Closed-loop neuromodulation system involving coordinated intervention of brain, spinal cord, and lumbosacral region

Abstract

Provided is a closed-loop neuromodulation system involving coordinated intervention of the brain, the spinal cord, and the lumbosacral region, which comprises a deep brain stimulation unit (401), a deep brain field potential sensing unit (402), a spinal cord stimulation unit (501), an evoked potential sensing unit (502), a control decision-making unit (10), a deep brain electrode (403), a spinal cord electrode (503), a lumbosacral electrode (602), a docking lead (601), a radio frequency transmission unit (20), and a wireless charging and power management unit (30). By constructing an application strategy for coordinated regulation of the brain, the spinal cord, and the lumbosacral region, only one neurostimulator needs to be implanted. It can be used alone for brain diseases or spinal cord-related diseases, and can also be used for coordinated stimulation for motor function reconstruction and recovery in paralyzed patients and patients with motor dysfunction, as well as for the treatment of urinary system complications. The whole system is modular in application, can be selectively used according to disease conditions, and has a wider application range.

Description

A closed-loop neuromodulation system that coordinates intervention in the brain, spinal cord, and lumbosacral region. Technical Field

[0001] This invention relates to the field of neurostimulation technology, specifically a closed-loop neuromodulation system that coordinates intervention in the brain, spinal cord, and lumbosacral region. Background Technology

[0002] Parkinson's disease (PD), also known as "tremor paralysis," is a common neurodegenerative disease in the elderly, characterized by motor symptoms including resting tremor, bradykinesia, rigidity, and postural instability. Approximately 90% of PD patients develop severe motor impairments in the later stages of the disease, such as gait disturbances, balance problems, and frozen gait. The most severe form, frozen gait, is characterized by a sudden obstruction of gait when starting, turning, or walking on complex terrain such as narrow spaces, easily leading to falls. This not only makes normal daily activities difficult for patients but also increases the risk of injury, hospitalization, and death. Traditional dopamine replacement therapy and deep brain stimulation (DBS) have limited effectiveness in treating motor disorders.

[0003] Spinal cord stimulation (SLS) is a method of reducing or relieving pain by using pulsed electrical stimulation of the spinal cord nerves. It is a medical device used to treat chronic pain, currently primarily for intractable pain caused by sympathetic nerve dysfunction and peripheral vascular disease, as well as extensive shoulder and back pain, peripheral nerve pain, stump pain, phantom limb pain, post-spinal cord injury pain, and postherpetic neuralgia. Beyond treating pain disorders, increasing research indicates that stimulation of the dura mater within the spinal canal at relevant spinal segments has clinical efficacy in treating movement disorders. Furthermore, related studies show a high correlation between lumbosacral nerves and lower limb motor function.

[0004] Existing implantable neurostimulation devices are all used independently. For example, a deep brain stimulator is implanted to treat deep brain diseases, a spinal cord stimulator is implanted to treat pain-related diseases, and a sacral nerve stimulator is implanted to treat urinary-related diseases. Each stimulator works independently and has no interconnected characteristics. When faced with complex disease features, a single stimulator cannot provide effective clinical improvement, such as severe motor dysfunction and urinary system complications in the later stages of Parkinson's disease, as well as motor dysfunction and urinary system complications after spinal cord injury.

[0005] In summary, in order to better address motor dysfunction problems under complex disease characteristics, this invention proposes to construct a neuromodulation system that coordinates intervention in the brain, spinal cord, and lumbosacral region. Summary of the Invention

[0006] The purpose of this invention is to provide a closed-loop neuromodulation system that coordinates intervention in the brain, spinal cord, and lumbosacral region, in order to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord and lumbosacral region, comprising a circular neurostimulator with an interface at the top and bottom of the circle, the interfaces being mutually exclusive, used to treat neurological diseases by implantation and electrical stimulation;

[0008] The control and decision unit is set as the control center of this system, used to regulate the stimulation output of the brain, spinal cord and lumbosacral region, decode and analyze bioelectric potential signals and manage peripheral units;

[0009] The stimulation unit includes a deep brain stimulation unit and a spinal cord stimulation unit. The deep brain stimulation unit and the spinal cord stimulation unit are used to stimulate and regulate the relevant lesion nuclei in the deep brain, the relevant target points in the spinal cord, and the nerves in the lumbosacral region, respectively.

