Postpartum breast duct detection and dredging integrated intelligent device based on flexible ultrasonic array

Abstract

The application discloses a postpartum mammary duct detection and dredging integrated intelligent device based on a flexible ultrasonic array, which comprises a flexible ultrasonic array probe, an ultrasonic driving channel, a signal detection channel, a temperature acquisition module, an A / D conversion module and a main control module. In a detection mode, the main control module controls the ultrasonic driving channel to emit a first ultrasonic signal; in a treatment mode, the main control module controls the ultrasonic driving channel to emit a second ultrasonic signal; the main control module adjusts the duty ratio and frequency of the ultrasonic driving signal, so that the first ultrasonic signal and the second ultrasonic signal have different duty ratios and frequencies; and the main control module is further configured to switch to the detection mode again to evaluate the treatment effect after treatment. The application integrates the two working modes of detection and treatment by the same flexible ultrasonic array probe, automatically switches the modes by the main control module, and does not need to replace the probe or rely on artificial subjective judgment of mammary duct blockage.

Description

Technical Field

[0001] This invention relates to the field of medical and nursing equipment technology, and in particular to an integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array. Background Technology

[0002] Postpartum women are prone to milk stasis, fat plug formation, or duct blockage because their breast tissue has not fully recovered. This can lead to breast engorgement, poor milk flow, and even mastitis. Blocked milk ducts are a common breast condition during postpartum lactation, affecting not only breastfeeding but also the mother's health. Therefore, timely detection and treatment are necessary.

[0003] Currently, clinical treatments for blocked milk ducts mainly include manual massage, warm compresses, and manual milk expression. While these methods can alleviate the problem to some extent, they still have limitations. For example, manual massage relies heavily on the experience of caregivers, involves strenuous activity, and has inconsistent effectiveness; warm compresses only promote blood circulation through localized heating, offering limited relief for clearing blockages within the milk ducts. Furthermore, these methods typically lack the ability to assess the internal structure of the milk ducts, making it difficult to promptly determine if a blockage has occurred, its location, and its severity.

[0004] With the development of medical ultrasound technology, ultrasound detection has been widely used in the examination of breast tissue structure due to its advantages such as being non-invasive, safe, and highly real-time. For example, existing technologies have proposed using ultrasound echoes to detect tissue condition and combining them with mechanical vibration to achieve tissue unblocking. However, these technologies mostly rely on independent vibration units to achieve percussion-like unblocking, resulting in a relatively simple mode of action and failing to fully utilize the multi-physical effects of ultrasound in tissues, leading to limited unblocking efficiency and adaptability. On the other hand, existing ultrasound probe technology has also improved in terms of frequency adjustment and imaging capabilities, such as achieving broadband ultrasound output through thermoacoustic effects to adapt to different tissue imaging needs. However, these technologies mainly focus on expanding imaging functions and lack the design of synergistic mechanisms for tissue unblocking or treatment processes, especially failing to address the synergistic utilization of vibration and thermal effects, and also lacking refined control methods for treatment safety.

[0005] Furthermore, while some physiotherapy devices can utilize ultrasonic vibrations or thermal effects to treat tissues, they often lack real-time temperature monitoring and intelligent adjustment mechanisms, making them prone to localized overheating and compromising safety. Therefore, designing a device that conforms to the curves of the breast, simultaneously provides mammary duct detection, unblocking, and physiotherapy functions, and can intelligently adjust according to temperature changes has become a pressing technical challenge in the field of postpartum breast care. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of the prior art and provide an integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array.

