Wearable device for improving lower limb ischemia and control method thereof

Abstract

The application discloses a wearable device for improving lower limb ischemia and a control method thereof, the device comprising a master control unit, an electrocardiosignal monitoring unit, a first electric pulse assembly and a second electric pulse assembly, wherein the first electric pulse assembly and the second electric pulse assembly are both composed of a medium-frequency pulse stimulation electrode with a pulse frequency of 1-100 Kz and a low-frequency pulse stimulation electrode with a pulse frequency of 50-300 Hz. The wearable device is a non-invasive, low-risk device connected through wireless communication, small in size, portable, low in cost, and does not require professional medical personnel to operate and can avoid skin damage and other risks caused by high pressure. The control method is based on electrocardiosignal setting control algorithm, so that the first pulse assembly and the second pulse assembly output electronic pulses with specific modulation waves according to preset instructions, produce hammering effect, improve lower limb hemodynamic environment, and effectively improve lower limb blood flow speed. The control method is simple to operate and high in precision.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and relates to a physiotherapy device and control method, specifically to a wearable device for improving lower limb ischemia and its control method. Background Technology

[0002] Peripheral arterial disease (PAD) is one of the most common vascular diseases, affecting more than 200 million people worldwide. Patients with PAD often experience limb ischemia, characterized by persistent foot pain at rest, which can lead to tissue necrosis in severe cases. It is primarily caused by thromboangiitis obliterans, lower extremity vascular endothelial dysfunction, and atherosclerotic lesions. Common complications resulting from PAD include diabetic foot, arteriosclerosis obliterans, and thromboangiitis obliterans. The end-stage of PAD is characterized by severe limb ischemia, leading to impaired quality of life, serious complications, and even death. Survey data shows that for patients with severe lower extremity ischemia (CLI) in the end-stage of peripheral arterial disease, the one-year amputation rate is as high as 30%, and the mortality rate is as high as 25%, with a long-term mortality rate exceeding that of patients with symptomatic coronary artery disease.

[0003] To alleviate lower limb ischemic attack (PAD), controlling inflammation and improving lower limb hemodynamics are two key approaches, with the latter being particularly important. It is crucial not only throughout the disease's progression, terminal stages, and recovery but also affects the control of inflammation. Currently, there are many treatment methods for lower limb ischemic diseases, such as lifestyle modifications, drug therapy, interventional therapy, and surgery, but none have achieved ideal results. Lifestyle modifications, primarily through exercise and smoking cessation, are more suitable for mild cases of lower limb ischemia and have limited effectiveness in severe cases. Drug therapy mainly involves antithrombotic and lipid-lowering medications, but its effect on improving lower limb hemodynamics is also limited. Traditional surgery has a high rate of residual thrombus, and the surgical trauma increases the risk of thrombosis recurrence and incision infection. Furthermore, surgery has drawbacks such as high patient expectations and poor vascular intervention.

[0004] In recent years, in addition to the methods mentioned above, some new physical therapies and mechanical preventive therapies have been developed, mainly employing intermittent pneumatic compression (IPC), graduated compression stockings (GCS), venous foot pumps (VFPs), and enhanced external counterpulsation (EECP). Among these, GCS and VFP compression therapy are mainly used for the treatment of lower extremity venous diseases, such as calf edema, varicose veins, and other chronic venous insufficiency diseases, as well as for the prevention of deep vein thrombosis; they have little effect on lower extremity ischemic diseases. IPC (Intra-pulmonary bypass) is believed to have some effect on improving arterial inflow in the lower leg, which is beneficial for the development of collateral circulation and the improvement of intermittent claudication. However, its efficacy and safety still require more clinical evidence to verify. Because IPC does not work in conjunction with the cardiac process, its effect on improving blood flow velocity in the lower limbs is very limited. Moreover, since IPC uses airbags that tightly wrap around the foot, lower leg, and thigh, if the patient has a lower limb infection, the airbag structure will have a negative impact on the infected area, increasing the risk of infection worsening. EECP (External Circulatory Pump) mainly improves blood perfusion to vital organs in the upper body. Its effect on improving blood flow velocity in the lower limbs is currently questionable, and it may even reduce blood flow inflow to the lower limbs during the cardiac cycle. Furthermore, the high-pressure air used in EECP carries the risk of skin abrasions, contusions, and lower limb muscle soreness, especially in cases where there are underlying diseases or infectious complications in the lower limbs, the risk is even higher. In addition, for IPC and EECP, which require high-pressure gas generation and control components, the devices are large, heavy and expensive, the operation is complicated, and professional medical personnel are required to operate them to prevent accidents. Their application scope is small and they are not suitable for use in non-medical institutions, especially ordinary households.

[0005] In summary, the three compression therapies mentioned above have relatively limited effects on improving lower limb hemodynamics. In addition, the potential serious risks of these mechanical stimulation-based compression therapies also limit their clinical application.

[0006] In view of this, it is necessary to further improve existing devices and control methods for improving lower limb ischemia in order to enhance the improvement effect, reduce risks and costs, and expand their application scope. Summary of the Invention

[0007] Therefore, the technical problem to be solved by this invention is that traditional methods for improving lower limb ischemia are ineffective, risky, costly, and difficult to operate. Therefore, this invention proposes a wearable device and its control method for improving lower limb ischemia that is effective, low-risk, portable, and easy to operate.

[0008] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0009] A first aspect of the present invention provides a wearable device for improving lower limb ischemia, comprising:

[0010] Main control unit

[0011] An electrocardiogram (ECG) signal monitoring unit is worn on the chest of the human body and is connected to the main control unit via signal transmission.

[0012] The first electrical pulse component is worn on the thigh of the human body and is connected to the main control unit. The first electrical pulse component includes at least two sets of first pulse stimulation electrodes. Each set of first pulse stimulation electrodes has at least three electrodes. The at least two sets of first pulse stimulation electrodes are respectively set on the outer and inner sides of the thigh. At least one set of third pulse stimulation electrodes is set at the end of the first pulse stimulation electrode away from the electrocardiogram signal monitoring unit.

