Synchronous monitoring system and method for pressure and microcirculation of diabetic foot and risk assessment method

Abstract

The invention provides a diabetic foot pressure and microcirculation synchronous monitoring system and method and a risk assessment method, and the system comprises a flexible pressure sensing layer, a laser Doppler module, a temperature monitoring module, a humidity monitoring module and a data processing unit. The flexible pressure sensing layer, the laser Doppler module, the temperature monitoring module and the humidity monitoring module are respectively in signal connection with the data processing unit; the data processing unit is connected with a user terminal. A data fusion model is constructed, data integration is enhanced, a synchronous monitoring system comprising a flexible pressure sensing layer, a laser Doppler module, a data processing unit and a user terminal is established, a laser probe is embedded into the insole at an inclination angle, and the signal receiving efficiency is optimized; foot temperature and humidity measurement is added, early infection is recognized, and the influence of the blood vessel state and temperature and humidity changes on foot fungi is evaluated; an ulcer risk grading algorithm based on pressure-blood flow coupling analysis is designed, the monitoring efficiency is improved, and personalized early warning suggestions can be provided; the structure is simple and wearing is convenient and comfortable.

Description

Technical Field

[0001] The present invention relates to the technical field of medical monitoring, and particularly to the fields of flexible sensing and laser Doppler technology; specifically, it relates to a system and method for synchronous monitoring of diabetic foot pressure and microcirculation, and a risk assessment method. Background Art

[0002] Currently, the monitoring technologies used for preventing and evaluating diabetic foot mainly include foot pressure detection and microcirculation monitoring. Among them, the system architecture of the foot pressure detection technology mainly includes the following components:

[0003] Pressure sensing insole: By embedding a flexible pressure sensor array (such as piezoresistive or capacitive sensors), it is used to measure the pressure distribution in each area of the sole of the foot and evaluate abnormal foot force.

[0004] Gait analysis system: Based on imaging or force plate technology, it analyzes the dynamic pressure changes of the foot during walking. Through the test of the sole pressure distribution during walking, it locates the areas with abnormally increased sole pressure and identifies potential ulcer risks.

[0005] The system architecture of the microcirculation monitoring technology mainly includes the following components:

[0006] Laser Doppler flowmeter (LDF): By emitting laser and receiving the scattered light frequency shift signal, it calculates the microcirculation blood flow velocity and blood flow volume;

[0007] Transcutaneous oxygen partial pressure monitoring (TcPO2): Measures the oxygen partial pressure on the skin surface, reflects the oxygen supply situation of foot tissues, and evaluates the degree of vascular lesions and local ischemia. However, TcPO2 monitoring is an indirect assessment of tissue perfusion level and cannot reflect dynamic blood flow changes.

[0008] However, the existing above-mentioned monitoring technologies for preventing and evaluating diabetic foot have the following objective disadvantages:

[0009] 1. Existing pressure detection or microcirculation monitoring devices can only independently measure pressure or blood flow parameters, have the limitations of single parameters, lack synchronous acquisition and analysis of multi-modal data, and are difficult to comprehensively evaluate the risk of foot lesions;

[0010] 2. The data feedback delay of traditional pressure detection devices is high, and the real-time performance is insufficient, and it is impossible to achieve real-time monitoring of dynamic walking or standing states;

[0011] 3. The device volume of the laser Doppler flowmeter is large, it needs to be fixed in a laboratory environment for use, the portability is poor, and it cannot meet the comfort requirements of daily wear;

[0012] 4. Data integration is lacking, and there is a lack of intelligent analysis algorithms for the correlation between pressure distribution and microcirculation parameters, and it is impossible to provide personalized early warning suggestions. Summary of the Invention

[0013] In view of this, the object of the present invention is to develop a synchronous monitoring system and method for diabetic foot pressure and microcirculation, a risk assessment method, construct a data fusion model, enhance data integration, establish a synchronous monitoring system including a flexible pressure sensing layer, a laser Doppler module, a data processing unit and a user terminal, embed the laser probe into the insole at an inclination angle of 28 - 32°, optimize the signal reception efficiency; increase the measurement of foot temperature and humidity, identify early infections, evaluate vascular status, and the impact of temperature and humidity changes on foot fungi; design an ulcer risk grading algorithm based on pressure - blood flow coupling analysis to improve the monitoring efficiency, and be able to provide personalized early warning suggestions according to the calculation results; and have a simple structure, strong integrity, convenient and comfortable to wear, good applicability, so as to facilitate popularization and application.

