Monitoring system and method for breast tissue

Abstract

The present disclosure provides a breast tissue monitoring system and method, and relates to the technical field of intelligent medical treatment. The method comprises: a sensor set in each preset subzone of breast tissue, the sensor set comprising an ultrasonic sensor, a pressure sensor and a temperature sensor, the sensor set being integrated into a wearable device through an integrated carrier; a first processor module for controlling the working state of the system; a second processor module for controlling the sensor set to collect data from the breast tissue and for controlling the excitation output of the ultrasonic sensor, a communication interface being arranged between the first processor module and the second processor module; the first processor module is further used for interacting with other electronic devices, the interaction comprising outputting and / or storing the collected data. The present disclosure integrates different types of sensors into the same wearable device to collect data, thereby helping to improve the accuracy of the monitoring system.

Description

Technical Field

[0001] This disclosure relates to the field of smart healthcare technology, and in particular to a monitoring system and method for breast tissue. Background Technology

[0002] In scenarios such as breast health monitoring, soft tissue condition observation, and home follow-up, ultrasound is usually applied to the skin surface using a single-point echo method.

[0003] Compared to desktop ultrasound equipment, adhesive or mobile devices are more susceptible to changes in the coupling medium, fluctuations in contact pressure, posture deviations, and ambient temperature drift, causing differences in echo amplitude, peak position, spectral characteristics, and background noise, thus affecting the accuracy of cross-time period or cross-batch comparisons. Therefore, a more accurate adhesive breast health monitoring solution is urgently needed. Summary of the Invention

[0004] In view of this, the purpose of this disclosure is to provide a monitoring system and method for breast tissue, which can specifically solve existing problems.

[0005] Based on the above objectives, in a first aspect, this disclosure proposes a breast tissue monitoring system, comprising: a sensor set in each preset partition of the breast tissue, the sensor set including an ultrasound sensor, a pressure sensor, and a temperature sensor, the sensor set being integrated into a wearable device via an integration carrier; a first processor module for controlling the operating state of the system; a second processor module for controlling the sensor set to collect data from the breast tissue and to excite the ultrasound sensor, a communication interface being provided between the first processor module and the second processor module; the first processor module is further configured to interact with other electronic devices, the interaction including outputting and / or storing the collected data, the data including pressure, temperature, and echoes of ultrasound waves emitted by the ultrasound sensor.

[0006] Secondly, a method for monitoring breast tissue is also provided, applied to the system as described in any one of the first aspects; the method includes: encapsulating the system output data according to a unified timestamp and saving it as a data frame; in response to a data frame processing instruction, reading the stored data frame, performing frame sequence reconstruction of the data frame to obtain a reconstructed data frame; preprocessing the echo reconstructed data frame corresponding to the echo in the reconstructed data frame and extracting the envelope to obtain the echo amplitude profile; extracting features from the echo reconstructed data frame, the echo amplitude profile, the pressure reconstructed data frame, and the temperature reconstructed data frame; and fusing the extracted features between different modes to obtain monitoring result information for each preset partition.

[0007] Thirdly, an electronic device is also provided, including a memory, a processor, and a computer program stored in the memory and executable on the processor, the processor running the computer program to implement the method of the first aspect.

[0008] Fourthly, a computer-readable storage medium is also provided, on which a computer program is stored, the computer program being executed by a processor to implement the method described in any one of the first aspects.

[0009] Fifthly, a computer program product is also provided, comprising a computer program that is executed by a processor to implement the method described in any one of the first aspects.

[0010] In summary, this disclosure has at least the following beneficial effects: by integrating different types of sensors into the same wearable device to collect data, comprehensive multimodal data collection of breast tissue can be achieved, which helps to improve the accuracy of the monitoring system. Attached Figure Description

[0011] In the accompanying drawings, unless otherwise specified, the same reference numerals throughout the various drawings denote the same or similar parts or elements. These drawings are not necessarily drawn to scale. It should be understood that these drawings depict only some embodiments disclosed in this disclosure and should not be construed as limiting the scope of this disclosure.

[0012] Figure 1 A schematic diagram of a breast tissue monitoring system according to an embodiment of the present disclosure is shown. Figure 2 A flowchart of a method for monitoring breast tissue according to an embodiment of the present disclosure is shown; Figure 3a A schematic diagram of a sensor in a method for monitoring breast tissue according to an embodiment of the present disclosure is shown; Figure 3b A schematic diagram of the layout of distributed sensors in a partition according to an embodiment of the present disclosure is shown; Figure 4a A schematic diagram of the signal link of the hardware acquisition and control system according to an embodiment of the present disclosure is shown; Figure 4b Another flowchart of a method for monitoring breast tissue according to an embodiment of the present disclosure is shown; Figure 5 A schematic diagram of the structure of an electronic device provided in an embodiment of the present disclosure is shown; Figure 6 A schematic diagram of a storage medium provided according to an embodiment of the present disclosure is shown. Detailed Implementation

[0013] The present disclosure will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the invention. Furthermore, it should be noted that, for ease of description, only the parts relevant to the invention are shown in the accompanying drawings.

[0014] It should be noted that, unless otherwise specified, the embodiments and features described in this disclosure can be combined with each other. This disclosure will now be described in detail with reference to the accompanying drawings and embodiments.

[0015] Figure 1 A breast tissue monitoring system of the present disclosure is illustrated. In an embodiment of the present disclosure, the system includes: a sensor set in each predetermined partition of the breast tissue, a first processor module, and a second processor module.