[0013] The second electrical pulse component is used to be worn on the lower leg of the human body and is connected to the main control unit. The second pulse component includes at least two sets of second pulse stimulation electrodes, each set of second pulse stimulation electrodes having at least three electrodes. The at least two sets of second pulse stimulation electrodes are respectively set on the outer and inner sides of the lower leg. At least one set of fourth pulse stimulation electrodes is set at the end of the second pulse stimulation electrode away from the electrocardiogram signal monitoring unit.

[0014] The pulse frequencies of the first and second pulse stimulation electrodes are 1-100 kHz, and the pulse frequencies of the third and fourth pulse stimulation electrodes are 50-300 Hz.

[0015] Preferably, the first pulse assembly further includes a first wearing part, the first wearing part including a first wearing part body, the first wearing part body being connected to at least one first adjustable connection part, the first wearing part body and the first adjustable connection part enclosing a wearing space, the first pulse stimulation electrode and the third pulse stimulation electrode being attached to the inner wall of the first wearing part body; the first wearing part body is also connected to a first temperature control module.

[0016] Preferably, the second pulse assembly further includes a second wearing part, the second wearing part including a second wearing part body, the second wearing part body being connected to at least one second adjustable connection part, the second wearing part body and the second adjustable connection part enclosing a wearing space, the second pulse stimulation electrode and the fourth pulse stimulation electrode being attached to the inner wall of the second wearing part body; the second wearing part body is also connected to a second temperature control module.

[0017] Preferably, the main control unit includes an adjustable wristband and a main controller connected to the adjustable wristband. The main controller includes a microprocessor, a communication module connected to the microprocessor, a data analysis and processing module, a data storage module, a display module, and a control module.

[0018] Preferably, the electrocardiogram (ECG) signal monitoring unit includes an adjustable chest strap and an ECG signal acquisition module connected to the adjustable chest strap, wherein the ECG signal acquisition module is wirelessly connected to the communication module.

[0019] Preferably, the first adjustable connection part includes a first hinged connector connected to one end of the first wearing part body and a first adjustable elastic band connected to the other end of the first wearing part body; the second adjustable connection part includes a second hinged connector connected to one end of the second wearing part body and a second adjustable elastic band connected to the other end of the second wearing part body.

[0020] A second aspect of the present invention provides a control method for the wearable device described above for improving lower limb ischemia, comprising the following steps:

[0021] Acquire human body signals, wherein the human body signals include at least electrocardiogram signals;

[0022] The human body signal is processed, and a control signal is generated based on the processing result. The processing result includes the R wave, T wave, or P wave signal in the acquired electrocardiogram signal.

[0023] Based on the control signal, the first pulse component and the second pulse component are controlled to output pulse modulation waves to alternately provide positive and negative stimulation.

[0024] Preferably, controlling the output pulse modulation wave of the first pulse component and the second pulse component to perform positive stimulation based on the control signal includes:

[0025] The second pulse stimulation electrode is controlled to output pulse modulation waves sequentially from the distal end of the lower leg to the proximal end of the lower leg.

[0026] After a preset time interval, the first pulse stimulation electrode is controlled to output pulse modulation waves sequentially from the distal end of the thigh to the proximal end of the thigh.

[0027] Preferably, controlling the output pulse modulation wave of the first pulse component and the second pulse component to perform negative stimulation based on the control signal includes:

[0028] The first pulse stimulation electrode is controlled to output pulse modulation waves sequentially from the proximal end of the thigh to the distal end of the thigh.

[0029] The second pulse stimulation electrode is controlled to output pulse modulation waves sequentially from the proximal end of the lower leg to the distal end of the lower leg.

[0030] Once a T-wave is detected, the first and second pulse stimulation electrodes are controlled to stop working.

[0031] Preferably, the negative stimulation process further includes the step of controlling the output pulse modulation wave of the third pulse stimulation electrode and the fourth pulse stimulation electrode;

[0032] Before controlling the first pulse component and the second pulse component to output pulse modulation waves alternately for positive and negative stimulation based on the control signal, the method further includes controlling the third pulse electrode and the fourth pulse electrode to output pulse modulation waves and controlling the first pulse component and the second pulse component to heat up to 35-45°C.

[0033] The technical solution of the present invention has the following advantages compared with the prior art:

[0034] (1) The wearable device for improving lower limb ischemia provided by this invention includes a main control unit, an electrocardiogram signal monitoring unit, a first electrical pulse component, and a second electrical pulse component. Both the first and second electrical pulse components are composed of a medium-frequency pulse stimulation electrode with a pulse frequency of 1-100 kHz and a low-frequency pulse stimulation electrode with a pulse frequency of 50-300 Hz. This allows for intervention of lower limb vascular movement in the thigh and calf areas using medium-frequency electronic pulses as the main power source, supplemented by low-frequency electronic pulses to reduce the impedance of distal microvessels. It is a non-invasive, low-risk, hemodynamically defined, and wirelessly connected wearable device that is more compact, portable, and cost-effective. It does not require professional medical personnel to operate, enabling more precise multi-level intervention, effectively improving lower limb blood flow velocity, and increasing blood perfusion to the distal lower limbs. Compared with conventional high-pressure driven compression devices, it also has the advantages of reduced volume and weight, lower cost, and avoids the risks of skin damage caused by high pressure.

[0035] (2) The control method for wearable devices for improving lower limb ischemia provided by the present invention is based on setting control algorithms according to electrocardiogram signals. The first pulse component and the second pulse component output electronic pulses with specific modulation waves according to preset instructions, generating a hammering effect, which causes the muscles and blood vessels of the lower limbs to produce regular deformation and movement, which is coordinated with the movement of the human heart, thereby achieving the purpose of improving the hemodynamic environment of the lower limbs, effectively increasing the blood flow velocity of the lower limbs, and increasing the blood perfusion of the distal lower limbs. The control method has high precision and can still control the pulse stimulation electrodes to work effectively even when the electrocardiogram signal is unstable or of poor quality. Attached Figure Description

[0036] To make the content of this invention easier to understand, the invention will be further described in detail below with reference to specific embodiments and accompanying drawings, wherein...

