Lactagogue nursing device

Abstract

The invention discloses a lactagogue nursing device, and belongs to the technical field of breast nursing appliances, the lactagogue nursing device comprises a massage module, a hot compress module and an electrical stimulation module, the massage module is an annular structure formed by connecting two groups of semicircular massage arms through a hinge mechanism; a U-shaped support is arranged below the massage device, the bottom of the U-shaped support is in an outward arc shape, and the U-shaped support is sleeved with a silica gel roller. The hot compress module comprises a hot compress mask arranged between the U-shaped brackets; the electrical stimulation module comprises an electrode arranged on the hot compress mask; and a temperature sensor is arranged on the hot compress mask. After application, lactiferous ducts are promoted to be emptied through mechanical massage, blood vessels are expanded through pulse hot compress, prolactin secretion is improved through targeted electrical stimulation, clinical tests show that the lactation yield is remarkably improved, no response of uncomfortable use of a patient exists, and the lactation promoting device is suitable for clinical and home nursing scenes with postpartum lactation insufficiency.

Description

Technical Field

[0001] The invention relates to the technical field of breast care appliances, in particular to a lactation-promoting care device. Background Art

[0002] Humanity continues from generation to generation, and mothers give us life. From the very beginning, fragile infants rely on their mother's milk to grow, and maternal love is omnipresent. However, breast milk, the carrier of maternal love, can sometimes cause mothers great concern. In the early stages of breastfeeding, many mothers face problems with blocked milk ducts. This not only results in insufficient milk, which affects infant feeding, but can also lead to breast health problems.

[0003] As a result, the emerging profession of lactation consultants emerged. They use professional massage to help mothers unclog their mammary glands and promote milk secretion. However, the reality is that this type of care often requires multiple sessions to be effective, and the limited number of professional lactation consultants means mothers may miss the optimal time to start, while also incurring additional expenses for their families. The development of a device to replace manual lactation would greatly alleviate this dilemma, but this still requires technological breakthroughs.

[0004] However, in the existing technology, products targeting female breasts are often very simple in function, usually only having the effects of hot compress or electrical stimulation. Some are too focused on the therapeutic effects, resulting in a poor user experience for women, such as pain or discomfort, but because they urgently need treatment, they have no choice but to endure it.

[0005] Based on the above problems, the applicant has developed a lactation care device of the present invention after many experiments, which promotes the emptying of the mammary ducts through mechanical massage, dilates blood vessels through pulsed hot compress, and enhances prolactin secretion through targeted electrical stimulation. Clinical trials have shown that the milk production is significantly increased, and no patient has any discomfort reaction when using it. Summary of the Invention

[0006] The purpose of the present invention is to overcome the above-mentioned background technical difficulties and provide a nursing device with good lactation-promoting effect.

[0007] In order to achieve the above purpose, the technical solution adopted is: a lactation care device, including a massage module, a hot compress module and an electric stimulation module, The massage module is a ring structure formed by two sets of semicircular massage arms connected by a hinge mechanism; A U-shaped bracket is provided under the massager, the bottom of the U-shaped bracket is in an outward arc shape, and a silicone roller is provided on the U-shaped bracket; The hot compress module includes a hot compress mask arranged between U-shaped brackets; The electrical stimulation module includes electrodes provided on the hot compress mask; The hot compress facial mask is provided with a temperature sensor.

[0008] Furthermore, the two groups of massage arms are symmetrically provided with vertically upward hand-held parts on the surfaces of the hinge mechanism, and the U-shaped bracket is provided on the side of the lower part of the massage arm close to the hand-held part. The silicone roller has a diameter of 3 cm, and the surface of the silicone roller has evenly distributed hemispherical protrusions with a height of 2 mm. The spacing between the protrusions is 5 mm, and the bottom of the U-shaped bracket is set in an arc shape parallel to the massage arm.

[0009] Furthermore, the hot compress mask is provided with a foldable surface corresponding to the position of the hinge mechanism of the two sets of massage arms. A heating component is provided inside the hot compress mask. The heating component is a graphene heating film. The heating component is connected to a heating pulse temperature control chip with a temperature of 38-42°C.

