RU2785417C2 - Determination of breast condition during milk extraction session - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: device for determination of a breast condition during a milk extraction session contains breast lining for accommodation of the user’s breast and a unit for measuring nipple elongation, made with the possibility of measurement of elongation of the nipple of the breast placed in breast lining at specific pressure in breast lining during the milk extraction session. The unit for determination of the breast condition is made with the possibility of determination of evaluative emptiness of the user’s breast, presence or absence of a milk ejection effect, or evaluative emptiness of the user’s breast and presence or absence of the milk ejection effect of the user’s breast as a condition of the user’s breast based on elongation of the nipple of the user’s breast. The unit for determination of the breast condition contains a storage device storing values of breast emptiness depending on the nipple elongation and specific pressure in breast lining, or a function of evaluation of breast emptiness, having the nipple elongation and specific pressure in breast lining as input data and breast emptiness as output data. A milk pump for milk extraction, a method for control of milk pump operation during the milk extraction session, and a computer-readable carrier containing a computer program for control of milk pump operation are disclosed.

EFFECT: provision of determination of a breast condition during a milk extraction session.

12 cl, 7 dwg

Description

[0001] The present invention relates to a breast detection device, a breast pump with a breast detection device, a breast pump control method with a breast detection device, and a computer program.

BACKGROUND OF THE INVENTION

[0002] Breast pumps can be used to extract milk from a mother's breast. In order for milk to begin to be expressed from the breast, the milk ejection reflex (RMR), also called the oxytocin reflex, must be triggered. For example, the sucking pattern in a child, i.e. applying positive and negative pressure to the nipple of the breast can stimulate the RVM. During RWM, oxytocin (OT) is released, which stimulates the contraction of myoepithelial cells surrounding the alveoli in the breast that contain milk.

Thanks to the RWM, milk is transferred from the alveoli through the channels and sacs to the nipple. The breast pump can stimulate the RVM by mimicking the baby's sucking pattern mechanically, i.e. performing cycles of sucking and loosening by applying increased pressure and reduced pressure. Sucking applied to the nipple or pressure applied to the breast allows milk to be extracted.

The flow of milk during a milk extraction session is intermittent because milk is transferred from the alveoli to the nipple only during the RWM. Incomplete emptying of the breast after breastfeeding or milk extraction increases the risk of breast inflammation, which is called mastitis.

[0003] US 2017/0172485 A1 and WO 2016/044368 A1 show a system and method for assessing changes in breast milk volume. The device is attached to the chest. The device contains a retractable part and a sensor for determining the amount of expansion or contraction of the skin of the breast to which the device is attached. The amount of expansion or contraction of the skin to which the device is attached is determined, and the change in breast volume is calculated based on the determined amount of expansion or contraction. The amount of milk extracted from the breast can be calculated based on the change in breast volume.

DISCLOSURE OF THE INVENTION

[0004] An object of the present invention can be stated as providing a breast sensing device, a breast pump with a breast sensing device, a method for controlling the operation of a breast pump with a breast sensing device, and a computer program that would allow the breast state to be determined during an extraction session. milk.

[0005] According to the first aspect of the present invention, a device for determining the condition of the breast. The device for determining the condition of the breast contains a breast pad, a block for measuring the lengthening of the nipple and a block for determining the state of the breast. The chest pad is made with the possibility of placing the user's chest in it. The nipple elongation measurement unit is configured to measure the nipple elongation of the breast placed in the breast pad at a specific pressure in the breast pad during a milk extraction session. The breast condition determination unit is configured to determine the estimated emptiness of the user's breast, the presence or absence of the milk ejection reflex, or the estimated emptiness of the user's breast and the presence or absence of the user's breast milk ejection reflex as the state of the user's breast, based on the elongation of the user's breast nipple.

[0006] A specific chest pad pressure can be provided as a target pressure applied to the chest pad, or a specific chest pad pressure can be measured in the chest pad, for example, using a pressure estimator.

[0007] The breast detection device may be configured for use on mammals such as humans or non-human mammals such as cattle, goats, sheep, or any other non-human mammal.

[0008] Because the breast condition detection unit is configured to determine the user's breast condition based on the nipple extension of the user's breast, and the nipple extension measurement unit is configured to measure nipple extension at a specific breast pad pressure during a milk extraction session, it can be the state of the breast during the milk extraction session was determined. This makes it possible to respond to a particular breast condition during a milk extraction session, such as changing the milk extraction parameters and/or ending the milk extraction session, depending on the particular breast condition of the user.

[0009] The determined condition of the user's chest may be the estimated emptying of the user's chest, the determined presence or absence of RVMs, or the estimated emptying of the user's breasts, and the determined presence or absence of the user's chest RVMs. The breast condition determination unit may be configured to evaluate the emptiness of the user's breast, to determine the presence or absence of RVM, or to evaluate the emptyness of the user's breast and to determine the presence or absence of RVM, based on the elongation of the nipple of the user's breast. The breast condition determination unit may comprise a breast emptying assessment unit configured to evaluate the user's breast emptying based on the user's breast nipple extension and/or an RPM determination unit configured to determine the presence or absence of an RPM based on the user's breast nipple extension.

[0010] The emptying of the breast corresponds to the amount of milk remaining in the user's breast. The amount of milk remaining in the breast can be represented, for example, as volume in cm3, amount of fluid in liters, or the ratio between the amount of milk remaining in the breast and the total amount of milk in the breast at the beginning of the milk extraction session. During a milk extraction session, milk is withdrawn from the breast and the amount of milk remaining in the breast is reduced until the milk extraction session is completed and/or all milk has been extracted.

[0011] Milk can be extracted from the breast during a milk extraction session, for example, by applying cycles of alternating high pressure and low pressure to a breast placed in a breast pad, i. applying sucking and releasing to the nipple, for example using a pressure source such as a vacuum pump. An overpressure is a pressure that is higher than a reduced pressure, and a reduced pressure is a pressure that is lower than the pressure in the environment of the chest pad, for example, a pressure below 1 bar. The increased pressure may be lower than the environmental pressure of the breast pad to provide basic sucking, i.e. providing a sucking force that is lower than the sucking force at reduced pressure. Alternatively, the increased pressure may be a pressure that is higher than the environmental pressure of the breast pad. The nipple is elongated due to sucking applied to the nipple. Nipple elongation should be understood as a change in the position of the tip of the nipple in the direction of sucking applied to the nipple. The elongation of the nipple depends on the applied sucking force caused by the particular pressure in the breast pad and the emptying of the user's breast. This makes it possible to determine when the breast is emptied by applying a particular chest pad pressure and measuring when nipple extension reaches a predetermined threshold that corresponds to an emptied breast at a particular breast pad pressure. A predetermined threshold for nipple elongation that corresponds to an emptied breast at a particular breast pad pressure may be determined, for example, during previous milk extraction sessions.

[0012] In order for milk to be extracted from the breast, the RWM must be activated. It is possible that the RVM is absent during some cycles of sucking and loosening. If there is no RVM, milk will not pass from the alveoli to the nipple, and only milk that has already been transferred to the nipple, such as milk in the channels and sacs of the breast, can be extracted from the breast. If RVM is absent for some time, milk cannot be extracted from the breast, i.e. there is no milk left in the channels and sacs, there is no flow of milk and the emptying of the breast remains unchanged. If milk is not extracted from the breast, then the elongation of the nipple does not change with the same sucking applied to the nipple, i.e. specific pressure in the chest pad, with subsequent cycles of alternating high pressure and low pressure. This makes it possible to detect whether a RVM is present or not by using a nipple elongation measuring unit to determine if the nipple elongation changes with the same suck applied to the nipple during subsequent cycles of alternating increased pressure and reduced pressure, provided that the breast not devastated. That the breast is not emptied can be determined, for example, when nipple extension is less than a predetermined nipple extension threshold that corresponds to an emptied breast at a particular breast pad pressure, or when the duration of the current milk extraction session ensures that the breast is not emptied, for example when the duration of the current milk extraction session is less than a predetermined duration threshold, eg less than 3 minutes, eg less than 2 minutes or less than 1 minute. A predetermined duration threshold may be determined, for example, from previous milk extraction sessions by measuring the appropriate duration to empty the breast.

[0013] Teat elongation can be measured for several cycles of alternating high and low pressure to study teat length over time. The elongation of the nipple during the cycle of increased and reduced pressure is maximum when the maximum reduced pressure is present in the breast pad and the sucking force acting on the nipple becomes maximum. The maximum reduced pressure is to be understood as the maximum reduced pressure that is provided in the chest pad during an appropriate cycle of alternating increased and reduced pressure, for example generated by a pressure source such as a vacuum pump. The same maximum reduced pressure can be provided in the breast pad during all or at least some cycles of alternating increased and reduced pressure, which allows the use of the maximum reduced pressure as a specific pressure in the breast pad to compare nipple extensions during different cycles, t .e. nipple elongation can be compared with maximum sucking applied to the nipple during all cycles, or at least some of the cycles. The use of very low reduced pressure, for example a pressure value well below 1 bar, improves the accuracy of the elongation measurement as teat elongation increases. The use of high reduced pressure, eg a pressure value that is only slightly below 1 bar, to compare teat elongation allows friction on the user's teat to be reduced and may be more comfortable for the user.

[0014] If the breast is empty, i. there is no milk left in the breast that can be extracted, then the elongation of the nipple at a particular pressure in the breast pad reaches its maximum value for a milk extraction session. Breast emptiness corresponding to an emptied breast, e.g. 100% breast emptiness, can be detected when nipple elongation reaches a predetermined threshold value corresponding to an emptied breast at a particular breast pad pressure, or when nipple elongation at a particular breast pad pressure is maximum and no longer changes between successive high pressure and low pressure cycles for a given number of cycles or a given time. The number of cycles or the set time must be large enough to ensure that there is no milk left in the breast that cannot be extracted during this period of time due to the lack of RWM. Alternatively, breast emptying corresponding to empty breasts can be detected when nipple elongation at a particular breast pad pressure is maximum and no longer changes between two successive cycles of increased pressure and decreased pressure in which the presence of RVM is detected.

[0015] The amount of milk at the beginning of a milk extraction session, corresponding to a full breast, can be estimated, for example, based on previous milk extraction sessions, for example, by measuring the amount of milk extracted during previous milk extraction sessions. Breast emptying can be assessed, for example, by comparing the currently measured nipple extension at a particular breast pad pressure with the maximum nipple extension at a particular breast pad pressure expected at the end of a milk extraction session, i.e. the maximum elongation of the nipple at a specific pressure in the chest pad for an emptied breast. The maximum nipple elongation at a particular breast pad pressure expected at the end of a milk extraction session may be based on measured nipple elongations at a particular breast pad pressure at the end of previous milk extraction sessions. In addition, teat elongation at a particular breast pad pressure measured during previous milk extraction sessions can be correlated with the ratio of milk extracted from the breast during the milk extraction session, for example, by measuring the amount of milk extracted. Alternatively, breast emptying may be estimated based on a breast emptying scoring function that uses nipple elongation and a specific breast pad pressure as inputs and provides breast emptying as an output. Breast emptying score function coefficients may be determined, for example, from training data collected during previous milk extraction sessions and using, for example, machine learning, regression analysis, or any other method to derive coefficients from the training data.

[0016] Due to the fact that the breast condition determination unit can be configured to evaluate the emptying of the user's breast based on the nipple extension of the user's breast, and the nipple extension measurement unit is configured to measure nipple extension at a specific pressure in the breast pad during a milk extraction session, breast emptying may be assessed during a milk extraction session. This allows the milk extraction session to be terminated when a predetermined breast emptying is reached, and it is possible to reduce the risk of mastitis caused by terminating the milk extraction session prematurely when the breast is not empty.