[0007] The objective of this invention is achieved through the following technical solution: In a first aspect, the present invention provides an integrated intelligent device for postpartum mammary duct detection and unblocking, comprising a flexible ultrasonic array probe, an ultrasonic drive channel, a signal detection channel, a temperature acquisition module, an A / D conversion module, and a main control module; wherein: The flexible ultrasound array probe is used to conform to the surface of the breast, emit ultrasound signals and receive echo signals. The ultrasonic drive channel is connected to the flexible ultrasonic array probe and is used to generate and output ultrasonic drive signals. The signal detection channel is connected to the flexible ultrasound array probe and is used to receive and process ultrasound echo signals from breast tissue. The temperature acquisition module is located inside the flexible ultrasonic array probe and is used to acquire the temperature of the area where the probe contacts the human body in real time. The A / D conversion module is connected to the signal detection channel and the main control module, and is used to convert the ultrasonic echo signal processed by the signal detection channel into a digital signal and input it to the main control module. The main control module is connected to the ultrasonic drive channel, the A / D conversion module, and the temperature acquisition module, respectively. The main control module is configured as follows: In detection mode, the ultrasonic drive channel is controlled to emit a first ultrasonic signal, and the location and degree of blockage are determined based on the echo signal processed by the signal detection channel. In treatment mode, the ultrasonic drive channel is controlled to emit a second ultrasonic signal, and the ultrasonic output power is dynamically adjusted according to the temperature information fed back by the temperature acquisition module during the treatment process, so that the temperature of the area where the probe contacts the human body is maintained within the preset hot compress temperature range. The main control module adjusts the duty cycle and frequency of the ultrasonic drive signal to make the first ultrasonic signal and the second ultrasonic signal have different duty cycles and frequencies. The first ultrasonic signal is used for detection, and the second ultrasonic signal is used to generate mechanical vibration unblocking effect and heat therapy effect. The main control module is also configured to switch back to the detection mode to assess the treatment effect after treatment.

[0008] Furthermore, the second ultrasonic signal output by the ultrasonic drive channel controlled by the main control module includes a low-frequency high duty cycle ultrasonic component and a high-frequency low duty cycle ultrasonic component; the main control module is configured to adjust the duration and output intensity of the two components according to the degree of blockage parameter.

[0009] Furthermore, the temperature acquisition module is equipped with multiple sets of distributed temperature sensors; the main control module can independently read the temperature data collected by each set of temperature sensors and adjust the ultrasonic output power at the corresponding position accordingly.

[0010] Furthermore, the flexible ultrasonic array probe is equipped with an ultrasonic transducer unit, which adopts a type 1-3 piezoelectric composite material structure or a multilayer piezoelectric ceramic stack structure and has dual-frequency resonance characteristics.

[0011] Furthermore, the flexible ultrasound array probe has a bendable and flexible structure that can conform to the curvature of the breast; the flexible ultrasound array probe has an acoustic coupling layer, an ultrasound array layer, a temperature acquisition layer, and a circuit layer stacked sequentially from the side that contacts the human skin outwards; the acoustic coupling layer is made of medical-grade silicone and is laid on the outermost working surface of the probe; the ultrasound array layer is used to arrange ultrasound transducer units; the temperature acquisition layer is used to arrange distributed temperature sensors; the circuit layer integrates signal leads and terminals, which are electrically connected to the ultrasound transducer units and temperature sensors, respectively.

[0012] Furthermore, the flexible ultrasonic array probe is evenly divided into eight independent fan-shaped sub-regions along the circumference; each fan-shaped sub-region is separately configured with an ultrasonic transducer unit, a temperature sensor and an independent power drive branch, and each independent power drive branch is connected to the wiring terminals of the circuit layer.

[0013] Furthermore, the ultrasonic drive channel includes an ultrasonic signal generation module and a power amplification drive module; the ultrasonic signal generation module is connected to the main control module and is used to generate ultrasonic drive signals of different frequencies and different duty cycles; the power amplification drive module has a built-in impedance matching circuit for amplifying the ultrasonic drive signals and sending them to the flexible ultrasonic array probe.

[0014] Furthermore, the signal detection channel includes an echo signal receiving module and a signal conditioning module; the signal conditioning module integrates a filtering circuit and a gain control circuit; the analog signal processed by the signal conditioning module is transmitted to the main control module through an A / D conversion module.

