Dynamic intelligent fixing device for lower limb rehabilitation

By integrating a dynamic leg adjustment frame, an adaptive foot fixation chamber, and a multi-dimensional stimulation system, combined with a dual-axis linkage motion mechanism and a central controller, the adaptability and coordinated control issues of lower limb fixation devices have been solved, enabling personalized rehabilitation management and improving lower limb rehabilitation outcomes and patient comfort.

CN120918870APending Publication Date: 2025-11-11THE FIRST AFFILIATED HOSPITAL OF ARMY MEDICAL UNIV
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Patent Information

Application Number
CN202511369575.5
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-24
Publication Date
2025-11-11

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Abstract

The invention relates to a dynamic intelligent fixing device for lower limb rehabilitation, which belongs to the technical field of medical instruments and comprises a dynamically adjustable leg supporting structure, a self-adaptive foot fixing device, a multi-modal stimulation system, a double-shaft linkage movement mechanism and an intelligent regulation and control system. The dynamic adjusting structure and the self-adaptive fixing device can adapt to different leg circumferences, foot types and joint motion ranges, and comfortable fixing and standard movement of a patient are guaranteed; the multi-mode stimulation system is combined with mechanical movement, pneumatic massage and myoelectricity stimulation to synergistically promote blood circulation of the lower limbs; the intelligent regulation and control system collects multi-dimensional physiological data in real time and dynamically optimizes motion parameters and stimulation intensity. The device solves the problems that an existing device is poor in adaptability, single in stimulation, lagged in regulation and control and the like, individualized precise adjuvant therapy is achieved, the lower limb rehabilitation effect and clinical benefits of postoperative lower limb fixation and VTE prevention are effectively improved, and meanwhile the operation complexity of medical staff is reduced.
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Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a dynamic intelligent fixation device for lower limb rehabilitation. Background Technology

[0002] Lower limb rehabilitation is a crucial aspect of functional recovery after surgery, involving multiple aspects such as maintaining joint range of motion, muscle strength training, and promoting blood circulation. Postoperative patients are prone to complications such as muscle atrophy, joint stiffness, and venous thromboembolism (VTE) due to prolonged bed rest and immobilization. VTE carries a high risk of disability and mortality. Ankle pump exercises, as a fundamental method of lower limb rehabilitation, effectively activate the calf muscles and promote blood return from the lower limbs through active or passive movements such as ankle flexion, extension, inversion, and eversion, thereby reducing the risk of complications. Therefore, developing a dynamically adaptable and intelligently adjustable lower limb immobilization device has significant clinical value in improving the standardization of rehabilitation training and enhancing patient prognosis.

[0003] Currently used lower limb immobilization devices face significant technical bottlenecks. In terms of mechanical structure, existing devices mostly employ rigid frames or fixation straps, making it difficult to adapt to changes in leg shape, joint range of motion, and degree of swelling among different patients. This results in insecure fixation or localized pressure, affecting patient comfort and the accuracy of movement trajectories. At the functional level, the fixation module and motion stimulation component of traditional devices are independent, lacking a coordinated control mechanism. This prevents dynamic adjustment of fixation force and rehabilitation parameters based on the patient's physiological state. Furthermore, the fixation devices themselves lack intelligent sensing capabilities, failing to monitor pressure distribution, temperature changes, and other data in real time, hindering personalized adaptation. In the area of ​​intelligent control, most devices only possess simple mechanical locking functions, unable to adaptively optimize fixation parameters based on multi-source physiological data feedback, thus limiting rehabilitation effectiveness.

[0004] In summary, there is an urgent need to develop a lower limb rehabilitation fixation device with dynamic adaptation, intelligent sensing, and multimodal collaborative functions. This device needs to address three core issues in existing technologies: first, achieving dynamic and precise fixation of the legs and feet to ensure comfort and proper movement for patients of different body types; second, constructing a synergistic mechanism between fixation and rehabilitation stimulation, enabling mechanical support, pneumatic massage, and electrical stimulation to complement each other; and third, establishing an intelligent control system based on multi-source data sensing to achieve real-time optimization of fixation parameters and rehabilitation strategies, thereby improving the overall effectiveness of lower limb rehabilitation and postoperative fixation. Summary of the Invention

[0005] In view of this, the purpose of this invention is to propose a dynamic intelligent fixation device for lower limb rehabilitation. This device comprises a leg dynamic adjustment frame consisting of a longitudinal main rod and a transverse flexible connecting rod with integrated pressure-sensing strips; a foot adaptive fixation chamber with micro-pressure and temperature sensors on its inner surface and an independent air chamber inside; a multi-dimensional stimulation system including a layered electromyography array and a pneumatic-mechanical composite massage component; a dual-axis linkage foot movement mechanism consisting of a plantar flexion-dorsiflexion electric telescopic rod and an inversion-eversion electric rotating shaft; a motion coordination feedback device consisting of signal transmission lines and linkage control rods; and a central controller integrating a multi-source data fusion processor and an adaptive control algorithm module. This addresses the problems of existing lower limb fixation devices, such as difficulty in adapting to differences in leg shape and joint mobility among patients, inability to dynamically adjust fixation parameters, lack of collaborative control mechanisms among functional modules, and difficulty in achieving adaptive adjustment of rehabilitation parameters based on multi-dimensional physiological data. This effectively improves the clinical efficacy of lower limb rehabilitation and postoperative fixation.

