Non-invasive spinal cord stimulator for upper limb motor function recovery

Abstract

The present invention relates to the technical field of neural stimulation, and specifically relates to a non-invasive spinal cord stimulator for upper limb motor function recovery, comprising a cervical spinal cord pulse control unit, an electrode connection unit, a motion monitoring unit, a wireless communication unit, a speech unit, a paradigm decision unit, an electrode array unit, and an artificial intelligence unit. In the present invention, the non-invasive spinal cord stimulator acts on a specific cervical spinal cord segment by means of non-invasive cervical spinal cord stimulation technology, inducing the reconstruction of a spinal cord neural network, strengthening synaptic connection, treating upper limb motor dysfunction of paralyzed individuals, and achieving upper limb motor function recovery.

Description

A non-invasive spinal cord nerve stimulator for upper limb motor function recovery Technical Field

[0001] This invention relates to the field of neurostimulation technology, specifically a non-invasive spinal cord nerve stimulator for the recovery of upper limb motor function. Background Technology

[0002] Spinal cord injury (SCI) refers to damage to the neural structures within the spinal canal (including the spinal cord, nerve roots, and cauda equina) caused by various factors, resulting in sensory, motor, reflex, and bowel and bladder dysfunction at or below the level of injury. Studies show that there are currently 3.74 million SCI patients in China, with approximately 90,000 new cases each year, of which cervical spinal cord injury accounts for 41.13%.

[0003] Spinal cord injury is extremely dangerous. If limb function rehabilitation is not effectively promoted, it can lead to life-threatening complications such as respiratory problems, pressure sores, urinary tract infections, and kidney failure. my country sees 90,000 new spinal cord injuries annually, with urinary tract complications being the most severe. 74% of patients experience urinary incontinence within three months, and each patient experiences an average of 10 urinary tract complications per year. Within five years of injury, the incidence of upper urinary tract injury increases rapidly, reaching 30 times that of the general population. Primary caregivers of spinal cord injury patients often bear a heavy physical, psychological, and financial burden, affecting their health and consequently reducing their quality of life.

[0004] Conventional treatment plans for spinal cord injury neurorepair mainly include surgical decompression at the injury site, nerve bridging, neuromodulation, and cell therapy. In specific applications of neuromodulation, epidural stimulation training can activate neural circuits, promote neural remodeling and functional recovery in patients with complete spinal cord injury, and improve trunk stability.

[0005] In summary, in order to enable more spinal cord injury patients to recover their corresponding motor functions, improve their quality of life, and alleviate the physical, psychological, and economic burdens on caregivers of spinal cord injuries, this invention designs a non-invasive spinal cord nerve stimulator for the recovery of upper limb motor function. Summary of the Invention

[0006] The purpose of this invention is to provide a non-invasive spinal cord nerve stimulator for the recovery of upper limb motor function, so as to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a non-invasive spinal cord nerve stimulator for upper limb motor function recovery, comprising a cervical spinal cord pulse control unit, an electrode connection unit, a motion monitoring unit, a wireless communication unit, a voice unit, a paradigm decision-making unit, an electrode array unit, and an artificial intelligence unit;

[0008] The cervical spinal cord pulse control unit is used to generate carrier-modulated stimulation electrical pulses in the C2-T1 segment of the cervical spinal cord. The pulses contact the body surface to produce a stimulation effect.

[0009] The electrode connection unit connects the individual pathway electrodes distributed in the cervical spinal cord segments to the cervical spinal cord pulse control unit;

[0010] The motion monitoring unit is attached to the corresponding movement part of the limb and provides real-time feedback on the movement of the wearing part through surface electromyography and inertial conduction.

[0011] The wireless communication unit is configured as a main radio frequency transceiver distributed in the cervical spinal cord pulse control unit and a slave radio frequency transceiver distributed in the motion monitoring unit. The main radio frequency transceiver supports information transmission and reception with external smart devices, and the slave radio frequency transceiver can perform self-organizing network applications, using the human body surface and torso as signal transmission medium paths to form a body area network, automatically selecting the unit with the optimal signal transmission and reception strength for signal merging and uploading and distributed information distribution.