[0017] The breast condition determination unit may be configured to adapt the setting of the chest pad depending on the determined breast condition of the user. The breast pad setting may include chest pad pressure, pressure applied to the breast pad, and/or other milk extraction session parameters such as frequency and/or intensity of the peristaltic action and/or massaging action of the compressible membrane on the breast pad. This allows the parameters of a milk extraction session to be adapted to improve milk extraction, for example, by adapting the breast pad setting to stimulate RVM when no RVM is detected, by adapting the breast pad settings to extract milk from the breast when RVM is detected, or by adapting the breast pad settings pads to stop milk ejection when estimated breast emptying indicates that the breast is empty. Adjustment of the breast pad for RVM stimulation may be, for example, applying high reduced pressure with a high frequency of alternating cycles of increased pressure and reduced pressure such that a low sucking force is applied to the nipple and/or the breast is massaged by a compressible membrane. Setting the breast pad to extract milk from the breast can be, for example, the application of very low reduced pressure with a low frequency of alternating cycles of increased pressure and reduced pressure so that a high sucking force is applied to the nipple and/or the breast is subjected to the peristaltic action of a compressible membrane. The setting of the breast pad may be transmitted, for example, to an external device, such as a pressure source of a breast pump connected to the breast detection device, to control the pressure applied to the breast pad by the pressure source. The breast pad setting can be used, for example, to control the pressure generation setting of a pressure source, such as a pressure source in a breast pump.

[0018] The device for determining the condition of the breast may include a control unit. The control unit may be part of a nipple length measurement unit or a breast condition determination unit. The control unit may be configured to control units in the device for determining the condition of the breast. The control unit may include a processor for processing data. The control unit may include a user interface to provide user interaction. Alternatively, the control unit may be connected to a user interface. The user interface may be configured to receive user input, such as selecting or adjusting preset nipple extension thresholds or preset breast emptying thresholds of the user, and generating control signals based on the user input. The control unit may be configured to send control signals to units in the breast condition determination device to control units in the breast condition determination device.

[0019] The control unit may be configured to activate the nipple extension measuring unit when the user's breast is placed in the breast pad. Alternatively or in addition, the control unit may be configured to activate the teat length measurement unit when a control signal issued by the user interface is received. The control unit may be configured to deactivate the breast detection device when the user's chest is removed from the chest pad. Alternatively or in addition, the control unit may be configured to deactivate the breast detection device when a control signal to deactivate the breast detection device is received, such as issued by a user interface. The control unit provides the ability to control the device to determine the state of the breast.

[0020] The breast state determination unit may comprise a breast state indication unit configured to indicate to the user a specific state of the user's breast. The breast condition indication unit may comprise a visual indication unit, an audible indication unit, an auto-off unit, any other breast condition indication unit such as a tactile indication unit, or any combination of a visual indication unit, an audible indication unit, an auto-off unit, or any other indication unit breast condition.

[0021] The visual indication unit may be, for example, a calibrator, a lighting unit, or a display capable of displaying a measure that represents a particular state of the user's chest, such as breast emptying. The visual indication unit may be configured to visually indicate a specific condition of the user's chest, such as emptying of the chest, detected presence of RVM, or detected absence of RVM.

[0022] An audible indication unit may be, for example, an alarm mechanism configured to generate a sound for a particular defined condition of the user's chest, for example, when the emptying of the breast reaches a predetermined threshold, for example, when the breast is empty or when, for example, there is 30% or 30 ml of milk. This allows the user to be able to indicate to the user a currently determined condition, e.g. estimated breast emptying, so that the user can decide when to end the milk extraction session, for example if the user wishes to leave the milk for later breastfeeding a short time after the milk extraction session. For example, control signals may be output to the breast status indication unit to adjust a predetermined breast emptying threshold to enable control when the breast emptying indication is issued by the breast status indication unit.

[0023] The auto-off unit may be configured to automatically end the milk extraction session when the user's predetermined breast condition is determined, such as when the user's breast is empty or when the breast emptying reaches a predetermined threshold. The automatic shutdown unit may be configured to generate a control signal to turn off a pressure source, such as a vacuum pump, connected to the breast pad, to automatically end the milk extraction session when the desired state of the user's breast is determined, for example, when the user's breast is empty or when the breast is empty. reaches the specified threshold value. The chest status display unit can be connected to the control unit. The control unit may be configured to implement the functions of the automatic shutdown unit.

[0024] The breast status indication unit may be configured to indicate to the user when the breast is empty. This provides an indication to the user when he can end the milk extraction session.

[0025] The nipple extension measurement unit may be configured to be placed on the user's chest, for example, by means of a mounting block such as a vacuum cup, or by embedding the nipple extension measurement unit or portions of the nipple extension measurement unit into the breast pad. Alternatively, a nipple extension measuring unit may be positioned near the user's chest to measure the nipple extension of the user's breast. The nipple elongation measuring unit may be located in or on the breast pad, for example, inside the breast pad material, or on the inside of the breast pad that comes into contact with the skin of the user's chest when the user's breast is placed in the breast pad, or on the outside of the breast pad. opposite the inside.

[0026] The nipple elongation measuring unit may be configured to measure the nipple elongation of a breast placed in a breast pad at a particular pressure in the breast pad during a milk extraction session based on an indirect measurement. An indirect measurement is a measurement without physical contact between the teat and the teat length measurement unit. This makes it possible to prevent friction between the hard surfaces of the breast pad and the nipple extension measurement unit, which can occur when the nipple extension measurement unit is in physical contact with the nipple. In addition, this allows for a more comfortable use of the breast detection device and improved user experience. Indirect measurements can be performed, for example, by using a camera, a distance sensor, or a pressure estimator to measure teat extension.

[0027] The teat length measurement unit may include a camera, a distance sensor, a pressure assessment unit, a teat shape measurement unit, or any combination thereof.

[0028] The camera is configured to record images of the user's breast nipple during a milk extraction session. Alternatively, the nipple extension measurement unit may be connected to an external camera, such as a mobile phone camera, which is configured to record images of the user's breast nipple during a milk extraction session and output the recorded images to the nipple extension measurement unit. If the nipple extension measurement unit comprises or is connected to a camera, and the camera is positioned such that the breast pad is in the field of view between the camera and the breast nipple, then the breast pad is transparent to light containing image information from the breast nipple to the camera. The camera provides the ability to evaluate nipple elongation at a specific breast pad pressure based on images recorded during a milk extraction session.

[0029] The distance sensor may be located opposite the tip of the nipple of the user's breast and axially aligned with the direction of nipple extension during the milk extraction session. The distance sensor may be an optical distance sensor, an acoustic distance sensor, or any other type of distance sensor. The distance sensor may be, for example, a proximity sensor such as a radar, sonar or ultrasonic sensor. The distance sensor may be configured to measure the distance between the distance sensor and the tip of the user's breast nipple during a milk extraction session. The distance sensor may, for example, be configured to measure the distance between the distance sensor and the nipple tip of the user's breast during a milk extraction session based on changes in the electromagnetic field or measured transit time. The distance sensor may be configured to measure the transit time of a signal, such as an ultrasonic or infrared signal, between the distance sensor and the tip of the user's nipple during a milk extraction session. The distance sensor provides the ability to estimate teat elongation at a particular breast pad pressure based on the distance between the distance sensor and the teat tip of the user's breast during a milk extraction session. The distance between the distance sensor and the teat tip of the user's breast during a milk extraction session may be measured, for example, based on changes in the electromagnetic field or based on transit time measurements during the milk extraction session.

[0030] The pressure estimation unit may comprise one or more pressure sensors. The pressure evaluation unit may be configured to measure a particular pressure in the chest pad. This makes it possible to measure a particular pressure in the chest pad, for example, if the pressure applied to the chest pad by, for example, a pressure source such as a vacuum pump is unknown. In addition, the pressure evaluation unit may be configured to measure pressure outside the chest pad. This makes it possible to measure the pressure applied to the chest pad and/or the pressure in the environment surrounding the chest pad. Nipple elongation can be measured, for example, using a camera, a distance sensor, a nipple shape measurement unit, or any combination thereof, when the pressure applied to the breast pad is unknown, and the pressure in the breast pad can be measured by a pressure estimator. This makes it possible to measure nipple elongation as a function of a particular breast pad pressure when the pressure applied to the breast pad is not known.

[0031] Alternatively or in addition, the pressure evaluation unit may be configured to estimate the pressure drop in the breast pad that houses the user's breast during a milk extraction session. The pressure drop depends on the volume formed between the breast and the breast pad. The volume can be provided, for example, by the teat channel. The volume between the breast and breast pad decreases as the nipple lengthens. The pressure evaluation unit provides the ability to estimate the elongation of the nipple at a particular pressure in the chest pad based on the change in volume between the breast and the breast pad.

[0032] Alternatively or in addition, the pressure evaluation unit may be configured to determine if the breast is correctly placed in the chest pad. The pressure evaluation unit may be configured to compare the pressure measured in the chest pad with the pressure applied to the chest pad, for example, by a pressure source such as a vacuum pump. Based on the difference between the measured and applied pressure, the pressure evaluation unit can determine if the breast is correctly placed in the chest pad, i. e. whether the breast is in the correct position on the chest pad. This allows an indication to the user as to whether the position of the chest pad on the chest needs to be changed in order to ensure proper operation of the breast detection device.

[0033] If the nipple extension measurement unit measures nipple extension using a camera, a distance sensor, a nipple shape measurement unit, or any combination thereof at a given pressure applied to the breast pad, then the pressure in the breast pad may be affected by nipple extension and the presence of milk in the breast pad. breast pad, e.g. due to an altered volume in the breast pad, i. the changed volume between the breast and breast pad. The pressure measured by the pressure estimator can be used to correct for an altered volume in the chest pad. Alternatively, the effect of the changed volume on the suction action of a pressure source, such as a vacuum pump, can be used to correct for the changed volume in the chest pad. As the volume in the chest pad decreases as the elongation increases, the volume required to be drawn by a pressure source, such as a vacuum pump, from the chest pad decreases to achieve a given pressure. This can be determined, for example, by measuring the time taken to reach the maximum reduced pressure applied to the chest pad.

[0034] The nipple shape measurement unit may be configured to measure the shape of a user's breast nipple during a milk extraction session. The lengthening of the nipple depends on the shape of the nipple, i.e. as the nipple lengthens, the shape of the nipple also changes. The nipple shape measurement unit provides the ability to estimate nipple elongation at a particular breast pad pressure based on the change in nipple shape at a particular breast pad pressure during a milk extraction session. The teat shape measurement unit may comprise a compressible membrane and a membrane shape measurement unit. The compressible membrane contains or defines at least one opening to allow passage of milk extracted from the breast. The compressible membrane and the membrane shape measuring unit may be configured to measure nipple elongation at a particular breast pad pressure during a milk extraction session. The compressible membrane may be positioned on the chest pad and may be configured to conform to the shape of the breast when the breast is placed in the chest pad. Additionally, the compressible membrane may be configured to allow the shape of the compressible membrane to adapt to the shape of the user's breast during a milk extraction session. The compressible membrane may comprise a reversibly deformable material.

[0035] The compressible membrane can be configured to expand from an unstretched state to a stretched state when the breast is placed in the chest pad. The compressible membrane, when in the unstretched state, can be configured to cover an area that is smaller than the surface area of the emptied breast and adapt to the shape of the breast when in the expanded state. The compressible membrane can be configured to conform to the shape of the breast during a milk extraction session by reducing the area covered by the compressible membrane during milk extraction from the breast and reducing the size and surface area of the breast. The membrane shape measurement unit may be configured to measure the shape of the compressible membrane during a milk extraction session to measure teat elongation at a particular breast pad pressure.

[0036] Alternatively, the compressible membrane may also be configured to depress the nipple and/or breast to some extent to perform a peristaltic action or massaging action on the nipple and/or breast to stimulate the RVM and/or to support milk extraction from the nipple . The peristaltic action supports the extraction of milk from the nipple and the massaging action stimulates the RVM. Such a compressible membrane is disclosed, for example, in WO 2010/109398 A1, which is incorporated herein by reference. The membrane shape measuring unit may be configured to correct additional strain caused by pressure on the nipple and/or breast to measure nipple elongation at a particular pressure in the breast pad. Alternatively, the membrane shape measurement unit can also be configured to use pressure on the nipple and/or breast to obtain information about the tightness of the nipple and/or breast. It can be used to improve the measurement of nipple elongation.