[0006] This invention is achieved through the following technical solution:

[0007] A dynamic intelligent fixation device for lower limb rehabilitation includes a leg dynamic adjustment frame and a foot adaptive fixation chamber. The foot adaptive fixation chamber is rotatably mounted at the bottom of the leg dynamic adjustment frame. A multi-dimensional stimulation system is fixedly installed inside the leg dynamic adjustment frame and the foot adaptive fixation chamber to stimulate the muscles of the patient's leg and foot. A dual-axis linkage foot movement mechanism and a motion feedback device are fixedly connected to the outside of the foot adaptive fixation chamber and the leg dynamic adjustment frame to drive the patient's foot to perform ankle pump movements. The device also includes a central controller, which is connected via wiring to the leg dynamic adjustment frame, the foot adaptive fixation chamber, the multi-dimensional stimulation system, the dual-axis linkage foot movement mechanism, and the motion feedback device. The central controller monitors the device's operating status and the patient's physiological data and adjusts the device based on the data.

[0008] Furthermore, the leg dynamic adjustment frame consists of a longitudinal main rod and a transverse flexible connecting rod. One end of the transverse flexible connecting rod is slidably connected to the longitudinal main rod via a slider, and the other end of the transverse flexible connecting rod is fixedly equipped with a flexible joint. The inner surface of the outer shell of the foot adaptive fixation chamber is equipped with a miniature pressure sensor and a temperature sensor. The interior of the foot adaptive fixation chamber is fixedly equipped with an air chamber for the toe area, an air chamber for the sole area, and an air chamber for the heel area. The air chambers for the toe area, the sole area, and the heel area are all connected to a miniature air pump through independent air tubes. The miniature pressure sensor, the temperature sensor, and the miniature air pump are connected to the central controller via wireless signals.

[0009] Furthermore, a pressure sensing strip is fixedly installed on the inner side of the leg dynamic adjustment frame, and the pressure sensing strip is connected to the central controller via a wireless signal.

[0010] Furthermore, the multidimensional stimulation system includes a layered electromyography (EMG) stimulation array and a pneumatic-mechanical composite massage component. The layered EMG stimulation array is located in the corresponding muscle areas of the legs and feet, and includes a surface electrode layer and a deep electrode layer. Each electrode is equipped with an independent stimulation intensity adjustment module. The pneumatic-mechanical composite massage component includes a leg airbag matrix and rotatable massage rollers mounted on the surface of the airbag matrix. The airbag matrix is ​​connected to an air pump via a micro-air tube, and the rotatable massage rollers are driven by a micro-motor. The layered EMG stimulation array and the pneumatic-mechanical composite massage component are fixedly and alternately disposed inside the leg dynamic adjustment frame.

[0011] Furthermore, the surface electrode layer is composed of multiple circular flexible electrode sheets, and the deep electrode layer is composed of needle-shaped microelectrodes.

[0012] Furthermore, the dual-axis linkage foot movement mechanism includes a plantar flexion-dorsiflexion electric telescopic rod and an inversion-eversion electric rotating shaft. The plantar flexion-dorsiflexion electric telescopic rod controls the plantar flexion-dorsiflexion movement of the foot, and the inversion-eversion electric rotating shaft controls the inversion-eversion movement. The motion coordination feedback device is located between the dual-axis linkage foot movement mechanism, the pneumatic-mechanical composite massage component, and the layered electromyographic stimulation array. The motion coordination feedback device consists of a signal transmission line and a linkage control rod.

[0013] Furthermore, an angle sensor is provided on the dual-axis linkage foot motion mechanism, and the angle sensor is connected to the central controller via a wireless signal.

[0014] Furthermore, the central controller includes a multi-source data fusion processor and an adaptive control algorithm module. The multi-source data fusion processor is used to receive and process data collected by pressure sensors, temperature sensors, acceleration sensors, gyroscopes, electromyography sensors, etc. The adaptive control algorithm module adjusts the operating parameters of the device based on the analysis results of the multi-source data fusion processor.