[0016] The system includes a sensor set in each predetermined region of the breast tissue, comprising an ultrasound sensor, a pressure sensor, and a temperature sensor, integrated into a wearable device via an integrated carrier; a first processor module for controlling the system's operating state; a second processor module for controlling the sensor set to collect data from the breast tissue and to excite the ultrasound sensor; a communication interface is provided between the first and second processor modules; the first processor module is also used to interact with other electronic devices, the interaction including outputting and / or storing the collected data, including pressure, temperature, and echoes of ultrasound waves emitted by the ultrasound sensor.

[0017] In this embodiment, the unilateral mammary gland can be divided into four quadrants centered on the nipple: upper outer, upper inner, lower outer, and lower inner. The direction from the center of the two breasts outwards is considered the "inner" direction. This invention employs a multi-point coverage approach, deploying a set of multimodal sensing units in each quadrant, with four quadrants corresponding to four sets of sensing units, thereby achieving multimodal coverage monitoring of the entire mammary gland. The carrier can be a flexible carrier that conforms to the breast tissue, such as a bra.

[0018] Each multimodal sensing unit in each zone includes at least: one flexible single-channel A-mode ultrasonic sensor, two flexible pressure sensors, and at least two flexible temperature sensors.

[0019] Specifically, the acquisition and control system is used to uniformly drive and acquire data from the attached multimodal sensing device, and then encapsulates the acquired data and outputs it to the wireless communication and terminal display side. The hardware system adopts a dual-processor architecture, which may include not only a first processor module and a second processor module, but also multimodal signal conditioning and interface circuits, transducer drive interfaces, power management modules, and radio frequency antenna units. The modules work together through high-speed data communication interfaces and electrical connections.

[0020] The first processor module is used for main control management and wireless communication, and is responsible for functions such as device operating status management, data caching, packetization, wireless protocol stack interaction with terminals, etc. The first processor module is electrically connected to the radio frequency antenna unit to complete wireless transmission and reception.

[0021] The second processor module is used for sensor acquisition and control, responsible for the excitation timing control of the ultrasonic transducer, acquisition link control, temperature-pressure sampling control, and timing organization of acquired data. A high-speed data communication interface is set between the first and second processor modules to transmit the multimodal data acquired by the second processor to the first processor module with high bandwidth, so as to meet the real-time or near-real-time transmission requirements of ultrasonic echo data.

[0022] The system is equipped with a transducer drive interface. The second processor module outputs an excitation control signal, which, through the transducer drive interface, forms an excitation pulse to drive the flexible ultrasonic sensor unit, achieving Mode A ultrasonic transmission. After receiving the echo, the ultrasonic sensor outputs an echo signal. This echo signal enters the multimodal signal conditioning and interface circuit, where necessary protection, filtering, and amplification are performed, forming an electrical signal suitable for subsequent sampling, i.e., data acquisition. The sampling and digitization of the echo signal can be achieved using the analog-to-digital conversion resources within the second processor module, or by the analog-to-digital conversion unit in the multimodal signal conditioning and interface circuit. This invention does not limit the specific integration location of the analog-to-digital conversion, but emphasizes that it should meet the bandwidth and sampling requirements for Mode A echo acquisition.

[0023] Temperature and pressure sensors serve as auxiliary modal signal sources, connected to the multimodal signal conditioning and interface circuit. After necessary signal conditioning, the signals are output to the second processor module for sampling and reading. The temperature / pressure sampling interface can be analog or digital; this invention does not limit the specific interface form, but it should meet the requirements of unified recording and data organization within the same acquisition cycle as the ultrasonic echo data.

[0024] For the four sets of multimodal combination nodes arranged in the four zones of the breast, the second processor module can use a multiplexed scanning method to sequentially excite and acquire echoes from the ultrasound measurement points in each zone, and simultaneously or quasi-synchronously read the pressure and temperature samples corresponding to that zone. Alternatively, independent acquisition channels can be configured for each zone's measurement points for parallel acquisition. Both of these channel organization methods are within the scope of protection of this invention. After the acquired multimodal data is initially organized by the second processor module, it is sent to the first processor module for further encapsulation and output through a high-speed data communication interface.

[0025] After receiving the acquired signal data uploaded by the second processor module, the first processor module can encapsulate it according to a preset data structure and send it to the terminal via a wireless link according to the communication strategy, or write it to a local cache / storage unit for subsequent reading. This invention does not limit the specific format of the encapsulated fields, but supports the differentiation and traceability of different partitions, different modes, and acquisition timing.

[0026] A channel refers to a channel identifier in the sense of data acquisition organization: it is used to distinguish "which partition, which measurement point, which mode (e.g., ultrasound, pressure, temperature), and which sensor number" is the data source. The system may use multiplexed scanning or parallel acquisition. Regardless of the physical implementation, the acquired data frames need a "channel identifier" for parsing and reconstruction. The channel identifier includes at least the partition number and mode type, and optionally also the sensor number within that mode.

[0027] In some optional implementations of any embodiment of this disclosure, the ultrasound sensor is used to emit ultrasound waves to the breast tissue in a single channel and receive the echo; the pressure sensor is used to acquire adhesion pressure information attached to the breast tissue, the adhesion pressure information being used to indicate adhesion stability; and the temperature sensor is used to monitor the temperature of the breast tissue.

