A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region

Abstract

The present invention discloses a closed-loop neural control system for coordinated intervention of the brain, spinal cord and lumbosacral region, including a deep brain stimulation unit, a deep brain field potential sensing unit, a spinal cord stimulation unit, an evoked potential sensing unit, a control decision unit, a deep brain electrode, a spinal cord electrode, a lumbosacral electrode, a connecting lead, a radio frequency transmission unit, and a wireless charging and power management unit. The present invention constructs an application strategy for coordinated regulation of the brain, spinal cord and lumbosacral region, and only needs to implant a neural stimulator. 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 and treatment of urinary system complications in paralyzed patients and patients with motor dysfunction. The whole system is modularly applied and can be selectively used according to the disease conditions, with a wider range of applications.

Description

Technical Field

[0001] The present invention relates to the field of nerve stimulation technology, and in particular to a closed-loop nerve regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region. Background Art

[0002] Parkinson's disease (PD), also known as "tremor paralysis", is a common degenerative disease of the nervous system in the elderly with characteristic movement symptoms, including resting tremor, bradykinesia, muscle rigidity and postural balance disorders. About 90% of PD patients develop severe movement disorders in the late stage of the disease, such as gait disorders, balance problems and freezing gait. The most serious freezing gait is manifested as sudden gait obstruction when walking on complex terrain such as starting, turning, and narrow places, which can easily cause patients to fall. This not only brings difficulties to patients' normal life activities, but also easily causes patients to be injured, increase the risk of hospitalization and death. Traditional dopamine replacement therapy and deep brain stimulation (DBS) have limited therapeutic effects on movement disorders.

[0003] Spinal cord stimulation is a method of using pulsed electrical stimulation to stimulate the spinal nerves to reduce or relieve pain. It is a medical device used to treat chronic pain. It is currently mainly used for intractable pain caused by sympathetic dysfunction and peripheral vascular lesions, a large range of shoulder and back pain, peripheral neuropathic pain, residual limb pain, phantom limb pain, pain after spinal cord injury, post-herpetic neuralgia, etc. In addition to treating painful diseases, more and more studies have shown that stimulating the dura mater in the spinal canal of the relevant spinal segments has a certain clinical effect on movement disorders. At the same time, related studies have shown that the lumbar sacral nerves are highly correlated with lower limb functional movement.

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

[0005] In summary, in order to better solve the problem of motor dysfunction under complex disease characteristics, the present invention proposes to construct a neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region. Summary of the invention

[0006] The purpose of the present invention is to provide a closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region to solve the problems raised in the above-mentioned background technology.

[0007] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region, comprising a circular neural stimulator, each with an interface on the upper and lower sides of the circle, the directions of the interfaces being mutually exclusive, for treating diseases related to the nervous system by electrical stimulation through implantation;

[0008] The control decision unit is set as the control center of the system, which is used to control the stimulation output of the brain, spinal cord and lumbar sacral, decode and analyze biopotential signals, and manage peripheral units;

[0009] The stimulation unit includes a deep brain stimulation unit and a spinal cord stimulation unit, which are used to stimulate and regulate the deep brain lesion nuclei, spinal cord related targets and lumbar sacral nerves respectively;

[0010] The electrodes include deep brain electrodes, spinal cord electrodes and lumbosacral electrodes, which are connected to a nerve stimulator buried under the clavicle to form signal transmission with the functional nuclei of the deep brain-related lesion area, the intraspinal dura mater of the spinal segment, and the lumbosacral nerves, and the output electrical pulses of the nerve stimulator are used for stimulation treatment;

[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 the nerve nuclei between brain electrodes in real time, and the evoked potential sensing unit is used to decouple the spinal cord signal characteristics;

[0012] A radio frequency transmission unit, used for wireless connection with an external program-controlled terminal;

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

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: by uniformly scheduling the output and timing of each unit through the control decision-maker in the neurostimulator, it can act on the brain, spinal cord and lumbar sacral region individually, or it can act on the brain, spinal cord and lumbar sacral region simultaneously. The system can also optimize the stimulation model learning and improve the stimulation parameters according to individual disease characteristics, so that patients can obtain the best improvement effect with less surgical trauma, thereby improving the treatment efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 It is a structural block diagram of a closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to a specific embodiment of the present invention;

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

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

[0018] Figure 2-C A diagram of a closed-loop neural stimulation system 3 for coordinated intervention of the brain, spinal cord and lumbar sacral region according to a specific embodiment of the present invention;

[0019] Figure 2-D A diagram of a closed-loop neurostimulation system 4 for coordinated intervention of the brain, spinal cord and lumbar sacral region according to a specific embodiment of the present invention;

[0020] Figure 3 A schematic diagram of a closed-loop neural stimulation system implant 1 for coordinated intervention of the brain, spinal cord and lumbar sacral region according to a specific embodiment of the present invention;

[0021] Figure 4 Schematic diagram of a closed-loop neural stimulation system implant 2 for coordinated intervention of the brain, spinal cord and lumbar sacral region according to a specific embodiment of the present invention.