[0014] The present invention provides a synchronous monitoring system for diabetic foot pressure and microcirculation, including: a flexible pressure sensing layer, a laser Doppler module, a temperature monitoring module, a humidity monitoring module, and a data processing unit. The flexible pressure sensing layer, the laser Doppler module, the temperature monitoring module, and the humidity monitoring module are respectively connected to the data processing unit by signals; the data processing unit is connected to a user terminal;

[0015] The flexible pressure sensing layer includes: piezoresistive sensors arranged in an array (preferably a 16×24 array), a flexible silicone substrate (preferably with a thickness of 0.5 mm), and the piezoresistive sensors are embedded inside the flexible silicone substrate, and the piezoresistive sensors cover the plantar tendon area (including the forefoot, arch, and heel);

[0016] The laser Doppler module includes: a plurality of integrated micro - laser probes, the wavelength of the micro - laser probes is 785 nm, and the micro - laser probes are embedded in the insole package at an inclination angle of 28 - 32°, covering the vulnerable ulcer areas of the forefoot, arch, and heel;

[0017] The piezoresistive sensors of the flexible pressure array of the present invention and the micro - laser probes of the laser Doppler adopt a conformal packaging method, with a simple and reasonable structure, strong integrity, and convenient and comfortable to wear.

[0018] The temperature monitoring module includes: an infrared sensor integrated on the surface layer of the insole, and the infrared sensor is 1.8 - 2.2 mm away from the skin surface;

[0019] The humidity monitoring module includes: a capacitive humidity sensor and a breathable electrode, distributed in the arch and interdigital areas (high sweat secretion areas), and co - planar packaged with the piezoresistive sensors;

[0020] The data processing unit includes: a built-in processor, a Bluetooth 5.0 module, and a storage chip; the Bluetooth 5.0 module is signal-connected to the built-in processor, and the built-in processor is signal-connected to the storage chip.

[0021] The present invention also provides a method for synchronously monitoring the pressure and microcirculation of diabetic feet, which uses the diabetic foot pressure and microcirculation synchronous monitoring system as described above, and includes:

[0022] Construct a data fusion model:

[0023] RISK Score = α × pressure index + β × blood flow attenuation rate + γ × myogenic signal disorder degree;

[0024] Among them, α, β, and γ are dynamic weight coefficients;

[0025] The flexible pressure sensing layer real-time collects the pressure values of each area of the sole, generates a dynamic pressure heat map, and calculates the peak pressure and pressure-time integral PTI;

[0026] The laser Doppler module emits low-power laser, and detects the blood flow velocity (cm / s), blood flow volume (PU), and myogenic oscillation frequency (0.05 - 0.15 Hz) of the microcirculation at a depth of 1 - 2 mm under the skin through the Doppler effect; when the local pressure > 150 kPa, the Doppler monitoring of the corresponding area is activated;

[0027] The temperature monitoring module performs non-contact overall temperature scanning on the sole area; the humidity monitoring module measures the skin surface sweat conductivity of the sole area;

[0028] Based on the constructed data fusion model, the data processing unit runs a multi-parameter correlation algorithm (such as automatically triggering blood flow monitoring when the pressure exceeds the threshold), dynamically adjusts the laser sampling frequency according to the pressure change; filters and processes the pressure and blood flow signals to achieve real-time monitoring of diabetic feet.

[0029] The present invention also provides a risk assessment method for synchronously monitoring the pressure and microcirculation of diabetic feet, which is applied to the diabetic foot pressure and microcirculation synchronous monitoring system as described above, and designs an ulcer risk grading algorithm based on pressure-blood flow coupling analysis, including:

[0030] Calculate the comprehensive risk score :

[0031] (1)

[0032] In formula (1), is the normalized pressure value at time t (current pressure / maximum tolerable pressure);

[0033] Indicates the critical pressure (evidence-based medicine threshold) for the occurrence of diabetic foot ulcers;

[0034] is the real-time microcirculation blood flow, in PU;

[0035] is the baseline blood flow;

[0036] is the myogenic oscillation frequency;

[0037] is the healthy reference value, = 0.1 Hz;

[0038] 、 、 are the dynamic weight coefficients, and the sum is 1.