[0028] For example, a flexible single-channel A-mode ultrasound sensor is placed at the center or a representative location of each zone as the main acoustic acquisition point for that zone, thereby acquiring A-mode echo information of the corresponding area. This ultrasound sensor is integrated onto a flexible carrier that can adhere to the surface of breast tissue and adapt to the soft, curved shape of the skin, reducing the risk of adhesion instability caused by local lifting or deformation.

[0029] Two flexible pressure sensors are placed beside the ultrasound sensor in each zone, and the two pressure sensors are arranged vertically (or equivalently longitudinally) relative to each other in a direction approximately perpendicular to the breast axis, forming a "vertically distributed dual pressure point" structure. This structure allows for the simultaneous sensing of changes in the adhesion contact pressure level and adhesion stability in the vicinity of the ultrasound measurement point, providing a characterization basis for adhesion conditions such as tightness, local slippage, or uneven pressure. The two pressure sensors can be located on one side of the ultrasound unit, or symmetrically arranged on both sides of the ultrasound sensor depending on the structural space; this invention does not limit this arrangement.

[0030] Considering the small size and flexible deployment of temperature sensors, multiple flexible temperature sensors are arranged along the local axis of the breast on the attachment carrier. These sensors are equidistantly distributed along the axis at a preset spacing to form a longitudinal sampling of the breast surface temperature field. Furthermore, temperature sensors can be added to areas of the breast or edge regions not monitored by other sensors within the designated area, without affecting the arrangement of ultrasound and pressure sensors. This further fills the sampling points and increases the temperature coverage density, thus more completely reflecting changes in temperature background, local temperature rise, or environmental drift during wear. This invention does not limit the specific number or spacing of temperature sensors; they can be configured according to breast size, wearable carrier size, and actual application requirements.

[0031] Four groups of multimodal sensing units are integrated onto a flexible silicone bra or an equivalent flexible attachment carrier, ensuring that the relative positions of each sensor are fixed and traceable. During wear, the carrier completes overall positioning, thereby improving consistency across repeated wear and the comparability of zoned measurement points. This zoned positioning can establish a wearing coordinate system using a body surface reference, defining the vertical / internal / external directions using the nipple as a local reference and combining it with the chest wall direction. Alternatively, an equivalent repeatable positioning method can be used to achieve consistency across multiple wears; this invention does not limit the selection of specific positioning markers.

[0032] This invention integrates different types of sensors into the same wearable device to collect data, thereby enabling comprehensive multimodal data collection of breast tissue and helping to improve the accuracy of the monitoring system.

[0033] In some optional implementations of any embodiment of this disclosure, the ultrasonic sensor is a flexible ultrasonic sensor, which includes: an ultrasonic transducer structure for transmitting and receiving ultrasonic echoes; electrodes connected to system pads via flexible wiring for electrical connection with the second processor module, wherein the electrode structure has a top-bottom symmetrical and left-right symmetrical distribution configuration; a flexible substrate layer for supporting the electrodes and the wiring structure associated with the electrodes; and a protective layer and skin adhesion structure for insulating and protecting breast tissue and for securing the system in place.

[0034] A flexible substrate layer can provide bendable support. Electrodes can be positioned in the transducer region. This transducer region is the effective working area in the flexible single-channel A-mode ultrasonic sensor that achieves electro-acoustic or acoustic-electric conversion. Alternatively, this transducer region can also be understood as the effective vibration zone of the acoustic aperture, typically corresponding to the effective excitation and reception area formed by the overlap of the piezoelectric material layer and the upper and lower electrodes. Positioning the electrodes in the transducer region means that the electrodes are arranged around or cover this effective area. The transducer region is the effective ultrasonic emission and echo reception area formed by the overlap of the piezoelectric layer and the electrodes, located in the central functional area of ​​the flexible ultrasonic unit.

[0035] A pad refers to an electrical connection pad on a flexible ultrasonic sensor unit (or a flexible substrate and an FPC). It is used to bring out the electrodes or traces of the unit and electrically connect them to the acquisition and control module, for example, through soldering, connectors, or ribbon cables. It is the lead-out pad for the sensor electrode traces, generally located at the edge of the flexible substrate or at the lead-out "tail," facilitating connection and avoiding interference with attachment and the acoustic working area. The pad is preferably located in the edge lead-out area of ​​the flexible substrate, i.e., the non-transducer area, for electrical connection to the external acquisition and control module via connectors or ribbon cables.

[0036] The electrode structure of the flexible ultrasonic sensor adopts a symmetrical distributed configuration, with the electrode areas arranged symmetrically within the transducer region and converged to the lead-out end via wiring. This symmetrical electrode arrangement effectively utilizes the transducer region while meeting the requirements of single-channel excitation and echo reception. Experiments show that this electrode configuration reduces the amount of piezoelectric material used and maintains good echo response performance while ensuring good response. This invention does not limit the specific geometric dimensions and spacing of the electrodes; the electrodes can be configured according to the transducer structure implementation, but should meet the requirements of manufacturability on a flexible substrate, reliable electrical connection, and stable operation under bending conditions.

[0037] In some optional implementations of any embodiment of this disclosure, the pressure sensor is a flexible pressure sensor, the pressure sensor adopts an interdigitated electrode structure, and the effective electrode edge and the working path length of the interdigitated electrode structure are greater than a first preset value and a second preset value, respectively; the temperature sensor is a flexible temperature sensor, the temperature sensor electrode adopts a serpentine structure, the serpentine structure is a stretchable interconnected configuration, and the target reference resistance of the electrode is determined by the extendable conductor path of the serpentine structure.

