Monitoring system and method for monitoring milk flow during breastfeeding or milking

Abstract

A monitoring system for monitoring milk flow during breastfeeding or milking uses a flow sensor assembly to monitor the level of milk flow from different regions of the breast. A map of the level of milk flow from different regions of the breast is then generated and displayed.

Description

Technical Field

[0001] This invention relates to a monitoring system and method for monitoring milk flow during breastfeeding or during milk expression with a breast pump, particularly for detecting blocked or blocked milk ducts. Background Technology

[0002] Breastfeeding is the most natural way to feed an infant, and it is associated with numerous short- and long-term medical and neurodevelopmental advantages. It is well-known that breastfeeding significantly reduces the risk of sudden infant death syndrome (SIDS), respiratory infections, gastrointestinal infections, necrotizing enterocolitis, allergic diseases, inflammatory bowel disease, celiac disease, obesity, childhood leukemia, and lymphoma. It also improves neurodevelopmental outcomes. Therefore, the American Academy of Pediatrics strongly recommends that mothers breastfeed for one year or longer.

[0003] Beyond the obvious health benefits, breastfeeding improves the bond between mother and baby. Therefore, it is the most natural thing for women to want to breastfeed. However, breastfeeding is also associated with a number of problems. Some mothers are unable to breastfeed, breastfeeding can be painful, and mothers often find it challenging to assess whether their baby is receiving enough milk. Blocked milk ducts can cause tender or painful lumps in the breast and, in the worst cases, lead to mastitis.

[0004] One concern for mothers is that they doubt whether they have produced enough milk for their babies. Furthermore, mastitis, cracked nipples, and nipple pain are significantly associated with poor positioning and attachment, which are crucial for effective breastfeeding. These nipple conditions mean that many mothers reluctantly wean off breastfeeding prematurely.

[0005] In the breast, there are multiple milk ducts, and each of them originates from a specific area of ​​the alveoli that contain milk.

[0006] To better understand milk flow in lactating women's breasts, various technical approaches have been developed. In clinical settings, ultrasound imaging and Doppler ultrasound techniques are promising tools for studying milk flow or detecting pathological lactation in the breast. For example, US 2009 / 0054771 has proposed using Doppler ultrasound sensors integrated into wearable bras to monitor milk flow during breastfeeding. Alternatively, laser Doppler perfusion monitoring has been proposed to monitor physiological changes in breast skin perfusion during milk drainage. Nipple shields with integrated flow sensors can also be used to measure total milk flow.

[0007] For mothers, having information about milk flow is important. However, simply monitoring milk flow alone cannot help them provide better feeding for their babies or reduce potential discomfort and pain during their daily activities. Many first-time mothers or young mothers especially need support and guidance on proper breastfeeding techniques. For example, it is recommended to change breastfeeding positions so that every part of the breast is emptied. Typically, the area of ​​the breast closest to the baby's chin is emptied when the baby is latched on.

[0008] EP 3 469 980 discloses a system for determining breast fullness, thus enabling monitoring of milk consumption based on changes in fullness. A firmness sensor is used to monitor the breast and map firmness to breast fullness levels.

[0009] Geddes Donna T, “The use of ultrasound to identify milk ejection in women – tips and pitfalls,” International Breast Feeding Journal, Biomed Central Ltd, LO, XP 021059960, discloses the use of ultrasound to image the lactating breast, thereby enabling the assessment of milk duct dilation and milk flow.

[0010] Therefore, there is a need for a method and system that can help mothers breastfeed. Summary of the Invention

[0011] This invention is defined by the claims.

[0012] According to an example of one aspect of the invention, a monitoring system for monitoring milk flow during breastfeeding is provided, the monitoring system comprising:

[0013] Acoustic or optical flow sensor assembly applied to the breast to monitor milk flow levels from different areas of the breast;

[0014] Processor, used to generate milk flow level maps for different areas of the breast; and

[0015] Display device for displaying the diagram as an image representing a front view of the breast.

