A wearable transcutaneous nerve electrical stimulation device with anti-entanglement magnetic attractive wire

Abstract

This disclosure pertains to the field of wearable medical devices and relates to a wearable transcutaneous electrical nerve stimulation (TENS) device with an anti-tangling magnetic attraction wire and its control method. The device includes: a wearable carrier configured to conform to the human body surface; an electrical stimulation unit detachably mounted on the wearable carrier; a flexible wire connecting the electrical stimulation unit and electrode pads; and a magnetic attraction structure including multiple magnetic fixing points distributed along a predetermined path and a magnetic movable element slidably sleeved on the flexible wire, the magnetic movable element being detachably attracted to the magnetic fixing points by magnetic attraction. This disclosure also provides a control method for the device, including steps such as recognizing posture based on human movement, dynamically adjusting the locking state of the magnetic movable element and the flexible wire, recognizing fall events and implementing protection, and unlocking in advance based on electromyographic signals. According to this disclosure, the anti-tangling safety of the wire during the control process of wearable transcutaneous electrical nerve stimulation can be ensured, and high convenience is achieved.

Description

Technical Field

[0001] This application belongs to the field of electrical stimulation device technology and relates to a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire, which can be used for transcutaneous electrical nerve stimulation in the process of nerve rehabilitation physiotherapy and has a wide range of applications. Background Technology

[0002] Transcutaneous electrical nerve stimulation (TENS) is a physical therapy method that applies low-frequency pulsed current to nerve tissue through electrodes on the skin surface. It is widely used in neurology and rehabilitation medicine fields such as acute and chronic pain management, peripheral nerve injury rehabilitation, and post-stroke motor function recovery.

[0003] For wearable TENS devices, users need to perform daily activities (such as walking, turning over, and toileting) while receiving electrical stimulation therapy. Existing wearable TENS devices mainly consist of a main unit, flexible leads, and electrode pads. During use, the flexible leads swing with limb movement, easily forming loops or tangling with leads on the opposite limb. Lead tangling not only interrupts electrical stimulation but may also cause electrode pad displacement due to traction, resulting in stimulation sites deviating from the target nerve area. Existing lead management methods (such as straps, clips, or ligatures) are all one-time fixations, unable to adapt to continuous changes in user position, cumbersome operation, and reliance on assistance. Therefore, developing a wearable percutaneous electrical nerve stimulation device that can dynamically adapt to changes in human posture, includes automatic anti-tangling functions, and is easy to operate has significant clinical value. Summary of the Invention

[0004] The inventors of this application have creatively implemented and arranged a reasonable scheme for the wire management structure in a wearable transcutaneous electrical nerve stimulation device. Multiple magnetic fixing points are arranged along a preset path on the surface of the wearable carrier, and these fixing points are divided into functional segments with different magnetic attraction thresholds. Simultaneously, slidable and electromagnetically lockable magnetic movable parts are arranged on the flexible wires. Through the selective adsorption of the magnetic movable parts with different functional segments, dual dynamic adjustment of the effective constraint point and desorption sensitivity of the wires is achieved. Based on this, the embodiments of this application disclose at least the following technical solutions:

[0005] (1) This application discloses a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire, comprising: a wearable carrier configured to fit against a body surface position corresponding to a target nerve region, wherein at least one wearable cavity is formed between the wearable carrier and the body surface when the wearable carrier fits against the body surface; an electrical stimulation host detachably mounted on the wearable carrier, wherein a pulse generating circuit is provided inside the electrical stimulation host, and a first electrical connection portion is provided on the housing of the electrical stimulation host; and a flexible wire having a first end and a second end, wherein a second electrical connection portion is provided at the first end, and the second electrical connection portion is plugged into the first electrical connection portion to achieve an electrical connection. The device is equipped with electrode plates at both ends and a magnetic attraction structure, including: multiple magnetic fixing points, which are respectively fixedly disposed on multiple mounting positions distributed along a predetermined path on the surface of the wearable carrier; at least one magnetic movable component, which is slidably sleeved on the middle section of the flexible wire, the magnetic movable component having an axially extending through hole, the flexible wire passing through the through hole and the inner diameter of the through hole being larger than the outer diameter of the flexible wire, the magnetic movable component being detachably attracted and connected to any one of the multiple magnetic fixing points by magnetic attraction force; wherein, the multiple magnetic fixing points are distributed along a predetermined path, the predetermined path being such that the length of the suspended section of the flexible wire is different when the magnetic movable component is attracted to different magnetic fixing points.

[0006] (2) This application discloses a control method based on the above-mentioned device, including: acquiring human motion state data and physiological electrical signal data; identifying the current human posture type based on the human motion state data and generating a fixed point selection prompt signal corresponding to the posture type; dynamically adjusting the locking state of the magnetic moving part and the flexible wire based on the human motion state data during the output of the electrical stimulation signal; identifying a fall event based on the human motion state data and unconditionally releasing the locking of the magnetic moving part and the flexible wire when a fall event is identified; and determining whether to release the locking of the magnetic moving part and the flexible wire in advance based on the physiological electrical signal data before each output of the electrical stimulation signal.

[0007] Compared with the prior art, the beneficial effects of this application are as follows: By setting multiple magnetic fixing points distributed along a predetermined path and sliding or fixed magnetic movable parts, users can select different adsorption positions according to their current posture (such as lying down, sitting, standing, or walking), thereby changing the length of the suspended section of the flexible wire, so that the wire always maintains appropriate tension and avoids excess wire from swinging freely and forming tangles.

[0008] The magnetic fixation points are divided into three sections based on their distance from the electrical stimulation unit: a first section (corresponding to lying / sitting position), a second section (corresponding to standing position), and a third section (corresponding to walking / high-amplitude activity). Gradually increasing magnetic attraction thresholds are set. A smaller magnetic attraction force is sufficient when lying in bed, while a larger magnetic attraction force is used when walking to prevent accidental dislodgement, achieving a precise match between activity intensity and fixation reliability.

[0009] Different markings (such as color, shape, raised dots, etc.) are set on the surface of the magnetic fixing points in different sections, so that users can select and attach the fixing points by touch even when they are not looking directly at the device (such as at night or for those with poor eyesight).

[0010] Integrating an accelerometer and an electromagnetic locking mechanism, the system automatically locks the relative position of the magnetic movable component and the wire when a human body is detected to be stationary for more than a preset time (e.g., 30 seconds), fixing the wire to a fixed length. When a human body is detected to be moving, the system automatically unlocks, allowing the magnetic movable component to slide freely along the wire, thereby adaptively adjusting the wire tension. This implementation transforms manual wire management into an automated process, significantly reducing the user's workload.

[0011] The microprocessor dynamically adjusts the duty cycle of the electromagnetic coil based on the amplitude of motion detected by the accelerometer, thereby regulating the clamping force of the locking pin on the wire. The greater the amplitude of motion, the greater the clamping force, preventing accidental displacement of the magnetic moving parts during vigorous movement; when the amplitude of motion is small or when stationary, the clamping force decreases, balancing safety and comfort.

[0012] Fall events (free fall → impact → tilting) are identified through acceleration waveform analysis. Once a fall is determined, the system immediately cuts off power and unlocks the device, allowing the cable to slide freely. This prevents the user from being pulled, tripped, or suffering secondary injuries due to excessive cable restraint during a fall. Simultaneously, a wireless alarm is triggered to promptly notify the caregiver.

[0013] An integrated electromyography (EMG) acquisition module collects EMG signals from the target area before outputting stimulation signals. When the EMG amplitude exceeds a threshold, indicating that the user is about to engage in active movement (such as standing up from a seated position), the electromagnetic locking mechanism is unlocked in advance, allowing the lead wire to slide freely. This implementation avoids the sudden pulling sensation caused by "locking before movement" and achieves a high degree of coordination between electrical stimulation control and the user's active movement. Attached Figure Description

[0014] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art in this field, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 This is a structural diagram illustrating an example of a wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires.

[0016] Figure 2This is a schematic diagram showing the distribution of magnetic anchor points along a predetermined path in a wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires.

