System and method for measuring human milk production

Abstract

A breast milk flow monitoring system in the form of a milk flow monitoring sensor is described and includes an electrode array and a controller. The electrodes include electrically conductive surfaces arranged to contact a skin surface of a breast. The controller generates a first excitation signal delivered via a first electrode to a first location on the breast and generates a second excitation signal delivered via the first electrode to the first location on the breast. The controller receives a first current response signal and a second current response signal. A bioimpedance spectroscopy analysis of the first current response signal and the second current response signal is performed, where the bioimpedance spectroscopy analysis is calibrated for breast milk flow. A breast milk flow parameter is determined based on the bioimpedance spectroscopy analysis.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 224,851, filed July 22, 2021, and U.S. Patent Application No. 17 / 870,497, filed July 21, 2021, the disclosures of which are incorporated herein by reference.

[0003] introduction

[0004] Milk production during lactation is a key parameter for infant nutrition and growth. Known methods for measuring milk production include monitoring ancillary parameters, such as infant weighing protocols. However, such methods are inconvenient, difficult to implement, slow, and have low resolution.

[0005] Reliable information regarding the nutrition of breastfed infants is still needed without compromising the convenience and health of the mother or the infant. Summary of the Invention

[0006] The concepts described herein generally relate to systems, devices, and methods for dynamically monitoring the flow of milk expressed from the breast during infant feeding or pumping.

[0007] One aspect of this disclosure may include a breast milk flow monitoring system in the form of a breast milk flow monitoring sensor, the sensor comprising: an electrode array including a first electrode, a second electrode, a third electrode, and a fourth electrode; and a controller. The first, second, third, and fourth electrodes include conductive surfaces arranged to contact the skin surface of the breast. The controller communicates with the first, second, third, and fourth electrodes; and operates to generate a first excitation signal transmitted via the first electrode to a first location on the breast, generate a second excitation signal transmitted via the first electrode to the first location on the breast, receive a first current response signal in response to the first excitation signal via one of the second, third, and fourth electrodes, receive a second current response signal in response to the second excitation signal via the first electrode, and perform bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, and the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow. Breast milk flow parameters are determined based on the bioimpedance spectroscopy analysis.

[0008] One aspect of this disclosure may include a first excitation signal that is a low-frequency excitation signal, and wherein the second excitation signal is a high-frequency excitation signal.

[0009] Another aspect of this disclosure may include controller operation to determine a ratio of a first current response signal to a second current response signal; and performing a bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow.

[0010] Another aspect of this disclosure may include Fourier transform analysis of bioimpedance spectroscopy to determine breast milk flow parameters by controlling the controller to perform a ratio of a first current response signal to a second current response signal.

[0011] Another aspect of this disclosure may include frequency response analysis of bioimpedance spectroscopy to determine breast milk flow parameters by performing controller operation to perform a ratio of a first current response signal to a second current response signal.

[0012] Another aspect of this disclosure may include adaptive filter analysis of bioimpedance spectroscopy to determine breast milk flow parameters by operating the controller to perform a ratio of a first current response signal to a second current response signal.

[0013] Another aspect of this disclosure may include the controller operating to determine a first parameter associated with at least one of impedance (z), reactance (Xc), resistance (R), and phase (Ph) of a first current response signal; to determine a second parameter associated with at least one of impedance (z), reactance (Xc), resistance (R), and phase (Ph) of a second current response signal; to determine a ratio of the first parameter to the second parameter; and to determine a breast milk flow parameter based on the ratio of the first parameter to the second parameter.

[0014] Another aspect of this disclosure may include a low-frequency excitation signal less than a high-frequency excitation signal, wherein the high-frequency excitation signal is less than 1000 kHz, and wherein the low-frequency excitation signal is greater than 3 kHz.

[0015] Another aspect of this disclosure may include a low-frequency excitation signal that is a single-frequency sine wave with a frequency less than 50 kHz.

[0016] Another aspect of this disclosure may include a high-frequency excitation signal that is a single-frequency sine wave with a frequency between 50 kHz and 1000 kHz.

[0017] Another aspect of this disclosure may include a low-frequency excitation signal that is a single-frequency sine wave with a frequency less than 50 kHz.

[0018] Another aspect of this disclosure may include a high-frequency excitation signal that is a single-frequency sine wave with a frequency between 50 kHz and 1000 kHz.

[0019] Another aspect of this disclosure may include a first excitation signal being a first broadband sine wave, and wherein a second excitation signal is a second broadband sine wave.

[0020] Another aspect of this disclosure may include a first electrode arranged to contact the surface of the breast at one of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola; and a second electrode arranged to contact the surface of the breast at another of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola.

[0021] Another aspect of this disclosure may include a third electrode arranged to contact the surface of the breast at one of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola; and a fourth electrode arranged to contact the surface of the breast at another of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola.

[0022] Another aspect of this disclosure may include fixing a first electrode, a second electrode, a third electrode, and a fourth electrode onto a flexible substrate.

[0023] Another aspect of this disclosure may include a fitting support, wherein a milk flow monitoring sensor is fixed to the fitting support; and wherein the fitting support is arranged to position a first electrode, a second electrode, a third electrode, and a fourth electrode in contact with the skin surface of the breast.

[0024] Another aspect of this disclosure may include a temperature sensor fixed to a fitting bracket and arranged to monitor the temperature of the breast; wherein the controller operates to receive an input signal from a temperature corresponding to the temperature of the breast, and to determine breast milk flow parameters based on a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and bioimpedance spectroscopy analysis of the breast temperature.

[0025] Another aspect of this disclosure may include a motion sensor fixed to a fitting bracket and arranged to monitor physical motion; wherein the controller operates to receive an input signal associated with physical motion near the motion sensor and to determine breast milk flow parameters based on a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and bioimpedance spectroscopy analysis of the physical motion.

[0026] Another aspect of this disclosure may include a motion sensor, such as an accelerometer.

[0027] Another aspect of this disclosure may include a motion sensor being a plurality of accelerometers, wherein the plurality of accelerometers correspond to a first electrode, a second electrode, a third electrode, and a fourth electrode.

[0028] Another aspect of this disclosure may include one of a plurality of accelerometers arranged to monitor overall body motion, and wherein one of the plurality of accelerometers is arranged to monitor breast motion.

[0029] Another aspect of this disclosure may include a strain gauge fixed to a fitting support near the skin surface of the breast; wherein the controller operates to receive input signals from the strain gauge and determine breast milk flow parameters based on bioimpedance spectroscopy analysis of a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and the input signals from the strain gauge.

[0030] Another aspect of this disclosure may include a cellular device including an executable application that communicates with a cloud environment; wherein the cellular device is configured to receive breast milk flow parameters from a controller, wherein the cellular device is configured to transmit the breast milk flow parameters to the cloud environment, and wherein the cellular device is configured to visually display the breast milk flow parameters.