[0022] Among them: control decision unit 10, radio frequency transmission unit 20, wireless charging and power management unit 30, deep brain 40, deep brain stimulation unit 401, deep brain field potential sensing unit 402, deep brain electrode 403, spinal cord 50, spinal cord stimulation unit 501, evoked potential sensing unit 502, spinal cord electrode 503, lumbar sacral nerve 60, connecting lead 601, lumbar sacral electrode 602. DETAILED DESCRIPTION

[0023] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0024] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and the like are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", and the like may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0025] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood by specific circumstances.

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

[0027] See also Figure 1-Figure 4 , a closed-loop neuromodulation system for coordinated intervention of the brain, spinal cord and lumbosacral region, comprising a circular neurostimulator, with an interface on the upper and lower sides of the circle, the directions of the interfaces being mutually exclusive, and used for treating diseases related to the nervous system through electrical stimulation by implantation;

[0028] The control decision unit 10 is set as the control center of the system, which is used to control the stimulation output of the brain, spinal cord and lumbar sacral, decode and analyze biopotential signals, and manage peripheral units;

[0029] The stimulation unit includes a deep brain stimulation unit 401 and a spinal cord stimulation unit 501, wherein the deep brain stimulation unit 401 and the spinal cord stimulation unit 501 are used to stimulate and regulate the deep brain 40 related lesion nuclei, the spinal cord 50 related target points and the lumbar sacral nerves 60 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, the spinal cord electrode 503, and the lumbosacral electrode 602 are connected to a neurostimulator buried under the clavicle to form a signal transmission with the functional nuclei of the lesion area related to the deep brain 40, the intraspinal dura mater of the vertebral 50 segment, and the lumbosacral nerve 60, and the output electric pulse of the neurostimulator is used for stimulation treatment;

[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 the nerve nuclei between brain electrodes in real time, and the evoked potential sensing unit 502 is used to decouple the spinal cord signal characteristics;

[0032] A radio frequency transmission unit 20, used for wireless connection with an external program-controlled terminal;

[0033] The wireless charging and power management unit 30 is used to couple with an external charging transmitter.

[0034] In the embodiment of the present invention, the neurostimulator has a circular design without edges and corners and dead angles, which can achieve minimal trauma to the surgical capsular band, highly fit the incision tissue, have no moving cavities, and reduce the occurrence of fluid accumulation and infection in the capsular band area;

[0035] In one example 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, an independent core is provided in the control decision unit 10 for edge artificial intelligence learning. The core runs at extremely low power consumption and low speed in the battery-powered mode of the neurostimulator. After the external wireless charging is connected, the core switches to the high-performance operation mode to increase the computing speed. The control decision unit 10 will decide and allocate the task volume of the edge artificial intelligence core according to the size of the data set. After the data set reaches the preset value, the original data can also be transmitted to the external control software via radio frequency. After the external software completes the machine learning, it will be wirelessly transmitted to the control decision unit 10 in the body.

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

[0038] As 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 conversion setting, cross pulse setting, action evoked potential visualization preview, and closed-loop / open-loop working mode setting.

[0039] As a preferred embodiment of the present invention, the deep brain electrode 403 transmits the output electrical pulses of the neurostimulator to the lesion nuclei of the brain, and can also be used to transmit the field potential signals of the deep 40 brain nuclei to the neurostimulator for collection and analysis; the deep brain electrode 403 is configured as a complete cylindrical electrode, and can also be expanded into a discontinuous arc-shaped cylindrical electrode, or can be expanded into a cortical electrode placed in a specific motor cortex area of ​​the brain.

[0040] As a preferred embodiment of the present invention, the spinal cord electrode 503 transmits the output electrical pulses of the neurostimulator to the relevant vertebral segments 50, which can be used for pain treatment, awakening vegetative patients, recovery of motor function, etc.; at the same time, it can be used to collect evoked motor potentials between specific electrodes at the relevant vertebral segments 50. The spinal cord electrode 503 is configured as a cylindrical electrode or a flat paddle electrode.