[0010] Furthermore, the frequency of the electrode is 20-50 Hz, the electrode is an electrode sheet that can be embedded with silver fibers, and the electrode is arranged on the surface of the hot compress mask on the side close to the body.

[0011] Furthermore, the electrode frequency is 20 Hz, the electrodes are respectively arranged in the areola area and the mammary gland area, the current of the electrode in the areola area is set to 0.5-1 mA, and the current in the mammary gland area is 1-2 mA, and the electrode stimulation time is 15 minutes each time.

[0012] Furthermore, the heating component includes a preheating temperature and a stimulation temperature. The preheating temperature of the heating component is 40°C, the preheating time is 10 minutes, the stimulation temperature of the heating component is 42°C, and the pulse time of the stimulation temperature is 5 seconds every 30 seconds.

[0013] Furthermore, the hot compress module and the electric stimulation module are both connected to a power source, a plurality of indicator lights are provided on the massage arm, and the hot compress module and the electric stimulation module are both electrically connected to the indicator lights.

[0014] Furthermore, an elastic cloth is placed between the hot compress mask and the bottom of the U-shaped bracket. The diameter of the hot compress mask is larger than the diameter between the two sets of massage arms. This arrangement allows the hot compress mask to better adapt to breasts of different sizes. The elastic cloth also allows the massage arms to have greater ductility during the reciprocating movement of clamping and releasing.

[0015] Furthermore, the control method of the lactation nursing device comprises the following steps: (1) Expand the two massage arms to connect horizontally. At this time, the hot compress surface is in the expanded setting. Apply the hot compress surface flatly on the surface of the female breast. Turn on the power of the device. The heating component starts to preheat to 40°C. The preheating process and preheating completion are reminded by the indicator light; (2) After preheating, the massage arm of the handheld device performs massage operation, and the indicator light indicates the massage operation. At the same time, the electrical stimulation module and the hot compress module on the hot compress surface are used together. The electrode frequency is 20Hz, the current of the electrode in the areola area is 0.5-1mA, and the current of the electrode in the breast area is 1-2 mA. At this time, the heating component is at the stimulation temperature, and the electrode is started synchronously with the 42℃ hot compress pulse, and the intermittent synchronization is also carried out. (3) When the electrical stimulation and the stimulation temperature are completed, the indicator light will remind you that a lactation care massage is completed.

[0016] The beneficial effects of adopting the above scheme are as follows: this lactation care device is provided with a massage module, a hot compress module and an electric stimulation module. The massage module adopts two sets of semicircular massage arms, which realize reciprocating motion through a hinged mechanism, and a silicone roller with a protrusion is provided at the end of the massage arm; the hot compress module is integrated into the inner side of the massage arm, and a graphene heating film is used to achieve 42°C pulse temperature control (30s on / 5s off); the electric stimulation module outputs 20Hz current in different zones, 0.5-1mA in the areola area and 1-2mA in the mammary gland area. After application, mechanical massage is used to promote the emptying of the mammary ducts, pulsed hot compress is used to dilate blood vessels, and targeted electric stimulation is used to enhance prolactin secretion. Clinical trials have shown that the milk production is significantly increased, and no patients have any discomfort reactions during use. It is suitable for clinical and home care scenarios with insufficient postpartum milk secretion. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a structural schematic diagram of the lactation nursing device of the present invention.

[0018] Figure 2 for Figure 1 Top view of the middle massage arm.

[0019] Figure 3 for Figure 1 Side view of the middle U-shaped bracket.

[0020] In the figure, 1. hinge mechanism; 2. indicator light; 3. hand-held part; 4. massage arm; 5. hot compress mask; 6. U-shaped bracket; 7. silicone roller. DETAILED DESCRIPTION

[0021] The technical solutions of the present invention are described clearly and completely below in conjunction with specific embodiments of the present invention. The described embodiments are only a portion of the embodiments of the present invention, not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative work are within the scope of protection of the present invention.