[0037] Figure 1 This is a schematic diagram of the wearing state of the wearable device for improving lower limb ischemia provided in Embodiment 1 of the present invention;

[0038] Figure 2 This is a schematic diagram of the main control unit in the wearable device provided in Embodiment 1 of the present invention;

[0039] Figure 3 This is an exploded view of the main control unit in the wearable device provided in Embodiment 1 of the present invention;

[0040] Figure 4 This is a schematic diagram of the main controller in the wearable device provided in Embodiment 1 of the present invention;

[0041] Figure 5 This is a schematic diagram of the structure of the first pulse component in the wearable device provided in Embodiment 1 of the present invention;

[0042] Figure 6 This is a schematic diagram of the structure of the second pulse component in the wearable device provided in Embodiment 1 of the present invention;

[0043] Figure 7 This is a schematic diagram of the wearable device provided in Embodiment 1 of the present invention;

[0044] Figure 8 This is a flowchart of the control method provided in Embodiment 2 of the present invention;

[0045] Figure 9 This is an electrocardiogram obtained in the control method provided in Embodiment 2 of the present invention;

[0046] Figure 10 This is a schematic diagram of the pulse output of positive stimulation in the control method provided in Embodiment 2 of the present invention;

[0047] Figure 11 This is a schematic diagram of the pulse output of negative stimulation in the control method provided in Embodiment 2 of the present invention.

[0048] The reference numerals in the figure are as follows: 1-Main control unit; 101-Adjustable wristband; 102-Main controller; 1021-Housing; 1022-Touchscreen; 1023-Control buttons; 1024-Function buttons; 1025-Synchronization button; 1026-Data interface; 1027-Charging interface; 2-ECG signal monitoring unit; 201-Adjustable chest strap; 202-ECG signal acquisition module; 3-First pulse assembly; 301-First pulse stimulation electrode; 302-Third pulse stimulation electrode; 303-First wearing part body; 304-First hinge connector; 305-First adjustable elastic band; 306-First light display module; 307-First pulse charging interface; 308-First pulse display module; 4-Second pulse assembly; 401-Second pulse stimulation electrode; 402-Fourth pulse stimulation electrode; 403-Second wearing part body; 404-Second hinge connector; 405-Second adjustable elastic band; 406-Second light display module; 407-Second pulse display module. Detailed Implementation

[0049] 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.

[0050] 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.

[0051] In the description of this invention, it should be understood that the terms "upper" and "lower" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed during use, or the orientation or positional relationship in which those skilled in the art would usually understand. They are only used to facilitate the description of this invention and to simplify the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0052] The terms "first," "second," etc., used in this invention are merely for descriptive purposes and have no special meaning.

[0053] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set" and "install" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0054] Example 1

[0055] This embodiment provides a wearable device for improving lower limb ischemia, which intervenes in blood flow velocity and direction to alleviate lower limb ischemia and can be applied to the technical field of lower limb ischemic disease treatment.

[0056] Please see Figure 1-6 The wearable device includes a main control unit 1. In this embodiment, the main control unit 1 is preferably a wrist-worn main control device, which is worn on the wrist of the human body to control other components. The main control unit 1 is connected to an electrocardiogram (ECG) signal monitoring unit 2. The ECG signal monitoring unit 2 is preferably a chest strap structure, which can be worn around the chest of the human body to monitor the ECG signal of the human body and transmit the ECG signal to the main control unit 1.

[0057] The main control unit 1 is also connected to a first pulse component 3, which can be worn on the thigh of the human body to output electrical pulses to the thigh. Specifically, the first pulse component 3 includes at least two sets of first pulse stimulation electrodes 301, which are respectively set on the inner and outer sides of the thigh, and each set of first pulse stimulation electrodes 301 has at least 3 electrodes. In this embodiment, each set of first pulse stimulation electrodes 301 includes 3 electrodes, which are arranged sequentially and spaced apart along the length of the thigh, so that the first pulse stimulation electrodes 301 can stimulate blood vessels in different muscle parts of the thigh. In this embodiment, the two sets of first pulse stimulation electrodes 301 are respectively used to adhere to the vastus lateralis and vastus medialis muscles to stimulate blood vessels on the inner and outer sides of the thigh, and the pulse frequency of the first pulse stimulation electrode 301 is 1-100KHz, the pulse width is 200-400us, the maximum output amplitude effective value is ≤25V (50mA), and the maximum output energy of a single pulse is ≤300mJ, which is a medium frequency pulse. A third pulse stimulation electrode 302 is also provided at the end of the first pulse stimulation electrode 301 that is away from the electrocardiogram signal monitoring unit 2. Based on the distance from the heart, the end of the thigh and calf closer to the heart is defined as the proximal end, and the end farther from the heart as the distal end; that is, the third pulse stimulation electrode 302 is located at the distal end of the thigh. In this embodiment, the third pulse stimulation electrode 302 is a group, and each group includes two pulse stimulation electrodes corresponding to the outer and inner sides of the thigh, respectively. The pulse frequency of the third pulse stimulation electrode 302 is 50-300Hz, the pulse width is 100-300µs, the maximum output energy is ≤250mJ, the single pulse charge at maximum output amplitude is ≥6μC, and the effective value of the maximum output amplitude is ≤25V (50mA), which is a low-frequency pulse. Of course, as an alternative implementation, the number of first pulse stimulation electrodes 301 and third pulse stimulation electrodes 302 in each group can also be other, as long as they can stimulate blood vessels in different thigh muscle locations; this is not limited here.