[0015] Furthermore, the central controller is configured to execute the following intelligent fixation and rehabilitation collaborative control method:

[0016] Step S1: Establish a personalized fixation force field model: When the patient's limb is placed in the device, the central controller collects initial pressure distribution data through the pressure sensing strip and the micro pressure sensor in the foot adaptive fixation chamber, and records the initial air pressure of the toe area air chamber, the sole area air chamber and the heel area air chamber and the angle of the transverse flexible connecting rod to establish an initial fixation force field benchmark that is bound to the patient's current limb status.

[0017] Step S2: Real-time dynamic pressure balance control: During rehabilitation training, pressure data is continuously monitored. If the pressure in a certain area is continuously higher or lower than the benchmark value and reaches the preset threshold and duration, the central controller instructs the micro air pump to perform micro-inflation or depressurization of the corresponding air chamber, and achieves dynamic balance of fixation force by adjusting the angle of the flexible joint.

[0018] Step S3: Coordinated fixation with rehabilitation exercises: The central controller predictively adjusts the fixation strategy based on the real-time movement phase and angle of the dual-axis linkage foot movement mechanism, including instructing the corresponding air chamber to increase air pressure to provide enhanced support during the joint activity tension increase phase, and restoring air pressure during the relaxation phase to promote blood circulation, forming a "breathing" fixation synchronized with physiological activities.

[0019] Step S4: Timing Synergy of Multimodal Stimulation: The central controller controls the start-up timing, intensity, and waveform of the layered electromyography array and the pneumatic-mechanical composite massage component, so that its output is precisely matched in timing with the plantar flexion, dorsiflexion, inversion, and eversion phases of the ankle pump movement, forming a multimodal synergistic effect of mechanical movement, neuromuscular electrical stimulation, and mechanical massage.

[0020] Furthermore, dynamic intelligent fixation and rehabilitation synergistic control methods for lower limb rehabilitation include:

[0021] Step S1: Receive data from pressure sensor, temperature sensor, angle sensor and electromyography sensor through multi-source data fusion processor;

[0022] Step S2: Based on the data, a personalized fixed force field model for the patient's current limb status is established and updated in real time through the adaptive control algorithm module;

[0023] Step S3: During the rehabilitation exercise, based on the fixed force field model and the real-time motion phase, the air pressure of each air chamber in the foot adaptive fixation chamber and the fitting angle of the leg dynamic adjustment frame are dynamically adjusted to maintain dynamic pressure balance and coordinate with the motion trajectory.

[0024] Step S4: Synchronously control the output parameters of the multidimensional stimulation system to couple it with the ankle pump movement driven by the dual-axis linkage foot movement mechanism in time sequence, so as to realize the three-dimensional integrated intelligent control of fixation, movement and stimulation.

[0025] The beneficial effects of this invention are as follows:

[0026] This invention, through its dynamically adjustable leg support structure and adaptive foot fixation device, can provide personalized fit according to different patients' leg circumference, foot shape, and joint range of motion, effectively avoiding problems such as insecure fixation or excessive local pressure, significantly improving patient comfort and exercise compliance. By integrating multimodal stimulation components and a biaxial linkage motion mechanism, mechanical movement, pneumatic massage, and electromyographic stimulation work synergistically to simultaneously activate superficial venous pumps and deep muscle groups, promoting venous blood return in the lower limbs and enhancing vascular circulation. Utilizing a multi-source data sensing intelligent control system, the device can collect physiological data such as electromyographic signals, pressure distribution, and joint angles in real time, and dynamically adjust fixation parameters and stimulation intensity based on data feedback. This enables individualized rehabilitation management, avoids the risk of overtraining, effectively improves lower limb rehabilitation outcomes and the clinical benefits of postoperative lower limb fixation and VTE prevention, while reducing the operational complexity for medical staff. Attached Figure Description

[0027] Figure 1 For the overall assembly structure drawing;

[0028] Figure 2 This is a front view of the overall structure;

[0029] Figure 3 This is a side view of the overall structure;

[0030] Figure 4 This is a diagram of the internal structure of a layered electromyography (EMG) array.

[0031] Figure 5 This is a diagram of the internal structure of a pneumatic-mechanical composite massage component.

[0032] Figure 6 Top view of the foot-adaptive fixed chamber;

[0033] Figure 7 A control relationship diagram for the coordination of intelligent fixation and rehabilitation;

[0034] Figure 8 This is the device control flowchart.