[0038] In these implementations, to enhance the ability to sense the adhesion status and changes in skin temperature, pressure sensors and temperature sensors are arranged near each flexible ultrasound sensor (within a preset distance) to form a near-field auxiliary measurement structure around the ultrasound monitoring point, which corresponds to the system layout of "four-zone four-group combination nodes of the breast".

[0039] Both the pressure and temperature sensors employ flexible, attachable electrode configurations. The flexible pressure sensor utilizes an interdigitated electrode structure. By increasing the effective electrode edge and the length of the action path, interdigitated electrodes enhance the measurability of electrical signal changes within a limited area, thereby improving pressure sensing sensitivity. This is suitable for monitoring minute pressure fluctuations and changes in contact state in breast implantation scenarios. The flexible temperature sensor employs a serpentine structure as a commonly used configuration for stretchable interconnects. The serpentine conductor extends the conductor path within a limited area to obtain the target reference resistance and can disperse strain during bending or stretching, improving reliability. This is suitable for stable temperature acquisition under repeated bending and micro-deformation conditions during wearable application.

[0040] Pressure sensors are used to characterize changes in contact pressure, adhesion stability, or coupling state. Temperature sensors are used to characterize skin surface temperature, ambient temperature, or local temperature drift. This invention does not limit the specific implementation type of the temperature and pressure sensors, such as piezoresistive, capacitive pressure sensors, thermistor, thin-film resistive, or integrated temperature sensors, nor does it limit the specific size parameters of their electrodes, but emphasizes that their electrode structure and packaging should meet the size, flexibility, reliability, and stability requirements of flexible wearable applications.

[0041] Adhesion refers to whether the device is attached to the skin and how firmly it adheres; this is a macroscopic contact relationship. Coupling refers to the quality of ultrasound energy transmission from the transducer into the tissue, determining whether the echo can be stable and comparable. It focuses more on whether the interface conditions are consistent. The coupling state refers to the acoustic transmission conditions between the transducer's exit surface and the tested tissue; changes in these conditions include variations in the coupling layer thickness, air bubble gaps, contact pressure, and incident angle, which lead to changes in echo amplitude and time structure.

[0042] Pressure sensors are used to characterize changes in contact pressure, adhesion stability, or coupling state. Temperature sensors are used to characterize skin surface temperature, ambient temperature, or local temperature drift. This invention does not limit the specific implementation type of the temperature and pressure sensors, such as piezoresistive, capacitive pressure sensors, thermistor, thin-film resistive, or integrated temperature sensors, nor does it limit the specific size parameters of their electrodes. However, the electrode structure and packaging in this invention should meet the requirements of size, flexibility, reliability, and stability in flexible wearable application scenarios.

[0043] In some optional implementations of any embodiment of this disclosure, the system further includes: a power management module, used to provide power to other modules in the system and perform voltage regulation management; the power management module is specifically used to perform at least one of the following functions: battery power supply, charge and discharge management, voltage regulation and conversion between circuits, power consumption control and power supply safety protection; and to wake up the execution of the function corresponding to the task according to the acquisition task and communication task; the wearable device operates in a low-power operation mode.

[0044] In these optional implementations, a power management module is uniformly included to provide power supply and voltage regulation for the first processor module, the second processor module, the multi-mode signal conditioning and interface circuit, the transducer drive interface, and the RF antenna-related circuits. The power management module may include battery power supply, charge / discharge management, DC-DC / LDO voltage regulation conversion, power consumption control, and safety protection units to support low-power operation and wearability safety of the wearable device. Both the first and second processor modules can enter a low-power operating mode. The power management module manages wake-up and power supply strategies based on the data acquisition and communication tasks. Specifically, the power management module adopts different wake-up or power supply strategies according to different task types. For example, when a data acquisition task arrives, the processors, front-end, and drive links related to data acquisition are woken up. When a communication task arrives, the wireless and main control packet transmission modules are woken up, while modules not involved remain in low power. The power management module wakes up the corresponding functional modules according to the data acquisition or communication task, while modules not involved in the task remain in sleep or low power mode.

[0045] In some optional implementations of any embodiment of this disclosure, the first processor module is electrically connected to the radio frequency antenna unit for wirelessly transmitting the collected data to the terminal and interacting with the wearable device, the data interaction including parameter configuration and status query.

[0046] The first processor module integrates wireless communication functionality and is electrically connected to the radio frequency antenna unit, enabling wireless transmission of collected data to the terminal and interaction between the terminal and the device, such as parameter configuration and status query. This invention can employ low-power wireless communication methods such as Bluetooth for data reporting in continuous wear scenarios, and can be expanded to other wireless methods such as Wi-Fi when needed; the specific communication standard is not limited.

[0047] The terminal interaction module can be a mobile application, tablet, dedicated receiving terminal, or cloud platform, used to display wearing status, record monitoring data, and provide a historical query interface. The terminal can receive multimodal acquisition data and device status information from the first processor module, and send necessary control commands back to the device to realize interactive functions such as acquisition start / stop, mode switching, and parameter setting.

