has a pressure build-up section and a pressure release section, wherein • The pressure relief section occupies at least 40% of the first pressure pattern over time; and / or • Wherein, the slope of the pressure relief section is equal to the slope of the pressure build-up section; and / or • Wherein, the pressure build-up section and the pressure release section are mirror images of each other with respect to a mirror line extending through the peak.

7. The pump system (30) according to any one of the preceding claims, wherein, The control unit is configured to adjust the frequency and / or the amplitude in each extrusion mode.

8. The pump system (30) according to any one of the preceding claims, wherein, The pump system is configured to be portable during use.

9. The pump system (30) according to any one of the preceding claims, comprising a motor shaft (32) connected to the stepper motor, wherein, The stepper motor (31) is configured to cause linear motion of the motor shaft (32), wherein the motor shaft (32) is configured to cause linear motion of the at least one membrane (25).

10. The pump system (30) according to any one of the preceding claims, comprising a motor shaft (32) connected to the stepper motor, wherein, The motor shaft (32) is rigidly connected to the outlet membrane (25).

11. The pump system (30) according to any one of the preceding claims, wherein, The control unit is configured to apply feedforward control and / or open-loop control to control the force unit.

12. A breast pump system for extracting milk from the nipple of a human breast, comprising a pump system (30) according to any of the preceding claims, further comprising at least one breast cup and a connecting tube configured to be connected at a first end to the breast cup and at a second end to the pressure outlet (21).

13. The system according to any one of the preceding claims, comprising a mobile application, wherein, The mobile application is configured to: • Executed on user equipment devices, • The control unit is communicatively connected to the pump system (30). • Transmit the user settings to the control unit, wherein the user can provide the user settings on the user equipment device.

14. A method for extracting milk from a human breast, the method comprising the step of using a pump system (30) according to any one of the preceding claims to subject the breast to a first extrusion mode pressure characteristic curve and / or a second extrusion mode pressure characteristic curve.

15. Non-transitory computer-readable instructions configured to cause a control unit of the pump system (30) according to any one of claims 1 to 11 or the system according to claim 12 or 13 to perform the method according to the preceding claim.

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