[0058] The main control unit 1 is also connected to a second electrical pulse component 4, which can be worn on the lower leg. The second electrical pulse component 4 includes at least two sets of second pulse stimulation electrodes 401, with at least three electrodes in each set. In this embodiment, the second electrical pulse component 4 includes two sets of second pulse stimulation electrodes 401, with three electrodes in each set. The electrodes in each set are arranged sequentially and at intervals along the direction from the proximal end to the distal end of the lower leg. The two sets of second electrical pulse stimulation electrodes 401 correspond to the lateral and posteromedial sides of the lower leg, respectively. The second pulse stimulation electrode 401 corresponding to the lateral side of the lower leg can be closely attached to the peroneus muscle to the tibialis anterior muscle, and the second pulse stimulation electrode 401 corresponding to the posteromedial side of the lower leg can be closely attached to the soleus muscle to the gastrocnemius muscle. The pulse frequency of the second pulse stimulation electrode 401 is 1-100KHz, the pulse width is 200-400us, the maximum effective value of the maximum output amplitude is ≤25V (50mA), and the maximum output energy of a single pulse is ≤300mJ, which is a medium frequency pulse. At least one set of fourth pulse stimulation electrodes 402 is provided at the end of each of the two sets of second pulse stimulation electrodes 401 that is furthest from the ECG signal monitoring unit 2, that is, the fourth pulse stimulation electrodes 402 are located at the distal end of the lower leg. In this embodiment, the fourth pulse stimulation electrodes 402 are a set, and each set of fourth pulse stimulation electrodes 402 includes two pulse stimulation electrodes corresponding to the outer side and the posteromedial side of the lower leg, respectively. The pulse frequency of the fourth pulse stimulation electrodes 402 is 50-300Hz, the pulse width is 100-300µs, the maximum output energy is ≤250mJ, the single pulse charge at maximum output amplitude is ≥6μC, and the effective value of the maximum output amplitude is ≤25V (50mA), which is a low-frequency pulse. Of course, as an alternative implementation, each set of second pulse stimulation electrodes 401 and fourth pulse stimulation electrodes 402 can also use other numbers, as long as they can stimulate blood vessels at different locations of the lower leg muscles, which is not limited here.

[0059] In the wearable device provided in this embodiment, a first electrical pulse component 3 and a second electrical pulse component 4 are arranged according to the location and direction of the lower limb arteries (peroneal artery, tibial artery, popliteal artery, femoral artery, iliac artery) and veins (peroneal vein, posterior tibial vein, popliteal vein, greater and lesser saphenous veins). The first pulse stimulation electrode 301 in the first electrical pulse component 3 and the second pulse stimulation electrode 401 in the second electrical pulse component 4 serve to output medium-frequency pulses. After modulation, the medium-frequency pulses are output as square waves, which can generate a hammering effect and an equivalent pressure of 10 kPa, thereby effectively inducing deformation and movement of the muscles and blood vessels of the lower limbs, calves, and thighs, ultimately achieving the goal of intervening in and regulating lower limb blood circulation. In addition, the third pulse stimulation electrode 302 and the fourth pulse stimulation electrode 402 serve to output low-frequency pulses, which can relax the muscles of the limbs, dilate blood vessels, and reduce the vascular impedance of the extremities. In this way, medium-frequency and low-frequency electrical pulse stimulation can be applied to the corresponding arterial and venous sites of the calves and thighs.

[0060] The wearable device provided in this embodiment for improving lower limb ischemia intervenes in lower limb vascular movement by using mid-frequency electronic pulses as the main power source in the thigh and calf areas, and is supplemented by low-frequency electronic pulses to reduce the impedance of distal microvessels. It is a non-invasive, low-risk wearable device with clear hemodynamics and wireless communication connection, which is more miniaturized, portable, and inexpensive. It can achieve more precise multi-level intervention without the need for professional medical personnel, effectively improving the blood flow velocity in the lower limbs and increasing the blood perfusion to the distal lower limbs. It can be widely used in primary medical institutions or homes. As a non-drug, non-surgical device for promoting lower limb blood flow and rehabilitation, it has significant value and application prospects.

[0061] Compared to conventional high-pressure driven compression devices (such as IPC, GCS, VFPs, EEPC), the wearable device provided in this embodiment, which uses a combination of medium and low-frequency electronic pulses in a specific frequency band as a power source, has advantages such as concentrated energy, fast response speed, small device size and weight, and low cost. It can also improve the accuracy of intervention and avoid the risks of skin damage caused by high pressure. In addition, the arrangement of the first electrical pulse component 3 and the second electrical pulse component 4 is determined based on the directional characteristics of the arteries and veins in the thigh and calf, which significantly improves the efficiency of inducing vascular deformation.

[0062] Specifically, please refer to Figure 2-4 The main control unit 1 is a wrist-worn main control unit, including an adjustable wristband 101 for wearing on the left wrist. The adjustable wristband 101 can be a Velcro wristband with a mounting part. When the main control unit 1 is worn on the wrist, the two ends of the adjustable wristband 101 are fastened together by interlocking Velcro. The mounting part of the adjustable wristband 101 is detachably connected to a main controller 102. The main controller 102 includes a housing 1021 and various functional modules (such as...) disposed inside the housing 1021. Figure 7 As shown, the functional module includes: a microprocessor, which is signal-connected to a main control communication module. In this embodiment, the main control communication module is preferably a Bluetooth communication module. The microprocessor is also signal-connected to a data analysis and processing module, a data storage module, a display module, a control module, and an A / D conversion module. The control module uses a microcontroller unit AVRMCU chip (such as the ATmega8 chip from Atmel), which has multiple 16-bit timers and 8-bit timers, and can realize multi-channel, sequential, and distributed intervention modes. It can accurately calculate the time nodes and time intervals of electrical pulse generation and issue commands to the waveform generator (CPLD) of the pulse component.

[0063] The A / D conversion module is used to convert the ECG signals acquired by the ECG signal monitoring unit 2 into digital signals. To power the main control unit 1, the microprocessor is also connected to a power module, preferably a rechargeable lithium battery.