[0037] Alternatively, the breast sensing device may be configured to allow the compressible membrane to adapt to the shape of the breast during the entire milk extraction session by providing increased pressure in the form of basic sucking in the breast pad in the form of alternating cycles of increased pressure and reduced pressure . Thereafter, the compressible membrane may be in continuous contact with the breast and nipple. The membrane shape measurement unit may be configured to measure the shape of the nipple when the compressible membrane is not used for a peristaltic action or massaging action, for example, with increased pressure in the form of basic sucking.

[0038] The membrane shape measurement unit may include tension sensors located on the compressible membrane to measure tension. The membrane shape measurement unit may be configured to measure the shape of the compressible membrane based on tension measurements on the tension sensors. Tension measurements provide the ability, for example, to obtain the local curvature of the compressible membrane, which can be used to measure the shape of the compressible membrane. The membrane shape measurement unit may be configured to measure the local curvature of a portion of the compressible membrane in physical contact with the nipple to measure nipple elongation at a particular breast pad pressure. Alternatively or in addition, the membrane shape measurement unit may include an accelerometer for estimating the shape of the compressible membrane. The shape of the breast and the shape of the nipple depend on the emptiness of the breast. Since the shape of the compressible membrane is adapted to the shape of the breast, the shape of the compressible membrane also depends on the emptying of the breast. The nipple shape measurement unit provides the ability to measure the elongation of the nipple at a particular pressure in the breast pad, based on the measured change in the shape of the nipple.

[0039] The membrane shape measurement unit can also be configured to measure the shape of the breast during a milk extraction session to improve the assessment of breast emptying. The membrane shape measurement unit may be configured to use an estimated shape of the compressible membrane to measure the shape of the breast. The shape of the breast depends on the emptiness of the breast. This makes it possible to evaluate the emptying of the breast, since additional information can be provided to evaluate the emptying of the user's chest. The shape of the breast may be, for example, an additional input to the breast emptying function, or the shape of the breast, together with nipple extension and specific pressure in the breast pad, may be correlated with breast emptying.

[0040] The nipple shape measurement unit may allow measurement of breast shape and nipple shape. The measured breast shape can be used to improve the assessment of breast emptying, and the measured nipple shape can be used to measure nipple elongation at a particular breast pad pressure. The compressible membrane and the membrane shape measuring unit can be used to measure the breast shape and the nipple shape, or just one of the breast shape and the nipple shape. If the nipple shape measurement unit is configured to measure only the shape of the breast, the nipple length measurement unit should contain an additional unit for measuring nipple extension during the milk extraction session, for example, a camera, a distance sensor, a pressure assessment unit, or a nipple shape measurement unit configured to nipple shape measurements to measure nipple elongation at a specific breast pad pressure during a milk extraction session.

[0041] The breast determination unit may be configured to be placed on the user's chest, for example, by means of an attachment unit such as a vacuum cup, or by incorporating the breast determination unit or parts of the breast determination unit into a chest pad. Alternatively, the breast detection unit may also reside on a server, computer, mobile phone, or other external network device. The breast condition determination unit is configured to receive the measured nipple extension of the user's breast at a specific pressure in the breast pad from the nipple extension measuring unit. The breast condition determination unit may be connected to the nipple length measurement unit. The connection can be wired or wireless. This enables the measured nipple extension of the user's breast at a specific breast pad pressure from the nipple extension measurement unit to the breast condition determination unit to determine the condition of the user's breast.

[0042] The breast condition determination unit may include a storage device. The storage device may be part of the control unit. Alternatively, the breast condition determination unit may be connected to a memory device. The memory device may store at least one breast emptying value depending on the elongation of the nipple and the particular pressure in the breast pad. Alternatively or in addition, the memory may store a breast emptying evaluation function having nipple extension and a particular breast pad pressure as input and breast emptying as output. At least one breast emptying value as a function of nipple elongation and specific breast pad pressure may be recorded during previous milk extraction sessions to use the at least one breast emptying value in subsequent milk extraction sessions and/or as training data. The coefficients for the breast emptying function may be determined, for example, based on training data collected during previous milk extraction sessions and using, for example, machine learning, regression analysis, or any other method to derive coefficients from the training data.

[0043] The chest pad is shaped to accommodate the user's chest. For example, the chest pad may be funnel-shaped. The chest pad may be made from a resilient material such as polyurethane or silicone. This allows for an improved fit to the wearer's chest as well as increased comfort. The breast pad may include a channel for the nipple. The nipple passage may be configured to accommodate a user's breast nipple. The teat channel allows for more accurate measurement of teat elongation and improved milk ejection.

[0044] The device for determining the condition of the breast may contain a power source. The power source may be configured to supply power to the nipple length measurement unit, the breast condition determination unit, the control unit, the breast condition indication unit, or any combination thereof. The power source may be, for example, a battery. This allows the mobile use of the device for determining the state of the breast.

[0045] According to another aspect of the present invention, a breast pump is provided. The breast pump contains a device for determining the condition of the breast according to one of paragraphs 1-6 of the claims or any embodiment of the device for determining the condition of the breast and a pressure source. The pressure source is in air communication with the breast pad and is configured to generate alternating high pressure and low pressure cycles in the breast pad to extract milk from the user's breast.

[0046] The pressure source may be a manually operated pump or an automatic pressure source such as an electric vacuum pump. This allows milk to be extracted from the user's breast.

[0047] The pressure source may be configured to implement a sucking pattern to stimulate the user's breast RVM and/or to extract milk from the breast. Preferably, the sucking pattern is cyclic. The pressure source may be configured to generate cycles of alternating increased pressure and reduced pressure in the breast pad so that the sucking and releasing forces acting on the nipple of the user's breast alternate in the breast pad.

[0048] The breast pump may include a breast pump control unit. The breast pump control unit may be configured to control the breast pump. The breast pump control unit may be configured to control the pressure source, the breast condition detection device, or the pressure source and the breast condition detection device. Alternatively, the control unit in the device for determining the state of the breast may be configured to control the pressure source. The breast pump control unit may include a user interface for interacting with the user. This makes it possible to centrally control all components of the breast pump via the breast pump control unit.

[0049] The control unit of the breast pump may be configured to synchronize the sampling timing of the nipple extension with a particular pressure in the breast pad generated by the pressure source. The particular pressure may be, for example, the maximum reduced pressure in the chest pad in the respective cycle of alternating increased pressure and reduced pressure. Alternatively or in addition, the nipple extension measurement unit may be configured to synchronize the timing of the nipple extension sampling with a specific breast pad pressure generated by the pressure source.

[0050] Teat elongation at a particular breast pad pressure can be measured, and measured elongations between different cycles of alternating increased pressure and reduced pressure can be compared, since nipple elongation is cyclical in following cycles of alternating increased pressure and reduced pressure in the breast pad. At the moment when the pressure source generates the maximum pressure in the breast pad, the elongation of the nipple has a local maximum. This makes it possible to measure teat elongation maxima and compare maxima. Measurement of teat elongation maxima, i.e. using the same maximum underpressure as the particular pressure in the alternating overpressure and underpressure cycles to be compared provides improved accuracy. In addition, in each successive cycle during a milk extraction session in which milk flow is present, the maximum nipple elongation increases as milk is withdrawn from the breast, and the nipple elongation depends on the emptying of the breast and the pressure in the breast pad. The global maximum nipple elongation at a given breast pad pressure is reached when the breast is emptied. This makes it possible to estimate when the breast is emptied by finding the global maximum nipple elongation at a particular breast pad pressure.

[0051] The breast condition determination unit may be configured to determine the condition of the breast, for example, to evaluate breast emptying, based on local maxima of nipple elongation at a particular breast pad pressure. The breast state determination unit may be configured to generate a breast state signal, such as a breast empty state signal, indicating that the user's breast is empty if a predetermined condition is met, such as if the nipple elongation at a particular breast pad pressure reaches a predetermined threshold value. if the change in maximum teat elongation between two successive cycles is below a given threshold for a given number of cycles or within a given period of time. The breast condition determination unit may be configured to output a breast condition signal, such as a breast emptying condition signal, to the breast condition indication unit. The breast condition indication unit may be configured to indicate to the user a certain condition, such as breast emptying, based on the breast condition signal. Alternatively or in addition, the breast condition detection unit may be configured to output a breast condition signal, such as an empty breast condition signal, to the breast pump control unit. The breast pump control unit may be configured to provide a control signal to the pressure source to end the milk extraction session if a breast status signal, such as an empty breast status signal, indicates that the user's breast is empty, or to adjust the pressure generation setting at the source. pressure depending on the signal of the state of the breast, for example, increasing or decreasing the frequency and/or pressure of cycles of alternating high pressure and low pressure generated by the pressure source. The breast condition signal may comprise an adapted chest pad setting used to control the pressure generation setting.

[0052] Alternatively or in addition, the breast pump controller may be configured to sample teat extension at a sampling rate that is at least 3 times the frequency of alternating high and low pressure breast pad pressure cycles generated by the pressure source. Alternatively or in addition, the nipple extension measuring unit may be configured to sample nipple extension at a sampling rate that is at least 3 times the frequency of alternating high and low breast pad pressure cycles generated by the pressure source. The teat elongation measurement unit may be configured to estimate teat elongation at a particular breast pad pressure for each cycle of alternating high pressure and low pressure, for example by interpolating measured sample values. The measured teat elongation may be, for example, a local maximum if the particular pressure in the breast pad is the maximum reduced pressure in the corresponding cycle. The nipple elongation measuring unit may be configured to output the measured nipple elongation, for example, a local maximum of nipple elongation, to the breast condition determination unit. The breast condition determination unit may be configured to determine the condition of the user's breast, such as estimating breast emptiness, based on measured nipple extension, such as based on a local maximum of nipple extension.

[0053] The breast pump may be configured to use a pressure generation setting adapted to measure teat extension to sample teat extension. The pressure generation setting can be controlled, for example, based on the chest pad setting. For example, the breast pump may be configured to use an increased duration at maximum reduced pressure compared to normal operation during milk extraction sessions or a lower maximum reduced pressure compared to normal operation during milk extraction sessions. This allows a more accurate measurement of teat elongation at a particular chest pad pressure if the maximum reduced pressure is used as the particular pressure. In normal operation, during milk extraction sessions, the reduced sucking pressure present in the breast pad is, for example, -50 mbar to -500 mbar for a duration of 10 ms to 5000 ms. Typically, the maximum reduced sucking pressure, such as a particular breast pad pressure, is present in the breast pad for between 1 ms and 500 ms.

[0054] The breast pump may be configured to implement a calibration measurement to estimate the maximum elongation of the nipple at a particular breast pad pressure that occurs when the user's breast is emptied. The breast pump may be configured to perform a calibration measurement in which milk is drawn from the breast until the breast has been emptied, for example within 30 minutes, 25 minutes, 20 minutes or 15 minutes. Alternatively or in addition, the breast pump may be configured to use one or more previous milk extraction sessions as calibration measurements. The global maximum teat elongation at a particular breast pad pressure in the calibration measurement or calibration measurements can be used as a measure for a subsequent milk extraction session to assess when the breast is emptied. This provides a more accurate assessment of breast emptying.

