Wearable device for breast health monitoring and breast health monitoring system

Abstract

The application discloses a wearable device and system for breast health monitoring, which comprises a sleeve, a wearing part arranged outside the sleeve and used for a wearer to wear the wearable device, a flexible bag arranged in the sleeve, and a monitoring assembly arranged in the flexible bag and close to the skin of the wearer. After the flexible bag is inflated, the monitoring assembly is pressed to form pressure on the breast of the wearer. According to the technical scheme of the application, the monitoring assembly is integrated on the basis of the inflatable flexible bag structure, the structural adaptation and the health monitoring function are deeply fused, and daily high-frequency, accurate and intelligent early auxiliary monitoring of breast diseases can be realized.

Description

Technical Field

[0001] This application relates to the field of medical and health monitoring technology, specifically to a wearable device and a breast health monitoring system for breast health monitoring. Background Technology

[0002] With the global incidence of breast diseases in women, such as breast cancer and breast hyperplasia, rising year by year, the need for early screening and routine monitoring is urgent. Traditional medical imaging examinations, such as mammography and ultrasound, are accurate but rely on specialized equipment and personnel, which cannot meet the needs of high-frequency daily monitoring.

[0003] In recent years, wearable devices have become an important direction for health management due to their convenience. However, there are currently few wearable devices specifically designed for breast health. For example, wearable devices such as smart chest straps monitor heart rate variability through photoelectric sensors inside the chest strap and record motion data using accelerometers. However, these devices can only monitor general physiological indicators and are not designed for breast tissue-specific parameters. Their functions are limited and they cannot be used for early warning of lesions.

[0004] Therefore, designing a breast health monitoring solution that balances wearing comfort and monitoring accuracy has become an urgent problem to be solved in this field. Utility Model Content

[0005] In view of this, in a first aspect, this application proposes a wearable device for breast health monitoring, comprising: Cover; A wearable component, disposed on the outside of the cover, is used by the wearer to wear the wearable device; A flexible bladder is disposed within the cover; A monitoring component is disposed within the flexible sac on the side close to the wearer's skin. When the flexible sac expands, it applies pressure to the monitoring component so that the monitoring component exerts pressure on the wearer's breast.

[0006] Preferably, the outer side of the cover is provided with a waterproof coating, and the inner side is provided with a breathable mesh fabric.

[0007] Preferably, the wearable component is an adhesive component that is fixed to the wearer's skin or clothing.

[0008] Preferably, the flexible capsule is made of a double-layer thermoplastic polyurethane material, and the edges of the capsule are heat-sealed.

[0009] Preferably, the flexible capsule uses a chitosan composite antibacterial film, and the capsule edges are heat-sealed.

[0010] Preferably, the monitoring components include: a pressure sensor array and a temperature sensor array; The flexible capsule has a groove on its inner side; The pressure sensor array is disposed in the groove of the flexible bladder; The temperature sensor array is attached inside the cover.

[0011] More preferably, the wearable device further includes: A capsule adjustment assembly is used to inflate the flexible capsule.

[0012] More preferably, the capsule adjustment assembly includes: Air guiding device and air filling device; One end of the air guiding device is connected to the inflation device, and the other end is connected to the inflation valve of the flexible bladder, so that the flexible bladder is inflated using the inflation device.

[0013] More preferably, the capsule adjustment assembly includes: Injection pump and reservoir; One end of the injection pump is connected to the reservoir, and the other end is connected to the inlet valve of the flexible bladder. The injection pump is used to inject liquid into the flexible bladder.

[0014] Preferably, the wearable device further includes: The control components include: a control module, a communication module, and a power module.

[0015] Secondly, this application also provides a breast health monitoring system, the system comprising: a wearable device and a server as described in the first aspect above.

[0016] The wearable device for breast health monitoring provided in this application includes a cover, a wearing component, a flexible capsule, and a monitoring component. After the flexible capsule expands, it applies pressure to the monitoring component so that the monitoring component exerts pressure on the wearer's breast, thereby monitoring the wearer's breast health status. This application integrates the monitoring component on the basis of an expandable flexible capsule structure, deeply integrating structural adaptation with health monitoring functions, and can realize daily high-frequency, accurate, and intelligent early auxiliary monitoring of breast lesions.