[0041] As a preferred embodiment of the present invention, the lumbar sacral electrode 602 transmits the output electrical pulses of the neurostimulator to the lumbar sacral nerve 60. When using the lumbar sacral electrode 602, a connecting lead 601 is required. The connecting lead 601 is a flexible adapter with a certain elastic deformation, which is used to connect one end of the spinal cord electrode 503 and one end of the lumbar sacral electrode 602, and extend the wire to a certain length. This design can prevent the electrode connected from the subclavian to the lumbar sacral nerve 60 from being pulled and broken; the lumbar sacral electrode 602 and the spinal cord electrode 503 can be used in a cross-combination, that is, only the spinal cord electrode 503 can be used, or only the lumbar sacral electrode 602 can be used, or one spinal cord electrode 503 and one lumbar sacral electrode 602 can be used.

[0042] As a preferred embodiment of the present invention, after sensing and capturing the discharge clusters of the neural nuclei between the brain electrodes, the deep brain field potential sensing unit 402 can decouple the signal, decode the biomarkers of specific diseases, and feed back the signal to the control decision unit 10 accordingly. At the same time, the original field potential signal will be stored in the flash memory unit of the in vivo stimulator in the form of event stamps for external programs to access and analyze. The deep brain field potential sensing unit 402 has a built-in basic version of the marker detection model when it is initially used. After being implanted in the human body, the model will perform edge artificial intelligence computing and learning to optimize the detection features of the basic model to make it highly matched with the individual using it, without any external regulatory intervention during this period.

[0043] As a preferred embodiment of the present invention, the evoked potential sensing unit 502 is initially in a closed-loop working mode after the spinal cord stimulation unit 501 is implanted in the human body. During operation, a cluster of pulse trains will be intermittently output from a specific electrode site and transmitted to the spinal nerves, and evoked potentials will be captured at specific collection electrodes in the spinal cord 50 and electrode sites in the brain to decouple the spinal cord signal characteristics; the built-in decoupler model of the sensing unit is a basic model based on statistical behavior. With the actual application after implantation in the human body, after accumulating a certain data set, the decoupler model will perform convolutional neural network learning and self-optimization to improve the decoupling accuracy. By using edge artificial intelligence technology, model learning can be completed at ultra-low power consumption.

[0044] As a preferred embodiment of the present invention, the radio frequency transmission unit 20, the radio frequency signal can effectively penetrate human tissue, on the one hand, is used to receive the command signal of the programmable terminal, and on the other hand, it is used to losslessly transmit the internal information of the neurostimulator and the collected original bioelectric signal to the external programmable terminal.

[0045] As another preferred embodiment of the present invention, the wireless charging and power management unit 30 is used to realize energy replenishment for the rechargeable battery. According to the working requirements of the circuits of each module of the neural stimulation system, different power supply chips are started to meet the power supply 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, which accumulates and collects the charges during the stimulation balance period to improve the energy utilization efficiency of the system.

[0046] The working principle of the present invention is as follows: for complex motor dysfunction diseases, when the neurostimulator is implanted in the human body, the deep brain 40 lesion site, the spinal cord 50 lesion site, and the lumbar sacral nerve 60 are calibrated by medical examination means, and the neurostimulator is buried in the subcutaneous tissue below the clavicle. The deep brain electrode 403 is implanted subcutaneously in the deep brain 40 lesion site in the skull, and the spinal cord electrode 503 is implanted subcutaneously in the chest and back into the spinal canal and the dura mater of the relevant vertebral 50 segment. The lumbar base electrode 602 is connected to the connecting lead 601 and the spinal cord electrode 503 from the back subcutaneously and implanted in the lumbar sacral nerve 60 site. After the implantation is completed, it can be The external programmable terminal establishes a wireless communication link with the neurostimulation system implanted in the body through the radio frequency transmission unit 20. The programmable terminal sends relevant command signals to the neurostimulator control decision unit 10 in the body. The neurostimulator control decision unit 10 can also transmit the internal information of the stimulator and the collected original 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 the circuits of each module of the neurostimulation system, different power supply chips are started to meet the power supply 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 above describes in detail the preferred implementation of this patent, but this patent is not limited to the above implementation. Various changes can be made within the knowledge scope of ordinary technicians in this field without departing from the purpose of this patent.