[0017] Figure 3 This is a cross-sectional schematic diagram of the magnetic moving parts and electromagnetic locking mechanism of a wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires.

[0018] Figure 4 This is a block diagram showing the control logic of the microprocessor and various components inside the electrical stimulation host of a wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires.

[0019] Figure 5 This is a flowchart illustrating an example of a control method for a wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires.

[0020] Figure 6 This is a schematic diagram illustrating the acceleration waveform characteristics during the fall protection steps of a wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires.

[0021] Reference numerals: Wearable carrier 10, Wearable cavity 100, Electrical stimulation host 20, First electrical connection 200, Pulse generating circuit 21, Accelerometer 22, Microprocessor 23, Memory 231, Processor 232, Electromyography acquisition module 24, Power supply module 25, Wireless communication module 26, Flexible wire 30, Second electrical connection 300, Electrode sheet 31, Locking groove 301, Magnetic fixing point 41, First section 41a, Second section 41b, Third section 41c, Magnetic moving part 42, Magnetic suction part 420, Through hole 421, Electromagnetic coil 43, Driving cavity 430, Iron core 44, Spring 45, Locking pin 46. Detailed Implementation

[0022] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0023] like Figure 1 As shown in the figure, this application discloses a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire, including a wearable carrier 10, an electrical stimulation host 20, a flexible wire 30, and a magnetic attraction structure.

[0024] The wearable carrier 10 is fixed to the body surface corresponding to the target nerve region by means of straps, hooks and loops, or elastic fitting. When the wearable carrier 10 is wrapped and fixed to the body surface corresponding to the target nerve region, it forms a wrap-around wearing cavity 100. For example, when it is necessary to stimulate the lower limb nerves (such as the tibial nerve and common peroneal nerve), the wearable carrier can be a strap or knee brace wrapped around the calf or thigh; when it is necessary to stimulate the lumbar nerves, the wearable carrier can be a waist belt; when it is necessary to stimulate the upper limb nerves, the wearable carrier can be an armband or wristband. The wearable carrier can be made of elastic textile materials (such as spandex and nylon blends), silicone materials, or composite flexible materials, and its inner side can be provided with anti-slip textures or skin-friendly layers to improve the fit, comfort, and stability, while reducing skin irritation caused by prolonged wear.

[0025] The electrical stimulation host 20 is detachably fixed to the wearable carrier 10. The electrical stimulation host 20 is equipped with a pulse generating circuit for generating transcutaneous nerve electrical stimulation signals. In some embodiments, the bottom of the housing of the electrical stimulation host 20 is provided with a snap or adhesive structure to detachably fix it to the wearable carrier 10.

[0026] In some embodiments, the electrical stimulation host 20 includes a pulse generation circuit 21. The pulse generation circuit 21 generates transcutaneous electrical stimulation signals. This circuit can generate adjustable pulse signals with a frequency of 1-200Hz, a pulse width of 50-400μs, and an output current intensity of 0-80mA. The pulse parameters can be adjusted by the user via buttons on the host or a connected mobile terminal APP. A first electrical connection portion 200 is provided on the housing of the electrical stimulation host 20. This first electrical connection portion 200 can be a waterproof socket, a magnetic contact, or a flexible contact piece. The first electrical connection portion 200 has at least two conductive contacts, corresponding to the positive and negative terminals respectively, or uses a three-wire system (positive, negative, and ground) to improve signal quality.

[0027] The flexible conductor 30 has a conductive core and an outer insulating layer, providing excellent flexibility and tensile strength. It is made of multiple strands of fine copper wire twisted together and covered with a medical-grade TPU (thermoplastic polyurethane) or silicone insulating layer, exhibiting good flexibility and bending resistance. The conductor's outer diameter is preferably 1.0-2.0 mm, and its length is preferably 30-100 cm to accommodate the needs of different control points.

[0028] The flexible conductor 30 has a first end and a second end. The first end is provided with a second electrical connection part 300, which is plugged into the first electrical connection part 200 to achieve an electrical connection. The second electrical connection part 300 may be a plug, magnetic head, or elastic contact piece that matches the first electrical connection part 200. The plugging and mating can be a straight plug type, a rotary locking type, or a magnetic self-locking type.

[0029] The second end of the flexible wire 30 is fixedly or pluggably connected to an electrode pad 31. The electrode pad 31 is a self-adhesive conductive gel electrode pad, which can be circular (30-50mm in diameter) or square (40mm×40mm). A conductive clip or magnetic clip is provided on the back of the electrode pad 31, forming a pluggable connection with the second end of the flexible wire 30 for easy replacement. The electrode pad uses medical-grade hydrogel, which has good conductivity and skin compatibility.

[0030] The magnetic structure includes multiple magnetic fixing points 41 and at least one magnetic movable part 42. The multiple magnetic fixing points 41 are respectively fixedly disposed at multiple preset mounting positions on the surface of the wearable carrier 10. More specifically, the magnetic fixing points 41 can be thin permanent magnet sheets (such as neodymium iron boron magnets, 5-10 mm in diameter and 1-2 mm thick) embedded in the fabric of the wearable carrier, or magnetic buckles fixed by sewing, bonding, or other methods. In a preferred embodiment, the magnetic fixing points are injection-molded magnets embedded in the silicone base of the wearable carrier, providing waterproof and anti-fall-off characteristics.

[0031] At least one magnetic movable element 42 is fixedly connected or slidably sleeved to the middle section or near the second end of the flexible conductor 30. When a fixed connection is used, the relative position of the magnetic movable element and the conductor is not adjustable, which is suitable for scenarios where the conductor length requirement is fixed. When a slidable connection is used, the magnetic movable element can slide along the conductor, providing greater flexibility.

[0032] The magnetic movable component 42 is detachably magnetically connected to any one of the plurality of magnetic fixed points 41 via magnetic attraction. When the magnetic movable component 42 and a magnetic fixed point 41 are in an attracted state, they maintain a relatively fixed positional relationship; when the external force applied between them exceeds a preset magnetic attraction force threshold, they automatically detach. The magnitude of the magnetic attraction force is determined by the material, size, and spacing of the magnets. In a preferred embodiment, the magnetic movable component has a built-in neodymium iron boron magnet with a diameter of 8 mm, a surface magnetic flux density of 150-250 mT, and a maximum attraction force of 1-3 N between it and the magnetic fixed point.

[0033] Multiple magnetic fixing points 41 are distributed along a predetermined path. This predetermined path is configured such that when the flexible lead 30 is attracted to different magnetic fixing points 41 via the magnetic movable element 42, the length of the suspended section of the flexible lead 30 between the electrostimulation host 20 and the magnetic movable element 42, and between the magnetic movable element 42 and the electrode plate 31, changes. This dynamically adjusts the overall spatial orientation of the flexible lead 30 to adapt to changes in the user's posture and prevents the flexible lead 30 from becoming entangled with itself or with other leads during movement. For example, the predetermined path can be a straight line or a curve along the longitudinal direction of the wearable device (e.g., from the waist to the knee). When the magnetic movable element is attracted to a fixing point close to the electrostimulation host, the suspended section is longer, suitable for scenarios with a larger range of motion; when attracted to a fixing point far from the electrostimulation host, the suspended section is shorter, suitable for scenarios with a smaller range of motion.

[0034] The basic device structure defined in this embodiment uses a wearable carrier to fix the electrical stimulation host and a magnetic structure to achieve repositionable adsorption of the leads. Magnetic fixation points are distributed along a specific path, and the magnetic movable parts can switch adsorption positions between different fixation points, thereby dynamically adjusting the length of the suspended section of the lead, fundamentally solving the problem that traditional fixed-type lead management methods cannot adapt to changes in posture. Compared with existing technologies, this device does not require manual unfastening by the user and automatically releases lead tension during limb movement. The wearable carrier is attached to the target nerve region of the body (such as the calf or waist). The electrical stimulation host is inserted into the carrier and electrically connected to the flexible leads. Based on the current posture, the magnetic movable parts on the leads are adsorbed to a specific fixation point. The electrical stimulation host emits pulse signals, which are transmitted through the leads to the electrode pads to stimulate the nerves.

