A wearable device for dynamically detecting lactation

Abstract

The present invention belongs to the technical field of breast milk secretion detection, and provides a wearable device for dynamically detecting the amount of milk secretion. The present invention includes a multimodal measurement device and a control unit. The multimodal measurement device includes at least two types of electrodes, and the electrodes include an excitation electrode close to the root of the breast and a measuring electrode close to the nipple. The multimodal measurement device also includes a micro-flow measurement mechanism, and at least two fluid channels are provided inside the micro-flow measurement mechanism. One end of the fluid channel is connected to the side of the wearable device close to the nipple, and the other end is connected to the outside of the wearable device. To ensure the uniformity of the current covering the breast, the measuring electrode close to the nipple is close to the measurement target tissue, which directly reflects the impedance changes of the lactation-related tissue; the micro-flow measurement mechanism is used to provide physical parameters independent of the impedance measurement, which can provide a reference standard for the lactation amount measured by impedance, and improve the robustness and accuracy of the lactation measurement system.

Description

Technical Field

[0001] The present invention relates to the technical field of breast milk secretion detection, and specifically provides a wearable device for dynamically detecting the amount of milk secretion. Background Art

[0002] It is generally recognized that breastfeeding is beneficial to both newborns and mothers, and mothers are generally encouraged to breastfeed as long as they have the ability to breastfeed. From the perspective of the overall health and growth and development of infants, breastfeeding is beneficial to newborns. In particular, breastfeeding significantly reduces the risk of many acute and chronic diseases. For example, studies have shown that breastfeeding infants are not prone to diarrhea, ear infections, respiratory infections, bacteremia, bacterial meningitis, botulism, necrotizing enteritis and urinary tract infections. In addition, breastfeeding can also give infants a sense of intimacy, warmth and security. Many studies have shown that breastfeeding is also beneficial to mothers. For example, statistically, breastfeeding mothers return to their normal weight faster, and breastfeeding can also restore mothers' ovulation, which is also beneficial to families who want to increase their children. In addition, the amount of milk consumed by breastfed infants is monitored to determine whether the amount of breast milk consumed by breastfeeding infants is sufficient, and whether the mother herself is at risk of diseases such as mammary gland obstruction. Prior art CN117731948A provides a breast massage device, a control method, a breast pump and a storage medium, including: a fitting portion and at least two. The fitting part is used to fit with the breast. The electrode part is installed on the fitting surface of the fitting part. The electrode part is installed on the fitting surface of the fitting part, and fits with the breast through the fitting part, so that the breast massage device can effectively perform electrical stimulation massage on the breast and / or detect the impedance value of the breast during operation. The inventor believes that there is a large room for improvement in the prior art. Summary of the invention

[0003] The purpose of the present invention is to conduct long-term non-contact and periodic contact detection of the impedance change rate of tissue fluid and fat in the lactating breast, obtain the volume ratio change of tissue fluid and fat, and realize dynamic detection of milk production. Secondly, the impedance fluctuation of tissue fluid and fat indicates related lactation diseases such as mammary duct blockage or inflammation; combined with the independent physical parameters of the micro-flow measurement mechanism data, the robustness and accuracy of the milk production measurement system are improved. To this end, the present invention provides a wearable device for dynamically detecting milk production, including a multi-modal measurement device and a control unit, the multi-modal measurement device includes at least two types of electrodes, the electrodes include an excitation electrode near the root of the breast and a measuring electrode near the nipple, the multi-modal measurement device also includes a micro-flow measurement mechanism, and at least two fluid channels are arranged inside the micro-flow measurement mechanism, one end of the fluid channel is connected to the side of the wearable device near the nipple, and the other end is connected to the outside of the wearable device. The excitation electrode close to the root of the breast is far away from the measurement point to ensure the uniformity of the current covering the breast. The measurement electrode close to the nipple is close to the measurement target tissue to directly reflect the impedance changes of the lactation-related tissues. Before lactation, the mammary duct is full of milk, with a high proportion of water and a low proportion of fat, and a low impedance. After lactation, the milk is discharged, the water content decreases, the fat proportion increases relatively, and the impedance value increases. The above-mentioned non-contact measurement can ensure that the milk during lactation is clean and hygienic, while avoiding contact with the baby and interfering with normal breastfeeding. The micro-flow measurement mechanism provides physical parameters independent of impedance measurement, which can provide a reference standard for the milk production measured by impedance, and improve the robustness and accuracy of the milk production measurement system. The micro-flow measurement mechanism is provided with at least two fluid channels, which can improve the robustness of the micro-flow measurement mechanism. At the same time, multiple fluid channels and impedance measurement can avoid differences in lactation postures, different milk flow rates and milk viscosities, and milk accumulation in the fluid channel, which affect the accuracy of milk production measurement.

