Pulse generation apparatus, device, and system for neuromodulation

Abstract

Embodiments of the present disclosure provide a pulse generation apparatus, device, and system for neuromodulation, relating to the technical field of medical devices. The pulse generation apparatus for neuromodulation comprises: a pulse generation unit, configured to be electrically connected to at least one electrode, the at least one electrode being configured to be disposed at a predetermined position of a target object; and a control unit, configured to control the pulse generation unit to generate target pulse signals and output the target pulse signals to the at least one electrode, so as to enable the at least one electrode to output the target pulse signals to a target region of the target object, wherein the target pulse signals comprise a first pulse signal and a second pulse signal having opposite polarities, and the first pulse signal and the second pulse signal have the same start time of signal output. The embodiments of the present disclosure employ the first pulse signal and the second pulse signal having opposite polarities and the same start time of signal output, which is conducive to achieving charge balance within the stimulation field strength, thereby ensuring the effect of neuromodulation.

Description

Pulse generation device, apparatus and system for neuromodulation TECHNICAL FIELD

[0001] The present disclosure relates to the technical field of medical devices, and in particular, the present disclosure relates to a pulse generation device, apparatus and system for neuromodulation. BACKGROUND

[0002] Neuromodulation technology is a technology that stimulates neural tissue through electrical or magnetic signals to change the electrical activity of nerve cells and thus affect the physiological functions of the human body.

[0003] However, the existing pulse signals for neuromodulation often have the problem of charge imbalance, and the secondary damage caused by the use of redundant pulses to balance them affects the effect of neuromodulation. SUMMARY

[0004] The present disclosure aims to solve at least one aspect of the above technical problems.

[0005] In a first aspect, the embodiments of the present disclosure provide a pulse generation device for neuromodulation, comprising:

[0006] a pulse generation unit for electrical connection with at least one electrode; the at least one electrode is arranged at a predetermined position of a target object;

[0007] a control unit electrically connected to the pulse generation unit, for controlling the pulse generation unit to generate a target pulse signal and output the target pulse signal to the at least one electrode, so that the at least one electrode outputs the target pulse signal to a target region of the target object; the target region is a region for neuromodulation;

[0008] wherein the target pulse signal comprises a first pulse signal and a second pulse signal with opposite polarity, and the start time of signal output of the first pulse signal and the second pulse signal is the same.

[0009] In one possible implementation, the waveforms of the first pulse signal and the second pulse signal are both rectangular, and the pulse signal parameters of the first pulse signal and the second pulse signal are the same, the pulse signal parameters including pulse width, amplitude and frequency.

[0010] In one possible implementation, the pulse signal parameters of the first pulse signal include at least one of the following: the pulse width of the first pulse signal ranges from 10 microseconds to 1000 microseconds, the amplitude of the first pulse signal ranges from 0.1 volt to 10.5 volts, and the frequency of the first pulse signal ranges from 1 to 1500 hertz; and / or,

[0011] The pulse signal parameter of the second pulse signal includes at least one of the following: a pulse width of the second pulse signal ranges from 10 microseconds to 1000 microseconds, an amplitude of the second pulse signal ranges from 0.1 volt to 10.5 volts, and a frequency of the second pulse signal ranges from 1 to 1500 hertz.

[0012] In a second aspect, the embodiments of the present disclosure provide a pulse generation device, comprising: at least one electrode, and the pulse generation device for neuromodulation of the first aspect;

[0013] Each electrode is provided with at least one electrode contact for outputting the first pulse signal or the second pulse signal.

[0014] In a possible implementation, applied to epilepsy, the at least one electrode includes at least one deep electrode and / or at least one cortical electrode.

[0015] The deep electrode is used to be implanted at a predetermined position of a deep part of a brain of the target object, and the cortical electrode is used to be implanted at a predetermined position of a cerebral cortex of the target object.

[0016] The pulse generation unit is electrically connected with the at least one deep electrode and the at least one cortical electrode, and is used to generate a target pulse signal.

[0017] The control unit is electrically connected with the pulse generation unit, and is used to, when detecting that the target object has epilepsy, control the pulse generation unit to generate a corresponding target pulse signal according to pre-stored initial pulse generation information, and output the target pulse signal to a target region of the target object through the at least one deep electrode and / or the at least one cortical electrode; the initial pulse generation information includes pulse parameter information and electrode information, the initial pulse generation information is pulse generation information determined by a terminal device according to a brain electrical signal of the target object, the electrode information represents information of the deep electrode and / or the cortical electrode used to output the target pulse signal, and the target region includes a lesion region of the epilepsy.

[0018] In a possible implementation, the electrode contact includes a first electrode contact.

[0019] The deep electrode includes an electrode outer tube, one end of the electrode outer tube is provided with at least one first connection contact for electrically connecting with the pulse generation unit, and the other end of the electrode outer tube is provided with at least one first electrode contact.

[0020] Each first electrode contact is used to output the first pulse signal or the second pulse signal, and / or sense a brain electrical signal.

[0021] In a possible implementation, the electrode contact includes a second electrode contact.

[0022] The cortical electrode comprises a fixedly connected connecting lead wire and an electrode patch, one end of the connecting lead wire is provided with at least one second connection contact for electrical connection with the pulse generating unit, and the electrode patch is arranged at the other end of the connecting lead wire, and the electrode patch comprises at least one second electrode contact;

[0023] Each second electrode contact is used for outputting the first pulse signal or the second pulse signal and / or sensing the brain electrical signal.

[0024] In a possible implementation, the control unit is further configured to acquire the brain electrical signal output from the at least one deep electrode and / or the at least one cortical electrode, determine an adjusted target region according to the brain electrical signal when it is determined that the target object has epilepsy, determine adjusted pulse generation information according to the adjusted target region, and control the pulse generating unit to generate a corresponding target pulse signal according to the adjusted pulse generation information.

[0025] In a possible implementation, the control unit is specifically configured to:

[0026] If the area of the target region is greater than the first threshold value, the control unit controls a group of first electrode contacts of the at least one deep electrode and / or a group of second electrode contacts of the at least one cortical electrode to output the target pulse signal.

[0027] If the area of the target region is greater than the second threshold value, the control unit controls at least two groups of first electrode contacts of the at least one deep electrode and / or at least two groups of second electrode contacts of the at least one cortical electrode to output the target pulse signal; the second threshold value is greater than the first threshold value.

[0028] In a possible implementation, the application is applied to Parkinson's disease, the at least one electrode comprises at least one deep electrode implanted at a predetermined position in the deep brain of the target object, each deep electrode comprises at least one electrode contact, and each electrode contact is used for outputting a pulse signal and / or sensing a brain electrical signal.

[0029] The pulse generating unit is electrically connected with the at least one deep electrode and is configured to generate a target pulse signal.

[0030] The control unit is electrically connected with the pulse generating unit and is configured to acquire the brain electrical signal output from the electrode contact of the at least one deep electrode, convert the brain electrical signal into a brain electrical digital signal and send the brain electrical digital signal to a terminal device, acquire pulse generation information sent by the terminal device, control the pulse generating unit to generate a target pulse signal according to the pulse generation information, and output the target pulse signal to a target region of the target object through the at least one deep electrode; the pulse generation information comprises pulse parameter information and electrode information, the electrode information represents information of the deep electrode used for outputting the target pulse signal, and the target region comprises a lesion region of Parkinson's disease.

[0031] In a possible implementation, the pulse signal parameter of the first pulse signal includes at least one of the following: a pulse width of the first pulse signal ranges from 20 microseconds to 450 microseconds, an amplitude of the first pulse signal ranges from 0 volt to 10.5 volt, a frequency of the first pulse signal ranges from 1 hertz to 260 hertz, and a current of the first pulse signal ranges from 1 milliampere to 30 milliampere; and / or,

[0032] The pulse signal parameter of the second pulse signal includes at least one of the following: a pulse width of the second pulse signal ranges from 20 microseconds to 450 microseconds, an amplitude of the second pulse signal ranges from 0 volt to 10.5 volt, a frequency of the second pulse signal ranges from 1 hertz to 260 hertz, and a current of the second pulse signal ranges from 1 milliampere to 30 milliampere.

[0033] In a possible implementation, for relieving pain, the at least one electrode is arranged at a target region of the target object, and the target region includes a pain region and / or a spinal cord.

[0034] The pulse generation unit is electrically connected with the at least one electrode, and is configured to generate a target pulse signal.

[0035] The control unit is configured to control the pulse generation unit to generate the target pulse signal, and output the target pulse signal to the target region through the at least one electrode, so as to stimulate a nerve related to pain of the target region.

[0036] In a possible implementation, the pulse signal parameter of the first pulse signal includes at least one of the following: a pulse width ranges from 20 microseconds to 1000 microseconds, an amplitude ranges from 0.01 volt to 15 volt, a frequency ranges from 20 hertz to 100 kilohertz, and a current ranges from 0.01 milliampere to 25.5 milliampere; and / or,

[0037] The pulse signal parameter of the second pulse signal includes at least one of the following: a pulse width ranges from 20 microseconds to 1000 microseconds, an amplitude ranges from 0.01 volt to 15 volt, a frequency ranges from 20 hertz to 100 kilohertz, and a current ranges from 0.01 milliampere to 25.5 milliampere.

[0038] In a third aspect, an embodiment of the present disclosure provides a pulse generation system, including: a terminal device and the pulse generation device of the second aspect.

[0039] The terminal device is in communication connection with the control unit, and the terminal device is configured to send pulse generation information to the control unit; the pulse generation information includes a pulse signal parameter of the first pulse signal, a pulse signal parameter of the second pulse signal, contact information corresponding to the first pulse signal, and contact information corresponding to the second pulse signal; the pulse signal parameter includes a pulse width, an amplitude, and a frequency, and the contact information is used to indicate an electrode contact of an electrode outputting a corresponding pulse signal.

[0040] The control unit is configured to control the pulse generation unit to generate the target pulse signal according to the pulse generation information, and output the target pulse signal to the at least one electrode.

[0041] In a possible implementation, the terminal device is further configured to determine a target region for neuroregulation according to the electroencephalogram digital signal, determine field strength distribution information corresponding to the target region according to the target region and a field strength distribution model, and determine the pulse generation information according to the field strength distribution information and a distribution of the electrode contacts of the at least one deep electrode.

[0042] The field strength distribution model is obtained by at least the following manner: obtaining a plurality of sample target regions and field strength distribution information corresponding to each sample target region; and training a preset initial model according to the plurality of sample target regions and the field strength distribution information corresponding to each sample target region to obtain the trained field strength distribution model.

[0043] In a possible implementation, the pulse generation device is applied to Parkinson's disease, and the terminal device is further configured to obtain the electroencephalogram digital signal sent by the control unit, convert the electroencephalogram digital signal into an electroencephalogram image by using predetermined software, extract a spectrum change corresponding to a beta frequency band of the electroencephalogram from the electroencephalogram image by using the predetermined software, and display the spectrum change, display a control interface for inputting the pulse generation information, obtain the pulse generation information in response to an input operation of the pulse generation information on the control interface, and send the pulse generation information to the control unit.

[0044] In a possible implementation, the control interface further includes a signal acquisition control.

[0045] The terminal device is further configured to send an electroencephalogram signal acquisition request to the control unit in response to a selection operation on the signal acquisition control.

[0046] The control unit is further configured to obtain an electroencephalogram signal output from the electrode contacts of the at least one deep electrode in response to the electroencephalogram signal acquisition request.

[0047] In a possible implementation, the pulse generation device is used for relieving pain, and the pulse generation system further includes an adjustment device configured to send adjustment information to the control unit, so that the control unit determines the pulse generation information according to the adjustment information, and controls the pulse generation unit to generate the target pulse signal according to the pulse generation information.

[0048] The pulse generation information includes pulse signal parameters of the first pulse signal, pulse signal parameters of the second pulse signal, contact information corresponding to the first pulse signal, and contact information corresponding to the second pulse signal.

[0049] The technical scheme provided by the embodiments of the present disclosure has the following beneficial effects:

[0050] The pulse generation device for neuromodulation provided by the embodiments of the present disclosure controls the pulse generation unit to generate a target pulse signal and output the target pulse signal to at least one electrode through the control unit, so that the at least one electrode outputs the target pulse signal to a target region of a target object, thereby outputting the first pulse signal and the second pulse signal at the same time through the first pulse signal and the second pulse signal with opposite polarities, so as to modulate the target region. Since the first pulse signal and the second pulse signal have opposite polarities, the pulse signals with opposite polarities are beneficial to realize charge balance within the stimulation field intensity, especially in the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the use of redundant pulses in the prior art to balance the charge, thereby ensuring the neuromodulation effect. BRIEF DESCRIPTION OF DRAWINGS

[0051] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the drawings needed to be used in the description of the embodiments of the present disclosure will be briefly introduced.

[0052] FIG. 1 is a schematic diagram of a framework of a pulse generation device provided by the embodiments of the present disclosure;

[0053] FIG. 2 is a schematic diagram of a framework of a pulse generation device for neuromodulation provided by the embodiments of the present disclosure;

[0054] FIG. 3 is a schematic diagram of a framework of another pulse generation device for neuromodulation provided by the embodiments of the present disclosure;

[0055] FIG. 4 is a schematic diagram of a structure of a deep electrode provided by the embodiments of the present disclosure;

[0056] FIG. 5 is a schematic diagram of a structure of a cortical electrode provided by the embodiments of the present disclosure;

[0057] FIG. 6 is a schematic diagram of a framework of a pulse generation unit provided by the embodiments of the present disclosure;

[0058] FIG. 7 is a schematic diagram of a structure of two groups of first electrode contacts of a deep electrode provided by the embodiments of the present disclosure, which output target pulse signals to form a stimulation field intensity and a cross field intensity;

[0059] FIG. 8 is a schematic diagram of a framework of a pulse generation system provided by the embodiments of the present disclosure;

[0060] FIG. 9 is a schematic diagram of a framework of a terminal device provided by the embodiments of the present disclosure;

[0061] FIG. 10 is a schematic diagram of a structure of a pulse generation device applied to epilepsy provided by the embodiments of the present disclosure;

[0062] FIG. 11 is a schematic diagram of a framework of another pulse generation system provided by the embodiments of the present disclosure;

[0063] Fig. 12 is a schematic diagram of a frame of a pulse generating device for Parkinson's disease according to an embodiment of the present disclosure;

[0064] Fig. 13 is a schematic diagram of a structure of a group of electrode contacts of a deep electrode according to an embodiment of the present disclosure;

[0065] Fig. 14 is a schematic diagram of a structure of another deep electrode according to an embodiment of the present disclosure;

[0066] Fig. 15 is a schematic diagram of a structure of yet another deep electrode according to an embodiment of the present disclosure;

[0067] Fig. 16 is a schematic diagram of a structure of a pulse generating system according to an embodiment of the present disclosure;

[0068] Fig. 17 is a schematic diagram of a structure of a pulse generating device for relieving pain according to an embodiment of the present disclosure;

[0069] Fig. 18 is a schematic diagram of a waveform structure of a target pulse signal according to an embodiment of the present disclosure;

[0070] Fig. 19 is a schematic diagram of a structure of an electrode needle according to an embodiment of the present disclosure;

[0071] Fig. 20 is a schematic diagram of a structure of an electrode patch according to an embodiment of the present disclosure;

[0072] Fig. 21 is a schematic diagram of a structure of a pulse generating system according to an embodiment of the present disclosure.

[0073] Fig. 21 is a schematic diagram of a structure of a pulse generating system according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0074] Embodiments of the present disclosure will be described below with reference to the accompanying drawings. It should be understood that the embodiments described below in conjunction with the drawings are exemplary descriptions of the technical solutions of the embodiments of the present disclosure, and do not limit the technical solutions of the embodiments of the present disclosure.