[0015] Furthermore, the device also includes a power management module and a human-machine interaction module; the power management module supplies power to the main control module, the ultrasonic drive channel, the signal detection channel, and the human-machine interaction module; the human-machine interaction module communicates bidirectionally with the main control module and includes a display screen and an operation panel, the operation panel having power on / off buttons, mode switching buttons, and parameter adjustment buttons.

[0016] Furthermore, the step of switching back to the detection mode to assess the treatment effect after treatment specifically includes: The pre-treatment blockage level was quantified as follows: , will the The quantified value of the degree of blockage after the second treatment is recorded as follows: ,in, , It is obtained by weighting the effective cross-sectional area reduction rate of the lumen, the normalized echo intensity of the blocked area, and the echo continuity index under the same detection frequency and gain conditions; according to Calculate the unblocking rate ,like If the value is less than the preset threshold, switch to treatment mode to continue treatment. If the value is greater than or equal to the preset threshold, the unblocking is completed and the treatment ends.

[0017] The beneficial effects of this invention are: (1) This invention integrates two working modes, detection and treatment, through the same flexible ultrasound array probe. The main control module realizes automatic mode switching, eliminating the need to replace the probe or rely on manual subjective judgment of breast blockage. In the detection stage, the device locates the blockage position and quantifies the degree of blockage through echo signal analysis, providing objective data for ultrasound output. In the treatment stage, the ultrasound output power is dynamically adjusted based on a temperature closed-loop feedback mechanism to avoid local overheating and improve the safety of the device.

[0018] (2) This invention directly utilizes the physical effects of ultrasound signals. The main control module controls the vibration amplitude and tissue heat generation rate by adjusting the ultrasound frequency and duty cycle, and can simultaneously output two types of ultrasound signals: low-frequency high duty cycle and high-frequency low duty cycle. Low-frequency ultrasound relies on mechanical vibration to peel off blockages such as fat plugs and protein plugs, reducing the adhesion between the blockages and the mammary duct wall; high-frequency ultrasound generates a gentle thermal effect to soften the blockages and improve local blood circulation. The two effects work synergistically to overcome the shortcomings of simple mechanical tapping in softening hard plugs and simple hot compresses in peeling off blockages.

[0019] (3) In the device of the present invention, the flexible ultrasound array probe is divided into eight independent fan-shaped sub-regions along the circumference. Each sub-region is equipped with a dedicated ultrasound transducer unit, an independent temperature sensor and a drive branch, so as to realize independent signal transmission, independent temperature acquisition and power adjustment of the sub-region. The device only outputs therapeutic ultrasound to the blocked sub-regions that are detected and identified, while the other sub-regions remain in standby mode, so as to realize targeted ultrasound output. At the same time, the temperature data of each sub-region is fed back to the main control separately. When the temperature of a single region is abnormal, only the power of the corresponding branch is adjusted. There is no need to reduce the ultrasound output of the entire region. This ensures that the target area is unblocked and the heat treatment effect is stable, and the overall temperature distribution of the probe is balanced, so as to solve the problem of local overheating or insufficient heat treatment caused by uneven adhesion to the breast surface.

[0020] (4) After treatment, the device can automatically switch back to the detection mode. The main control module can automatically calculate the unblocking rate and compare it with the preset threshold. If the unblocking rate does not meet the standard, the treatment and re-examination process will be automatically repeated until the unblocking rate meets the standard. In this way, a closed loop of "detection → treatment → quantitative assessment → iterative intervention" is constructed, which gets rid of the limitation of manually determining the treatment endpoint. The detection and intervention results are stable and suitable for various usage scenarios such as postpartum home care and primary medical care. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the structure of an integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array, provided as an exemplary embodiment of the present invention.

[0022] Figure 2 This is a schematic diagram of the overall external structure of the flexible ultrasonic array probe in an exemplary embodiment of the present invention.