[0004] Preferably, the excitation electrode is an arc electrode, which covers the area where the central angle of the root of the breast is greater than 330°, and the measuring electrode is a point electrode, which is conjugately distributed around the nipple. The excitation electrode is an arc electrode, which has a supporting effect on the breast, and dynamic measurement requires long-term wearing of the present invention. The excitation electrode fits the shape of the breast, which can improve the comfort of wearing. At the same time, the arc electrode can ensure the uniformity of the current covering the breast; the measuring electrode is a point electrode, which avoids breast discomfort caused by excessive volume, and accurately measures the target point of the lactating tissue. Furthermore, the excitation electrode and the measuring electrode can use medical silver chloride or gold-plated flexible electrodes to ensure conductivity, antibacterial and biocompatibility; the substrate of the excitation electrode and the measuring electrode uses flexible silicone or polyimide film to fit the curved surface of the breast.

[0005] Preferably, the control unit can apply an excitation signal to the breast through the excitation electrode, and the measuring electrode can detect the amplitude change of the excitation signal of other electrodes inside the breast and transmit it to the control unit. The measuring electrode detects the current injected into the tissue through the excitation electrode to avoid the influence of the skin resistance contact impedance.

[0006] Preferably, the micro-flow measurement mechanism includes a sucking area, which is a circular area 2 to 3 cm away from the micro-flow measurement mechanism, and both ends of the fluid channel are located inside the sucking area, and the fluid channel is provided with a part of the channel located outside the sucking area. The sucking area is the area in direct contact with the baby. During breastfeeding, the liquid in the fluid channel cools down less because the baby is close to this area; at the same time, in order to ensure the safety of the baby's sucking process, the sucking area uses biocompatible silicone so that the area can be sterilized at high temperature and high pressure.

[0007] Preferably, a thermal mass flow sensor is attached to the outside of the fluid channel, and the thermal mass flow sensor is located outside the sucking area. The thermal mass flow sensor measures the flow of the fluid according to the temperature change of the fluid during the flow process to obtain the milk production data; the thermal mass flow sensor is located outside the sucking area to avoid damage to the thermal mass flow sensor caused by high temperature and high pressure sterilization; the fluid channel is located outside the sucking area, and the temperature drop changes significantly, which is conducive to the sensor obtaining flow data.

[0008] Preferably, the excitation electrode is provided with a corresponding measuring electrode, and the measuring electrode is located on the extension line of the angular bisector of the central angle of the corresponding excitation electrode. The excitation electrode is provided with a corresponding measuring electrode and the measuring electrode is located on the extension line of the angular bisector of the central angle of the corresponding excitation electrode, which can avoid the complication of the current path and reduce the asynchronous error of the measuring electrode.

[0009] Preferably, the electrode is in contact with the skin, the excitation signal of the control unit is greater than 10Khz, and the excitation signal has at least two frequency currents at the same time, and the current intensity is 10μA to 1mA. The excitation signal frequency greater than 10kHz can inhibit electrochemical reactions such as DC polarization at the interface between the skin and the electrode, reduce the polarization effect, and different frequencies are suitable for different tissues, distinguishing the changes in water or tissue fluid and fat. The current intensity is controlled at 10μA to 1mA, which can effectively penetrate biological tissues while avoiding affecting biological tissues.

[0010] Preferably, the wearable device includes a wearable body, electrodes and a control unit fixed to the wearable body, and a micro-flow measurement mechanism of a detachable structure. Impedance measurement is a non-contact measurement to dynamically detect changes in milk production, and the flow measurement mechanism adopts a detachable structure, which facilitates high-temperature and high-pressure sterilization of the mechanism after each milk flows through, to avoid bacterial growth and adverse effects on the breast and baby.