[0031] Another aspect of this disclosure may include a breast milk flow monitoring system comprising: a breast milk flow monitoring sensor including an electrode array including a first electrode, a second electrode, a third electrode, and a fourth electrode; and a controller; wherein the first electrode, the second electrode, the third electrode, and the fourth electrode include conductive surfaces arranged to contact the skin surface of the breast; wherein the controller communicates with the first electrode, the second electrode, the third electrode, and the fourth electrode; and wherein the controller operates to: generate a first excitation signal transmitted via the first electrode to a first location on the breast, wherein the first excitation signal is calibrated for breast milk flow; generate a second excitation signal transmitted via the first electrode to the first location on the breast, wherein the second excitation signal is calibrated for breast milk flow; receive a first current response signal in response to the first excitation signal via one of the second electrode, the third electrode, and the fourth electrode; receive a second current response signal in response to the second excitation signal via said one of the second electrode, the third electrode, and the fourth electrode; perform bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, and the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow; and determine breast milk flow parameters based on the bioimpedance spectroscopy analysis.

[0032] The foregoing summary is not intended to represent every possible implementation or aspect of this disclosure. Rather, the foregoing summary is intended to illustrate some novel aspects and features disclosed herein. The foregoing features and advantages, as well as other features and advantages, will become apparent from the following detailed description of representative implementations and modes for carrying out this disclosure, taken in conjunction with the accompanying drawings and claims. Attached Figure Description

[0033] One or more embodiments will now be described by way of example with reference to the accompanying drawings, wherein:

[0034] Figure 1 The schematic illustration shows elements of a breast milk flow monitoring system according to the present disclosure, which includes a milk flow monitoring sensor that communicates with a controller, wherein the controller communicates with a user application and / or a cloud environment.

[0035] Figure 2 and Figure 3 The illustration shows the components of a breast milk flow monitoring system according to the present disclosure, which includes a breast milk flow monitoring sensor that communicates with a controller and is attached to clothing.

[0036] Figure 4 An embodiment of a breast milk flow monitoring system according to the present disclosure is illustrated, the breast milk flow monitoring system including a milk flow monitoring sensor arranged on an adjustable belt.

[0037] Figure 5 and Figure 6 An embodiment of a breast milk flow monitoring system according to the present disclosure is illustrated, the breast milk flow monitoring system including a milk flow monitoring sensor arranged on a truncated conical support.

[0038] Figure 7 and Figure 8 An embodiment of a breast milk flow monitoring system according to the present disclosure is illustrated, the breast milk flow monitoring system including a milk flow monitoring sensor arranged on a truncated conical support.

[0039] Figure 9 The illustration shows a front view of the torso of a human female body, including multiple anatomical landmarks, according to this disclosure.

[0040] Figure 10 A flowchart according to this disclosure is illustrated schematically.

[0041] The accompanying drawings are not necessarily drawn to scale, but may present a slightly simplified representation of the various preferred features disclosed herein, including, for example, specific dimensions, orientations, positions, and shapes. Details associated with these features will be determined in part by the specific intended application and environment of use. Detailed Implementation

[0042] As described and shown herein, the components of the disclosed embodiments can be arranged and designed in a variety of different configurations. Therefore, the following detailed description is not intended to limit the scope of the claimed disclosure, but only represents possible embodiments thereof. Furthermore, while numerous specific details are set forth in the following description to provide a thorough understanding of the embodiments disclosed herein, some embodiments may be practiced without some of these details. Moreover, for clarity, certain technical materials understood in the relevant art have not been described in detail to avoid unnecessarily obscuring this disclosure.

[0043] Furthermore, the accompanying drawings are in a simplified form. For convenience and clarity only, directional terms such as top, bottom, left, right, upper, above, above, below, lower, back, and front may be used relative to the drawings. These and similar directional terms should not be construed as limiting the scope of this disclosure. Moreover, as shown and described herein, this disclosure may be practiced without the presence of elements not specifically disclosed herein.

[0044] The following detailed description is merely exemplary in nature and is not intended to limit application or use. Furthermore, it is not intended to be bound by any express or implied theory presented herein. In all the accompanying drawings, corresponding reference numerals denote similar or corresponding parts and features.

[0045] As used herein, the term "system" can refer to one or a combination of mechanical and electrical actuators, sensors, controllers, application-specific integrated circuits (ASICs), combinational logic circuits, software, firmware, and / or other components arranged to provide the described functionality.

[0046] This document describes implementations based on functional and / or logical block components and various processing steps. Such block components can be implemented by any number, combination, or set of mechanical and electrical hardware, software, and / or firmware components configured to perform specified functions. For example, implementations can employ various combinations of mechanical and electrical components, integrated circuit components, memory elements, digital signal processing elements, logic elements, lookup tables, etc., which can perform various functions under the control of one or more microprocessors or other control devices. Furthermore, those skilled in the art will understand that implementations can be practiced by combining any number of mechanical and / or electronic systems.

[0047] For the sake of brevity, this document may not describe the conventional components and technologies, as well as other functional aspects (and the various operating components of the system) of the system in detail. Furthermore, the connecting lines shown in the various figures included herein are intended to illustrate exemplary functional relationships and / or physical couplings between the various elements. Many alternative or additional functional relationships or physical connections may exist in implementations.

[0048] The concepts described herein provide a breast milk flow monitoring system comprising a milk flow monitoring sensor consisting of one or more electrode pairs or electrode arrays and a controller. The electrode pairs(s) may communicate with the controller via a wiring harness comprising one or more cables. In some embodiments, the milk flow monitoring sensor further includes a temperature sensor and / or a motion sensor, such as an inertial monitoring unit (IMU) comprising one or more accelerometers.

[0049] The breast milk flow monitoring system uses a controller and a milk flow monitoring sensor to measure the resistance between electrodes caused by subcutaneous tissue or fluid under the skin, mammary glands, and the milk contained therein, analyzed using bioimpedance spectroscopy. Bioimpedance refers to the measurement of the resistance of living tissue in response to an externally applied current.

[0050] As milk flows, sprays, is sucked out, or expressed from the breast, the bioimpedance value changes with the fluid leaving the breast. Bioimpedance values ​​can be calibrated to indicate the level of milk in the breast and the amount of milk leaving the breast through suction or feeding, and also to indicate milk replenishment in the breast between feedings.

[0051] Each electrode pair of the breast milk flow monitoring sensor has a first electrode for transmitting an excitation signal and a second electrode for receiving a current response signal. Each electrode array of the breast milk flow monitoring sensor has a first electrode for transmitting an excitation signal and one or more electrodes for receiving a current response signal. Each electrode includes a conductive surface for contact with the skin surface of the breast. The controller operates to generate an excitation signal, which is transmitted to the breast via the first electrode. The excitation signal is calibrated for breast milk flow. The controller receives a current response signal in response to the excitation signal via the second electrode and performs bioimpedance spectroscopy analysis using the excitation signal and the current response signal. The bioimpedance spectroscopy analysis is calibrated for breast milk flow. The controller determines breast milk flow parameters based on the bioimpedance spectroscopy analysis.

[0052] The process of generating excitation signals, receiving current response signals, and performing bioimpedance spectroscopy analysis can be repeated multiple times during an infant feeding event.

[0053] The breast milk flow monitoring system can be activated by some form of triggering mechanism (including but not limited to pressing a button on the controller) or by voice activation.

[0054] The electrodes of the milk flow monitoring sensor can be embedded, adhered to, or otherwise physically attached to a support formed of a material molded to fit onto and directly contact a portion of the surface of the breast, such as being positioned on, attached to, or placed between the breast and a bra or bralette, breast shield, breast pump funnel, or otherwise operatively attached to the surface skin of the breast. The substrate of the support can be silicon or other inert, non-reactive materials suitable for placement on the skin.