[0023] Figure 3 This is a schematic diagram of the layered cross-sectional structure of the flexible ultrasonic array probe and its associated operation panel in an exemplary embodiment of the present invention.

[0024] Figure 4 This is a flowchart illustrating the usage method of the integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array, as described in an exemplary embodiment of the present invention.

[0025] Figure 5 This is a schematic diagram of the independent detection and temperature control of eight zones of a flexible ultrasonic array probe in an exemplary embodiment of the present invention. Detailed Implementation

[0026] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0027] This invention aims to provide an integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array, solving the problems of existing technologies that rely on manual experience, separate detection and treatment functions, low operational efficiency, and difficulty in effectively ensuring safety during mammary duct detection and unblocking. Its core idea is to integrate ultrasound detection and ultrasound therapy functions using a single flexible ultrasound array probe, with automatic switching between detection and treatment modes via a main control module. In treatment mode, the probe's dual-frequency piezoelectric transducer structure outputs ultrasound signals of different frequencies and duty cycles, respectively generating mechanical vibration and thermal softening effects. The probe's working surface is divided into multiple independent sector-shaped zones, with distributed temperature sensors enabling independent ultrasound output and closed-loop temperature control for each zone. After completing the therapy, the device automatically collects breast echo data to quantify the unblocking effect, minimizing subjective human intervention throughout the process and balancing unblocking effectiveness with safety.

[0028] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0029] Example: This embodiment provides an integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array. (See also...) Figure 1 It includes: a flexible ultrasonic array probe, an ultrasonic drive channel, a signal detection channel, a temperature acquisition module, an A / D conversion module, a power management module, a human-machine interaction module, and a main control module; the functions of each module are as follows: Power management module: Used to provide stable operating power for each functional module.

[0030] Main control module: As the core control unit of the system, it is connected to the ultrasonic drive channel, signal detection channel, temperature acquisition module, A / D conversion module and human-machine interaction module, respectively, and is used to realize signal control, data processing and logical judgment.

[0031] The ultrasound drive channel includes an ultrasound signal generation module and a power amplification drive module. The ultrasound signal generation module is connected to the main control module and generates an ultrasound drive signal. The power amplification drive module is connected to the ultrasound signal generation module and amplifies the ultrasound drive signal, outputting the amplified signal to the ultrasound array probe to drive the probe to emit ultrasound waves. The ultrasound signal generation module generates ultrasound drive signals of different frequencies and duty cycles to adapt to switching between detection and treatment modes.

[0032] Signal detection channel: includes an echo signal receiving module and a signal conditioning module. The echo signal receiving module is connected to the ultrasound array probe and is used to receive echo signals generated by breast tissue. The signal conditioning module is connected to the echo signal receiving module and is used to amplify, filter and adjust the gain of the echo signal. The processed analog signal is transmitted to the main control module for analysis and processing through the A / D conversion module.

[0033] A / D conversion module: Connected to the signal conditioning module and the main control module, it is used to convert analog signals into digital signals and transmit them to the main control module for analysis and processing.

[0034] Temperature acquisition module: Located inside the flexible ultrasonic array probe, used to acquire the temperature of the area where the probe contacts the human body in real time.

[0035] Human-machine interaction module: Connected to the main control module, it is used to display detection results, operating status and parameter information, and receive control commands input by the user, thereby realizing the operation and control of the equipment.

[0036] Through the coordinated work of the above modules, the transmission of ultrasound signals, the reception and processing of echo signals, and the intelligent control of the treatment process are realized, thereby completing the detection and unblocking of mammary ducts.