[0039] Furthermore, the method for calculating the comprehensive risk score includes:

[0040] Calculate the pressure index term, and the expression is:

[0041] (2)

[0042] In formula (2), Indicates the critical pressure (evidence-based medicine threshold) for the occurrence of diabetic foot ulcers;

[0043] The quantization logic of the pressure index term is: the closer the pressure value is to the critical value, the linearly increasing mechanical damage risk index;

[0044] The dynamic adjustment rule of the pressure index term is:

[0045] During walking, the dynamic weight coefficient From 0.4 → 0.7: Enhance the sensitivity to instantaneous pressure peaks;

[0046] During sitting, the dynamic weight coefficient From 0.7 → 0.4: Reduce the weight of static pressure.

[0047] Furthermore, the method for calculating the comprehensive risk score also includes:

[0048] Calculate the blood flow attenuation term, and the expression is:

[0049] (3)

[0050] The blood flow attenuation term reflects the degree of loss of microcirculation compensatory ability (a 30% decrease in blood flow corresponds to a term value of 0.3);

[0051] The dynamic adjustment rule of the blood flow attenuation term is:

[0052] When ΔQ / Δt >10%, the dynamic weight coefficient From 0.3 to 0.5: focus on acute ischemic events;

[0053] Blood flow recovery period, dynamic weight coefficient Down to 0.2: Reduce false positives.

[0054] Furthermore, the method for calculating the comprehensive risk score further includes:

[0055] Calculate the disorder term of myogenic signal, the expression is:

[0056] (4)

[0057] The myogenic signal disorder term reflects abnormal neural regulation through the deviation of myogenic oscillation frequency (normal range 0.05-0.15 Hz);

[0058] when When it exceeds 0.05~0.15Hz, a Level III warning is directly triggered.

[0059] Furthermore, the dynamic weight coefficient 、 、 The dynamic allocation mechanism includes: short-term adjustment, patient baseline correction;

[0060] The short-term adjustment is based on the real-time motion status (see Table 1). 、 、 0.7, 0.2, 0.1 respectively; when sitting quietly 、 、 0.4, 0.5, 0.1 respectively; during sleep at night 、 、 They are 0.3, 0.6, and 0.1 respectively;

[0061] Table 1: Short-term adjustments: based on real-time motion status

[0062] Motion state α β γ Walking 0.7 0.2 0.1 Sitting still 0.4 0.5 0.1 Nighttime sleep 0.3 0.6 0.1

[0063] The patient baseline correction is to adjust individual parameters based on the 72-hour monitoring data at the time of first use:

[0064] Obese patients with a BMI ≥ 30: Increase by 0.1 to strengthen the pressure weight;

[0065] Patients with vascular disease have an ABI < 0.9: Increase by 0.15 to enhance blood flow weight.

[0066] Furthermore, the risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation further includes: according to the calculated comprehensive risk score , perform risk grading and intervention (as shown in Table 2); the method for risk grading and intervention includes: dividing the risk level into level I, level II, and level III;

[0067] The RISK threshold for level I is 1.5 - 2.0, the RISK threshold for level II is 2.0 - 3.0, and the RISK threshold for level III is > 3.0;

[0068] The response measure for level I is vibration prompt + gait correction advice; the response measure for level II is locking the high-risk area + generating a 3D decompression insole; the response measure for level III is remote medical intervention + emergency braking advice.

[0069] Table 2: Risk grading and intervention logic

[0070] Risk level RISK threshold Response measures Biomedical mechanism Level I 1.5~2.0 Vibration prompt + Gait correction advice Early metabolic imbalance, Reversible microcirculation spasm Level II 2.0~3.0 Lock high-risk areas + Generate 3D decompression insoles Capillary collapse, Endothelial cell damage Level III >3.0 Telemedicine intervention + Emergency braking advice Microthrombosis, Irreversible tissue hypoxia .

[0071] The present invention improves the monitoring efficiency and the accuracy of risk assessment by designing and developing an ulcer risk grading algorithm based on pressure-blood flow coupling analysis, and can provide personalized early warning suggestions according to the calculation results.