[0016] This system monitors milk flow within the breast. By creating a milk flow map, low-flow milk ducts can be detected early, before serious problems arise, as reduced milk flow from localized areas of the breast becomes visible. Images can, for example, be color-coded to different flow levels. The generated flow map allows for personalized guidance on how to position the baby during the next feeding period, thereby reducing the occurrence of blocked milk ducts and discomfort.

[0017] Thresholds can be applied to flow levels to enable the detection of blocked ducts.

[0018] The processor, for example, is used to generate 2D maps of milk flow levels for different regions in a 2D plane. This provides a simple and intuitive representation. The 2D plane is, for example, parallel to the front of the breastfeeding mother. Therefore, it is a representation of the front view of the breast, from which different regions can be easily identified and distinguished.

[0019] Milk flow level is, for example, the average flow per unit area for a 2D map of the breastfeeding or partial breastfeeding period. Other measurements may be used, such as peak flow or other statistical representations of flow conditions associated with each specific area.

[0020] The flow sensor assembly includes an acoustic or optical flow sensor assembly. Its purpose is to monitor flow along the mammary ducts.

[0021] In one set of examples, the flow sensor assembly includes an ultrasonic sensor, and the processor is adapted to obtain the flow level by performing Doppler ultrasound processing. This is a known method for measuring flow information within a body from an externally applied sensor.

[0022] The processor may be adapted to:

[0023] Identifying milk ducts through ultrasound image analysis;

[0024] Determine the orientation of the mammary ducts; and

[0025] Determine the flow level along the direction of the mammary duct.

[0026] In this way, milk flow information can be obtained more accurately by determining the milk flow rate along the direction of the milk duct rather than the usual flow rate, such as the milk flow rate in the usual outward direction.

[0027] The processor can also be adapted to identify the diameter of the milk ducts. In addition to flow information, this information can help identify blocked milk ducts.

[0028] The flow sensor assembly includes, for example, an array of sensor patches for application onto the breast. Using an array of sensor patches enables better resolution and accuracy of flow information across the breast region.

[0029] The processor is adapted to obtain a reference map of flow levels in different areas of the breast before initiating breastfeeding, and to generate a map of milk flow levels taking into account the reference map. This reference map serves as a calibration tool and is capable of filtering blood flow information from milk flow measurements.

[0030] The flow sensor assembly can be integrated into a bra or breast pump delivery kit. When used as part of a breast pump delivery kit, it can be used to detect the number of milk ejection reflexes (MER) or milk ejection reflexes, which can then be used to control the breast pump.

[0031] The processor can be adapted to generate recommendations for mothers based on analysis of milk flow level maps. These recommendations may identify blocked milk ducts, or milk ducts that are currently blocked, or provide information on the optimal position of the baby to optimize breastfeeding.

[0032] The present invention also provides a method for monitoring milk flow during breastfeeding, comprising:

[0033] Signals are obtained from an acoustic or optical flow sensor assembly applied to the breast and monitoring milk flow levels from different areas of the breast;

[0034] Generate a graph of milk flow levels in different regions of the breast; and

[0035] The image is shown as a representation of a front view of the breast.

[0036] The method includes, for example, generating a 2D map of milk flow levels for different regions in a 2D plane, and determining the milk flow level as the average flow per unit area for the 2D map of the breastfeeding period or the partial breastfeeding period.

[0037] This method can be implemented in software.

[0038] These and other aspects of the invention will become apparent from the embodiments described below. Attached Figure Description

[0039] To better understand the invention and to more clearly illustrate how to implement it, reference will now be made to the accompanying drawings by way of example only, wherein:

[0040] Figure 1 A monitoring system for monitoring milk flow during breastfeeding or during milk expression using a breast pump is shown.

[0041] Figure 2 This demonstrates that the flow sensor assembly can be integrated into bra-style clothing or wearable patches;

[0042] Figure 3A Doppler ultrasonic sensor for flow sensing is shown;

[0043] Figure 4 A 2D flow diagram is shown;

[0044] Figure 5 A smartphone with a smartphone application for performing processing and serving as a display is shown; and

[0045] Figure 6 A method for monitoring milk flow during breastfeeding or during milking is shown. Detailed Implementation

[0046] The invention will be described with reference to the accompanying drawings.