[0075] Those skilled in the art can understand that the singular forms "a," "an," and "the" used herein include plural forms unless specifically stated otherwise. It should be further understood that the terms "include" and "contain" used in the embodiments of the present disclosure mean that the corresponding features can be implemented as the presented features, information, data, steps, operations, elements, and / or components, but do not exclude other features, information, data, steps, operations, elements, components, and / or combinations thereof supported by the present technology. It should be understood that when we say that an element is "connected" or "coupled" to another element, the element can be directly connected or coupled to the other element, or it can mean that the element and the other element establish a connection relationship through an intermediate element. In addition, "connected" or "coupled" used herein can include wireless connection or wireless coupling. The term "and / or" used herein indicates at least one of the items defined by the term, for example, "A and / or B" indicates implementation as "A", or implementation as "A", or implementation as "A and B".

[0076] For the purpose, technical solutions and advantages of the present disclosure to be clearer, the embodiments of the present disclosure will be described in further detail below with reference to the drawings.

[0077] It has been found through research that neuromodulation technology is a technology that stimulates neural tissue through electrical or magnetic signals to change the electrical activity of nerve cells, thereby affecting the physiological functions of the human body. This technology has been widely used in the medical field, such as deep brain stimulation (DBS) for treating Parkinson's disease, epilepsy, and other diseases, and spinal cord stimulation (SCS) for treating chronic pain, etc.

[0078] However, there are still some deficiencies in the precision and effectiveness of treatment. For example, the accuracy of neuromodulation treatment depends largely on the positioning of the lesion and the precise implantation of the electrode. In actual conditions, sometimes the source of the patient's lesion is not significant, or with the passage of time, the patient's own movement, etc. will cause the electrode implantation position to deviate, thereby greatly reducing the accuracy of treatment.

[0079] In addition, the current existing neuromodulation products mainly rely on a single channel in waveform generation, which to some extent limits the flexibility of the product. For example, waveform generation through a single channel will result in a relatively single treatment mode, which has a fixed stimulation site and stimulation range, and cannot be flexibly regulated according to the specific condition of the patient.

[0080] The pulse generating device, apparatus and system for neuromodulation provided by the present disclosure aim to solve the above technical problems of the prior art.

[0081] Referring to FIG. 1, a frame diagram of a pulse generation device 10 is provided. As shown in FIG. 1, the pulse generation device 10 includes at least one electrode 120 and a pulse generation apparatus 110 for neural modulation according to the embodiments of the present disclosure.

[0082] Optionally, the electrode 120 can be implanted at a predetermined position in the deep brain or a predetermined position in the cerebral cortex.

[0083] Referring to FIG. 2, a frame diagram of the pulse generation apparatus 110 for neural modulation is provided. As shown in FIG. 2, the pulse generation apparatus 110 for neural modulation includes a pulse generation unit 111 and a control unit 112.

[0084] The pulse generation unit 111 is configured to be electrically connected to the at least one electrode 120, and the at least one electrode 120 is configured to be arranged at a predetermined position of a target object.

[0085] The control unit 112 is electrically connected to the pulse generation unit 111, and the control unit 112 is configured to control the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to the at least one electrode 120, so that the at least one electrode 120 outputs the target pulse signal to a target region of the target object; the target region is a region for neural modulation.

[0086] The target pulse signal includes a first pulse signal and a second pulse signal with opposite polarities, and the first pulse signal and the second pulse signal have the same starting time of signal output.

[0087] Specifically, the pulse generation unit 111 is configured to generate a target pulse signal and output the target pulse signal to the at least one electrode 120.

[0088] The pulse generation apparatus 110 for neural modulation according to the embodiments of the present disclosure controls the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to the at least one electrode 120 through the control unit 112, so that the at least one electrode 120 outputs the target pulse signal to a target region of a target object, thereby outputting the first pulse signal and the second pulse signal at the same time through the first pulse signal and the second pulse signal with opposite polarities, so as to modulate the target region. Since the first pulse signal and the second pulse signal have opposite polarities, the pulse signals with opposite polarities greatly achieve charge balance within the stimulation field intensity, especially in the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the use of redundant pulses in the prior art to balance the charge, and thereby ensuring the neural modulation effect.

[0089] In some embodiments, the pulse signal parameter of the first pulse signal is the same as the pulse signal parameter of the second pulse signal; the pulse signal parameter comprises pulse width, amplitude and frequency; or,

[0090] At least one of the pulse width, amplitude and frequency of the first pulse signal is different from at least one of the pulse width, amplitude and frequency of the second pulse signal.

[0091] Optionally, the pulse signal parameter of the first pulse signal is the same as the pulse signal parameter of the second pulse signal, and the first pulse signal and the second pulse signal are bidirectional symmetric pulse signals, which can ensure charge balance.

[0092] Optionally, the pulse width, amplitude and frequency of the first pulse signal can also be different from the pulse width, amplitude and frequency of the second pulse signal, and at least one of the pulse width, amplitude and frequency can be different.

[0093] The pulse signal parameter of the first pulse signal is the same as the pulse signal parameter of the second pulse signal in the embodiments of the present disclosure, so that charge balance can be achieved in the formed stimulation field strength. The pulse signal parameter of the first pulse signal is different from the pulse signal parameter of the second pulse signal, so that the stimulation strength of a certain local position can be adjusted in the formed stimulation field strength to achieve the distribution of different stimulation amounts of the stimulation target. On the basis of effective stimulation, the giving of stimulation amount is reduced, the harm of redundant pulses to the patient is avoided, and low-power operation of the device is facilitated.

[0094] In some embodiments, the waveform of the first pulse signal comprises at least one of the following: rectangular wave, triangular wave, trapezoidal wave and sinusoidal wave; and / or, the waveform of the second pulse signal comprises at least one of the following: rectangular wave, triangular wave, trapezoidal wave and sinusoidal wave.

[0095] In some embodiments, the waveform of the first pulse signal and the waveform of the second pulse signal are both rectangular, the pulse signal parameter of the first pulse signal is the same as the pulse signal parameter of the second pulse signal, and the pulse signal parameter comprises pulse width, amplitude and frequency.

[0096] Specifically, in a set of effective stimulation waveforms, the waveform of the first pulse signal and the waveform of the second pulse signal are not limited to square wave, but can also be triangular wave, trapezoidal wave, sinusoidal wave and the like. The waveforms of the first pulse signal and the second pulse signal can be different from each other, and even the waveforms of multiple first pulse signals or multiple second pulse signals can be different from each other, and different waveforms will also produce different stimulation field strengths. The greater the stimulation waveform slope, the more rapid the neuron response. However, for local neural clusters, the response situation can be very complex, and in practical application, different waveforms can be considered to achieve the effect of activating / inhibiting neurons.

[0097] It is found through research that the resting potential of neurons is-70 mV, the threshold voltage enabling neurons to transmit electrical signals is-50 to-55 mV, and conversely, if the transmission of electrical signals is to be prevented, the potential of neurons must be no higher than-55 mV. Therefore, for the local nerve tissue around the contact point, the amplitude can be determined according to the size of the tissue and the range that needs to be activated, and the pulse width can be determined according to the signal transmission characteristics corresponding to the disease; the frequency range is determined according to the refractory period of the electrical signal transmission of neurons, and the refractory period is about 3 ms. In theory, the stimulation above 330 Hz has little effect on neurons.

[0098] In some embodiments, the pulse signal parameters of the first pulse signal include at least one of the following: the pulse width ranges from 10 microseconds to 1000 microseconds, the amplitude ranges from 0.1 volt to 10.5 volts, and the frequency ranges from 1 to 1500 Hz; and / or, the pulse signal parameters of the second pulse signal include at least one of the following: the pulse width ranges from 10 microseconds to 1000 microseconds, the amplitude ranges from 0.1 volt to 10.5 volts, and the frequency ranges from 1 to 1500 Hz.

[0099] Alternatively, the pulse width of the first pulse signal can be 10 microseconds, 200 microseconds, 500 microseconds, 700 microseconds, 1000 microseconds, etc., the amplitude can be 0.1 volt, 2 volts, 5 volts, 7 volts, 10.5 volts, etc., and the frequency can be 1 Hz, 500 Hz, 1000 Hz, 1500 Hz, etc. Similarly, the pulse width of the second pulse signal can be 10 microseconds, 200 microseconds, 500 microseconds, 700 microseconds, 1000 microseconds, etc., the amplitude can be 0.1 volt, 2 volts, 5 volts, 7 volts, 10.5 volts, etc., and the frequency can be 1 Hz, 500 Hz, 1000 Hz, 1500 Hz, etc.

[0100] In some embodiments, the time interval between adjacent two pulses of the first pulse signal ranges from 0 milliseconds to 100 milliseconds; and / or, the time interval between adjacent two pulses of the second pulse signal ranges from 0 milliseconds to 100 milliseconds.

[0101] Alternatively, the time interval between adjacent two pulses of the first pulse signal can be 3 milliseconds, 50 milliseconds, 100 milliseconds, etc. Similarly, the time interval between adjacent two pulses of the second pulse signal can be 3 milliseconds, 50 milliseconds, 100 milliseconds, etc.

[0102] In practice, after delivering a signal, neurons will enter a refractory period, and stimulating neurons during the refractory period will have no effect. Therefore, stimulating after a suitable interval can achieve the desired effect, save energy, and avoid unnecessary side effects. There is a certain time interval T between the end of a stimulation and the start of the next stimulation, and the time intervals of the plurality of stimulation blanking periods T can be the same or different.

[0103] Referring to FIG. 3, the embodiment of the present disclosure provides another schematic diagram of the framework of the pulse generation device 110 for neuromodulation. As shown in FIG. 3, the pulse generation unit 111 further comprises a signal conversion module 1111.

[0104] The signal conversion module 1111 is electrically connected with the control unit 112 and is used to be electrically connected with the at least one electrode 120. The signal conversion module 1111 is used to pre-process the brain electrical signal output by the at least one electrode 120, convert the pre-processed brain electrical signal into a brain electrical digital signal, and send the brain electrical digital signal to the control unit 112. The brain electrical digital signal is used to determine the target pulse signal.

[0105] Optionally, the signal pre-processing includes signal processing modes such as filtering processing, amplification processing, etc. The control unit 112 can determine the target pulse signal according to the brain electrical digital signal.

[0106] In the pulse generation device 10 of the embodiment of the present disclosure, each electrode 120 is provided with at least one electrode contact point for outputting the first pulse signal or the second pulse signal; the at least one electrode 120 comprises at least one deep electrode 121 and / or at least one cortical electrode 122; the deep electrode 121 is used to be implanted at a predetermined position of the deep brain of the target object, and the cortical electrode 122 is used to be implanted at a predetermined position of the cerebral cortex of the target object.

[0107] The deep electrode 121 of the embodiment of the present disclosure is used to be implanted in the deep brain, and the cortical electrode 122 is implanted in the cerebral cortex. The cortical electrode 122 is used for some lesions that occur in the cerebral cortex. In actual application, corresponding electrodes can be selected according to different situations.

[0108] Referring to FIG. 4, the embodiment of the present disclosure provides a structural schematic diagram of the deep electrode 121. As shown in FIG. 4, the electrode contact point comprises a first electrode contact point 1213. The deep electrode 121 comprises an electrode outer tube 1211, one end of the electrode outer tube 1211 is provided with at least one first connection contact point 1212 for being electrically connected with the pulse generation unit 111, and the other end of the electrode outer tube 1211 is provided with at least one first electrode contact point 1213.

[0109] Each first electrode contact point 1213 is used to output the first pulse signal or the second pulse signal, and / or sense the brain electrical signal.

[0110] As an example, as shown in FIG. 4, one end of the electrode outer tube 1211 is provided with at least two first connection contact points 1212 for being electrically connected with the pulse generation unit 111, and the other end of the electrode outer tube 1211 is provided with at least two first electrode contact points 1213.

[0111] Specifically, the monopolar stimulation mode is that at least one first electrode contact 1213 of one deep electrode 121 outputs a pulse signal, and the bipolar stimulation mode is that at least two first electrode contacts 1213 of one deep electrode 121 output pulse signals.

[0112] Referring to FIG. 5, the embodiment of the present disclosure provides a structural schematic diagram of a cortical electrode 122. As shown in FIG. 5, the electrode contacts include second electrode contacts 1224. The cortical electrode 122 includes a fixedly connected connecting wire 1221 and an electrode patch 1222, one end of the connecting wire 1221 is provided with at least one second connecting contact 1223 for electrical connection with the pulse generation unit 111, and the electrode patch 1222 is arranged at the other end of the connecting wire 1221, and the electrode patch 1222 includes at least one second electrode contact 1224.

[0113] Each second electrode contact 1224 is used to output a first pulse signal or a second pulse signal, and / or sense a brain electrical signal.

[0114] As an example, as shown in FIG. 5, one end of the connecting wire 1221 is provided with at least two second connecting contacts 1223 for electrical connection with the pulse generation unit 111, and the electrode patch 1222 includes at least two second electrode contacts 1224.

[0115] In some embodiments, the first electrode contact 1213 is a ring contact arranged around the circumference of the electrode outer tube 1211; or, at least two first electrode contacts 1213 are arranged at intervals along the circumference of the electrode outer tube 1211; and / or, at least two first electrode contacts 1213 are arranged at intervals along the axis of the electrode outer tube 1211.

[0116] In actual application, the contact of the conventional electrode is a ring contact, and the directional electrode adopts more stimulation contacts, so that the distribution of the current can be more accurately controlled, thereby realizing directional stimulation of the specific function of the target nucleus. The distribution of the electrode contacts, the spacing between the electrode contacts, the width of the electrode contacts, etc. can be different, thereby generating different types of electrodes, which can be selected and used according to clinical needs.

[0117] The power supply of the pulse generation device 110 for neural regulation in the embodiment of the present disclosure can adopt a double current source. Because a single current source configures multiple field strengths, each field strength is consistent, while the double current source can realize arbitrary setting of two electric field strengths, so that the configuration of different stimulation field strengths is more flexible.

[0118] Referring to FIG. 6, the embodiment of the present disclosure provides a frame schematic diagram of a pulse generation unit 111. As shown in FIG. 6, the pulse generation unit 111 includes a first pulse generation module 1112 for generating a first pulse signal and a second pulse generation module 1113 for generating a second pulse signal.

[0119] Part of the electrode contacts are electrically connected to the first pulse generation module 1112, and the other part of the electrode contacts are electrically connected to the second pulse generation module 1113.

[0120] Optionally, the electrode contacts are electrically connected to the first pulse generation module 1112 to form a first waveform channel, and the electrode contacts are electrically connected to the second pulse generation module 1113 to form a second waveform channel. The first pulse signal is generated by the first waveform channel, and the second pulse signal is generated by the second waveform channel, and the first pulse signal and the second pulse signal are respectively and simultaneously generated at different electrode contacts. Of course, the first pulse signal can be generated at the electrode contact, and the second pulse signal can be generated at the stimulator housing.

[0121] In some embodiments, among the two adjacent electrode contacts of each electrode 120, one electrode contact is electrically connected to the first pulse generation module 1112, and the other electrode contact is electrically connected to the second pulse generation module 1113.

[0122] In some embodiments, the control unit 112 is further configured to control the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to at least one group of electrode contacts of the at least one electrode 120; each group of electrode contacts includes two electrode contacts, one of which is electrically connected to the first pulse generation module 1112, and the other of which is electrically connected to the second pulse generation module 1113.

[0123] Specifically, the at least one first pulse signal and the at least one second pulse signal constitute a group of effective stimulation waveforms. In practical applications, the target region can be stimulated by the at least one group of effective stimulation waveforms, so as to achieve neural regulation.

[0124] The pulse generation device 10 of the embodiments of the present disclosure includes a pulse generation apparatus 110 for neural regulation. The detailed functions of the pulse generation device 10 can be described in the pulse generation apparatus 110 for neural regulation shown in the foregoing, and will not be described here again.

[0125] The pulse generation device 10 of the embodiments of the present disclosure can adopt at least two current paths, each of which can respectively and simultaneously generate a target pulse signal. The target pulse signal is composed of a pair of first pulse signal and second pulse signal with equal or unequal size (pulse width, amplitude, frequency) and opposite polarity.