[0048] Figure 2 A method for monitoring breast tissue according to an embodiment of the present disclosure is shown. Applied to the system as described in any one of claims 1-5; the method includes: Step S201: Encapsulate the system output data according to a unified timestamp and save it as a data frame; Step S202: In response to the data frame processing instruction, read the stored data frame, and perform frame sequence reconstruction of the data frame to obtain a reconstructed data frame; Step S203: Preprocess the echo reconstructed data frame corresponding to the echo in the reconstructed data frame and extract the envelope to obtain the echo amplitude profile; Step S204: Extract features from the echo reconstructed data frame, the echo amplitude profile, the pressure reconstructed data frame, and the temperature reconstructed data frame; Step S205: Fuse the extracted features between different modes to obtain the monitoring result information of each preset partition.

[0049] The monitoring results are quantitative indicators that characterize the likelihood of abnormal changes in the monitored breast or soft tissue.

[0050] In some optional implementations of this embodiment, the step of preprocessing and extracting the envelope of the echo reconstructed data frame corresponding to the echo in the reconstructed data frame to obtain the echo amplitude profile includes: when the wearable device has been worn, analyzing the reconstructed data frame corresponding to the attachment pressure information collected by the pressure sensor; if the analysis result indicates that the attachment stability is strong, performing preprocessing and extracting the envelope of the echo reconstructed data frame corresponding to the echo in the reconstructed data frame to obtain the echo amplitude profile.

[0051] If the adhesion pressure information does not exceed the corresponding threshold, it indicates that the adhesion stability is strong.

[0052] Optionally, the attachment pressure information includes at least one of the following: pressure magnitude, pressure fluctuation amplitude, and pressure change rate; the method further includes: if the analysis result indicates that the reconstructed data frame corresponding to any one of the pressure magnitude, the pressure fluctuation amplitude, and the pressure change rate exceeds the corresponding threshold, marking the reconstructed data frame exceeding the corresponding threshold as low confidence or removing the reconstructed data frame.

[0053] In some optional implementations of this embodiment, if the sampling rates of different sensors in the sensor set are different, the temperature reconstruction data frame, pressure reconstruction data frame and echo reconstruction data frame in the reconstructed data frame are aligned under the same time reference, and the alignment includes interpolation processing and / or resampling processing.

[0054] In some optional implementations of this embodiment, the feature extraction from the echo reconstruction data frame, the echo amplitude profile, the pressure reconstruction data frame, and the temperature reconstruction data frame includes: extracting at least one of the following acoustic features from the echo reconstruction data frame and the echo amplitude profile: peak position, peak amplitude, peak width, energy distribution, attenuation slope, and number of peaks; extracting attachment stability features and contact state features from the pressure reconstruction data frame; and extracting absolute temperature features and temperature drift features from the temperature reconstruction frame.

[0055] Specifically, the system encapsulates and saves the ultrasonic echo, temperature, and pressure data from each zone into multimodal data frames using a unified timestamp. The algorithm processes these stored data frames as input, eliminating the need for real-time participation during the acquisition process. The specific steps include: Data Reading and Frame Reassembly: Read data frames from each partition from the storage medium / host computer database, complete data integrity verification, channel identifier resolution, and frame sequence reassembly. If necessary, interpolate / resample data at different sampling rates to align temperature, pressure, and echo data on the same time reference.

[0056] Adhesion quality assessment and invalid frame rejection: Adhesion stability is assessed based on indicators such as pressure amplitude range, pressure fluctuation amplitude, and pressure change rate. When the pressure is too low, too high, or fluctuates rapidly, the corresponding data frame is marked as low confidence or rejected, and a "re-adhesion / retest required" prompt is given at the output.

[0057] Temperature compensation and depth calibration: The echo depth axis is compensated based on the effect of temperature on sound speed and propagation time delay. Optionally, the echo flight time is converted into an equivalent depth / structure position (e.g., calculated using a sound speed and round-trip propagation model) to reduce peak position drift caused by temperature variations across time periods, thereby improving the consistency of historical comparisons.

[0058] Ultrasonic echo preprocessing and envelope extraction: For each measurement point, the A-mode echo undergoes preprocessing including DC offset removal, amplitude normalization, and noise suppression (optional filtering). Further envelope analysis is performed to obtain a stable echo amplitude profile, providing robust input for subsequent peak detection and energy statistics.

[0059] Feature extraction: Acoustic features such as peak position, peak amplitude, peak width, energy distribution, attenuation slope, and number of peaks are extracted from the envelope and original echo. Adhesion stability and contact state features are extracted from the pressure signal. Absolute temperature and temperature drift features are extracted from the temperature signal, forming a zone-level feature vector.

[0060] Multimodal fusion, trend analysis, and anomaly detection: Weighted fusion of three modal features yields comprehensive monitoring results and their temporal trends at the zonal level. The fusion process employs a combination of time-delay correlation and morphological features to achieve robust detection. Furthermore, a continuous multi-frame consistency constraint is introduced to suppress false alarms caused by sporadic noise and attachment disturbances. The final output includes anomaly zoning alerts, risk levels, and trend indicators.

[0061] Among them, the time trend involves arranging key indicators of a specific region, such as regional monitoring results, peak positions, and energy characteristics, into a time sequence and observing their direction and magnitude of change over time. This includes aspects such as continuous increase or decrease, slope, moving average, and degree of deviation from the baseline. This is used for trend judgment and early warning in continuous monitoring. The time trend can be calculated from a sequence of monitoring results measured over multiple consecutive frames or multiple times, and includes, but is not limited to, moving averages, slopes, and relative baseline offsets.

