Multifunctional treatment and evaluation device and method for varicose veins of lower limbs

Abstract

The application discloses a multifunctional treatment and evaluation device and method for varicose veins of lower limbs, which comprises a multifunctional treatment bandage, a treatment evaluation instrument and a host computer, the multifunctional treatment bandage is connected with the treatment evaluation device and is used for actively intervening and monitoring varicose vein positions, the treatment evaluation device is connected with the host computer and is used for signal transmission and processing, and the host computer is used for data analysis and processing and visual operation. The multifunctional treatment evaluation device has the advantages of simple operation, low cost, multiple built-in prescription modes, and the ability of detecting, treating and evaluating the conditions of patients with varicose veins of lower limbs, and has a wide application prospect in the field of treating varicose veins.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multifunctional treatment evaluation device and method for treating varicose veins of the lower extremities. Background Technology

[0002] In recent years, with the accelerating aging of the world's population, the prevalence of chronic venous insufficiency (CVI) has been increasing, easily leading to varicose veins in the lower extremities. Varicose veins can cause various physical and psychological problems, including extreme swelling of the limbs, loss of limb function, anxiety, and depression. Compression therapy is one of the clinically proven effective methods for preventing and treating chronic venous insufficiency. Its working principle is to apply gradient pressure from bottom to top to muscle tissue, which then transmits the pressure to the veins, promoting venous blood return and improving congestion symptoms, thereby achieving the therapeutic goal. Electrical impedance tomography (EIT) is an ideal medical imaging technology with broad application prospects, characterized by high detection accuracy and good visualization, and can be used for long-term continuous physiological monitoring and disease diagnosis. However, currently, there is no medical device that integrates treatment and evaluation.

[0003] This invention provides a multifunctional treatment and evaluation device and method for varicose veins of the lower extremities. It utilizes EIT technology to achieve high-precision detection and visual impedance imaging of varicose vein sites for disease assessment. Active intervention treatment is performed using methods such as electrical stimulation, electrical heating, and balloon compression. The instrument is simple to operate, low in cost, and has multiple built-in prescription modes. It can perform disease detection, treatment, and evaluation for patients with varicose veins of the lower extremities, and has broad application prospects in the field of varicose vein treatment. Summary of the Invention

[0004] The purpose of this invention is to address the technical deficiencies in the existing technology by providing a multifunctional treatment and evaluation device for varicose veins of the lower extremities.

[0005] Another object of the present invention is to improve the evaluation method of the above-mentioned evaluation device.

[0006] The technical solution adopted to achieve the purpose of this invention is:

[0007] A multifunctional treatment evaluation device includes a multifunctional treatment strap, a treatment evaluation instrument, and a host computer. The multifunctional treatment strap is connected to the treatment evaluation device for active intervention and monitoring of varicose vein sites. The treatment evaluation device is connected to the host computer for transmitting and processing input signals. The host computer is used to receive signals and perform data analysis, processing, and visualization.

[0008] The multifunctional treatment bandage includes a heating pad, a functional electrode, a flexible airbag, a temperature sensor, and a pressure sensor. The heating pad, functional electrode, and flexible airbag are used for active intervention on varicose vein sites, and the functional electrode, temperature sensor, and pressure sensor are used for real-time monitoring of varicose vein sites.

[0009] The treatment evaluation instrument includes a power module, a pressure module, a temperature module, an EIT module, a pulse generation module, a relay module, an air pump, and a USB data module. The pressure module receives electrical signals generated by a pressure sensor, the temperature module receives electrical signals generated by a temperature sensor, the EIT module is used to generate high-frequency alternating current and identify voltage signals, the pulse generation module is used to generate pulse current, the relay module is used to control the opening and closing of the heating element, air pump, solenoid valve, and pulse generator, the air pump is connected to a multifunctional treatment strap for inflating the air pump, and the USB data module is used to transmit the collected signals to a host computer.