[0055] Alternatively or in addition, the breast emptying detection unit may be configured to estimate the amount of milk in the user's breast at the beginning of a milk extraction session based on a calibration measurement, for example, by measuring the amount of milk extracted from one or more previous milk extraction sessions and using the measured amount of extracted milk as an estimate of the amount of milk in the user's breast at the start of a subsequent milk retrieval session. The estimate of the amount of milk in the user's breast at the beginning of the milk extraction session, for example, can be further multiplied by a correction factor to increase or decrease the estimated amount of milk in the user's breast depending on the history of the milk extraction sessions. For example, if the history of milk extraction sessions shows a decrease or increase in the amount of milk with each subsequent milk extraction session, a correction factor can be used to decrease or increase the estimated amount of milk in the user's breast at the beginning of the subsequent milk extraction session. Estimating the amount of milk in a user's breast at the start of a milk retrieval session provides an indication of breast emptying during a milk retrieval session. Nipple elongation at a particular breast pad pressure can be correlated with the current amount of milk remaining in the breast to provide an indication of breast emptying during a milk extraction session.

[0056] The breast pump may include a chest unit and a base unit. The chest block may include a chest pad. In addition, the chest block may include a device for determining the condition of the breast or parts of the device for determining the condition of the breast. The chest block may be configured to be placed on the chest of the user. The base unit may contain a pressure source, a power source, or a pressure source and a power source. The power source is configured to supply power. The chest unit and the base unit can be connected via a connecting path. The connecting path may contain an air channel, a power line, an optical connection, or any combination thereof.

[0057] The power line may be a power cord connecting the breast pump base unit to the breast unit to supply power to the breast unit. Alternatively or in addition, the chest unit may be powered by a power source contained in the breast detection device.

[0058] The breast block may include a container for storing the extracted milk. The chest block may include a chest pad connector for connecting the chest pad to the container.

[0059] The device for determining the condition of the breast can be connected to any suitable breast pump or be part of it.

[0060] According to yet another aspect of the present invention, the use of measuring nipple elongation of a user's breast at a particular sucking force applied to the nipple during a milk extraction session is provided. The specific sucking force applied to the nipple is generated by applying a specific pressure to the nipple. The measurement is used to determine the condition of the user's chest. The determined condition of the user's breasts may be the estimated emptying of the user's chest, the determined presence or absence of an RVM, or the estimated emptying of the user's chest and the determined presence or absence of the user's chest RVMs.

[0061] According to another aspect of the present invention, a method for controlling the operation of a breast pump according to paragraph 7 of the claims or any embodiment of a breast pump is provided. The method includes the following steps:

- generating cycles of alternating high pressure and low pressure in the breast pad to extract milk from the user's breast,

- measuring the elongation of the nipple of the breast placed in the breast pad at a specific pressure in the breast pad during the milk extraction session, and

- determining the state of the breast of the user based on the elongation of the nipple of the user's breast. The determined condition of the user's breasts may be the estimated emptying of the user's chest, the determined presence or absence of an RVM, or the estimated emptying of the user's chest and the determined presence or absence of the user's chest RVMs.

[0062] The method may be a non-therapeutic method. The non-therapeutic method makes it possible to increase the amount of milk extracted by the breast pump since, for example, the respective milk extraction session can be completed as soon as the breast is emptied and the breast pump can be used without undue delay to extract milk from the other breast in a new milk extraction session. The non-therapeutic method can be used, for example, to control the operation of a breast pump in the dairy cattle field to increase the amount of milk extracted from dairy cattle by determining the point in time when the breast from which the milk is extracted is empty, and the pump can be applied to the next breasts, for example, of another cow. This makes it possible to reduce the time during which the breast pump tries to extract milk from an already emptied breast.

[0063] The method may include the following step:

- indication of a certain state of the user's chest.

Alternatively or in addition, the method may include the following step:

- an indication when the user's chest is empty.

[0064] The method may include the following step:

- measurement of pressure in the chest pad to determine when a particular pressure occurs in the chest pad.

[0065] The method may include the following step:

- recording images of the user's breast nipple during a milk extraction session. The elongation of the user's breast nipple at a particular breast pad pressure during a milk extraction session is measured based on the recorded images.

[0066] Alternatively or in addition, the method may include the following step:

- measuring the distance between the tip of the nipple of the user's breast and a fixed point opposite the tip and aligned along the axis with the direction in which the nipple elongates during a milk extraction session. The elongation of the nipple of the user's breast at a particular pressure in the breast pad during the milk extraction session is measured based on the measured distance between the tip of the nipple and the specified fixed point during the milk extraction session. Distance can be measured, for example, based on changes in the electromagnetic field, or based on the transit time of a signal, such as an ultrasonic or infrared signal, during a milk extraction session.

[0067] Alternatively or in addition, the method may include the following step:

- assessing the pressure drop in the breast pad in which the user's breast is placed during the milk extraction session. The elongation of the user's breast nipple at a particular breast pad pressure during a milk extraction session is measured based on the estimated pressure drop across the breast pad.

[0068] Alternatively or in addition, the method may include the following step:

- measuring the shape of the nipple during the milk extraction session. The nipple elongation of the user's breast at a particular breast pad pressure during a milk extraction session is measured based on the measured nipple shape at a particular breast pad pressure during a milk extraction session. Measurement of the shape of the nipple can be done, for example, by measuring the shape of the compressible membrane adapted to the shape of the breast during a milk extraction session. The shape of the compressible membrane can be measured, for example, by measuring the tension at various positions on the compressible membrane and obtaining the local curvature of the portion of the compressible membrane that is in physical contact with the nipple during a milk extraction session to measure the elongation of the nipple at a particular pressure in the breast pad during milk extraction session. Based on the local curvature, the shape of the compressible membrane can be measured during the milk extraction session. From the shape of the compressible membrane, a nipple shape can be obtained that can be used to measure nipple elongation at a particular breast pad pressure during a milk extraction session. Alternatively or in addition, measurement of the shape of the nipple during the milk extraction session can be performed based on the measurements taken by the accelerometer to evaluate the shape of the compressible membrane.

[0069] The method may include the following step:

- measurement of the shape of the breast during the milk extraction session to improve the assessment of breast emptiness. Measurement of the shape of the breast can be performed, for example, by measuring the shape of the compressible membrane that encloses the breast and which is adapted to the shape of the breast during a milk extraction session. The shape can be measured, for example, by measuring the tension at various positions on the compressible membrane and obtaining the local curvature of a portion of the compressible membrane at the positions. Based on the local curvature, the shape of the compressible membrane can be measured during the milk extraction session. The shape of the compressible membrane can be used to provide additional information for assessing the emptying of the user's chest.

[0070] According to another aspect of the present invention, a computer program is provided for controlling the operation of a breast pump according to claim 7 or any embodiment of a breast pump. The computer program contains program code means that cause the processor to execute the method according to claim 9 of the claims or any embodiment of the method when said computer program is run on the processor.

[0071] According to another aspect, a computer-readable medium is provided that stores the computer program of claim 12. Alternatively or in addition, the computer readable medium may store a computer program in any embodiment of the computer program.

[0072] It should be understood that the breast detection device of claim 1, the breast pump of claim 7, the method of claim 9, the computer program of claim 12, and the computer-readable medium of claim 13 have similar and /or identical preferred embodiments, which, in particular, are defined in the dependent claims.

[0073] It should be understood that a preferred embodiment of the present invention may also be any combination of the dependent claims or the above embodiments with the corresponding independent claim.

[0074] These and other aspects of the invention will be apparent and explained with reference to the embodiments described below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0075] In the presented drawings:

in fig. 1 is a schematic illustration of a first embodiment of a device for detecting the condition of a breast in a first embodiment of a breast pump, as an example,

in fig. 2A is an exemplary schematic of the breast pad of a breast detection device, where the breast is placed in the breast pad and nipple elongation at a particular breast pad pressure at the beginning of a milk extraction session is minimal,

in fig. 2B shows an intermediate nipple extension at a specific breast pad pressure during a milk extraction session,

in fig. 2C depicts the maximum nipple elongation at a particular breast pad pressure at the end of a milk extraction session,

in fig. 2D graphically depicts nipple elongation over time during a milk extraction session as an example,

in fig. 3, by way of example, schematically shows a second embodiment of a device for determining the state of the breast in a second embodiment of a breast pump,

in fig. 4 shows, by way of example, a third embodiment of a device for detecting the condition of a breast in a third embodiment of a breast pump,

in fig. 5, by way of example, schematically shows a fourth embodiment of a device for detecting the condition of a breast in a fourth embodiment of a breast pump,

in fig. 6 is a schematic representation of a fifth embodiment of a device for detecting the condition of a breast in a fifth embodiment of a breast pump, as an example,

in fig. 7 shows an embodiment of the method for controlling the operation of a breast pump.

IMPLEMENTATION OF THE INVENTION

[0076] FIG. 1 is a schematic illustration of a first embodiment of a breast detection device 10 in a first embodiment of a breast pump 100 by way of example. the amount of milk remaining in the breast 12 of the user 14. In other embodiments, the breast detection device may be configured to determine the presence or absence of RVM, or to assess the emptying of the breast and to determine the presence or absence of RVM. The breast pump 100 can be used to extract milk from the breast 12 of the user 14. The breast pump 100 includes a chest unit 110 and a base unit 120. The chest unit 110 and the base unit 120 are connected via a connecting path 130. The chest unit 110 includes a device 10 for determining the condition of the breast and can be placed on the chest 12 of the user 14.

[0077] The breast condition detection device 10 includes a breast pad 16, a nipple length measurement unit 17 in the form of a camera 18, a breast condition determination unit 20 comprising a breast emptying assessment unit 21, and a breast condition indication unit in the form of an alarm mechanism 22. In other embodiments, the teat length measurement unit may be, for example, a distance sensor, a pressure assessment unit, or a teat shape measurement unit. In still other embodiments, the teat length measurement unit may comprise a camera, a distance sensor, a pressure assessment unit, a teat shape measurement unit, or any combination thereof. The camera, distance sensor, and pressure evaluation unit provide the ability to measure the elongation of the nipple of the user's breast at a specific pressure in the breast pad on the basis of indirect measurement, i.e. without physical contact with the nipple. In addition, a pressure evaluation unit can be used to measure a particular pressure in the chest pad. In other embodiments, in addition or alternatively, the breast condition indication unit may comprise a PBM determination unit to determine the presence or absence of a PBM.

[0078] The breast pad 16 is funnel-shaped to comfortably accommodate the breast 12 therein and has a nipple channel 24 for receiving the nipple 26 of the breast 12. In this embodiment, the breast pad 16 is made of polyurethane. In other embodiments, the breast pad may have any other shape that allows the placement of the breast, and, in addition, may also be made of any other elastic material, such as silicone.

[0079] Camera 18 is positioned such that it can record images of the nipple 26 when breast 12 is placed in breast pad 16. Breast pad 16 is translucent to allow camera 18 to capture images of the nipple 26. In other embodiments, the camera may be positioned directly on the chest pad, for example, built into the chest pad (see Fig. 3 and Fig. 6). In yet other embodiments, the camera may be removable from the chest pad.

[0080] FIG. 2A, 2B and 2C, by way of example, schematically depict what the recorded images of the nipple 26 look like in the nipple channel 24.

[0081] The camera 18 processes the recorded images by measuring the elongation of the nipple 26 over time and measures the maximum elongation of the nipple 26 at the maximum reduced pressure in the breast pad 16 during each sucking and loosening cycle, i.e. chamber 18 outputs measured local maxima of nipple extension 26 at maximum reduced pressure in breast pad 16. In other embodiments, nipple extension may be measured at a different specific pressure. In this embodiment, the camera 18 includes an antenna 28 that transmits the local maxima of the elongation of the nipple 26 to the block 21 evaluation of the emptying of the breast.

[0082] The breast emptying assessment unit 21 includes a control unit 30 and an antenna 32. The control unit includes a processor 34, a memory 36, and a sensor in the form of a proximity sensor 38. In other embodiments, the sensor may also be, for example, a temperature sensor or any other sensor that makes it possible to determine that the breast is placed in the chest pad. The control unit 30 controls the operation of the device 10 for detecting the state of the breast and, in particular, the unit 21 for assessing the emptying of the breast and the unit 17 for measuring the length of the nipple in the form of a camera 18.