[0126] The occurrence of the first pulse signal and the second pulse signal can form various forms of stimulation field intensity between the electrode and the target region, and the spatial diversity of the stimulation field intensity can improve the spatial accuracy of the stimulation. The dynamic controllability of the stimulation can also be achieved without changing the electrode position, and at least two stimulation field intensities can be obtained while the pulse signals are output from multiple electrode contacts, so that the at least two stimulation field intensities act on the target region in cooperation.

[0127] According to the patient condition or the different stimulation electrode contacts, the embodiments of the present disclosure can generate multiple stimulation field intensities, and the multiple stimulation field intensities can be partially overlapped, and the overlapped field intensity part can enhance the stimulation. At the same time, when the electrode 120 is displaced, the precise stimulation and the adjustable stimulation area can be achieved by adjusting the position of the field intensity, instead of the way of replacing or adjusting the electrode through craniotomy surgery. Therefore, the present disclosure can achieve flexible movement of the stimulation target area in the brain without moving the electrode.

[0128] Referring to FIG. 7, the embodiments of the present disclosure provide a structural schematic diagram of two groups of first electrode contacts 1213 of a deep electrode 121 outputting target pulse signals to form stimulation field intensity and cross field intensity. As shown in FIG. 7, the two groups of first electrode contacts 1213 of the deep electrode 121 output target pulse signals, in each group of first electrode contacts 1213, one first electrode contact 1213 outputs a first pulse signal, and the other first electrode contact 1213 outputs a first pulse signal. The two groups of first electrode contacts 1213 output target pulse signals to form two stimulation field intensities, the overlapping field intensity of the two stimulation field intensities forms a cross field intensity, the cross field intensity covers the target region, and the stimulation on the target region can be enhanced.

[0129] In actual application, the deep electrode 121 to be used and the number of first electrode contacts 1213 of the deep electrode 121 outputting pulse signals can be determined according to the size, position and required field intensity of the target region and other factors. For example, one group of first electrode contacts 1213 or three groups of first electrode contacts 1213 or more groups of first electrode contacts 1213 of the same deep electrode 121 can also be used to output target pulse signals.

[0130] Based on the above principle, the pulse generation device 10 of the embodiments of the present disclosure can achieve dynamic controllability of the stimulation according to the real condition of the patient and the selection of the stimulation site, involve different field intensity distribution and intensity change. The stimulation field intensity generated by the waveform can be independently generated, or can be in the form of partial overlap and local intensity difference.

[0131] The pulse generation device 10 of the embodiments of the present disclosure can also achieve multi-point coordinated stimulation by the synergy of multiple channels, obtaining stimulation field intensity at multiple points simultaneously, thereby achieving multi-point coordinated stimulation. This coordinated stimulation mode can fully utilize the interaction between different points to bring more precise and effective neural regulation effects to patients.

[0132] The pulse generation device 10 of the embodiments of the present disclosure adopts a deep electrode 121 and / or a cortical electrode 122 design, and achieves precise stimulation of the nervous system by precisely controlling stimulation parameters. Compared with traditional neural stimulators, the embodiments of the present disclosure have higher stimulation effects and safety, while reducing unnecessary energy consumption and potential impact on surrounding tissues.

[0133] The pulse generation device 10 of the embodiments of the present disclosure provides an innovative deep electrode 121 and / or a cortical electrode 122 design, and achieves precise stimulation of the nervous system by precisely controlling parameters of the first pulse signal and the second pulse signal. This design has high flexibility and adjustability, and can meet different treatment needs, providing a new solution for the treatment and rehabilitation of nervous system diseases.

[0134] Referring to FIG. 8, the embodiments of the present disclosure provide a schematic diagram of a framework of a pulse generation system 1. As shown in FIG. 8, the pulse generation system 1 includes a terminal device 20 and the pulse generation device 10 of the embodiments of the present disclosure.

[0135] The terminal device 20 is in communication connection with the control unit 112, and the terminal device 20 is configured to send pulse generation information to the control unit 112. The pulse generation information includes pulse signal parameters of the first pulse signal, pulse signal parameters of the second pulse signal, contact information corresponding to the first pulse signal, and contact information corresponding to the second pulse signal. The pulse signal parameters include pulse width, amplitude, and frequency, and the contact information is used to represent the electrode contact of the electrode 120 outputting the corresponding pulse signal.

[0136] The control unit 112 is configured to control the pulse generation unit 111 to generate a target pulse signal according to the pulse generation information, and output the target pulse signal to at least one electrode 120.

[0137] In some embodiments, the control unit 112 is configured to send the electroencephalogram digital signal to the terminal device 20 when it is determined that there is an abnormal neural signal according to the electroencephalogram digital signal sent by the signal conversion module 1111 of the pulse generation unit 111.

[0138] Referring to FIG. 9, the embodiment of the present disclosure provides a schematic diagram of a framework of a terminal device 20. As shown in FIG. 9, the terminal device 20 comprises a display device 210 and a server 220, and the terminal device 20 is configured to generate an electroencephalogram wave by using a debugging software of the server 220, display the electroencephalogram wave on the display device 210, and send pulse generation information to the control unit 112 in response to the pulse generation information obtained by the debugging software.

[0139] In actual application, when the pulse generation device 10 detects an abnormal neural signal, a piece of filtered, amplified and converted electroencephalogram digital signal can be stored according to a preset scheme in the pulse generation device 10. The stored electroencephalogram digital signal is transmitted to the server 220 of the closed-loop neural stimulator debugging management software 5. The electroencephalogram digital signal of the server 220 can be read by the closed-loop neural stimulator debugging management software, and an electroencephalogram waveform is generated on the debugging software for analysis by a doctor. After analyzing the electroencephalogram data of the patient, the doctor can adjust the stimulation scheme on the debugging software and save it to the pulse generation device 10.

[0140] As an example, an electroencephalogram (EEG) signal is collected by the cortical electrode 122 and the deep electrode 121, the collected EEG signal is transmitted to the signal conversion module 1111, and then transmitted to the front end of the amplification circuit of the signal conversion module 1111 through the analog switch of the signal conversion module 1111. The amplification circuit removes direct current and interference signals through high-pass filtering and low-pass filtering, and amplifies the EEG signal. The amplified EEG signal is converted into an electroencephalogram digital signal through analog-digital (A / D) conversion of the signal conversion module 1111. The electroencephalogram digital signal is processed by an algorithm in the control unit 112 to determine whether there is an abnormal neural signal. If the determination result is that there is an abnormal neural signal, a stimulation pulse is given according to the preset pulse signal parameters in the control unit 112, and the stimulation pulse is transmitted to the lesion area by the electrode 120 for neural regulation.

[0141] In some embodiments, the terminal device 20 is further configured to determine a target area for neural regulation according to the electroencephalogram digital signal, determine field strength distribution information corresponding to the target area according to the target area and a field strength distribution model, and determine pulse generation information according to the field strength distribution information and a distribution of the electrode contacts.

[0142] The field strength distribution model is obtained by at least the following method: obtaining a plurality of sample target areas and field strength distribution information corresponding to each sample target area; and training a preset initial model according to the plurality of sample target areas and the field strength distribution information corresponding to each sample target area to obtain a trained field strength distribution model.

[0143] Optionally, the field intensity distribution generated by the target pulse signal generated by the control unit 112 according to the pulse generation information can cover the target region and achieve the neuromodulation of the target region.

[0144] In practical applications, in order to achieve the best neuromodulation effect, the pulse signal design of the pulse generation system 1 provided by the embodiments of the present disclosure also involves the optimization and adjustment of the pulse signal parameters. Such optimization and adjustment can be performed according to the specific condition of the patient, individual differences, and real-time feedback during the treatment process.

[0145] The pulse generation system 1 of the embodiments of the present disclosure can realize an intelligent pulse signal parameter adjustment method through the terminal device 20 and the control unit 112. The terminal device 20 can establish a field intensity distribution model between the pulse signal parameters and the neuromodulation effect based on a machine learning algorithm by learning and analyzing a large amount of treatment data of patients. During the treatment process, the system can set the strength and distribution of the stimulation field according to the real-time physiological signals and treatment feedback of the patient, or according to the distance between the stimulation site and the electrode contact, to automatically adjust the amplitude, width, and interval of the pulse signal, so as to realize personalized and precise treatment. Of course, appropriate stimulation field intensity can also be selected for precise stimulation according to the position of the stimulation site and the electrode contact.

[0146] The pulse generation system 1 of the embodiments of the present disclosure can also realize the remote adjustment function of the pulse signal parameters through the terminal device 20 and the control unit 112. The doctor or therapist can adjust the pulse signal parameters of the neurostimulator in real time through the remote control system to adapt to the changes in the treatment process of the patient. Such remote adjustment function not only improves the convenience and flexibility of the treatment, but also enables the doctor or therapist to more conveniently monitor the treatment of the patient and timely adjust the treatment plan.

[0147] The pulse generation system 1 of the embodiments of the present disclosure includes the pulse generation device 10, and the detailed functions of the pulse generation system 1 can be specifically referred to the description of the corresponding pulse generation device 10 shown in the foregoing, which will not be described herein.

[0148] By applying the embodiments of the present disclosure, at least the following beneficial effects can be achieved:

[0149] (1) The embodiment of the present disclosure controls the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to at least one electrode 120 through the control unit 112, so that at least one electrode 120 outputs the target pulse signal to the target region of the target object, thereby outputting the first pulse signal and the second pulse signal at the same time through the first pulse signal and the second pulse signal with opposite polarities, so that the target region is regulated by nerves. Because the polarities of the first pulse signal and the second pulse signal are opposite, the opposite polarity pulse signals greatly achieve charge balance within the stimulation field strength, especially during the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the charge balance of the redundant pulse in the prior art, and thereby ensuring the nerve regulation effect.

[0150] (2) The pulse generation unit 111 of the embodiment of the present disclosure includes a first pulse generation module 1112 and a second pulse generation module 1113, which can correspond to generate a first pulse signal and a second pulse signal, respectively, and the requirements of the circuit of the pulse generation device 110 for nerve regulation are reduced, and the first pulse generation module 1112 and the second pulse generation module 1113 can be independently controlled. The use of the first pulse generation module 1112 and the second pulse generation module 1113 can double the stimulation effect, but the required current / voltage of the first pulse generation module 1112 and the second pulse generation module 1113 is less, thereby making the design of the pulse generation device 110 for nerve regulation of the embodiment of the present disclosure more flexible and adjustable.

[0151] (3) The starting time of the first pulse signal and the second pulse signal of the embodiment of the present disclosure is the same, which can prolong the action time of charge balance to a certain extent, and the charge balance effect is better. At the same time, the embodiment of the present disclosure can also be that the action time of charge balance and the effective stimulation time are performed at the same time, which can balance the excess charge while effectively stimulating, and ensures that the tissue is not damaged by the excess charge.

[0152] (4) The first pulse signal and the second pulse signal with opposite polarities used in the embodiment of the present disclosure have the same starting time, compared with the stimulation waveform in the prior art (the existing waveform is a bipolar pulse signal with opposite positive and negative polarities, and the positive pulse signal and the negative pulse signal of the bipolar pulse signal have a certain interval), the embodiment of the present disclosure can shorten the stimulation refractory period, and can generate multiple groups of stimuli in the same stimulation time, which can faster regulate the target tissue and shorten the regulation time.

[0153] As an example, the first embodiment of the present application provides a pulse generation device and a pulse generation system applied to epilepsy, which will be specifically introduced below.

[0154] Epilepsy is a chronic brain disease characterized by recurrent seizures. It is triggered by abnormal electrical discharges in the brain, and the disease is characterized by recurrence and short duration. The causes of epilepsy include muscle contraction, cortical dysplasia, brain tumor, head trauma, central nervous system infection, etc., and may be related to genetics. The onset of epilepsy is not limited to any age group, and children and the elderly are relatively common. According to statistics, epilepsy affects more than 70 million people worldwide, and the incidence in China is between 5‰ and 7‰, with about 400,000 to 600,000 new cases diagnosed each year.

[0155] The main manifestation of epilepsy is sudden and unprovoked seizures, and the symptoms of seizures vary, but the same patient has similar manifestations each time. Symptoms can include a momentary loss of consciousness and a fall, unusual sensations in the limbs, hallucinations, repeated words or single syllables, body or eye rotation, etc.

[0156] There is no specific treatment for epilepsy, and the main treatment is drug therapy, which aims to control the disease and reduce the frequency of seizures, so that patients can achieve no seizures, no side effects, and a normal quality of life. During medication, patients must regularly monitor drug blood levels to adjust the medication regimen. Patients' lifestyle habits can also directly affect the state of the disease, so improving lifestyle, such as maintaining good sleep, avoiding excessive fatigue and stress, avoiding excessive drinking and smoking, etc., is also an important measure to prevent seizures.

[0157] Before a seizure, some patients can predict that they will have a seizure hours or even days in advance. These premonitions can include unusual sensations in the limbs or some unexplained sensations. Some people also experience changes in taste, smell, and hearing. Some patients may also experience blurred vision.

[0158] These early symptoms are not necessarily related to seizures, but these premonitions can help patients prepare in advance for seizures. Such as taking anti-epileptic drugs in advance, avoiding putting themselves in dangerous situations, and preparing for injury prevention when the disease occurs.

[0159] The pulse generator and pulse generation system for epilepsy provided in the embodiment are designed to solve at least one of the above technical problems related to epilepsy.

[0160] Referring to FIG. 8, the disclosure provides a structural schematic diagram of a pulse generation system 1. As shown in FIG. 8, the pulse generation system 1 includes a terminal device 20 and a pulse generation device 10 for epilepsy according to the embodiment of the disclosure.

[0161] Referring to FIG. 10, the disclosure provides a structural schematic diagram of the pulse generation device 10 applied to epilepsy. As shown in FIG. 10, the pulse generation device 10 applied to epilepsy includes at least one deep electrode 121, at least one cortical electrode 122, a pulse generation unit 111, and a control unit 112.

[0162] Optionally, the terminal device 20 is in communication connection with the control unit 112, and the terminal device 12 is configured to acquire the brain electrical digital signal of the target object and display, display an input interface for inputting initial pulse generation information, acquire the initial pulse generation information in response to an input operation of the initial pulse generation information on the input interface, and send the initial pulse generation information to the control unit 112.

[0163] The at least one deep electrode 121 is implanted at a predetermined position of the deep brain of the target object, and the at least one cortical electrode 122 is implanted at a predetermined position of the cerebral cortex of the target object. The pulse generation unit 111 is electrically connected to the at least one deep electrode 121 and the at least one cortical electrode 122, and the pulse generation unit 111 is configured to generate a target pulse signal.

[0164] The control unit 112 is electrically connected to the pulse generation unit 111, and the control unit 112 is configured to, when detecting that the target object has epilepsy, control the pulse generation unit 111 to generate a corresponding target pulse signal according to pre-stored initial pulse generation information, and output the target pulse signal to a target region of the target object through the at least one deep electrode 121 and / or the at least one cortical electrode 122. The initial pulse generation information includes pulse parameter information and electrode information, the initial pulse generation information is pulse generation information determined by the terminal device 20 according to the brain electrical digital signal of the target object, the electrode information represents information of the deep electrode 121 and / or the cortical electrode 122 used to output the target pulse signal, and the target region includes a lesion region of epilepsy.

[0165] Specifically, the control unit 112 controls the pulse generation unit 111 to generate a target pulse signal whose field strength range covers the target region according to the initial pulse generation information, so as to regulate the epilepsy condition safely and effectively.

[0166] Optionally, the control unit 112 can determine which deep electrode 121 and / or cortical electrode 122 needs to output the pulse signal according to the electrode information, so as to output the target pulse signal to the target region.