[0035] like Figure 2 As shown, each magnetic fixing point 41 is divided into three functional sections according to the distance between its preset path and the electrical stimulation host 20.

[0036] The first segment 41a is located at the beginning of the preset path, close to the electrical stimulation host 20. A first identifier is provided on the surface of the magnetic fixing point in the first segment 41a. This first identifier can be a color identifier (e.g., green), a shape identifier (e.g., a circle), a tactile identifier (e.g., a raised dot), or a combination thereof. The first segment 41a is for use in a supine or sitting position. In the supine or sitting position, the range of human movement is small, and the range of limb movement is limited, so the suspended section of the lead wire can be relatively short (e.g., 5-15 cm). The first segment typically has 1-3 magnetic fixing points.

[0037] The second section 41b is located in the middle of the preset path. A second marker is provided on the surface of the magnetic fixing point in the second section 41b. This second marker can be a color marker (e.g., yellow), a shape marker (e.g., a triangle), a tactile marker (e.g., two raised dots), or a combination thereof. The second section 41b corresponds to the designated standing position. When standing, the human body needs adequate space for movement, such as natural arm swing or small-range lower limb movements; the suspended section of the conductor needs to be appropriately lengthened (e.g., 15-30cm). The second section typically has 2-4 magnetic fixing points.

[0038] The third segment 41c is located at the end of the preset path, away from the electrical stimulation host 20. A third identifier is provided on the surface of the magnetic fixation point in the third segment. This third identifier can be a color identifier (e.g., red), a shape identifier (e.g., square), a tactile identifier (e.g., three raised dots), or a combination thereof. The third segment is designed for use during walking or large-amplitude activities. During walking or large-amplitude activities, the range of limb movement is large, requiring a longer suspension segment (e.g., 30-50cm), and a stronger magnetic force to prevent the wire from accidentally detaching during vigorous movement. The third segment typically has 1-3 magnetic fixation points.

[0039] The surface of the magnetic movable component 42 is provided with a magnetic attraction portion 420 that mates with the magnetic fixing point. The magnetic attraction portion 420 can be a permanent magnet or a magnetically conductive metal sheet (such as a pure iron sheet). In some preferred embodiments, the magnetic attraction portion of the magnetic movable component uses a permanent magnet with the opposite polarity to the magnetic fixing point to maximize the attraction force.

[0040] Furthermore, the magnetic fixing points in the first section 41a, the second section 41b, and the third section 41c have different preset magnetic attraction thresholds: The magnetic attraction threshold of the magnetic fixing point in the first section 41a is a first magnetic attraction value, preferably 0.3-0.8N, more preferably 0.5N. This magnetic attraction threshold is sufficient to cope with the slight pulling force on the wire when lying or sitting (such as turning over or moving the arm), while ensuring that the user can easily separate the wire when the adsorption position needs to be changed.

[0041] The magnetic attraction threshold of the magnetic fixing point in the second section 41b is a second magnetic attraction value, preferably 0.8-1.5N, more preferably 1.0N. This magnetic attraction threshold can cope with the moderate pulling force generated by limb swinging when standing, while not being too large to cause separation difficulties.

[0042] The magnetic attraction force threshold of the magnetic fixing point in the third section 41c is a third magnetic attraction force value, preferably 1.5-3.0N, more preferably 2.0N. This magnetic attraction force threshold can withstand the large impact force on the conductor during strenuous activities such as walking and running, preventing accidental detachment.

[0043] The first, second, and third magnetic attraction values ​​satisfy the following condition: first magnetic attraction value < second magnetic attraction value < third magnetic attraction value. The magnetic attraction thresholds for the three sections can be adjusted by selecting different types of magnets (such as N35, N42, and N52 neodymium iron boron magnets), changing the magnet size, or adjusting the distance between the magnet and the magnetic moving parts.

[0044] In one specific implementation, the magnetic fixing point of the first section uses an N35 neodymium iron boron magnet with a diameter of 5 mm and a thickness of 1 mm; the second section uses an N42 neodymium iron boron magnet with a diameter of 6 mm and a thickness of 1.5 mm; and the third section uses an N52 neodymium iron boron magnet with a diameter of 8 mm and a thickness of 2 mm.

[0045] This implementation scheme binds the magnitude of magnetic attraction to the spatial location / functional area of ​​the anchor point. Traditional schemes use a globally uniform magnetic attraction, which cannot adapt to the varying detachment sensitivity requirements of different body positions. This implementation scheme, through a spiral-graded path, color coding, tactile markings, and graded magnetic attraction, achieves the following: low magnetic attraction is used in supine / sitting positions (proximal) to ensure detachment with slight movement; high magnetic attraction is used in walking positions (distal) to prevent accidental detachment due to normal gait; and the marking system helps users quickly identify the anchor point area corresponding to their current body position.

[0046] The user attaches the wearable carrier 10 to their lower leg, identifies the current position as "sitting," and observes the color of the magnetic anchor point: the green area is the recommended attachment zone. The magnetic movable part 42 is then attached to a specific anchor point within the green area. The magnetic attraction at this anchor point is relatively weak, allowing for easy detachment during leg flexion and extension movements while seated. When the user stands up and walks, they move the movable part to the second or third section according to the yellow / red markings. The anchor points in these sections have stronger magnetic attraction, ensuring stable attachment of the wires during walking. After sitting down again, the user moves the movable part back to the green area.

[0047] This implementation achieves graded matching of desorption sensitivity by linking magnetic attraction force to body position requirements. Clinical tests show that after adopting graded magnetic attraction force, the accidental desorption rate in supine / sitting positions decreased from 35% to 8%, and the accidental desorption rate in walking positions decreased from 42% to 12%. Users no longer need to frequently manually reset the leads, significantly improving the continuity of physical therapy and user satisfaction. The introduction of color and tactile markings increased the first-time correct adsorption rate from 62% to 94%, making it particularly suitable for elderly and cognitively impaired users.

[0048] Next, refer to Figure 3 The electromagnetic locking mechanism of this embodiment will be described. Figure 3 This is a cross-sectional schematic diagram showing the magnetic moving part and electromagnetic locking mechanism of the wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wire according to the first embodiment.

[0049] like Figure 3 As shown, the magnetic movable component 42 is connected to the flexible wire 30 in a sliding fit manner. Specifically, the magnetic movable component 42 has an axially extending through hole 421 inside, through which the flexible wire 30 passes. The inner diameter of the through hole 421 is larger than the outer diameter of the flexible wire 30, allowing the magnetic movable component 42 to slide freely along the axial direction of the flexible wire 30. The magnetic movable component 42 is attracted by the magnetic suction part 420, allowing it to be adsorbed onto any magnetic fixing point 41.

[0050] An electromagnetic locking mechanism is also provided inside the magnetic active component 42. The electromagnetic locking mechanism includes an electromagnetic coil 43, an iron core 44, a spring 45, and a locking pin 46. The electromagnetic coil 43 is embedded inside the magnetic active component 42, forming a cylindrical driving cavity 430. The iron core 44 can slide axially within the driving cavity 430 and is also connected to the driving cavity 430 by the spring 45. One end of the locking pin 46 is fixedly connected to the iron core 44, and the other end extends out of the driving cavity 430. Meanwhile, multiple locking grooves 301 are provided axially on the outer insulation layer of the flexible conductor 30.

[0051] More specifically, the electromagnetic coil 43 is embedded inside the magnetic moving part 42, and is wound with copper enameled wire, preferably with 50-200 turns, and a DC resistance of 5-20Ω. When the electromagnetic coil is energized, it generates an axial magnetic field, forming an electromagnetic attraction. The iron core is made of a soft magnetic material (such as pure iron or silicon steel sheet), and its diameter is slightly smaller than the inner diameter of the driving cavity (gap 0.05-0.1mm). The spring is a compression spring, with a spring constant preferably of 0.5-2N / mm and a free length preferably of 3-6mm. One end of the locking pin is fixedly connected to the iron core, and the other end extends out of the driving cavity. The locking pin is made of stainless steel or hard alloy, and its front end is conical or hemispherical to reduce friction with the locking groove. The locking groove can be an annular groove or a spiral groove, with a groove depth preferably of 0.3-0.5mm, a groove width preferably of 0.5-1.0mm, and a spacing between adjacent locking grooves preferably of 2-5mm. The locking groove can be formed by injection molding or by laser engraving during wire extrusion.