[0035] Explanation of reference numerals in the attached figures:

[0036] 1. Leg dynamic adjustment frame; 101. Longitudinal main rod; 102. Lateral flexible connecting rod; 1022. Flexible joint; 2. Foot self-adaptive fixation chamber; 201. Outer shell; 202. Miniature pressure sensor; 203. Temperature sensor; 204. Toe area air chamber; 205. Sole area air chamber; 206. Heel area air chamber; 3. Multidimensional stimulation system; 301. Layered electromyographic stimulation array; 3011. Surface electrode layer; 3012. Deep electrode layer; 302. Pneumatic-mechanical composite massage component; 3021. Leg airbag matrix; 3022. Massage roller; 3023. Miniature motor; 4. Dual-axis linkage foot movement mechanism; 401. Plantar flexion-dorsiflexion electric telescopic rod; 402. Inversion-eversion electric rotating shaft; 5. Motion coordination feedback device; 6. Central controller; 7. Operation control interface. Detailed Implementation

[0037] like Figure 1-8 As shown, this invention provides an embodiment of a dynamic intelligent fixation device for lower limb rehabilitation. The core structure includes a leg dynamic adjustment frame 1, a foot adaptive fixation chamber 2, a multi-dimensional stimulation system 3, a dual-axis linkage foot movement mechanism 4, a motion coordination feedback device 5, and a central controller 6. All components form an organic whole through a precision mechanical structure and electrical signal network, achieving dynamic adaptation, multi-modal stimulation, and intelligent control of the patient's lower limbs.

[0038] The device uses a leg dynamic adjustment frame 1 as its basic support structure, which consists of a longitudinal main rod 101 and a transverse flexible connecting rod 102. The longitudinal main rod 101 is vertically arranged, with a T-shaped groove on its inner side along its length. One end of the transverse flexible connecting rod 102 is slidably connected to the T-shaped groove of the longitudinal main rod 101 via a slider. The slider can move up and down along the groove and is fixed in position by a locking structure. The other end is fixed with a flexible joint 1022. The foot adaptive fixation chamber 2 is set at the bottom of the leg dynamic adjustment frame 1 via a rotating connection assembly, and its angle can be adjusted around the connection point. The multidimensional stimulation system 3 is integrated inside the leg dynamic adjustment frame 1 and inside the foot adaptive fixation chamber 2. The dual-axis linkage foot movement mechanism 4 is fixed to the outside of the foot adaptive fixation chamber 2. The motion coordination feedback device 5 connects the dual-axis linkage foot movement mechanism 4 and the multidimensional stimulation system 3. The central controller 6 is connected to each component via wiring.

[0039] The longitudinal main rod 101 is made of medical-grade aluminum alloy, and its inner T-shaped groove provides sliding guidance for the transverse flexible connecting rod 102. A slider is fixedly connected to one end of the transverse flexible connecting rod 102, forming a sliding pair after being embedded in the T-shaped groove. The height is fixed by operating the locking structure on the slider. The flexible joint 1022 at the other end of the transverse flexible connecting rod 102 uses a silicone-coated metal hinge structure, allowing for multi-angle bending. A pressure sensing strip, a long strip-shaped thin-film sensor, is fixed to the inner side of the longitudinal main rod 101 via an adhesive method. The signal output end is connected to the central controller 6 via a wireless module to monitor leg contact pressure in real time.

[0040] The inner surface of the outer shell 201 of the foot adaptive fixation chamber 2 is equipped with miniature pressure sensors 202 and temperature sensors 203, which are distributed in a matrix pattern in the toe, sole, and heel areas. Inside the outer shell 201 are air chambers 204 for the toe area, 205 for the sole area, and 206 for the heel area, all three connected to a miniature air pump on the side of the outer shell 201 via independent air tubes. The miniature pressure sensors 202, temperature sensors 203, and miniature air pump communicate wirelessly with the central controller 6 to achieve dynamic pressure control and temperature monitoring of the foot.

[0041] The multidimensional stimulation system 3 includes a layered electromyography (EMG) stimulation array 301 and a pneumatic-mechanical composite massage component 302, which are fixed at intervals to the inner side of the leg dynamic adjustment frame 1 and the inner wall of the foot adaptive fixation chamber 2. The layered EMG stimulation array 301 includes a surface electrode layer 3011 and a deep electrode layer 3012, each electrode is equipped with an independent stimulation intensity adjustment module. The surface electrode layer 3011 is composed of circular flexible electrode sheets, and the deep electrode layer 3012 is composed of needle-shaped microelectrodes. The pneumatic-mechanical composite massage component 302 includes a leg airbag matrix 3021 and a rotatable massage roller 3022. The airbag matrix 3021 is connected to an air pump through a micro-air tube, and the massage roller 3022 is driven by a micro-motor 3023 to achieve pneumatic compression and mechanical massage.