[0010] Electrodes include deep brain electrodes, spinal cord electrodes, and lumbosacral electrodes. The deep brain electrodes, spinal cord electrodes, and lumbosacral electrodes are connected to a nerve stimulator implanted under the clavicle, forming a functional nucleus related to the deep brain lesion area, the spinal canal dura mater of the spinal segment, and the lumbosacral nerve signal transmission. Stimulation therapy is performed using the output electrical pulses of the nerve stimulator.

[0011] The sensing unit includes a deep brain field potential sensing unit and an evoked potential sensing unit. The deep brain field potential sensing unit is used to sense and capture the discharge clusters of neural nuclei between brain electrodes in real time, and the evoked potential sensing unit is used to decouple spinal cord signal characteristics.

[0012] Radio frequency transmission unit, used for wireless connection with external programmable terminal;

[0013] The wireless charging and power management unit is used to couple with an external charging transmitter. It has a charge recovery and conversion module consisting of a supercapacitor and a charge pump to collect the accumulated charge during the stimulation equilibrium period.

[0014] Compared with the prior art, the beneficial effects of the present invention are: by uniformly scheduling the output and timing of each unit by the control decision unit in the neurostimulator, it can act on the brain, spinal cord and lumbosacral region individually, or act on the brain, spinal cord and lumbosacral region simultaneously. The system can also optimize the stimulation model and improve the stimulation parameters according to individual disease characteristics, so that patients can obtain the best improvement effect with less surgical trauma and improve the treatment effectiveness. Attached Figure Description

[0015] Figure 1 is a structural block diagram of a closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord, and lumbosacral region according to a specific embodiment of the present invention.

[0016] Figure 2-A is a diagram of a closed-loop neurostimulation system 1 for coordinated intervention of the brain and spinal cord according to a specific embodiment of the present invention;

[0017] Figure 2-B is a diagram of a closed-loop neurostimulation system 2 for coordinated intervention of the brain and spinal cord according to a specific embodiment of the present invention;

[0018] Figure 2-C is a diagram of a closed-loop neural stimulation system for coordinated intervention of the brain, spinal cord, and lumbosacral region according to a specific embodiment of the present invention.

[0019] Figure 2-D is a diagram of a closed-loop neural stimulation system for coordinated intervention of the brain, spinal cord, and lumbosacral region according to a specific embodiment of the present invention.

[0020] Figure 3 is a schematic diagram of the implantation of a closed-loop nerve stimulation system for coordinated intervention of the brain, spinal cord and lumbosacral region according to a specific embodiment of the present invention.

[0021] Figure 4 is a schematic diagram of the implantation of a closed-loop nerve stimulation system for coordinated intervention of the brain, spinal cord and lumbosacral region according to a specific embodiment of the present invention.

[0022] The components include: a control decision unit 10, a radio frequency transmission unit 20, a wireless charging and power management unit 30, a deep brain unit 40, a deep brain stimulation unit 401, a deep brain field potential sensing unit 402, a deep brain electrode 403, a spinal cord unit 50, a spinal cord stimulation unit 501, an evoked potential sensing unit 502, a spinal cord electrode 503, a lumbosacral nerve 60, a connecting lead 601, and a lumbosacral electrode 602. Detailed Implementation

[0023] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0024] 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.

[0025] 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.

[0026] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0027] Please refer to Figures 1-4. A closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord and lumbosacral region includes a circular neurostimulator with an interface at the top and bottom of the circle. The interfaces are mutually exclusive and are used to treat neurological diseases through implantation and electrical stimulation.

[0028] The control decision unit 10 is set as the control center of this system, used to regulate the stimulation output of the brain, spinal cord and lumbosacral region, decode and analyze bioelectric potential signals and manage peripheral units.

[0029] The stimulation unit includes a deep brain stimulation unit 401 and a spinal cord stimulation unit 501. The deep brain stimulation unit 401 and the spinal cord stimulation unit 501 are used to stimulate and regulate the lesion nuclei related to the deep brain 40, the target points related to the spinal cord 50, and the nerves 60 in the lumbosacral region, respectively.

[0030] The electrodes include a deep brain electrode 403, a spinal cord electrode 503, and a lumbosacral electrode 602. The deep brain electrode 403, spinal cord electrode 503, and lumbosacral electrode 602 are connected to a nerve stimulator implanted under the clavicle, forming a functional nucleus related to the lesion area in the deep brain 40, the dura mater in the spinal canal of the vertebral segment 50, and the nerves in the lumbosacral region 60 for signal transmission. Stimulation therapy is performed using the output electrical pulses of the nerve stimulator.

