Intelligent free skin flap vascular crisis monitor

Abstract

The application discloses an intelligent free skin flap vascular crisis monitor, and belongs to the technical field of medical devices.The monitor comprises a signal emission and reception module, which is provided with a red light and infrared light emitter, a reflected light receiver and a multi-modal sensor, and adopts a flexible medical silica gel outer layer with negative pressure adsorption and a built-in micro pressure sensor; a signal sampling and amplification circuit module, which is used for high sampling rate acquisition and two-stage signal amplification; an MCU signal processing module, which is internally provided with a deep learning algorithm, and is used for filtering interference, calculating blood oxygen and comprehensive perfusion index FPI, and identifying crisis types; and a result output module, which is used for displaying data and alarming.The application realizes the advantages of high precision, fast response, small size, portability, intraoperative and bedside use, and compatibility with an electrocardiograph monitor through multi-modal fusion monitoring, self-adaptive fitting and signal compensation, intelligent crisis identification and other technologies, effectively reduces medical costs, and improves the success rate of skin flap transplantation surgery.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an intelligent free flap vascular crisis monitoring device. Background Technology

[0002] Vascularized free flap transplantation is currently the preferred method for repairing tissue defects, especially large defects in areas such as the head, neck, and limbs. This technique involves transplanting composite tissues (such as skin, muscle, and bone) with their own blood supply system from one part of the body to another, and then performing microsurgical anastomosis with the blood vessels of the recipient area to repair and reconstruct the shape and function of the defect. Compared with traditional repair methods, it has significant advantages such as aesthetic appearance and good functional recovery.

[0003] However, complications following free flap transplantation, especially vascular crisis, are key factors affecting the success rate of the procedure. Vascular crisis typically refers to postoperative spasm and thrombosis of the anastomosing vessels, leading to insufficient arterial blood supply or impaired venous return, which can result in flap necrosis in severe cases. Clinically, vascular crisis usually occurs within 24-72 hours postoperatively. Once it occurs, surgical exploration and intervention must be performed within the golden time frame (usually within a few hours) to salvage the flap. Therefore, continuous, accurate, and real-time monitoring of the flap's blood supply status postoperatively is crucial.

[0004] Currently, commonly used clinical methods for monitoring skin flaps mainly rely on the clinical experience of medical staff, making subjective judgments by periodically observing indicators such as the flap's color, temperature, swelling degree, and capillary refill time. These methods are not only labor-intensive and difficult to implement continuous monitoring, but more importantly, they are highly subjective, lack quantitative standards, and cannot guarantee accuracy, easily delaying the best rescue opportunity. When necessary, doctors will use needle puncture on the skin flap to observe bleeding, which is an invasive procedure that brings additional pain and infection risks to the patient.

[0005] With technological advancements, methods for assessing flap viability using blood oxygen saturation monitoring have emerged. The principle is based on photoplethysmography (PPG), which calculates arterial blood oxygen saturation by measuring the difference in absorption of specific wavelengths (usually red and infrared) of light by oxyhemoglobin and deoxyhemoglobin in the tissue. When a flap experiences ischemia, its tissue oxygen saturation decreases. Therefore, percutaneous blood oxygen saturation monitoring has been experimentally proven to be an effective method for dynamic flap monitoring. However, currently available imported equipment for clinical application is extremely expensive, and only a few large tertiary hospitals possess a limited number of such devices, failing to meet the enormous clinical demand. Although there are relevant patents in China, such as the utility model patent with publication number CN220512842U entitled "A Continuous Monitoring Device for Skin Flap Temperature and Blood Oxygen Saturation," it still has many shortcomings: First, its monitoring accuracy and response speed have not been verified and explained, which may lead to delayed results and affect the timely detection of crises; Second, its product structure is complex and its size is relatively large, which is not conducive to use in narrow areas such as the mouth, and it is inconvenient to operate, resulting in poor popularity; Third, its application scenarios are limited, usually only suitable for bedside use, which restricts patients' early postoperative activity and increases the risk of complications such as deep vein thrombosis in the lower extremities.