[0012] The voice unit is used to control the parameters of the non-invasive spinal nerve stimulator via voice, making it easier for people with limited limb motor function to control the spinal nerve stimulator device independently.

[0013] Paradigm decision-making unit, a treatment prescription deployed in a non-invasive spinal nerve stimulator and artificial intelligence unit, is used to achieve adaptive selection of optimal stimulation parameters in the C2-T1 segment of the cervical spinal cord.

[0014] The electrode array unit consists of multi-channel electrodes distributed in the C2-T1 segment of the cervical spinal cord. The electrodes are equipped with imaging markers to effectively mark the damaged cervical spinal cord area during the initial electrode wearing and when adjusting the stimulation paradigm.

[0015] The artificial intelligence unit is configured as an AI application software program distributed on a smartphone. It is used to display the medical imaging data of the cervical spinal cord segment of the patient with cervical spinal cord injury and fuse it with the X-ray or fluorescence imaging markers in the electrode array unit. It automatically depicts the mapping relationship between the electrode channel worn by the human body and the cervical spinal cord segment, recommends the preferred stimulation parameters, and infers and predicts the optimal treatment paradigm that is suitable for the patient's disease outcome.

[0016] Compared with the prior art, the beneficial effects of the present invention are: by wearing a non-invasive stimulator on the body surface of the cervical spinal cord segment, a non-invasive, wearable application scheme can be used to perform pulse stimulation with specific parameters on specific damaged segments between C2 and T1 of the cervical spinal cord, thereby inducing the reconstruction of the spinal cord network, strengthening synaptic connections, and guiding the long-term recovery of limb motor function through neural plasticity. Attached Figure Description

[0017] Figure 1 is a block diagram of a non-invasive spinal cord nerve stimulator system for upper limb motor function recovery according to a specific embodiment of the present invention;

[0018] Figure 2-1 shows the front and rear views of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0019] Figure 2-2 is a view of the non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention after wearing;

[0020] Figures 2-3 are left-side views of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0021] Figure 3 is a matrix diagram of non-invasive spinal nerve stimulator combinations for upper limb motor function recovery according to a specific embodiment of the present invention.

[0022] Figure 4 is a schematic diagram of the dynamic stimulation dose of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0023] Figure 5-1 is a diagram illustrating the stimulation effect of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0024] Figure 5-2 is a diagram illustrating the stimulation effect of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0025] Figure 5-3 is a diagram illustrating the stimulation effect of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0026] Figure 5-4 is a diagram illustrating the stimulation effect of a non-invasive spinal nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0027] Figure 5-5 shows the stimulation effect of a non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to a specific embodiment of the present invention.

[0028] The system includes: a cervical spinal cord pulse control unit 10, an electrode connection unit 20, a motion monitoring unit 30, a wireless communication unit 40, a voice unit 50, a paradigm decision-making unit 60, an electrode array unit 70, and an artificial intelligence unit 80. Detailed Implementation

[0029] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0030] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0031] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0032] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0033] Please refer to Figures 1-2. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery includes a cervical spinal cord pulse control unit 10, an electrode connection unit 20, a motion monitoring unit 30, a wireless communication unit 40, a voice unit 50, a paradigm decision unit 60, an electrode array unit 70, and an artificial intelligence unit 80.

[0034] The cervical spinal cord pulse control unit 10 is used to generate carrier-modulated stimulation electrical pulses in the C2-T1 segment of the cervical spinal cord, and the pulses contact the body surface to produce a stimulation effect.

[0035] Electrode connection unit 20 connects multiple pathway electrodes distributed in the cervical spinal cord segment to cervical spinal cord pulse control unit 10;

[0036] The motion monitoring unit 30 is attached to the corresponding movement part of the limb and provides real-time feedback on the movement of the wearing part through surface electromyography and inertial conduction.

[0037] The wireless communication unit 40 is configured as a main radio frequency transceiver distributed in the cervical spinal pulse control unit 10 and a slave radio frequency transceiver distributed in the motion monitoring unit 30. The main radio frequency transceiver supports information transmission and reception with external smart devices, and the slave radio frequency transceiver can perform self-organizing network applications, using the human body surface and torso as signal transmission medium paths to form a body area network, automatically selecting the unit with the optimal signal transmission and reception strength for signal merging and uploading and distributed information distribution.