[0011] The present invention detects the impedance change rate of tissue fluid and fat in the lactating breast, obtains the volume ratio change of tissue fluid and fat, realizes non-contact dynamic detection of milk production, and the impedance fluctuation of tissue fluid and fat indicates breast duct blockage or inflammation and other related lactation diseases; combines the independent physical parameters of the micro-flow measurement mechanism data to improve the robustness and accuracy of the milk production measurement system, and has the following beneficial effects: the excitation electrode close to the root of the breast is far away from the measurement point to ensure the uniformity of the current covering the breast, and the measurement electrode close to the nipple is close to the measurement target tissue to directly reflect the lactation-related tissues. The impedance change of tissue; the above-mentioned non-contact measurement can ensure that the milk during lactation is clean and hygienic, while avoiding contact with the baby and interfering with normal breastfeeding; the micro-flow measurement mechanism provides physical parameters independent of impedance measurement, which can provide a reference standard for the milk production measured by impedance, and improve the robustness and accuracy of the milk production measurement system; the micro-flow measurement mechanism is provided with at least two fluid channels, which can improve the robustness of the micro-flow measurement mechanism, and also avoid differences in lactation postures, different milk flow rates and milk viscosities, and milk accumulation in the fluid channel, which affects the accuracy of milk production measurement. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the implementation methods of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for the implementation methods or the description of the prior art. Obviously, the drawings described below are only exemplary, and for ordinary technicians in this field, other implementation drawings can be derived from the provided drawings without creative work.

[0013] Figure 1 This is a schematic diagram of the structure of a wearable device for dynamically detecting milk production; Figure 2 A side view of a wearable device for dynamically detecting milk production; Figure 3 It is a partial enlarged view of the electrode layout of the present invention; Figure 4 It is a structural schematic diagram of the micro-flow measurement mechanism of the present invention; Figure 5 It is a side view of the micro-flow measurement mechanism of the present invention; Figure 6 It is a structural schematic diagram of Embodiment 2 of the present invention; Figure 7 It is a schematic structural diagram of the electrode layout of the second embodiment of the present invention.

[0014] Explanation of the reference numerals: 1 wearing body; 11 excitation electrode; 11A arc electrode; 12 measuring electrode; 12A point electrode; 2 control unit; 3 micro-flow measurement mechanism; 31 fluid channel; 32 thermal mass flow sensor; 33 sucking area; 34 channel outlet; 35 channel inlet. DETAILED DESCRIPTION

[0015] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0016] Embodiment 1 Combination Figure 1 and Figure 2 As shown, a wearable device for dynamically detecting the amount of milk secretion includes a multimodal measuring device and a control unit 2. The multimodal measuring device includes two types of electrodes, including an excitation electrode 11 near the root of the breast and a measuring electrode 12 near the nipple. The multimodal measuring device also includes a micro-flow measuring mechanism 3. Two fluid channels 31 are arranged inside the micro-flow measuring mechanism 3. The channel inlet 35 of the fluid channel 31 is connected to the side of the wearable device near the nipple, and the channel outlet 34 of the fluid channel 31 is connected to the outside of the wearable device. The control unit 2 can apply an excitation signal to the breast through the excitation electrode 11, and the measuring electrode 12 can detect the amplitude change of the excitation signal of other electrodes inside the breast and transmit it to the control unit 2. The measuring electrode 12 detects the current injected into the tissue through the excitation electrode 11 to avoid the influence of the skin resistance contact impedance. The control unit 2 can automatically judge the significant abnormality of the impedance, for example, the impedance change amplitude is greater than 20%, triggering the user to wear it again. Reminder.

[0017] Through the above settings, the excitation electrode 11 close to the root of the breast is kept away from the measuring point to ensure the uniformity of the current covering the breast, and the measuring electrode 12 close to the nipple is close to the measuring target tissue to directly reflect the impedance changes of the lactation-related tissues. Before lactation, the mammary duct is full of milk, with a high proportion of water and a low proportion of fat, and a low impedance. After lactation, the milk is discharged, the proportion of water decreases, the proportion of fat increases relatively, and the impedance value increases; the above-mentioned non-contact measurement can ensure that the milk during lactation is clean and hygienic, while avoiding contact with the baby and interfering with normal breastfeeding; the micro-flow measurement mechanism 3 provides physical parameters independent of impedance measurement, which can provide a reference standard for the milk production measured by impedance, and improve the robustness and accuracy of the milk production measurement system; the micro-flow measurement mechanism 3 is provided with at least two fluid channels 31, which can improve the robustness of the micro-flow measurement mechanism 3, and at the same time avoid differences in lactation postures, different milk flow rates and milk viscosities, and milk accumulation in the fluid channel 31, which affects the accuracy of milk production measurement.