[0006] Therefore, there is an urgent clinical need for an intelligent flap monitoring device that is highly accurate, fast-responding, compact and lightweight, easy to use, cost-effective, and widely applicable, in order to overcome the shortcomings of existing technologies and improve the success rate of free flap transplantation surgery and patient prognosis. Summary of the Invention

[0007] Based on the problems existing in the above-mentioned background technology, the present invention proposes an intelligent free flap vascular crisis monitoring instrument to solve the problems of insufficient monitoring accuracy and response speed, large product size, and limited application scenarios of existing flap blood oxygen monitoring instruments.

[0008] The embodiments of the present invention are implemented as follows: This invention provides an intelligent free flap vascular crisis monitoring device, comprising: A signal transmitting and receiving module includes a flexible substrate, and a red light emitter, an infrared light emitter, and a reflected light receiver integrated on the flexible substrate; the lower surface of the flexible substrate is provided with a negative pressure adsorption layer for attaching a skin flap, the negative pressure adsorption layer is made of flexible medical silicone material, and a negative pressure cavity is formed on its bonding surface. The signal sampling and amplification circuit module has its input terminal electrically connected to the output terminal of the reflected light receiver, and is used to acquire the reflected light signal at a preset high sampling rate and perform secondary amplification processing. The MCU signal processing module has its input terminal electrically connected to the output terminal of the signal sampling and amplification circuit module. The MCU signal processing module has built-in filtering algorithms for filtering out signal interference, blood oxygenation algorithms for calculating blood oxygen saturation, and multimodal fusion algorithms for fusing multimodal signals and generating flap perfusion index (FPI). The result output module is electrically connected to the output terminal of the MCU signal processing module. It is used to display the blood oxygen saturation, heart rate and flap perfusion index (FPI) output by the MCU signal processing module, and to issue an alarm signal when the monitored parameters exceed a preset threshold.

[0009] In an intelligent free flap vascular crisis monitoring device, a unique negative pressure adsorption layer design allows the probe to adhere tightly and stably to the flap surface. This effectively solves the problems of poor adhesion, signal loss, or the introduction of motion artifacts caused by gravity and patient movement in traditional probes, ensuring signal acquisition quality from the source and laying the foundation for subsequent accurate analysis. High sampling rate and a two-stage amplification circuit ensure the integrity and high fidelity of the original physiological signals, enabling subsequent algorithm processing based on richer and more accurate data, thereby improving the accuracy of blood oxygenation measurement. The concept of the "Flap Perfusion Index (FPI)" is proposed. Unlike simple blood oxygen saturation, FPI integrates multiple perfusion-related parameters, reflecting subtle changes in flap microcirculation more comprehensively and earlier, potentially providing earlier warnings of vascular crises than a single indicator. Automated and quantitative monitoring and alarm functions replace traditional manual observation and experience-based judgment, reducing subjective errors and enabling 24 / 7 continuous operation to ensure timely detection of any abnormalities.

[0010] Specifically, a monitoring method for an intelligent free flap vascular crisis monitoring device includes the following steps: S1. A signal transmitting and receiving module with a negative pressure adsorption layer is attached to the skin flap surface, and the attachment pressure is monitored in real time by a miniature pressure sensor. S2, red and infrared light emitters alternately emit light, and reflected light receivers receive reflected light signals. At the same time, multimodal sensors collect micro-blood flow or oxygenation distribution signals. S3, the signal sampling and amplification circuit module acquires various signals from step S2 at a sampling rate of 500Hz and performs secondary amplification; S4. The MCU signal processing module dynamically adjusts the signal transmission intensity or amplification gain based on the feedback from the miniature pressure sensor, and performs adaptive filtering on the amplified signal to remove motion artifacts. The S5 and MCU signal processing modules have built-in blood oxygenation and multimodal fusion algorithms to calculate the filtered signal and generate blood oxygen saturation, heart rate and flap perfusion index (FPI). The S6 MCU signal processing module's built-in deep learning timing signal processing module analyzes the dynamic trends of blood oxygen waveform and FPI to determine whether vascular crisis exists and its type. S7 The result output module displays the parameters and analysis results generated by S5 and S6 in real time, and issues corresponding local and / or remote alarms according to the crisis level when the parameters are abnormal or when a vascular crisis is determined.