[0062] Time-delay correlation quantities refer to the displacement / delay characteristics of ultrasound echoes on the time axis, either as a whole or for key structures. Examples include the time of arrival (TOF) or peak position change of the main or characteristic peak. The time shift (lag) is obtained by correlating / matching the current echo with the baseline echo. These are "characteristic quantities" used for fusion and discrimination. The time-delay correlation quantities include the characteristic peak arrival time, peak position shift, or the time shift obtained by correlating and matching the echo with the baseline.

[0063] The "continuous multi-frame consistency constraint" primarily constrains the temporal consistency of anomaly detection-related outputs or key features to suppress sporadic noise. For example, it constrains the triggering of zone monitoring results only after N consecutive frames exceeding a threshold; it constrains key echo features, such as peak position, peak amplitude, energy distribution, and attenuation indicators, to exhibit consistent changes across multiple consecutive frames; it can also be combined with attachment quality (pressure gating) to downweight and remove low-confidence frames. The consistency constraint acts on zone monitoring results and / or key echo features, requiring anomalies to meet consistency conditions before an alarm is output.

[0064] This disclosure also provides a breast tissue monitoring system capable of performing distributed multimodal attachment monitoring of the four quadrants of the breast.

[0065] This system is a wearable device comprising four flexible single-channel Mode A ultrasound sensor units, positioned at the center or representative locations of the four quadrants of the breast: upper outer, upper inner, lower outer, and lower inner. Temperature and pressure sensors are placed adjacent to each ultrasound unit, forming four sets of combined ultrasound-temperature-pressure measurement points. These four sets of measurement points form an integrated patch structure via a flexible substrate or carrier, allowing for multi-point coverage of the entire breast with a single positioning step when wearing the device.

[0066] The patch structure may include a skin-side adhesive layer, a flexible substrate support layer, and an outer protective layer. The skin-side adhesive layer is used to achieve stable adhesion and improve consistency during repeated wear; the flexible substrate is used to support the ultrasonic electrodes and wiring, as well as the temperature / pressure sensor connections. The outer protective layer is used for insulation and to prevent sweat intrusion. This invention does not limit the material and structure of the adhesive layer, but it should meet the requirements of wearability comfort and long-term wear safety.

[0067] This embodiment provides a data acquisition and control module. The data acquisition and control module includes: The ultrasonic excitation drive circuit and echo receiving front-end circuit are used to excite and receive the echoes of the four flexible ultrasonic units; the analog-to-digital conversion circuit is used to digitize the echo signals; the temperature and pressure sampling interface is used to acquire the temperature and pressure signals corresponding to the four sets of combined measurement points; the control and processing unit is used to manage the acquisition sequence, trigger control, data encapsulation and communication; the communication interface and local storage unit are used for data transmission and necessary cache records.

[0068] In this embodiment, the channel organization for the four ultrasonic measurement points can adopt a polling scanning method: the control processing unit sequentially excites and acquires echoes from each ultrasonic unit according to a preset order, and reads the corresponding temperature and pressure data simultaneously with or within adjacent time windows and packages them into the same recording unit. Alternatively, a multi-channel parallel acquisition method can be used to achieve higher temporal resolution; this invention is not limited to this approach.

[0069] In this example, the system algorithm and data processing can be implemented according to the following process: (1) Data reading and sequence reconstruction: Read the storage / cache record units, sort and reconstruct them into a four-quadrant time series according to "partition number + timestamp"; mark and remove lost frames, out-of-order data, and abnormal timestamp data.

[0070] (2) Adhesion quality gate and invalid rejection: Pressure is used as the adhesion criterion to check the pressure range, fluctuation and sudden change; if the pressure is too low, it is judged as insufficient coupling, if it is too high, it is judged as excessive pressure, and fluctuation / sudden change is judged as unstable contact; invalid or low confidence records are not included in the judgment, and only "re-attach / retest is required" is output.

[0071] (3) Temperature compensation and depth alignment: Based on the calibrated "temperature-velocity of sound" relationship or by looking up a table, the echo delay is compensated, the propagation time is converted into equivalent depth and aligned, and the peak position drift caused by temperature drift is reduced.

[0072] (4) Echo preprocessing and envelope acquisition: The effective echo is de-DC, normalized and optionally denoised, and the envelope is extracted as a stable amplitude profile for subsequent peak and energy analysis.

[0073] (5) Acoustic feature extraction: For “new / enhanced reflection peaks, peak position shift, and abnormal post-peak attenuation”, extract the main peak position / amplitude / peak width / number of peaks, as well as windowed energy, energy distribution and post-peak attenuation index.

[0074] (6) Baseline establishment and zonal comparison: Individual baselines are established using data from the stable period of attachment; the four quadrant features are compared at the same time to highlight local anomalies and suppress the interference of global attachment changes.

[0075] (7) Fusion and anomaly triggering: Fusion of acoustic anomaly degree and attachment / temperature state to form zoning risk indicators and perform trend analysis; weighting by attachment quality, combined with continuous consistency constraints, outputting zoning anomaly and risk level when conditions are met.

[0076] (8) Output and record: Output the risk trend of each quadrant, attached status prompts, abnormal time and partition number and corresponding depth / feature summary, and save the results for retesting and comparison and long-term tracking.