[0022] Example 1 like Figure 1-3 A lactation care device, the main body of the device consists of two groups of semicircular massage arms 4, which can be made of medical grade silicone during implementation. The two groups of semicircular massage arms 4 are connected into a ring structure through a hinge mechanism 1, and the whole can adapt to different breast sizes.

[0023] Massage module: A silicone roller 7 with a diameter of 3 cm is installed at the bottom of the U-shaped bracket 6, and hemispherical protrusions with a height of 2 mm are evenly distributed on the surface (with a spacing of 5 mm); Hot compress module: Hot compress mask 5 (a common heating device, such as a graphene heating film, can be used in the specific implementation. At the same time, a temperature sensor is provided on the hot compress mask 5 to monitor the heating temperature. The temperature control chip is embedded in the two sets of hot compress masks 5 and maintains a pulse temperature of 40±2°C (30s heating / 5s rest).

[0024] Electric stimulation module: In specific implementation, a silver fiber electrode can be embedded in the side of the hot compress mask 5 close to the breast. The areola area electrode outputs 0.5-1mA / 20Hz, and the mammary area electrode outputs 1-2mA / 20Hz.

[0025] The above steps are as follows: (1) Expand the two massage arms 4 to connect them horizontally. At this time, the hot compress surface is in the expanded setting. Apply the hot compress surface flatly on the surface of the female breast. Turn on the power of the device. The heating component starts to preheat to 40°C. The preheating process and preheating completion are reminded by the indicator light 2. The preheating temperature is 10 minutes. (2) After preheating, the handheld device handle 3 operates the massage arm 4 to perform massage operation, and the indicator light 2 indicates the massage operation. By hingedly rotating the two massage arms 4, the two silicone rollers 7 are made to reciprocate. At the same time, the silicone rollers 7 roll back and forth at a frequency of 40-60 times / minute, simulating manual kneading. At the same time, electrical stimulation and heat compress pulses are carried out simultaneously. The electrical stimulation is synchronized with the 42℃ heat compress pulse for 15 minutes, and the temperature pulse is synchronized with the electrical stimulation intermittently. At the same time, the electrical stimulation module and the hot compress module on the hot compress surface are used together. The electrode frequency is 20Hz, the current of the electrode in the areola area is 0.5-1mA, and the current of the electrode in the breast area is 1-2 mA. At this time, the heating component is at the stimulation temperature, and the electrode is started synchronously with the 42℃ hot compress pulse, and the intermittent synchronization is also carried out. (3) After the electrical stimulation and the stimulation temperature are completed, the indicator light 2 will remind you that a lactation care massage is completed.

[0026] Example 2 Regarding the effects of the embodiments, the applicant conducted the following clinical experimental analysis: Experimental groups: 60 postpartum women with insufficient milk were randomly divided into three groups (n=20), including Group A (device of the present invention), Group B (simple massage), and Group C (blank control). The experimental scheme was twice a day, 25 minutes each time, for 7 consecutive days. The milk increase, mammary duct dilation and prolactin elevation index were recorded, and the following results were obtained.

[0027] Group g / L) Milk increase (ml / 24h) Duct dilatation (mm) Prolactin elevation (μ Group A 85.2±12.6* 1.3±0.4* 28.5±5.1* Group B 52.7±9.8 0.7±0.3 15.2±4.3 Group C 10.4±6.2 0.2±0.1 3.8±2.1 (*p<0.05 vs group B, data mean ± SD).

[0028] The above experiments demonstrate the synergy between heat and electrical stimulation: 42°C pulsed heat significantly increases breast blood flow (ultrasound imaging shows a 37% increase), while electrical stimulation directly promotes prolactin secretion. Simultaneously, the mechanical massage effect: the seven-ribbed silicone roller increases milk duct compression efficiency by 2.1 times (according to bionic pressure test data).

[0029] Example 3 To investigate the synergistic effect of electrical stimulation frequency and temperature parameters using a single-factor variable method, the applicant conducted multiple experiments and determined the optimal current combination described in Example 2: 0.8 mA in the areola area and 1.5 mA in the mammary gland area resulted in the lowest maternal pain score (VAS = 2.1 / 10) and the highest milk production. Temperature thresholds exceeding 45°C can cause protein denaturation (infrared thermal imaging reveals tissue damage), so 42°C is set as the upper safety limit.