[0055] The accompanying drawings are provided only to illustrate certain embodiments and not to limit the scope of the embodiments. Figure 1 The components of a breast milk flow monitoring system 100 are schematically shown. The system includes a milk flow monitoring sensor 10 in communication with a controller 50. The controller 50 is capable of processing signals from the milk flow monitoring sensor 10 and performing bioimpedance spectroscopy analysis to determine breast milk flow parameters. The controller 50 includes input / output and signal processing circuitry 52, a memory device 54 storing one or more executable algorithms, collected data, and one or more calibrated data, and a processor 56.

[0056] Alternatively or additionally, the breast milk flow monitoring system 100 may be calibrated to take into account extracellular and intracellular fluid movements in the breast other than milk, which may include water or blood, wherein such movements are associated with breast milk flow.

[0057] In one embodiment, the milk flow monitoring sensor 10 includes a sensor array corresponding to a first electrode pair 20 and a second electrode pair 30, which may be arranged on flexible substrates 24, 34, which may be placed in a bonding support (not in...). Figure 1 (As shown in the figure). The milk flow monitoring sensor 10 employs two electrode pairs 20 and 30. Alternatively, the milk flow monitoring sensor 10 may employ a single electrode pair. Alternatively, the milk flow monitoring sensor 10 may, without limitation, employ three, four, or five electrode pairs, etc. Alternatively, the milk flow monitoring sensor 10 may employ three, four, five, or six electrodes arranged separately.

[0058] The first electrode pair 20 includes a first electrode 21 and a second electrode 22, and the second electrode pair 30 includes a third electrode 31 and a fourth electrode 32.

[0059] The first electrode 21, the second electrode 22, the third electrode 31, and the fourth electrode 32 are arranged to be in direct contact with the skin surface of the lactating breast to maximize surface contact and signal coupling and conductivity with the skin surface. Direct contact between the respective electrodes and the proximal skin surface can be achieved via dry contact or via an inserted conductive gel.

[0060] The first electrode 21, the second electrode 22, the third electrode 31, and the fourth electrode 32 are arranged to contact, adhere to, or otherwise dock with the skin to transmit and / or receive electrical signals, and may be made of stainless steel, silver, metal alloys, or other materials without limitation. The first electrode 21, the second electrode 22, the third electrode 31, and the fourth electrode 32 may be dry electrodes, wet electrodes, semi-dry electrodes, or combinations thereof.

[0061] Each of the first electrode 21, the second electrode 22, the third electrode 31, and the fourth electrode 32 communicates with the controller 50. In one embodiment, as shown, the first electrode 21, the second electrode 22, the third electrode 31, and the fourth electrode 32 communicate with the controller 50 via cable 15. Alternatively, one or more of the first electrode 21, the second electrode 22, the third electrode 31, and the fourth electrode 32 may communicate wirelessly with the controller 50.

[0062] In one embodiment, the flexible substrate 24 includes a first electrode 21 and a third electrode 31, and the flexible substrate 34 includes a second electrode 22 and a fourth electrode 32.

[0063] In one embodiment, the milk flow monitoring sensor 10 includes a temperature sensor 18 disposed on one of the flexible substrates 24, 34 to be in direct contact with the skin surface of the breast.

[0064] In one embodiment, the milk flow monitoring sensor 10 includes a motion sensor 16. In one embodiment, the motion sensor 16 is an inertial measurement unit (IMU) including one or more accelerometers, disposed on one of the flexible substrates 24, 34 for direct contact with the skin surface of the breast. In one embodiment, a single motion sensor 16 may be used. In one embodiment, multiple motion sensors 16 may be used, wherein the multiple motion sensors 16 are implemented adjacent to or integrated with one of the first electrode 21, second electrode 22, third electrode 31, and fourth electrode 32. The motion sensor 16 may not be limited to a piezoelectric accelerometer, a piezoresistive membrane, or other motion sensing device capable of sensing vibrations, motion artifacts, etc.

[0065] Motion sensor 16 monitors the physical movement of the breast, which may be motion artifacts indicating infant nursing or suckling. When multiple motion sensors 16 are used, they can be arranged, configured, and / or calibrated to measure different movements. As a non-limiting example, a first motion sensor of the multiple motion sensors 16 may be arranged on a support to monitor the overall body movement of the nursing mother, a second motion sensor of the multiple motion sensors 16 may be arranged to monitor breast movement due to nursing, and other sensors of the multiple motion sensors 16 may be arranged to monitor other vibrations and / or movements.

[0066] The milk flow monitoring sensor 10 has minimal components and can be positioned non-invasively over the nipple region of the breast, thus not interfering with the breastfeeding infant. The positioning of the milk flow monitoring sensor 10 on the breast is flexible, thus adaptable to a range of breast sizes and structures. Furthermore, the milk flow monitoring sensor 10 can be used with nipple shields or other devices. (See reference...) Figure 9 An example location for locating the milk flow monitoring sensor 10 is shown and described.

[0067] As described in more detail herein, controller 50 includes algorithms, calibration, and other signal processing capabilities to generate one or more excitation signals, which are transmitted to a first electrode 21 of the first electrode pair 20 and a third electrode 31 of the second electrode pair 30. Controller 50 receives one or more current response signals via a second electrode 22 of the first electrode pair 20 and a fourth electrode 32 of the second electrode pair 30. In one embodiment, the first excitation signal transmitted to the first electrode 21 of the first electrode pair 20 may occur simultaneously with a second excitation signal transmitted to the third electrode 31 of the second electrode pair 30. Alternatively, in one embodiment, the first excitation signal transmitted to the first electrode 21 of the first electrode pair 20 may alternate with the second excitation signal transmitted to the third electrode 31 of the second electrode pair 30.

[0068] In one embodiment, the controller 50 operates to generate a first excitation signal transmitted to a first location on the breast via a first electrode 21, wherein the first excitation signal is calibrated for breast milk flow. The controller 50 receives a first current response signal in response to the first excitation signal via one or more of a second electrode 22, a third electrode 31, and a fourth electrode 32.

[0069] The controller 50 then generates a second excitation signal transmitted to a first position on the breast via the first electrode 21, wherein the second excitation signal is also calibrated for breast milk flow. The controller 50 receives a second current response signal in response to the first excitation signal via one or more of the second electrode 22, the third electrode 31, and the fourth electrode 32.

[0070] In one embodiment, the first excitation signal is a low-frequency excitation signal, and the second excitation signal is a high-frequency excitation signal. In one embodiment, the low-frequency excitation signal is a single-frequency sine wave with a frequency less than 50 kHz, and the high-frequency excitation signal is a single-frequency sine wave with a frequency between 50 kHz and 1000 kHz. Alternatively, the first excitation signal is a broad-spectrum sine wave covering the low-frequency range, and the second excitation signal is a broad-spectrum sine wave covering the high-frequency range.

[0071] The controller 50 performs bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, and the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow rate to determine breast milk flow rate parameters. In one embodiment, this includes the controller 50 determining the ratio of the first current response signal to the second current response signal and performing bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow rate to determine breast milk flow rate parameters.