[0072] The present invention also provides a computer-readable storage medium, on which a computer program is stored, and when the program is executed by a processor, it implements the diabetic foot pressure and microcirculation synchronous monitoring method and the diabetic foot pressure and microcirculation synchronous monitoring risk assessment method as described above.

[0073] The present invention also provides a computer device, the computer device includes a memory, a processor, and a computer program stored on the memory and executable on the processor, and when the processor executes the program, it implements the diabetic foot pressure and microcirculation synchronous monitoring method and the diabetic foot pressure and microcirculation synchronous monitoring risk assessment method as described above.

[0074] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0075] The diabetes foot pressure and microcirculation synchronous monitoring system, method, and risk assessment method provided by the present invention enhance data integration by constructing a data fusion model, establish a synchronous monitoring system including a flexible pressure sensing layer, a laser Doppler module, a data processing unit, and a user terminal, embed the laser probe into the insole at an inclination angle of 28-32°, optimizing the signal reception efficiency; identify early infections, evaluate vascular status, and the impact of temperature and humidity changes on foot fungi by adding foot temperature and humidity measurement; design an ulcer risk grading algorithm based on pressure-blood flow coupling analysis, improving the monitoring efficiency, and providing personalized early warning suggestions according to the calculation results; and has a simple structure, strong integrity, is convenient and comfortable to wear, has good applicability, and is conducive to popularization and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] By reading the detailed description of the preferred embodiments below, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention.

[0077] In the drawings:

[0078] Figure 1 is a flowchart of the synchronous monitoring of diabetes foot pressure and microcirculation in an embodiment of the present invention in actual application;

[0079] Figure 2 is a schematic diagram of the composition of a computer device in an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0080] The exemplary embodiments will be described in detail herein, and the examples are shown in the drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present disclosure. On the contrary, they are only examples of systems and products consistent with some aspects of the present disclosure as detailed in the appended claims.

[0081] The terms used in the present disclosure are only for the purpose of describing particular embodiments and are not intended to limit the present disclosure. The singular forms "a", "the", and "that" used in the present disclosure and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0082] It should be understood that although the terms first, second, third, etc. may be used in this disclosure to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this disclosure, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "at the time of" or "when" or "in response to determining."

[0083] The embodiments of the present invention are described in further detail below.

[0084] The embodiment of the present invention provides a diabetic foot pressure and microcirculation synchronous monitoring system, including a flexible pressure sensing layer, a laser Doppler module, a temperature monitoring module, a humidity monitoring module, and a data processing unit. The flexible pressure sensing layer, the laser Doppler module, the temperature monitoring module, and the humidity monitoring module are respectively connected to the data processing unit for signal connection; the data processing unit is connected to a user terminal;

[0085] The flexible pressure sensing layer includes a 16×24 array of piezoresistive sensors and a flexible silicone substrate (0.5 mm thick). The piezoresistive sensors are embedded in the flexible silicone substrate and cover the plantar tendon area (including the forefoot, arch, and heel).

[0086] The laser Doppler module includes multiple integrated micro laser probes with a wavelength of 785nm. The micro laser probes are embedded in the insole at a 30° angle, covering the ulcer-prone areas of the forefoot, arch, and heel.

[0087] The piezoresistive sensor of the flexible pressure array and the micro laser probe of the laser Doppler of this embodiment are packaged in a conformal manner, which has a simple and reasonable structure, strong integrity, is comfortable and convenient to wear, has good applicability, and is easy to promote and apply.

[0088] The temperature monitoring module includes an infrared sensor integrated into the surface of the insole, with the infrared sensor 2.0 mm away from the skin surface;

[0089] The humidity monitoring module includes a capacitive humidity sensor and a breathable electrode, which are distributed in the arch and interdigital areas (areas with high sweat secretion) and are coplanarly packaged with the piezoresistive sensor.

[0090] The data processing unit includes a built-in processor, a Bluetooth 5.0 module, and a memory chip; the Bluetooth 5.0 module is signal-connected to the built-in processor, and the built-in processor is signal-connected to the memory chip.