[0018] like Figure 3 As shown, the excitation electrode 11 is an arc electrode 11A, and the arc electrode 11A covers the area of ​​350° at the central angle of the root of the breast. The measuring electrode 12 is a point electrode 12A, and the measuring electrode 12 is conjugately distributed around the nipple. The excitation electrode 11 is an arc electrode 11A, which has a supporting effect on the breast, and dynamic measurement requires long-term wearing of the present invention. The excitation electrode 11 fits the shape of the breast, which can improve the comfort of wearing. At the same time, the arc electrode 11A can ensure the uniformity of the current covering the breast; the measuring electrode 12 is a point electrode 12A, which avoids breast discomfort caused by excessive volume, and accurately measures the target point of the lactating tissue. Furthermore, the excitation electrode 11 and the measuring electrode 12 can use medical silver chloride or gold-plated flexible electrodes to ensure conductivity, antibacterial and biocompatibility; the substrate of the excitation electrode 11 and the measuring electrode 12 uses flexible silicone or polyimide film to fit the curved surface of the breast. The electrode is in contact with the skin, and the excitation signal of the control unit 2 is greater than 10kHz. The excitation signal has two frequency currents at the same time, namely low frequency 50kHz and high frequency 100kHz. The low frequency mainly reflects the change of extracellular fluid, corresponding to the water loss caused by milk secretion, and the high frequency is mainly used to penetrate the cell membrane, detect the intracellular fluid and fat content, and assist in distinguishing tissue components. Both frequencies use a sine wave with a total harmonic distortion of less than 1%. It should be noted that the low-frequency signal can take any value greater than 10kHz and not more than 60kHz, for example, 15kHz, 20kHz, 25kHz, 30kHz, 35kHz, 40kHz, 45kHz, 50kHz, 55kHz, 60kHz, and the high-frequency signal can take any value greater than 60kHz and not more than 1000kHz, for example, 80kHz, 90kHz, 100kHz, 110kHz, 120kHz, 130kHz, 140kHz, 150kHz. The frequency ratio of the high-frequency signal to the low-frequency signal is greater than 2. The intensity of the current is 50μA. An excitation signal frequency greater than 10kHz can suppress electrochemical reactions such as DC polarization at the skin and electrode interface and reduce polarization effects. Different frequencies are suitable for different tissues and can distinguish changes in water or tissue fluid and fat. Current intensity controlled at 50μA can effectively penetrate biological tissues while avoiding affecting them.

[0019] Combination Figure 4 and Figure 5As shown, the micro-flow measurement mechanism 3 includes a sucking area 33, which is a circular area with a diameter of 2.5 cm from the micro-flow measurement mechanism 3, and both ends of the fluid channel 31 are located inside the sucking area 33, and the fluid channel 31 has a part of the channel located outside the sucking area 33. The sucking area 33 is the area in direct contact with the baby. During breastfeeding, since the baby is close to this area, the temperature drop of the liquid in the fluid channel 31 is small; at the same time, in order to ensure the safety of the baby's sucking process, the sucking area 33 uses biocompatible silicone so that this area can be sterilized at high temperature and high pressure.

[0020] like Figure 4 As shown, a thermal mass flow sensor 32 is closely attached to the outside of the fluid channel 31, and the thermal mass flow sensor 32 is located outside the sucking area 33. The thermal mass flow sensor 32 measures the flow of the fluid according to the temperature change of the fluid during the flow process to obtain the milk production data; the thermal mass flow sensor 32 is located outside the sucking area 33, which can avoid damage to the thermal mass flow sensor 32 caused by high temperature and high pressure sterilization; the fluid channel 31 is located outside the sucking area 33, and the temperature drop changes significantly, which is conducive to the sensor to obtain flow data.

[0021] The wearable device includes a wearable body 1, an electrode and a control unit 2 fixed to the wearable body 1, and a micro-flow measurement mechanism 3 of a detachable structure. Impedance measurement is a non-contact measurement to dynamically detect changes in milk production. The flow measurement mechanism adopts a detachable structure, which is convenient for high-temperature and high-pressure sterilization of the mechanism after each milk flows through, to avoid bacterial growth and adverse effects on the breast and baby.

[0022] Embodiment 2 Different from the first embodiment, in this embodiment, the excitation electrode 11 is provided with a corresponding measuring electrode 12, the excitation electrode 11 is a symmetrical ring electrode covering 340° of the breast root, the electrode width is 5 mm, symmetrical point electrodes 12A are provided around the nipple, the electrode diameter is 3 mm, and the measuring electrode 12 is located on the extension line of the angular bisector of the central angle of the corresponding excitation electrode 11. The excitation electrode 11 is provided with a corresponding measuring electrode 12 and the measuring electrode 12 is located on the extension line of the angular bisector of the central angle of the corresponding excitation electrode 11, which can avoid the complication of the current path and reduce the asynchronous error of the measuring electrode 12.