[0011] Furthermore, the signal transmitting and receiving module also includes a miniature Doppler sensor or near-infrared spectral sensor integrated on the flexible substrate for monitoring local micro-blood flow or oxygenation distribution. The output terminal of the miniature Doppler sensor or near-infrared spectral sensor is also electrically connected to the input terminal of the signal sampling and amplification circuit module to provide data input for the multimodal fusion algorithm.

[0012] Miniature Doppler sensors, by emitting ultrasound and detecting the frequency shift caused by red blood cell movement, can measure the blood flow velocity and volume in the local microcirculation of the skin flap in real time. Near-infrared spectroscopy sensors can penetrate deeper tissues to obtain changes in the concentration of oxyhemoglobin and deoxyhemoglobin, thereby assessing the tissue's oxygen metabolism. These two types of sensors (or one of them) work synchronously with the PPG sensor; the acquired data is processed by the same acquisition and amplification circuit before being input into the MCU. A multimodal fusion algorithm comprehensively analyzes multidimensional data, including blood oxygen saturation from the PPG, microvascular perfusion from the Doppler, and tissue oxygenation rate from NIRS.

[0013] A simple drop in blood oxygenation cannot distinguish between arterial occlusion and venous crisis. By introducing microflow monitoring, a clear distinction can be made: in arterial occlusion, the microflow signal will drop sharply or disappear, and blood oxygenation will decrease rapidly; in venous crisis, due to blood stasis in the early stages, the microflow signal may show weakened fluctuations or even reverse, while tissue oxygenation gradually decreases. This combination of multimodal information allows the system not only to issue alarms but also to intelligently indicate "suspected arterial crisis" or "suspected venous crisis," providing invaluable decision-making information for clinicians to take targeted rescue measures.

[0014] Changes in microcirculation often precede changes in macroscopic blood oxygen saturation. By monitoring microblood flow and local tissue oxygen metabolism, it may be possible to detect early signs of a crisis before blood oxygen saturation has significantly decreased, thus enabling more timely warnings.

[0015] Furthermore, the signal transmitting and receiving module also includes a miniature pressure sensor embedded in the flexible substrate. The sensing surface of the miniature pressure sensor faces the negative pressure adsorption layer, and its output terminal is electrically connected to the input terminal of the MCU signal processing module. The MCU signal processing module is also used to dynamically adjust the emission intensity of the red light emitter and the infrared light emitter or the gain of the signal sampling and amplification circuit module according to the contact pressure value monitored in real time by the miniature pressure sensor. When the contact pressure value is lower than the preset bonding threshold, it generates a bonding abnormality prompt signal and sends it to the result output module.

[0016] A miniature pressure sensor is integrated within the flexible substrate of the probe, enabling real-time and precise sensing of the contact pressure between the probe and the skin flap. This pressure value is fed back to the MCU in real time. The MCU has a preset optimal contact pressure range. When the pressure value detected by the pressure sensor is within this range, the system operates normally. If the pressure value deviates from the optimal range (e.g., due to probe loosening caused by patient movement), the MCU will respond immediately: on the one hand, by dynamically adjusting the light intensity of the transmitter or the gain of the amplification circuit, it attempts to compensate for signal attenuation or fluctuations caused by changes in contact, in order to maintain signal quality; on the other hand, if the pressure value remains below the preset "abnormal contact" threshold, indicating that the probe has become severely loose and signal accuracy cannot be guaranteed by parameter adjustments, the MCU will generate an "abnormal contact" warning signal, which will be displayed in the output module to remind medical staff to re-secure the probe.

[0017] Furthermore, the built-in filtering algorithm of the MCU signal processing module includes an adaptive filtering algorithm, which dynamically adjusts the filtering parameters based on the contact pressure value fed back by the miniature pressure sensor to suppress motion artifact interference caused by loose fit.

[0018] Motion artifacts are one of the most significant sources of interference in photoplethysmography (PPG). Their spectra often overlap with physiological signals, making them difficult to remove effectively with filters of fixed parameters. This solution utilizes a pressure sensor to directly measure the "cause of motion artifacts"—changes in contact pressure. The MCU uses the pressure sensor's changing signal as a reference, inputting it into an adaptive filter. This filter algorithm dynamically adjusts its filtering parameters based on the characteristics of the reference signal, thereby more accurately identifying and subtracting interference components caused by pressure changes (motion) from contaminated PPG signals, preserving the true physiological signals.