Claims

1. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region, characterized in that: It includes a circular neurostimulator, with an interface on the upper and lower sides of the circle, and the interfaces are mutually exclusive in direction, and is used for treating diseases related to the nervous system through electrical stimulation by implantation; A control decision unit (10) is provided as the control center of the system, and is used to control the stimulation output of the brain, spinal cord and lumbar sacral region, decode and analyze biopotential signals, and manage peripheral units; The stimulation unit comprises a deep brain stimulation unit (401) and a spinal cord stimulation unit (501), wherein the deep brain stimulation unit (401) and the spinal cord stimulation unit (501) are respectively 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 lumbar sacral nerves (60); The electrodes include a deep brain electrode (403), a spinal cord electrode (503) and a lumbosacral electrode (602). The deep brain electrode (403), the spinal cord electrode (503) and the lumbosacral electrode (602) are connected to a nerve stimulator buried under the clavicle to form signal transmission with the functional nuclei of the lesion area related to the deep brain (40), the dura mater in the spinal canal of the vertebral (50) segment, and the lumbosacral nerve (60), and the output electric pulse of the nerve stimulator is used for stimulation treatment; The sensing unit comprises a deep brain field potential sensing unit (402) and an evoked potential sensing unit (502), wherein the deep brain field potential sensing unit (402) is used to sense and capture the discharge clusters of the nerve nuclei between brain electrodes in real time, and the evoked potential sensing unit (502) is used to decouple the spinal cord signal characteristics; The evoked potential sensing unit (502) is initially in a closed-loop working mode after the spinal cord stimulation unit (501) is implanted in the human body. During operation, a cluster of pulse trains are intermittently output from a specific electrode site and transmitted to the spinal nerves, and evoked potentials are captured at specific collection electrodes in the spinal cord (50) and electrode sites in the brain; A radio frequency transmission unit (20), used for wirelessly connecting to an external program-controlled terminal; The wireless charging and power management unit (30) is used for coupling with an external charging transmitter and is provided with a charge recovery and conversion module composed of a super capacitor and a charge pump, and collects the accumulated charge during the stimulation balance period.

2. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to claim 1, characterized in that: The control decision unit (10) can perform decoding analysis, process biopotential signals sensed by different units, and manage peripheral units, including radio frequency transmission, wireless charging, and power distribution; an independent core is provided in the control decision unit (10) for edge artificial intelligence learning. The control decision unit (10) will make decisions and allocate the task volume of the edge artificial intelligence core according to the size of the data set. After the data set reaches a preset value, the original data can also be transmitted to an external control software end via radio frequency, and the external software completes machine learning and then transmits it wirelessly to the control decision unit (10) in the body.

3. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to claim 1, characterized in that: The deep brain stimulation unit (401) performs stimulation site selection, stimulation site alternating coding, stimulation amplitude setting, stimulation frequency setting, stimulation pulse width setting, stimulation interval setting, frequency conversion setting, stimulation electric field visual preview, and closed-loop / open-loop working mode setting.

4. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral 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 conversion setting, cross pulse setting, action evoked potential visual preview, and closed-loop / open-loop working mode setting.

5. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral 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 nucleus (40) to the neurostimulator for collection and analysis; the deep brain electrode (403) is configured as a complete cylindrical electrode, which can be expanded into a discontinuous arc-shaped cylindrical electrode, or can be expanded into a cortical electrode placed in a specific motor cortex area of ​​the brain.

6. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to claim 1, characterized in that: The spinal cord electrode (503) transmits the output electrical pulse of the nerve stimulator to the relevant spinal segment (50) for pain treatment, awakening of vegetative patients, and recovery of motor function; it is also used to collect evoked motor potentials between specific electrodes at the relevant spinal segment (50). The spinal cord electrode (503) is configured as a cylindrical electrode or a flat paddle electrode.

7. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to claim 1, characterized in that: The lumbar sacral electrode (602) transmits the output electrical pulses of the nerve stimulator to the lumbar sacral nerve (60). When the lumbar sacral electrode (602) is used, a connecting lead (601) is used. The connecting lead (601) is a flexible adapter with a certain elastic deformation, which is used to connect one end of the spinal cord electrode (503) to one end of the lumbar sacral electrode (602). The lumbar sacral electrode (602) and the spinal cord electrode (503) are used in a cross-combination or separately.

8. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to claim 1, characterized in that: After sensing and capturing the discharge cluster of the neural nuclei between the brain electrodes, the deep brain field potential sensing unit (402) decouples the signal, decodes the biomarkers of the specific disease, and feeds back the signal 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 program access and analysis. The deep brain field potential sensing unit (402) has a built-in basic version of the marker detection model when it is initially used. After being implanted in the human body, the model will perform edge artificial intelligence computing and learning to optimize the detection characteristics of the basic model so that it is highly matched with the individual using it. During this period, no external regulation intervention is required.

9. A closed-loop neural regulation system for coordinated intervention of the brain, spinal cord and lumbar sacral region according to claim 1, characterized in that: The radio frequency transmission unit (20) effectively penetrates human tissue and is used to receive command signals from a program-controlled terminal on the one hand, and to losslessly transmit information inside the neurostimulator and collected original bioelectric signals to an external program-controlled terminal on the other hand.

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