[0091] The embodiment of the present invention further provides a method for synchronously monitoring diabetic foot pressure and microcirculation, which uses the above-mentioned synchronous monitoring system for diabetic foot pressure and microcirculation, including:

[0092] Construct a data fusion model:

[0093] RISK Score = α × Pressure Index + β × Blood Flow Attenuation Rate + γ × Myogenic Signal Disorder Degree;

[0094] Among them, α, β, and γ are dynamic weight coefficients;

[0095] The flexible pressure sensing layer collects the pressure values of each area on the sole of the foot in real time, generates a dynamic pressure thermogram, and calculates the peak pressure and the pressure-time integral PTI;

[0096] The laser Doppler module emits low-power laser, and detects the blood flow velocity (cm / s), blood flow volume (PU), and myogenic oscillation frequency (0.05 - 0.15 Hz) of the microcirculation at a depth of 1 - 2 mm under the skin through the Doppler effect; when the local pressure > 150 kPa, the Doppler monitoring of the corresponding area is activated;

[0097] The temperature monitoring module performs non-contact overall temperature scanning on the sole area; the humidity monitoring module measures the skin surface sweat conductivity of the sole area;

[0098] Based on the constructed data fusion model, the data processing unit runs a multi-parameter correlation algorithm, automatically triggers blood flow monitoring when the pressure exceeds the threshold, and dynamically adjusts the laser sampling frequency according to the pressure change; filters and processes the pressure and blood flow signals to achieve real-time monitoring of diabetic foot.

[0099] Figure 1 The process of synchronous monitoring of diabetic foot pressure and microcirculation in the embodiments of the present invention is shown.

[0100] The embodiments of the present invention also provide a risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation, which is applied to the synchronous monitoring system of diabetic foot pressure and microcirculation as described above, and designs an ulcer risk grading algorithm based on pressure-blood flow coupling analysis, including:

[0101] Calculate the comprehensive risk score :

[0102] (1)

[0103] In formula (1), is the normalized pressure value at time t (current pressure / maximum tolerable pressure);

[0104] represents the critical pressure for the occurrence of diabetic foot ulcer (evidence-based medicine threshold);

[0105] is the real-time microcirculation blood flow volume, in unit PU;

[0106] is the baseline blood flow;

[0107] is the myogenic oscillation frequency;

[0108] is the healthy reference value, = 0.1Hz;

[0109] and and are the dynamic weight coefficients, and their sum is 1.

[0110] Further, the method for calculating the comprehensive risk score includes:

[0111] Calculating the pressure index term, and the expression is:

[0112] (2)

[0113] In formula (2), represents the critical pressure for the occurrence of diabetic foot ulcers (evidence-based medicine threshold);

[0114] The quantification logic of the pressure index term is: the closer the pressure value is to the critical value, the linearly increasing the mechanical damage risk index;

[0115] The dynamic adjustment rule of the pressure index term is:

[0116] During walking, the dynamic weight coefficient changes from 0.4 → 0.7: enhancing the sensitivity to the instantaneous pressure peak;

[0117] During sitting still, the dynamic weight coefficient changes from 0.7 → 0.4: reducing the weight of the static pressure.

[0118] Among them, the expression for calculating the blood flow attenuation term is:

[0119] (3)

[0120] The blood flow attenuation term reflects the degree of loss of microcirculation compensatory ability (a 30% decrease in blood flow corresponds to a term value of 0.3);

[0121] The dynamic adjustment rule of the blood flow attenuation term is:

[0122] When ΔQ / Δt > 10%, the dynamic weight coefficient changes from 0.3 → 0.5: paying attention to acute ischemic events;

[0123] During the blood flow recovery period, the dynamic weight coefficient decreases to 0.2: reducing false alarms.

[0124] The expression for calculating the myogenic signal disorder term is as follows:

[0125] (4)

[0126] The myogenic signal disorder term reflects abnormal nerve regulation through the deviation of the myogenic oscillation frequency (normal range 0.05 - 0.15 Hz);

[0127] When exceeds 0.05~0.15 Hz, a level III warning is directly triggered.