[0047] It should be understood that while the detailed description and specific examples illustrate exemplary embodiments of the apparatus, system, and method, they are for illustrative purposes only and are not intended to limit the scope of the invention. These and other features, aspects, and advantages of the apparatus, system, and method of the present invention will become more readily apparent from the following description, the appended claims, and the accompanying drawings. It should be understood that the drawings are merely schematic and not drawn to scale. It should also be understood that the same reference numerals are used in all the drawings to denote the same or similar parts.

[0048] This invention provides a monitoring system for monitoring milk flow during breastfeeding or milking. The system uses a flow sensor assembly to monitor milk flow levels from different areas of the breast. A map of milk flow levels from different areas of the breast is then generated and displayed.

[0049] Figure 1 A monitoring system for monitoring milk flow during breastfeeding or during milk expression using a breast pump is illustrated. The system includes a flow sensor assembly 12 applied to the breast to monitor milk flow levels from different areas of the breast. The flow sensor assembly may include a single flow sensor, but... Figure 1 The example shows an array of sensors 14 for positioning against different areas of the breast.

[0050] Milk flow levels do not need to be numerical (e.g., flow rate); they can simply be normalized to relative values, i.e., indicators of relatively high and relatively low flow rates.

[0051] Different regions are typically the 3D volume of the breast. However, as will be clear from the following discussion, it is often sufficient to consider flows associated only with (i.e., through) a region in a 2D plane that typically extends across the entire area of ​​the breast. Thus, the 2D plane can represent the top, bottom, and sides of the breast, and the flows associated with different locations within this plane are of interest.

[0052] The processor 20 generates a milk flow level map for different regions of the breast based on the signals from the flow sensor assembly. The display device 22 displays the map as an image.

[0053] The display device can be a device with a pixel array, such as a remote display device with which a processor communicates. However, it can be a simpler device, such as an LED array integrated into clothing, whereby the position of the emitting LEDs directly indicates the area below the breast, and the type of light output (e.g., color) can indicate the condition of the breast.

[0054] This system monitors milk flow within the breast. By creating a milk flow map, low-flow milk ducts can be detected early, before serious problems arise, as reduced milk flow from localized areas of the breast becomes visible. The images can be color-coded, for example, to indicate different flow levels.

[0055] Figure 2 The left figure shows that the flow sensor assembly 12 can be integrated into the bra-type garment 30. Multiple sensors 14 are used to ensure that milk flow from the entire breast volume can be measured. Instead of the bra-type garment 30, the milk flow sensor 14 can be integrated into a wearable patch 32, such as... Figure 2 As shown in the right figure. There can be one or more such patches.

[0056] Different techniques (acoustic and optical) are known to be used to measure changes in milk flow or breast skin perfusion during milk ejection.

[0057] In a preferred embodiment, a Doppler ultrasound sensor is used to measure the milk flow rate through the milk ducts.

[0058] Figure 3 A Doppler ultrasound sensor 40 with a field of view 42 covering the mammary ducts 44 of the breast 46 is shown. The measured Doppler signal depends on the direction of the milk flow relative to the direction of the ultrasound beam, such that the determined flow rate is not directly equal to the flow rate along the mammary ducts.

[0059] In one approach, using one or more sensors placed in a known position relative to the breast, and assuming the milk ducts are directed toward the nipple (which may be, for example, at the center of the ring of the ultrasound sensor 14), the measured Doppler velocity can be converted into a flow rate (e.g., milk volume per unit time) along the direction of the milk ducts.

[0060] In another approach, the orientation of the mammary ducts relative to the ultrasound sensor assembly can be determined by analyzing the acquired ultrasound images. In this case, the processor can perform both 3D ultrasound imaging and Doppler ultrasound imaging.

[0061] This makes it possible to quantitatively measure milk flow rate.