[0010] In the above technical solution, the functional electrode can be used as a monitoring electrode for impedance imaging analysis of varicose veins, and as an intervention electrode for electrical stimulation therapy of varicose veins.

[0011] In the above technical solution, the multifunctional treatment bandage consists of, from the outside to the inside, an airbag nozzle, an outer fabric, an airbag, a spacer fabric, a heating element, a temperature sensor, a pressure sensor, an inner fabric, and a functional electrode. The airbag nozzle is located on the outside of the outer fabric of the multifunctional treatment bandage. The airbag is encapsulated by the spacer fabric and fixed between the outer fabric and the spacer fabric. The heating element, temperature sensor, and pressure sensor are fixed on the inside of the inner fabric. The functional electrode is fixed on the outside of the inner fabric.

[0012] In the above technical solution, the airbag is rectangular in design and can be encapsulated and formed using flexible film materials such as polyurethane through a hot pressing process. The temperature sensor can be made of Pt100 or similar materials. The heating element can be made of flexible heating fabric or flexible film. The pressure sensor can be made of flexible organic film, which is convenient for integration with fabric.

[0013] In the above technical solution, the output terminals of the temperature sensor, heating element, pressure sensor, and functional electrode are respectively connected to the male connector via a wire. A female connector is provided on the chassis of the treatment evaluation device. The input terminals of the pressure module, temperature module, EIT module, pulse generation module, and relay module are respectively connected to the female connector on the chassis. The male connector is plugged into the female connector.

[0014] In the above technical solution, the EIT module includes a signal generator, a voltage-to-current circuit, an analog multiplexer, a signal processing circuit, etc., and is used for electrical impedance tomography of varicose veins.

[0015] In the above technical solution, the host computer has a built-in instrument control program developed based on LabVIEW software for data processing and instrument control.

[0016] Another aspect of the present invention includes an evaluation method for a multifunctional treatment evaluation device, comprising the following steps:

[0017] Step 1: Place at least one multi-functional therapeutic bandage on the lower limb of the human body;

[0018] Step 2: Turn on the treatment evaluation instrument and host computer to perform treatment and evaluation;

[0019] Perform initialization operations, and after initialization is complete, perform initial evaluation and analysis;

[0020] During the evaluation and analysis, the EIT module applies a safe alternating current to the human body through the functional electrodes and receives the measurement response information. This information is then transmitted to the host computer via the data transmission module. The host computer then uses its built-in algorithm to reconstruct the resistivity distribution image of the affected area.

[0021] After the initial evaluation and analysis, varicose vein treatment will be initiated.

[0022] During pressurization therapy, the relay closes, the air pump works, the pressure sensor collects the air pump pressure signal and transmits it to the pressure module, the pressure module receives the signal and transmits it to the host computer through the data transmission module;

[0023] During heat therapy, the relay closes, the heating element works, the temperature sensor collects the temperature signal and transmits it to the temperature module, and the temperature module receives the signal and transmits it to the host computer through the data transmission module.

[0024] During electrical stimulation therapy, the relay closes, and the pulse generator operates;

[0025] The host computer displays the curves of electrical resistance, pressure, and temperature in real time;

[0026] After the treatment was completed, a second evaluation and analysis was conducted, following the same process as the initial evaluation and analysis.

[0027] After the measurement is completed, the host computer will conduct a comprehensive evaluation of the treatment process.

[0028] In the above technical solution, the heating element, functional electrode and airbag can work independently or work in conjunction according to the system's built-in prescription.

[0029] In the above technical solution, the multifunctional treatment bandage can be used alone or in combination.