[0019] Furthermore, the MCU signal processing module also has a built-in deep learning-based timing signal processing module, which is used to analyze the dynamic trends of blood oxygen waveform and multimodal signals. When a characteristic waveform caused by venous return obstruction is identified, a warning signal of "suspected venous crisis" is output; when a characteristic waveform caused by arterial obstruction is identified, a warning signal of "suspected arterial crisis" is output and an alarm is activated.

[0020] Furthermore, the result output module includes a miniature display screen and an audible and visual alarm integrated on the circuit board of the MCU signal processing module. Integrating the display screen with the MCU motherboard eliminates the need for an additional display module and connecting cables, achieving a miniaturized design for the intelligent free flap vascular crisis monitor and ensuring the portability of the device. The result output module also includes a data connection cable that matches the interface of an external electrocardiogram monitor, used to transmit flap blood oxygenation data and heart rate data to the electrocardiogram monitor in real time for synchronous display and comparison. This allows the flap data to be displayed side by side with other vital signs of the patient (such as heart rate, blood pressure, and blood oxygen saturation) on the same screen. Doctors can intuitively compare the patient's overall blood oxygen saturation and the local blood oxygen saturation of the transplanted flap on the same electrocardiogram monitor screen.

[0021] Furthermore, the result output module also includes a wireless data transmission unit, used to establish a communication connection with a mobile terminal or hospital central workstation via Bluetooth or Wi-Fi to achieve real-time data upload and remote alarm; the alarm signal is divided into two levels according to the severity of the crisis: when the flap perfusion index (FPI) decreases but does not reach the severe threshold, a low-level warning is triggered, and a reminder is pushed through the mobile terminal; when the rate of FPI decrease is greater than a preset rate threshold, or the blood oxygen saturation is lower than 85% and lasts for more than 5 minutes, a high-level alarm is triggered, and a warning is issued through the local audible and visual alarm of the monitor and by pushing the alarm to the on-duty doctor's terminal.

[0022] Furthermore, the flexible substrate of the signal transmitting and receiving module, the negative pressure adsorption layer, and the entire outer shell of the monitor are all made of materials resistant to immersion in medical-grade disinfectant and ultraviolet light irradiation. Because the entire device can be sterilized by ultraviolet light or disinfectant, doctors can immediately place the sterile monitor probe on the sutured skin flap after the flap vascular anastomosis is completed to monitor the immediate patency of the anastomosis and verify the surgical effect. The product is reusable, reducing the cost per use. Disinfection is performed using standard clinical disinfection methods, requiring no special disinfection equipment or procedures, making it easy to operate, compliant with hospital infection control standards, and readily accepted by medical staff.

[0023] Furthermore, the overall thickness of the signal transmitting and receiving module is less than 1 mm, and the maximum thickness after combining with the negative pressure adsorption layer does not exceed 2 mm; the volume of the entire monitor is less than 50 cubic centimeters. Integrating the core optoelectronic devices onto a flexible substrate less than 1 mm thick, combined with an equally ultra-thin negative pressure adsorption layer, ensures that the total thickness of the entire probe portion does not exceed 2 mm. This ultra-thin probe, less than 2 mm, allows for easy placement in extremely confined areas such as the oral cavity and nasal cavity for monitoring, greatly expanding the product's clinical application range. Simultaneously, through a highly integrated design, the circuit board, MCU, battery, wireless module, and micro-display are compactly packaged together, keeping the main unit's volume within 50 cubic centimeters. It can be easily held in the hand or attached to the patient's clothing, truly achieving portable, wearable monitoring. Patients can get out of bed and use the toilet while wearing the device, facilitating rapid postoperative recovery and reducing complications.