[0031] The sensing unit includes a deep brain field potential sensing unit 402 and an evoked potential sensing unit 502. The deep brain field potential sensing unit 402 is used to sense and capture the discharge clusters of neural nuclei between brain electrodes in real time, and the evoked potential sensing unit 502 is used to decouple spinal cord signal characteristics.

[0032] The radio frequency transmission unit 20 is used for wireless connection with an external programmable terminal;

[0033] The wireless charging and power management unit 30 is used for coupling connection with an external charging transmitter.

[0034] In this embodiment of the invention, the nerve stimulator has a circular design without sharp edges or blind spots, which can minimize trauma to the surgical capsule, closely match the incision tissue, eliminate moving cavities, and reduce fluid accumulation and infection in the capsule area.

[0035] In one embodiment of the present invention, the control decision unit 10 can perform decoding analysis, process the biopotential signals sensed by different units, and manage peripheral units, generally including radio frequency transmission, wireless charging, power distribution, etc.

[0036] Secondly, the control decision unit 10 is equipped with an independent core for edge artificial intelligence learning. This core operates at extremely low power consumption and low speed in the neurostimulator battery-powered mode. After external wireless charging is connected, the core switches to a high-performance operating mode to improve the computing speed. The control decision unit 10 will decide and allocate the workload of the edge artificial intelligence core according to the size of the dataset. After the dataset reaches the preset value, the raw data can also be wirelessly transmitted to the external control software via radio frequency. The external software will then complete the machine learning and wirelessly transmit the data back to the control decision unit 10 inside the body.

[0037] As a preferred embodiment of the present invention, the deep brain stimulation unit 401 can perform stimulation site selection, stimulation site alternation encoding, stimulation amplitude setting, stimulation frequency setting, stimulation pulse width setting, stimulation interval setting, frequency transformation setting, stimulation electric field visualization preview, and closed-loop / open-loop working mode setting.

[0038] In a preferred embodiment of the present invention, the spinal cord stimulation unit 501 can perform stimulation site selection, stimulation amplitude setting, stimulation frequency setting, stimulation pulse width setting, stimulation interval setting, frequency transformation setting, cross pulse setting, visual preview of action evoked potentials, and closed-loop / open-loop working mode setting.

[0039] In a preferred embodiment of the present invention, the deep brain electrode 403 transmits the output electrical pulses of the neurostimulator to the brain lesion nucleus, and can also be used to transmit the field potential signal of the deep brain nucleus to the neurostimulator for acquisition and analysis; the deep brain electrode 403 is set as a complete cylindrical electrode, or can be extended to a non-continuous arc-shaped cylindrical electrode, or can be extended to a cortical electrode placed in a specific motor cortical region of the brain.

[0040] As a preferred embodiment of the present invention, the spinal cord electrode 503 transmits the output electrical pulses of the nerve stimulator to the relevant vertebral segment 50, which can be used for pain treatment, awakening of vegetative state patients, and recovery of motor function; at the same time, it can be used to collect induced motor potentials between specific electrodes at the relevant vertebral segment 50. The spinal cord electrode 503 is set as a cylindrical electrode, or it can be a planar paddle electrode.

[0041] In a preferred embodiment of the present invention, the lumbosacral electrode 602 transmits the output electrical pulses of the nerve stimulator to the lumbosacral nerve 60. When using the lumbosacral electrode 602, a connecting lead 601 is required. The connecting lead 601 is a flexible adapter with a certain degree of elastic deformation, used to connect one end of the spinal cord electrode 503 to one end of the lumbosacral electrode 602, extending the lead wire to a certain length. This design can prevent the electrode connected from below the clavicle to the lumbosacral nerve 60 from breaking under stress. The lumbosacral electrode 602 and the spinal cord electrode 503 can be used in combination, that is, only the spinal cord electrode 503 can be used, only the lumbosacral electrode 602 can be used, or one spinal cord electrode 503 and one lumbosacral electrode 602 can be used.

[0042] In a preferred embodiment of the present invention, after the deep brain field potential sensing unit 402 senses and captures the discharge clusters of neural nuclei between brain electrodes, it can decouple the signal, decode biomarkers of specific diseases, and feed back to the control decision unit 10 accordingly. At the same time, the original field potential signal is stored in the flash memory unit of the in vivo stimulator in the form of an event stamp for external programs to access and analyze. The deep brain field potential sensing unit 402 has a basic biomarker detection model built in when it is first used. After it is implanted in the human body, the model will perform edge artificial intelligence computing learning to optimize the detection features of the basic model so that it is highly matched with the individual user. During this period, no external control intervention is required.