[0077] This embodiment employs a four-quadrant breast coverage layout to achieve multi-point acquisition of common breast areas of interest, improving coverage of local changes and enhancing the comparability of repeated home-based monitoring. A flexible single-channel mode A ultrasound sensor unit is used to improve adhesion and adaptability to curved skin surfaces, reducing the risk of coupling instability caused by local lifting or slippage. Temperature and pressure sensors are placed in the near field at each ultrasound measurement point to simultaneously reflect adhesion contact and temperature conditions, providing a more complete data foundation for subsequent data processing and early warning. The system hardware architecture is modular, facilitating wearable integration, low-power implementation, and terminal expansion deployment.

[0078] like Figure 3a As shown in the figure, a schematic diagram of the sensor structure is presented.

[0079] like Figure 3b As shown in the figure, a schematic diagram of the layout of distributed sensors in the partition is presented.

[0080] like Figure 4a The diagram shows a schematic of the signal link in the hardware acquisition and control system.

[0081] like Figure 4b The diagram shows a flowchart of the monitoring process for breast tissue.

[0082] This disclosure provides a breast tissue monitoring device for performing the breast tissue monitoring method described in the above embodiments.

[0083] The breast tissue monitoring device and the breast tissue monitoring method provided in the above embodiments of this disclosure are based on the same inventive concept and have the same beneficial effects as the methods adopted, run or implemented by the applications stored therein.

[0084] This disclosure also provides an electronic device corresponding to the breast tissue monitoring method provided in the foregoing embodiments, for performing the aforementioned breast tissue monitoring method. This disclosure is not limiting.

[0085] Please refer to Figure 5 This illustrates a schematic diagram of an electronic device provided by some embodiments of the present disclosure. For example... Figure 5 As shown, the electronic device 50 includes: a processor 500, a memory 501, a bus 502, and a communication interface 503. The processor 500, the communication interface 503, and the memory 501 are connected via the bus 502. The memory 501 stores a computer program that can run on the processor 500. When the processor 500 runs the computer program, it executes the method provided in any of the foregoing embodiments of this disclosure.

[0086] The memory 501 may include high-speed random access memory (RAM) or non-volatile memory, such as at least one disk storage device. Communication between this system network element and at least one other network element is achieved through at least one communication interface 503 (which can be wired or wireless), such as the Internet, wide area network, local area network, or metropolitan area network.

[0087] Bus 502 can be an ISA bus, PCI bus, or EISA bus, etc. The bus can be divided into an address bus, a data bus, a control bus, etc. The memory 501 is used to store programs. After receiving an execution instruction, the processor 500 executes the program. The breast tissue monitoring method disclosed in any of the foregoing embodiments of this disclosure can be applied to the processor 500, or implemented by the processor 500.

[0088] The processor 500 may be an integrated circuit chip with signal processing capabilities. In implementation, each step of the above method can be completed by the integrated logic circuitry in the hardware of the processor 500 or by instructions in software form. The processor 500 may be a general-purpose processor, including a central processing unit (CPU), a network processor (NP), etc.; it may also be a digital signal processor (DSP), an application-specific integrated circuit (ASIC), an off-the-shelf programmable gate array (FPGA), or other programmable logic devices, discrete gate or transistor logic devices, or discrete hardware components. It can implement or execute the methods, steps, and logic block diagrams disclosed in the embodiments of this disclosure. The general-purpose processor may be a microprocessor or any conventional processor. The steps of the methods disclosed in the embodiments of this disclosure can be directly embodied in the execution of a hardware decoding processor, or executed by a combination of hardware and software modules in the decoding processor. The software modules may reside in random access memory, flash memory, read-only memory, programmable read-only memory, electrically erasable programmable memory, registers, or other mature storage media in the art. The storage medium is located in memory 501. The processor 500 reads the information in memory 501 and, in conjunction with its hardware, completes the steps of the above method.

[0089] The electronic device provided in this disclosure and the breast tissue monitoring method provided in this disclosure are based on the same inventive concept and have the same beneficial effects as the methods they employ, operate, or implement.

[0090] This disclosure also provides a computer-readable storage medium corresponding to the breast tissue monitoring method provided in the foregoing embodiments. Please refer to... Figure 6 The computer-readable storage medium shown is an optical disc 60, on which a computer program (i.e., a program product) is stored. When the computer program is run by a processor, it executes the breast tissue monitoring method provided in any of the foregoing embodiments.

[0091] It should be noted that examples of the computer-readable storage medium may also include, but are not limited to, phase-change memory (PRAM), static random access memory (SRAM), dynamic random access memory (DRAM), other types of random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other optical and magnetic storage media, which will not be elaborated here.

[0092] The computer-readable storage medium provided in the above embodiments of this disclosure and the breast tissue monitoring method provided in the embodiments of this disclosure are based on the same inventive concept and have the same beneficial effects as the methods adopted, run or implemented by the applications stored therein.

[0093] It should be noted that: In the foregoing text, the terms "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. Furthermore, it should be noted that the scope of the methods and apparatuses in this disclosure is not limited to performing functions in the order shown or discussed, but may also include performing functions substantially simultaneously or in the reverse order, depending on the functions involved. For example, the described methods may be performed in a different order than described, and various steps may be added, omitted, or combined. Additionally, features described with reference to certain examples may be combined in other examples.

[0094] Through the above description of the embodiments, those skilled in the art can clearly understand that the methods of the above embodiments can be implemented by means of software plus necessary general-purpose hardware platforms. Of course, they can also be implemented by hardware, but in many cases the former is a better implementation method. Based on this understanding, the technical solution of this disclosure, in essence, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product is stored in a storage medium (such as ROM / RAM, magnetic disk, optical disk), and includes several instructions to cause a terminal (which may be a mobile phone, computer, server, air conditioner, or network device, etc.) to execute the methods described in the various embodiments of this disclosure.