[0062] However, qualitative milk flow estimates (such as relative flow rate information or total flow rate information between different areas of the breast for breastfeeding purposes) are sufficient for generating flow maps for support and guidance purposes, as well as for detecting blocked milk ducts.

[0063] Note that the obtained flow level may not be directional at all. For example, instead of obtaining flow information directly from the Doppler signal, one can use only the amplitude of the Doppler signal (i.e., power Doppler). Directional flow information is not obtained, but this measurement depends less on the Doppler angle, thus allowing the detection of low flow velocities.

[0064] When using 3D ultrasound imaging, changes in duct diameter can be automatically obtained from the acquired ultrasound images to provide information about milk flow levels. Changes in duct diameter are physiologically related to the milk ejection reflex (MER), but not necessarily directly to milk flow. As a result, blocked ducts may still change their diameter during feeding due to MER. However, combined measurements of duct diameter from ultrasound image analysis combined with Doppler flow information can be used to accurately determine milk flow through the ducts. Blocked ducts can also be detected from the combination of detected duct diameter changes and a lack or reduction in milk flow.

[0065] Using wearable ultrasound patches means that the milk ducts are compressed less compared to measurements using conventional ultrasound transducers, thus allowing for improved milk flow monitoring.

[0066] Ultrasonic transducers are, for example, CMUT sensors or sensor arrays or PMUT sensors or sensor arrays. To ensure good acoustic coupling between the sensor assembly and the skin, an ultrasonic gel can be added. Alternatively, recently developed hydrogels can be used to guarantee good acoustic coupling.

[0067] Processor 20 is used, for example, to generate 2D maps of milk flow levels for different regions in a 2D plane. Figure 3 As shown, the sensor assembly has a field of view encompassing a vertical plane passing through the breast 46. This vertical plane is more typically parallel to the front of the breastfeeding mother (i.e., only vertical when the mother is upright). The ultrasonic transducer can be manipulated using an electron beam to adjust the orientation of the plane. Flow information through different planes can then be acquired and subsequently combined into a 2D plane.

[0068] It is possible to use an accelerometer to measure the orientation of the mother / breast, which would give some indication of breast deformation during breastfeeding, and then that can be taken into account.

[0069] Figure 4A 2D image of a grayscale image 50 with grayscale key 52 is shown. Of course, in practice, a color image and color key would be appropriate. Region 54 represents an area of ​​low milk flow, and thus indicates a potentially blocked duct. The image includes the entire breast and therefore shows the outer contour of the breast, allowing the location of different flow areas relative to the breast as a whole to be determined.

[0070] This provides a simple and intuitive representation. Therefore, it is a frontal view representation of the breast, from which different areas can be easily identified and distinguished. The 2D diagram is combined with or overlaid with a frontal view representation of the breast. In this example, the 2D diagram provides a simplified representation without requiring depth information. Specifically, Figure 4 The image provided sufficient information to the mother regarding the flow rate and to enable her to take action to resolve the issue.

[0071] As mentioned above, flow measurements from multiple sensors can be combined based on the fact that the sensors are integrated into the clothing in known relative positions. Alternatively, the positions of the individual sensors can be identified using position sensors such as gyroscopes or accelerometers or any type of beacon (e.g., infrared). These possible position sensors... Figure 1 This is shown as cell 24. However, flow maps can even be generated from a single sensor.

[0072] A flow map can be created by acquiring the average flow per unit area throughout the entire breastfeeding period or periodically during the breastfeeding period (in which case it can evolve in real time during feeding / milking). Furthermore, the average flow per unit area of ​​a 2D plane can be normalized using the total average flow.

[0073] Flow rates in different areas of the breast can be compared to detect low milk flow, which may indicate blocked milk ducts. Furthermore, thresholds can be set to identify low flow rates in specific breast areas that can be considered at risk of duct blockage. This flow map can be saved and used to monitor multiple breastfeeding periods. The average of several days' flow maps can then be used to detect a potential increase in the risk of blocked ducts.

[0074] Additional sensors, such as accelerometers or gyroscopes, can also be used to detect a baby's sucking movements. These sensors... Figure 1 This is shown as Unit 26. When used with a breast pump, the pump's vacuum level can be monitored, which indicates the movement of the breast pump's compression components.