[0064] A touch screen 1022 is connected to one surface of the housing 1021. The touch screen 1022 is connected to the display module and is also connected to control buttons 1023, function buttons 1024 and synchronization buttons 1025. The above buttons are used to realize different control functions. A data interface 1026 and a charging interface 1027 are provided on one side of the housing 1021, which are used for data transmission and connection to an external power source, respectively.

[0065] The ECG signal monitoring unit 2 is a chest strap structure that can be worn on the chest. It includes an adjustable chest strap 201 and an ECG signal acquisition module 202 connected to the adjustable chest strap 201. The adjustable chest strap 201 is an elastic band or a strap-like structure connected at both ends by buckles or Velcro. Figure 7 As shown, the ECG signal acquisition module 202 includes an ECG communication module, preferably a low-power IoT BLE4.0 / 5.0 Bluetooth communication module, which is signal-connected to the main control communication module. It also includes a signal amplification module and signal acquisition electrodes connected to each other. The signal acquisition electrodes are fabric electrodes used to acquire human ECG signals. The acquired ECG signals are amplified and converted from analog to digital by the signal amplification module, and then transmitted to the main control unit 1 through the ECG communication module. The signal amplification module includes an amplification circuit. In this embodiment, the signal amplification circuit uses a precision instrument amplifier (such as the AD62* series from Analog Devices). The amplification circuit is also connected to high-pass and low-pass filter / notch filter circuits and an analog-to-digital (A / D) conversion circuit. The A / D conversion circuit uses a high-speed, low-power 16-bit analog-to-digital (A / D) converter (such as the AD7705 from Analog Devices, the TLC548 / 549 from TI, etc.). The signal acquisition electrodes are connected to a DSP control chip, which serves as the core device for data acquisition, transmission, and control hardware processing circuits. This chip can be the TMS320LF2407 chip from TI.

[0066] To power the ECG signal detection unit 2, the ECG signal acquisition module 202 is connected to a rechargeable lithium battery. The chest-strap ECG signal monitoring unit 2 provided in this embodiment identifies and extracts the R, S, T, and P waves of the ECG based on a DSP chip, and transmits them to the main control unit 1 after analog-to-digital conversion. Compared with traditional external counterpulsation devices that use wet ECG electrode patches and complex wiring connections, the aforementioned wireless ECG signal monitoring unit 2 has a simpler structure, is easier to wear, simpler to operate, and offers better comfort.

[0067] like Figure 5As shown, the first pulse component 3 provided in this embodiment includes a first wearing part, which specifically includes a first wearing part body 303. The first wearing part body 303 is made of plastic and includes two oppositely arranged sheet-like structures with arcuate curved surfaces. The two sheet-like structures are adapted to fit the inner and outer sides of the human thigh. The first wearing part body 303 is connected to at least one first adjustable connecting part. The first adjustable connecting part and the first wearing part body 303 enclose a wearing space. By adjusting the first adjustable connecting part, the inner wall surface of the first wearing part body 303 is tightly fitted to the thigh. Two sets of first pulse stimulation electrodes 301 and two third pulse stimulation electrodes 302 are respectively attached to the inner sidewall of the first wearing part body 303 and are arranged at intervals along the length direction of the first wearing part body 3031. The first pulse stimulation electrodes 301 and the third pulse stimulation electrodes 302 are both disc-shaped electrodes. The first adjustable connection part includes a first hinge connector 304 connected to one end of the first wearing part body 301 and a first adjustable elastic band 305 connected to the other end of the first wearing part body 303. Specifically, the first hinge connector 304 is connected to the sides of the two sheet-like structures respectively, connecting the two sheet-like structures together. The other ends of the two sheet-like structures are respectively connected to the first adjustable elastic band 305. The first adjustable elastic band 305 can further achieve tightness adjustment through a Velcro structure.

[0068] Furthermore, the first wearable body 303 is also connected to a first temperature control module (not shown in the figure), which is connected to a far-infrared heating module. This module is used to adjust the temperature of the contact area with the human body by raising the temperature of the metal electrodes that are in close contact with the skin of the lower limbs, thereby providing a heat therapy effect. A first light display module 306 is connected to one side of the first wearable body 303 to display the working status of the electrodes. The first wearable body 303 is internally equipped with a first pulse control module (microprocessor), which adopts an arbitrary waveform generator CPLD (such as Altera's MAXⅡ series chip), a first pulse communication module, and a first pulse power supply module. The first pulse control module is a control circuit board, and the first pulse communication module is a Bluetooth module. The first pulse communication module is signal-connected to the main control communication module. After receiving the instruction from the main control unit 1, the first pulse control module controls the first pulse stimulation electrode 301 and the third pulse stimulation electrode 302 to emit electronic pulse signals according to specific modulation waves, frequencies, bandwidths, amplitudes, sequential intervals, and spatial positions. The first pulse power module is a rechargeable lithium battery. To provide power to the rechargeable lithium battery, the first wearable part body 303 is also connected to a first pulse charging interface 307. The first pulse control module is also connected to a first pulse display module 308, which is used to display information such as the power level, temperature, and operation time of the first pulse component 3.