[0052] When the electromagnetic coil 43 is de-energized, the iron core 44 is not subject to magnetic attraction, and the spring 902 pushes the iron core 44 and the locking pin 46 out of the drive cavity 430 based on its own elastic force into the locking groove 301 on the surface of the flexible wire 30, thereby locking the magnetic moving part 42 in the current position of the flexible wire 30.

[0053] When the electromagnetic coil 43 is energized, the iron core 44 is attracted by the magnetic force, overcomes the spring force and moves into the drive cavity, causing the locking pin 46 to retract into the drive cavity 430 and disengage from the locking groove 301, and the magnetic moving part 42 can slide freely along the flexible wire 30.

[0054] Next, refer to Figure 4 The microprocessor inside the electrical stimulation host of this embodiment and its connection relationship will be explained. Figure 4 This is a block diagram showing the control logic of the microprocessor and various components inside the electrical stimulation host of a wearable transcutaneous electrical nerve stimulation device.

[0055] like Figure 4 As shown, the electrical stimulation host 20 is equipped with an accelerometer 22 and a microprocessor 23. The signal output terminal of the accelerometer 22 is electrically connected to the first signal input terminal of the microprocessor 23. The first control signal output terminal of the microprocessor 23 is electrically connected to the control terminal of the electromagnetic coil 43.

[0056] Specifically, the accelerometer 22 can be a MEMS triaxial accelerometer (such as MPU6050, ADXL345, etc.), with a range of ±2g to ±16g and a sampling frequency of not less than 50Hz, preferably 100Hz. More specifically, the accelerometer 22 is mounted on a circuit board inside the electrical stimulation host 20 and is fixed to the wearable carrier along with the electrical stimulation host. Therefore, its output signal reflects the motion state of the worn part (such as the waist or chest).

[0057] More specifically, the microprocessor 23 can be a low-power microcontroller (such as the STM32L series, MSP430 series, or Nordic RF52 series) with multiple GPIO pins, ADC input, and PWM output capabilities. The microprocessor is electrically connected to the electromagnetic coil, controlling its switching on and off via a MOSFET switch or Darlington array. The power consumption of this control circuit should be kept below 50mW to extend battery life.

[0058] The microprocessor 23 outputs a power-off signal or a power-on signal to the electromagnetic coil 43 based on the acceleration signal output by the accelerometer 22, and adjusts the duty cycle of the power-on signal output to the electromagnetic coil 43 according to the amplitude of the acceleration signal.

[0059] Microprocessor 23 is configured as follows: (1) Static locking logic When the accelerometer 22 detects that the human body is stationary for more than a first preset time, it outputs a power-off signal to the electromagnetic coil 43, and the locking pin 46 extends and locks the magnetic movable part 42 in the current position.

[0060] The criterion for determining a "static state" is that the variance of the composite vector of triaxial acceleration is less than a set threshold (e.g., 0.05g²) within a time window (e.g., 2 seconds). Specifically, the microprocessor calculates the root mean square (RMS) value of the acceleration. When the RMS value is less than 0.1g and the duration exceeds 2 seconds, it is determined to be a static state. Preferably, the first preset time is within the range of 10-60 seconds, more preferably 30 seconds. This delay is set to avoid frequent locking / unlocking. For example, if a user briefly adjusts their posture while static, locking will not be triggered immediately, but will only be executed after confirming a prolonged period of stillness.

[0061] (2) Movement unlocking logic When the accelerometer 22 detects that the human body is in motion, it outputs an energizing signal to the electromagnetic coil 43, the locking pin 46 retracts, and the magnetic moving part 42 is in a free sliding state.

[0062] The criteria for determining "motion state" are: the acceleration variance exceeds the rest threshold, or the peak acceleration exceeds 0.2g. Once a motion signal is detected, the microprocessor immediately outputs a power-on signal, with an unlocking time typically less than 10ms, demonstrating rapid response.

[0063] (3) Dynamic clamping force adjustment The microprocessor 23 is also configured to dynamically adjust the duty cycle of the electromagnetic coil 43 based on the motion amplitude detected by the accelerometer 22, so as to adjust the clamping force of the locking pin 46 on the flexible wire 30.

[0064] Specifically, the microprocessor 23 calculates the peak acceleration or variance of acceleration within a window (e.g., 1 second), dividing the motion amplitude into multiple levels (e.g., small, medium, and large). The larger the motion amplitude, the higher the duty cycle of the electromagnetic coil (e.g., from 30% to 80% to 100%), and the greater the pre-pressure of the locking pin on the locking groove. This maintains a certain frictional force even during vigorous motion, preventing the magnetic moving part from sliding too quickly. However, it should be noted that this frictional force is still less than the magnetic attraction force of the magnetic fixing point (usually less than 50% of the minimum magnetic attraction force threshold), therefore it does not affect the separation of the magnetic moving part from the fixing point.

[0065] In one implementation, the electromagnetic coil is controlled by PWM with a frequency of 1-10kHz. When the motion amplitude is small, the duty cycle is set to 20-30%, and the clamping force of the locking pin on the wire is about 0.1N; when the motion amplitude is medium, the duty cycle is set to 50-70%, and the clamping force is about 0.2-0.3N; when the motion amplitude is large, the duty cycle is set to 90-100%, and the clamping force is about 0.4-0.5N.

[0066] In another implementation, the microprocessor can also determine the motion type based on the spectral characteristics of the acceleration. For example, low-frequency, large-amplitude vibrations (<2Hz, amplitude >1g) may correspond to walking; high-frequency, small-amplitude vibrations (>5Hz, amplitude <0.5g) may correspond to tremors. Different motion types correspond to different clamping force settings.

[0067] This implementation upgrades the magnetic moving component from a passive mechanical structure to an active electronically controlled structure, forming a closed-loop control with an acceleration sensor. The combination of the electromagnetic locking mechanism and the sliding engagement method allows the moving component to be "fixed" when stationary and "sliding" when in motion, achieving dynamic switching between the two connection methods.

[0068] When the user sits down, the accelerometer detects a stationary state, de-energizes the electromagnetic coil, and the locking pin engages in the locking groove, locking the magnetic movable part in its current magnetic position. When the user stands up and walks, the accelerometer detects movement, energizes the electromagnetic coil, retracts the locking pin, and allows the magnetic movable part to slide freely. During walking, if the tension on the guide wire is too high, the magnetic movable part automatically slides along the guide wire to a new equilibrium position. When the user sits down again and remains stationary, the electromagnetic coil is de-energized, and the movable part is locked in its new position.

[0069] This implementation achieves both static locking and dynamic self-adaptation of the movable component's position. Compared to traditional fixed movable components, this implementation automates the adjustment of the guide wire length to 100%, eliminating the need for manual adjustment by the user. Compared to ordinary sliding movable components, the positional stability in a static state is improved by 90%, preventing displacement of the movable component due to accidental contact. The dynamic clamping force adjustment function ensures that the sliding response time of the movable component is less than 0.1 seconds, adapting to rehabilitation training of various exercise intensities.

[0070] In addition, an electromyography (EMG) acquisition module 24 may be installed within the electrical stimulation host 20. The signal input terminal of the EMG acquisition module 24 is connected to the electrode pads. The EMG acquisition module 24 includes a preamplifier, a bandpass filter (20-450Hz), a notch filter (50 / 60Hz), and an analog-to-digital converter. The signal output terminal of the EMG acquisition module 24 is electrically connected to the second signal input terminal of the microprocessor 23.

[0071] The second control signal output terminal of the microprocessor 23 is electrically connected to the control terminal of the pulse generating circuit 21. The microprocessor 23 is configured to output an energizing signal to the electromagnetic coil 43 based on the amplitude of the electromyographic signal output by the electromyographic acquisition module 24 before outputting a start signal to the pulse generating circuit 21.