[0075] In both cases, the determined motion can be used to process (i.e., filter) the signal obtained by the ultrasound sensor to remove noise artifacts caused by motion. The vacuum cycle of the breast pump can be used to synchronize the sampling time with the movement of the baby or the breast pump.

[0076] Augmented reality (AR) can be used to display flow maps directly onto a user's breasts using a smartphone or tablet camera, whether live or from a still image. The flow map can even be displayed directly on a bra or patch using an LED array or OLED display as described above. Therefore, any suitable display technology can be used to present the output information to the user in a way that allows for easy association between the information and the relevant area of ​​the breast.

[0077] Information from the milk flow chart can be used to provide feedback to the mother. The mother can easily locate a blocked duct by looking for lumps or hard spots in the indicated area. Suggestions on how to resolve the problem can be given, such as applying breast massage or warm compresses to the area to allow milk flow and prevent complete blockage of the duct.

[0078] Another useful method to remove blockages in the ducts is to hold a vibrating object (such as an electric toothbrush) close to the blockage against the skin. Additionally, it can provide guidance on the baby's position during breastfeeding. For example, if a low milk flow area is detected on the left side of the breast, the baby's chin should be pointed towards that area during the next feeding. The baby will empty that area during the next feeding, preventing breast tenderness and uncomfortable lumps.

[0079] Figure 5 A smartphone with a smartphone application for processing and used as a display is shown. It demonstrates that the displayed image can represent two breasts.

[0080] Therefore, the flow sensor assembly wirelessly transmits the measured signal to a smartphone, which then processes the data (or even sends it to a remote data processing center).

[0081] The image display includes a flow graph, textual descriptions 60 indicating the flow graph, a representation 62 of the appropriate breastfeeding position, and textual descriptions 64 of the appropriate breastfeeding position. This allows for personalized breastfeeding recommendations.

[0082] When the flow sensor assembly is incorporated into a breast pump system, the system can be used to detect the milk ejection reflex (MER) and the number of MER events. This can be used as part of the control system for the breast pump system.

[0083] Of course, there is blood flow in the breast, just like in any other part of the body. To further distinguish milk flow from noise caused by blood flow and movement, a first measurement of the breast can be taken before the start of breastfeeding to provide calibration. Alternatively or additionally, measurements can be taken at the start of breastfeeding but before milk flow begins, until MER is detected. This provides a reference diagram that can be extracted from the milk flow map.

[0084] This system can be used for real-time monitoring during breastfeeding. For this purpose, the flow graph can be updated periodically, for example, every period T, where T is between 1 second and 2 minutes, or for example, between 10 seconds and 1 minute. By continuously monitoring the flow, conditions such as mastitis can be detected. This can, for example, involve using machine learning (and training) to identify the evolution of the flow graph.

[0085] Personalized recommendations for feeding location, duration, etc., can also be exported using machine learning algorithms.

[0086] Figure 6 Methods for monitoring milk flow during breastfeeding or during milking are shown, including:

[0087] In step 70, a signal is obtained from a flow sensor assembly applied to the breast and monitoring milk flow levels from different areas of the breast;

[0088] In step 72, a graph of milk flow levels in different regions of the breast is generated; and

[0089] In step 74, the figure is displayed as an image.

[0090] The example above is based on a 2D graph. However, the graph can be represented as part of a 3D breast model.

[0091] This process can be performed locally or remotely.

[0092] As described above, this system utilizes a processor to perform data processing. The processor can be implemented in various ways, using software and / or hardware, to perform a variety of required functions. A processor typically employs one or more microprocessors that can be programmed using software (e.g., microcode) to perform the desired functions. A processor can be implemented as a combination of dedicated hardware for performing certain functions and one or more programmable microprocessors and associated circuitry for performing other functions.

[0093] Examples of circuits that may be used in various embodiments of this disclosure include (but are not limited to) conventional microprocessors, application-specific integrated circuits (ASICs), and field-programmable gate arrays (FPGAs).