[0038] The voice unit 50 is used to control the parameters of the non-invasive spinal nerve stimulator via voice, which facilitates the self-control of the spinal nerve stimulator device by people with limited limb motor function.

[0039] Paradigm decision unit 60, a treatment prescription deployed in non-invasive spinal nerve stimulator and artificial intelligence unit 80, is used to achieve adaptive selection of optimal stimulation parameters in the C2-T1 segment of the cervical spinal cord.

[0040] Electrode array unit 70, a multi-channel electrode distributed in the C2-T1 segment of the cervical spinal cord, with imaging markers on the electrodes, which are used to effectively mark the damaged cervical spinal cord area when the electrodes are first worn and when the stimulation paradigm is adjusted.

[0041] Artificial intelligence unit 80 is configured as an artificial intelligence application software program distributed on a smartphone, which is used to display the medical imaging data of the cervical spinal cord segment of the patient with cervical spinal cord injury and fuse it with the X-ray or fluorescence imaging marks in the electrode array unit 70, and automatically depict the mapping relationship between the electrode channel worn by the human body and the cervical spinal cord segment.

[0042] In this embodiment of the invention, the stimulation pulse can be output synchronously or asynchronously through multiple channels. The time interval of the asynchronous output is controllable, and it produces stimulation effects with different stimulation depths, different stimulation intensities, and different stimulation activation volumes at the contact points with the body surface, as shown in the stimulation effect diagrams in Figures 5-1 to 5-5.

[0043] The electrode connection unit 20 is set with a flexible micro-mechanical snap-fit ​​connection, which is stable and reliable and eliminates the risk of detachment caused by shaking.

[0044] The connector supports the selection of 2-9 stimulation output pathways, and features both bedridden and daily non-bedridden modes. In bedridden mode, the flexible electrode connector unit can connect the spinal cord stimulator to the C2-T1 segment electrodes via physical leads. In daily non-bedridden mode, the spinal cord stimulator and stimulation electrodes are integrated through the electrode connector unit 20, and are fixed to the C2-T1 segments in a non-invasive manner on the body surface.

[0045] In one embodiment of the present invention, the motion monitoring unit 30 is configured as a flexible patch sensing device;

[0046] Among them, surface electromyography is used to capture the potential peak value, potential group delay, and effective width value of electromyographic signals of the moving muscle groups;

[0047] Inertial transmission is used to capture instantaneous burst acceleration and slow release acceleration of muscles, as well as the velocity, acceleration, and rotation angle of a limb changing from a resting state to a moving state, and the velocity, acceleration, and rotation angle of a limb changing from a moving state to a resting state.

[0048] By capturing the instantaneous burst acceleration of muscles through inertial conduction and fusing it with the potential peaks and potential group delays of muscle groups captured by surface electromyography, the micro-movement characteristics of human limbs can be accurately and reliably characterized.

[0049] As a preferred embodiment of the present invention, the voice unit 50 supports speaker-specific and speaker-independent speech recognition applications.

[0050] As a preferred embodiment of the present invention, as shown in Figures 3-4, the paradigm decision unit 60 combines the signal characteristics collected by the motion monitoring unit 30 and the interpretation and analysis of the cervical spinal cord injury site by the artificial intelligence unit 80 to select the optimal paradigm for outputting stimulation parameters, and has stimulation safety limit management. The stimulation strategy is a stimulation function:

[0051] F(nme,act,level,mul_nme)=S nme ×V act ×D nme ×Stim level ×ε mul_nme ×μ0×K

[0052] Among them, S nme V is the area of ​​action. act For the activation region (activation volume), D nme Stim is the spacing between the stimulation electrodes. level Let ε be the stimulus ranking function. mul_nme is the multi-electrode output function, μ0 is the stimulus adjustment factor, and K is the normalization compensation coefficient;

[0053] Stimulus Rating Function level (HV,I,F,PW,T,POL)=HV×F× ×T×POL;

[0054] Where HV is the high voltage coefficient, F is the stimulation frequency, PW is the pulse width, I is the current intensity, T is the pulse period, and POL is the waveform coefficient.