[0017] Other features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0018] The accompanying drawings, which form part of this application, are used to provide a further understanding of this application, and the illustrative embodiments and descriptions thereof are used to explain this application. In the drawings: Figure 1 This is a schematic diagram of a wearable device for breast health monitoring according to a preferred embodiment of this application; Figure 2 This is a schematic diagram of a flexible capsule according to a preferred embodiment of this application; Figure 3 This is a schematic diagram of the control module and sensor array according to a preferred embodiment of this application.

[0019] Reference numerals: 1-Cover; 2-Wearing component; 3-Flexible bladder; 4-Monitoring component; 5-Blood bladder adjustment component; 51-Air delivery device; 52-Inflation device; 6-Control component. Detailed Implementation

[0020] The technical solution of this application will now be described in detail with reference to the accompanying drawings and embodiments.

[0021] In a first aspect, this application provides a wearable device for breast health monitoring, such as... Figure 1-3 As shown, the device includes: a cover 1, a wearable component 2, a flexible sac 3, and a monitoring component 4. The wearable component 2 is located on the outside of the cover 1 for wearing the wearable device on the wearer. The flexible sac 3 is located inside the cover 1, and the monitoring component 4 is located inside the flexible sac 3 on the side closest to the wearer's skin. When the flexible sac 3 inflates, it applies pressure to the monitoring component 4, causing it to adhere closely to the wearer's skin and exert pressure on the wearer's breasts. This allows the device to monitor the wearer's breast health by assessing the firmness of the skin near the breast tissue.

[0022] In the above structure, the wearable device is essentially a reusable chest patch. The pressure from the expansion of the flexible bladder 3 allows the monitoring component 4 to fit snugly against the wearer's skin, thereby increasing the accuracy of the monitoring.

[0023] Additionally, the wearable device may include a control component 6, which comprises a control module, a communication module, and a power module. The control module acquires data monitored by the monitoring component 4. In some scenarios, the control module may also have local computing capabilities to analyze the monitoring data without a network connection. The communication module is used for data transmission within the wearable device and between it and its external environment. The power module provides power to the wearable device.

[0024] In one specific implementation, the main control chip of the control module is a Nordic nRF52832, with a main frequency of 64MHz, 64KB of RAM, and 512KB of Flash. It integrates a 16-bit analog-to-digital converter (ADC) to simultaneously acquire temperature and pressure monitoring data, with sampling accuracy controlled within ±0.05%. Single-bus communication is used for temperature monitoring data acquisition. For pressure monitoring data acquisition, an analog voltage output is amplified by a programmable gain amplifier before being sampled by the ADC. In normal monitoring mode, the control module samples at a frequency of 1Hz, transmitting data 10 times per day. In low-power mode, the control module samples at a frequency of 0.5Hz, transmitting data 5 times per day. Additionally, the control module can incorporate a Kalman filter algorithm to eliminate motion noise and a temperature compensation algorithm to correct for ambient temperature interference.

[0025] The communication module supports Bluetooth and near-field communication. Bluetooth has a transmission rate of 2Mbps and a transmission distance of at least 10m. The communication protocol allows for customizable data formats, including timestamps, sensor IDs, temperature values, pressure values, etc., and is compatible with mainstream mobile operating systems.

[0026] The power module includes a 500mAh rechargeable lithium polymer battery with a nominal voltage of 3.7V and a charging cut-off voltage of 4.2V, supporting both wired and wireless charging. Wired charging current is 500mA, with a full charge time of no more than 1 hour; wireless charging full charge time is no more than 2 hours. Under normal monitoring mode, the battery life is no less than 7 days. Under low power mode, the battery life is no less than 14 days.

[0027] In the implementation of the cover 1, the overall shape is arc-shaped, made of skin-friendly and breathable fabric, with a waterproof coating on the outside and a breathable mesh on the inside.