[0083] Antenna 32 receives signals from camera 18. The signals contain information regarding local maxima of teat elongation 26.

[0084] The processor 34 processes the signals received by the antenna 32 from the camera 18. In addition, the processor may receive control signals from the memory 36 or from the proximity sensor 38. The control signals may contain, for example, sensor data or may be conventional control signals to activate or deactivate the camera 18 or the alarm mechanism 22.

[0085] The memory 36 stores the breast pad settings, pressure generation settings, operating modes, and a computer program for controlling the operation of the breast condition detection device 10.

[0086] The proximity sensor 38 detects when the chest 12 of the user 14 is placed in the chest pad 16 and provides a control signal to activate the camera 18 via the antenna 32 to the camera 18. The proximity sensor 38 is optional. In other embodiments, the breast detection device does not include a sensor, and the nipple length measurement unit can be manually activated.

[0087] In other embodiments, the control unit deactivates the breast detection device when the user's breast is removed from the chest pad. The control unit may also deactivate the breast condition detecting device when a control signal to deactivate the breast detecting device is received, for example issued via the user interface.

[0088] The control unit 30 enables the control of the breast detection device 10 so that the camera 18 turns on automatically when the breast is placed in the breast pad 16. In this embodiment, the control unit 30 deactivates the camera 18 when the breast emptying evaluation unit 21 detects that chest 12 is empty.

[0089] In this embodiment, the breast emptying estimator 21 evaluates breast emptying based on local maxima of nipple elongation 26 at the maximum reduced pressure in the breast pad 16. specific pressure in the chest pad. The breast emptying evaluation unit 21 generates a breast emptying state signal indicating that the breast 12 of the user 14 is empty if a predetermined condition is satisfied. In this embodiment, the condition is that the elongation of the nipple 26 at the maximum reduced pressure in the breast pad 16 reaches a predetermined threshold value. The predetermined threshold value is specific to the user 14 and can be obtained, for example, from a calibration measurement. In calibration measurement, the user's maximum nipple extension at maximum breast pad reduced pressure during a milk extraction session can be measured with the breast empty, and the maximum nipple extension at maximum breast pad reduced pressure can be set as a predetermined threshold value. Alternatively, the maximum elongation at another specific breast pad pressure may be measured with the breast emptied and set as a predetermined threshold if the maximum elongation of the nipple during a milk extraction session is compared to the predetermined specific pressure threshold. In addition, the predetermined threshold value may be slightly less than the maximum teat extension, for example, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm or 0.5 mm less than the maximum teat extension, in order to avoid that the emptiness of the breast will not be determined. The maximum elongation of the user's breast nipple can also be derived from previous milk extraction sessions. In other embodiments, the predetermined condition may, for example, be that the change in maximum teat elongation at a particular breast pad pressure during a milk extraction session between two consecutive cycles of alternating high pressure and low pressure with milk flow is less than a predetermined threshold value, for example , 0.5 mm.

[0090] The breast emptying evaluation unit 21 outputs a breast emptying status signal to the alarm mechanism 22 . The alarm mechanism 22 indicates breast emptying to the user based on the breast emptying condition signal by issuing a specific audible alarm.

[0091] In this embodiment, the connection path 130 includes an air passage 140 and a power line in the form of a power cord 150. The power cord 150 supplies power to the breast emptying evaluation unit 21 and the alarm mechanism 22 . In other embodiments, the power line may also supply power to the teat length measurement unit. In still other embodiments, the nipple length measurement unit, the breast emptying assessment unit, and/or the breast condition indication unit may be powered from a power source located on the breast unit. In addition, the power line can be used to transmit data, such as control signals.

[0092] The device 10 for determining the state of the breast is connected to the connecting path 130 through the connector 40 of the chest pad.

[0093] The breast pad connector 40 includes a milk storage container 42 for storing the extracted milk 44. In this embodiment, the user 14 removes the breast 12 from the breast pad 16, thereby completing the milk extraction session. The milk 44 extracted during the milk extraction session is stored in the milk storage tank 42 .

[0094] The chest pad connector 40 and container 42, together with the breast detection device 10, form a chest block 110.

[0095] The base unit 120 includes a pressure source in the form of a vacuum pump 46, a power supply 48, a breast pump control unit 50, and a user interface in the form of a dip switch 52. In other embodiments, the user interface may also be, for example, a touch display, a simple switch , button, or any other user interface that allows the user to interact with the breast pump.

[0096] The vacuum pump 46 is in air communication through an air passage 140 with the breast pad 16 to generate cycles of alternating high pressure and low pressure in the breast pad 16 to extract milk from the breast 12 of the user 14. This allows the generation of a sucking pattern with alternating sucking cycles. and weakening. Typical sucking and relaxing cycles last from 0.5 seconds to 2 seconds, such as 0.6 seconds, 1.25 seconds, or 1.32 seconds, so that 30 to 120 sucking and relaxing cycles are generated per minute. In other embodiments, the vacuum pump may be replaced by any other pressure source that is capable of generating alternating high pressure and low pressure cycles. The vacuum pump can be replaced, for example, with a manual vacuum pump, which is controlled by a handle. Such a manual vacuum pump, for example, can be built into the chest unit. This enables improved mobile control.

[0097] The power supply 48 supplies power to the components of the base unit 120 and through the power cord 150 also to the components of the chest unit 110.

[0098] The breast pump control unit 50 includes a processor 34'. The breast pump control unit 50 controls the operation of the vacuum pump 46 and the power supply 48 . This makes it possible to control the breast pump 100. The breast pump control unit 50 includes an antenna for communication with the breast emptying assessment unit 21 and a camera 18 (not shown). An antenna is not required. Alternatively, the breast pump control unit 50 may also be connected to the breast condition detection unit and/or the nipple length measurement unit via a wired connection, for example via a connecting path. In other embodiments, the breast pump control unit may also be used to control the breast detection device. This provides the possibility of centralized control of the breast pump and all its components.

[0099] In this embodiment, the breast pump control unit 50 enables the sampling of the teat extension 26 at a sampling rate that is at least 3 times the frequency of the alternating high pressure and low pressure cycles in the breast pad 16 generated by the vacuum pump 46. In others In embodiments, the breast pump control unit may synchronize the timing of nipple extension sampling with a specific pressure, such as the maximum reduced pressure, in the breast pad generated by the pressure source.

[0100] In other embodiments, a breast pump may be used with a pressure generation setting adapted to measure nipple extension to sample nipple extension. For example, a breast pump may be used for an extended duration of maximum reduced pressure compared to normal operation during milk extraction sessions or a lower maximum reduced pressure compared to normal operation during milk extraction sessions. A lower maximum reduced pressure applies a higher sucking force to the nipple of the user's breast. This allows a more accurate measurement of teat extension at a particular chest pad pressure if the maximum reduced pressure is used as the particular pressure. In normal operation, during milk extraction sessions, the reduced sucking pressure present in the breast pad is, for example, -50 mbar to -500 mbar for a duration of 10 ms to 5000 ms, for example 500 ms to 2000 ms. Typically, a maximum reduced sucking pressure, such as a particular chest pad pressure, is present in the chest pad for between 1 ms and 500 ms.

[0101] In addition, the breast pump can be used to implement a calibration measurement to estimate the maximum elongation of the nipple at the maximum reduced pressure that occurs when the user's breast is emptied. In other embodiments, a different specific pressure may be used in the calibration measurement. The maximum nipple elongation in previous milk extraction sessions may be recorded and the maximum nipple elongation in previous milk extraction sessions may be used, for example, as the maximum nipple elongation corresponding to the elongation at which the breast is determined to be empty.

[0102] Measuring the elongation of the user's nipple during a milk extraction session can be used to assess the emptiness of the user's breasts. This makes it possible to judge when the user's breast is empty and when the user can end the milk extraction session without the additional risk of mastitis caused by milk remaining in the breast.

[0103] In FIG. 2A-2C are exemplary schematic representations of recorded images of the nipple 26 in the nipple channel 24 in the funnel chest pad 16 of the breast detection device 10 shown in FIG. 1 at the same maximum reduced pressure in the chest pad 16 in each of the three recorded images. Other images with different nipple extensions may be recorded for a different specific pressure (not shown).

[0104] In FIG. 2D, by way of example, graphically depicts the extension 54 of the nipple 26 over time 56. The maxima 58 of the extension 54 of the nipple 26 increase over time 56. The maxima 58 of the extension 54 of the nipple 26 depicted in the graph of FIG. 2D are extensions 54 of the nipple 26 at the same maximum reduced pressure in the breast pad 16. The extension 54 of the nipple 26 follows a sucking and loosening pattern driven by a cycle of alternating increased pressure and decreased pressure. With an increase in sucking, i.e. depressurization, the extension 54 of the teat 26 increases to reach the maximum for the maximum depressurization. With a decrease in sucking, i.e. As the pressure rises, during periods of release, the elongation 54 of the teat 26 decreases again. The elongation minima 54 depend on the sucking pattern being performed on the teat 26, eg if there is enough time for relaxation and/or if basic sucking is present, eg if the overpressure is less than 1 bar. In this embodiment, an increasing base sucking is provided, i. e. during release, the increased pressure in the breast pad 16 is higher than the maximum reduced pressure, but higher than the pressure around the breast pad 16, and the increased pressure is reduced after a series of sucking and releasing cycles to increase basal sucking over time. In addition, in the graph of Fig. 2D does not show cycles without milk flow.

[0105] Typically, a milk extraction session takes approximately 15 minutes for a single breast, and typically 30 to 120 sucking and loosening cycles are performed per minute. In FIG. 2D shows a much lower frequency, which does not match the actual pump frequency that would be used. Fig. 2D is for illustrative purposes and shows that the elongation 54 of the teat 26 cyclically increases over time 54 and that the peaks 60, 62, 64 of the elongation of the teat 26 at maximum reduced pressure in the breast pad 16 increase over time 54 as milk is extracted from chest 12.

[0106] In FIG. 2A shows the tip 27 of the teat 26 in a position that corresponds to a local maximum 60 of the extension 54 of the teat 26 at maximum reduced pressure in the breast pad 16 after approximately half of the second milk extraction session.

[0107] In FIG. 2B shows an intermediate nipple extension 26 at a local maximum 62 of the nipple extension 54 26 at maximum reduced pressure in the breast pad 16 after approximately 5 minutes of a milk extraction session.

[0108] In FIG. 2C depicts the maximum teat extension 26 with a maximum of 64 teat extensions 54 26 at maximum reduced pressure in the breast pad 16 at the end of a milk extraction session. In this case, the milk extraction session takes 12.5 minutes. The maximum 64 nipple extension at the maximum reduced pressure in the chest pad 16 reaches a predetermined threshold value corresponding to an emptied breast. The breast 12 is thus determined to be empty and the milk extraction session is terminated. In another embodiment, the milk extraction session could be completed provided that the maxima of teat extension 26, following the maximum 64 of teat extension 54 26, do not change, for example, less than a threshold value of 0.5 mm, at a maximum reduced pressure in the breast pad 16 for a given number of peaks, a given duration, or with an RTM.

[0109] In FIG. 3, by way of example, schematically shows a second embodiment of the breast detection device 10' in a second embodiment of the breast pump 100'. The breast pump 100' contains a chest unit 110' and a base unit 120', which are connected via a connecting path 130'. The connecting path 130' contains an air channel 140 and a power and data line in the form of a power cord 150. The chest block 110' is positioned on the chest 12 of the wearer 14. The chest block 110' includes a portion of the breast detection device 10', a breast pad connector 40, and a milk storage container 42.