[0042] The dual-axis linkage foot movement mechanism 4 includes a plantar flexion-dorsiflexion electric telescopic rod and an inversion-eversion electric rotating shaft 402. One end of the plantar flexion-dorsiflexion electric telescopic rod is connected to the lower end of the leg dynamic adjustment frame 1, and the other end is hinged to the bottom of the foot adaptive fixation chamber 2; the inversion-eversion electric rotating shaft 402 vertically passes through the middle of the foot adaptive fixation chamber 2, and both ends are fixed to the outer shell 201. The motion coordination feedback device 5 consists of a signal transmission line and a linkage control rod. The signal transmission line connects the angle sensor to the central controller 6, and the linkage control rod realizes the coordination between mechanical movement and stimulation components. The angle sensor on the dual-axis linkage foot movement mechanism 4 is wirelessly connected to the central controller 6 to provide real-time feedback on the movement angle.

[0043] The central controller 6 includes a multi-source data fusion processor and an adaptive control algorithm module, and is connected to the operation control interface 7 via a wireless signal. The multi-source data fusion processor receives and processes data from miniature pressure sensors 202, temperature sensors 203, pressure sensing strips, angle sensors, etc., and the adaptive control algorithm module adjusts the operating parameters accordingly. The operation control interface 7 includes operation buttons, knobs, and status indicator lights for inputting commands and displaying status.

[0044] In this embodiment, the patient first lies supine. Medical staff then vertically fix the longitudinal main rod 101 along the edge of the bed, securing it to the bed railing via a tripod at the bottom to ensure overall stability. Next, the transverse flexible connecting rod 102 is operated, slowly sliding the slider down the T-shaped groove of the longitudinal main rod 101 while observing the real-time data feedback from the pressure sensor. When the pressure value reaches the preset initial contact threshold, the sliding is stopped and the locking knob is tightened. At this point, the flexible joint 1022 precisely conforms to the lateral depression of the patient's knee joint. This process requires ensuring that the transverse flexible connecting rod 102 remains parallel to the longitudinal axis of the patient's thigh, with an error not exceeding 5°, to guarantee the accuracy of subsequent movement trajectories.

[0045] After the patient's foot is placed in the adaptive foot fixation chamber 2, the central controller 6 immediately initiates the initialization program: the miniature pressure sensor 202 collects pressure data at 32 points on the foot at a frequency of 50Hz, and the temperature sensor 203 simultaneously measures the skin surface temperature distribution. The multi-source data fusion processor extracts features from these data, identifying the locations of key anatomical structures such as the heel, bulbus, and arch of the foot. Based on this, the adaptive control algorithm module generates a personalized inflation plan. The miniature air pump first injects an initial air pressure of 0.5 kPa into the toe area inflation chamber 204, maintains it for 3 seconds, and then increases the pressure in the ball of the foot inflation chamber 205 at a rate of 0.1 kPa / s until the pressure value fed back by the pressure sensor bar reaches 1.2 kPa; finally, the heel area inflation chamber 206 is inflated to 1.5 kPa, forming a three-point support structure in the front, middle, and back. Throughout the inflation process, the temperature sensor 203 continuously monitors the system. If the temperature change in a certain area exceeds 0.5℃ / minute, the system automatically adjusts the air pressure increase rate of the corresponding inflation chamber.

[0046] The device's dynamic intelligent fixation function continues to operate after initialization, ensuring optimized and personalized fixation strength throughout the rehabilitation process. Its specific implementation steps and principles are as follows:

[0047] Dynamic fixed reference establishment: After the initial inflation procedure is completed, the adaptive control algorithm module of the central controller 6 sets the real-time pressure data fed back by the micro pressure sensor 202 and the pressure sensing strip as the initial reference value. At the same time, the system records the internal pressure values ​​of each inflation chamber 204, 205, and 206 and the angular position of the transverse flexible connecting rod 102, forming a "fixed force field" model bound to the patient's current limb state.

[0048] Real-time monitoring and fine-tuning feedback loop:

[0049] Pressure Balance Maintenance: During rehabilitation training, contact pressure changes due to muscle contraction, slight limb movement, or swelling. Pressure sensing strips and miniature pressure sensors 202 continuously collect data at a frequency of 50Hz. When the system detects that the pressure in a certain area remains above the baseline value by 15% for more than 3 seconds, the central controller 6 determines that there is a risk of compression at that point and immediately instructs the miniature air pump to slightly depressurize the corresponding area's inflation chambers 204, 205, and 206 (e.g., adjusting by 0.05 kPa each time) until the pressure returns to within the safe threshold.

[0050] Loosening Warning and Compensation: Conversely, if the pressure is detected to be continuously lower than the baseline value by 20%, the system determines that the fixation has become loose. The central controller 6 will instruct the micro air pump to slightly replenish the corresponding inflation chamber. At the same time, the bending angle of the lateral flexible connecting rod 102 can be slightly adjusted (e.g., ±1°) through the micro drive mechanism integrated in the flexible joint 1022 to re-tighten and fix it, ensuring the stability of the movement trajectory.