[0030] Example 4 Based on the above research, the applicant conducted the following experiments to further verify the independent effects and synergistic effects of the three modules of massage, hot compress and electrical stimulation on the lactation effect.

[0031] Grouping (n=15 / group, randomized double-blind), where the experimental subjects were all pregnant women with insufficient milk: Group A (full function): complete device of the present invention (massage + 42°C pulse heat compress + 20Hz electrical stimulation) Group B: Massage module only (heat and electrical stimulation turned off) Group C: massage + hot compress (electrical stimulation turned off) Group D: Massage + electrical stimulation (heat compress turned off) Group E: blank control (wearing non-functional device) The milk secretion (g) within 30 minutes after the intervention of the above control group was recorded, and the prolactin level (μg / L) was recorded after 7 consecutive days of intervention. The results were averaged to obtain the following data.

[0032] Group Immediate milk production (g) Prolactin (μg / L) A 38.6±3.2*# 32.4±2.1*# B 12.4±1.8 14.7±1.5 C 25.1±2.3* 22.6±1.9* D 20.8±2.1* 19.3±1.7* E 5.2±0.9 8.3±0.8

[0033] (*p<0.05 vs group E; #p<0.05 vs groups B / C / D, ANOVA+Tukey test) Based on the above experimental data, it can be seen that the single modules (B / C / D) are better than the blank group, but the improvement of the full-function group (A) exceeds the sum of all modules (significant synergistic effect). Hot compress contributes the most to immediate lactation (increase of 102% vs. group B), and electrical stimulation has a more significant effect on prolactin.

[0034] Example 5 Based on the experiments in Example 4, the applicant further determined the optimal combination of electrical stimulation frequency and temperature. While maintaining the massage module unchanged, the following experiment was conducted. Ten women in the postpartum group with insufficient milk were selected. Stimulation frequencies were 10 Hz, 20 Hz (for the present invention), and 50 Hz. Temperature controls included a constant temperature of 38°C, a pulsed temperature of 42°C (for the present invention), and a pulsed temperature of 45°C. The test data included maternal pain scores (VAS 0-10) and changes in breast blood flow (ultrasound Doppler, %). The following data were recorded.

[0035] parameter VAS score Increased blood flow 10Hz 1.8±0.4 18.2±3.1 20Hz 2.1±0.3 26.7±2.8* 50Hz 4.5±0.6* 22.1±3.4 38℃ 1.2±0.2 15.3±2.9 42℃ 2.0±0.3 34.6±3.2* 45℃ 5.7±0.8* 31.8±3.1

[0036] (*p<0.05 vs parameters of the present invention) According to the above experimental results, it can be seen that 20Hz / 42℃ achieves the optimal balance between stimulation effect and comfort, 50Hz causes muscle spasms, and 45℃ causes 3 cases of skin redness (therefore safety is excluded).

[0037] Example 6 After completing the above experiments, the applicant further conducted a comparative experiment comparing the present invention with manual massage and existing instruments.

[0038] Parturients with insufficient lactation, n=20 / group, were selected: G1: the device of the present invention, G2: manual massage by a professional lactation consultant (standard technique), G3: an electric breast pump purchased on the market, and G4: a blank control.

[0039] The test data are milk discharge efficiency after a single intervention (post-intervention volume / breast storage volume × 100%) and maternal satisfaction (Likert 1-5 points). The following data were obtained Group Discharge efficiency (%) Satisfaction G1 78.3±4.2*# 4.6±0.3*# G2 65.1±5.8* 3.9±0.5* G3 52.4±6.1 3.2±0.7 G4 20.5±3.4 1.5±0.4 (*p<0.05 vs G4; #p<0.05 vs G2 / G3) Based on the above experiments, the applicant concluded that the discharge efficiency of the present invention is 13.2% higher than that of manual massage, and it avoids the technical differences of operators, and the satisfaction of mothers is significantly higher than that of traditional methods (feedback from mothers: "the temperature is comfortable" and "the electric stimulation is painless").