[0030] In the above technical solution, the LABVIEW software incorporates multiple data processing algorithms, enabling precise control of the treatment process. First, a neural network-based PID heating control algorithm ensures the heating element operates in its most stable state, while maintaining a good match between control parameters and the heating system, achieving optimal heating therapy results. Second, a sensitivity analysis-based pressure control algorithm controls the air pump flow rate, offering better robustness and ensuring minimal pressure fluctuations during pressurized treatment. Third, a multi-scenario data analysis and fusion algorithm based on SVM, decision trees, random forests, and neural networks integrates and analyzes data collected during treatment, comprehensively analyzing the user's health status and various parameter indicators, providing reference suggestions and basis for subsequent treatment evaluation.

[0031] Compared with the prior art, the beneficial effects of the present invention are:

[0032] 1. The functional electrode of the present invention for intervention and monitoring adopts the design concept of bidirectional use of the same electrode, which saves the internal space of the multifunctional treatment bandage and improves the utilization rate of the electrode.

[0033] 2. The multifunctional treatment evaluation device of this invention integrates monitoring and intervention treatment. Utilizing EIT technology, it achieves high-precision detection and visualized electrical impedance imaging of varicose vein sites. This not only provides precise guidance for varicose vein intervention treatment but also enables comprehensive evaluation of post-treatment effects, effectively solving the problem of inaccurate detection during varicose vein treatment. Active intervention treatment using methods such as electrical stimulation, electrical heating, and balloon compression significantly improves the treatment effect of varicose veins.

[0034] 3. The treatment evaluation device of the present invention uses a simple hardware module structure and has a low cost, which can effectively reduce the cost of the treatment evaluation device.

[0035] 4. The treatment evaluation device software of the present invention is based on LabVIEW programming, which is simple to operate, highly visualized, and can be further developed.

[0036] 5. The treatment evaluation device software of the present invention contains a variety of data algorithms, which can accurately control the treatment process and further mine and analyze the data after treatment. Attached Figure Description

[0037] Figure 1 The image shown is an inner layer diagram of the multifunctional therapeutic bandage.

[0038] Figure 2 The image shown is a cross-sectional view of the multifunctional treatment bandage.

[0039] Figure 3 The image shown is an outer layer diagram of the multifunctional therapeutic bandage.

[0040] Figure 4 The image shown is a front view of the treatment evaluation device chassis.

[0041] Figure 5 The image shown is a schematic diagram of the overall treatment evaluation device.

[0042] Figure 6 The diagram shown is the control principle diagram of the EIT module.

[0043] Figure 7 The diagram shown is a schematic of the control principle of the treatment evaluation device.

[0044] In the diagram: 100-Multifunctional treatment bandage; 101-Heating pad; 102-Functional electrode; 103-Temperature sensor; 104-Pressure sensor; 105-Hook and loop fastener A-side; 106-Hook and loop fastener B-side; 107-Airbag nozzle; 108-Signal output port; 109-Outer fabric; 110-Airbag; 111-Inner fabric; 112-Spacer fabric; 200-Treatment evaluation chassis; 201-Relay module; 202-Pulse generation module; 203-Temperature module; 204-Pressure module; 205-EIT module; 206-USB data module; 207-Power module; 208-Air pump; 209-Solenoid valve; 210-Power switch; 211-Signal input port; 212-Air outlet; 213-LED light; 300-Host computer; 301-Data cable. Detailed Implementation

[0045] The present invention will be further described in detail below with reference to the accompanying drawings.

[0046] Example 1:

[0047] A multifunctional therapeutic bandage 100 has a three-layer structure, namely an outer bandage layer, an inner bandage layer, and an inner bandage layer.

[0048] like Figure 1 As shown, the inner layer of the strap includes an inner fabric 111, a Velcro A-side 105, and a functional electrode 102. The Velcro A-side 105 is attached to the surface of the inner fabric 111 by sewing. The functional electrode 102 is mainly made of multi-strand silver wire and is attached to the surface of the inner fabric 111 by embroidery.