[0055] As a preferred embodiment of the present invention, the imaging marker is set to the form of X-ray or fluorescence. During operation, combined with the high specificity of the human cervical spinal cord segment, the optimal limb movement recovery effect is obtained with the minimum stimulation dose.

[0056] Each electrode can be used as a positive electrode, a negative electrode, or an open circuit, avoiding the need to repeatedly adjust the electrode position after wearing it on the human body.

[0057] In a preferred embodiment of the present invention, the artificial intelligence unit 80 will recommend preferred stimulus parameters and preferred paradigms based on the above mapping relationship and in conjunction with the initial intelligent model.

[0058] The AI ​​unit 80 is equipped with both high-computing-power AI for network service applications and medium-computing-power intelligent edge AI. It prioritizes operation in intelligent edge AI mode, saving system power consumption while achieving high-quality inference computation. For high-performance applications, it can choose to operate in high-computing-power AI mode. In intelligent edge AI mode, image interpretation and decision analysis are performed locally without a network connection. Based on accumulated image samples and historical data such as the patient's treatment parameters and paradigm selection, the AI ​​unit infers and predicts the optimal treatment paradigm suitable for the patient's disease outcome and synchronously updates the treatment paradigm to the non-invasive spinal cord stimulator, enabling the non-invasive spinal cord stimulator to operate offline without the AI ​​unit.

[0059] Referring to Figures 2-5, the entire system operation process is as follows: The electrode array unit 70 is attached to the patient's cervical spinal cord segment. X-ray or fluorescently labeled image data is transmitted to the artificial intelligence unit 80. The artificial intelligence unit 80 displays the medical image data of the cervical spinal cord segment of the patient with cervical spinal cord injury and fuses it with the contrast markers of the electrode array unit 70. It automatically depicts the mapping relationship between the electrode channel worn by the human body and the cervical spinal cord segment, recommends optimal stimulation parameters, and then transmits the stimulation parameters to the cervical spinal cord pulse control unit 10. A carrier-modulated stimulation electrical pulse is generated in the C2-T1 segment of the cervical spinal cord. The pulse current produces a stimulation effect at the contact site on the body surface. The motion monitoring unit 30, attached to the corresponding movement part of the limb, provides real-time feedback on the movement of the wearing part through surface electromyography and inertial conduction, capturing accurate and reliable representations of the micro-movement characteristics of the human limb. Then, the relevant data of the motion monitoring unit 30 is collected through the wireless communication unit 40, and the control information of the artificial intelligence unit 80 is transmitted to the cervical spinal cord pulse control unit 10 through the wireless communication unit 40. During use, the nine pathway electrodes distributed in the cervical spinal cord segment are connected to the cervical spinal cord pulse control unit 10 through the electrode connection unit 20. The user can realize voice control of the parameters of the non-invasive spinal cord nerve stimulator through the voice unit 50.

[0060] The preferred embodiments of this patent have been described in detail above. However, this patent is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of this patent.