[0051] Coordinated Fixation with Movement Patterns: Dynamic fixation is not static but intelligently linked to the movement patterns of the dual-axis linkage foot movement mechanism 4. For example, when the plantar flexion-dorsiflexion electric telescopic bar 401 performs a large-angle dorsiflexion movement, the tension in the front of the ankle increases. The adaptive control algorithm module will predictively instruct the inflatable chambers 205 in the forefoot area and 204 in the toe area to appropriately increase the air pressure by 0.1-0.2 kPa to provide stronger counter-support and prevent the foot from sliding within the fixation chamber; while in the plantar flexion relaxation phase, the air pressure returns to normal levels to promote blood circulation. This dynamic fluctuation of fixation force constitutes an intelligent, physiologically adaptive "breathing" fixation system.

[0052] Then, under the synchronized conditions of intelligent fixation, assisted rehabilitation and coordinated exercise training are carried out: Medical staff select the corresponding exercise mode for the treatment stage through the operation control interface 7. When patients select "passive exercise mode" in the early postoperative period, the central controller 6 sets the initial movement amplitude of the plantar flexion-dorsiflexion electric telescopic bar 401 to ±20°, and the movement cycle to 4 seconds / time; the rotation angle range of the inversion-eversion electric rotating shaft 402 is set to ±10°, forming a composite movement trajectory with the plantar flexion-dorsiflexion electric telescopic bar 401 with a 90° phase difference. After patients in the recovery period select "active assistance mode", the system first enters a 5-minute baseline data acquisition phase: the electromyographic signal characteristics when patients voluntarily attempt ankle pump exercises are recorded through the layered electromyographic stimulation array 301, and the driving torque of the plantar flexion-dorsiflexion electric telescopic bar 401 and the inversion-eversion electric rotating shaft 402 are dynamically adjusted.

[0053] Regarding the stimulation parameter settings, the initial output intensity of the circular flexible electrode sheet of the surface electrode layer 3011 is 2mA, and the frequency is 5Hz; the output intensity of the needle-shaped microelectrode of the deep electrode layer 3012 is 5mA, and the frequency is 80Hz. The inflation pressure of the leg airbag matrix 3021 of the pneumatic-mechanical composite massage component 302 is set to 0.8-1.2kPa in a cyclical variation. The rotation speed of the massage roller 3022 and the movement speed of the plantar flexion-dorsiflexion electric telescopic rod 401 maintain a synchronous ratio of 1:1.5 to ensure the synergistic effect of mechanical massage and joint movement.

[0054] After treatment is initiated, the dual-axis linkage foot movement mechanism 4 operates according to a preset trajectory: the servo motor of the plantar flexion-dorsiflexion electric telescopic rod 401 receives a PWM control signal sent by the central controller 6, and reduces the motor's output speed from 3000 r / min to 5 r / min through a planetary gear reducer, driving the piston rod to achieve precise linear displacement control. The brushless DC motor of the electric rotating shaft 402 achieves an angular positioning accuracy of ±0.1°. Angle sensors collect joint angle data in real time and compare it with the preset trajectory. If the deviation exceeds 2°, the central controller 6 immediately adjusts the control parameters to form a closed-loop position control.

[0055] During exercise, the layered electromyography (EMG) array 301 and the pneumatic-mechanical composite massage component 302 are activated synchronously: when the plantar flexion-dorsiflexion electric telescopic rod 401 drives the foot to dorsiflex, the surface electrode layer 3011 releases low-frequency pulses to stimulate the tibialis anterior muscle, while the deep electrode layer 3012 simultaneously stimulates the soleus muscle; at the same time, the proximal airbags of the leg airbag matrix 3021 inflate first, and with the plantar flexion of the foot, the inflation wave is transmitted to the distal end in sequence, forming a pressure gradient consistent with the direction of blood return. The micro motor 3023 of the massage roller 3022 achieves closed-loop speed control through a Hall sensor, ensuring a constant rotational speed of 30 r / min under different load conditions.

[0056] The motion feedback device 5 achieves precise synchronization between mechanical movement and massage actions through a linkage control lever: when the piston rod of the plantar flexion-dorsiflexion electric telescopic rod 401 extends to 70% of its stroke, the linkage control lever triggers the airbag inlet valve to open; when the piston rod retracts to 30% of its stroke, the valve closes, forming a periodic massage that matches the phase of joint movement. The signal transmission line adopts a shielded twisted-pair cable design, effectively suppressing electromagnetic interference between high-frequency electromyographic signals and motor drive signals, ensuring that the data transmission error between the angle sensor and the central controller 6 is less than 0.01%.