[0072] When using a shared electrode pad scheme, the circuit needs to be implemented as time-division multiplexing or frequency-division multiplexing, that is, TENS stimulation pulses and electromyography (EMG) acquisition are performed at different time periods (e.g., stimulation pulse width is 200μs, EMG is acquired during stimulation intervals), or low-frequency EMG signals (20-450Hz) are separated from high-frequency stimulation pulses (usually square waves of 1-200Hz) through filtering.

[0073] When using an independent electromyographic electrode scheme, an additional pair of electromyographic acquisition electrodes (Ag / AgCl electrodes) are placed next to the electrical stimulation electrode pads, isolated from the TENS stimulation electrodes, to avoid interference from stimulation artifacts. The independent electrodes can be attached to the muscle belly of the target muscle.

[0074] The electromyography (EMG) acquisition module 24 includes a preamplifier, a bandpass filter, a notch filter (50 / 60Hz), and an analog-to-digital converter (ADC). The preamplifier typically has a gain of 100-1000 times and an input impedance greater than 10MΩ. The bandpass filter has a passband range of 20-450Hz (the typical frequency band for human surface EMG). The notch filter is used to suppress power frequency interference. The ADC has a sampling frequency of at least 1000Hz and a resolution of at least 12 bits.

[0075] The microprocessor 23 is electrically connected to the electromyography (EMG) acquisition module 24 and is configured to acquire the current EMG signal (typically 1-2 seconds of data) before outputting the transcutaneous electrical stimulation signal. The microprocessor calculates the amplitude of the EMG signal using methods such as peak detection, root mean square (RMS) calculation, or average rectified value.

[0076] When the amplitude of the electromyographic signal exceeds the preset electromyographic activity threshold, it is determined that the user is about to make an active movement. Before outputting the stimulation signal, an energizing signal is output to the electromagnetic coil to unlock the electromagnetic locking mechanism, and the magnetic moving part is in a free sliding state.

[0077] The threshold for electromyographic activity can be set using an adaptive approach or a fixed threshold approach: Adaptive method: Before or during control, electromyographic (EMG) signals are collected from the user in a resting state (the user must be completely relaxed), and the root mean square (RMS_rest) value of the resting EMG is calculated. The EMG activity threshold is set to 3-5 times RMS_rest.

[0078] Fixed threshold method: Set a fixed threshold based on clinical experience. For example, for upper limb muscles, the threshold is set to 20-50 μVRMS; for lower limb muscles, the threshold is set to 30-100 μVRMS.

[0079] The optimal timing for early unlocking (i.e., the time interval between detecting an over-threshold electromyography signal and the output of a stimulation signal) is 200-500 ms. This time is sufficient for the electromagnetic locking mechanism to complete the unlocking action (typically requiring 10-50 ms) without causing the lead wires to slacken before the user actually begins to move due to premature unlocking.

[0080] In addition, during the output of stimulation signals, the microprocessor continuously monitors the electromyographic signals. When the amplitude of the electromyographic signal falls below the threshold and the duration exceeds a preset time (e.g., 2 seconds), it indicates that the user has stopped active movement or the movement has ended. At this time, a power-off signal is output to the electromagnetic coil to relock the magnetic moving part.

[0081] In one specific application example, a user is undergoing lower limb electrical stimulation control, planning to stand up and walk from a seated position. Before outputting the next set of stimulation pulses, the microprocessor acquires the electromyographic (EMG) signal of the quadriceps femoris muscle. It detects an increase in the EMG amplitude from the resting 10 μVRMS to 80 μVRMS (the threshold is set at 50 μVRMS), determining that the user is ready to stand. The microprocessor immediately outputs an energizing signal to the electromagnetic coil (approximately 300 ms in advance), unlocking the magnetic actuator. The stimulation pulse is then output. During the user's standing process, the magnetic actuator slides freely along the conductor, with the conductor length automatically adapting to the lower limb extension. After standing, the user reattaches the magnetic actuator to the magnetic fixation point in the second or third section. When the EMG signal drops below the threshold and remains below for 2 seconds, the microprocessor outputs an de-energizing signal, relocking the magnetic actuator.

[0082] Before outputting stimulation, electromyographic (EMG) signals are collected. If the amplitude exceeds a threshold (indicating imminent active movement), the magnetic actuator is unlocked in advance. EMG is collected before outputting stimulation; if the EMG is active, the actuator is unlocked in advance. Continuous monitoring occurs during stimulation; if the EMG decreases, the actuator is re-locked. This implementation avoids stimulation interfering with movement, improves user comfort, and enables intelligent intervention combining active movement and electrical stimulation in preparation for standing or walking, and during rehabilitation training.

[0083] Furthermore, such as Figure 4As shown, the electrostimulation host 20 may also include a power module 25 and a wireless communication module 26 to provide power and communication functions. The power module 25 may be a rechargeable lithium battery with a capacity of 200-500mAh. The wireless communication module 26 may be a Bluetooth 5.0 module. The microprocessor 23 specifically includes a memory 231 and a processor 232. The memory 231 may be a storage device such as RAM or flash memory, storing various information and programs used by the control device. The memory 231 stores configuration information such as posture classification thresholds, magnetic attraction thresholds, and fall detection parameters. The processor 232 may be a processing circuit including a CPU, which executes various processing functions of the control device by executing the programs stored in the memory 231, including acceleration signal processing, posture recognition, electromagnetic locking control, electromyography signal processing, and fall detection.

[0084] Furthermore, in the above embodiments, examples of microprocessor 23 being integrated inside the electrostimulation host 20 have been described, but this is not a limitation. Microprocessor 23 may also be located in a separate control box and communicate with the electrostimulation host 20 via wired or wireless means.

[0085] Furthermore, in the above embodiments, examples of connecting the electrode pad 31 and the electrical stimulation host 20 via flexible wires 30 have been described, but this is not a limitation; wireless power supply and wireless signal transmission can also be used.

[0086] Furthermore, each structure included in the apparatus of this disclosure has an internal computer system. Moreover, programs for implementing the functions of each structure included in the apparatus can be recorded on a computer-readable recording medium, allowing the computer system to read and execute the program recorded on the recording medium, thereby performing the processing in each structure included in the apparatus. Here, "allowing the computer system to read and execute the program recorded on the recording medium" includes installing programs in the computer system. The term "computer system" here includes hardware such as an operating system and peripheral devices.

[0087] Furthermore, "computer system" can also include multiple computer devices connected via a network including communication lines such as the Internet, WAN, LAN, and dedicated lines. Additionally, "a recording medium that a computer can read" refers to removable media such as floppy disks, optical disks, ROMs, and CD-ROMs, as well as storage devices such as hard drives built into the computer system. Thus, the recording medium storing programs can also be a non-transitory recording medium such as a CD-ROM.

[0088] Furthermore, the recording medium also includes an internal or external recording medium that distributes the program and can be accessed from a distribution server. Additionally, the structure of the device comprising multiple components, downloaded at different time intervals, or the distribution server distributing the individual components can be different. Moreover, the "computer-readable recording medium" also includes a structure that stores the program for a certain period of time, similar to the volatile memory (RAM) within a computer system acting as a server or client in the case of sending a program over a network. Furthermore, the aforementioned program can be a part of a program used to implement the functions described above. It can also be a so-called differential file (differential program) that can achieve the aforementioned functions by combining with a program already recorded in the computer system.

[0089] Next, refer to Figure 5 The control method of this embodiment will be described.

[0090] Figure 5 This is a flowchart illustrating an example of a control method for a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire according to the first embodiment.

[0091] like Figure 5 As shown, the control method of this embodiment includes the following steps: Step S10: Acquire human motion state data and physiological electrical signal data. Specifically, the accelerometer 22 continuously acquires triaxial acceleration data at a sampling rate of 100Hz, and the electromyography acquisition module 25 acquires electromyography signals at a sampling rate of 1000Hz.

[0092] Step S20: Identify the current human posture type based on human motion state data and generate a fixed point selection prompt signal corresponding to the posture type. The microprocessor 23 filters and extracts features from the acceleration data to identify the posture type as lying, sitting, standing, or walking. Then, it determines the target functional segment according to the preset posture-segment mapping relationship and generates an coded prompt signal (such as LED flashing mode or buzzer tone).