Claims

1. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery, characterized in that, It includes a cervical spinal cord pulse control unit (10), an electrode connection unit (20), a motion monitoring unit (30), a wireless communication unit (40), a voice unit (50), a paradigm decision-making unit (60), an electrode array unit (70), and an artificial intelligence unit (80). The cervical spinal cord pulse control unit (10) is used to generate carrier-modulated stimulation electrical pulses in the C2-T1 segment of the cervical spinal cord, and the pulses produce a stimulation effect when they come into contact with the body surface; the electrode connection unit (20) connects multiple pathway electrodes distributed in the cervical spinal cord segment to the cervical spinal cord pulse control unit (10); the motion monitoring unit (30) is attached to the corresponding movement part of the limb and provides real-time feedback on the movement of the wearing part through surface electromyography and inertial conduction. The wireless communication unit (40) is configured as a main radio frequency transceiver distributed in the cervical spinal cord pulse control unit (10) and a slave radio frequency transceiver distributed in the motion monitoring unit (30). The main radio frequency transceiver supports information transmission and reception with external smart devices, and the slave radio frequency transceiver can perform self-organizing network applications. The voice unit (50) is used to realize voice control of the parameters of the non-invasive spinal nerve stimulator; the paradigm decision unit (60) is deployed in the treatment prescription of the non-invasive spinal nerve stimulator and the artificial intelligence unit (80). The electrode array unit (70) is a multi-channel electrode distributed in the C2-T1 segment of the cervical spinal cord. The electrodes are provided with imaging markers to effectively mark the damaged cervical spinal cord area when the electrodes are first worn and the stimulation paradigm is adjusted. The artificial intelligence unit (80) is configured as an artificial intelligence application software program distributed on a smartphone, which is used to display the medical imaging data of the cervical spinal cord segment of the patient with cervical spinal cord injury and fuse it with the X-ray or fluorescence imaging markers in the electrode array unit (70) mentioned above, automatically depict the mapping relationship between the electrode channel worn by the human body and the cervical spinal cord segment, recommend the preferred stimulation parameters, and infer and predict the optimal treatment paradigm that is suitable for the patient's disease outcome.

2. The non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 1, characterized in that, The stimulation pulses are configured to be multi-channel synchronous output or multi-channel asynchronous output, with controllable asynchronous output time intervals, producing stimulation effects with different stimulation depths, intensities, and activation volumes at the contact points with the body surface.

3. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 2, characterized in that, The electrode connection unit (20) is configured as a flexible micromechanical snap-fit ​​connection, supporting the selection of 2-9 stimulation output channels, and has both bedridden use mode and daily non-bedridden mode.

4. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 3, characterized in that, The motion monitoring unit (30) is configured as a flexible patch sensing device.

5. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 4, characterized in that, The surface electromyography (SEMG) is used to capture the peak potential, potential group delay, and effective width of the electromyographic signal of the moving muscle group.

6. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 5, characterized in that, The inertial transmission is used to capture the instantaneous burst acceleration and slow release acceleration of muscles, as well as the velocity, acceleration, and limb rotation angle of a limb changing from a resting state to a moving state, and the velocity, acceleration, and limb rotation angle data of a limb changing from a moving state to a resting state.

7. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 6, characterized in that, The voice unit (50) supports person-specific and person-independent voice recognition applications.

8. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 7, characterized in that, The paradigm decision unit (60) combines the signal characteristics collected by the motion monitoring unit (30) and the interpretation and analysis of the cervical spinal cord injury site by the artificial intelligence unit (80) to select the optimal paradigm for outputting stimulation parameters. It has stimulation safety limit management capabilities, wherein the stimulation strategy is a stimulation function: F(nme, act, level, mul_nme) = S nme × V act × D nme × Stim level × ε mul_nme × μ0× K Among them, S nme V is the area of ​​action. act For the activation region (activation volume), D nme Stim is the spacing between the stimulation electrodes. level Let ε be the stimulus ranking function. mul_nme is the multi-electrode output function, μ0 is the stimulus adjustment factor, and K is the normalization compensation coefficient; Stimulus Rating Function level (HV,I,F,PW,T,POL)=HV×F× ×T×POL; Where HV is the high voltage coefficient, F is the stimulation frequency, PW is the pulse width, I is the current intensity, T is the pulse period, and POL is the waveform coefficient.

9. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 8, characterized in that, The imaging markers are set in the form of X-rays or fluorescence, and combined with the high specificity of the human cervical spinal cord segments, the optimal limb movement recovery effect is obtained with the minimum stimulation dose. Each electrode can be used as a positive electrode, a negative electrode, or an open circuit.

10. A non-invasive spinal cord nerve stimulator for upper limb motor function recovery according to claim 9, characterized in that, The artificial intelligence unit (80) is a high-computing-power artificial intelligence based on network service applications and a medium-computing-power intelligent edge artificial intelligence. It is used to display the medical image data of the cervical spinal cord segment of the injured population and fuse it with the imaging marks of the electrode array unit (70) to automatically depict the mapping relationship between the electrode channel worn by the human body and the cervical spinal cord segment.

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