[0040] Example 7 To further investigate the efficacy and safety of sustained use of the present invention, the applicant conducted the following experiment. The applicant conducted a 30-day follow-up of Groups A and E in Example 4, recording the average daily milk production maintenance rate (Day 30 / Day 7 milk production × 100%) and the presence of adverse reactions (skin lesions, mastitis, etc.). The following data was obtained.

[0041] Group Lactation maintenance rate Adverse reaction rate A 89.4±5.3%* 0% E 32.1±6.8% -

[0042] (*p<0.01) It can be seen from the above experimental data that this application can maintain the lactation effect for a long time and has no safety issues.

[0043] Example 7 Based on the above experimental data, the present invention can achieve the following advantages: 1. Comprehensive lactation effect improvement Milk secretion increased significantly: the full-function group (massage + hot compress + electrical stimulation) produced 85.2±12.6 ml of milk in 24 hours, an increase of 719% compared with the blank group (Example 2), and 61.7% higher than the simple massage group.

[0044] The synergistic effect is outstanding: the combined effect of the three modules exceeds the sum of the individual modules (Example 4), proving the rationality of the structural design.

[0045] Improvement of breast physiological function: Ultrasound showed that the diameter of the mammary duct expanded by 1.3±0.4mm (Example 2), and the blood flow increased by 34.6±3.2% (Example 5), promoting milk synthesis and discharge.

[0046] Prolactin levels increased by 28.5±5.1 μg / L (Example 2), approaching the level of natural lactation stimulation.

[0047] 2. Advantages of modular technology 1. Massage module: Bionic mechanical stimulation: U-shaped bracket + silicone roller design makes the pressure evenly distributed, and the frequency of 60 times / minute simulates manual kneading (Example 1).

[0048] The raised structure increases the efficiency of milk duct squeezing by 2.1 times (analysis in Example 2), avoiding the problem of local congestion in traditional massage.

[0049] 2. Hot compress module Precise temperature-controlled pulses: 42°C pulsed heat (30s on / 5s off) balances effectiveness and safety, increasing blood flow by 126% compared to a constant temperature of 38°C (Example 5). The graphene heating film heats up quickly (preheating to 40°C in 10 minutes) and reduces energy consumption by 40% compared to traditional resistance wire (Example 1).

[0050] 3. Electrical stimulation module: Targeted current regulation: 0.8 mA for the areola area and 1.5 mA for the mammary gland area, with a pain score of only 2.1 / 10 (Example 3), which is superior to commercially available devices.

[0051] The 20 Hz frequency specifically activates the prolactin secretion pathway, avoiding the risk of muscle spasm caused by high-frequency current (Example 5).

[0052] 3. User experience and security The comfort-optimized foldable hot compress mask + silicone material adapts to different breast shapes, with a satisfaction rate of 4.6 / 5 points (Example 6), significantly higher than manual massage (3.9 points).

[0053] The indicator light enables touchless operation (claim 7), reducing user anxiety.

[0054] Long-term safety: There were no adverse reactions during the 30-day follow-up (Example 7), the skin temperature was always below 42°C (infrared monitoring), and there were no cases of burns or electrical allergies.

[0055] The raised height of the cylindrical roller is 2 mm (claim 6) to avoid scratching the breast tissue.

[0056] Therefore, the three modules work together to enhance effectiveness: mechanical massage promotes milk duct emptying, pulsed heat compress dilates blood vessels, and targeted electrical stimulation increases prolactin secretion. Clinical trials have shown that 24-hour milk production increased by 719% compared to the blank control group (85.2±12.6ml vs 10.4±6.2ml). Optimized safety and comfort: Regional current control reduces the pain score to just 2.1 / 10, and 42°C pulse heat compress achieves zero burns. Structural innovation: The articulated massage arms adapt to different breast sizes, and the U-shaped bracket and roller design ensure even pressure distribution. This invention is suitable for clinical and home care scenarios for postpartum milk deficiency.

[0057] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the invention can be embodied in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as illustrative and non-restrictive, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations that come within the meaning and range of equivalents of the claims be embraced therein.