[0028] In one specific embodiment, the cover 1 is made of a blend of 80% cotton and 20% modal, with a 0.05mm thick polyurethane waterproof coating on the outside and a 30D breathable mesh fabric with a pore size of 0.5mm and a breathability of not less than 500g / m²·24h on the inside. The cover 1 is 150 to 200mm long, covering the area from the base of the breast to the nipple, and 80 to 120mm wide to accommodate different breast widths.

[0029] In one embodiment of the wearable component 2, the wearable component 2 may be an adhesive component, used to attach and fix the wearable device to the wearer's skin or clothing.

[0030] In one specific embodiment, the wearable part 2 is a Velcro, sewn onto the outer edge of the cover 1, with a hook and loop width of 20mm, an adhesive force of not less than 5N / cm, and the ability to be repeatedly fastened not less than 50 times.

[0031] Alternatively, wearable component 2 can be a shape memory polymer fixing kit or a negative pressure adsorption structure. If a temperature-sensitive shape memory polymer is used, wearable component 2 automatically conforms to the contours of the human body at a preset temperature, achieving a secure fixation without the need for Velcro. If the wearable device needs to be closely fitted to the body surface, a micro-vacuum pump can be used to create a slight negative pressure between the device and the skin, utilizing atmospheric pressure for fixation.

[0032] In the implementation of the flexible capsule 3, the capsule body is an arc shape that matches the contour of the breast. The flexible capsule 3 is made entirely of a double-layer thermoplastic polyurethane material, with the edges of the capsule body sealed by heat pressing. Alternatively, the flexible capsule 3 can also be made of a chitosan composite antibacterial membrane, with the edges of the capsule body also requiring heat pressing sealing. Chitosan naturally possesses antibacterial, biocompatible, and breathable properties. When made into a film, it serves as the inner layer that comes into direct contact with the skin, meeting the sterility requirements of medical settings while also aiding wound healing and adding bioactive nursing properties.

[0033] In one specific embodiment, the flexible capsule 3 employs a double-layer sealing structure made of food-grade thermoplastic polyurethane material with a Shore A hardness of 60 to 70. The inner sealing layer is 0.1 mm thick, and the outer sealing layer is 0.2 mm thick. The edges of the double sealing layers are heat-pressed for sealing. The initial volume of the flexible capsule 3 body is 50 to 200 mL, suitable for four basic sizes: S / M / L / XL. The difference in basic volume between different sizes of the flexible capsule 3 is achieved through injection molding, allowing users to select the corresponding size according to their chest circumference.

[0034] Regarding the implementation of monitoring component 4, as described above, monitoring component 4 can monitor the wearer's breast health status by monitoring the hardness of the skin near the breast. Furthermore, existing research also indicates that breast lesions can cause abnormal skin hardness and may also increase skin temperature. Based on this, monitoring component 4 in this application includes a pressure sensor array and a temperature sensor array. A groove for placing the pressure sensor array is provided inside the flexible pouch 3, and the temperature sensor array is adhered to the inside of the cover 1 or disposed in the groove of the flexible pouch 3 using acrylic adhesive. Preferably, if the temperature sensor and pressure sensor are arranged overlapping, the temperature sensor is closer to the wearer's skin, and the pressure sensor is disposed on the side of the temperature sensor away from the wearer's skin. This application, through dual-parameter monitoring of hardness and temperature, increases the dimensions for subsequent assessment of breast health, further improving the accuracy of monitoring.

[0035] In one specific embodiment, the temperature sensor array is a digital temperature sensor, employing a single-bus communication protocol with an accuracy controlled within ±0.1℃ and a measurement range of 0 to 50℃. It is arranged in a 5mm × 5mm array within the flexible capsule 3, close to the skin, covering the upper outer quadrant, lower outer quadrant, upper inner quadrant, lower inner quadrant, and nipple area of ​​the breast. Simultaneously, each sensor is adhered to the inner side of the capsule using medical-grade acrylic adhesive with a shear strength ≥2MPa, with an adhesive layer thickness of 0.02mm to avoid skin allergies.