[0167] The target object is provided with at least one deep electrode 121 and at least one skin electrode 122, and the pulse generation unit 111 is electrically connected with the at least one deep electrode 121 and the at least one skin electrode 122, so that when the control unit 112 detects that the target object has epilepsy, the control unit 112 can control the pulse generation unit 111 to generate a corresponding target pulse signal according to the pre-stored initial pulse generation information, and output the target pulse signal to the target region of the target object through the at least one deep electrode 121 and / or the at least one skin electrode 122, thereby realizing the treatment of the lesion region of epilepsy. The pre-stored initial pulse generation information of the embodiment of the present disclosure is the pulse generation information determined on the terminal device 20 according to the brain electrical digital signal of the target object, which can effectively regulate the epilepsy of the target object, and avoid the technical problems of large risk and large side effects caused by drug treatment or surgical treatment.

[0168] The pulse generation device 10 for epilepsy of the embodiment of the present disclosure can be used in cooperation with an electroencephalograph and the like, and can monitor the neural activity state of a patient in real time to provide data support for accurate regulation of pulse signals. For example, the pulse generation device 10 for epilepsy can obtain the brain waves of a patient in advance, analyze the brain waves, and analyze and judge according to the characteristics of abnormal brain waves (such as the type, frequency, amplitude, waveform, and the like of abnormal brain waves), and output an optimal stimulation pulse signal. Before the pulse generation device 10 for epilepsy is implanted, the optimal stimulation waveform is input into the pulse generation device 10 for epilepsy, so that after the product is implanted, the optimal stimulation pulse signal matched with the patient can be directly used for treatment, the epilepsy regulation effect is good, and the time for doctors to regulate various parameters and try to regulate and the adaptation time of the patient are saved.

[0169] In some embodiments, the target pulse signal includes a first pulse signal and a second pulse signal with opposite polarities, and the start time of signal output of the first pulse signal and the second pulse signal is the same.

[0170] In some embodiments, the pulse parameter information includes pulse signal parameters of the first pulse signal and pulse signal parameters of the second pulse signal; the pulse signal parameters include pulse width, amplitude, frequency, and current;

[0171] The pulse signal parameters of the first pulse signal are the same as the pulse signal parameters of the second pulse signal, or at least one of the pulse width, amplitude, frequency, and current of the first pulse signal is different from at least one of the pulse width, amplitude, frequency, and current of the second pulse signal.

[0172] Optionally, the pulse signal parameters of the first pulse signal and the second pulse signal are the same, and the first pulse signal and the second pulse signal are bidirectional symmetric pulse signals, which can ensure charge balance.

[0173] Optionally, the pulse width, amplitude, frequency, and current of the first pulse signal can be different from those of the second pulse signal, and at least one of the pulse width, amplitude, frequency, and current can be different.

[0174] Optionally, the waveform of the first pulse signal includes any one of the following: a rectangular wave, a triangular wave, a trapezoidal wave, and a sinusoidal wave; and the waveform of the second pulse signal includes any one of the following: a rectangular wave, a triangular wave, a trapezoidal wave, and a sinusoidal wave.

[0175] As an example, the waveforms of the first pulse signal and the second pulse signal are both rectangular, and the pulse signal parameters of the first pulse signal and the second pulse signal are the same.

[0176] Specifically, in the set of effective stimulation waveforms, the waveforms of the first pulse signal and the second pulse signal are not limited to square waves, but can also be triangular waves, trapezoidal waves, sinusoidal waves, etc. The waveforms of the first pulse signal and the second pulse signal can be different from each other, and even the waveforms of multiple first pulse signals or multiple second pulse signals can be different from each other. Different waveforms will produce different stimulation field strengths. The greater the slope of the stimulation waveform, the more rapidly the neuron responds. However, for local nerve clusters, the response conditions can be very complex. In practical applications, different waveforms can be considered to achieve the effect of activating / inhibiting neurons.

[0177] It has been found through research that the resting potential of a neuron is -70 mV, and the threshold voltage that enables the neuron to transmit electrical signals is -50 to -55 mV. Conversely, if you want to prevent electrical signal transmission, you must make the neuron potential not higher than -55 mV. Therefore, for the local nerve tissue around the contact, the amplitude can be determined according to the size of the tissue and the range that needs to be activated, and the pulse width can be determined according to the signal transmission characteristics of the disease. The frequency range is determined according to the refractory period of the electrical signal transmission of the neuron, which is about 3 ms. In theory, a stimulation of more than 330 Hz will not have a great impact on the neuron.

[0178] In some embodiments, the pulse signal parameters of the first pulse signal include at least one of the following: the pulse width ranges from 20 microseconds to 450 microseconds, the amplitude ranges from 0.01 volts to 10 volts, the frequency ranges from 2 hertz to 333 hertz, and the current ranges from 0.5 milliampere to 25.5 milliampere; and / or,

[0179] The pulse signal parameters of the second pulse signal include at least one of the following: a pulse width ranging from 20 microseconds to 450 microseconds, an amplitude ranging from 0.01 volts to 10 volts, a frequency ranging from 2 hertz to 333 hertz, and a current ranging from 0.5 milliampere to 25.5 milliampere.

[0180] Alternatively, the pulse width of the first pulse signal can be 20 microseconds, 200 microseconds, 300 microseconds, 450 microseconds, etc., the amplitude can be 0.01 volts, 2 volts, 5 volts, 7 volts, 10 volts, etc., the frequency can be 2 hertz, 100 hertz, 200 hertz, 333 hertz, etc., and the current can be 0.5 milliampere, 10 milliampere, 15 milliampere, 25.5 milliampere, etc. Similarly, the pulse width of the second pulse signal can be 20 microseconds, 200 microseconds, 300 microseconds, 450 microseconds, etc., the amplitude can be 0.01 volts, 2 volts, 5 volts, 7 volts, 10 volts, etc., the frequency can be 2 hertz, 100 hertz, 200 hertz, 333 hertz, etc., and the current can be 0.5 milliampere, 10 milliampere, 15 milliampere, 25.5 milliampere, etc.

[0181] In some embodiments, the time interval between adjacent two pulses of the first pulse signal ranges from 0 milliseconds to 55 milliseconds; and / or, the time interval between adjacent two pulses of the second pulse signal ranges from 0 milliseconds to 55 milliseconds.

[0182] Alternatively, the time interval between adjacent two pulses of the first pulse signal can be 3 milliseconds, 20 milliseconds, 35 milliseconds, 55 milliseconds, etc. Similarly, the time interval between adjacent two pulses of the second pulse signal can be 3 milliseconds, 20 milliseconds, 35 milliseconds, 55 milliseconds, etc.

[0183] Referring to Table 1, an embodiment of pulse signal parameters is shown, which can employ a pulse width ranging from 160 microseconds, an amplitude ranging from 0.01 volts to 10 volts, a frequency of 200 hertz, and a current of 1 milliampere.

[0184] Table 1

[0185] Alternatively, the conventional use of pulse width ranges from 60 milliseconds to 90 milliseconds, and the output ranges from 20 milliseconds to 450 milliseconds; the conventional use of amplitude ranges from 2 volts to 3 volts, and the output ranges from 0 volts to 10 volts; the frequency is generally 130 hertz, the low frequency stimulation is 60 hertz to 80 hertz, the high frequency stimulation is 130 hertz to 150 hertz, and the output ranges from 2 hertz to 255 hertz; the conventional use of current is 1.3 milliampere to 2 milliampere, and the output ranges from 0.5 to 25.5 milliampere.

[0186] Optionally, the pulse width can be 60 milliseconds, 70 milliseconds, 80 milliseconds, 90 milliseconds, etc., the amplitude can be 2 volts, 2.5 volts, 3 volts, etc., the low-frequency stimulation can be 60 Hz, 70 Hz, 80 Hz, etc., the high-frequency stimulation can be 130 Hz, 140 Hz, 150 Hz, and the current can be 1.3 mA, 1.7 mA, 2 mA, etc.

[0187] Referring to FIG. 4, the embodiment of the present disclosure provides a structural schematic diagram of a deep electrode 121. As shown in FIG. 4, the deep electrode 121 includes an electrode outer tube 1211, one end of the electrode outer tube 1211 is provided with at least one first connection contact 1212 for electrically connecting with the pulse generating unit 111, and the other end of the electrode outer tube 1211 is provided with at least one first electrode contact 1213; each first electrode contact 1213 is used for outputting a first pulse signal or a second pulse signal, and / or sensing a brain electrical signal.

[0188] As an example, as shown in FIG. 4, one end of the electrode outer tube 1211 is provided with at least two first connection contacts 1212 for electrically connecting with the pulse generating unit 111, and the other end of the electrode outer tube 1211 is provided with at least two first electrode contacts 1213.

[0189] Referring to FIG. 5, the embodiment of the present disclosure provides a structural schematic diagram of a cortical electrode 122. As shown in FIG. 5, the cortical electrode 122 includes a fixedly connected connection lead 1221 and an electrode patch 1222, one end of the connection lead 1221 is provided with at least one second connection contact 1223 for electrically connecting with the pulse generating unit 111, and the electrode patch 1222 is arranged at the other end of the connection lead 1221, and the electrode patch 1222 includes at least one second electrode contact 1224; each second electrode contact 1224 is used for outputting a first pulse signal or a second pulse signal, and / or sensing a brain electrical signal.

[0190] Optionally, each first connection contact 1212 corresponds to one first electrode contact 1213 for electrical connection, and each second connection contact 1223 corresponds to one second electrode contact 1224 for electrical connection.

[0191] As an example, as shown in FIG. 5, one end of the connection lead 1221 is provided with at least two second connection contacts 1223 for electrically connecting with the pulse generating unit 111, and the electrode patch 1222 includes at least two second electrode contacts 1224.

[0192] In some embodiments, each deep electrode 121 includes 4-8 first electrode contacts 1213, and the distance between two adjacent first electrode contacts 1213 is 8-12 mm; and / or each cortical electrode 122 includes 4-8 second electrode contacts 1224, and the distance between two adjacent second electrode contacts 1224 is 8-12 mm.

[0193] Referring to FIG. 6, the embodiment of the present disclosure provides a schematic diagram of a framework of the pulse generation unit 111. The pulse generation unit 111 includes a first pulse generation module 1112 for generating a first pulse signal and a second pulse generation module 1113 for generating a second pulse signal.

[0194] Part of the first electrode contacts 1213 of each deep electrode 121 is electrically connected to the first pulse generation module 1112, and the other part of the first electrode contacts 1213 is electrically connected to the second pulse generation module 1113.

[0195] Part of the second electrode contacts 1224 of each cortical electrode 122 is electrically connected to the first pulse generation module 1112, and the other part of the second electrode contacts 1224 is electrically connected to the second pulse generation module 1113.

[0196] Optionally, the electrode information represents information of the first electrode contacts 1213 of each deep electrode 121 and / or the second electrode contacts 1224 of each cortical electrode 122 for outputting the target pulse signal. Therefore, the electrode information is information of the electrode contacts of the deep electrode 121 and / or the cortical electrode 122 that need to be used in the epilepsy treatment.

[0197] The embodiment of the present disclosure can generate multiple stimulation field strengths according to the patient condition or different stimulation electrode contacts, and the multiple stimulation field strengths can be partially overlapped, and the overlapped field strength part can enhance the stimulation. At the same time, when the electrode is displaced, the precise stimulation and adjustable stimulation area can be achieved by adjusting the position of the field strength, instead of replacing or adjusting the electrode through craniotomy surgery again. Therefore, the present disclosure can achieve flexible movement of the stimulation target area in the brain without moving the electrode.

[0198] In some embodiments, the control unit 112 is further configured to acquire an electroencephalogram signal output from the at least one deep electrode 121 and / or the at least one cortical electrode 122, determine an adjusted target region according to the electroencephalogram signal when the target object has epilepsy according to the electroencephalogram signal, determine adjusted pulse generation information according to the adjusted target region, and control the pulse generation unit 111 to generate a corresponding target pulse signal according to the adjusted pulse generation information.

[0199] Optionally, before the pulse generation device 10 for epilepsy is implanted, the doctor can implant a plurality of SEEG electrodes in the patient's head, the plurality of SEEG electrodes are short-term implantation, the brain electrical signals are collected from the SEEG electrodes, and the positions of the lesions are confirmed according to the brain electrical signals, so as to determine the target region.

[0200] After the pulse generation device 10 for epilepsy is implanted in the patient's head, the lesion region of the patient's epilepsy may change due to the development of the disease, for example, the lesion becomes larger or smaller, new lesions are added, and the target region to be treated changes, and then the pulse generation information needs to be adjusted again to treat the patient's disease.

[0201] The control unit 112 can obtain the brain electrical signals output from the at least one deep electrode 121 and / or the at least one cortical electrode 122, so that when the target object has epilepsy, the adjusted target region can be determined according to the brain electrical signals, the adjusted target region includes the lesion region of epilepsy, and then the adjusted pulse generation information is determined according to the adjusted target region, that is, the new pulse parameter information and electrode information. The electrode information represents the information of the deep electrode 121 and / or the cortical electrode 122 for outputting the target pulse signal, and the information of the deep electrode 121 and / or the cortical electrode 122 can include the selection of the contact, the monopolar stimulation mode, the bipolar stimulation mode, the stimulation direction, the characteristics, distribution and strength of the stimulation field, etc.

[0202] Optionally, the brain electrical signal can be converted into a brain electrical digital signal after signal amplification, filtering and other signal preprocessing processes, so as to facilitate the control unit 112 to determine whether epilepsy occurs.

[0203] In some embodiments, the control unit 112 is specifically configured to: if the area of the target region is greater than a first threshold value, control a group of first electrode contacts 1213 of the at least one deep electrode 121 and / or a group of second electrode contacts 1224 of the at least one cortical electrode 122 to output the target pulse signal; if the area of the target region is greater than a second threshold value, control at least two groups of first electrode contacts 1213 of the at least one deep electrode 121 and / or at least two groups of second electrode contacts 1224 of the at least one cortical electrode 122 to output the target pulse signal; and the second threshold value is greater than the first threshold value.

[0204] Specifically, in a group of first electrode contacts 1213, one first electrode contact 1213 outputs a first pulse signal, and another first electrode contact 1213 outputs a second pulse signal.

[0205] Specifically, in a group of second electrode contacts 1224, one second electrode contact 1224 outputs a first pulse signal, and another second electrode contact 1224 outputs a second pulse signal.

[0206] Optionally, the embodiments of the present disclosure can only adjust the amplitude, pulse width, frequency and current, while the waveform is fixed, and the waveform needs to be adjusted during treatment.

[0207] According to the needs of the target area and the stimulation intensity, the corresponding contact output pulse is selected, for example, if a group of electrode contacts output pulse is selected, a field strength is formed around the group of electrode contacts, which can be suitable for the case where the lesion or seizure range is small; if the lesion or seizure range is large, two groups of spaced electrode contacts can be selected to output pulse at the same time, so that an elliptical field strength is formed between the two groups of spaced electrode contacts.

[0208] Optionally, the second threshold and the first threshold are determined according to practical experience, that is, the embodiments of the present disclosure can match at least one group of electrode contacts to work at the same time according to the size of the target area. The overlapping area of the field strengths of the two groups of electrode contacts can cover the target area, thereby enhancing the field strength of the target area.

[0209] Optionally, the first pulse signal and the second pulse signal are respectively and simultaneously generated from different electrode contacts, or the first pulse signal can be generated from the electrode contact, and the second pulse signal can be generated from the shell of the deep electrode 121.

[0210] Optionally, the monopolar stimulation mode is that at least one first electrode contact 1213 of a deep electrode 121 outputs a pulse signal, and the bipolar stimulation mode is that at least two first electrode contacts 1213 of a deep electrode 121 output pulse signals.

[0211] In some embodiments, the control unit 112 is specifically configured to: if the position of the target area is located in the deep brain of the target object, control at least one deep electrode 121 to output a target pulse signal to the target area; if the position of the target area is located in the cerebral cortex of the target object, control at least one cortical electrode 122 to output a target pulse signal to the target area; and if the position of the target area is located in the deep brain and the cerebral cortex of the target object, control at least one deep electrode 121 and at least one cortical electrode 122 to output a target pulse signal to the target area.

[0212] The embodiments of the present disclosure can determine to use the corresponding electrode according to the specific position where epilepsy occurs, so as to be suitable for various epilepsy patients.