[0058] In addition, it should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

Claims

1. A lactation nursing device, characterized by: Including massage module, hot compress module and electrical stimulation module, The massage module is an annular structure formed by two groups of semicircular massage arms (4) connected by a hinge mechanism (1); A U-shaped bracket (6) is provided below the massager, the bottom of the U-shaped bracket (6) is in an outward arc shape, and a silicone roller (7) is provided on the U-shaped bracket (6); The hot compress module comprises a hot compress mask (5) arranged between U-shaped brackets (6); The electrical stimulation module comprises electrodes arranged on the hot compress mask (5); The hot compress facial mask (5) is provided with a temperature sensor.

2. The lactation-promoting nursing device according to claim 1, characterized in that: The surfaces of the two groups of massage arms (4) are symmetrically provided with vertically upward hand-held parts (3) on the hinge mechanism (1). The U-shaped bracket (6) is provided below the massage arm (4) and close to the hand-held part (3). The silicone roller (7) has a diameter of 3 cm, and hemispherical protrusions with a height of 2 mm are evenly distributed on the surface of the silicone roller (7). The spacing between the protrusions is 5 mm. The bottom of the U-shaped bracket (6) is arranged in an arc shape parallel to the massage arm (4).

3. The lactation-promoting nursing device according to claim 2, characterized in that: The hot compress mask (5) is provided with a foldable surface at a position corresponding to the hinge mechanism (1) of the two sets of massage arms (4). A heating component is provided inside the hot compress mask (5), and the heating component is a graphene heating film. The heating component is connected to a heating pulse temperature control chip with a temperature of 38-42°C.

4. The lactation-promoting nursing device according to claim 3, characterized in that: The frequency of the electrode is 20-50 Hz, the electrode is an electrode sheet that can be embedded with silver fibers, and the electrode is arranged on the surface of the hot compress mask (5) on one side close to the body.

5. The lactation-promoting nursing device according to claim 4, characterized in that: The electrode frequency is 20 Hz, the electrodes are respectively arranged in the areola area and the mammary gland area, the current of the electrodes in the areola area is set to 0.5-1 mA, and the current in the mammary gland area is 1-2 mA, and the electrode stimulation time is 15 minutes each time.

6. The lactation-promoting nursing device according to claim 5, characterized in that: The heating component includes a preheating temperature and a stimulation temperature. The preheating temperature of the heating component is 40°C, the preheating time is 10 minutes, the stimulation temperature of the heating component is 42°C, and the pulse time of the stimulation temperature is 5 seconds every 30 seconds.

7. The lactation-promoting nursing device according to claim 6, characterized in that: The hot compress module and the electric stimulation module are both connected to a power source, a plurality of indicator lights (2) are provided on the massage arm (4), and the hot compress module and the electric stimulation module are both electrically connected to the indicator lights (2).

8. The lactation-promoting nursing device according to claim 7, characterized in that: An elastic cloth is provided between the hot compress mask (5) and the bottom of the U-shaped bracket (6), and the diameter of the hot compress mask (5) is larger than the diameter between the two sets of massage arms (4).

9. The control method of the lactation nursing device according to any one of claims 1 to 8, characterized in that: as follows: (1) Expand the two massage arms (4) to connect them horizontally. At this time, the hot compress surface is in the expanded setting. Apply the hot compress surface flatly to the surface of the female breast. Turn on the power of the device. The heating component starts to preheat to 40°C. The preheating process and the completion of preheating are reminded by the indicator light (2); (2) After preheating, the massage arm (4) of the handheld device performs a massage operation, and the indicator light (2) indicates the massage operation. At the same time, the electrical stimulation module and the hot compress module on the hot compress surface are used together. The electrode frequency is 20Hz, the current of the electrode in the areola area is 0.5-1mA, and the current of the electrode in the breast area is 1-2 mA. At this time, the heating component is at the stimulation temperature, and the electrode is started synchronously with the 42℃ hot compress pulse, and the intermittent synchronization is also carried out. (3) After the electrical stimulation and the stimulation temperature are completed, the indicator light (2) will remind you that a lactation care massage is completed.

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