[0024] Furthermore, the preset sampling rate of the signal sampling and amplification circuit module is 500Hz. A sampling rate of 500Hz means acquiring 500 data points per second. The frequency of human pulse wave signals is typically between 0.5-5Hz. According to the Nyquist sampling theorem, to reconstruct the signal without distortion, the sampling rate should be at least twice the highest frequency of the signal (i.e., 10Hz). A sampling rate of 500Hz far exceeds this requirement, enabling extremely fine capture of every detail of the pulse waveform, including minute features such as the dichroic notch, thereby improving the overall system stability and reliability.

[0025] The beneficial effects of this invention are: The intelligent free flap vascular crisis monitor of this invention simplifies the expensive and scarce flap blood oxygen saturation measurement equipment into a single-structure probe, combining it with blood oxygen saturation monitors widely used in hospitals at all levels. This not only meets the needs of clinicians for postoperative flap vascular crisis monitoring but also allows for widespread adoption in hospitals at all levels at a lower cost, satisfying the enormous demand from both medical staff and patients. Furthermore, it utilizes electronic engineering technology to achieve wireless, continuous, real-time, and non-invasive dynamic monitoring, enabling early detection of flap vascular crises and embolism types, and automatically alerting medical staff, saving time for flap rescue. This product boasts ultra-high monitoring accuracy, extremely fast response speed, material advantages, size advantages, and intraoperative usability, thereby improving the success rate of flap surgery in clinical practice, effectively reducing medical costs, and increasing the success rate of flap transplantation surgery. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. The above and other objects, features, and advantages of the present invention will become clearer through the accompanying drawings. The same reference numerals indicate the same parts in all the drawings. The drawings are not intentionally drawn to scale to actual dimensions; the focus is on illustrating the main points of the invention.

[0027] Figure 1 This is a theoretical structural diagram of an intelligent free flap vascular crisis monitoring device.

[0028] Figure 2 This is a schematic diagram of the structure of an intelligent free flap vascular crisis monitoring device.

[0029] The module consists of: 1. Signal transmission and reception module; 2. Signal sampling and amplification circuit module; 3. MCU signal processing module; and 4. Result output module. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments 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, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0031] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0032] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0033] like Figure 1 and Figure 2 As shown, the intelligent free flap vascular crisis monitoring device provided by the present invention mainly includes the following parts: Signal Transmission and Reception Module 1: This is the component that directly contacts the patient's skin flap. It comprises an extremely thin (<1mm thick) flexible polyimide substrate. The substrate integrates a red LED (wavelength 660nm) and an infrared LED (wavelength 940nm), as well as a high-sensitivity silicon photodiode as a reflected light receiver. On the lower surface of the substrate, a negative pressure adsorption layer made of medical-grade flexible silicone is applied. Its contact surface is designed with tiny grid-like grooves, creating a negative pressure cavity manually or using a miniature negative pressure generator, allowing it to gently adhere to the skin flap surface. A MEMS miniature pressure sensor is also embedded inside the substrate, with its sensing surface facing the negative pressure adsorption layer, used to sense the contact pressure between the probe and the skin flap in real time. In addition, a miniature Doppler ultrasound sensor is integrated on the substrate to detect the blood flow velocity within the skin flap's microvessels. All sensor and transmitter leads are routed through a flexible circuit board to a single, extremely thin shielded cable, connecting to the main unit.

[0034] Signal sampling and amplification circuit module 2: This module is located inside the main unit and is electrically connected to the signal transmitting and receiving modules via a shielded cable. Its core includes a high-precision analog-to-digital converter (ADC) that synchronously samples each signal at a sampling rate of 500Hz. The sampled signal first enters a preamplifier for primary amplification, then enters a programmable gain amplifier for secondary amplification, and finally outputs to the MCU signal processing module. The gain of this module can be dynamically adjusted by the MCU according to the signal strength.

[0035] MCU Signal Processing Module 3: This module is based on a high-performance, low-power ARM Cortex-M4 core microcontroller. The MCU internally integrates various software algorithms, including: Adaptive filtering algorithm: Receive pressure signal from miniature pressure sensor and PPG signal from reflected light receiver, use pressure signal as reference, and adaptively filter out motion artifacts from PPG signal.

[0036] Blood oxygen calculation algorithm: Based on the classic Lambert-Beer law, it calculates arterial blood oxygen saturation SpO2 and heart rate according to the ratio of the reflection intensity of red light and infrared light.