[0128] Dynamic weight coefficients 、 、 The dynamic allocation mechanism includes: short-term adjustment, patient baseline correction;

[0129] Among them, the short-term adjustment is based on the real-time motion state (as shown in Table 1). When walking 、 、 are 0.7, 0.2, 0.1 respectively; when sitting still 、 、 are 0.4, 0.5, 0.1 respectively; when sleeping at night 、 、 are 0.3, 0.6, 0.1 respectively;

[0130] Table 1: Short-term adjustment: based on real-time motion state

[0131] Motion state α β γ Walking 0.7 0.2 0.1 Sitting still 0.4 0.5 0.1 Nighttime sleep 0.3 0.6 0.1

[0132] Patient baseline correction is to adjust individual parameters according to the 72-hour monitoring data at the first use: <(

[0133] For obese patients with BMI ≥ 30: Increase by 0.1 to strengthen the pressure weight;

[0134] For patients with vascular lesions and ABI < 0.9: Increase by 0.15 to strengthen the blood flow weight.

[0135] According to the calculated comprehensive risk score ,risk grading and intervention are carried out (as shown in Table 2); the risk levels are divided into level I, level II, and level III;

[0136] The RISK threshold for level I is 1.5~2.0, the RISK threshold for level II is 2.0~3.0, and the RISK threshold for level III is > 3.0;

[0137] The response measures for Level I are vibration prompts + gait correction suggestions; the response measures for Level II are locking high-risk areas + generating 3D decompression insoles; the response measures for Level III are remote medical intervention + emergency braking suggestions.

[0138] Table 2: Risk Grading and Intervention Logic

[0139] Risk level RISK threshold Response measures Biomedical mechanism Level I 1.5~2.0 Vibration prompt + Gait correction advice Early metabolic imbalance, Reversible microcirculation spasm Level II 2.0~3.0 Lock high-risk areas + Generate 3D decompression insoles Capillary collapse, Endothelial cell damage Level III >3.0 Telemedicine intervention + Emergency braking advice Microthrombosis, Irreversible tissue hypoxia 。

[0140] In this embodiment, according to the calculation results of the above-mentioned ulcer risk grading algorithm based on pressure-blood flow coupling analysis, personalized early warning suggestions are provided.

[0141] The embodiment of the present invention also provides a computer device, Figure 2 which is a schematic structural diagram of a computer device provided by the embodiment of the present invention; see the attached drawings Figure 2 As shown, the computer device includes: an input system 23, an output system 24, a memory 22, and a processor 21; the memory 22 is used to store one or more programs; when the one or more programs are executed by the one or more processors 21, the one or more processors 21 implement the diabetes foot pressure and microcirculation synchronous monitoring method and the diabetes foot pressure and microcirculation synchronous monitoring risk assessment method provided by the above-mentioned embodiment; wherein the input system 23, the output system 2, the memory 22, and the processor 21 can be connected by a bus or other means, Figure 2 taking the connection by bus as an example.

[0142] The memory 22, as a readable and writable storage medium of a computing device, can be used to store software programs and computer-executable programs, such as the program instructions corresponding to the diabetes foot pressure and microcirculation synchronous monitoring method and the diabetes foot pressure and microcirculation synchronous monitoring risk assessment method described in the embodiment of the present invention; the memory 22 mainly includes a program storage area and a data storage area. Among them, the program storage area can store an operating system and application programs required for at least one function; the data storage area can store data created according to the use of the device, etc.; in addition, the memory 22 can include a high-speed random access memory, and can also include a non-volatile memory, such as at least one magnetic disk storage device, a flash memory device, or other non-volatile solid-state storage devices; in some instances, the memory 22 can further include a memory remotely set relative to the processor 21, and these remote memories can be connected to the device through a network. Examples of the above-mentioned network include but are not limited to the Internet, an enterprise internal network, a local area network, a mobile communication network, and their combinations.

[0143] The input system 23 can be used to receive input digital or character information, and generate key signal inputs related to the user settings and function controls of the device; the output system 24 can include display devices such as a display screen.

[0144] The processor 21 executes various functional applications and data processing of the device by running software programs, instructions, and modules stored in the memory 22, that is, implements the above-mentioned method for synchronous monitoring of diabetic foot pressure and microcirculation and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation.

[0145] The computer device provided above can be used to execute the method for synchronous monitoring of diabetic foot pressure and microcirculation and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation provided by the above embodiments, and has corresponding functions and beneficial effects.