[0072] Bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal may include determining a parameter associated with at least one of impedance (z), reactance (Xc), resistance (R), and phase (Ph) based on the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal, and determining a breast milk flow parameter based on said at least one of impedance (z), reactance (Xc), resistance (R), and phase (Ph).

[0073] In one embodiment, the first excitation signal transmitted to the first electrode 21 of the first electrode pair 20 may be in the form of a low-frequency sine wave lasting less than 100 ms, wherein the low-frequency waveform is less than 50 kHz. In one embodiment, the second excitation signal transmitted to the second electrode 31 of the second electrode pair 30 may be in the form of a high-frequency sine wave lasting less than 100 ms, wherein the high-frequency waveform is between 50 kHz and 1000 kHz.

[0074] The first and second current response signals received via the second electrode 22, the third electrode 31, and the fourth electrode 32 represent the current that has passed through the intermediate breast tissue and skin tissue and originates from the first electrode. When available, temperature input from the temperature sensor 18 and parameters associated with the physical movement of the breast are also monitored.

[0075] Controller 50 performs bioimpedance spectroscopy analysis of one or more excitation signals and one or more current response signals, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow. In one embodiment, the bioimpedance spectroscopy analysis calibrated for breast milk flow may include measuring the current passing through breast tissue at various excitation voltage frequencies in the form of electrical cell-substrate impedance sensing (ECIS). Controller 50 then determines breast milk flow parameters based on the bioimpedance spectroscopy analysis. This operation may be performed multiple times during a single breastfeeding event.

[0076] Figure 2 and Figure 3 The diagram illustrates the reference. Figure 1 The milk flow monitoring sensor 10 described is an element of an embodiment similar to the milk flow monitoring sensor 210, which includes at least one electrode pair 220 and a controller 250. In one embodiment, the milk flow monitoring sensor 210 may include a temperature sensor 218 and / or, in another embodiment, may include one or more motion sensors 216. Alternatively or additionally, the milk flow monitoring sensor 210 may include one or more strain gauges.

[0077] A milk flow monitoring sensor 210 is attached to wearable clothing, such as a nursing bra 200 in one embodiment. A nursing infant 224 is also shown. The nursing bra 200 includes a support portion 236 supporting cups 230, which consist of cup frames 232 and removable plates 234. The milk flow monitoring sensor 210 is attached to each cup frame 232 in a defined position to facilitate the placement of electrode pairs 221, 222 so that they are in direct physical contact with the skin of the breast 240. A controller 250 may be attached to the support portion 236. The milk flow monitoring sensor 210 and the controller 250 are removable to facilitate cleaning of the nursing bra 200. As shown, the milk flow monitoring sensor 210 is attached to the right side of the nursing bra 200 for monitoring the right breast. A second milk flow monitoring sensor (not shown) will be attached to the left side of the nursing bra 200 to monitor the left breast and communicate with the controller 250.

[0078] The controller 250 transmits information from the milk flow monitoring sensor 210, including total milk flow mass or volume, body temperature, activity, time, date, duration of feeding, and other data. The breastfeeding mother can add additional information (parent input 252), such as the infant's weight after feeding, weight changes, infant condition (e.g., alertness, drowsiness, irritability, etc.), diaper status, and other information. Other information may also be transmitted from a third party (third-party input 254). This information may include information from the current feeding period, historical data, daily analysis, trend data, comparative analysis, etc. The aforementioned information can be analyzed to identify trends, outliers, etc., and transmitted to the parent via a dedicated application on a mobile phone, tablet, or other device (270). The aforementioned information can also be analyzed to identify trends, outliers, etc., and transmitted to a medical professional or other consultant via a dedicated application on a mobile phone, tablet, or other device (280). Analysis of bioimpedance data can be performed in real time and / or offline. Bioimpedance data is acquired during milking and aggregated with other data in the controller 260 or in a cloud environment.

[0079] Figure 4 The diagram illustrates the reference. Figure 1 The described breast milk flow monitoring system 100 is similar to an embodiment of the breast milk flow monitoring system 400, which includes a milk flow monitoring sensor 410 communicating with a controller 450 via a wiring cable 415. In this embodiment, the milk flow monitoring sensor 410 is arranged on an adjustable belt 412, which may be substantially conical in shape and have fasteners 414 to facilitate adjustment of the length of the adjustable belt 412 and thus the diameter of the adjustable belt 412. The milk flow monitoring sensor 410 includes a first electrode pair 420 and a second electrode pair 430, respectively having electrodes 421, 422, 431, and 432. In one embodiment, the milk flow monitoring sensor 410 may include a temperature sensor 418 and / or, in another embodiment, may include one or more motion sensors 416. Alternatively or additionally, the milk flow monitoring sensor 410 may include one or more strain gauges.

[0080] The adjustable length and, consequently, diameter of the adjustable band 412 allow the milk flow monitoring sensor 410 to adapt to different breast sizes. The adjustable band 412 is made of silicone or other materials using extrusion, molding, or other methods. The milk flow monitoring sensor 410 is configured to be placed directly on the breast skin in an arrangement that allows the electrodes of the first electrode pair 420 and the second electrode pair 430 to be in direct contact with the breast skin without interfering with infant feeding.

[0081] Figure 5 and Figure 6 Schematic illustration of the reference Figure 1 The described breast milk flow monitoring system 100 is similar to an embodiment of the breast milk flow monitoring system 500, which includes a milk flow monitoring sensor 510 communicating with a controller 550 via a wiring cable 515. In this embodiment, the milk flow monitoring sensor 510 is arranged on a frustoconical support 512, which has a hole 514 at its distal end. The hole 514 provides an opening through which the nipple, areola, and distal end of the breast can protrude, thereby allowing infant feeding. The frustoconical support 512 is made of silicone or other flexible material and can be formed by molding, extrusion, or other forming methods.

[0082] The milk flow monitoring sensor 510 includes a first electrode pair 520 and a second electrode pair 530, each having electrodes 521, 522, 531, and 532. In one embodiment, the milk flow monitoring sensor 510 may include a temperature sensor 518 and / or a motion sensor 516. The electrodes 521, 522, 531, and 532, the temperature sensor 518, and the motion sensor 516 may be molded, attached, or otherwise attached to the frustoconical support 512 in a manner that allows them to contact the breast skin at a target location.

[0083] Figure 7 and Figure 8 Schematic illustration of the reference Figure 1 The described breast milk flow monitoring system 100 is similar to an embodiment of the breast milk flow monitoring system 700, which includes a milk flow monitoring sensor 710 communicating with a controller 750 via a wiring cable 715. In this embodiment, the milk flow monitoring sensor 710 is arranged on a frustoconical bracket 712, which has a hole 714 at its distal end. The hole 714 provides an opening through which only the nipple can protrude, thereby allowing infant feeding. The frustoconical bracket 712 is made of silicone or other flexible material.

[0084] The milk flow monitoring sensor 710 includes a first electrode pair 720 and a second electrode pair 730, correspondingly having electrodes 721, 722, 731, and 732. In one embodiment, the milk flow monitoring sensor 710 may include a temperature sensor 718 and / or a motion sensor 716. The electrodes 721, 722, 731, and 732, the temperature sensor 718, and the motion sensor 716 may be molded, attached, or otherwise attached to a tapered support 712 in a manner that enables contact with the breast skin at a target location. In one embodiment, the milk flow monitoring sensor 710 may include a temperature sensor 718 and / or, in another embodiment, may include one or more motion sensors 716. Alternatively or additionally, the milk flow monitoring sensor 710 may include one or more strain gauges or piezoelectric sensors.