[0043] In a preferred embodiment of the present invention, the evoked potential sensing unit 502 initially operates in a closed-loop mode after the spinal cord stimulation unit 501 is implanted into the human body. During operation, it intermittently outputs a series of pulses from specific electrode sites to the spinal cord nerves and captures evoked potentials at specific acquisition electrodes in the spinal cord 50 and brain electrode sites to decouple spinal cord signal features. The decoupler model built into the sensing unit is a basic model based on statistical behavior. With the real application after implantation into the human body, after accumulating a certain data set, the decoupler model will undergo convolutional neural network learning and self-optimization to improve decoupling accuracy. Utilizing edge artificial intelligence technology, model learning can be completed under ultra-low power consumption.

[0044] As a preferred embodiment of the present invention, the radio frequency transmission unit 20 can effectively penetrate human tissue. On the one hand, it is used to receive instruction signals from the programmable terminal, and on the other hand, it transmits the information inside the neurostimulator and the collected raw bioelectric signals to the external programmable terminal without loss.

[0045] In another preferred embodiment of the present invention, the wireless charging and power management unit 30 is used to replenish the energy of the rechargeable battery. According to the working requirements of each module circuit of the neurostimulation system, different power supply chips are activated to meet the power conditions required for low voltage and low speed, low voltage and high speed, high voltage and low speed, and high voltage and high speed operation. At the same time, the power management unit has a charge recovery and conversion module composed of a supercapacitor and a charge pump to collect the accumulated charge during the stimulation equilibrium period and improve the energy utilization efficiency of the system.

[0046] The working principle of this invention is as follows: For complex motor dysfunction diseases, when implanting the neurostimulator into the human body, medical examinations are used to pinpoint the lesion sites in the deep brain (40), spinal cord (50), and lumbosacral nerves (60). The neurostimulator is then implanted subcutaneously below the clavicle. A deep brain electrode (403) is implanted subcutaneously in the neck into the deep brain lesion site (40). A spinal cord electrode (503) is implanted subcutaneously in the chest and back into the epidural space of the relevant vertebral segment (50). A lumbar electrode (602) is connected subcutaneously in the back to the spinal cord electrode (503) via a connecting wire (601), and implanted into the lumbosacral nerve (60). After implantation, the device can be... The external programmable terminal establishes a wireless communication link with the implanted neurostimulation system through the radio frequency transmission unit 20. The programmable terminal sends relevant command signals to the neurostimulator control and decision unit 10 inside the body. Alternatively, the neurostimulator control and decision unit 10 can transmit information from inside the stimulator and the collected raw bioelectric signals to the external programmable terminal without loss. The wireless charging and power management unit 30 is used to couple with the external charging transmitter. According to the working requirements of each module circuit of the neurostimulation system, different power supply chips are activated to meet the power conditions required for low voltage and low speed, low voltage and high speed, high voltage and low speed, and high voltage and high speed operation.

[0047] 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 closed-loop neuromodulation system for synergistic intervention of the brain, spinal cord, and lumbosacral region, characterized in that, It includes a circular neurostimulator with an interface at the top and bottom of the circle. The interfaces are mutually exclusive and are used to treat neurological diseases through electrical stimulation via implantation. The control decision unit (10) is set as the control center of this system, used to regulate the stimulation output of the brain, spinal cord and lumbosacral region, decode and analyze bioelectric potential signals and manage peripheral units; The stimulation unit includes a deep brain stimulation unit (401) and a spinal cord stimulation unit (501). The deep brain stimulation unit (401) and the spinal cord stimulation unit (501) are used to stimulate and regulate the lesion nuclei related to the deep brain (40), the target points related to the spinal cord (50), and the lumbosacral nerves (60), respectively. The electrodes include a deep brain electrode (403), a spinal cord electrode (503), and a lumbosacral electrode (602). The deep brain electrode (403), spinal cord electrode (503), and lumbosacral electrode (602) are connected to a nerve stimulator implanted under the clavicle to form a signal transmission mechanism for the functional nuclei of the lesion area related to the deep brain (40), the dura mater in the spinal canal of the vertebral segment (50), and the lumbosacral nerve (60). The nerve stimulator is used to stimulate the treatment by outputting electrical pulses. The sensing unit includes a deep brain field potential sensing unit (402) and an evoked potential sensing unit (502). The deep brain field potential sensing unit (402) is used to sense and capture the discharge clusters of neural nuclei between brain electrodes in real time, and the evoked potential sensing unit (502) is used to decouple spinal cord signal characteristics. The evoked potential sensing unit (502) initially operates in a closed-loop mode after the spinal cord stimulation unit (501) is implanted into the human body. During operation, it will intermittently output a series of pulses from specific electrode sites to the spinal cord nerves and capture evoked potentials at specific acquisition electrodes and brain electrode sites in the spinal cord (50). Radio frequency transmission unit (20) is used for wireless connection with external programmable terminal; The wireless charging and power management unit (30) is used to couple with an external charging transmitter and has a charge recovery and conversion module consisting of a supercapacitor and a charge pump to collect the accumulated charge during the stimulation equilibrium period.