[0037] Multimodal fusion algorithm: The calculated SpO2 and the micro-perfusion volume (MFI) extracted from the Doppler sensor 160 are fused according to the preset weights (e.g., FPI=0.6*SpO2+0.4*MFI) to generate the flap comprehensive perfusion index FPI.

[0038] Deep learning classification algorithm: A pre-trained lightweight neural network model (such as TCN temporal convolutional network) is deployed in the MCU to analyze the dynamic change trend of PPG waveform and FPI in real time and output the classification results of "normal", "suspected venous crisis" and "suspected arterial crisis".

[0039] Output Module 4: This module includes a 0.96-inch OLED micro-display integrated on the MCU circuit board for real-time display of SpO2, heart rate, FPI values ​​and waveforms; and an audible and visual alarm for local alerts. The module also features a standard ECG monitor data interface, allowing connection to ECG monitors from various mainstream brands via a dedicated data cable, transmitting flap data to the monitor in analog or digital signal format. Additionally, it includes a Bluetooth 5.0 module for wireless data communication with the nurse station's mobile app or central workstation.

[0040] The main unit of the entire monitoring device is encased in a compact shell made of ABS medical-grade plastic, with overall dimensions of 40mm x 40mm x 30mm, a volume of approximately 48cm³, and a weight of approximately 50 grams. The materials used for the shell and probe have been carefully selected to withstand povidone-iodine immersion and ultraviolet irradiation for sterilization.

[0041] Specifically, a monitoring method for an intelligent free flap vascular crisis monitoring device includes the following steps: S1. A signal transmitting and receiving module with a negative pressure adsorption layer is attached to the skin flap surface, and the attachment pressure is monitored in real time by a miniature pressure sensor. S2, red and infrared light emitters alternately emit light, and reflected light receivers receive reflected light signals. At the same time, multimodal sensors collect micro-blood flow or oxygenation distribution signals. S3, the signal sampling and amplification circuit module acquires various signals from step S2 at a sampling rate of 500Hz and performs secondary amplification; S4. The MCU signal processing module dynamically adjusts the signal transmission intensity or amplification gain based on the feedback from the miniature pressure sensor, and performs adaptive filtering on the amplified signal to remove motion artifacts. The S5 and MCU signal processing modules have built-in blood oxygenation and multimodal fusion algorithms to calculate the filtered signal and generate blood oxygen saturation, heart rate and flap perfusion index (FPI). The S6 MCU signal processing module's built-in deep learning timing signal processing module analyzes the dynamic trends of blood oxygen waveform and FPI to determine whether vascular crisis exists and its type. S7 The result output module displays the parameters and analysis results generated by S5 and S6 in real time, and issues corresponding local and / or remote alarms according to the crisis level when the parameters are abnormal or when a vascular crisis is determined.

[0042] In summary, the intelligent free flap vascular crisis monitoring device of this invention simplifies the expensive and scarce flap blood oxygen saturation measurement equipment into a single-structure probe, combining it with blood oxygen saturation monitors widely used in hospitals at all levels. This not only meets the needs of clinicians for postoperative flap vascular crisis monitoring but also allows for widespread adoption in hospitals at all levels at a lower cost, satisfying the vast demand from both medical professionals and patients. Furthermore, it utilizes electronic engineering technology to achieve wireless, continuous, real-time, and non-invasive dynamic monitoring, enabling early detection of flap vascular crises and embolism types, and automatically alerting medical staff, saving time for flap rescue. This product boasts ultra-high monitoring accuracy, extremely fast response speed, material advantages, size advantages, and intraoperative usability, thereby improving the success rate of flap surgery in clinical practice, effectively reducing medical costs, and increasing the success rate of flap transplantation surgery.