[0085] Figure 9A schematic front view of a female torso is shown, including a breast 900 with a nipple 909 and an areola 910, and multiple anatomical landmarks identifiable on its surface. These anatomical landmarks describe the potential target locations of the electrodes of the electrode pairs or electrode arrays employed in one embodiment of the milk flow monitoring sensor described herein. The anatomical landmarks include an upper medial location 901 away from the areola, a lower medial location 902 away from the areola, a lower lateral location 903 away from the areola, an upper lateral location 904 away from the areola, an upper medial location 905 near the areola, a lower medial location 906 near the areola, a lower lateral location 907 near the areola, and an upper lateral location 908 near the areola. As used herein, the terms “away” and “near” refer to the relative distance of the exemplary location on the skin surface of the breast relative to the areola 910. For example, proximal positions 905, 906, 907, and 908 on the skin surface of breast 900 are closer to the areola 909 than distal positions 901, 902, 903, and 904 on the skin surface of breast 900. Distal positions 901, 902, 903, and 904 on the skin surface of breast 900 are farther from the areola 901 than proximal positions 905, 906, 907, and 908 on the skin surface of breast 900. Furthermore, in one embodiment, the distances of the proximal positions 905, 906, 907, and 908 from the areola 901 can all be the same. Alternatively, the distances from the areola 901 can differ for each of the proximal positions 905, 906, 907, and 908. Similarly, in one embodiment, the distances of the distal positions 901, 902, 903, and 904 from the areola 901 can all be the same. Alternatively, the distance from the areola 901 may differ for each of the distal positions 901, 902, 903, and 904. Furthermore, the proximal positions 905, 906, 907, and 908 and the distal positions 901, 902, 903, and 904 are shown oriented along lines at 45 degrees, 135 degrees, 225 degrees, and 315 degrees relative to a common plane defined as parallel to the chest wall; however, the concept of electrode placement is not limited to this. Placement may be in other orientations determined during calibration or other events to optimize or maximize signal integrity from the electrodes.

[0086] In one embodiment, the first electrode of the electrode pair or electrode array is arranged to contact the skin surface of the breast 900 at one of the following locations: an upper inner position 901 away from the areola, a lower inner position 902 away from the areola, a lower outer position 903 away from the areola, an upper outer position 904 away from the areola, an upper inner position 905 near the areola, a lower inner position 906 near the areola, a lower outer position 907 near the areola, and an upper outer position 908 near the areola. In this embodiment, the second electrode of the electrode pair or electrode array is arranged to contact the skin surface of the breast at another of the following locations: an upper inner position 901 away from the areola, a lower inner position 902 away from the areola, a lower outer position 903 away from the areola, an upper outer position 904 away from the areola, an upper inner position 905 near the areola, a lower inner position 906 near the areola, a lower outer position 907 near the areola, and an upper outer position 908 near the areola.

[0087] The electrodes of each electrode pair or electrode array may be placed in a common plane defined by being parallel to the chest wall, orthogonal to the chest wall, along a line defined by a transverse axis, or along a line defined by a longitudinal axis. Alternatively, the electrodes of each electrode pair or electrode array may be placed in an inclined plane relative to the chest wall, or inclined relative to the transverse axis, or inclined relative to the longitudinal axis. Examples of common planes include parallel planes containing positions 901, 902, 903, and 904; parallel planes containing positions 905, 906, 907, and 908; orthogonal planes containing positions 901 and 904; orthogonal planes containing positions 903 and 904; orthogonal planes containing positions 904 and 906; orthogonal planes containing positions 903 and 905; orthogonal planes containing positions 905 and 906; inclined planes containing positions 901, 904, 905, and 908; inclined planes containing positions 901, 904, 906, and 907; and inclined planes containing positions 903, 904, 905, and 906. Examples of common planes defined by the locations provided herein are illustrative and non-limiting, and it should be understood that electrode pairs may be placed on the surface of the breast skin at locations other than the exemplary locations shown in the accompanying drawings, and in common planes that may be parallel to, orthogonal to, or inclined to the chest wall, in addition to the exemplary common planes described herein.

[0088] The positioning of the milk flow monitoring sensor on the breast can be indicated by commands uploaded to a software application on a handheld device such as a smartphone or tablet, or by light projected onto the breast to indicate correct or incorrect positioning, or by a visual indicator on the phone that uses an onboard camera and still photos or videos of the milk flow monitoring sensor on the breast to assess electrode position. Assistive positioning devices can be used to position or delineate the electrodes in an acceptable location. Computer vision algorithms can be used in conjunction with a breast motion monitor to indicate correct or incorrect positioning displayed in real time on images or videos of the breast.

[0089] During operation, controller 50 generates an excitation signal for breast milk flow calibration. The controller transmits the excitation signal to the surface of the breast via a first electrode.

[0090] The second electrode of the milk flow monitor monitors the current response signal in response to the excitation signal transmitted to the breast skin via the first electrode. Bioimpedance spectroscopy analysis considers the resistance of the tissue or subcutaneous fluid beneath the skin, the mammary glands, and the milk contained therein. As milk flows from, sprays out, is suctioned, or expressed from the breast, the bioimpedance value changes with the fluid leaving the breast. Bioimpedance values ​​can be calibrated to indicate the level of milk in the breast and the amount of milk leaving the breast through suction or infant feeding.

[0091] Figure 10 Schematic illustration of the reference Figures 1 to 8 The flowchart 950 associated with the described implementation of the breast milk flow monitoring system illustrates the actions and information flow related to determining the breast milk flow in use using the implementation of the breast milk flow monitoring system.

[0092] Before breastfeeding or pumping, in response to oxytocin release and other factors, breast milk will accumulate near the nipple area within the breast (step 951). The breast milk flow monitoring system is positioned on the breast directly or via a pump interface or shield (step 952), and milk flow is initiated upon feeding or pumping, with the milk flow monitoring sensor periodically capturing data (step 953).

[0093] The milk flow monitoring system may include an automatic trigger to initiate milk flow monitoring upon detection of milk flow. Alternatively, the milk flow monitoring system may have a manually operated trigger initiated by the breastfeeding mother. The manually operated trigger may be included on the physical controller 50 or as part of a user application running on a handheld device.

[0094] When milk flow begins due to suction (step 960), milk is captured by a breast pump retainer or bottle (step 961), and the captured milk volume and / or milk mass is measured and recorded (step 962).

[0095] When milk flow begins due to feeding (step 980), the infant drinks the milk directly (step 981), and the infant's quality and other data can be obtained after feeding (step 982). Other data may include, but are not limited to, the infant's weight, weight changes, the infant's condition (e.g., alertness, drowsiness, irritability, etc.), the mother's interpretation of the actual feeding time, and whether the infant drank breast milk during feeding.

[0096] Bioimpedance data analysis can be performed in real time and / or offline (step 970). Bioimpedance data is captured during milking and aggregated in the controller or cloud environment along with other data, as well as data from cases 960 and 980 (step 971). Data from steps 960, 980, and 970 are used to fine-tune the calibration formula (step 972).