[0036] Alternatively, the temperature sensor array can also employ a strain-sensing fiber array composed of flexible fibers based on conductive polymers and metal wires. In this strain-sensing fiber array, the resistance value of the conductive fibers changes detectably with variations in two external conditions: tensile deformation due to pressure changes and changes in ambient temperature. By directly weaving these fibers into the sheath 1 or the flexible bladder 3, a distributed temperature sensing network is formed. By collecting resistance signals and inferring pressure and temperature parameters, this approach can replace the array layout of electronic temperature sensors, utilizing the inherent physical properties of the materials to achieve parameter monitoring.

[0037] The pressure sensor array can be composed of resistive and capacitive pressure sensors, with a range of 0 to 100 kPa, an accuracy within ±1%, and a response time of no more than 10 ms. This pressure sensor array is arranged at the same density as the temperature sensor array, with one pressure sensor position corresponding to one temperature sensor position, forming a two-dimensional "temperature-pressure" matrix. Simultaneously, the entire pressure sensor array is embedded in a 0.5 mm deep and 2 mm wide groove inside the flexible capsule 3, and is soldered to a flexible printed circuit board using conductive silver paste with a resistivity of no more than 0.01 Ω·cm to ensure signal transmission stability. This flexible printed circuit board can also be embedded in the groove of the flexible capsule 3.

[0038] Regarding the expansion method of the flexible capsule 3, the wearable device also includes a capsule adjustment component 5, which is used to expand or contract the flexible capsule 3. The capsule adjustment component 5 includes a manual mode and an automatic mode, which the user can switch between as needed. To achieve the automatic mode, an independent lithium battery can also be integrated into the capsule adjustment component 5.

[0039] If the flexible sac 3 is inflated by inflating it with air by the sac body adjustment assembly 5, then in this manner, the sac body adjustment assembly 5 includes: an air guiding device 51 and an inflation device 52. The air guiding device 51 includes a medical-grade silicone air guiding tube and a Luer connector. One end of the air guiding tube is connected to the inflation device 52, and the other end is connected to the inflation valve of the flexible sac 3 through the Luer connector to ensure airtightness. The inflation device 52 is used to inflate or deflate the flexible sac 3.

[0040] Furthermore, the inflation device 52 includes: an elastic airbag, an air pump, a bladder pressure sensor, a one-way valve, and a pressure indicator bar. When the elastic airbag is pressed, air inside the airbag enters the air guide tube through the one-way valve and finally inflates the flexible bladder 3 to complete manual inflation. When the airbag is released, the air inlet valve of the one-way valve closes and the air outlet valve opens, allowing for manual deflation by pressing the flexible bladder 3. During automatic inflation, the air pump is controlled to inflate the flexible bladder 3 via a separate control chip in the inflation device 52 or a control module in the control component 6. Simultaneously, the bladder pressure sensor provides real-time feedback on the air pressure value inside the flexible bladder 3 until the set target value is reached. Alternatively, the inflation device 52 may also include a passive pressure balancing structure such as a bellows and a spring damping element. During automatic inflation, the elastic deformation of the bellows and the damping characteristics of the spring automatically adapt to pressure fluctuations during human movement. By replacing "active pressure control" with "passive adaptation," the system can be simplified while meeting basic pressure adaptation requirements.

[0041] In one specific embodiment, the elastic airbag is made of rubber and has a volume of 30 mL. The pressure indicator bar is graduated from 0 to 0.5 MPa. The air pump has a volume of 5 mm × 5 mm × 10 mm and a maximum air pressure of 0.6 MPa. The airbag pressure sensor has an accuracy within ±0.01 MPa. The inflation device 52 has an independent chip integrating a pulse width modulation drive circuit, and the lithium battery capacity is 10 mAh.