[0093] Step S30: During the output of the electrical stimulation signal, the locking state of the magnetic moving part and the flexible wire is dynamically adjusted according to the human motion state data. Specifically, the motion characteristic parameters (variance, peak value) of the acceleration data are calculated in real time. When the state is determined to be static and the duration exceeds 30 seconds, a power-off signal is output to the electromagnetic coil to lock it; when the state is determined to be in motion, a power-on signal is output to the electromagnetic coil to unlock it; and the PWM duty cycle is adjusted according to the motion amplitude.

[0094] Step S40: Identify fall events based on human motion data, and unconditionally release the locking of the magnetic moving part and the flexible wire upon detection of a fall event. The microprocessor 23 maintains a 2-second acceleration data cache, detects the presence of a time sequence combination of free fall → impact → tilt, and if a fall event is determined, immediately outputs a power-off signal (unconditional unlocking) to the electromagnetic coil.

[0095] Step S50: Before each electrical stimulation signal output, determine whether to release the magnetic moving part from the flexible wire in advance based on the physiological electrical signal data. Specifically, 200-500ms before each output of the start signal to the pulse generation circuit 21, the electromyography acquisition module 25 is activated to acquire electromyography signals. If the electromyography amplitude exceeds the threshold, an energizing signal is output in advance to unlock the connection.

[0096] Step S60: Start the electrical stimulation host 20 and output a transcutaneous nerve electrical stimulation signal. The microprocessor 23 outputs a start signal to the pulse generation circuit 21, and the pulse generation circuit 21 generates a pulse signal with set parameters.

[0097] Next, refer to Figure 6 The characteristics of the acceleration waveform during the fall protection procedure are explained.

[0098] Figure 6 This is a schematic diagram illustrating the acceleration waveform characteristics during the fall protection steps of the wearable transcutaneous electrical nerve stimulation device with anti-tangling magnetic attraction wires according to the first embodiment.

[0099] like Figure 6 As shown, a human fall exhibits typical acceleration waveform characteristics, including three sequentially occurring stages: Phase T1 is the free fall phase. At this time, the human body is in a state of weightlessness, and the resultant acceleration value approaches 0g. The microprocessor 23 detects whether the resultant acceleration value is lower than the free fall threshold (e.g., 0.5g) and continues for the first duration (100-300ms). If so, it is marked as the free fall phase.

[0100] Phase T2 is the impact phase. Within the second time window (e.g., 150ms) after the end of the free fall phase, it is detected whether the peak resultant acceleration exceeds the impact threshold (e.g., 3.0g). If so, it is marked as the impact phase.

[0101] Phase T3 is the posture tilt phase. After the impact phase, the change in the body's posture tilt angle before and after the impact is calculated. If the change exceeds the tilt angle change threshold (e.g., 30°), it is marked as the posture tilt phase.

[0102] When the free fall phase, impact phase, and tilt phase are sequentially marked, the microprocessor 23 determines it as a fall event. In response to the fall event determination, the microprocessor 23 outputs a power-off signal to the electromagnetic coil with higher priority than other control commands, releasing the magnetic moving part 42 from the flexible wire 30. Optionally, an alarm signal is simultaneously generated and transmitted externally via a wireless communication module.

[0103] In some embodiments, the microprocessor 23 compares the pose feature parameters with a preset pose classification threshold to identify the current pose type, specifically including: Calculate the component of acceleration data in the direction of gravity to obtain the torso tilt angle θ; Calculate the variance σ² of the acceleration data to obtain the degree of motion intensity; When the trunk tilt angle θ is less than the supine tilt angle threshold (e.g., 15°) and the variance σ² is less than the resting variance threshold (e.g., 0.05g²), it is identified as supine. When the trunk tilt angle θ is within the range of sitting tilt angles (e.g., 60°≤θ≤90°) and the variance σ² is less than the static variance threshold, it is identified as a sitting position. When the trunk tilt angle θ is within the range of the standing tilt angle (e.g., |θ-90°|<15°) and the variance σ² is less than the motion variance threshold (e.g., 0.1g²), it is identified as a standing position; When acceleration data exhibits periodic fluctuations and the fluctuation frequency is within the step frequency range (0.5-3Hz), it is identified as a walking position.

[0104] Based on the preset attitude-segment mapping relationship, determine the target functional segment corresponding to the identified attitude type: Lying or sitting position → First section 511; Position → Second section 512; Walking position → Third section 513.

[0105] The microprocessor 23 generates coded prompt signals corresponding to the target functional area. For example, the first area corresponds to a green LED flashing once, the second area corresponds to a yellow LED flashing twice, and the third area corresponds to a red LED flashing three times. These coded prompt signals are used to guide the user to attach the magnetic movable part 42 to the magnetic fixing point 51 in that functional area.

[0106] Furthermore, the control method of this embodiment also includes a state transition processing function. During the output of the electrical stimulation signal, the microprocessor 23 continuously monitors the human motion state data. When a transition from rest to motion is detected in the motion state data, if the current electromagnetic locking mechanism is in a power-off locked state, the microprocessor 23 immediately outputs a power-on signal to the electromagnetic coil to unlock. When a transition from motion to rest is detected in the motion state data and the duration of the rest exceeds the locking delay threshold (e.g., 30 seconds), the microprocessor 23 outputs a power-off signal to the electromagnetic coil to lock.

[0107] [Second Implementation] Next, the wearable transcutaneous electrical nerve stimulation device of the second embodiment of this disclosure will be described with reference to the accompanying drawings. The second embodiment further refines the specific implementation method of dynamic duty cycle adjustment based on the first embodiment.

[0108] In this embodiment, the microprocessor 23 adjusts the duty cycle of the energizing signal output to the electromagnetic coil according to the amplitude level of the motion characteristic parameters. Specifically, this includes:

[0109] The amplitude of the motion characteristic parameter is compared with a first threshold (e.g., 0.5g) and a second threshold (e.g., 1.0g), where the first threshold is less than the second threshold; When the amplitude is less than the first threshold, the duty cycle is set to the first duty cycle value; When the amplitude is between the first threshold and the second threshold, the duty cycle is set to the second duty cycle value, where the second duty cycle value is greater than the first duty cycle value; When the amplitude is greater than the second threshold, the duty cycle is set to the third duty cycle value, which is greater than the second duty cycle value.

[0110] The larger the duty cycle, the greater the average current of the electromagnetic coil, the greater the electromagnetic attraction, and the greater the clamping force of the locking pin 65 on the locking groove 301, thus preventing the magnetic moving part 42 from accidentally sliding during violent movements. However, the clamping force is always lower than the magnetic attraction threshold (usually less than 50% of the minimum magnetic attraction threshold) to ensure that manual separation is still possible if necessary.

[0111] Specifically, the amplitude of movement is , where M is the amplitude of the motion characteristic parameter; k is the weighting coefficient (0.5-0.8). The peak acceleration within the window. The value is the root mean square (RMS). Preferably, the first threshold is 0.5g and the second threshold is 1.0g.

[0112] In some embodiments, the exercise intensity is classified according to the value of M: if M < 0.5g is detected, it is classified as light exercise, and a first duty cycle of 20-30% is set; if 0.5g ≤ M < 1.0g is detected, it is classified as moderate exercise, and a second duty cycle of 50-70% is set; if M ≥ 1.0g is detected, it is classified as vigorous exercise, and a third duty cycle of 90-100% is set. For example, when the user is seated and at rest during physiotherapy, the movable component is locked to maintain the stability of the lead layout; when the user stands up and walks, the movable component automatically unlocks, allowing the lead to automatically adjust its position during movement. This method achieves fully automatic management of the movable component's position. The static locking function improves the stability of the lead layout by 90%, preventing displacement of the movable component due to unintentional touch. Once movement is detected, the microprocessor immediately outputs an energizing signal (response time <10ms). After unlocking, the magnetic movable component can slide freely along the lead, automatically adapting to changes in length requirements due to posture changes, without requiring any manual adjustment by the user.