[0110] The device 10' for determining the state of the breast includes a breast pad 16', a nipple elongation evaluation unit 17' containing a camera 18, and a nipple shape measurement unit 18'. The nipple shape measurement unit 18' comprises a compressible membrane 66 and a membrane shape measurement unit in the form of a tension sensor 68. In addition, the breast determination device 10' includes a breast determination unit 20' comprising a breast emptying assessment unit 21' disposed in the base unit 120'. In other embodiments, the breast emptying scoring unit may be located in the chest unit. To measure teat lengthening, only one of the chamber 18 and the teat shape measuring unit 18' is needed. The use of both the camera 18 and the nipple shape measurement unit 18' to measure the elongation of the nipple provides an increase in the accuracy of the measurement. In other embodiments, the tension sensors may be replaced by an accelerometer or any other membrane shape measurement unit that provides the ability to measure the shape of the compressible membrane during a milk extraction session.

[0111] The breast pad 16' includes a nipple channel 24 in which the nipple of the breast 12 of the user 14 is placed during a milk extraction session. The breast pad 16' is pressurized and depressurized to extract milk from the breast 12 of the user 14. The extracted milk 44 is stored in the milk storage container 42. The overpressure and underpressure are provided through the air passage 140 and the chest pad connector 40 from the base unit 120'. The 16' chest pad is funnel-shaped and made of polyurethane. In other embodiments, the chest pad may have a different shape, and may also be made of another elastic material, such as silicone. The compressible membrane 66 and tension sensors 68 contained in the nipple shape measurement unit 18' are built into the breast pad 16'. The camera 18 is also integrated into the chest pad 16'. A camera 18 is located on the teat channel 24 and records images during a milk extraction session. The recorded images are transmitted to the base unit 120' via the power cord 150.

[0112] The compressible membrane 66 encloses the chest 12 of the wearer 14 when the chest 12 is placed in the chest pad 16'. The compressible membrane 66 has a small opening that allows the extracted milk 44 from the teat to pass through the teat passage 24 and through the breast pad connector 40 into the milk storage container 42 . In other embodiments, the compressible membrane can also be configured to provide an opening that allows the passage of milk (not shown). The compressible membrane 66 can compress and expand depending on the shape of the breast 12 of the wearer 14, i. e. the compressible membrane 66 may be in an unstretched state, may be stretched into a stretched state, and again reduced in size to compress to an unstretched state. The compressible membrane 66 allows the shape of the compressible membrane 66 to adapt to the shape of the breast 12 of the user 14 during a milk extraction session. In this embodiment, the compressible membrane 66 is made from a reversibly deformable material such as a silicone elastomer, a latex material, or rubber. In the unstretched state, the compressible membrane 66 covers an area that is smaller than the area of the surface of the chest 12 of the user 14 in the emptied state, i.e. the area of the surface covered by the compressible membrane 66 in the unstretched state is smaller than the area of the surface of the emptied breast. When the breast 12 is placed in the breast pad 16', and therefore also in the compressible membrane 66, the compressible membrane 66 is stretched into a stretched state, which allows the compressible membrane 66 to adapt to the shape of the breast 12. During the milk extraction session, milk is extracted from the breast 12 , and the size and, therefore, the area of the surface of the chest 12 is reduced. The compressible membrane 66 adapts to the shape of the breast 12 during a milk extraction session by reducing the area covered. Thus, the compressible membrane 66 can adapt to the shape of the breast 12 during a milk extraction session by reducing the size of the compressible membrane 66 when milk is withdrawn from the breast 12 until the end of the milk extraction session.

[0113] Tension sensors 68 are distributed over the surface of the compressible membrane 66 at various positions on the compressible membrane 66. The tension sensors 68 measure the shape of the compressible membrane 66 during a milk extraction session to improve the assessment of breast emptying. In particular, a portion of the compressible membrane 66 is in physical contact with the nipple, and in this embodiment, some tension sensors 68 are located around the nipple (not shown). Tension sensors 68 measure local tension, which corresponds to local curvature. The shape of the compressible membrane 66, which corresponds to the shape of the breast 12, can be estimated based on data from the tension sensors 68. The shape of the nipple can also be measured based on the local curvature measured from tension sensors 68 located around the nipple. This makes it possible to measure nipple elongation, since nipple elongation depends on the shape of the nipple. In addition, the shape of the breast 12 and the amount of milk remaining in the breast 12 are related. This provides additional information to evaluate breast emptying. The tension sensors 68 are connected to the base unit 120' via a power cord 150. This allows signals from the teat shape measuring unit 18' to be transmitted to the main unit 120' via the power cord 150.

[0114] In other embodiments, the compressible membrane can also exert pressure on the nipple and/or breast to some extent to perform a peristaltic action or massaging action on the nipple and/or breast to stimulate the RVM and/or to maintain milk extraction from the nipple. Such a compressible membrane is disclosed, for example, in WO 2010/109398 A1, which is incorporated herein by reference. The membrane shape measurement unit may be configured to correct additional strain caused by pressure on the nipple and/or breast to measure nipple elongation at a particular pressure in the breast pad. Alternatively, the membrane shape measurement unit can also be configured to use pressure on the nipple and/or breast to obtain information about the tightness of the nipple and/or breast.

[0115] In still other embodiments, base sucking may be provided in the breast pad to allow the compressible membrane to adapt to the shape of the breast during the entire milk extraction session. Thereafter, the compressible membrane is in continuous contact with the breast and nipple. The membrane shape measurement unit may be configured to measure the shape of the nipple when the compressible membrane is not used for a peristaltic action or massaging action, such as under increased pressure in the form of base suction.

[0116] The base unit 120' includes a breast pump control unit 50', a vacuum pump 46, a power source 48, and a breast status indication unit in the form of an automatic shutdown unit 22'. In other embodiments, the automatic shutdown unit may also be part of the breast pump control unit 50'. In still other embodiments, the automatic shutdown unit may be replaced by any other breast indication unit, such as a visual indication unit, an audible indication unit, or any other type of breast indication unit, such as a tactile indication unit.

[0117] The breast pump control unit 50' includes a breast emptying assessment unit 21'. The block 21' evaluation of the emptiness of the breast contains a block 30' control. The control unit 30' includes a processor 34 and a storage device 36.

[0118] The processor 34 processes the signals received via the power cord 150 from the camera 18 and the teat shape measuring unit 18'. In addition, the processor can receive control signals from the memory 36.

[0119] The memory 36 stores the breast pad settings, the pressure generation settings, the operating modes, and the computer program for controlling the device 10' to determine the state of the breast. In addition, the memory stores a table with breast emptying values depending on nipple extensions and specific pressure in the breast pad 16'. Breast emptying values, dependent on nipple extensions and specific 16' breast pad pressure, are recorded during previous milk extraction sessions for use in subsequent milk extraction sessions. The stored table is used to return the breast emptying corresponding to the measured nipple extension at a specific 16' chest pad pressure. If the measured nipple elongation and/or pressure in the breast pad 16' is between the two stored values, then an interpolated breast emptying can be ensured. In addition, the memory 36 stores a history of the milk extraction session with the amount of milk extracted during previous milk extraction sessions and corresponding to the time of the milk extraction sessions. This enables the delivery of an estimated amount of milk in the breast 12 at the beginning of the milk extraction session. When it is determined that the breast emptying is below the threshold value, in this embodiment, less than 1% of milk is left in the breast 12 of the user 14 compared to the amount of milk in the breast 12 at the beginning of the milk extraction session, the breast emptying evaluation unit 21' generates an empty state signal chest, which is issued to the block 22' automatic shutdown. The automatic switch-off unit 22' completes the milk extraction session by automatically switching off the breast pump 100'.

[0120] Alternatively or in addition, in other embodiments, the memory stores a breast emptying evaluation function having nipple extension and a specific breast pad pressure as input and breast emptying as output. Breast emptying values based on nipple extensions and specific breast pad pressure recorded during previous milk extraction sessions can be used as training data to determine coefficients for a breast emptying scoring function based on machine learning, regression analysis, or any other inference method coefficients based on training data.

[0121] The breast pump control unit 50' controls the operation of the breast pump 100'. The breast pump control unit 50' controls the sucking pattern produced by the vacuum pump 46, the power supplied by the power supply 48, and the nipple length measurement unit 17' comprising the chamber 18 and the nipple shape measurement unit 18'.

[0122] Vacuum pump 46 generates cycles of alternating high pressure and low pressure, and applies high pressure and low pressure to chest cup 16' via air passage 140 and chest pad connector 40. In other embodiments, the vacuum pump may be replaced by any other pressure source, such as a handle for applying high pressure and low pressure to the chest pad.

[0123] The power supply 48 supplies power to the components of the base unit 120' and to the chest unit 110' through the power cord 150.

[0124] Operation of the breast pump 100' shown in FIG. 3, similar to the operation of the breast pump 100 shown in FIG. 1. Breast pump 100' and breast pump 100 assess breast emptying using recorded camera images. However, the breast pump 100' and the breast pump 100 differ from each other in that the breast pump 100' additionally measures the elongation of the nipple at a specific pressure in the breast pad 16' using the nipple shape measurement unit 18'. Thus, the average value can be calculated in two ways by measuring the elongation of the nipple at a specific pressure in the breast pad 16'. In addition, breast emptying assessment is performed in the 100’ breast pump based on a table with breast emptying values depending on nipple extensions and specific pressure values in the 16’ breast pad. In addition, the breast pump 100' automatically turns off when the amount of milk remaining in the breast 12 is less than 1% of the estimated amount of milk at the beginning of the milk extraction session.

[0125] In FIG. 4, by way of example, schematically shows a third embodiment of a breast detection device 10'' in a third embodiment of a breast pump 100''.

[0126] The 100'' breast pump contains a 110'' chest unit and a 120'' base unit. The chest unit 110'' may be located on the chest 12. The chest unit 110'' and the base unit 120'' are connected via a connecting path 130. In this embodiment, the connecting path 130 includes an air channel 140 and a power and data line in the form of a cord 150 nutrition.

[0127] The device 10'' for determining the condition of the breast includes a breast pad 16'', a unit 17'' measuring nipple lengthening, containing a distance sensor in the form of an ultrasonic sensor 18'', a battery 70, a unit 20'' determining the condition of the breast, containing a block 21'' evaluation of the emptying of the breast, and a block indicating the state of the breast in the form of a display 22''.

[0128] The 16″ breast pad includes a nipple channel 24 that houses an 18″ ultrasonic transducer. In FIG. 4 shows the breast 12 moving away from the breast pad 16'' after the milk extraction session is completed. The breast pad connector 40 includes a milk storage container 42 for storing the extracted milk 44. During a milk extraction session, the nipple 26 of the breast 12 is positioned in the teat channel 24.

[0129] The 18'' ultrasonic sensor may be positioned opposite the tip 27 of the nipple 26 of the breast 12 and axially aligned with the direction of nipple extension 26 during a milk extraction session. The 18″ ultrasonic transducer measures the transit time of ultrasound between the 18″ ultrasonic transducer and the tip 27 of the nipple 26 of the breast 12 during a milk extraction session to measure the elongation of the nipple 26 at a specific pressure in the 16″ breast pad. In other embodiments, the ultrasonic sensor may be replaced with another distance sensor, such as an acoustic sensor or an optical distance sensor to measure the distance between the tip of the user's nipple and the distance sensor. The ultrasonic sensor can also be replaced with a proximity sensor such as radar, sonar or the like. In other embodiments, the distance between the distance sensor and the tip of the user's nipple may also be measured based on changes in the electromagnetic field or measurements of the transit time of a signal, such as an infrared signal.

[0130] The measured teat extension 26 is output to the 120″ base unit via the power cord 150 from the 18″ ultrasonic transducer.

[0131] In this embodiment, the battery 70 supplies power to the ultrasonic sensor 18″. Battery 70 is optional. The battery 70 is rechargeable and can be charged via the power cord 150 .

[0132] The 120'' base unit contains a 50'' breast pump control unit, a vacuum pump 46, a power supply 48, and a 22'' display.

[0133] The breast emptying evaluation unit 21'' comprises a control unit 30' with a processor 34 and a memory 36. The breast emptying evaluation unit 21'' uses a breast emptying evaluation function having nipple elongation at maximum reduced pressure as input and breast emptying. as output. In other embodiments, the breast scoring unit may also use other breast emptying assessment methods, such as using a different specific breast pad pressure, or a method based on a table with breast emptying values dependent on nipple extensions and specific breast pad pressure, or assessing when the breast is emptied by comparing nipple elongation at a particular breast pad pressure for successive cycles of alternating increased pressure and decreased pressure.