[0069] The first pulse component 3 provided in this embodiment encapsulates a rechargeable battery, control circuit board, Bluetooth module, etc., within a first wearable body 303 made of plastic, improving product integration and reducing size. Furthermore, the first wearable body 303 has a concave arc surface, resulting in better contact with the skin of the human thigh, thus allowing the first pulse stimulation electrode 301 and the third pulse stimulation electrode 302 to better conform to the thigh skin. Specifically, it includes two plastic sheet-like structures corresponding to the outer and inner sides of the thigh, respectively. The two plastic sheet-like structures are connected by a first hinge connector 304 and an adjustable elastic band 305. In this embodiment, there are four first hinge connectors 304 and four adjustable elastic bands 305, spaced apart and connected to the first wearable body 303. This adjustable connection structure makes the first pulse component 3 easy to wear, ergonomic, provides a tighter fit, and offers better comfort. The first hinge connector 304 and the adjustable elastic band 305 make the adjustment of the first wearing part body 303 more flexible and precise, and also reduce the probability of pulse stimulation electrode displacement caused by mechanical vibration during the intervention process. The control circuit board integrates a boost circuit, a rectifier circuit, a filter circuit, and a voltage regulator circuit. Since the current amplitude of the electronic pulse output is low, while the resistance of the human body surface is high, a boost circuit is needed to increase the output electronic pulse voltage to a sufficiently high level. This invention patent uses a transformer to add the output DC signal to a high-frequency carrier wave, using the transformer to achieve voltage boosting. Then, after passing through the rectifier circuit, filter circuit, and voltage regulator circuit, a constant current source electronic pulse that meets the voltage and current requirements is finally output and applied to the human body. The structure of the second pulse component 4 is basically the same as that of the first pulse component 3, such as... Figure 6As shown, the device includes a second wearing part, specifically a second wearing part body 403. The second wearing part body 403 includes two oppositely arranged plastic sheet-like structures with arcuate curved surfaces. The two sheet-like structures are adapted to fit the inner and outer sides of the human lower leg. The second wearing part body 403 is connected to at least one second adjustable connecting part. The second adjustable connecting part and the second wearing part body 403 enclose a wearing space. By adjusting the second adjustable connecting part, the inner wall surface of the second wearing part body 403 is tightly fitted to the lower leg. Two sets of second pulse stimulation electrodes 401 and two fourth pulse stimulation electrodes 402 are respectively attached to the inner sidewall of the second wearing part body 403 and are arranged at intervals along the length direction of the second wearing part body 403. The second pulse stimulation electrodes 401 and the fourth pulse stimulation electrodes 402 are both disc-shaped electrodes. The second adjustable connection includes a second hinge connector 404 connected to one end of the second wearing part body 401 and a second adjustable elastic band 405 connected to the other end of the second wearing part body 403. Specifically, the second hinge connector 404 is connected to the sides of the two sheet-like structures respectively, connecting the two sheet-like structures together. The other ends of the two sheet-like structures are respectively connected to the second adjustable elastic band 405. The second adjustable elastic band 405 can further be adjusted for tightness through a Velcro structure.

[0070] Furthermore, the second wearable unit body 403 is connected to a second temperature control module, which in turn is connected to a far-infrared heating module. This module regulates the temperature at the point of contact with the body by raising the temperature of the metal electrodes that are in close contact with the skin of the lower limbs, thus providing a heat therapy effect. A second light display module 406 is connected to one side of the second wearable unit body 403 to display the working status of the electrodes. The second wearable unit body 403 internally houses a second pulse control module, a second pulse communication module, and a second pulse power supply module. The second pulse control module is a control circuit board, and the second pulse communication module is a Bluetooth module connected to the main control communication module. The second pulse power supply module is a rechargeable lithium battery. To provide power to the rechargeable lithium battery, the second wearable unit body 403 is also connected to a second pulse charging interface 407. The second pulse control module is also connected to a second pulse display module 407, which displays information such as the battery level, temperature, and treatment time of the second pulse component 4.

[0071] Since the structure and function of the second pulse component 4 are basically the same as those of the first pulse component 3, its technical effects and advantages are also basically the same as those of the first pulse component 3, and will not be elaborated here.

[0072] Example 2

[0073] This embodiment provides a control method for a wearable device for improving lower limb ischemia, as provided in Embodiment 1. Figure 8 As shown, it includes the following steps:

[0074] First, measure the person's blood pressure. If the blood pressure is less than or equal to 160 / 100 mmHg, proceed with the following control steps:

[0075] S1. Acquire human body signals, including at least electrocardiogram (ECG) signals.

[0076] The signal acquisition electrodes in the ECG signal monitoring unit 2 measure the ECG signal of the human body.

[0077] S2. Process the acquired human body signals and generate control signals based on the processing results. The processing results include R wave, T wave, or P wave signals in the acquired electrocardiogram signals.

[0078] Specifically, it includes:

[0079] S21. Human body signal processing steps: The electrocardiogram (ECG) signal is amplified by the amplification module, and the amplified ECG signal is transmitted to the main control unit 1 wirelessly. In the main control unit 1, filtering and A / D conversion are performed by the A / D conversion module, and the cardiac cycle is calculated by the data analysis and processing module to obtain the R wave, T wave or P wave signals in the ECG signal.

[0080] S22. Judgment step: The main control unit 1 judges whether the heart rate (HR) in the electrocardiogram signal is less than or equal to 100. If not, the treatment operation is exited. If so, a control signal is generated according to the processing result to synchronize the first pulse component 3 and the second pulse component 4 with the main control unit 1.

[0081] S23. Preheating step: When HR is less than or equal to 100, the main control unit 1 controls the third pulse stimulation electrode 302 in the first pulse assembly 3 and the fourth pulse stimulation electrode 402 in the second pulse assembly 4 to output a specific modulation wave with an exponential waveform under the following parameters: pulse frequency is 50-300Hz (low frequency); pulse width is 100-300us; maximum output energy of a single pulse: ≤250mJ; single pulse charge at maximum output amplitude: ≥6μC; maximum effective value of output amplitude: ≤25V (50mA). At the same time, the main control unit 1 controls the first temperature control module 305 and the second temperature control module 405 to heat up to 35-45℃. The preheating step time is 3-5min.

[0082] The above preheating steps, through low-frequency stimulation pulses to stimulate the distal thighs and calves and supplement with heating, achieve the intervention efficiency of relaxing lower limb muscles and blood vessels, reducing vascular resistance, and improving hemodynamics.

[0083] S3. Based on the control signal, control the output pulse modulation waves of the first pulse component and the second pulse component to alternately perform positive (returning direction) stimulation and negative stimulation.