[0037] In one exemplary embodiment, such as Figure 2 As shown, the flexible ultrasound probe includes a peripheral flexible fitting structure 1 and a central functional area 2, with an overall low-stiffness, bendable configuration. The peripheral flexible fitting structure 1 is preferably made of medical-grade silicone material, and its outline matches the curvature of the breast surface. During use, it can form a large-area contact with the skin, thereby improving the contact stability between the probe and the breast and effectively preventing slippage caused by changes in body position or external disturbances during detection or treatment, ensuring the continuity and consistency of the acoustic coupling state. Furthermore, the central functional area 2 adopts a raised structure design, which can create appropriate contact pressure in the local area during the fitting state, helping to improve acoustic coupling conditions and increase the penetration depth of the ultrasound signal.

[0038] Among them, see Figure 3The central functional area 2, from the side in contact with human skin outwards, sequentially stacks an acoustic coupling layer 11, an ultrasonic array layer 12, a temperature acquisition layer 13, and a circuit layer 14. The acoustic coupling layer 11 is used for direct contact with human skin to reduce acoustic impedance mismatch and improve the transmission efficiency of ultrasound waves. The ultrasonic array layer 12 consists of multiple ultrasonic transducer units for transmitting and receiving ultrasound signals. The temperature acquisition layer 13 contains a temperature sensor for real-time monitoring of the probe's temperature during operation. The circuit layer 14 provides electrical connections between each functional layer and external circuits, ensuring the stability of signal transmission. Through this layered structure design, the probe can stably perform detection and treatment functions while maintaining good flexibility and fit.

[0039] More preferably, in an exemplary embodiment, the ultrasonic transducer unit in the flexible ultrasonic array probe adopts a type 1-3 piezoelectric composite material or a multilayer stacked structure, and has dual-frequency resonance characteristics: generating low-frequency ultrasound in the kHz band for unblocking treatment, and generating high-frequency ultrasound in the MHz band for detection.

[0040] For example, the ultrasonic transducer unit adopts a type 1-3 piezoelectric composite material structure, consisting of piezoelectric pillars embedded in a flexible polymer matrix. By optimizing the geometric dimensions and periodic parameters of the piezoelectric pillars, the transducer unit possesses multiple resonant characteristics in different frequency bands. Another example is the ultrasonic transducer unit employing a multi-layer stacked structure, formed by alternating stacks of multiple thin piezoelectric ceramic sheets and flexible dielectric layers. The overall structure generates kHz-level low-frequency resonances in the thickness direction to meet the needs of ultrasound therapy for deep tissue applications; simultaneously, each individual piezoelectric ceramic sheet generates MHz-level high-frequency resonances within its own thickness dimension for precise detection. Through the synergistic effect of the outer flexible bonding structure and the internal multi-layer flexible functional units, the probe of this invention achieves a balance between stable adhesion and efficient treatment while ensuring comfort.

[0041] As an optimized implementation plan, such as Figure 5 As shown, the flexible ultrasound array probe can be divided into eight fan-shaped sub-regions Z1-Z8 along the circumference with the probe center as the center. Each region includes a set of independently transmit / receive ultrasound transducer units, a temperature sensor, and a power drive branch addressed separately by the main control module. During detection, the main control module sequentially selects each region from Z1 to Z8 to acquire echo data and maps the blockage location to the corresponding region. During treatment, therapeutic ultrasound is applied only to the target region or its adjacent regions, while the corresponding branches are adjusted according to the feedback from each temperature sensor. It can be understood that eight regions are the preferred number, and four to twelve sub-regions can be used when the probe size or array density changes.

[0042] In one exemplary embodiment, the operation panel provided by the human-computer interaction module is as follows: Figure 3 As shown, the device includes a display area 31 and a key input area. The display area 31 displays the detection image, operating status, and parameter information. The key input area includes numeric input keys 32 and function control keys. The function control keys include a device power on / off control key 33, an intelligent / manual adjustment mode key 34, a detection mode key 35, and a treatment / heat therapy mode key 36. The numeric input keys 32 are used to input parameters for adjustment. This structural design allows the operator to intuitively operate the device and adjust the detection and treatment process according to actual needs.