[0134] The 22'' display provides a graphical representation of breast emptying over time, estimated based on breast emptying function. This allows the user to decide when to end the milk extraction session.

[0135] In FIG. 5, by way of example, is a schematic representation of a fourth embodiment of a breast detection device 10''' in a fourth embodiment of a breast pump 100'''.

[0136] The 100''' breast pump contains a 110''' chest unit and a 120''' base unit. The chest unit 110''' and the base unit 120''' are connected through a connecting path 130, which contains an air channel 140 and a power and data line in the form of a power cord 150.

[0137] The device 10''' for determining the state of the breast includes a breast pad 16''', a unit 17''' measuring the elongation of the nipple, containing a block 18''' pressure assessment, a battery 70, a unit 20''' determine the state of the breast, comprising a breast emptying evaluation unit 21''' located in the base unit 120''' and a breast condition indication unit in the form of a light alarm 22'''.

[0138] The breast pad 16''' includes a nipple channel 24 in which a pressure evaluation unit 18''' is located. In FIG. 5 shows the breast 12 moving away from the breast pad 16''' after the milk extraction session is completed. The breast pad connector 40 includes a milk storage container 42 for storing the extracted milk 44. During a milk extraction session, the nipple 26 of the breast 12 is positioned in the teat channel 24.

[0139] The pressure evaluation unit 18''' estimates the pressure drop in the breast pad 16''' that houses the breast 12 during a milk extraction session. The pressure drop depends on the volume in the teat channel 24 . The volume in the teat port 24 decreases as the teat 26 lengthens at a particular chest pad pressure of 16″. The pressure evaluation unit 18''' allows the elongation of the teat 26 to be estimated based on the change in volume in the teat passage 24. In this embodiment, the pressure evaluation unit 18''' comprises two pressure sensors (not shown). In other embodiments, the pressure estimator may comprise one or more pressure sensors, and the pressure estimator may measure a particular pressure in the chest pad. This makes it possible to measure a particular pressure in the chest pad, for example, if the pressure applied to the chest pad by, for example, a pressure source such as a vacuum pump is unknown. In addition, the pressure evaluation unit can measure the pressure outside the chest pad. This makes it possible to measure the pressure applied to the chest pad and/or the pressure in the environment surrounding the chest pad.

[0140] The teat extension 26 is provided to the 120″ base unit via the power cord 150 from the pressure assessment unit 18″.

[0141] In this embodiment, the battery 70 supplies power to the pressure evaluation unit 18″. Battery 70 is optional. The battery 70 is rechargeable and can be charged via the power cord 150 .

[0142] The base unit 120''' contains a breast pump control unit 50''', a vacuum pump 46, a power supply 48, and a user interface in the form of a touch screen 52.

[0143] The breast pump control unit 50''' comprises a breast emptying assessment unit 21'''.

[0144] The breast emptying evaluation unit 21''' comprises a control unit 30' with a processor 34 and a memory 36. The breast emptying evaluation unit 21''' uses a breast emptying evaluation function having a nipple extension 26 and a specific pressure in the breast pad 16' '' as input and breast emptiness as output. In other embodiments, the breast scoring unit may also use other methods of estimating breast emptying, for example, based on a table of breast emptying values depending on nipple extensions and specific breast pad pressure, or estimating when the breast is emptied by comparing nipple extension at specific pressure in the chest pad for successive cycles of alternating high pressure and low pressure. The breast emptiness evaluation unit 21''' outputs a breast emptiness status signal to the light alarm 22'''.

[0145] The light alarm 22''' gives a visual indication of breast emptying over time based on the breast emptying state signal, for example, by flashing or bright light of different colors, such as green, yellow, and red, or continuously changing color depending on the amount milk remaining in the breast to indicate empty breasts. This allows the user to decide when to end the milk extraction session.

[0146] In FIG. 6, by way of example, is a schematic representation of a fifth embodiment of the device 10'''' for determining the state of the breast in the fifth embodiment of the breast pump 100''''.

[0147] The 100'''' breast pump contains a 110'''' chest unit and a 120'''' base unit. The chest unit 110'''' and the base unit 120'''' are connected through a connecting path 130, which contains an air channel 140 and a power and data line in the form of a power cord 150.

[0148] The device 10'''' for determining the state of the breast contains a breast pad 16'''', a unit 17'''' measuring the elongation of the nipple, containing a camera 18, a battery 70, a unit 20'''' determining the state of the breast, containing block 23 determine RWM, located in the base unit 120''''.

[0149] Breast pad 16'''' contains a channel 24 for the nipple. A camera 18 is located on the nipple channel 24 for recording images of the nipple 26 of the breast 12. In FIG. 6 shows the breast 12 moving away from the breast pad 16'''' after the milk extraction session is completed. The breast pad connector 40 includes a milk storage container 42 for storing the extracted milk 44. During a milk extraction session, the nipple 26 of the breast 12 is placed in the teat channel 24.

[0150] The camera 18 records images of the nipple 26 during the milk extraction session. The camera allows the elongation of the nipple 26 to be estimated based on the recorded images.

[0151] The teat extension 26 measured by the teat extension measuring unit 17'''' is output to the base unit 120'''' via the power cord 150 from the camera 18.

[0152] In this embodiment, battery 70 supplies power to camera 18. Battery 70 is optional. The battery 70 is rechargeable and can be charged via the power cord 150 .

[0153] The base unit 120'''' contains a breast pump control unit 50'''', a vacuum pump 46, a power supply 48, and a user interface in the form of a touch screen 52.

[0154] The breast pump control unit 50'''' comprises a RVM determination unit 23.

[0155] The RPM determination unit 23 comprises a control unit 30″ with a processor 34 and a memory 36. The RPM determination unit 23 determines whether an RPM is present or absent based on the extension of the teat 26, i.e. block 23 determining the RWM determines the absence or presence of the RWM. The RPM determination unit 23 compares the elongation of the nipple 26 at a specific chest pad pressure of 16″ between successive cycles of alternating high pressure and low pressure, and determines whether the breast is empty. If the breast is not emptied and the nipple extension 26 at a particular pressure in the breast pad 16'''' does not change between successive cycles of alternating high and low pressure, then the absence of RVM is determined. If the elongation of the nipple 26 at a particular pressure in the breast pad 16'''' changes between successive cycles of alternating high and low pressure, then the presence of RVM is determined. In this embodiment, a breast is defined as non-empty if the duration of the current milk extraction session is less than a predetermined duration threshold of 3 minutes. In other embodiments, the specified duration threshold may be 2 minutes or 1 minute, for example. In other embodiments, the breast condition determination unit may comprise a breast emptying evaluation unit for assessing the emptyness of the user's breast. The breast emptying scoring block can be used to determine that the breast is not empty. In other embodiments, the breast condition determination unit may determine the condition of the user's breast. The determined condition of the user's breasts may be the estimated emptying of the user's chest, the determined presence or absence of RVMs, or the estimated emptying of the user's breasts and the determined presence or absence of the user's chest RMBs.

[0156] The RPM determination unit 23 adapts the setting of the chest pad depending on the presence or absence of the RPM. In other embodiments, the breast condition determination unit may be configured to adapt the chest pad setting depending on the particular condition of the user's chest, for example, based on breast emptying and/or the absence or presence of RVMs. In this embodiment, the RPM detecting unit 23 is configured to adapt the setting of the breast pad to stimulate the RPM when the absence of the RPM is determined and to improve milk extraction when the presence of the RPM is determined. In this embodiment, the setting of the breast pad for RVM stimulation is a high reduced pressure at a high frequency of alternating cycles of increased pressure and reduced pressure such that a low sucking force is applied to the nipple at a high frequency. Additionally or alternatively, in other embodiments, a massaging motion of a compressible membrane may be used to stimulate the RVM. In this embodiment, the setting of the breast pad for milk extraction is a very low reduced pressure at a low frequency of alternating cycles of high pressure and low pressure, such that a high sucking force is applied to the nipple at a low frequency. Additionally or alternatively, in other embodiments, the peristaltic movement of a compressible membrane may be used to extract milk from the breast. This allows for improved RWM activation and milk extraction during a milk extraction session.

[0157] FIG. 7 shows an embodiment of the method for controlling the operation of a breast pump. The breast pump contains a device for determining the state of the breast and a source of pressure. The device for determining the state of the breast contains a breast patch for placing the user's breasts in it, a nipple elongation measurement unit for measuring the elongation of the nipple of the breast placed in the breast pad at a specific pressure in the breast pad during a milk extraction session, and a breast condition determination unit in the form of a block assessment of breast emptying. The nipple length measurement unit comprises a camera, a distance sensor in the form of an ultrasonic sensor, a pressure assessment unit and a nipple shape measurement unit. In other embodiments, the ultrasonic sensor may be replaced by another distance sensor, such as a proximity sensor such as radar, sonar, or the like. In other embodiments, the teat length measurement unit may comprise only one of a camera, a distance sensor, a pressure estimation unit, and a teat shape measurement unit. In this embodiment, the teat shape measurement unit comprises a compressible membrane and a membrane shape measurement unit with tension sensors. In other embodiments, the membrane shape measuring unit may be an accelerometer.

[0158] In step 200, the method generates cycles of alternating high pressure and low pressure in the breast pad to extract milk from the user's breast. To generate cycles of alternating high pressure and low pressure in the breast pad, a pressure source is used to mimic the sucking and releasing pattern that stimulates the RVM and to extract milk from the breast nipple. In this embodiment, the pressure source is an electronic vacuum pump. In other embodiments, the vacuum pump may be a manually operated vacuum pump, such as a crank operated vacuum pump.

[0159] At step 210, the elongation of the user's nipple is measured at a particular pressure in the breast pad during the milk extraction session. In this embodiment, four different methods for measuring teat elongation are performed in sub-steps 212, 214, 216, and 218.

[0160] At step 212, images of the user's breast nipple are recorded during the milk extraction session. The elongation of the user's breast nipple at a particular breast pad pressure during a milk extraction session is measured based on the recorded images.

[0161] At step 214, the ultrasound travel time is measured between the tip of the user's breast nipple and a fixed point opposite the tip and axially aligned with the direction in which the nipple elongates during a milk extraction session. The elongation of the user's breast nipple at a particular breast pad pressure during a milk extraction session is measured based on the measured ultrasound transit time. In other embodiments, the distance between the fixed point and the tip of the user's breast nipple during the milk extraction session may be measured based on changes in the electromagnetic field or based on measurements of the transit time of other signals, such as an infrared signal, during the milk extraction session.

[0162] At step 216, the pressure drop in the breast pad that houses the user's breast during the milk extraction session is evaluated. The elongation of the user's breast nipple at a particular breast pad pressure during a milk extraction session is measured based on the estimated pressure drop across the breast pad.

[0163] At step 218, the shape of the nipple is measured during the milk extraction session. The elongation of the user's breast nipple at a particular breast pad pressure during a milk extraction session is measured based on the measured nipple shape at a particular breast pad pressure during a milk extraction session. The shape of the nipple can be measured by measuring the shape of the compressible membrane adapted to the shape of the breast during a milk extraction session. In this embodiment, the shape of the compressible membrane is measured by measuring the tension at various positions on the compressible membrane and obtaining the local curvature of the portion of the compressible membrane that is in physical contact with the nipple during a milk extraction session to measure the elongation of the nipple at a particular breast pad pressure during the session. milk extraction. Based on the local curvature, the shape of the compressible membrane is measured during the milk extraction session. From the shape of the compressible membrane, a nipple shape is obtained, which is used to measure the elongation of the nipple at a specific pressure in the breast pad during a milk extraction session. In other embodiments, the teat shape during the milk extraction session is measured using an accelerometer to evaluate the shape of the compressible membrane.