[0042] If the flexible bladder 3 is inflated by injecting liquid into it, the bladder adjustment component 5 can include a micro-injection pump, a reservoir, and a one-way valve. In this method, the injection pump injects saline or other liquids from the reservoir into the sealed chamber of the flexible bladder 3, utilizing the incompressibility of the liquid to generate stable pressure. Simultaneously, the liquid medium can also serve additional functions such as moistening the wound in wound care and maintaining a local warm environment in rehabilitation therapy, replacing the pressure control logic of gas and achieving the dual value of "pressure supply + medium function." Of course, in this method, the bladder adjustment component 5 can also include automatic and manual modes. The basic principle is similar to the automatic and manual modes during inflation. In automatic mode, a control module or independent control chip is required, which will not be elaborated further here.

[0043] The wearable device for breast health monitoring provided in this application includes a cover, a wearing component, a flexible capsule, and a monitoring component. After the flexible capsule expands, it applies pressure to the monitoring component so that the monitoring component exerts pressure on the wearer's breast, thereby monitoring the wearer's breast health status. This application integrates the monitoring component on the basis of an expandable flexible capsule structure, deeply integrating structural adaptation with health monitoring functions, and can realize daily high-frequency, accurate, and intelligent early auxiliary monitoring of breast lesions.

[0044] Secondly, this application also provides a breast health monitoring system, which includes a wearable device and a server for breast health monitoring as described in the first aspect above. The wearable device can monitor and analyze the wearer's breast health status locally, or the wearable device can upload monitoring data to the server for analysis of the wearer's breast health status. Of course, the server can also update the analysis algorithm to the wearable device.

[0045] In one specific implementation, the wearable device's control module acquires monitoring data from the monitoring components and obtains the wearer's breast health status data based on the monitoring data. Alternatively, the wearable device's control module acquires monitoring data from the monitoring components and sends the monitoring data to a server via a communication module, whereby the server obtains the wearer's breast health status data based on the monitoring data. The above monitoring process can also support lesion risk warnings.

[0046] Furthermore, both local analysis of wearable devices and cloud analysis of servers can be achieved based on an intelligent analysis model that combines temperature and hardness characteristics. This model is an AI learning model.

[0047] In one specific implementation, the intelligent analysis model of the temperature-hardness combined characteristics described above can be trained based on 10,000 clinical data cases to analyze the temperature-hardness combined characteristics. For example, during training, if the temperature of a certain area is consistently greater than 36.8℃ and the hardness is greater than 20kPa, then that area is marked as a "suspicious lesion area".

[0048] Other preferred embodiments of the breast health monitoring system provided in this application, the technical problems they can solve, and the technical effects they can achieve are the same as those of the wearable devices for breast health monitoring described above, and will not be repeated here.

[0049] The workflow of the breast health monitoring system is described below in a specific embodiment. The workflow generally consists of five steps: initialization, wearing and adjustment, data acquisition, transmission and analysis, and early warning alerts.

[0050] Initialization step 1: Upon first use, the wearer scans the wearable device's QR code to bind the device via the mobile app, selects the flexible bladder model (S / M / L / XL), and the app automatically matches the recommended inflation pressure, for example, 0.25MPa is recommended for size M.

[0051] Step 2: Fitting and Adjustment: Secure the fitting 2 around the inside of the bra, ensuring the flexible bladder 3 fits snugly against the chest skin. If the fit is not tight, select manual / automatic inflation mode. In manual mode, press the elastic air bladder to inflate the flexible bladder 3, and observe the pressure indicator bar to see if the air pressure reaches the target pressure. In automatic mode, the APP sends an inflation command to the air pump, causing the air pressure inside the flexible bladder 3 to reach the target pressure.

[0052] The third step is data acquisition: Control component 6 synchronously acquires monitoring data from the temperature and pressure sensors in monitoring component 4 at a frequency of 1Hz. After acquisition, motion noise is eliminated using a Kalman filter algorithm, and the ambient temperature is corrected using a temperature compensation algorithm.