[0043] In one exemplary embodiment, the main control module is configured as follows: In detection mode, the ultrasonic drive channel is controlled to emit a first ultrasonic signal, and the location and degree of blockage are determined based on the echo signal processed by the signal detection channel. In treatment mode, the ultrasonic drive channel is controlled to emit a second ultrasonic signal, and the ultrasonic output power is dynamically adjusted according to the temperature information fed back by the temperature acquisition module during treatment to control the temperature of the area where the probe contacts the human body. The main control module adjusts the duty cycle and frequency of the ultrasonic drive signal to make the first ultrasonic signal and the second ultrasonic signal have different duty cycles and frequencies. The first ultrasonic signal is used for detection, and the second ultrasonic signal is used to generate mechanical vibration unblocking effect and heat therapy effect. The main control module is also configured to switch back to the detection mode to assess the treatment effect after treatment.

[0044] It is understandable that the frequency of the first ultrasonic signal mentioned above is in the MHz range (high frequency), and the frequency of the second ultrasonic signal mentioned above is in the kHz range (low frequency). Here, "high frequency" and "low frequency" refer to the relative frequencies of the two ultrasonic signals.

[0045] Specifically, in this exemplary embodiment, when an ultrasound signal propagates through breast tissue, it generates reflected echoes when encountering interfaces between media with different acoustic impedances. When the mammary ducts are patent, the medium inside the ducts is uniform milk, resulting in low amplitude and stable waveform of the echo signal. When a mammary duct is blocked, a significant difference in acoustic impedance exists between the blockage (such as milk fat plugs, protein plugs, etc.) and the milk and duct wall tissue, generating strong reflected echoes. The main control module can inversely calculate the location and degree of blockage by analyzing the amplitude, delay, and spectral characteristics of the echo signal.

[0046] In treatment mode, the main control module adjusts the duty cycle and frequency of the ultrasound drive signal to produce ultrasound outputs with different physical effects from the ultrasound transducer. For example, low-frequency, high-duty-cycle signals generate strong mechanical vibrations, acting on the blockage to loosen and remove it; high-frequency, low-duty-cycle signals are mainly converted into heat energy through tissue absorption, achieving a heat therapy effect. Furthermore, during treatment, the temperature acquisition module provides real-time feedback on the temperature of the probe contact area, and the main control module dynamically adjusts the output power accordingly, forming a closed-loop control. It is understandable that "low frequency" and "high frequency" in treatment mode refer to two different operating frequencies in the kHz range. For example, in treatment mode, the output of low-frequency, high-duty-cycle ultrasound signals specifically refers to a frequency of 20–100 kHz and a duty cycle of 80%; the output of high-frequency, low-duty-cycle ultrasound signals specifically refers to a frequency of 200–800 kHz and a duty cycle of 15%.

[0047] In treatment mode, low-frequency, high-duty-cycle ultrasonic signals are output to loosen and peel off blockages through mechanical vibration, thereby reducing the adhesion between the blockages and the tube wall. High-frequency, low-duty-cycle ultrasonic signals are output to generate a temperature rise through tissue absorption of ultrasound, raising the local tissue temperature to a preset temperature range (preferably 40℃-43℃) for heat therapy. The duration and output intensity of the low-frequency, high-duty-cycle and high-frequency, low-duty-cycle ultrasonic signals are dynamically allocated according to the degree of blockage, forming a synergistic unblocking effect of vibration loosening and heat therapy softening.

[0048] In practical applications, the main control module can dynamically allocate the duration and output intensity of the two modes based on the blockage degree parameters (such as echo amplitude and blockage size) obtained under the detection mode. For example, for hard, tightly adhered blockages, the proportion of the low-frequency, high-duty-cycle mode is increased to enhance mechanical loosening; for loose but large blockages, the proportion of the high-frequency, low-duty-cycle mode is increased to enhance thermal softening. This can be manually set according to the actual situation. That is, in this embodiment, the timing combination and intensity allocation of the two effects can be adaptively adjusted according to the degree of blockage. Compared with single-effect treatment methods (such as pure massage or pure thermal compress), it can improve the unblocking efficiency, shorten the treatment time, and improve patient comfort.