[0213] The embodiments of the present disclosure can also analyze the real-time acquired electroencephalogram signals, and then optimize the optimal stimulation pulse signal, so as to truly realize precise stimulation, high-efficiency stimulation, full-coverage stimulation and personalized treatment.

[0214] Referring to FIG. 11, another schematic diagram of the pulse generation system 1 is provided. The pulse generation system 1 further comprises a magnet piece 50 for the target subject to wear, and the pulse generation device 10 for epilepsy further comprises a magnet induction module 130.

[0215] The magnet induction module 130 is configured to send a collection electrical signal to the control unit 112 when the magnet piece 50 is located within a predetermined distance range of the magnet induction module 130, and the control unit 112 is further configured to acquire and record the brain electrical signal output from the at least one deep electrode 121 and / or the at least one cortical electrode 122 in response to receiving the collection electrical signal.

[0216] In actual application, when the patient with epilepsy anticipates that he / she will have a seizure, the magnet induction module 130 inside the pulse generation device 10 for epilepsy, which is sensitive to the magnet, can convert the change of the magnetic field into a collection electrical signal recognizable by the control unit 112 by moving the magnet piece 50 across the location where the pulse generation device 10 for epilepsy is implanted, and the control unit 112 records the corresponding brain electrical signal after receiving the collection electrical signal.

[0217] Optionally, the pulse generation device 10 for epilepsy is fixed on the head of the target subject.

[0218] In some embodiments, the magnet induction module 130 comprises a Hall switch. The Hall switch is configured to send a collection electrical signal to the control unit 112 when the Hall switch senses a change in the magnetic field.

[0219] Optionally, when a piece of metal or semiconductor sheet with current passing through is placed vertically in the magnetic field, a potential difference will be generated at both ends of the sheet, which is called the Hall effect. The Hall switch senses the change in the magnetic field by using the Hall effect to output an electrical signal. The input end of the Hall switch is characterized by the magnetic induction intensity B, and when the B value reaches a certain degree (such as B1), the flip-flop inside the Hall switch flips, and the output level state of the Hall switch also flips, so that the collection electrical signal representing the change in the magnetic field can be output.

[0220] The control unit 112 can be a CPU (Central Processing Unit), a general-purpose processor, a DSP (Digital Signal Processor), an ASIC (Application Specific Integrated Circuit), an FPGA (Field Programmable Gate Array) or other programmable logic device, a transistor logic device, a hardware component, or any combination thereof. It can implement or execute various exemplary logical blocks, modules and circuits described in conjunction with the disclosure. The control unit 112 can also be a combination of computing functions, such as one or more microprocessor combinations, combinations of DSP and microprocessor, etc.

[0221] As an example, the embodiment of the present disclosure provides a pulse generation method applied to the pulse generation system 1 of the embodiment of the present disclosure, which comprises:

[0222] (1) The terminal device 12 acquires the digital signal of the brain waves of the target object and displays it, displays an input interface for inputting initial pulse generation information, and in response to the input operation of the initial pulse generation information to the input interface, acquires the initial pulse generation information and sends it to the control unit 112.

[0223] (2) The control unit 112 stores the initial pulse generation information, and when detecting that the target object has a seizure, controls the pulse generation unit 111 to generate a corresponding target pulse signal according to the pre-stored initial pulse generation information, and outputs the target pulse signal to the target region of the target object through at least one deep electrode 121 and / or at least one cortical electrode 122.

[0224] (3) The control unit 112 acquires the brain wave signal output from at least one deep electrode 121 and / or at least one cortical electrode 122, and when determining that the target object has a seizure according to the brain wave signal, determines an adjusted target region according to the brain wave signal, determines adjusted pulse generation information according to the adjusted target region, and controls the pulse generation unit 111 to generate a corresponding target pulse signal according to the adjusted pulse generation information.

[0225] Optionally, the control unit 112 can further control the at least one deep electrode 121 to output the target pulse signal to the target region when it is determined that the area of the target region is greater than a first threshold; control the at least one deep electrode 121 to output the target pulse signal to the target region when it is determined that the area of the target region is greater than a second threshold; and control the at least one deep electrode 121 to output the target pulse signal to the target region when it is determined that the area of the target region is greater than a third threshold; the second threshold is greater than the first threshold, and the third threshold is greater than the second threshold.

[0226] Optionally, the control unit 112 can further control the at least one deep electrode 121 to output the target pulse signal to the target region when it is determined that the position of the target region is located in the deep brain of the target object; control the at least one cortical electrode 122 to output the target pulse signal to the target region when it is determined that the position of the target region is located in the cerebral cortex of the target object; and control the at least one deep electrode 121 and the at least one cortical electrode 122 to output the target pulse signal to the target region when it is determined that the position of the target region is located in the deep brain and the cerebral cortex of the target object.

[0227] Optionally, the control unit 112 can further, in response to receiving the collected electrical signal, acquire and record the electroencephalogram signal output from the at least one deep electrode 121 and / or the at least one cortical electrode 122, determine an adjusted target region according to the electroencephalogram signal, determine adjusted pulse generation information according to the adjusted target region, and control the pulse generation unit 111 to generate a corresponding target pulse signal according to the adjusted pulse generation information.

[0228] By applying the embodiments of the present disclosure, the following beneficial effects can be achieved:

[0229] (1) The embodiments of the present disclosure are provided with the at least one deep electrode 121 and the at least one cortical electrode 122 on the head of the target object, and the pulse generation unit 111 is electrically connected with the at least one deep electrode 121 and the at least one cortical electrode 122, so that when the control unit 112 detects that the target object has epilepsy, the control unit 112 can control the pulse generation unit 111 to generate a corresponding target pulse signal according to the pre-stored initial pulse generation information, and output the target pulse signal to the target region of the target object through the at least one deep electrode 121 and / or the at least one cortical electrode 122, thereby achieving treatment of the lesion region of epilepsy. The pre-stored initial pulse generation information of the embodiments of the present disclosure is determined according to the electroencephalogram digital signal of the target object on the terminal device 20, and can effectively regulate and control the epilepsy of the target object, thereby avoiding the technical problems of high risk and large side effects caused by drug treatment or surgical treatment.

[0230] (2) The target pulse signal of the embodiment of the present disclosure includes a first pulse signal and a second pulse signal with opposite polarities and outputs the first pulse signal and the second pulse signal simultaneously. Because the first pulse signal and the second pulse signal have opposite polarities, the pulse signals with opposite polarities largely achieve charge balance within the stimulation field intensity, especially in the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect and avoiding the secondary damage caused by the use of redundant pulses in the prior art to balance the charges, thereby ensuring the nerve regulation effect.

[0231] (3) The first pulse signal and the second pulse signal of the embodiment of the present disclosure have the same starting time, which can lengthen the action time of charge balance to a certain extent and achieve better charge balance effect. At the same time, the embodiment of the present disclosure can also make the action time of charge balance and the effective stimulation time at the same time, so as to achieve the balance of redundant charges while effective stimulation and ensure that the tissue is not damaged by redundant charges.

[0232] (4) The first pulse signal and the second pulse signal of the embodiment of the present disclosure have opposite polarities and the same starting time. Compared with the stimulation waveform in the prior art (the existing waveform is a bipolar pulse signal with opposite positive and negative polarities, and the positive pulse signal and the negative pulse signal of the bipolar pulse signal have a certain interval), the embodiment of the present disclosure can shorten the stimulation refractory period, generate multiple groups of stimulation in the same stimulation time, and faster regulate the target tissue, thereby shortening the regulation time.

[0233] (5) The embodiment of the present disclosure can perform real-time inspection and adjustment of pulse generation information according to the patient's condition, so that when the lesion area of the patient's epilepsy changes with the development of the condition, the control unit 112 can acquire the brain electrical signals output from the at least one deep electrode 121 and / or the at least one cortical electrode 122, so that when the target object has epilepsy, the adjusted target area can be determined according to the brain electrical signals, and then the adjusted pulse generation information is determined according to the adjusted target area, thereby realizing more convenient monitoring of the treatment of the patient and timely adjustment of the treatment scheme. Therefore, the embodiment of the present disclosure can analyze the brain electrical signals acquired in real time, and then optimize the optimal stimulation pulse signal, thereby truly realizing precise stimulation, high-efficiency stimulation, full-coverage stimulation, and personalized treatment.

[0234] (6) The control unit 112 of the embodiment of the present disclosure can determine the at least one deep electrode 121 and / or the at least one cortical electrode 122 to be used according to the position of the target area, so as to determine the use of the corresponding electrode according to the specific position where epilepsy occurs, which can be suitable for various epilepsy patients and has strong applicability.

[0235] As an example, the second embodiment of the present application provides a pulse generator and a pulse generation system applied to Parkinson's disease, which will be specifically introduced below.

[0236] Parkinson's disease, also commonly known as "paralysis agitans", is a neurodegenerative disease. The main cause of this disease is the degeneration and death of dopaminergic neurons in the substantia nigra, which may be related to genetics, environmental factors and aging of the nervous system, etc. It is recognized that aging is the most important factor in the occurrence of Parkinson's disease, and the disease has a significant high incidence in the elderly, with a slightly higher incidence in men than in women.

[0237] The symptoms of Parkinson's disease vary, mainly manifested as motor and non-motor symptoms. Motor symptoms include resting tremor, muscle rigidity, bradykinesia and postural instability. Non-motor symptoms mainly include constipation, olfactory dysfunction, sleep disorders, autonomic dysfunction and mental and cognitive disorders, etc.

[0238] Parkinson's disease is a highly specific degeneration of dopamine-containing cells in the substantia nigra of the midbrain. The substantia nigra degeneration in Parkinson's disease leads to a lack of dopamine in the striatum. It is possible to effectively control patients with PD in the first 5-7 years of treatment, after which a series of common debilitating complications occur, which are collectively referred to as late motor fluctuations.

[0239] Currently, there are many patients, few doctors, and long diagnosis time in the society, which cannot early detection, early diagnosis and early treatment. The early diagnosis and course analysis of Parkinson's disease is not easy. Especially for the evaluation method of motor symptoms of Parkinson's disease, the international generally adopts Parkinson's Disease Rating Scale UPDRS and MDS-UPDRS to evaluate the patient's condition. Each doctor scores and comprehensively evaluates the patient's condition by manually observing the patient's fluency in completing the specified action. The complete process is time-consuming and labor-intensive, increasing the burden on doctors, and there are errors due to different mental states of doctors.

[0240] Existing drugs usually have side effects when taken by patients, such as motor complications (e.g. response oscillation, wearing off phenomena and drug-induced movement difficulties, as well as nausea, daytime sleepiness, sleep attacks, orthostatic hypotension or impulse control disorders. Symptomatic treatment of non-motor symptoms of PD (e.g. sleep disturbances, anxiety and depression) is also available. However, so far, no approved treatment has been proven to protect neurons or change the course of the disease. There is an urgent need for new therapies targeting the underlying causes of Parkinson's disease, and unlike symptomatic therapies, can slow its continued progression.

[0241] The pulse generator and the pulse generation system applied to Parkinson's disease provided by the present disclosure aim to solve at least one of the above technical problems related to Parkinson's disease.

[0242] Referring to FIG. 8, the embodiment of the present disclosure provides a framework schematic diagram of a pulse generation system 1. As shown in FIG. 8, the pulse generation system 1 includes a terminal device 20 and the pulse generation device 10 for Parkinson applied by the embodiment of the present disclosure.

[0243] Referring to FIG. 12, the embodiment of the present disclosure provides a framework schematic diagram of the pulse generation device 10 for Parkinson. As shown in FIG. 12, the embodiment of the present disclosure provides a pulse generation device 10 for Parkinson, which includes at least one deep electrode 121, a pulse generation unit 111 and a control unit 112.

[0244] The terminal device 20 is in communication connection with the control unit 112. The terminal device 20 is configured to acquire the electroencephalogram digital signal sent by the control unit 112, convert the electroencephalogram digital signal into an electroencephalogram image through a predetermined software, extract the frequency spectrum change corresponding to the beta band of the electroencephalogram from the electroencephalogram image by using a predetermined software, and display the frequency spectrum change. The terminal device 20 displays a control interface for inputting pulse generation information. In response to an input operation of the pulse generation information on the control interface, the terminal device 20 acquires the pulse generation information and sends the pulse generation information to the control unit 112.

[0245] The at least one deep electrode 121 is implanted in a predetermined position of the deep brain of the target object. Each deep electrode 121 includes at least one first electrode contact 1213. Each first electrode contact 1213 is configured to output a pulse signal and / or sense an electroencephalogram signal.

[0246] The pulse generation unit 111 is in electrical connection with the at least one deep electrode 121. The pulse generation unit 111 is configured to generate a target pulse signal.

[0247] The control unit 112 is in electrical connection with the pulse generation unit 111. The control unit 112 is configured to acquire the electroencephalogram signal output from the first electrode contact 1213 of the at least one deep electrode 121, convert the electroencephalogram signal into an electroencephalogram digital signal and send the electroencephalogram digital signal to the terminal device 20, acquire the pulse generation information sent by the terminal device 20, control the pulse generation unit 111 to generate the target pulse signal according to the pulse generation information, and output the target pulse signal to a target region of the target object through the at least one deep electrode 121. The pulse generation information includes pulse parameter information and electrode information. The electrode information represents information of the deep electrode 121 used to output the target pulse signal. The target region includes a lesion region of Parkinson.

[0248] Specifically, the control unit 112 controls the target pulse signal generated by the pulse generation unit 111 to cover the target region in the field intensity range, so as to regulate the Parkinson disease, which is safe and effective.

[0249] Optionally, the electrode information includes information of the deep electrodes 121 and information of the first electrode contacts 1213, and the control unit 112 can determine, according to the electrode information, which first electrode contact 1213 of which deep electrode 121 needs to output the pulse signal to output the target pulse signal to the target region.

[0250] Specifically, each first electrode contact 1213 of the deep electrode 121 can only output the pulse signal, can only sense the brain electrical signal, or can respectively realize the output of the pulse signal and the sensing of the brain electrical signal at different time periods.

[0251] Optionally, before converting the brain electrical signal into a brain electrical digital signal, the control unit 112 can further perform signal preprocessing on the brain electrical signal, and the signal preprocessing includes signal processing modes such as filtering processing and amplification processing.

[0252] Optionally, the pulse generation device 10 applied to Parkinson's disease is fixed on the head of the target object.

[0253] At least one deep electrode 121 of the pulse generation device 10 applied to Parkinson's disease of the embodiment of the present disclosure is implanted in a predetermined position of the deep brain of the target object, each deep electrode 121 includes at least one first electrode contact 1213, each first electrode contact 1213 is used to output a pulse signal and / or sense a brain electrical signal, so that the control unit 112 can acquire the brain electrical signal output from the first electrode contact 1213 of the at least one deep electrode 121, convert the brain electrical signal into a brain electrical digital signal, and send the brain electrical digital signal to the terminal device 20, so that the doctor can analyze the condition of the target object according to the brain electrical digital signal received by the terminal device 20, thereby determining the pulse generation information, the control unit 112 acquires the pulse generation information sent by the terminal device 20, controls the pulse generation unit 111 to generate a target pulse signal according to the pulse generation information, and outputs the target pulse signal to the target region of the target object through the at least one deep electrode 121, thereby realizing the treatment of the lesion region of Parkinson's disease.

[0254] The pulse generation device 10 applied to Parkinson's disease of the embodiment of the present disclosure is used to output a pulse signal through the deep electrode 121 implanted on the head of the target object to treat the target object, the target pulse signal is obtained according to the pulse generation information of the targeted treatment given by the brain electrical signal of the target object, and the treatment effect can be ensured. Moreover, the brain electrical signal of the target object is acquired through the at least one deep electrode 121, so that the brain electrical signal of the target object can be acquired in real time through the deep electrode 121, and the brain electrical signal of the target object does not need to be checked through other devices, thereby saving manpower and resources. Therefore, the embodiment of the present disclosure can target the Parkinson's disease of the target object by acquiring the brain electrical signal and outputting the pulse signal through the deep electrode 121, and ensure the treatment effect.