[0084] Specifically, when the T wave and P wave are accurately detected, the second pulse stimulation electrode 401 is controlled to output pulse modulation waves sequentially from the distal end of the calf to the proximal end of the calf. The time interval between each second pulse stimulation electrode outputting a pulse modulation wave is 10-15ms. Then, after a 10-15ms interval, the first pulse stimulation electrode 301 is controlled to output pulse modulation waves sequentially from the distal end of the thigh to the proximal end of the thigh. The time interval between each first pulse stimulation electrode 301 being activated sequentially is 10-15ms. When the P wave is detected, the first pulse stimulation electrode 301 and the second pulse stimulation electrode 401 stop working.

[0085] Among them, the pulse modulation wave output by the first pulse stimulation electrode 301 and the second pulse stimulation electrode 401 is a medium-frequency square wave electrical pulse modulation wave based on low-frequency modulation. The parameters are frequency 1-100kHz, pulse width 200-400us, maximum output amplitude effective value ≤25V (50mA), and maximum output energy of a single pulse ≤300mJ. This electrical pulse modulation wave can simulate the hammering and squeezing effect, act on the blood vessels of the lower limbs, produce regular deformation, and promote the return of blood from the lower limbs to the upper body during the diastolic phase.

[0086] When an R-wave is detected, the first pulse stimulation electrode 301 is controlled to sequentially output a mid-frequency square wave pulse modulation wave in the direction from the proximal end of the thigh to the distal end of the thigh; the second pulse stimulation electrode 401 is controlled to sequentially output a pulse modulation wave in the direction from the proximal end of the calf to the distal end of the calf; when a T-wave is detected, the first pulse stimulation electrode 301 and the second pulse stimulation electrode 302 are controlled to stop working.

[0087] The specific steps and algorithms used in the above positive stimulation process are as follows:

[0088] (1) When the main control unit can accurately acquire the T wave and P wave in the electrocardiogram signal, the first algorithm is adopted:

[0089] S31. Calculate the holding time based on the detected T wave and P wave signals in the electrocardiogram signal:

[0090] Δt PM =t P -t T ;

[0091] Among them, t P t represents the time point of the P wave in the cardiac cycle. T The time point of the T wave in the cardiac cycle (e.g.) Figure 9 (As shown).

[0092] S32, the main control unit 1 controls the activation of the second pulse stimulation electrode 401 (first stage) located at the farthest end, and outputs the aforementioned mid-frequency square wave electrical pulse modulation wave based on low-frequency modulation (e.g., Figure 10As shown), the time point at which the distal second pulse stimulation electrode 401 begins to activate is: t infl1 =t T ;

[0093] Among them, t T For the time node of the T wave in the cardiac cycle, the duration of the low-frequency modulation is:

[0094] Δt1=Δt PM .

[0095] S33, the main control unit 1 controls the remaining second pulse stimulation electrodes 401 and the first pulse stimulation electrode 301 (except for the one at the nearest end) to sequentially (in order) activate mid-frequency stimulation pulses along the direction from the distal end to the proximal end, forming a multi-level sequential electrical pulse effect. The activation time interval between two adjacent pulse stimulation electrodes is:

[0096]

[0097] Wherein, △t infl The duration of the multi-stage sequential action is, in this embodiment, adjustable within the range of 60-100ms, where n is the number of stages of electrical pulse pressure application, and n≥3.

[0098] In multi-level electrical pulse stimulation, the time point of action of the i-th level (any level in the multi-level electrical pulse) intermediate frequency electrical pulse is:

[0099] t infli =t infl1 +(i-1)·Δt seg ;

[0100] The duration of low-frequency modulation of the i-th intermediate frequency electrical pulse is:

[0101] Δt i =Δt PM -(i-1)Δt seg .

[0102] S34, control the first pulse stimulation electrode 301 at the nearest end (last stage) to start the intermediate frequency stimulation pulse.

[0103] The timing of the action of the first pulse stimulation electrode at the nearest end is as follows:

[0104] t inflL =t infl1 +(n-2)·Δt seg ;

[0105] The low-frequency modulation duration of this mid-frequency stimulation pulse is:

[0106] Δt n =Δt PM -(n-2)Δtseg .

[0107] (2) When the main control unit cannot accurately acquire the ECG T wave and P wave, the second algorithm is used:

[0108] S31' Obtain the R wave from the electrocardiogram and calculate and determine the cardiac cycle T. CC .

[0109] S32', the main control unit 1 controls the activation of the second pulse stimulation electrode 401 (first stage) at the farthest end, outputting the aforementioned mid-frequency square wave electrical pulse modulation wave based on low-frequency modulation, wherein the time node for the activation of the second pulse stimulation electrode 401 at the farthest end is: t infl1 =t R +k1·T cc ;

[0110] Among them, t R Let k1 be the time node of the R-wave, and k1 be a constant.

[0111] The closing time of the most distal second pulse stimulation electrode 401: t detl =t R +k2·T cc ;

[0112] Where k2 is a constant, and the range of values ​​for k1 and k2 is: k1∈[0.2,0.25]; k2∈[0.8,0.85].

[0113] S33', the main control unit 1 controls the remaining second pulse stimulation electrodes 401 and the first pulse stimulation electrode 301 (except the one at the nearest end) to sequentially (in order) activate mid-frequency stimulation pulses along the direction from the distal end to the proximal end, forming a multi-level sequential electrical pulse effect. The activation time interval between two adjacent pulse stimulation electrodes is:

[0114]

[0115] Wherein, △t infl The duration of the multi-stage sequential action is adjustable from 60 to 100 ms; n is the number of stages of the electrical pulse pressure action, n≥3.

[0116] In multi-level electrical pulse stimulation, the time point of action of the i-th level (any level in the multi-level electrical pulse) intermediate frequency electrical pulse is:

[0117] t infli =t infl1 +(i-1)·Δt seg1 ;

[0118] Low-frequency modulation duration of the i-th level electrical pulse:

[0119] Δt i =ΔtPM -(i-1)·Δt seg1 .

[0120] S34': Control the first pulse stimulation electrode 301 at the nearest end (last stage) to start the intermediate frequency stimulation pulse.