[0049] Based on the above description of the integrated intelligent device, this embodiment also provides a method for using the device, see [link to documentation]. Figure 4 It includes the following processes: S1. Activate the device and attach the flexible ultrasound array probe to the surface of the breast to form a good acoustic coupling interface between the probe and the skin, thereby ensuring that the ultrasound signal can be efficiently transmitted to the breast tissue and improving the accuracy and stability of detection and treatment. S2. Control the ultrasound drive channel to emit ultrasound signals to detect mammary ducts; the ultrasound signals can be emitted according to preset scanning paths and frequency parameters to achieve comprehensive coverage detection of the mammary duct area; S3. Receive and process the echo signal. The echo signal is received by the probe and transmitted to the system for amplification, filtering and signal processing to obtain the structural information of the mammary ducts. Then, the condition and degree of blockage of the mammary ducts are determined to provide a basis for subsequent treatment. S4. Based on the test results, switch to treatment mode. During treatment, output therapeutic ultrasound in sequence, following the high-frequency test completion, followed by low-frequency vibration unblocking and heat therapy maintenance. Each sub-region independently adjusts its temperature: when the region temperature is below 40℃, appropriately increase the output power of that region to raise the temperature; when the region temperature reaches 40℃ but is below 43℃, maintain or fine-tune the output power to keep the temperature within the heat therapy range; when the region temperature reaches 43℃ ​​but is below 44℃, reduce the output power to prevent further temperature increases; when the region temperature reaches or exceeds 44℃, immediately stop the ultrasound output of that region and issue a temperature alarm.

[0050] S5. After treatment, switch back to detection mode to obtain post-treatment mammary duct status information. Record the pre-treatment blockage level as... , will the The quantified value of the degree of blockage after the second treatment is recorded as follows: ,in , The unblocking rate is obtained by weighting the effective cross-sectional area reduction rate of the lumen, the normalized echo intensity of the blocked area, and the echo continuity index under the same detection frequency and gain conditions; according to Calculate. If If it is less than the preset threshold, repeat steps S4 and S5; if If the value is greater than or equal to the preset threshold, the unblocking is completed and the treatment ends.

[0051] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An integrated intelligent device for postpartum mammary duct detection and unblocking based on a flexible ultrasound array, characterized in that, include: The system includes a flexible ultrasonic array probe, an ultrasonic drive channel, a signal detection channel, a temperature acquisition module, an A / D conversion module, and a main control module; among which: The flexible ultrasound array probe is used to conform to the surface of the breast, emit ultrasound signals and receive echo signals. The ultrasonic drive channel is connected to the flexible ultrasonic array probe and is used to generate and output ultrasonic drive signals. The signal detection channel is connected to the flexible ultrasound array probe and is used to receive and process ultrasound echo signals from breast tissue. The temperature acquisition module is installed inside the flexible ultrasonic array probe and is used to acquire the temperature of the area where the probe contacts the human body in real time. The A / D conversion module is connected to the signal detection channel and the main control module, and is used to convert the ultrasonic echo signal processed by the signal detection channel into a digital signal and input it to the main control module. The main control module is connected to the ultrasonic drive channel, the A / D conversion module, and the temperature acquisition module, respectively. The main control module is configured as follows: In detection mode, the ultrasonic drive channel is controlled to emit a first ultrasonic signal, and the location and degree of blockage are determined based on the echo signal processed by the signal detection channel. In treatment mode, the ultrasonic drive channel is controlled to emit a second ultrasonic signal, and the ultrasonic output power is dynamically adjusted according to the temperature information fed back by the temperature acquisition module during the treatment process, so that the temperature of the area where the probe contacts the human body is maintained within the preset hot compress temperature range. The main control module adjusts the duty cycle and frequency of the ultrasonic drive signal to make the first ultrasonic signal and the second ultrasonic signal have different duty cycles and frequencies. The first ultrasonic signal is used for detection, and the second ultrasonic signal is used to generate mechanical vibration unblocking effect and heat therapy effect. The main control module is also configured to switch back to the detection mode to assess the treatment effect after treatment.