2. The closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The control decision unit (10) can perform decoding analysis, process the biopotential signals sensed by different units, and manage peripheral units, including radio frequency transmission, wireless charging, and power distribution. The control decision unit (10) is equipped with an independent kernel for edge artificial intelligence learning. The control decision unit (10) will decide and allocate the workload of the edge artificial intelligence kernel according to the size of the dataset. After the dataset reaches the preset value, the original data can also be wirelessly transmitted to the external control software terminal via radio frequency. The external software will complete the machine learning and then wirelessly transmit it to the control decision unit (10) in the body.

3. The closed-loop neuromodulation system for synergistic intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The deep brain stimulation unit (401) performs stimulation site selection, stimulation site alternation encoding, stimulation amplitude setting, stimulation frequency setting, stimulation pulse width setting, stimulation interval setting, frequency transformation setting, stimulation electric field visualization preview, and closed-loop / open-loop working mode setting.

4. The closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The spinal cord stimulation unit (501) performs stimulation site selection, stimulation amplitude setting, stimulation frequency setting, stimulation pulse width setting, stimulation interval setting, frequency transformation setting, cross pulse setting, action evoked potential visualization preview, and closed-loop / open-loop working mode setting.

5. The closed-loop neuromodulation system for synergistic intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The deep brain electrode (403) transmits the output electrical pulses of the neurostimulator to the brain lesion nucleus, and is used to transmit the field potential signal of the deep brain (40) nucleus to the neurostimulator for acquisition and analysis; the deep brain electrode (403) is set as a complete cylindrical electrode, which can be extended to a non-continuous arc-shaped cylindrical electrode, or can be extended to a cortical electrode placed in a specific motor cortex region of the brain.

6. The closed-loop neuromodulation system for synergistic intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The spinal cord electrode (503) transmits the output electrical pulses of the nerve stimulator to the relevant spinal (50) segment for pain treatment, vegetative state arousal, and motor function recovery; at the same time, it is used to collect induced motor potentials between specific electrodes at the relevant spinal (50) segment. The spinal cord electrode (503) is set as a cylindrical electrode or a planar paddle electrode.

7. The closed-loop neuromodulation system for synergistic intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The lumbosacral electrode (602) transmits the output electrical pulses of the nerve stimulator to the lumbosacral nerve (60). When using the lumbosacral electrode (602), a connecting lead (601) is used. The connecting lead (601) is a flexible adapter with a certain elastic deformation, used to connect one end of the spinal cord electrode (503) to one end of the lumbosacral electrode (602). The lumbosacral electrode (602) and the spinal cord electrode (503) can be used in combination or alone.

8. The closed-loop neuromodulation system for synergistic intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, After sensing and capturing the discharge clusters of neural nuclei between brain electrodes, the deep brain field potential sensing unit (402) decouples the signal, decodes biomarkers of specific diseases, and feeds it back to the control decision unit (10). The original field potential signal is stored in the flash memory unit of the in vivo stimulator in the form of an event stamp for external programs to access and analyze. The deep brain field potential sensing unit (402) has a basic version of the marker detection model built in when it is first used. After it is implanted into the human body, the model will perform edge artificial intelligence computing learning to optimize the detection features of the basic model so that it is highly matched with the individual user. During this period, no external regulation intervention is required.

9. The closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord, and lumbosacral region according to claim 1, characterized in that, The radio frequency transmission unit (20) effectively penetrates human tissue, and on the one hand, it is used to receive instruction signals from the programmable terminal, and on the other hand, it transmits the information inside the nerve stimulator and the collected raw bioelectric signals to the external programmable terminal without loss.

Images