[0255] In addition, the pulse generation device 10 applied to Parkinson's disease in the embodiment of the present disclosure can realize regular checking of the condition of the target object, timely adjustment of the pulse generation information of the treatment according to the brain electrical signals of the target object, and further guarantee of the treatment effect.

[0256] In some embodiments, the target pulse signal includes a first pulse signal and a second pulse signal with opposite polarities, and the starting time of the signal output of the first pulse signal and the second pulse signal is the same.

[0257] In some embodiments, the pulse parameter information includes pulse signal parameters of the first pulse signal and pulse signal parameters of the second pulse signal; the pulse signal parameters include pulse width, amplitude, frequency and current;

[0258] The pulse signal parameters of the first pulse signal are the same as the pulse signal parameters of the second pulse signal, or at least one of the pulse width, amplitude, frequency and current of the first pulse signal is different from at least one of the pulse width, amplitude, frequency and current of the second pulse signal.

[0259] Optionally, the pulse signal parameters of the first pulse signal are the same as the pulse signal parameters of the second pulse signal, and the first pulse signal and the second pulse signal are bidirectional symmetric pulse signals, which can guarantee charge balance.

[0260] Optionally, the pulse width, amplitude, frequency and current of the first pulse signal can also be different from the pulse width, amplitude, frequency and current of the second pulse signal, and at least one of the pulse width, amplitude, frequency and current can also be different.

[0261] The pulse signal parameters of the first pulse signal are the same as the pulse signal parameters of the second pulse signal in the embodiment of the present disclosure, so that charge balance can be realized in the formed stimulation field strength. The pulse signal parameters of the first pulse signal are not the same as the pulse signal parameters of the second pulse signal, so that the stimulation strength of a certain local position can be adjusted in the formed stimulation field strength to achieve the distribution of different stimulation amounts of the stimulation target. On the basis of effective stimulation, the giving of the stimulation amount is reduced, the harm of the redundant pulses to the patient is avoided, and the low-power operation of the device is facilitated.

[0262] Specifically, in the set of effective stimulation waveforms, the waveforms of the first pulse signal and the second pulse signal are not limited to square waves, but can also be triangular waves, trapezoidal waves, sine waves, etc. The waveforms of the first pulse signal and the second pulse signal can be different, and even the waveforms of multiple first pulse signals or multiple second pulse signals can be different, and different waveforms will produce different stimulation field strengths. The greater the slope of the stimulation waveform, the faster the neuron response, but for local nerve clusters, it can make the response situation very complex, and in practical applications, different waveforms can be considered to achieve the effect of activating / inhibiting neurons.

[0263] In some embodiments, the pulse signal parameters of the first pulse signal include at least one of the following: a pulse width ranging from 20 microseconds to 450 microseconds, an amplitude ranging from 0 volts to 10.5 volts, a frequency ranging from 1 hertz to 260 hertz, and a current ranging from 1 milliampere to 30 milliampere; and / or,

[0264] The pulse signal parameters of the second pulse signal include at least one of the following: a pulse width ranging from 20 microseconds to 450 microseconds, an amplitude ranging from 0 volts to 10.5 volts, a frequency ranging from 1 hertz to 260 hertz, and a current ranging from 1 milliampere to 30 milliampere.

[0265] Alternatively, the pulse width of the first pulse signal can be 20 microseconds, 100 microseconds, 200 microseconds, 300 microseconds, 450 microseconds, etc., the amplitude can be 0.1 volts, 2 volts, 5 volts, 7 volts, 10.5 volts, etc., the frequency can be 1 hertz, 100 hertz, 150 hertz, 260 hertz, etc., and the current can be 1 milliampere, 10 milliampere, 20 milliampere, 30 milliampere, etc. Similarly, the pulse width of the second pulse signal can be 20 microseconds, 100 microseconds, 200 microseconds, 300 microseconds, 450 microseconds, etc., the amplitude can be 0.1 volts, 2 volts, 5 volts, 7 volts, 10.5 volts, etc., the frequency can be 1 hertz, 100 hertz, 150 hertz, 260 hertz, etc., and the current can be 1 milliampere, 10 milliampere, 20 milliampere, 30 milliampere, etc.

[0266] Referring to FIG. 4, the embodiment of the present disclosure provides a structural schematic diagram of a deep electrode 121. As shown in FIG. 4, the deep electrode 121 includes an electrode outer tube 1211, one end of the electrode outer tube 1211 is provided with at least one connection contact 1112 for electrical connection with the pulse generating unit 111, and the other end of the electrode outer tube 1211 is provided with at least one first electrode contact 1213.

[0267] Each first electrode contact 1213 is electrically connected to one connection contact 1112 through a wire.

[0268] As an example, as shown in FIG. 4, one end of the electrode outer tube 1211 is provided with at least two connection contacts 1112 for electrical connection with the pulse generation unit 111, and the other end of the electrode outer tube 1211 is provided with at least two first electrode contacts 1213.

[0269] Optionally, in the monopolar stimulation mode, the at least one first electrode contact 1213 of the deep electrode 121 outputs the pulse signal, and in the bipolar stimulation mode, the at least two first electrode contacts 1213 of the deep electrode 121 output the pulse signal.

[0270] In some embodiments, the first electrode contact 1213 is a ring-shaped contact arranged around the circumference of the electrode outer tube 1211, or the at least two first electrode contacts 1213 are arranged at intervals along the circumference of the electrode outer tube 1211, and / or the at least two first electrode contacts 1213 are arranged at intervals along the axis of the electrode outer tube 1211.

[0271] The embodiments of the present disclosure can generate a plurality of stimulation field strengths according to the patient's condition or different stimulation electrode contacts, and the plurality of stimulation field strengths can be partially overlapped, and the overlapping field strength part can enhance the stimulation. At the same time, when the electrode is displaced, the precise stimulation and adjustable stimulation area can be achieved by adjusting the position of the field strength, instead of replacing or adjusting the electrode through craniotomy surgery. Therefore, the present disclosure can achieve flexible movement of the stimulation target area in the brain without moving the electrode.

[0272] Optionally, the control unit 112 is further configured to control the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to at least one pair of first electrode contacts 1213 of the at least one deep electrode 121; each pair of first electrode contacts 1213 includes two first electrode contacts 1213, one first electrode contact 1213 is electrically connected with the first pulse generation module 1112, and the other first electrode contact 1213 is electrically connected with the second pulse generation module 1113.

[0273] Specifically, the at least one first pulse signal and the at least one second pulse signal constitute a set of effective stimulation waveforms, and in practical application, the target area can be stimulated by the at least one set of effective stimulation waveforms, so as to achieve the regulation of Parkinson's symptoms.

[0274] Optionally, the control unit 112 can be a CPU (Central Processing Unit), a general-purpose processor, a DSP (Digital Signal Processor), an ASIC (Application Specific Integrated Circuit), an FPGA (Field Programmable Gate Array) or other programmable logic device, a transistor logic device, a hardware component, or any combination thereof. It can implement or execute various exemplary logical blocks, modules and circuits described in conjunction with the disclosure. The control unit 112 can also be a combination of computing functions, such as a combination of one or more microprocessors, a combination of DSP and microprocessor, etc.

[0275] Referring to FIG. 13, the embodiment of the present disclosure provides a structural diagram of a group of first electrode contacts 1213 of a deep electrode 121. As shown in FIG. 13, the first electrode contacts 1213 arranged along the circumference of the electrode outer tube 1211 form a group of first electrode contacts 1213, and the number of each group of first electrode contacts 1213 is 2-4. In the embodiment shown in FIG. 13, four first electrode contacts 1213 are taken as an example.

[0276] Optionally, at least two groups of first electrode contacts 1213 are arranged along the axial direction of the electrode outer tube 1211, and the length of the first electrode contacts 1213 along the axial direction of the electrode outer tube 1211 is 0.5-1.5 mm.

[0277] Referring to FIG. 14, the embodiment of the present disclosure provides another structural diagram of a deep electrode 121. As shown in FIG. 14, the length of the first electrode contacts 1213 along the axial direction of the electrode outer tube 1211 is L1, and L1 can be 0.5 mm, 1 mm or 1.5 mm, etc.

[0278] In some embodiments, the first electrode contacts 1213 are elliptical, the length of the first electrode contacts 1213 along the circumference of the electrode outer tube 1211 is 0.8-1 mm, and the length of the first electrode contacts 1213 along the axial direction of the electrode outer tube 1211 is 0.5-0.7 mm.

[0279] The distance between the axes of the two adjacent first electrode contacts 1213 along the circumference of the electrode outer tube 1211 is 0.6-0.8 mm.

[0280] Optionally, the length along the circumference of the electrode outer tube 1211 can be 0.8 mm, 0.9 mm, 1 mm, etc. The length along the axis of the electrode outer tube 1211 is 0.5 mm, 0.6 mm, 0.7 mm, etc.; the spacing between the axes of the two adjacent first electrode contacts 1213 along the circumference of the electrode outer tube 1211 can be 0.6 mm, 0.7 mm, 0.8 mm, etc.

[0281] Referring to FIG. 15, the embodiment of the present disclosure provides another structure diagram of the deep electrode 121. As shown in FIG. 15, the spacing L2 between the axes of the two adjacent first electrode contacts 1213 along the circumference of the electrode outer tube 1211 can be 0.75 mm.

[0282] Referring to FIG. 6, the embodiment of the present disclosure provides a structure diagram of the pulse generation unit 111. As shown in FIG. 6, the pulse generation unit 111 includes a first pulse generation module 1112 for generating a first pulse signal and a second pulse generation module 1113 for generating a second pulse signal.

[0283] Among the two adjacent first electrode contacts 1213, one first electrode contact 1213 is electrically connected to the first pulse generation module 1112, and the other first electrode contact 1213 is electrically connected to the second pulse generation module 1113.

[0284] The pulse generation system 1 of the embodiment of the present disclosure includes the pulse generation device 10 applied to Parkinson, and the detailed function description of the pulse generation system 1 can be referred to the description of the pulse generation device 10 applied to Parkinson shown in the foregoing, which will not be described here.

[0285] The pulse generation system 1 of the embodiment of the present disclosure is used to treat the target object by outputting the pulse signal through the deep electrode 121 implanted in the head of the target object, and the target pulse signal is obtained according to the brain electrical signal of the target object, which can ensure the treatment effect. Moreover, the brain electrical signal of the target object is obtained through at least one deep electrode 121, so that the brain electrical signal of the target object can be obtained in real time through the deep electrode 121, and the brain electrical signal of the target object does not need to be checked through other devices, which saves manpower and resources. Therefore, the pulse generation system 1 of the embodiment of the present disclosure can regulate the Parkinson disease of the target object through the deep electrode 121 to obtain the brain electrical signal and output the pulse signal, which can ensure the treatment effect. In addition, the pulse generation system 1 of the embodiment of the present disclosure can realize regular checking of the disease of the target object, timely adjustment of the pulse generation information of the treatment according to the brain electrical signal of the target object, and further guarantee of the treatment effect.

[0286] In some embodiments, the control interface of the terminal device 20 of the pulse generation system 1 further comprises a signal acquisition control. The terminal device 20 is further configured to, in response to a selection operation on the signal acquisition control, send an electroencephalogram signal acquisition request to the control unit 112; and the control unit 112 is further configured to, in response to the electroencephalogram signal acquisition request, acquire the electroencephalogram signal output from the first electrode contact 1213 of the at least one deep electrode 121.

[0287] The deep electrode 121 of the embodiment of the present disclosure can acquire the electroencephalogram signal in real time, or acquire the electroencephalogram signal under the control of the control unit 112, so that the doctor can regularly examine the Parkinson's patient through the terminal device 20, and adjust the pulse generation information through the electroencephalogram signal, and treat the Parkinson's patient according to the disease development, so as to ensure the treatment effect and save equipment and manpower.

[0288] Referring to FIG. 16, the embodiment of the present disclosure provides a structural schematic diagram of a pulse generation system 1. As shown in FIG. 16, the pulse generation system 1 further comprises a programmer 30; the programmer 30 is connected with the control unit 112 through Bluetooth, and the programmer 30 is connected with the terminal device 20 through a data line; the control unit 112 is configured to send the electroencephalogram digital signal to the programmer 30; and the programmer 30 is configured to send the electroencephalogram digital signal to the terminal device 20.

[0289] Referring to FIG. 16, the pulse generation system 1 further comprises a charging coil 40; the programmer 30 performs electromagnetic resonance coupling transmission through the charging coil 40 to wirelessly charge the pulse generation device 10 for Parkinson's.

[0290] Optionally, the programmer 30 can be a patient programmer, which uses its own battery to perform electromagnetic resonance coupling transmission through the charging coil 40 to wirelessly charge the pulse generation device 10 for Parkinson's.

[0291] As an example, the embodiment of the present disclosure provides a pulse generation method applied to the pulse generation system 1 of the embodiment of the present disclosure, and the pulse generation method comprises:

[0292] (1) The terminal device 20 sends an electroencephalogram signal acquisition request to the control unit 112 in response to a selection operation on the signal acquisition control; and the control unit 112 acquires the electroencephalogram signal output from the first electrode contact 1213 of the at least one deep electrode 121 in response to the electroencephalogram signal acquisition request, and converts the electroencephalogram signal into an electroencephalogram digital signal and sends the electroencephalogram digital signal to the terminal device 20.

[0293] (2) The terminal device 20 acquires the electroencephalogram digital signal sent by the control unit 112, converts the electroencephalogram digital signal into an electroencephalogram image through predetermined software, extracts the spectrum change corresponding to the beta band of the electroencephalogram from the electroencephalogram image by using predetermined software, and displays the spectrum change. A control interface for inputting pulse generation information is displayed, and in response to an input operation of the pulse generation information on the control interface, the pulse generation information is acquired and sent to the control unit 112.

[0294] (3) The control unit 112 controls the pulse generation unit 111 to generate a target pulse signal according to the pulse generation information, and outputs the target pulse signal to a target region of the target object through at least one deep electrode 121.

[0295] The application of the embodiments of the present disclosure can at least achieve the following technical effects:

[0296] (1) The control unit 112 of the embodiments of the present disclosure can acquire the electroencephalogram signal output from the first electrode contact 1213 of the at least one deep electrode 121, convert the electroencephalogram signal into an electroencephalogram digital signal, and send the electroencephalogram digital signal to the terminal device 20, so that the doctor can analyze the condition of the target object according to the electroencephalogram digital signal received by the terminal device 20, thereby determining the pulse generation information. The control unit 112 acquires the pulse generation information sent by the terminal device 20, controls the pulse generation unit 111 to generate a target pulse signal according to the pulse generation information, and outputs the target pulse signal to a target region of the target object through at least one deep electrode 121, thereby realizing the treatment of the lesion region of Parkinson's disease. The embodiments of the present disclosure treat the target object by outputting a pulse signal through the deep electrode 121 implanted in the head of the target object. The target pulse signal is obtained according to the pulse generation information of the targeted treatment given by the electroencephalogram signal of the target object, which can ensure the treatment effect. Moreover, the acquisition of the electroencephalogram signal of the target object is through at least one deep electrode 121, so that the electroencephalogram signal of the target object can be acquired in real time through the deep electrode 121, without the need for additional devices to check the electroencephalogram signal of the target object, thereby saving manpower and resources. Therefore, the embodiments of the present disclosure can regulate and control the Parkinson's disease of the target object by acquiring the electroencephalogram signal and outputting the pulse signal through the deep electrode 121, thereby ensuring the treatment effect.

[0297] (2) The target pulse signal of the embodiments of the present disclosure includes a first pulse signal and a second pulse signal with opposite polarities and outputs the first pulse signal and the second pulse signal simultaneously. Since the first pulse signal and the second pulse signal have opposite polarities, the opposite polarity pulse signals to a large extent realize the charge balance within the stimulation field strength, especially in the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the charge balance using redundant pulses in the prior art, thereby ensuring the neuroregulation effect.