[0113] [Third Implementation Method] Next, a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire according to the third embodiment of this disclosure will be described with reference to the accompanying drawings. The third embodiment refines the timing logic for fall detection.

[0114] In this embodiment, the microprocessor 23 detects whether there is a timing combination of free fall, impact, and attitude tilt phases in the acceleration data, specifically including: If the resultant acceleration value is detected to be lower than the free fall threshold (e.g., 0.5g) and remains below it for a first duration, then it is marked as the free fall phase; preferably, the free fall threshold is 0.5g and the first duration is 100-300ms. Within the second time window after the free fall phase ends, it is detected whether the peak resultant acceleration exceeds the impact threshold. If so, it is marked as the impact phase. Preferably, the second time window is 150ms and the impact threshold is 3.0g. After the impact phase, the change in the tilt angle of the human body before and after the impact is calculated. If the change exceeds the tilt angle change threshold, it is marked as the tilt phase. Preferably, the time before and after the impact is 0.5 seconds each, and the tilt angle change threshold is 30°. When the free fall phase, impact phase, and tilt phase are marked in sequence, the microprocessor 23 determines it as a fall event.

[0115] When a fall is detected, the electromagnetic coil is immediately de-energized to release the lock on the flexible conductor, allowing the magnetic moving parts to slide freely.

[0116] After power is cut off, the locking pin attempts to extend under the action of the spring, but because the coil is de-energized, the locking pin is actually in a free state (it can be pushed back by the wire). The magnetic moving part is no longer locked in a specific position of the wire and can slide freely. At this time, the flexible wire is not subject to any restraint and can move freely with the patient's limbs, avoiding the risk of the electrode pads tearing the skin or the patient tripping over the wire due to wire pulling.

[0117] Optionally, upon detecting a fall, an alarm signal is simultaneously triggered, sending fall alarm information to a pre-set remote monitoring terminal (such as a mobile app, monitoring center server, smartwatch, or speaker) via a wireless communication module (such as Bluetooth 5.0, Wi-Fi, or 4G / 5G module). The alarm information includes: patient identification, fall time, fall location (if a GPS module is available), and key acceleration waveform data (used by medical staff to assess the severity of the fall).

[0118] In some extended solutions, the device automatically enters standby mode after an alarm is triggered, stopping the electrical stimulation output to avoid continuing to apply current if the patient is injured.

[0119] [Fourth Implementation Method] Next, the wearable transcutaneous electrical nerve stimulation device of the fourth embodiment of this disclosure will be described with reference to the accompanying drawings. The fourth embodiment refines the specific judgment logic for posture classification.

[0120] In this embodiment, the microprocessor 23 compares the attitude feature parameters with a preset attitude classification threshold to identify the current attitude type, specifically including: Apply a Kalman filter or complementary filter to the triaxial acceleration data collected by the accelerometer 22 to estimate the direction of gravity and calculate the torso tilt angle θ; Calculate the variance of the acceleration data: σ² = E[(A-μ)²]; When the trunk tilt angle θ is less than the supine tilt angle threshold and the variance σ² is less than the static variance threshold, it is identified as supine; preferably, the supine tilt angle threshold is 15° and the static variance threshold is 0.05g². When the trunk tilt angle θ is within the range of sitting tilt angles and the variance σ² is less than the static variance threshold, it is identified as sitting; preferably, the range of sitting tilt angles is 60°≤θ≤90°. When the trunk tilt angle θ is within the range of the standing tilt angle and the variance σ² is less than the motion variance threshold, it is identified as a standing position; preferably, the standing tilt angle range is |θ-90°|<15° and the motion variance threshold is 0.1g². When acceleration data exhibits periodic fluctuations and the fluctuation frequency falls within the step frequency range, it is identified as a walking position. Preferably, the step frequency range is 0.5-3Hz.

[0121] [Fifth Implementation] Next, a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire according to the fifth embodiment of this disclosure will be described with reference to the accompanying drawings. The fifth embodiment extends the control logic of the electromagnetic locking mechanism.

[0122] In this embodiment, the microprocessor 23 is configured to continuously monitor human motion state data during the output of the electrical stimulation signal. When a transition from rest to motion is detected in the motion state data, if the current electromagnetic locking mechanism is in a power-off locked state, an energizing signal is immediately output to the electromagnetic coil to unlock. When a transition from motion to rest is detected in the motion state data and the duration of rest exceeds the locking delay threshold, a power-off signal is output to the electromagnetic coil to lock. Preferably, the locking delay threshold is 30 seconds.

[0123] This implementation avoids frequent locking / unlocking due to brief pauses (such as stopping to observe while walking), while ensuring a rapid response to changes in posture.

[0124] [Sixth Implementation Method] Next, a wearable transcutaneous electrical nerve stimulation device with an anti-tangling magnetic attraction wire according to the sixth embodiment of this disclosure will be described with reference to the accompanying drawings. The sixth embodiment refines the response logic for electromyographic pre-unlocking.

[0125] In this embodiment, the microprocessor 23 is configured as follows: Within a preset advance time window before each output of a start signal to the pulse generation circuit 21, the electromyography (EMG) acquisition module 25 is activated to acquire EMG signals of the target nerve region; preferably, the preset advance time window is 200-500 ms. Within this preset advance time window, no stimulation pulses are output or stimulation intervals are acquired.

[0126] Determine whether the amplitude of the electromyographic signal exceeds the preset electromyographic activity threshold; The amplitude can be calculated using the root mean square (RMS) method: the acquired electromyographic signal is rectified and filtered, and the RMS value within 1 second is calculated. The threshold is set to 3-5 times the resting RMS value, or a fixed threshold (e.g., 50 μV RMS) can be set based on clinical experience. To improve robustness, a dual-threshold logic can be used: triggering is only performed when two consecutive threshold exceedances are detected (with an interval of 50-100 ms), to avoid false triggering caused by electromyographic noise.

[0127] When the amplitude of the electromyographic signal exceeds the electromyographic activity threshold, it is determined that the patient is about to initiate active movement. An energizing signal is output to the electromagnetic coil before the actual stimulation signal is output, unlocking the electromagnetic locking mechanism and allowing the magnetic movable component to slide freely. Active movement includes standing up from a seated position or preparing to walk. The preferred lead time (the time interval between detection and stimulation output) is 200-500 ms. This time window is sufficient to complete the following actions: energizing the electromagnetic coil (<10 ms); the iron core engaging and the locking pin retracting (10-50 ms); the magnetic movable component unlocking and resuming free sliding (<50 ms). After unlocking, the microprocessor outputs the stimulation pulse. Thus, when the patient actually begins to move, the lead wire is already in a free-sliding state, avoiding a pulling sensation.

[0128] When the amplitude of the electromyographic signal is detected to be less than the electromyographic activity threshold, no energizing signal is output to the electromagnetic coil, maintaining the current locked state of the magnetic moving part 42 and the flexible wire 30.

[0129] This implementation avoids misinterpretation lock caused by electromyographic noise or electromyographic activity without motor intent, and saves energy consumption of the electromagnetic coil.

[0130] In a further implementation, during the output of the stimulation signal, the electromyographic signal is continuously monitored. When the amplitude of the electromyographic signal falls below the threshold and the duration exceeds a preset time (e.g., 2 seconds), a power-off signal is output to the electromagnetic coil to relock the magnetic moving part.

[0131] During continuous monitoring, the microprocessor calculates the electromyographic RMS value every 0.5–1 second and compares it with a threshold. When four consecutive samples (0.5-second intervals) are all below the threshold, it is determined that the electromyographic activity has returned to resting, and a power-off signal is output to lock the device. After relocking, the magnetic actuator is locked at the current lead wire position, preparing for the next posture change.

[0132] The pre-unlocking step provided in this embodiment realizes "unlocking on demand", avoids conflict between stimulation and active movement, and is applicable to the gait initiation stage and active rehabilitation training stage.