2. The apparatus according to claim 1, characterized in that, The main control module controls the second ultrasonic signal output by the ultrasonic drive channel, which includes a low-frequency high duty cycle ultrasonic component and a high-frequency low duty cycle ultrasonic component; the main control module is configured to adjust the duration and output intensity of the two components according to the degree of blockage parameter.

3. The apparatus according to claim 2, characterized in that, The temperature acquisition module is equipped with multiple sets of distributed temperature sensors; the main control module can independently read the temperature data collected by each set of temperature sensors and adjust the ultrasonic output power at the corresponding position accordingly.

4. The apparatus according to claim 1, characterized in that, The flexible ultrasonic array probe is equipped with an ultrasonic transducer unit, which adopts a type 1-3 piezoelectric composite material structure or a multilayer piezoelectric ceramic stack structure and has dual-frequency resonance characteristics.

5. The apparatus according to claim 1, characterized in that, The flexible ultrasound array probe has a bendable and flexible structure that can conform to the curvature of the breast. The flexible ultrasound array probe has an acoustic coupling layer, an ultrasound array layer, a temperature acquisition layer, and a circuit layer stacked sequentially from the side that contacts the human skin outwards. The acoustic coupling layer is made of medical-grade silicone and is laid on the outermost working surface of the probe. The ultrasound array layer is used to arrange the ultrasound transducer unit. The temperature acquisition layer is used to arrange the distributed temperature sensor. The circuit layer integrates signal leads and terminals, which are electrically connected to the ultrasound transducer unit and the temperature sensor, respectively.

6. The apparatus according to claim 1, characterized in that, The flexible ultrasonic array probe is evenly divided into eight independent fan-shaped sub-regions along the circumference; each fan-shaped sub-region is equipped with a set of ultrasonic transducer units, a temperature sensor and an independent power drive branch, and each independent power drive branch is connected to the wiring terminals of the circuit layer.

7. The apparatus according to claim 1, characterized in that, The ultrasonic drive channel includes an ultrasonic signal generation module and a power amplification drive module; the ultrasonic signal generation module is connected to the main control module and is used to generate ultrasonic drive signals with different frequencies and different duty cycles; the power amplification drive module has a built-in impedance matching circuit for amplifying the ultrasonic drive signal and sending it to the flexible ultrasonic array probe.

8. The apparatus according to claim 1, characterized in that, The signal detection channel includes an echo signal receiving module and a signal conditioning module; the signal conditioning module integrates a filtering circuit and a gain control circuit; the analog signal processed by the signal conditioning module is transmitted to the main control module through an A / D conversion module.

9. The apparatus according to claim 1, characterized in that, The device also includes a power management module and a human-machine interaction module; the power management module supplies power to the main control module, the ultrasonic drive channel, the signal detection channel, and the human-machine interaction module; the human-machine interaction module communicates bidirectionally with the main control module and includes a display screen and an operation panel, the operation panel having power on / off buttons, mode switching buttons, and parameter adjustment buttons.

10. The apparatus according to any one of claims 1 to 9, characterized in that, The step of switching back to the detection mode to assess the treatment effect after treatment specifically includes: The pre-treatment blockage level was quantified as follows: , will the The quantified value of the degree of blockage after the second treatment is recorded as follows: ,in, , It is obtained by weighting the effective cross-sectional area reduction rate of the lumen, the normalized echo intensity of the blocked area, and the echo continuity index under the same detection frequency and gain conditions; according to Calculate the unblocking rate ,like If the value is less than the preset threshold, switch to treatment mode to continue treatment. If the value is greater than or equal to the preset threshold, the unblocking is completed and the treatment ends.

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