[0121] The timing of the action of the first pulse stimulation electrode at the nearest end is as follows:

[0122] t inflL =t infl1 +(n-2)·Δt seg1 ;

[0123] The low-frequency modulation duration of this mid-frequency stimulation pulse is:

[0124] Δt n =Δt PM -(n-2)·Δt seg1 .

[0125] The specific steps and algorithms used in the above negative stimulus process are as follows:

[0126] S35. Obtain the R wave from the electrocardiogram and calculate the duration of negative stimulation intervention within one cardiac cycle:

[0127] Δt Nag =k1T cc .

[0128] S36. The main control unit 1 controls the activation of the first pulse stimulation electrode 301 (first stage) located at the nearest end, and outputs the aforementioned mid-frequency square wave electrical pulse modulation wave based on low-frequency modulation (e.g., Figure 11 As shown), the time point at which the first pulse stimulation electrode 301 at the nearest end starts t Nag1 =t R .

[0129] S37. The main control unit 1 controls the remaining first pulse stimulation electrodes 301 and second pulse stimulation electrodes 301 (except for the most distal one) to sequentially (in order) activate mid-frequency stimulation pulses along the direction from proximal to distal, forming a multi-level sequential electrical pulse effect. The activation time interval between two adjacent pulse stimulation electrodes is:

[0130]

[0131] In multi-level electrical pulse stimulation, the time point of action of the i-th level (any level in the multi-level electrical pulse) intermediate frequency electrical pulse is:

[0132] t Nagi =t R +(i-1)·Δt seg2 .

[0133] S34': Control the second pulse stimulation electrode 401, which is located at the farthest end (last stage), to start the intermediate frequency stimulation pulse.

[0134] The timing of the action of the second pulse stimulation electrode at the furthest end is:

[0135] t NagL =t R +(n-2)·Δt seg2 .

[0136] During the aforementioned negative stimulation process, the low-frequency electrical pulses of the third pulse stimulation electrode 302 and the fourth pulse stimulation electrode 402 are continuously activated simultaneously to reduce the vascular impedance of the distal thigh and calf and guide blood flow to the distal end.

[0137] In this embodiment, controlling the output pulse modulation waves of the first pulse component 3 and the second pulse component 4 to alternately perform positive and negative stimulation is specifically as follows: first, repeat the above positive stimulation steps to complete 5 cardiac cycles to promote blood return to the upper body aorta, and then repeat the above negative stimulation steps to 10 cardiac cycles to promote blood flow to the distal lower limbs. The above positive and negative stimulation are repeated for 30-45 minutes to complete the control process of the wearable device.

[0138] This embodiment achieves effective regulation of local blood flow in the lower limbs by sequentially controlling the first pulse component 3 and the second pulse component 4 based on a specific control algorithm, thus overcoming the technical problems existing in traditional pneumatic drive technology.

[0139] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A wearable device for improving lower limb ischemia, characterized in that, include: Main control unit An electrocardiogram (ECG) signal monitoring unit is worn on the chest of the human body and is connected to the main control unit via signal transmission. The first electrical pulse component is worn on the thigh of the human body and is connected to the main control unit. The first electrical pulse component includes at least two sets of first pulse stimulation electrodes. Each set of first pulse stimulation electrodes has at least three electrodes. The at least two sets of first pulse stimulation electrodes are respectively set on the outer and inner sides of the thigh. At least one set of third pulse stimulation electrodes is set at the end of the first pulse stimulation electrode away from the electrocardiogram signal monitoring unit. The second electrical pulse component is worn on the lower leg of the human body and is connected to the main control unit. The second electrical pulse component includes at least two sets of second pulse stimulation electrodes. Each set of second pulse stimulation electrodes has at least three electrodes. The at least two sets of second pulse stimulation electrodes are respectively set on the outer and inner sides of the lower leg. At least one set of fourth pulse stimulation electrodes is set at the end of the second pulse stimulation electrode away from the electrocardiogram signal monitoring unit. The pulse frequencies of the first and second pulse stimulation electrodes are 1-100 kHz, and the pulse frequencies of the third and fourth pulse stimulation electrodes are 50-300 Hz. The first and second electrical pulse components are used to output pulse modulation waves to alternately provide positive and negative stimulation.

2. The wearable device for improving lower limb ischemia according to claim 1, characterized in that, The first electrical pulse assembly further includes a first wearing part, which includes a first wearing part body. The first wearing part body is connected to at least one first adjustable connection part. The first wearing part body and the first adjustable connection part enclose a wearing space. The first pulse stimulation electrode and the third pulse stimulation electrode are attached to the inner wall of the first wearing part body. The first wearing part body is also connected to a first temperature control module.

3. The wearable device for improving lower limb ischemia according to claim 2, characterized in that, The second electrical pulse assembly further includes a second wearing part, which includes a second wearing part body. The second wearing part body is connected to at least one second adjustable connection part. The second wearing part body and the second adjustable connection part enclose a wearing space. The second pulse stimulation electrode and the fourth pulse stimulation electrode are attached to the inner wall of the second wearing part body. The second wearing part body is also connected to a second temperature control module.

4. The wearable device for improving lower limb ischemia according to claim 1, characterized in that, The main control unit includes an adjustable wristband and a main controller connected to the adjustable wristband. The main controller includes a microprocessor, a communication module connected to the microprocessor, a data analysis and processing module, a data storage module, a display module, and a control module.

5. The wearable device for improving lower limb ischemia according to claim 4, characterized in that, The electrocardiogram (ECG) signal monitoring unit includes an adjustable chest strap and an ECG signal acquisition module connected to the adjustable chest strap. The ECG signal acquisition module is wirelessly connected to the communication module.

6. The wearable device for improving lower limb ischemia according to claim 3, characterized in that, The first adjustable connection part includes a first hinged connector connected to one end of the first wearing part body and a first adjustable elastic band connected to the other end of the first wearing part body; the second adjustable connection part includes a second hinged connector connected to one end of the second wearing part body and a second adjustable elastic band connected to the other end of the second wearing part body.

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