[0043] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An intelligent free flap vascular crisis monitoring device, characterized in that, include: A signal transmitting and receiving module includes a flexible substrate, and a red light emitter, an infrared light emitter, and a reflected light receiver integrated on the flexible substrate; The lower surface of the flexible substrate is provided with a negative pressure adsorption layer for attaching the skin flap. The negative pressure adsorption layer is made of flexible medical silicone material and forms a negative pressure cavity on its bonding surface. The signal sampling and amplification circuit module has its input terminal electrically connected to the output terminal of the reflected light receiver, and is used to acquire the reflected light signal at a preset high sampling rate and perform secondary amplification processing. The MCU signal processing module has its input terminal electrically connected to the output terminal of the signal sampling and amplification circuit module. The MCU signal processing module has built-in filtering algorithms for filtering out signal interference, blood oxygenation algorithms for calculating blood oxygen saturation, and multimodal fusion algorithms for fusing multimodal signals and generating flap perfusion index (FPI). The result output module is electrically connected to the output terminal of the MCU signal processing module. It is used to display the blood oxygen saturation, heart rate and flap perfusion index (FPI) output by the MCU signal processing module, and to issue an alarm signal when the monitored parameters exceed a preset threshold.

2. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The signal transmitting and receiving module also includes a miniature Doppler sensor or near-infrared spectral sensor integrated on the flexible substrate for monitoring local micro-blood flow or oxygenation distribution. The output terminal of the miniature Doppler sensor or near-infrared spectral sensor is also electrically connected to the input terminal of the signal sampling and amplification circuit module to provide data input for the multimodal fusion algorithm.

3. The intelligent free flap vascular crisis monitoring device according to claim 1 or 2, characterized in that, The signal transmitting and receiving module also includes a miniature pressure sensor embedded in the flexible substrate. The sensing surface of the miniature pressure sensor faces the negative pressure adsorption layer, and its output terminal is electrically connected to the input terminal of the MCU signal processing module. The MCU signal processing module is also used to dynamically adjust the emission intensity of the red light emitter and the infrared light emitter or the gain of the signal sampling and amplification circuit module according to the contact pressure value monitored in real time by the miniature pressure sensor. When the contact pressure value is lower than the preset bonding threshold, it generates a bonding abnormality prompt signal and sends it to the result output module.

4. The intelligent free flap vascular crisis monitoring device according to claim 3, characterized in that, The built-in filtering algorithm of the MCU signal processing module includes an adaptive filtering algorithm. This algorithm dynamically adjusts the filtering parameters based on the contact pressure value fed back by the miniature pressure sensor to suppress motion artifact interference caused by loose fit.

5. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The MCU signal processing module also has a built-in deep learning-based timing signal processing module, which is used to analyze the dynamic trends of blood oxygen waveform and multimodal signals. When a characteristic waveform caused by venous return obstruction is identified, a warning signal of "suspected venous crisis" is output; when a characteristic waveform caused by arterial obstruction is identified, a warning signal of "suspected arterial crisis" is output and an alarm is activated.

6. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The result output module includes a miniature display screen and an audible and visual alarm integrated on the circuit board of the MCU signal processing module; the result output module also includes a data connection cable that matches the interface of an external electrocardiogram monitor, used to transmit skin flap blood oxygen data and heart rate data to the electrocardiogram monitor in real time for synchronous display and comparison.

7. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The result output module also includes a wireless data transmission unit, used to establish a communication connection with a mobile terminal or hospital central workstation via Bluetooth or Wi-Fi to achieve real-time data upload and remote alarm. The alarm signal is divided into two levels according to the severity of the crisis: when the flap perfusion index (FPI) decreases but does not reach the severe threshold, a low-level warning is triggered, and a reminder is pushed to the mobile terminal; when the rate of FPI decrease is greater than the preset rate threshold, or the blood oxygen saturation is lower than 85% for more than 5 minutes, a high-level alarm is triggered, and a warning is issued through the local audible and visual alarm of the monitor and by pushing the alarm to the on-duty doctor's terminal.

8. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The flexible substrate of the signal transmitting and receiving module, the negative pressure adsorption layer, and the entire outer shell of the monitor are all made of materials that can withstand immersion in medical-grade disinfectant and exposure to ultraviolet light.

9. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The overall thickness of the signal transmitting and receiving module is less than 1 mm, and the maximum thickness after being combined with the negative pressure adsorption layer does not exceed 2 mm; the volume of the entire monitoring instrument is less than 50 cubic centimeters.

10. The intelligent free flap vascular crisis monitoring device according to claim 1, characterized in that, The preset sampling rate of the signal sampling and amplification circuit module is 500Hz.

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