[0097] Analysis of bioimpedance data acquired during milking can be combined with other data used for calibration improvements and aggregated in the controller or cloud environment.

[0098] Information acquired and / or exported during feeding is transmitted to the breastfeeding mother and / or other persons via one or more user interfaces defined by the user application and can be accessed via mobile phones, tablets, computers, etc. The output information may include information from each breast (left or right) during the current feeding period, historical data, daily analysis, trend data, comparative analysis, etc. (Step 983).

[0099] Data from steps 962, 982, and 971 can be transferred from the controller to a cloud environment for analysis, calibration, etc. (Step 983). Sensor and / or bioimpedance data can be correlated in a database with one or more of the following: the infant, the nursing mother, the time of day, the start time and the elapsed time and date of feeding or suctioning, the duration of the feeding period, and other data such as body temperature, infant weight, weight change, and infant condition (e.g., alertness, drowsiness, irritability, etc.). The data can also be correlated with a group of infants and / or nursing mothers defined as having one or more common parameters, and / or otherwise associated with data groups for analysis and calibration improvement.

[0100] In this specification and the appended claims, "cloud computing" can be defined as a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage devices, applications, and services), which can be rapidly configured through virtualization and deployed with minimal management effort or service provider interaction, and then scaled accordingly. The cloud model can consist of various features (e.g., on-demand self-service, broad network access, resource aggregation, rapid elasticity, measurement services, etc.), service models (e.g., Software as a Service (SaaS), Platform as a Service (PaaS), Infrastructure as a Service (IaaS), and deployment models (e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.).

[0101] The term "controller," and related terms such as microcontroller, controller, control unit, processor, etc., refer to one or more applications-specific integrated circuits (ASICs), one or more field-programmable gate arrays (FPGAs), one or more electronic circuits, one or more central processing units (e.g., one or more microprocessors), and associated non-transient memory components (read-only, programmable read-only, random access, hard drives, etc.) in the form of memory and storage devices. Non-transient memory components are capable of storing machine-readable instructions in the form of one or more software or firmware programs or routines, one or more combinational logic circuits, one or more input / output circuits and devices, signal conditioning, buffer circuits, and other components, which can be accessed and executed by one or more processors to provide the described functions. One or more input / output circuits and devices include analog-to-digital converters and associated devices that monitor inputs from sensors, wherein such inputs are monitored at a preset sampling frequency or in response to a trigger event. Software, firmware, program, instruction, control routine, code, algorithm, and similar terms refer to a controller-executable instruction set including calibration and lookup tables. Each controller executes one or more control routines to provide the required functions. Routines can be executed periodically, for example, once every 100 microseconds during an ongoing operation. Alternatively, routines can be executed in response to the occurrence of a triggering event. Communication between the controller, actuator, and / or sensor can be achieved using direct wired point-to-point links, networked communication bus links, wireless links, or other communication links. Communication includes the exchange of data signals, including, for example, electrical signals transmitted through a conductive medium; electromagnetic signals propagating through air; optical signals transmitted through an optical waveguide; and so on. Data signals may include discrete, analog, and / or digitized analog signals representing inputs from sensors, actuator commands, and communication between the controller.

[0102] Using ordinal numbers such as first, second, and third does not necessarily imply a sense of sequential order, but rather distinguishes multiple instances of an action or structure.

[0103] The term "signal" refers to a physically identifiable indicator that transmits information and can be a suitable waveform (e.g., electrical, optical, magnetic, mechanical, or electromagnetic), such as analog signals, digital signals, sine waves, triangle waves, square waves, vibrations, etc., that can be transmitted through a medium.

[0104] The terms “calibration,” “calibrated,” and related terms refer to the result or process of associating a desired parameter of a device or system with one or more sensed or observed parameters. The calibration described herein can be simplified to a storable parameter table, multiple executable formulas, or other suitable form that can be used as part of a measurement or control routine.

[0105] A parameter is defined as a measurable quantity that represents a physical property of a device or other element that can be identified using one or more sensors and / or a physical model. Parameters can be discrete values ​​(e.g., "1" or "0"), percentages (e.g., 0% to 100%), or infinitely variable values.

[0106] The following terms provide an example configuration of the breast milk flow monitoring system disclosed herein.

[0107] Clause 1: A breast milk flow monitoring system comprising: a breast milk flow monitoring sensor including an electrode array including a first electrode, a second electrode, a third electrode, and a fourth electrode; and a controller; wherein the first electrode, the second electrode, the third electrode, and the fourth electrode include conductive surfaces arranged to contact the skin surface of the breast; wherein the controller communicates with the first electrode, the second electrode, the third electrode, and the fourth electrode; and wherein the controller operates to: generate a first excitation signal transmitted to a first location on the breast via the first electrode; generate a second excitation signal transmitted to the first location on the breast via the first electrode; receive a first current response signal in response to the first excitation signal via one of the second electrode, the third electrode, and the fourth electrode; receive a second current response signal in response to the second excitation signal via said one of the second electrode, the third electrode, and the fourth electrode; perform bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, and the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow; and determine breast milk flow parameters based on the bioimpedance spectroscopy analysis.

[0108] Clause 2: The breast milk flow monitoring system according to Clause 1, wherein the first excitation signal includes a low-frequency excitation signal, and wherein the second excitation signal includes a high-frequency excitation signal.

[0109] Clause 3: A breast milk flow monitoring system according to any one of Clauses 1 and 2 further includes a controller that operates to: determine a ratio of a first current response signal to a second current response signal; and perform a bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow.

[0110] Clause 4: A breast milk flow monitoring system according to any one of Clauses 1 to 3, wherein the controller is operated to perform a bioimpedance spectroscopy analysis of the ratio of a first current response signal to a second current response signal, including the controller being operated to perform a Fourier transform analysis of the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal to determine the breast milk flow parameters.

[0111] Clause 5: A breast milk flow monitoring system according to any one of Clauses 1 to 4, wherein the controller is operated to perform a bioimpedance spectroscopy analysis of the ratio of a first current response signal to a second current response signal, including the controller being operated to perform a frequency response analysis of the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal to determine breast milk flow parameters.

[0112] Clause 6: A breast milk flow monitoring system according to any one of Clauses 1 to 5, wherein the controller operates to perform bioimpedance spectroscopy analysis of the ratio of a first current response signal to a second current response signal, including adaptive filter analysis of the controller operating to perform bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal to determine breast milk flow parameters.

[0113] Clause 7: A breast milk flow monitoring system according to any one of Clauses 1 to 6, wherein the controller operates to perform a bioimpedance spectroscopy analysis of the ratio of a first current response signal to a second current response signal, comprising the controller operating to: determine a first parameter associated with at least one of impedance (z), reactance (Xc), resistance (R), and phase (Ph) of the first current response signal; determine a second parameter associated with at least one of impedance (z), reactance (Xc), resistance (R), and phase (Ph) of the second current response signal; determine the ratio of the first parameter to the second parameter; and determine a breast milk flow parameter based on the ratio of the first parameter to the second parameter.