[0164] To measure nipple extension at a particular breast pad pressure, only one of sub-steps 212, 214, 216, and 218 need be performed. Performing more than one of steps 212, 214, 216, and 218 allows for improved measurement accuracy of nipple extension at a particular pressure. in the breast pad because an average value, eg a weighted average, for nipple extension can be determined based on four different measured nipple extensions at a particular breast pad pressure.

[0165] At step 220, the shape of the breast is measured during the milk extraction session to improve the assessment of breast emptying. In this embodiment, the breast shape measurement is performed by measuring the shape of the compressible membrane that encloses the breast and is adapted to the shape of the breast during a milk extraction session. In this embodiment, shape is measured by measuring the tension at various positions on the compressible membrane and obtaining the local curvature of a portion of the compressible membrane at the positions. Based on the local curvature, the shape of the compressible membrane is measured during the milk extraction session. The shape of the compressible membrane is used to provide additional information for assessing the emptying of the user's chest. In other implementations, an accelerometer and data obtained from it can be used to measure the shape of the breast and provide additional information to assess the emptiness of the user's chest. Step 220 is optional. Steps 210 and 220 may be performed in an interchangeable order.

[0166] In step 230, the emptying of the user's chest is evaluated based on the elongation of the user's breast nipple. In addition, in this embodiment, the shape of the breast is taken into account to evaluate the emptying of the breast. In this embodiment, a breast emptying evaluation function is provided to evaluate breast emptying. The breast emptying function is trained on training data recorded during previous milk extraction sessions using machine learning. Alternatively, other methods can be used to generate a breast emptying scoring function that allows the estimation of breast emptying based on nipple elongation and a particular breast pad pressure. In still other embodiments, a table of breast emptying values based on nipple extensions and specific breast pad pressure can be used to evaluate breast emptying based on measured nipple extension at a particular breast pad pressure. The table may be based on data recorded during a previous milk extraction session. In still other embodiments, at 230, when the breast is emptied can be assessed by assessing when nipple extension at a particular breast pad pressure does not change for a given number of cycles or a given time, such as when measuring nipple extension at a particular pressure. in the chest pad is less than a predetermined threshold value for a predetermined number of consecutive cycles of alternating high pressure and low pressure. In still other embodiments, step 230 may be replaced with a step of determining the condition of the user's breast based on the elongation of the user's nipple. The determined condition of the user's breasts may be the estimated emptying of the user's chest, the determined presence or absence of RVMs, or the estimated emptying of the user's breasts and the determined presence or absence of the user's chest RMBs.

[0167] At step 240, the user is given an indication that the breast is empty. In this embodiment, an off signal is generated that turns off the breast pump. In other embodiments, an indication that the user's chest is empty may be given, and the indication may be given, for example, in the form of a visual and/or audible signal, such as a light alarm or an audible alarm. This allows the milk extraction session to end when the breast is empty or when the breast emptying has reached a level at which the user decides to end the milk extraction session. Step 240 is optional. In other embodiments, an indication of a specific state of the user's chest is provided.

[0168] Although the present invention has been illustrated and described in detail in the drawings and in the description above, such illustration and description should be considered as an illustration or example, and not as a limitation; the present invention is not limited to the disclosed embodiments.

[0169] Other variations of the described embodiments can be understood and implemented by a person skilled in the art in the implementation of the present invention in practice after reading the drawings, description and appended claims.

[0170] In the claims, the word "comprising" does not exclude the presence of other elements or steps, and singular grammatical indicators do not exclude the plural.

[0171] One block, processor or other device may satisfy the functions of several elements listed in the claims. The mere fact that certain measures are listed in mutually distinct dependent clauses does not in itself indicate that a combination of these measures cannot be used to an advantage.

[0172] Operations such as generating cycles of alternating high pressure and low pressure in the breast pad to extract milk from the user's breast, measuring the elongation of the user's nipple at a particular pressure in the breast pad during the milk extraction session, determining the condition of the user's breast based on the elongation of the nipple of the breast of the user, estimating the emptyness of the user's breasts based on the elongation of the nipple of the user's breasts, indicating a certain state of the user's breasts, indicating the emptying of the user's breasts, recording images of the nipple of the user's breasts during a milk extraction session, measuring the distance between the tip of the user's breast nipple and a fixed point opposite the tip and axially aligned with the direction in which the nipple elongates during a milk extraction session, measuring the transit time of ultrasound between the tip of the user's breast nipple and a fixed point opposite the tip and aligned along the axis with the direction in which the nipple is elongated during the milk extraction session, assessing the pressure drop in the breast pad in which the user's breast is placed during the milk extraction session, measuring the shape of the breast during the milk extraction session to improve the assessment of breast emptying, and others, performed by one or more blocks or devices may be performed by any other number of blocks or devices. These operations and/or method may be implemented as a means of computer program code and/or as specialized hardware.

[0173] A computer program may be stored/distributed on a suitable medium, such as an optical storage medium or solid state media provided with or as part of other hardware, but may also be distributed in other forms such as via the Internet, Ethernet, or other wired or wireless telecommunication systems.

[0174] All references in the claims should not be construed as limiting its scope.

[0175] The present invention relates to a device for determining the condition of the breast. The device for determining the state of the breast contains a breast pad, a unit for measuring the elongation of the nipple and a unit for determining the state of the breast. The chest pad can accommodate the user's chest. The nipple elongation measuring unit can measure the nipple elongation of a breast placed in a breast pad at a particular pressure in the breast pad during a milk extraction session. The breast condition determination unit may determine the breast condition based on the elongation of the nipple. The breast condition device may be able to assess the amount of milk remaining in the breast during a milk extraction session when the breast is empty, and whether the milk ejection reflex is present or absent in the breast.

Claims (28)

1. A device (10, ..., 10'''') for determining the state of the breast during a milk extraction session, containing: - a chest pad (16, …, 16'''') to accommodate the breast (12) of the user (14) and - block (17, ..., 17'''') measuring nipple elongation, configured to measure the elongation of the nipple (26) of the breast (12) placed in the breast pad (16, ..., 16''''), when specific pressure in the breast pad (16, …, 16'''') during the milk extraction session, and - block (20, ..., 20'''') determining the state of the breast, configured to determine the estimated emptying of the breast (12) of the user (14), the presence or absence of the milk ejection reflex, or the estimated emptying of the breast (12) of the user (14) and the presence or absence of milk ejection reflex of the breast (12) of the user (14) as the state of the breast (12) of the user (14), based on the elongation of the nipple (26) of the breast (12) of the user (14), while the breast condition determination unit comprises a memory storing breast emptying values versus nipple elongation and specific breast pad pressure, or a breast emptying evaluation function having nipple extension and specific breast pad pressure as input and breast emptying as output. 2. The device (10, …, 10'''') according to claim 1, in which the unit (20, …, 20'''') for determining the state of the breast is configured to adapt the setting of the chest pad depending on the specific state of the breast ( 12) user (14). 3. The device (10, ..., 10'''') according to claim 2, containing a block (22, 22'', 22''') indicating the state of the chest, configured to indicate to the user (14) a certain state of the chest (12 ) user (14). 4. The device (10, ..., 10'''') according to claim 3, in which the unit (17, ..., 17'''') measuring the lengthening of the nipple is configured to measure the lengthening of the nipple (26) of the breast (12), placed in the breast pad (16, …, 16''''), at a specific pressure in the breast pad (16, …, 16'''') during a milk extraction session, based on an indirect measurement. 5. The device (10, …, 10'''') according to claim 3, in which the unit (17, …, 17'''') for measuring teat lengthening comprises: - a camera (18) for recording images of the nipple (26) of the breast (12) of the user (14) during the milk extraction session, - a distance sensor (18"), located opposite the tip (27) of the nipple (26) of the breast (12) of the user (14) and aligned along the axis with the direction of the nipple extension (26) during the milk extraction session, and the sensor (18'') distance is configured to measure the distance between the distance sensor (18'') and the tip (27) of the nipple (26) of the breast (12) of the user (14) during a milk extraction session, - a pressure evaluation unit (18''') for assessing the pressure drop in the breast pad (16''') in which the breast (12) of the user (14) is placed during the milk extraction session, and/or - block (18') measuring the shape of the nipple to measure the shape of the nipple (26) of the breast (12) of the user (14) during the milk extraction session. 6. The device (10, 10', 10'', 10''') according to claim 5, in which the block (20, ..., 20'''') for determining the condition of the breast contains a memory device (36) storing at least at least one breast emptying value depending on nipple extension (26) and specific breast pad pressure (16, 16', 16'', 16'''), or breast emptying rating function having nipple extension (26) and specific pressure in chest pad (16, 16', 16'', 16''') as input and breast emptying as output. 7. Breast pump (100, …, 100'''') for extracting milk (44), containing: - a device (10, ..., 10'''') for determining the condition of the breast according to one of paragraphs. 1-6 and - a pressure source (46) communicating through the air with the chest pad (16, ..., 16'''') to generate cycles of alternating high pressure and low pressure in the chest pad (16, …, 16'''') for extracting milk (44) from the breast (12) of the user (14). 8. Breast pump (100, ..., 100'''') according to claim 7, containing a breast pump control unit (50, ..., 50'''') configured to synchronize the moment of sampling the nipple extension (26) with a specific pressure in the breast pad (16, ..., 16'''') generated by a pressure source (46), or with the possibility of providing sampling of the teat extension (26) with a sampling rate that is at least 3 times higher than the frequency of cycles of alternating increased pressure and reduced pressure in the chest pad (16, ..., 16'''') generated by the pressure source (46). 9. A method for controlling the operation of a breast pump (100, ..., 100'''') according to claim 7 during a milk extraction session, including the following steps: - generating cycles of alternating high pressure and low pressure in the breast pad (16, ..., 16'''') to extract milk (44) from the breast (12) of the user (14), - measuring the elongation of the nipple (26) of the breast (12) placed in the breast pad (16, …, 16'''') at a specific pressure in the breast pad (16, …, 16'''') during a milk extraction session , and - determining the estimated emptying of the breast (12) of the user (14), the presence or absence of the milk ejection reflex, or the estimated emptying of the breast (12) of the user (14) and the presence or absence of the milk ejection reflex of the breast (12) of the user (14) as a breast condition (12) of the user (14), based on the extension of the nipple (26) of the breast (12) of the user (14). 10. The method according to claim 9, including the step of indicating a certain state of the chest (12) of the user (14). 11. The method according to p. 10, including the following steps: - recording images of the nipple (26) of the breast (12) of the user (14) during the milk extraction session, while based on the recorded images, the elongation of the nipple (26) of the breast (12) of the user (14) is measured at a specific pressure in the breast pad (16, 16', 16'''') during a milk extraction session, - measurement of the distance between the tip (27) of the nipple (26) of the breast (12) of the user (14) and a fixed point located opposite the tip (27) and aligned along the axis with the direction of nipple extension (26) during a milk extraction session, while elongation the nipple (26) of the breast (12) of the user (14) at a specific pressure in the chest pad (16") during the milk extraction session is measured based on the measured distance between the tip (27) of the nipple (26) and the specified fixed point, - assessment of the pressure drop in the breast pad (16''') in which the breast (12) of the user (14) is placed during the milk extraction session, while elongation of the nipple (26) of the breast (12) of the user (14) at a specific pressure in breast pad (16''') during a milk extraction session is measured based on the estimated pressure drop across the breast pad (16'''), and/or - measurement of the shape of the nipple (26) during the milk extraction session, while the elongation of the nipple (26) of the breast (12) of the user (14) at a specific pressure in the breast pad (16') during the milk extraction session is measured based on the measured shape of the nipple ( 26). 12. A computer-readable medium (36) containing a computer program for controlling the operation of the breast pump (100, 100', 100'', 100''') according to claim 7 during a milk extraction session, containing program code tools that cause the processor (34) to execute ) method according to claim 9 when said computer program is started on the processor (34).

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