[0023] The present invention realizes the detection of the impedance change rate of tissue fluid and fat of the lactating breast, obtains the volume ratio change of tissue fluid and fat, realizes non-contact dynamic detection of milk production, and the impedance fluctuation of tissue fluid and fat indicates breast duct blockage or inflammation and other related lactation diseases; combined with the independent physical parameters of the data of the micro-flow measurement mechanism 3, the robustness and accuracy of the milk production measurement system are improved, and has the following beneficial effects: the excitation electrode 11 close to the root of the breast is far away from the measurement point to ensure the uniformity of the current covering the breast, and the measurement electrode 12 close to the nipple is close to the measurement target tissue to directly reflect the lactation-related tissue impedance changes; the above-mentioned non-contact measurement can ensure that the milk during lactation is clean and hygienic, while avoiding contact with the baby and interfering with normal breastfeeding; the micro-flow measurement mechanism 3 is used to provide physical parameters independent of impedance measurement, which can provide a reference standard for the milk production measured by impedance, and improve the robustness and accuracy of the milk production measurement system; the micro-flow measurement mechanism 3 is provided with at least two fluid channels 31, which can improve the robustness of the micro-flow measurement mechanism 3, and at the same time avoid differences in lactation postures, different milk flow rates and milk viscosities, and milk accumulation in the fluid channel 31, which affects the accuracy of milk production measurement.

[0024] The above embodiments and / or implementation methods are only used to illustrate the preferred embodiments and / or implementation methods for realizing the technology of the present invention, and are not intended to limit the implementation methods of the technology of the present invention in any form. Any technical personnel in this field may make slight changes to other equivalent embodiments without departing from the scope of the technical means disclosed in the content of the present invention, but they should still be regarded as technologies or embodiments that are essentially the same as the present invention.

Claims

1. A wearable device for dynamically detecting milk production, comprising a multimodal measurement device and a control unit (2), characterized in that: The multimodal measurement device comprises at least two types of electrodes, the electrodes comprising an excitation electrode (11) close to the root of the breast and a measurement electrode (12) close to the nipple. The multimodal measurement device also comprises a micro-flow measurement mechanism (3), wherein at least two fluid channels (31) are provided inside the micro-flow measurement mechanism (3), and one end of the fluid channel (31) is connected to a side of the wearable device close to the nipple, and the other end is connected to the outside of the wearable device.

2. A wearable device for dynamically detecting lactation according to claim 1, characterized in that: The excitation electrode (11) is an arc electrode (11A), the arc electrode (11A) covers an area at the root of the breast with a central angle greater than 330°, and the measurement electrode (12) is a point electrode (12A), the measurement electrode (12) is conjugately distributed around the nipple.

3. A wearable device for dynamically detecting lactation according to claim 2, characterized in that: The control unit (2) can apply an excitation signal to the breast via the excitation electrode (11), and the measuring electrode (12) can detect amplitude changes of the excitation signals of other electrodes inside the breast and transmit them to the control unit (2).

4. A wearable device for dynamically detecting lactation according to claim 1, characterized in that: The micro-flow measurement mechanism (3) comprises a suction area (33), the suction area (33) being a circular area 2 to 3 cm away from the micro-flow measurement mechanism (3), the two ends of the fluid channel (31) being located inside the suction area (33), and the fluid channel (31) being provided with a part of the channel being located outside the suction area (33).

5. A wearable device for dynamically detecting lactation according to claim 4, characterized in that: A thermal mass flow sensor (32) is closely attached to the outside of each fluid channel (31), and the thermal mass flow sensor (32) is located outside the suction area (33).

6. A wearable device for dynamically detecting lactation according to claim 2, characterized in that: The excitation electrode (11) is provided with a corresponding measuring electrode (12), and the measuring electrode (12) is located on an extension line of the angular bisector of the central angle of the corresponding excitation electrode (11).

7. A wearable device for dynamically detecting lactation according to claim 3, characterized in that: The electrode is in contact with the skin, the excitation signal of the control unit (2) is greater than 10Khz, the excitation signal has at least two frequency currents at the same time, and the intensity of the current is 10μA to 1mA.

8. A wearable device for dynamically detecting lactation according to claim 1, characterized in that: The wearable device comprises a wearable body (1), the electrodes and the control unit (2) are fixed to the wearable body (1), and the micro-flow measurement mechanism (3) is a detachable structure.

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