[0114] Clause 8: A breast milk flow monitoring system according to any one of Clauses 1 to 7, wherein the low-frequency excitation signal is less than the high-frequency excitation signal, wherein the high-frequency excitation signal is less than 1000KHz, and wherein the low-frequency excitation signal is greater than 3KHz.

[0115] Clause 9: A breast milk flow monitoring system according to any one of Clauses 1 to 8, wherein the low-frequency excitation signal comprises a single-frequency sine wave with a frequency of less than 50 kHz.

[0116] Clause 10: A breast milk flow monitoring system according to any one of Clauses 1 to 9, wherein the high-frequency excitation signal comprises a single-frequency sine wave with a frequency between 50 kHz and 1000 kHz.

[0117] Clause 11: A breast milk flow monitoring system according to any one of Clauses 1 to 10, wherein the first excitation signal comprises a first broad-spectrum sine wave, and wherein the second excitation signal comprises a second broad-spectrum sine wave.

[0118] Clause 12: A breast milk flow monitoring system according to any one of Clauses 1 to 11, wherein a first electrode is arranged to contact the surface of the breast at one of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola; and wherein a second electrode is arranged to contact the surface of the breast at another of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola.

[0119] Clause 13: A breast milk flow monitoring system according to any one of Clauses 1 to 12, wherein a third electrode is arranged to contact the surface of the breast at one of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola; and wherein a fourth electrode is arranged to contact the surface of the breast at another of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola.

[0120] Clause 14: A breast milk flow monitoring system according to any one of Clauses 1 to 13, wherein the milk flow monitoring sensor further includes a first electrode, a second electrode, a third electrode and a fourth electrode fixed to a flexible substrate.

[0121] Clause 15: A breast milk flow monitoring system according to any one of Clauses 1 to 14 further includes a fitting bracket; wherein the milk flow monitoring sensor is fixed to the fitting bracket; and wherein the fitting bracket is arranged to position the first electrode, the second electrode, the third electrode and the fourth electrode in contact with the skin surface of the breast.

[0122] Clause 16: A breast milk flow monitoring system according to any one of Clauses 1 to 14 further includes a temperature sensor fixed to a fitting bracket and arranged to monitor the temperature of the breast; wherein the controller operates to receive an input signal from a temperature corresponding to the temperature of the breast, and to determine breast milk flow parameters based on a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and bioimpedance spectroscopy analysis of the breast temperature.

[0123] Clause 17: A breast milk flow monitoring system according to any one of Clauses 1 to 16 further includes a motion sensor fixed to a fitting bracket and arranged to monitor physical motion; wherein the controller operates to receive an input signal from the motion sensor associated with physical motion proximity to the sensor, and to determine breast milk flow parameters based on a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and bioimpedance spectroscopy analysis of the physical motion.

[0124] Clause 18: A breast milk flow monitoring system pursuant to any of Clauses 1 to 17, wherein the motion sensor includes an accelerometer.

[0125] Clause 19: A breast milk flow monitoring system according to any one of Clauses 1 to 18, wherein the motion sensor includes a plurality of accelerometers, wherein the plurality of accelerometers correspond to a first electrode, a second electrode, a third electrode and a fourth electrode.

[0126] Clause 20: A breast milk flow monitoring system pursuant to any of Clauses 1 to 19, wherein one of a plurality of accelerometers is arranged to monitor overall body motion and one of a plurality of accelerometers is arranged to monitor breast motion.

[0127] Clause 21: A breast milk flow monitoring system according to any one of Clauses 1 to 20, wherein the motion sensor includes a piezoelectric sensor fixed to a fitting bracket near the skin surface of the breast; wherein the controller operates to receive an input signal from the piezoelectric sensor and determine breast milk flow parameters based on a bioimpedance spectroscopy analysis of a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and the input signal from the piezoelectric sensor.

[0128] Clause 22: A breast milk flow monitoring system according to any one of Clauses 1 to 21 further includes a strain gauge fixed to a fitting bracket near the skin surface of the breast; wherein the controller operates to receive an input signal from the strain gauge and determine breast milk flow parameters based on a bioimpedance spectroscopy analysis of a first excitation signal, a second excitation signal, a first current response signal, a second current response signal, and the input signal from the strain gauge.

[0129] Clause 23: A breast milk flow monitoring system pursuant to any one of Clauses 1 to 22 further includes: a cellular device including an executable application, the cellular device communicating with a cloud environment; wherein the cellular device is configured to receive breast milk flow parameters from a controller, wherein the cellular device is configured to transmit the breast milk flow parameters to the cloud environment, and wherein the cellular device is configured to visually display the breast milk flow parameters.

[0130] Clause 24: A breast milk flow monitoring system comprising: a breast milk flow monitoring sensor including a plurality of electrodes; and a controller; wherein the plurality of electrodes include conductive surfaces arranged to contact a skin surface of the breast; wherein the controller communicates with the plurality of electrodes; and wherein the controller operates to: generate a first excitation signal transmitted to a first location on the breast via a first electrode of the plurality of electrodes; generate a second excitation signal transmitted to the first location on the breast via the first electrode of the plurality of electrodes; receive a first current response signal in response to the first excitation signal via other electrodes of the plurality of electrodes; receive a second current response signal in response to the second excitation signal via other electrodes of the plurality of electrodes; perform bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, and the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow; and determine breast milk flow parameters based on the bioimpedance spectroscopy analysis.

[0131] Clause 25: A breast milk flow monitoring system comprising: a breast milk flow monitoring sensor including an electrode array including a first electrode, a second electrode, a third electrode, and a fourth electrode; and a controller; wherein the first electrode, the second electrode, the third electrode, and the fourth electrode include conductive surfaces arranged to contact a skin surface of the breast; wherein the controller communicates with the first electrode, the second electrode, the third electrode, and the fourth electrode; and wherein the controller operates to: generate a first excitation signal transmitted via the first electrode to a first location on the breast, wherein the first excitation signal is calibrated for breast milk flow; generate a second excitation signal transmitted via the first electrode to the first location on the breast, wherein the second excitation signal is calibrated for breast milk flow; receive a first current response signal in response to the first excitation signal via one of the second electrode, the third electrode, and the fourth electrode; receive a second current response signal in response to the second excitation signal via said one of the second electrode, the third electrode, and the fourth electrode; perform bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, and the second current response signal, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow, and determines breast milk flow parameters based on the bioimpedance spectroscopy analysis.

[0132] Flowcharts and block diagrams within flowcharts illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of this disclosure. In this regard, each block in a flowchart or block diagram may represent a module, segment, or code portion, including one or more executable instructions for implementing one or more specified logical functions. It should also be noted that each block in a block diagram and / or flowchart, and combinations of blocks in a block diagram and / or flowchart, may be implemented by a system based on special-function hardware or a combination of special-function hardware and computer instructions that performs the specified functions or actions. These computer program instructions may also be stored in a computer-readable medium that can instruct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of art comprising a set of instructions that implements the functions / actions specified in the flowchart and / or one or more block diagram blocks.

[0133] The detailed description and accompanying drawings or figures are intended to support and describe this teaching, but the scope of this teaching is defined only by the claims. While some best modes and other embodiments for carrying out this teaching have been described in detail, various alternative designs and embodiments exist for practicing the teaching as defined in the claims.