[0049] like Figure 2As shown, the strap includes a heating element 101, a temperature sensor 103, a pressure sensor 104, an airbag 110, and a spacer fabric 112. The heating element 101 is a flexible heating fabric, which is fixed to the surface of the spacer fabric 112 by heat-pressing. The temperature sensor 103 is located on the surface of the heating element and is used to monitor the surface temperature of the heating element 101 in real time. The pressure sensor 104 is located on the surface of the spacer fabric 112 and is used to monitor the pressure applied to the human body by the airbag 110 in real time. The airbag 110 is rectangular and located between the outer layer fabric 109 and the spacer fabric 112. After inflation, it is used to provide pressure to the surface of the human body.

[0050] like Figure 3 As shown, the outer layer of the strap includes a Velcro B-side 106, an airbag nozzle 107, a signal output port 108, and an outer fabric 109. The airbag nozzle 107 is attached to the airbag 110 with adhesive and is used to inflate the airbag 110. The nozzle opening is located on the surface of the outer fabric 109. The signal output port 108 is located on the surface of the outer fabric 109. The internal wires are connected to the heating element 101, the functional electrode 102, the temperature sensor 103, and the pressure sensor 104 to transmit signals to the instrument.

[0051] A method for operating a multifunctional therapeutic bandage 100 includes the following steps:

[0052] The heating element 101 provides heat therapy to the human body. Based on information obtained from the temperature sensor 103, a PID algorithm is used to achieve precise control of heating, reducing errors and improving system stability and response speed. The airbag 110 provides pressure therapy to the human body. Based on information obtained from the pressure sensor 104, a pressure control algorithm based on sensitivity analysis is used to achieve precise control of pressurization. The functional electrode 102 can serve as the electrical stimulation electrode of the pulse generation module 202, providing different intensities of electrical stimulation to the human body through software adjustment. It can also serve as the monitoring electrode of the EIT module 205 to perform impedance detection on the human body.

[0053] Example 2:

[0054] A multifunctional treatment evaluation device includes an instrument chassis 200, a host computer 300, and a data cable 301.

[0055] like Figure 4As shown, the front panel of the chassis 200 includes a power switch 200, a signal input port 211, an air outlet 212, and an LED light 213. The signal input port 211 is connected to the signal output port 108 to receive signals from the temperature sensor 103 and the pressure sensor 104, and to control the heating element 101 and the functional electrode 102. The air outlet 212 is connected to an air tube for inflating the airbag 110. The LED light 213 is used to display the data transmission status of the signal. When the instrument reads the sensor signal, the LED light is on; otherwise, the LED light is off.

[0056] like Figure 5 As shown, the chassis 200 includes a relay module 201, a pulse generation module 202, a temperature module 203, a pressure module 204, an EIT module 205, a USB data module 206, a power module 207, an air pump 208, and a solenoid valve 209. The signal input port 211 on the chassis is connected to the relay module 201, the pulse generation module 202, the temperature module 203, the pressure module 204, and the EIT module 205, respectively. The air outlet 212 on the chassis is connected to the air pump 208. The relay module 201, the pulse generation module 202, the temperature module 203, and the pressure module 204 are connected to the USB data module 206 using a daisy-chain method. The power module 207 is used to supply power to the various modules inside the instrument.

[0057] The pulse generation module 202 is used to generate pulse current. The temperature module 203 receives the electrical signal generated by the temperature sensor. The pressure module 204 receives the electrical signal generated by the pressure sensor. The EIT module 205 includes a signal generator, a voltage-to-current circuit, an analog multiplexer, a signal processing circuit, etc., and is used to generate high-frequency AC current and identify voltage signals. The relay module is connected to the pulse generation module 202, the EIT module 205, the input port 211, the air pump 208, and the solenoid valve 209. After receiving the instruction from the host computer 300, it controls the opening and closing of the heating element, the air pump, the solenoid valve, and the pulse generator.

[0058] The host computer 300 has a built-in instrument control program developed based on LabVIEW software, which integrates data acquisition, processing and instrument control. The host computer 300 is connected to the USB data module 206 of the clothing comfort measurement system via USB data cable 301 to complete data reception and control signal transmission, and realize data communication with the measurement system.