[0053] Step 4: Data Transmission and Analysis. Monitoring data is transmitted to a mobile app via Bluetooth. This app generates a two-dimensional heatmap based on the temperature monitoring data, with a color mapping range of 36.0 to 37.5°C. It also generates a hardness distribution map based on the pressure data, with a color mapping range of 0 to 30 kPa. The mobile app incorporates an intelligent analysis model based on the combined temperature and hardness characteristics. The main interface of the mobile app displays the temperature heatmap on the left, using a red-yellow-green gradient to represent increasing temperature, and the hardness distribution map on the right, using a blue-green-yellow gradient to represent increasing hardness. The top displays real-time temperature and pressure monitoring data, and the bottom includes function buttons for "Suspicious Area Marking," "Historical Data," and "Warning Records."

[0054] Step 5: Early Warning Prompts. The mobile app pushes real-time warning information based on the analysis results, such as "A suspicious lesion has been found in the upper outer quadrant of the left breast; it is recommended to seek medical attention within 7 days." Additionally, in long-term monitoring mode, the app can generate trend reports, such as "The average monthly temperature in a certain area has increased by 0.5℃, and the average monthly hardness has increased by 3 kPa," to help determine the progression of the lesion.

[0055] The preferred embodiments of this application have been described in detail above. However, this application is not limited to the specific details of the above embodiments. Within the scope of the technical concept of this application, various simple modifications can be made to the technical solution of this application, and these simple modifications all fall within the protection scope of this application.

[0056] It should also be noted that the various specific technical features described in the above embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, this application will not describe the various possible combinations separately.

[0057] Furthermore, various different embodiments of this application can be combined in any way, as long as they do not violate the spirit of this application, they should also be regarded as the content disclosed by this invention.

Claims

1. A wearable device for breast health monitoring, characterized in that, The wearable device includes: Cover (1); Wearing component (2) is disposed on the outside of the cover (1) for the wearer to wear the wearable device; A flexible bladder (3) is disposed inside the cover (1); The monitoring component (4) is disposed inside the flexible pouch (3) on the side close to the wearer's skin. When the flexible pouch (3) expands, it applies pressure to the monitoring component (4) so ​​that the monitoring component (4) exerts pressure on the wearer's breast.

2. The wearable device according to claim 1, characterized in that, The outer side of the cover (1) is provided with a waterproof coating, and the inner side is provided with a breathable mesh.

3. The wearable device according to claim 1, characterized in that, The wearable part (2) is an adhesive part that is fixed to the wearer's skin or clothing.

4. The wearable device according to claim 1, characterized in that, The flexible capsule (3) is made of double-layer thermoplastic polyurethane material, and the edges of the capsule are sealed by heat pressing.

5. The wearable device according to claim 1, characterized in that, The flexible capsule (3) uses a chitosan composite antibacterial membrane and the edges of the capsule are sealed by heat pressing.

6. The wearable device according to claim 1, characterized in that, The monitoring component (4) includes: a pressure sensor array and a temperature sensor array; The flexible capsule (3) has a groove on its inner side; The pressure sensor array is disposed in the groove of the flexible bladder (3); The temperature sensor array is attached inside the cover (1).

7. The wearable device according to claim 1, characterized in that, The wearable device also includes: The cyst body adjustment component (5) is used to inflate the flexible cyst (3).

8. The wearable device according to claim 7, characterized in that, The capsule adjustment component (5) includes: Air guiding device (51) and air filling device (52); One end of the air guiding device (51) is connected to the inflation device (52), and the other end is connected to the inflation valve of the flexible bladder (3). The inflation device (52) is used to inflate the flexible bladder (3).

9. The wearable device according to claim 7, characterized in that, The capsule adjustment component (5) includes: Injection pump and reservoir; One end of the injection pump is connected to the reservoir, and the other end is connected to the inlet valve of the flexible bladder (3). The injection pump is used to inject liquid into the flexible bladder (3).

10. The wearable device according to claim 1, characterized in that, The wearable device also includes: The control component (6) includes: a control module, a communication module, and a power supply module.

11. A breast health monitoring system, characterized in that, The system includes: a wearable device and a server as described in any one of claims 1-10.

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