[0094] In various implementations, a processor may be associated with one or more storage media, such as volatile and non-volatile computer memories (e.g., RAM, PROM, EPROM, and EEPROM). The storage media may be encoded with one or more programs that, when executed on one or more processors and / or controllers, perform the required functions. The various storage media may be fixed within the processor or controller, or they may be transferable, allowing one or more programs stored thereon to be loaded into the processor.

[0095] Computer programs can be stored / distributed on suitable media, such as optical or solid-state media provided with or as part of other hardware, but they can also be distributed in other forms, such as via the Internet or other wired or wireless telecommunications systems.

[0096] The mere fact that certain measures are described in mutually different dependent claims does not imply that combinations of these measures cannot be used advantageously.

[0097] By studying the accompanying drawings, the disclosure, and the appended claims, those skilled in the art can understand and implement variations of the disclosed embodiments when carrying out the claimed invention. In the claims, the word "comprising" does not exclude other components or steps, and the indefinite articles "a" or "an" do not exclude a plurality. If the term "suitable" is used in the claims or description, it should be noted that the term "suitable" is intended to be equivalent to the term "configured as." Any reference numerals in the claims should not be construed as limiting the scope.

Claims

1. A monitoring system (10) for monitoring milk flow during breastfeeding or milking, comprising: An acoustic or optical flow sensor assembly (12) is applied to the breast and has a known placement relative to the breast to monitor milk flow levels from different areas of the breast; Processor (20) for generating milk flow level maps for different regions of the breast; and Display device (22) for displaying the image as an image of the entire breast, from which different areas can be discovered and identified along with a front view representation of the entire breast.

2. The system according to claim 1, wherein the processor (20) is used to generate 2D maps of milk flow levels for different regions in a 2D plane.

3. The system of claim 2, wherein the 2D plane is parallel to the front of the breastfeeding mother.

4. The system according to claim 2 or 3, wherein the milk flow level is the average flow per unit area of ​​a 2D graph for the breastfeeding period or partial breastfeeding period.

5. The system according to any one of claims 1 to 3, wherein the flow sensor assembly (12) includes an ultrasonic sensor, and the processor (20) is adapted to obtain the flow level by performing Doppler ultrasonic processing.

6. The system according to claim 5, wherein the processor (20) is adapted to: Identifying milk ducts through ultrasound image analysis; Determine the orientation of the mammary ducts; and Determine the flow level in the direction of the milk duct.

7. The system according to claim 6, wherein the processor (20) is further adapted to identify the diameter of the mammary duct.

8. The system of claim 4, wherein the flow sensor assembly (12) includes an array of sensor patches for application onto the breast.

9. The system according to any one of claims 1 to 3, wherein the processor (20) is adapted to obtain a reference map of flow levels in different regions of the breast before initiating breastfeeding, and to generate the milk flow level map in consideration of the reference map.

10. The system according to any one of claims 1 to 3, wherein the flow sensor assembly (12) is integrated into a bra-type garment (30) or a breast pump extrusion kit.

11. The system according to any one of claims 1 to 3, wherein the processor (20) is adapted to generate recommendation information for breastfeeding mothers based on the analysis of the milk flow level map.

12. A method for monitoring milk flow during breastfeeding or milking, comprising: Based on signals obtained from an acoustic or optical flow sensor assembly applied to the breast, signals representing milk flow level maps are generated for different regions of the breast, the acoustic or optical flow sensor assembly having a known placement position relative to the breast, and monitoring milk flow levels from different regions of the breast; The image described therein is an image of the entire breast, and different areas can be identified from the image along with a front view representation of the entire breast.

13. The method of claim 12, comprising: Generate 2D maps of milk flow levels for different regions in a 2D plane, and determine the average flow rate per unit area of ​​the 2D map for use during breastfeeding or partial breastfeeding.

14. A computer program product comprising a set of computer program code, wherein when the set of computer program code is run on a computer, the set of computer program code is adapted to perform the method according to claim 12 or 13.

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