[0095] The embodiments of this disclosure have been described above with reference to the accompanying drawings. These are merely specific implementations of this disclosure, but this disclosure is not limited to the specific implementations described above. The specific implementations described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this disclosure without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of this disclosure.

Claims

1. A monitoring system for breast tissue, characterized in that, include: A sensor set in each predetermined region of breast tissue, the sensor set including an ultrasound sensor, a pressure sensor and a temperature sensor, the sensor set being integrated into a wearable device via an integration carrier; The first processor module is used to control the operating state of the system; The second processor module is used to control the sensor set to collect data from the breast tissue and to excite the ultrasound sensor. A communication interface is provided between the first processor module and the second processor module. The first processor module is also used to interact with other electronic devices, the interaction including outputting and / or storing acquired data, the data including pressure, temperature and echoes of ultrasonic waves emitted by the ultrasonic sensor.

2. The method according to claim 1, characterized in that, The ultrasound sensor is used to emit ultrasound waves into the breast tissue in a single channel and receive the echo. The pressure sensor is used to acquire the adhesion pressure information attached to the breast tissue, and the adhesion pressure information is used to indicate the adhesion stability. The temperature sensor is used to monitor the temperature of the breast tissue.

3. The method according to claim 1, characterized in that, The ultrasonic sensor is a flexible ultrasonic sensor, and the ultrasonic sensor shown includes: An ultrasonic transducer structure is used for transmitting and receiving ultrasonic echoes. The electrodes are connected to the system pads via flexible traces to be electrically connected to the second processor module. The electrode structure has a top-bottom symmetrical and left-right symmetrical distribution configuration. A flexible substrate layer is used to support the electrode and the wiring structure associated with the electrode; The protective layer is attached to the skin to provide insulation and protection for breast tissue, and to secure the system in place.

4. The method according to claim 1, characterized in that, The pressure sensor is a flexible pressure sensor, and the pressure sensor adopts an interdigital electrode structure. The effective electrode edge and the working path length of the interdigital electrode structure are greater than a first preset value and a second preset value, respectively. The temperature sensor is a flexible temperature sensor, and the electrodes of the temperature sensor adopt a serpentine structure. The serpentine structure is a stretchable interconnected configuration, and the target reference resistance of the electrodes is determined by the extendable conductor path of the serpentine structure.

5. The method according to claim 1, characterized in that, The system also includes: The power management module is used to provide power to other modules in the system and to perform voltage regulation management; The power management module is specifically used to perform at least one of the following functions: battery power supply, charge and discharge management, voltage regulation and conversion between circuits, power consumption control and power supply safety protection; and to wake up the execution of the function corresponding to the task according to the acquisition task and communication task. The wearable device operates in a low-power mode.

6. A method for monitoring breast tissue, characterized in that, Applied to the system as described in any one of claims 1-5; the method comprises: The system output data is encapsulated with a unified timestamp and saved as a data frame; In response to a data frame processing instruction, the stored data frame is read, and the frame sequence of the data frame is reassembled to obtain a reassembled data frame. Preprocess the echo reconstructed data frame corresponding to the echo in the reconstructed data frame and extract the envelope to obtain the echo amplitude profile; Features are extracted from the echo reconstruction data frame, the echo amplitude profile, the pressure reconstruction data frame, and the temperature reconstruction data frame; The extracted features are fused across different modalities to obtain monitoring results for each preset partition.

7. The method according to claim 6, characterized in that, The step of preprocessing and extracting the envelope of the echo reconstructed data frame corresponding to the echo in the reconstructed data frame to obtain the echo amplitude profile includes: When the wearable device is already worn, the reconstructed data frames corresponding to the attachment pressure information collected by the pressure sensor are analyzed. If the analysis results indicate that the attachment stability is strong, preprocessing is performed on the echo reconstruction data frame corresponding to the echo in the reconstruction data frame and the envelope is extracted to obtain the echo amplitude profile.

8. The method according to claim 7, characterized in that, The attachment pressure information includes at least one of the following: pressure magnitude, pressure fluctuation amplitude, and pressure change rate; The method further includes: If the analysis results indicate that the reconstructed data frame corresponding to any of the pressure magnitude, pressure fluctuation amplitude, and pressure change rate exceeds the corresponding threshold, the reconstructed data frame exceeding the corresponding threshold is marked as low confidence or is removed.

9. The method according to claim 6, characterized in that, If the sampling rates of different sensors in the sensor set are different, the temperature reconstruction data frame, pressure reconstruction data frame and echo reconstruction data frame in the reconstructed data frame are aligned under the same time reference. The alignment includes interpolation processing and / or resampling processing.

10. The method according to claim 6, characterized in that, The extraction of features from the echo reconstruction data frame, the echo amplitude profile, the pressure reconstruction data frame, and the temperature reconstruction data frame includes: From the echo reconstruction data frame and the echo amplitude profile, extract at least one of the following acoustic features: peak position, peak amplitude, peak width, energy distribution, attenuation slope, and number of peaks; Extract attachment stability features and contact state features from the pressure reconstruction data frame; Extract absolute temperature features and temperature drift features from the temperature reconstruction data frame.

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