Claims

1. A breast milk flow monitoring system, comprising: A milk flow monitoring sensor, comprising an electrode array including a first electrode, a second electrode, a third electrode, and a fourth electrode; as well as Controller; The first electrode, the second electrode, the third electrode, and the fourth electrode include conductive surfaces configured to contact the skin surface of the breast; The controller communicates with the first electrode, the second electrode, the third electrode, and the fourth electrode; and The controller operation is as follows: A first excitation signal is generated and transmitted to a first location on the breast via the first electrode. A second excitation signal is generated and transmitted to the first location on the breast via the first electrode. Wherein, the first excitation signal includes a low-frequency excitation signal, and the second excitation signal includes a high-frequency excitation signal. A first current response signal in response to the first excitation signal is received via one of the second, third, and fourth electrodes. A second current response signal in response to the second excitation signal is received via one of the second, third, and fourth electrodes. Determine the ratio of the first current response signal to the second current response signal. A bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal is performed, wherein the bioimpedance spectroscopy analysis is calibrated for breast milk flow rate, and The breast milk flow parameters were determined based on the aforementioned bioimpedance spectroscopy analysis. The controller operation of performing the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal includes the following controller operation: Determine a first parameter associated with at least one of the impedance (z), reactance (Xc), resistance (R), and phase (Ph) of the first current response signal; Determine a second parameter associated with at least one of the impedance (z), reactance (Xc), resistance (R), and phase (Ph) of the second current response signal; Determine the ratio of the first parameter to the second parameter; and The breast milk flow rate parameter is determined based on the ratio of the first parameter to the second parameter.

2. The breast milk flow monitoring system according to claim 1, wherein the controller operation of performing the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal includes the controller operation being: Fourier transform analysis of the bioimpedance spectrum analysis, which measures the ratio of the first current response signal to the second current response signal, is performed to determine the breast milk flow parameters.

3. The breast milk flow monitoring system according to claim 1, wherein the controller operation of performing the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal includes the controller operation being: Frequency response analysis of the bioimpedance spectroscopy analysis, which measures the ratio of the first current response signal to the second current response signal, is used to determine the breast milk flow parameters.

4. The breast milk flow monitoring system according to claim 1, wherein the controller operation of performing the bioimpedance spectroscopy analysis of the ratio of the first current response signal to the second current response signal includes the controller operation being: An adaptive filter analysis of the bioimpedance spectrum analysis, which measures the ratio of the first current response signal to the second current response signal, is performed to determine the breast milk flow parameters.

5. The breast milk flow monitoring system according to claim 1, wherein the low-frequency excitation signal is less than the high-frequency excitation signal, wherein the high-frequency excitation signal is less than 1000KHz, and wherein the low-frequency excitation signal is greater than 3KHz.

6. The breast milk flow monitoring system according to claim 1, wherein the low-frequency excitation signal comprises a single-frequency sine wave with a frequency of less than 50 kHz.

7. The breast milk flow monitoring system according to claim 1, wherein the high-frequency excitation signal comprises a single-frequency sine wave with a frequency between 50 kHz and 1000 kHz.

8. The breast milk flow monitoring system according to claim 1, wherein the first excitation signal comprises a first broad-spectrum sine wave, and wherein the second excitation signal comprises a second broad-spectrum sine wave.

9. The breast milk flow monitoring system of claim 1, wherein the first electrode is configured to contact the surface of the breast at one of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola. The second electrode is configured to contact the surface of the breast at one of the following locations: the upper inner side position away from the areola, the lower inner side position away from the areola, the lower outer side position away from the areola, the upper outer side position away from the areola, the upper inner side position close to the areola, the lower inner side position close to the areola, the lower outer side position close to the areola, and the upper outer side position close to the areola.

10. The breast milk flow monitoring system of claim 1, wherein the third electrode is configured to contact the surface of the breast at one of the following locations: an upper inner position away from the areola, a lower inner position away from the areola, a lower outer position away from the areola, an upper outer position away from the areola, an upper inner position close to the areola, a lower inner position close to the areola, a lower outer position close to the areola, and an upper outer position close to the areola. The fourth electrode is configured to contact the surface of the breast at one of the following locations: the upper inner position away from the areola, the lower inner position away from the areola, the lower outer position away from the areola, the upper outer position away from the areola, the upper inner position close to the areola, the lower inner position close to the areola, the lower outer position close to the areola, and the upper outer position close to the areola.

11. The breast milk flow monitoring system according to claim 1, wherein the breast milk flow monitoring sensor further comprises the first electrode, the second electrode, the third electrode and the fourth electrode fixed on a flexible substrate.

12. The breast milk flow monitoring system according to claim 1, further comprising a fitting bracket; The milk flow monitoring sensor is fixed to the fitting bracket; and The fitting support is arranged to position the first electrode, the second electrode, the third electrode, and the fourth electrode in contact with the skin surface of the breast.

13. The breast milk flow monitoring system according to claim 12, further comprising a temperature sensor fixed to the fitting bracket and arranged to monitor the temperature of the breast; The controller operation is as follows: It receives an input signal from a temperature sensor corresponding to the temperature of the breast, and The breast milk flow parameters are determined by bioimpedance spectroscopy analysis based on the first excitation signal, the second excitation signal, the first current response signal, the second current response signal, and the temperature of the breast.

14. The breast milk flow monitoring system according to claim 12, further comprising a motion sensor fixed to the fitting bracket and arranged to monitor physical motion; The controller operation is as follows: Receives an input signal from the motion sensor associated with physical motion near the motion sensor, and The breast milk flow parameters are determined based on the bioimpedance spectrum analysis of the first excitation signal, the second excitation signal, the first current response signal, the second current response signal, and the physical motion.

15. The breast milk flow monitoring system according to claim 14, wherein the motion sensor includes an accelerometer.

16. The breast milk flow monitoring system according to claim 14, wherein the motion sensor includes a plurality of accelerometers, wherein the plurality of accelerometers correspond to the first electrode, the second electrode, the third electrode and the fourth electrode.

17. The breast milk flow monitoring system of claim 16, wherein one of the plurality of accelerometers is arranged to monitor overall body motion, and wherein one of the plurality of accelerometers is arranged to monitor breast motion.

18. The breast milk flow monitoring system of claim 14, wherein the motion sensor comprises a piezoelectric sensor fixed to the fitting bracket near the skin surface of the breast; wherein the controller operates to receive an input signal from the piezoelectric sensor and determine the breast milk flow parameters based on the bioimpedance spectroscopy analysis of the first excitation signal, the second excitation signal, the first current response signal, the second current response signal, and the input signal from the piezoelectric sensor.

19. The breast milk flow monitoring system according to claim 12, further comprising a strain gauge fixed to the fitting bracket near the skin surface of the breast; The controller operation is as follows: Receive the input signal from the strain gauge, and The breast milk flow parameters are determined by bioimpedance spectroscopy analysis based on the first excitation signal, the second excitation signal, the first current response signal, the second current response signal, and the input signal from the strain gauge.

20. The breast milk flow monitoring system according to claim 1, further comprising: This includes cellular devices that can execute applications and communicate with a cloud environment; The cellular device is configured to receive the breast milk flow parameters from the controller. The cellular device is configured to transmit the breast milk flow parameters to the cloud environment, and The cellular device is configured to visually display the breast milk flow parameters.

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