[0146] The embodiment of the present invention further provides a storage medium containing computer-executable instructions. The computer-executable instructions are used to execute the method for synchronous monitoring of diabetic foot pressure and microcirculation and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation provided by the above embodiments when executed by a computer processor. The storage medium is any of various types of memory devices or storage devices, including: installation media such as CD-ROMs, floppy disks, or tape systems; computer system memories or random access memories such as DRAM, DDR RAM, SRAM, EDO RAM, Rambus RAM, etc.; non-volatile memories such as flash memories, magnetic media (such as hard disks or optical storage); registers or other similar types of memory elements, etc.; the storage medium may also include other types of memories or combinations thereof; additionally, the storage medium may be located in the first computer system in which the program is executed, or may be located in a different second computer system that is connected to the first computer system through a network (such as the Internet); the second computer system may provide program instructions to the first computer for execution. The storage medium includes two or more storage media that may reside in different locations (such as in different computer systems connected through a network). The storage medium may store program instructions executable by one or more processors (such as specifically implemented as a computer program).

[0147] Certainly, for the storage medium containing computer-executable instructions provided by the embodiment of the present invention, the computer-executable instructions are not limited to the method for synchronous monitoring of diabetic foot pressure and microcirculation and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation described in the above embodiments, and can also execute relevant operations in the method for synchronous monitoring of diabetic foot pressure and microcirculation and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation provided by any embodiment of the present invention.

[0148] So far, the technical solution of the present invention has been described in conjunction with the preferred embodiments shown in the accompanying drawings. However, it is easily understood by those skilled in the art that the protection scope of the present invention is obviously not limited to these specific embodiments. Without departing from the principle of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will fall within the protection scope of the present invention.

[0149] The above are only the preferred embodiments of the present invention and are not used to limit the present invention; for those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent substitution, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. Diabetic foot pressure and microcirculation synchronous monitoring system, characterized in that, Comprising: A flexible pressure sensing layer, a laser Doppler module, a temperature monitoring module, a humidity monitoring module, and a data processing unit. The flexible pressure sensing layer, the laser Doppler module, the temperature monitoring module, and the humidity monitoring module are respectively connected to the data processing unit by signal; the data processing unit is connected to a user terminal; The flexible pressure sensing layer includes: piezoresistive sensors arranged in an array, and a flexible silicone substrate. The piezoresistive sensors are embedded inside the flexible silicone substrate, and the piezoresistive sensors cover the plantar tendon area; The laser Doppler module includes: a plurality of integrated micro laser probes. The wavelength of the micro laser probes is 785 nm. The micro laser probes are embedded in the insole package at an inclination angle of 28 - 32°, covering the vulnerable ulcer areas of the forefoot, arch, and heel; The temperature monitoring module includes: an infrared sensor integrated on the surface layer of the insole. The infrared sensor is 1.8 - 2.2 mm away from the skin surface; The humidity monitoring module includes: a capacitive humidity sensor and a breathable electrode, which are distributed in the arch and toe areas and are encapsulated coplanarly with the piezoresistive sensors; The data processing unit includes: a built-in processor, a Bluetooth 5.0 module, and a storage chip; the Bluetooth 5.0 module is connected to the built-in processor by signal, and the built-in processor is connected to the storage chip by signal.

2. Method for synchronous monitoring of diabetic foot pressure and microcirculation, using the diabetic foot pressure and microcirculation synchronous monitoring system according to claim 1, characterized in that, Comprising: Constructing a data fusion model: RISK Score = α × Pressure Index + β × Blood Flow Attenuation Rate + γ × Myogenic Signal Disorder Degree; Wherein, α, β, γ are dynamic weight coefficients; The flexible pressure sensing layer real-time collects the pressure values of each area of the sole, generates a dynamic pressure heat map, and calculates the peak pressure and the pressure-time integral PTI; The laser Doppler module emits low-power laser, and detects the blood flow velocity, blood flow volume, and myogenic oscillation frequency of the microcirculation at a depth of 1 - 2 mm under the skin through the Doppler effect; when the local pressure > 150 kPa, the Doppler monitoring of the corresponding area is activated; The temperature monitoring module performs a non-contact overall temperature scan of the sole area; the humidity monitoring module measures the skin surface sweat conductivity of the sole area; Based on the constructed data fusion model, the data processing unit runs a multi-parameter correlation algorithm, dynamically adjusts the laser sampling frequency according to the pressure change; filters and processes the pressure and blood flow signals to achieve real-time monitoring of diabetic foot.

3. Risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation, applied to the diabetic foot pressure and microcirculation synchronous monitoring system as described in claim 1, characterized in that, Designing an ulcer risk grading algorithm based on pressure-blood flow coupling analysis, including: Calculate the comprehensive risk score : （1） In formula (1), is the normalized pressure value at time t, that is, the current pressure / the maximum tolerable pressure; Indicates the critical pressure at which diabetic foot ulcers occur; is the real-time microcirculation blood flow, in PU (perfusion unit); is the baseline blood flow rate; is the myogenic oscillation frequency; is a health reference value, = 0.1 Hz; , , are dynamic weight coefficients, and the sum is 1.

4. The risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation according to claim 3, wherein The method for calculating the comprehensive risk score includes: Calculating the pressure index term, and the expression is: （2） In formula (2), represents the critical pressure for the occurrence of diabetic foot ulcers; The quantization logic of the pressure index term is: the closer the pressure value is to the critical value, the linearly increasing the mechanical damage risk index; The dynamic adjustment rule of the pressure index term is: During walking, the dynamic weight coefficient From 0.4 → 0.7: Enhance the sensitivity to instantaneous pressure peaks; During sitting, dynamic weight coefficient From 0.7 → 0.4: Reduce the weight of static pressure.

5. The risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation according to claim 4, wherein The method for calculating the comprehensive risk score further includes: Calculating the blood flow attenuation term, and the expression is: （3） The blood flow attenuation term reflects the degree of loss of microcirculation compensation ability (when the blood flow volume decreases by 30%, the corresponding term value is 0.3); The dynamic adjustment rule of the blood flow attenuation term is: When ΔQ / Δt > 10%, the dynamic weight coefficient Changes from 0.3 to 0.5: Pay attention to acute ischemic events; Blood flow recovery period, dynamic weight coefficient Drop to 0.2: Reduce false alarms.

6. The risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation according to claim 5, characterized in that, The method for calculating the comprehensive risk score further includes: Calculating the myogenic signal disorder term, and the expression is: （4） The myogenic signal disorder item reflects abnormal nerve regulation through the deviation of the myogenic oscillation frequency; When exceeds 0.05 - 0.15 Hz, directly trigger a Level III warning.

7. The risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation according to claim 6, wherein The dynamic weight coefficient and and 's dynamic allocation mechanism includes: short-term adjustment, patient baseline correction; Among them, the short-term adjustment is based on the real-time motion state. When walking, , , are 0.7, 0.2, and 0.1 respectively; when sitting still, , , are 0.4, 0.5, and 0.1 respectively; when sleeping at night, , , are 0.3, 0.6, and 0.1 respectively; The patient baseline correction adjusts individual parameters according to the 72-hour monitoring data at the first use: BMI ≥ 30 for obese patients: Increase by 0.1 and strengthen the pressure weight; ABI < 0.9 in patients with vascular lesions: Increase by 0.15 to enhance blood flow weight.

8. The risk assessment method for synchronous monitoring of diabetic foot pressure and microcirculation according to claim 6, characterized in that, It also includes: Based on the calculated comprehensive risk score , risk grading and intervention are carried out; The method for risk grading and intervention includes: dividing the risk level into grade I, grade II, and grade III; The RISK threshold for grade I is 1.5 - 2.0, the RISK threshold for grade II is 2.0 - 3.0, and the RISK threshold for grade III is > 3.0; The response measures for grade I are vibration prompt + gait correction advice; the response measures for grade II are locking the high-risk area + generating 3D decompression insoles; the response measures for grade III are remote medical intervention + emergency braking advice.

9. A computer-readable storage medium having a computer program stored thereon, characterized in that, When the program is executed by the processor, it implements the method for synchronous monitoring of diabetic foot pressure and microcirculation as described in claim 2 and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation as described in any one of claims 3 - 8.

10. A computer device, the computer device comprising a memory, a processor, and a computer program stored on the memory and executable on the processor, characterized in that, When the processor executes the program, it implements the method for synchronous monitoring of diabetic foot pressure and microcirculation as described in claim 2 and the method for risk assessment of synchronous monitoring of diabetic foot pressure and microcirculation as described in any one of claims 3 - 8.

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