[0059] like Figure 6 As shown, the EIT module includes a signal generator, a voltage-to-current circuit, an analog multiplexer, a signal processing circuit, etc., for generating high-frequency alternating current and identifying voltage signals, thereby realizing electrical impedance tomography of varicose veins.

[0060] Example 3:

[0061] like Figure 7 As shown, an evaluation method for a multifunctional treatment evaluation device includes the following steps:

[0062] Place the multifunctional therapeutic bandage (100) on the varicose veins of the lower extremities and adjust the tightness of Velcro A (105) and Velcro B (106) to make it suitable for human wear.

[0063] Connect the air bag nozzle (107) and signal output port (108) of the multifunctional treatment strap (100) to the air outlet (212) and signal input port (211) of the treatment evaluation device (200) chassis, respectively, and turn on the power button (210) of the treatment evaluation device (200).

[0064] Connect the USB data transfer cable (301) to the host computer (300), open the software, perform the initialization operation, and proceed to the next step after the initialization is complete.

[0065] In the initial impedance analysis measurement, the EIT module (205) first applies a safe alternating current to the human body through the functional electrode (102), and then receives the measurement response information of the varicose vein site. The resistivity distribution image of the site is reconstructed by the algorithm built into the host computer (300). At the same time, the host computer (300) displays the impedance curve of the measured site. By comparing with the internal database, the condition is detected, and analysis results and prescription suggestions are given. The operator can make fine adjustments to the prescription based on experience. After the determination is completed, the next step of varicose vein treatment is carried out.

[0066] In the pressure treatment process, the relay module (201) first receives the instruction, the relay closes and the air pump (208) starts to work, the pressure sensor (104) collects the pressure of the airbag (110) in real time, when the pressure reaches the specified pressure value, the relay module (201) opens and the air pump (208) stops working, and pressure treatment is performed under constant pressure. When the set pressure treatment time is reached, the solenoid valve (209) opens to release pressure and end the pressure treatment process.

[0067] In the heating treatment process, the relay module (201) first receives an instruction, the relay closes, the heating element (101) starts to work, the temperature sensor (103) collects the skin temperature in real time, when the temperature reaches the set temperature value, the relay module (201) turns on, the heating element (101) stops working, and heating treatment is carried out at a constant temperature. When the temperature is 2 degrees Celsius lower than the set temperature value, the heating restarts, and it works repeatedly within the set temperature range until the heating treatment process ends.

[0068] During the electrical stimulation treatment, the pulse generation module (202) receives an instruction and drives the functional electrode (102) to work. During the electrical stimulation treatment, the frequency of electrical stimulation can be automatically switched according to the prescription settings. When the set electrical stimulation treatment time is reached, the pulse generation module (202) turns off, ending the electrical stimulation treatment process.

[0069] The impedance analysis measurement after treatment is performed in the same manner as the initial impedance analysis measurement. After the impedance measurement is completed, the host computer (300) performs a comprehensive analysis on the data generated by the measurement, based on the initial impedance analysis measurement process, and evaluates the treatment results. At the same time, the measurement data can be stored in the host computer (300) to continuously supplement the original reference data, which can provide further reference for the later treatment evaluation.

[0070] The host computer (300) can display the curves of pressure, temperature and impedance values ​​measured in real time. After the measurement is completed, the system can export all the collected data and generate an Excel spreadsheet.