[0298] (3) The first pulse signal and the second pulse signal of the embodiment of the present disclosure have the same starting time, which can prolong the action time of charge balance to a certain extent, and the charge balance effect is better. At the same time, the embodiment of the present disclosure can also make the action time of charge balance and the effective stimulation time at the same time, so as to balance the excess charge while effectively stimulating, and ensure that the tissue is not damaged by the excess charge.

[0299] (4) The first pulse signal and the second pulse signal of the embodiment of the present disclosure have opposite polarities, and the starting times of the first pulse signal and the second pulse signal are the same. Compared with the stimulation waveform in the prior art (the existing waveform is a bipolar pulse signal with opposite positive and negative polarities, and the positive pulse signal and the negative pulse signal of the bipolar pulse signal have a certain interval), the embodiment of the present disclosure can shorten the stimulation refractory period, generate multiple groups of stimulation in the same stimulation time, and faster adjust the target tissue, thereby shortening the adjustment time.

[0300] (5) The embodiment of the present disclosure can periodically check the condition of the target object, adjust the pulse generation information of the treatment in a timely manner according to the electroencephalogram of the target object, and treat the Parkinson's patient according to the development of the disease, so as to ensure the treatment effect and save equipment and manpower.

[0301] As an example, the third embodiment of the present application provides a pulse generation device and system for relieving pain, and a wearable device, which will be described in detail below.

[0302] Chronic pain is a major symptom of a remote injury. Chronic pain disease is widespread in everyone's body. Chronic pain is a symptom, which occurs from a remote injury. The occurrence of chronic pain also indicates that the body constitution is declining or other parts of the body may have a health crisis. Because of the pain it brings to the patient, it can cause sleep disorders, lack of appetite, mental collapse, even personality distortion and home unrest, etc., resulting in many patients choosing to commit suicide due to the inability to endure long-term pain. It has a serious impact on the life and quality of life of the elderly.

[0303] Among them, cancer pain is a feeling caused by the information of the pain site needing repair or regulation being transmitted to the nerve center, which is one of the main causes of pain in patients with advanced cancer. In patients with pain, 50% to 80% of pain cannot be effectively controlled due to various reasons.

[0304] The causes of cancer pain can be divided into three categories: pain directly caused by tumors, accounting for about 88%; pain caused by cancer treatment, accounting for about 11%; and pain indirectly caused by tumors, accounting for about 1%. A small number of tumor patients may also experience pain unrelated to the tumor in clinical practice, for example, a lung cancer patient may experience low back and leg pain due to the presence of a herniated disc at the same time. Therefore, the cause of pain in cancer patients must be diagnosed.

[0305] With the continuous development of science and technology, the medical field relies not only on drugs but also on various treatment instruments for patient treatment, such as super laser pain treatment instruments, ultrasonic treatment instruments, and infrared treatment instruments. Among them, the super laser pain treatment instrument irradiates the nerve ganglion, nerve trunk, nerve plexus, pain point, and acupoint of the patient through laser, uses the photoelectric, photomagnetic, photochemical, photoimmunity, and photoenzyme effects produced by light acting on the human body, and can effectively treat inflammatory, neurological, and traumatic pain in patients.

[0306] The ultrasonic treatment instrument acts on the human body with ultrasonic waves to achieve the treatment purpose. The ultrasonic waves act on human tissues to produce mechanical action, thermal action, and cavitation action, resulting in accelerated blood flow in local tissues, improved blood circulation, increased peristalsis of blood vessel walls, enhanced cell membrane permeability, ion redistribution, vigorous metabolism, reduced hydrogen ion concentration in tissues, increased pH value, relaxed muscles, decreased muscle tension, and reduced or relieved pain. Changes in local tissues during ultrasonic treatment can affect the body in a certain stage or the whole body through the neural-humoral pathway, thereby playing a therapeutic role.

[0307] The infrared treatment instrument acts on the treatment site through the penetration ability of infrared rays, can penetrate the skin, directly produce a thermal effect on muscles, subcutaneous tissues, and the like, accelerate blood circulation, increase metabolism, reduce pain, increase muscle relaxation, produce a massage effect, and the like.

[0308] However, the above-mentioned pain treatment methods are mainly physical therapy for ordinary and less severe pain. However, they have little effect on cancer pain or some chronic pain of unknown cause.

[0309] The pain relief pulse generating device and system and wearable device provided by the present disclosure aim to solve at least one of the above technical problems related to pain.

[0310] Referring to FIG. 17, the present disclosure provides a structural schematic diagram of a pain relief pulse generating device 110. As shown in FIG. 17, the pain relief pulse generating device 110 includes at least one electrode 120, a pulse generating unit 111, and a control unit 112.

[0311] The at least one electrode 120 is arranged at a target region of a target object, each electrode 120 includes at least one electrode contact, and the target region includes a pain region and / or a spinal cord.

[0312] The pulse generation unit 111 is electrically connected with the at least one electrode, and the pulse generation unit 111 is configured to generate a target pulse signal.

[0313] The control unit 112 is electrically connected with the pulse generation unit 111, and the control unit 112 is configured to control the pulse generation unit 111 to generate the target pulse signal and output the target pulse signal to the target region through the at least one electrode, so as to stimulate the nerve related to the pain of the target region.

[0314] The target pulse signal includes a first pulse signal and a second pulse signal with opposite polarities, and the first pulse signal and the second pulse signal have the same starting time of signal output.

[0315] The pain relief pulse generation device 110 of the embodiment of the present disclosure sets the at least one electrode 120 at the target region of the target object, and the control unit 112 can control the pulse generation unit 111 to generate the target pulse signal and output the target pulse signal to the target region through the at least one electrode 120, so as to stimulate the nerve related to the pain of the target region. Therefore, the embodiment of the present disclosure can interfere with the pain signal or inhibit the pain signal by stimulating the nerve related to the pain of the target region, so as to achieve the purpose of relieving the pain.

[0316] Optionally, the embodiment of the present disclosure stimulates the Aβ fiber through the target pulse signal, so that the transmission gate is closed, and the signal of the A-δ or C fiber with a small diameter cannot be transmitted,

[0317] Meanwhile, the target pulse signal used by the pain relief pulse generation device 110 of the embodiment of the present disclosure includes the first pulse signal and the second pulse signal with opposite polarities, and the pulse signals with opposite polarities are beneficial to realize the charge balance in the stimulation field intensity, especially in the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the charge balance of the redundant pulse in the prior art, and ensuring the effect of relieving the pain.

[0318] Referring to FIG. 18, the embodiment of the present disclosure provides a waveform structure diagram of a target pulse signal. As an example, as shown in FIG. 18, the pulse signal parameters of the first pulse signal and the pulse signal parameters of the second pulse signal are the same, one first pulse of the first pulse signal and one second pulse of the second pulse signal are opposite and symmetrical in polarity, that is, the first pulse signal and the first pulse signal are bidirectional symmetrical pulse signals, which can completely ensure the charge balance.

[0319] Optionally, the pulse width, amplitude, frequency and current of the first pulse signal can also be different from the pulse width, amplitude, frequency and current of the second pulse signal, and at least one of the pulse width, amplitude, frequency and current can be different.

[0320] In some embodiments, the pulse signal parameters of the first pulse signal include at least one of the following: a pulse width ranging from 20 microseconds to 1000 microseconds, an amplitude ranging from 0.01 volts to 15 volts, a frequency ranging from 20 hertz to 100 kilohertz, a current ranging from 0.01 milliampere to 25.5 milliampere; and / or,

[0321] The pulse signal parameters of the second pulse signal include at least one of the following: a pulse width ranging from 20 microseconds to 1000 microseconds, an amplitude ranging from 0.01 volts to 15 volts, a frequency ranging from 20 hertz to 100 kilohertz, a current ranging from 0.01 milliampere to 25.5 milliampere.

[0322] Optionally, the pulse width of the first pulse signal can be 20 microseconds, 200 microseconds, 500 microseconds, 700 microseconds, 1000 microseconds, etc., the amplitude can be 0.01 volts, 2 volts, 5 volts, 10 volts, 15 volts, etc., the frequency can be 20 hertz, 500 hertz, 50 kilohertz, 100 kilohertz, etc., and the current can be 0.01 milliampere, 10 milliampere, 15 milliampere, 25.5 milliampere, etc. Similarly, the pulse width of the second pulse signal can be 20 microseconds, 200 microseconds, 500 microseconds, 700 microseconds, 1000 microseconds, etc., the amplitude can be 0.01 volts, 2 volts, 5 volts, 10 volts, 15 volts, etc., the frequency can be 20 hertz, 500 hertz, 50 kilohertz, 100 kilohertz, etc., and the current can be 0.01 milliampere, 10 milliampere, 15 milliampere, 25.5 milliampere.

[0323] The pulse signal parameters of the first pulse signal of the embodiments of the present disclosure are the same as the pulse signal parameters of the second pulse signal, so that charge balance can be achieved in the formed stimulation field strength. The pulse signal parameters of the first pulse signal are different from the pulse signal parameters of the second pulse signal, so that the stimulation strength of a certain local position can be adjusted in the formed stimulation field strength to achieve the distribution of different stimulation amounts of the stimulation target. On the basis of effective stimulation, the giving of stimulation amount is reduced, unnecessary side effects are avoided, and low-power operation of the device is facilitated.

[0324] In practice, after a neuron transmits a signal, it enters a refractory period, and stimulation of the neuron has no response in the refractory period. Therefore, stimulation after a suitable interval can achieve the effect, save energy, and avoid unnecessary side effects. There is a certain time interval T between the end of a stimulation and the start of the next stimulation, and the time intervals of the plurality of stimulation blanking periods T can be the same or different.

[0325] In some embodiments, the time interval T between adjacent two pulses of the first pulse signal ranges from 0 millisecond to 500 milliseconds; and / or, the time interval T between adjacent two pulses of the second pulse signal ranges from 0 millisecond to 500 milliseconds.

[0326] Optionally, the time interval T between adjacent two pulses of the first pulse signal can be 3 milliseconds, 100 milliseconds, 300 milliseconds, 500 milliseconds, etc. Similarly, the time interval T between adjacent two pulses of the second pulse signal can be 3 milliseconds, 100 milliseconds, 300 milliseconds, 500 milliseconds, etc.

[0327] In some embodiments, the waveform of the first pulse signal includes at least one of the following: a rectangular wave, a triangular wave, a trapezoidal wave, and a sinusoidal wave; and / or, the waveform of the second pulse signal includes at least one of the following: a rectangular wave, a triangular wave, a trapezoidal wave, and a sinusoidal wave.

[0328] In some embodiments, the waveform of the first pulse signal and the waveform of the second pulse signal are both rectangular, and the pulse signal parameters of the first pulse signal and the pulse signal parameters of the second pulse signal are the same, the pulse signal parameters including pulse width, amplitude, and frequency.

[0329] Specifically, in the set of effective stimulation waveforms, the waveforms of the first pulse signal and the second pulse signal are not limited to square waves, but can also be triangular waves, trapezoidal waves, sinusoidal waves, etc. The waveforms of the first pulse signal and the second pulse signal can be different from each other, and even the waveforms of multiple first pulse signals or multiple second pulse signals can be different from each other, and different waveforms will produce different stimulation field strengths. The greater the stimulation waveform slope, the more rapid the neuron response, but for local neural clusters, it can make the response situation very complex. In practical applications, different waveforms can be considered to achieve the effect of activating / inhibiting neurons.

[0330] In some embodiments, the electrode contact includes a first electrode contact 1213.

[0331] Referring to FIG. 19, the present disclosure provides a structural schematic diagram of an electrode needle 1201. As shown in FIG. 19, the at least one electrode includes at least one electrode needle 1201, and the electrode needle 1201 is implanted into a target area; the electrode needle 1201 includes an electrode rod 1202, one end of the electrode rod 1202 is provided with at least one first electrode contact 1213, and each first electrode contact 1213 is electrically connected with the pulse generation unit 111.

[0332] As an example, one end of the electrode rod 1202 is provided with at least two first electrode contacts 1213. In monopolar stimulation mode, at least one first electrode contact 1213 of one electrode needle 1201 outputs a pulse signal, and in bipolar stimulation mode, at least two first electrode contacts 1213 of one electrode needle 1201 output pulse signals.

[0333] Referring to FIG. 19, the first electrode contact 1213 is a ring-shaped contact arranged around the circumference of the electrode rod 1202; each electrode needle 1201 includes 4-8 first electrode contacts 1213, and the distance L1 between two adjacent first electrode contacts 1213 is 2-5 mm.

[0334] Alternatively, the distance L1 between two adjacent first electrode contacts 1213 can be 2 mm, 3 mm, 4 mm, 5 mm, etc.

[0335] In some embodiments, the electrode contact includes a second electrode contact 1224.

[0336] Referring to FIG. 20, the present disclosure provides a structural schematic diagram of an electrode patch 1203. As shown in FIG. 20, the at least one electrode includes at least one electrode patch 1203, which is attached to the target area; the electrode patch 1203 includes an electrode patch 1222, which includes at least one second electrode contact 1224; each second electrode contact 1224 is electrically connected to the pulse generation unit 111.

[0337] As an example, as shown in FIG. 20, the electrode patch 1222 includes at least two second electrode contacts 1224.

[0338] Referring to FIG. 20, the second electrode contact 1224 is square-shaped, and a plurality of second electrode contacts 1224 are arranged in an array on the electrode patch 1222. In some embodiments, the second electrode contact 1224 is circular-shaped, and a plurality of second electrode contacts 1224 are arranged in at least one column of second electrode contacts 1224 on the electrode patch 1222.

[0339] Referring to FIG. 6, the present disclosure provides a structural schematic diagram of a pulse generation unit 111. The pulse generation unit 111 includes a first pulse generation module 1112 for generating a first pulse signal and a second pulse generation module 1113 for generating a second pulse signal; a portion of the electrode contacts are electrically connected to the first pulse generation module 1112, and another portion of the electrode contacts are electrically connected to the second pulse generation module 1113.

[0340] The control unit 112 is further configured to output a target pulse signal to at least one electrode contact group of the at least one electrode according to the target pulse signal generated by the control pulse generation unit 111; each electrode contact group includes two electrode contacts, one of which is electrically connected to the first pulse generation module 1112, and the other of which is electrically connected to the second pulse generation module 1113.

[0341] Optionally, in the two adjacent electrode contacts, one is electrically connected to the first pulse generation module 1112, and the other is electrically connected to the second pulse generation module 1113.

[0342] Specifically, the at least one first pulse signal and the at least one second pulse signal constitute an effective stimulation waveform, and in practical applications, the target area can be stimulated by the at least one effective stimulation waveform, so as to achieve the purpose of relieving pain.

[0343] The embodiments of the present disclosure can generate a plurality of stimulation field strengths according to the pain points of the pain area of the patient, and the plurality of stimulation field strengths can be partially overlapped, and the overlapping field strength part can enhance the stimulation.

[0344] Optionally, the control unit 112 can be a CPU (Central Processing Unit, central processing unit), a general-purpose processor, a DSP (Digital Signal Processor, digital signal processor), an ASIC (Application Specific Integrated Circuit, application specific integrated circuit), an FPGA (Field Programmable Gate Array, field programmable gate array) or other programmable logic device, transistor logic device, hardware component or any combination thereof. It can implement or execute various exemplary logic blocks, modules and circuits described in combination with the disclosure. The control unit 112 can also be a combination of computing functions, such as a combination of one or more microprocessors, a combination of DSP and microprocessor, etc.

[0345] The embodiments of the present disclosure provide a wearable device, which comprises a connecting structure and the pain relieving pulse generation device 110 of the embodiments of the present disclosure; the connecting structure is detachably connected with the pain relieving pulse generation device 110, and the connecting structure is used to be fixedly connected at a predetermined position of a target object.

[0346] Optionally, the connecting structure can be fixed at the waist, arm, leg, neck or head of the target object.