[0057] During treatment, the pressure sensor continuously monitors the pressure distribution in different areas of the leg. When the pressure on the inner side of the knee joint exceeds 1.8 kPa for 5 seconds, the central controller 6 issues a fine-tuning command: the shape memory alloy wire built into the flexible joint 1022 of the laterally bendable connecting rod 102 is energized and heated, producing a 2° angular offset, redistributing the contact pressure. During this process, the piezoelectric film sensor of the pressure sensor updates the data at a sampling rate of 100 Hz, forming a real-time closed loop of pressure feedback.

[0058] Temperature sensor 203 collects the foot skin temperature every 15 seconds. If the temperature of a certain area exceeds 34℃, the system automatically executes a cooling program: the air pressure in the corresponding area's air chamber is reduced by 0.2 kPa, while the rotation speed of the massage rollers 3022 in that area is increased to 40 r / min, achieving physical cooling by enhancing airflow. If the temperature continues to rise to 36℃, the central controller 6 immediately pauses the electromyographic stimulation of that area and issues a visual alarm through the operation control interface 7.

[0059] This embodiment, through the design of a dynamically adjustable leg support structure and an adaptive foot fixation device, can provide personalized adaptation based on different patients' leg circumference, foot shape, and joint range of motion. This achieves intelligent fixation and precise support, effectively avoiding problems such as insecure fixation or excessive local pressure, significantly improving patient comfort and the standardization of rehabilitation training. By integrating multimodal stimulation components and a dual-axis linkage motion mechanism, mechanical movement, pneumatic massage, and electromyographic stimulation work synergistically on the basis of fixation, simultaneously activating superficial and deep muscle groups, promoting lower limb blood circulation, and enhancing rehabilitation momentum. Utilizing a multi-source data sensing intelligent control system, the device can collect physiological data such as pressure distribution, temperature, and joint angles in real time, and dynamically adjust fixation parameters and stimulation intensity based on data feedback. This enables individualized rehabilitation management, avoids the risk of overtraining, effectively improves lower limb rehabilitation outcomes and the clinical benefits of VTE prevention, while reducing the operational complexity for medical staff.

[0060] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A dynamic intelligent fixation device for lower limb rehabilitation, characterized in that: The device includes a leg dynamic adjustment frame and a foot adaptive fixation chamber. The foot adaptive fixation chamber is rotatably mounted at the bottom of the leg dynamic adjustment frame. A multi-dimensional stimulation system is fixedly installed inside the leg dynamic adjustment frame and the foot adaptive fixation chamber to stimulate the patient's leg and foot muscles. A dual-axis linkage foot movement mechanism and a motion feedback device are fixedly connected to the outside of the foot adaptive fixation chamber and the leg dynamic adjustment frame to drive the patient's foot to perform ankle pump movements. The device also includes a central controller, which is connected to the leg dynamic adjustment frame, the foot adaptive fixation chamber, the multi-dimensional stimulation system, the dual-axis linkage foot movement mechanism, and the motion feedback device via wiring. The central controller is used to monitor the device's operating status and the patient's physiological data, and to make adjustments based on the data.

2. The lower limb rehabilitation dynamic intelligent fixation device according to claim 1, characterized in that: The leg dynamic adjustment frame consists of a longitudinal main rod and a transverse flexible connecting rod. One end of the transverse flexible connecting rod is slidably connected to the longitudinal main rod via a slider, and the other end of the transverse flexible connecting rod is fixedly equipped with a flexible joint. The inner surface of the outer shell of the foot adaptive fixation chamber is equipped with a miniature pressure sensor and a temperature sensor. The interior of the foot adaptive fixation chamber is fixedly equipped with an air chamber for the toe area, an air chamber for the sole area, and an air chamber for the heel area. The air chambers for the toe area, the sole area, and the heel area are all connected to a miniature air pump through independent air tubes. The miniature pressure sensor, the temperature sensor, and the miniature air pump are connected to the central controller via wireless signals.

3. The lower limb rehabilitation dynamic intelligent fixation device according to claim 2, characterized in that: A pressure sensing strip is fixedly installed on the inner side of the leg dynamic adjustment frame, and the pressure sensing strip is connected to the central controller via a wireless signal.

4. The lower limb rehabilitation dynamic intelligent fixation device according to claim 3, characterized in that: The multidimensional stimulation system includes a layered electromyography (EMG) stimulation array and a pneumatic-mechanical composite massage component. The layered EMG stimulation array is located in the corresponding muscle areas of the legs and feet, and includes a surface electrode layer and a deep electrode layer. Each electrode is equipped with an independent stimulation intensity adjustment module. The pneumatic-mechanical composite massage component includes a leg airbag matrix and rotatable massage rollers mounted on the surface of the airbag matrix. The airbag matrix is ​​connected to an air pump through a micro-air tube, and the rotatable massage rollers are driven by a micro-motor. The layered EMG stimulation array and the pneumatic-mechanical composite massage component are fixedly and alternately arranged inside the leg dynamic adjustment frame.