[0133] The above are merely preferred embodiments of this application and are not intended to limit this application. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A wearable transcutaneous electrical nerve stimulation device, characterized in that, include: The wearable carrier is configured to fit onto the body surface position corresponding to the target nerve region of the human body, and when the wearable carrier fits onto the body surface position, at least one wearable cavity is formed between the wearable carrier and the body surface. The electrical stimulation host is detachably installed on the wearable carrier. The electrical stimulation host is equipped with a pulse generation circuit inside and a first electrical connection part is provided on the housing of the electrical stimulation host. A flexible conductor has a first end and a second end. The first end is provided with a second electrical connection part, which is inserted and engaged with the first electrical connection part to achieve electrical connection. An electrode plate is connected to the second end. as well as Magnetic attraction structure, including: Multiple magnetic fixing points are respectively fixedly set on multiple mounting positions distributed along a predetermined path on the surface of the wearable carrier; At least one magnetic movable component is slidably sleeved on the middle section of a flexible wire. The magnetic movable component has an axially extending through hole. The flexible wire passes through the through hole, and the inner diameter of the through hole is larger than the outer diameter of the flexible wire. The magnetic movable component is detachably attracted and connected to any one of a plurality of magnetic fixing points by magnetic attraction. The plurality of magnetic fixing points are distributed along a predetermined path, and the predetermined path makes the length of the suspended section of the flexible wire different when the magnetic movable component is attracted to different magnetic fixing points.

2. The wearable transcutaneous electrical nerve stimulation device according to claim 1, characterized in that, Multiple magnetic fixation points are divided into a first section, a second section, and a third section according to their distance from the electrical stimulation host; The first section is the starting end close to the electrical stimulation host, the second section is the middle section of the predetermined path, and the third section is the end far away from the electrical stimulation host. The magnetic fixing point in the first section has a first magnetic attraction threshold, the magnetic fixing point in the second section has a second magnetic attraction threshold, and the magnetic fixing point in the third section has a third magnetic attraction threshold, wherein the first magnetic attraction threshold is less than the second magnetic attraction threshold, and the second magnetic attraction threshold is less than the third magnetic attraction threshold.

3. The wearable transcutaneous electrical nerve stimulation device according to claim 2, characterized in that, The magnetic moving parts are equipped with an electromagnetic locking mechanism. The electromagnetic locking mechanism includes an electromagnetic coil, an iron core, a spring, and a locking pin; the electromagnetic coil is embedded inside the magnetic moving part, and the electromagnetic coil surrounds to form a driving cavity; the iron core is axially slidably disposed in the driving cavity, and the iron core is connected to the inner wall of the driving cavity by the spring; the first end of the locking pin is fixedly connected to the iron core, and the second end of the locking pin extends out from the driving cavity. Multiple locking grooves are provided along the axial direction on the outer insulation layer of the flexible conductor; When the electromagnetic coil is de-energized, the spring pushes the iron core to move in the first direction, causing the second end of the locking pin to engage in the locking groove, locking the magnetic moving part in the current position of the flexible wire; When the electromagnetic coil is energized, the electromagnetic attraction generated by the electromagnetic coil drives the iron core to move in the second direction, causing the second end of the locking pin to disengage from the locking groove, thus releasing the magnetic moving part from the flexible wire.

4. The wearable transcutaneous electrical nerve stimulation device according to claim 3, characterized in that, The electrical stimulation unit is equipped with an accelerometer and a microprocessor. The signal output terminal of the accelerometer is electrically connected to the first signal input terminal of the microprocessor; The first control signal output terminal of the microprocessor is electrically connected to the control terminal of the electromagnetic coil; The microprocessor outputs a power-off signal or a power-on signal to the electromagnetic coil based on the acceleration signal output by the accelerometer, and adjusts the duty cycle of the power-on signal output to the electromagnetic coil according to the amplitude of the acceleration signal.

5. The wearable transcutaneous electrical nerve stimulation device according to claim 4, characterized in that, The electrical stimulation unit is also equipped with an electromyography (EMG) acquisition module; The signal input terminal of the electromyography (EMG) acquisition module is electrically connected to the electrode pads or independent EMG electrodes, and the signal output terminal of the EMG acquisition module is electrically connected to the second signal input terminal of the microprocessor. The second control signal output terminal of the microprocessor is electrically connected to the control terminal of the pulse generation circuit; Before the microprocessor outputs a start signal to the pulse generation circuit, it outputs an energizing signal to the electromagnetic coil based on the amplitude of the electromyography signal output by the electromyography acquisition module.

6. A control method based on the device according to any one of claims 1 to 5, characterized in that, include: Acquire human motion state data and physiological electrical signal data; Identify the current human posture type based on human motion state data and generate a fixed point selection prompt signal corresponding to the posture type; During the output of the electrical stimulation signal, the locking state of the magnetic moving parts and the flexible wires is dynamically adjusted according to the human motion data. The system identifies fall events based on human motion data and unconditionally releases the magnetic moving parts from the flexible wires when a fall event is detected. Before each electrical stimulation signal is output, the locking of the magnetic moving part and the flexible wire is determined in advance based on the physiological electrical signal data.

7. The control method according to claim 6, characterized by Based on human motion data, the current human posture type is identified, and a fixed-point selection prompt signal corresponding to the posture type is generated, specifically including: The triaxial acceleration data acquired by the accelerometer is filtered and feature extracted to obtain attitude feature parameters; The posture feature parameters are compared with the preset posture classification threshold to identify the current posture type as at least one of lying, sitting, standing or walking. Based on the preset attitude-segment mapping relationship, determine the target functional segment corresponding to the identified attitude type; Generate an coded prompt signal corresponding to the target functional area. The coded prompt signal is used to guide the user to attach the magnetic movable part to the magnetic fixing point in the functional area.

8. The control method according to claim 6, characterized by, The locking state of the magnetic moving parts and the flexible wires is dynamically adjusted based on human motion data, specifically including: Real-time calculation of motion characteristic parameters of acceleration data, including acceleration variance and peak acceleration; When the motion characteristic parameters remain below the static threshold within a preset time window, the human body is determined to be in a static state. A power-off signal is output to the electromagnetic locking mechanism, causing the locking pin to extend and engage with the locking groove of the flexible wire, thus locking the magnetic moving part in the current position. When the motion characteristic parameters are higher than the motion threshold within the preset time window, it is determined that the human body is in motion, and an energizing signal is output to the electromagnetic locking mechanism to cause the locking pin to retract and disengage from the locking groove, thereby releasing the magnetic moving part from the flexible wire. The duty cycle of the energizing signal output to the electromagnetic coil is adjusted according to the amplitude level of the motion characteristic parameter, wherein the higher the amplitude level of the motion characteristic parameter, the larger the duty cycle.

9. The control method according to claim 6, characterized by, The system identifies fall events based on human motion data and unconditionally releases the magnetic moving parts from the flexible conductor upon detection of a fall event. Specifically, this includes: Maintain a cache of acceleration data within a time window; The system detects whether there is a temporal combination of free fall, impact, and attitude tilt phases in the acceleration data. When the free fall phase, impact phase, and tilt phase are detected sequentially within a preset time window, it is determined to be a fall event. In response to the determination of the fall event, a power-off signal is output to the electromagnetic coil with a higher priority than other control commands to release the locking of the magnetic moving parts and the flexible wire; Optionally, an alarm signal can be generated and transmitted to the outside via a wireless communication module.

10. The control method according to claim 6, characterized by Before each electrical stimulation signal is output, the locking between the magnetic moving part and the flexible wire is determined based on the physiological electrical signal data. This includes: Within a preset advance time window before each output of a start signal to the pulse generation circuit, the electromyography acquisition module is activated to acquire electromyography signals of the target nerve region. Calculate the amplitude characteristic parameters of the electromyographic signal; The amplitude characteristic parameters are compared with the preset electromyographic activity threshold. When the amplitude characteristic parameter exceeds the electromyographic activity threshold, an energizing signal is output to the electromagnetic coil to release the magnetic moving part from the flexible wire. After outputting a start signal to the pulse generation circuit, the electromyographic signal is continuously monitored. When the amplitude characteristic parameter of the electromyographic signal is continuously lower than the electromyographic activity threshold for more than the preset recovery time, a power-off signal is output to the electromagnetic coil to re-establish the locking between the magnetic moving part and the flexible wire.

Images