[0071] The above description is only a typical embodiment of the present invention. It should be noted that, for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A multi-functional treatment evaluation device for varicose veins of lower extremities, characterized by, The utility model relates to a kind of medical treatment system, including multifunctional treatment bandage, treatment evaluation instrument, host computer, the multifunctional treatment bandage connects treatment evaluation device, for active intervention and monitoring varicose position, the treatment evaluation device connects host computer, for signal transmission and processing, the host computer is used for data analysis and processing and visual operation; The multifunctional treatment bandage includes heating sheet, functional electrode, flexible air bag, temperature sensor and pressure sensor, the heating sheet, functional electrode and flexible air bag are used for active intervention on varicose position, the functional electrode, temperature sensor and pressure sensor are used for real-time monitoring on varicose position, the functional electrode can be used as monitoring electrode for impedance imaging analysis on varicose position, and can be used as intervention electrode for electric stimulation treatment on varicose position. The multifunctional treatment bandage is air bag air nozzle-outer fabric-air bag-separation fabric-heating sheet-temperature sensor-pressure sensor-inner fabric-functional electrode from outside to inside, the air bag air nozzle is arranged outside the outer fabric of multifunctional treatment bandage, the air bag is encapsulated by separation fabric, fixed in the middle of outer fabric and separation fabric, the heating sheet, temperature sensor and pressure sensor are fixed in inner fabric, and the functional electrode is fixed in the outer layer of inner fabric. The treatment evaluation instrument includes EIT module, the EIT module includes signal generator, voltage-to-current circuit, analog multiplexer and signal processing circuit, for electrical impedance tomography on varicose position.

2. The multi-functional therapeutic evaluation apparatus according to claim 1, wherein The treatment evaluation instrument also includes power module, pressure module, temperature module, pulse generation module, relay module, air pump and USB data module, the pressure module receives electrical signal generated by pressure sensor, the temperature module receives electrical signal generated by temperature sensor, the EIT module is used for high-frequency alternating current generation and voltage signal identification, the pulse generation module is used for generating pulse current, the relay module is used for controlling the opening and closing of heating sheet, air pump, electromagnetic valve and pulse generator, the air pump is connected with multifunctional treatment bandage, for air inflation, and the USB data module is used for transmitting collected signal to host computer.

3. The multi-functional therapeutic evaluation apparatus according to claim 2, wherein The output terminals of temperature sensor, heating sheet, pressure sensor and functional electrode of multifunctional treatment bandage are connected to male head through a wire, female head is arranged on the treatment evaluation device case, the input terminals of pressure module, temperature module, EIT module, pulse generation module and relay module are connected to female head on the case, and the male head is inserted into the female head.

4. The multi-functional therapeutic evaluation apparatus according to claim 1, wherein The host computer is built-in instrument control program based on LABVIEW software development, for data processing and instrument control.

5. The evaluation method of the multifunctional treatment evaluation device as described in claim 1, characterized in that, The utility model includes the following steps: Step 1, at least one multifunctional treatment bandage is placed on human lower limbs; Step 2, turn on treatment evaluation instrument and host computer, for treatment and evaluation; Initialization operation is carried out, after initialization is completed, initial evaluation analysis is carried out. In the evaluation analysis, the EIT module applies safe alternating current to the human body through functional electrodes and receives measurement response information, which is transmitted to the host computer through the data transmission module. After the preliminary evaluation analysis, varicose vein treatment is performed. During pressure treatment, the relay is closed, the air pump works, the pressure sensor collects the air pump pressure signal, and the pressure module receives the signal and transmits it to the host computer through the data transmission module. During heating treatment, the relay is closed, the heating sheet works, the temperature sensor collects the temperature signal, and the temperature module receives the signal and transmits it to the host computer through the data transmission module. During electrical stimulation treatment, the relay is closed and the pulse generator works. The host computer displays the real-time resistance, impedance, pressure, and temperature curves. After treatment, the evaluation analysis is performed again, and the process is consistent with the initial evaluation analysis. After measurement, the host computer performs comprehensive evaluation of the treatment process.

6. The evaluation method of the multifunctional treatment evaluation device according to claim 5, characterized in that, The heating sheet, functional electrode, and air bag can work independently or cooperatively according to the system's built-in prescription.

7. The evaluation method of the multifunctional treatment evaluation device according to claim 5, characterized in that, The multifunctional treatment bandage can be used independently or in multiple cooperative actions.

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