5. The lower limb rehabilitation dynamic intelligent fixation device according to claim 4, characterized in that: The surface electrode layer is composed of multiple circular flexible electrode sheets, and the deep electrode layer is composed of needle-shaped microelectrodes.

6. The lower limb rehabilitation dynamic intelligent fixation device according to claim 5, characterized in that: The dual-axis linkage foot movement mechanism includes a plantar flexion-dorsiflexion electric telescopic rod and an inversion-eversion electric rotating shaft. The plantar flexion-dorsiflexion electric telescopic rod controls the plantar flexion-dorsiflexion movement of the foot, and the inversion-eversion electric rotating shaft controls the inversion-eversion movement. The motion coordination feedback device is located between the dual-axis linkage foot movement mechanism, the pneumatic-mechanical composite massage component, and the layered electromyographic stimulation array. The motion coordination feedback device consists of a signal transmission line and a linkage control rod.

7. A lower limb rehabilitation dynamic intelligent fixation device according to claim 6, characterized in that... An angle sensor is installed on the dual-axis linkage foot movement mechanism, and the angle sensor is connected to the central controller via a wireless signal.

8. The lower limb rehabilitation dynamic intelligent fixation device according to claim 7, characterized in that... The central controller includes a multi-source data fusion processor and an adaptive control algorithm module. The multi-source data fusion processor is used to receive and process data collected by pressure sensors, temperature sensors, acceleration sensors, gyroscopes, electromyography sensors, etc. The adaptive control algorithm module adjusts the operating parameters of the device according to the analysis results of the multi-source data fusion processor.

9. A dynamic intelligent fixation device for lower limb rehabilitation according to claim 8, characterized in that, The central controller is configured to execute the following intelligent fixation and rehabilitation collaborative control method: Step S1: Establish a personalized fixation force field model: When the patient's limb is placed in the device, the central controller collects the initial pressure distribution data through the pressure sensing strip and the micro pressure sensor in the foot adaptive fixation chamber, and records the initial air pressure of the toe area air chamber, the sole area air chamber and the heel area air chamber and the angle of the transverse flexible connecting rod to establish an initial fixation force field benchmark that is bound to the patient's current limb status. Step S2: Real-time dynamic pressure balance control: During rehabilitation training, pressure data is continuously monitored. If the pressure in a certain area is continuously higher or lower than the benchmark value and reaches the preset threshold and duration, the central controller instructs the micro air pump to perform micro-inflation or depressurization of the corresponding air chamber, and achieves dynamic balance of fixation force by adjusting the angle of the flexible joint. Step S3: Coordinated fixation with rehabilitation exercises: The central controller predictively adjusts the fixation strategy based on the real-time movement phase and angle of the dual-axis linkage foot movement mechanism, including instructing the corresponding air chamber to increase air pressure to provide enhanced support during the joint activity tension increase phase, and restoring air pressure during the relaxation phase to promote blood circulation, forming a "breathing" fixation synchronized with physiological activities; Step S4: Timing Synergy of Multimodal Stimulation: The central controller controls the start-up timing, intensity, and waveform of the layered electromyography array and the pneumatic-mechanical composite massage component, so that its output is precisely matched in timing with the plantar flexion, dorsiflexion, inversion, and eversion phases of the ankle pump movement, forming a multimodal synergistic effect of mechanical movement, neuromuscular electrical stimulation, and mechanical massage.

10. A dynamic intelligent fixation and rehabilitation coordinated control method for lower limb rehabilitation, applied to the fixation device as described in any one of claims 1-8, characterized in that, The method includes: Step S1: Receive data from pressure sensor, temperature sensor, angle sensor and electromyography sensor through multi-source data fusion processor; Step S2: Based on the data, a personalized fixed force field model for the patient's current limb status is established and updated in real time through the adaptive control algorithm module; Step S3: During the rehabilitation exercise, based on the fixed force field model and the real-time motion phase, the air pressure of each air chamber in the foot adaptive fixation chamber and the fitting angle of the leg dynamic adjustment frame are dynamically adjusted to maintain dynamic pressure balance and coordinate with the motion trajectory. Step S4: Synchronously control the output parameters of the multidimensional stimulation system to couple it with the ankle pump movement driven by the dual-axis linkage foot movement mechanism in time sequence, so as to realize the three-dimensional integrated intelligent control of fixation, movement and stimulation.

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