[0347] In some embodiments, the connecting structure comprises a first connecting band and a second connecting band; the first connecting band and the second connecting band are each detachably connected with the pain-relieving pulse generating device 110; the first connecting band and the second connecting band are used to be detachably connected to enclose a ring shape.

[0348] Optionally, the end of the first connecting band and the end of the second connecting band can be adhesively connected, so that a size-adjustable ring structure that can be enclosed into a ring shape is adapted to the size of different patients.

[0349] The wearable device of the embodiments of the present disclosure sets at least one electrode 120 at a target region of a target object, and the control unit 112 can control the pulse generating unit 111 to generate a target pulse signal and output the target pulse signal to the target region through the at least one electrode 120 to stimulate the pain-related nerves of the target region. Therefore, the embodiments of the present disclosure can stimulate the Aβ fiber through the target pulse signal, so that the transmission gate is closed, and the signal of the A-δ or C fiber with a small diameter cannot be transmitted, thereby playing a role of interfering with or inhibiting the pain signal, so as to achieve the purpose of relieving pain.

[0350] Meanwhile, the target pulse signal used by the wearable device of the embodiments of the present disclosure comprises a first pulse signal and a second pulse signal with opposite polarities, and the pulse signals with opposite polarities are beneficial to realize charge balance within the stimulation field intensity, especially in the synchronous output phase of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the use of redundant pulses in the prior art, and ensuring the effect of relieving pain.

[0351] Referring to FIG. 21, the embodiments of the present disclosure provide a structural schematic diagram of a pulse generating system 1. When the pulse generating device is used for relieving pain, the pulse generating system 1 can further comprise an adjusting device 60 and the pain-relieving pulse generating device 110 of the embodiments of the present disclosure.

[0352] The adjusting device 60 is used to send adjustment information to the control unit 112, so that the control unit 112 determines pulse generating information according to the adjustment information, and controls the pulse generating unit 111 to generate a target pulse signal according to the pulse generating information.

[0353] The pulse generating information comprises pulse signal parameters of the first pulse signal, pulse signal parameters of the second pulse signal, contact information corresponding to the first pulse signal, and contact information corresponding to the second pulse signal.

[0354] Optionally, the contact information is used to indicate the electrode contact of the electrode 120 outputting the pulse signal.

[0355] Optionally, the adjusting device 60 is in communication connection or electrical connection with the control unit 112.

[0356] The pulse generation system 1 applied to the embodiments of the present disclosure can at least achieve the following technical effects:

[0357] The pulse generation system 1 of the embodiments of the present disclosure sets at least one electrode 120 at a target region of a target object, and the control unit 112 can control the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to the target region through the at least one electrode 120 to stimulate the related nerves of pain in the target region. The pulse generation system 1 of the embodiments of the present disclosure can stimulate the Aβ fiber through the target pulse signal, so that the transmission gate is closed, and the signals of the A-δ or C fiber with small diameter cannot be transmitted, thereby playing a role of interfering with or inhibiting the pain signal, so as to achieve the purpose of relieving pain.

[0358] Meanwhile, the target pulse signal adopted by the pulse generation system 1 of the embodiments of the present disclosure includes a first pulse signal and a second pulse signal with opposite polarities, and the pulse signals with opposite polarities are beneficial to achieve charge balance within the stimulation field intensity, especially in the synchronous output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the charge balance of the redundant pulse in the prior art, and ensuring the effect of relieving pain.

[0359] In some embodiments, the adjusting device 60 includes an increase adjusting module and a decrease adjusting module, and the adjusting information includes increase information and decrease information.

[0360] The adjusting device 60 is configured to send the increase information or the decrease information to the control unit 112 in response to a selected operation of the increase adjusting module or the decrease adjusting module; the control unit 112 is configured to adjust the current pulse generation information to the next pulse generation information according to the arrangement order of the pre-stored multiple pulse generation information in response to receiving the increase information, or adjust the current pulse generation information to the previous pulse generation information according to the arrangement order of the pre-stored multiple pulse generation information in response to receiving the decrease information; and the multiple pulse generation information is arranged in the order from weak to strong of the field intensity of the corresponding generated target pulse signal.

[0361] Optionally, the pre-stored multiple pulse generation information is set in advance, and different degrees of stimulation can be achieved by setting different pulse signal parameters and different electrode contact output pulse information, and the user can adjust according to his own needs.

[0362] Optionally, the increase adjusting module and the decrease adjusting module can be manually pressed adjusting buttons, and the increase adjusting module and the decrease adjusting module can also be corresponding adjusting controls. The adjusting device 60 includes a touch display screen, and the touch display screen includes an increase adjusting control and a decrease adjusting control, so as to facilitate the user to select and operate.

[0363] The adjusting device 60 of the embodiment of the present disclosure adjusts the gear of the output target pulse signal according to the demand of the target object, so as to realize that the user can flexibly control the field intensity of the output target pulse signal. For example, when the user feels that there is still some pain, the increasing adjusting module can be pressed, so that the field intensity of the output target pulse signal is increased, and the pain of the user is further relieved. Meanwhile, when the user feels that the pain is relieved, the decreasing adjusting module can be pressed, so that the field intensity of the output target pulse signal is decreased, and overstimulation is avoided. Therefore, the target pulse signal of the embodiment of the present disclosure can be flexibly adjusted according to the demand of the user, and the user experience is improved.

[0364] As an example, the embodiment of the present disclosure provides a pulse generation method applied to the pulse generation system 1 of the embodiment of the present disclosure, and the pulse generation method comprises the following steps of:

[0365] (1) The control unit 112 controls the pulse generation unit 111 to generate a target pulse signal according to initial pulse generation information, and outputs the target pulse signal to a target region through at least one electrode, so as to stimulate the related nerves of the pain of the target region.

[0366] Optionally, the initial pulse generation information is default pulse generation information, and the user can further adjust to the gear required by himself through the adjusting device 60.

[0367] (2) At least one adjusting operation is performed: the adjusting device 60 sends the increasing information or the decreasing information to the control unit 112 in response to the selected operation of the increasing adjusting module or the decreasing adjusting module; the control unit 112 adjusts the current pulse generation information to the next pulse generation information according to the arrangement order of the pre-stored multiple pulse generation information in response to receiving the increasing information; or adjusts the current pulse generation information to the previous pulse generation information according to the arrangement order of the pre-stored multiple pulse generation information in response to receiving the decreasing information.

[0368] Optionally, the increasing adjusting module and the decreasing adjusting module can be manually pressed adjusting buttons, and the increasing adjusting module and the decreasing adjusting module can also be corresponding adjusting controls. The adjusting device 60 comprises a touch display screen, and the touch display screen comprises an increasing adjusting control and a decreasing adjusting control, so as to facilitate the user to select and operate.

[0369] By applying the embodiment of the present disclosure, at least the following technical effects can be achieved:

[0370] (1) The embodiment of the present disclosure sets at least one electrode 120 at a target region of a target object, and the control unit 112 can control the pulse generating unit 111 to generate a target pulse signal and output the target pulse signal to the target region through the at least one electrode 120 to stimulate the related nerves of pain in the target region. Therefore, the embodiment of the present disclosure can stimulate the Aβ fiber through the target pulse signal, so that the transmission gate is closed, and the signal of the A-δ or C fiber with a small diameter cannot be transmitted, thereby playing a role of interfering with or inhibiting the pain signal, so as to achieve the purpose of relieving pain.

[0371] (2) The target pulse signal of the embodiment of the present disclosure includes a first pulse signal and a second pulse signal with opposite polarities and outputs the first pulse signal and the second pulse signal at the same time. Since the first pulse signal and the second pulse signal have opposite polarities, the pulse signals with opposite polarities can achieve charge balance in the stimulation field to a great extent, especially in the synchronization output stage of the first pulse signal and the second pulse signal, while ensuring the stimulation effect, avoiding the secondary damage caused by the charge balance of the redundant pulse in the prior art, and thus ensuring the nerve regulation effect.

[0372] (3) The starting time of the first pulse signal and the second pulse signal of the embodiment of the present disclosure is the same, which can prolong the action time of charge balance to a certain extent, and the charge balance effect is better. At the same time, the embodiment of the present disclosure can also be that the action time of charge balance and the effective stimulation time are performed at the same time, so that the redundant charge can be balanced while the effective stimulation is performed, and the tissue is prevented from being damaged by the redundant charge.

[0373] (4) The first pulse signal and the second pulse signal with opposite polarities are used in the embodiment of the present disclosure, and the starting time of the first pulse signal and the second pulse signal is the same. Compared with the stimulation waveform in the prior art (the existing waveform is a bipolar pulse signal with opposite polarities of positive and negative, and the positive pulse signal and the negative pulse signal of the bipolar pulse signal have a certain interval), the embodiment of the present disclosure can shorten the stimulation refractory period, generate multiple groups of stimulation in the same stimulation time, and more quickly regulate the target tissue and shorten the regulation time.

[0374] (5) The adjustment device 60 of the embodiment of the present disclosure adjusts the gear of the output target pulse signal according to the needs of the target object, so that the user can flexibly control the field strength of the output target pulse signal. For example, when the user feels that there is still some pain, the increase adjustment module can be pressed to increase the field strength of the output target pulse signal, so as to further relieve the pain of the user. At the same time, when the user feels that the pain is relieved, the decrease adjustment module can be pressed to decrease the field strength of the output target pulse signal, so as to avoid excessive stimulation. Therefore, the target pulse signal of the embodiment of the present disclosure can be flexibly adjusted according to the needs of the user, and the user experience is improved.

[0375] It should be understood that although each operation step in the flowcharts of the embodiments of the present disclosure is indicated by an arrow, the implementation order of the steps is not limited to the order indicated by the arrow. Unless otherwise specified herein, in some implementation scenarios of the embodiments of the present disclosure, the implementation steps in each flowchart can be executed in other orders as required. In addition, part or all of the steps in each flowchart can include multiple sub-steps or multiple stages based on the actual implementation scenario. Part or all of these sub-steps or stages can be executed at the same time, and each of these sub-steps or stages can also be executed at different times. In the scenario where the execution times are different, the execution order of these sub-steps or stages can be flexibly configured as required, and the embodiments of the present disclosure do not limit this.

[0376] In the embodiments of the present disclosure, the term "module" or "unit" refers to a computer program or a part of a computer program with a predetermined function, and works together with other related parts to achieve a predetermined target, and can be implemented entirely or partially by using software, hardware (such as a processing circuit or a memory) or a combination thereof. Similarly, one processor (or multiple processors or memories) can be used to implement one or more modules or units. In addition, each module or unit can be a part of an integral module or unit that includes the functions of the module or unit.

[0377] The above is only an optional implementation of some implementation scenarios of the present disclosure, and it should be pointed out that, for those skilled in the art, without departing from the technical concept of the present disclosure, other similar implementation means based on the technical idea of the present disclosure are also within the protection scope of the embodiments of the present disclosure.

Claims

1. A pulse generator for neural modulation, wherein, include: A pulse generation unit for electrical connection to at least one electrode; At least one of the electrodes is used to be positioned at a predetermined location on the target object; A control unit, electrically connected to the pulse generating unit, is used to control the pulse generating unit to generate a target pulse signal and output the target pulse signal to at least one of the electrodes, so that at least one of the electrodes outputs the target pulse signal to the target area of ​​the target object; The target region is the region where neural modulation is performed; The target pulse signal includes a first pulse signal and a second pulse signal with opposite polarities, and the first pulse signal and the second pulse signal have the same start time for signal output.

2. The pulse generator for neural modulation according to claim 1, characterized in that, Both the waveforms of the first pulse signal and the second pulse signal are rectangular. The pulse signal parameters of the first pulse signal and the second pulse signal are the same, including pulse width, amplitude, and frequency.

3. A pulse generating device, wherein, include: At least one electrode, and a pulse generator for neural modulation as described in any one of claims 1-2; Each of the electrodes is provided with at least one electrode contact for outputting a first pulse signal or a second pulse signal.

4. The pulse generating device according to claim 3, characterized in that, For use in epilepsy, at least one of the electrodes comprises at least one deep electrode and / or at least one cortical electrode; The deep electrode is used to be implanted at a predetermined location deep within the brain of the target subject, and the cortical electrode is used to be implanted at a predetermined location in the cerebral cortex of the target subject; The pulse generating unit is electrically connected to at least one deep electrode and at least one dermal electrode, and is used to generate a target pulse signal; The control unit is electrically connected to the pulse generating unit and is used to control the pulse generating unit to generate a corresponding target pulse signal according to the pre-stored initial pulse generation information when the target object is detected to have epilepsy, and to output the target pulse signal to the target area of ​​the target object through at least one of the deep electrodes and / or at least one of the dermal electrodes; The initial pulse generation information includes pulse parameter information and electrode information. The initial pulse generation information is pulse generation information determined by the terminal device based on the EEG digital signal of the target object. The electrode information represents the information of deep electrodes and / or cortical electrodes used to output the target pulse signal. The target region includes the lesion region of the epilepsy.

5. The pulse generating device according to claim 4, wherein, The electrode contacts include a first electrode contact; The deep electrode includes an electrode outer tube, one end of which is provided with at least one first contact point for electrical connection with the pulse generating unit, and the other end of which is provided with at least one first electrode contact. Each of the first electrode contacts is used to output a first pulse signal or a second pulse signal, and / or to sense electroencephalogram (EEG) signals.

6. The pulse generating device according to claim 4, wherein, The electrode contacts include a second electrode contact; The cortical electrode includes a fixedly connected connecting wire and an electrode patch. One end of the connecting wire is provided with at least one second contact point for electrical connection with the pulse generating unit. The electrode patch is provided at the other end of the connecting wire and includes at least one second electrode contact point. Each of the second electrode contacts is used to output a first pulse signal or a second pulse signal, and / or to sense electroencephalogram (EEG) signals.

7. The pulse generating device according to claim 4, wherein, The control unit is further configured to acquire electroencephalogram (EEG) signals output from at least one of the deep electrodes and / or at least one of the cortical electrodes, and when it is determined that the target object has epilepsy based on the EEG signals, to determine an adjusted target region based on the EEG signals, to determine adjusted pulse generation information based on the adjusted target region, and to control the pulse generation unit to generate a corresponding target pulse signal based on the adjusted pulse generation information.

8. The pulse generating device according to claim 7, wherein, The control unit is specifically used for: If the area of ​​the target region is greater than the first threshold, then control at least one set of first electrode contacts of the deep electrode and / or at least one set of second electrode contacts of the dermal electrode to output the target pulse signal; If the area of ​​the target region is greater than the second threshold, then control at least two sets of first electrode contacts of at least one deep electrode and / or at least two sets of second electrode contacts of at least one dermal electrode to output the target pulse signal; The second threshold is greater than the first threshold.

9. The pulse generating device according to claim 3, wherein, For application in Parkinson's disease, at least one of the electrodes includes at least one deep electrode, implanted at a predetermined location deep within the brain of the target subject; each of the deep electrodes includes at least one electrode contact, and each of the electrode contacts is used to output pulse signals and / or sense electroencephalogram (EEG) signals; The pulse generating unit is electrically connected to at least one of the deep electrodes and is used to generate a target pulse signal; The control unit is electrically connected to the pulse generating unit and is used to acquire EEG signals output from the electrode contacts of at least one of the deep electrodes, convert the EEG signals into digital EEG signals and send them to the terminal device, acquire pulse generation information sent by the terminal device, control the pulse generating unit to generate a target pulse signal according to the pulse generation information, and output the target pulse signal to the target area of ​​the target object through at least one of the deep electrodes. The pulse generation information includes pulse parameter information and electrode information. The electrode information represents the information of the deep electrode used to output the target pulse signal. The target region includes the lesion region of Parkinson's disease.

10. The pulse generating device according to claim 9, wherein, The pulse signal parameters of the first pulse signal include at least one of the following: the pulse width of the first pulse signal is in the range of 20 microseconds to 450 microseconds; the amplitude of the first pulse signal is in the range of 0 volts to 10.5 volts; the frequency of the first pulse signal is in the range of 1 Hz to 260 Hz; and the current of the first pulse signal is in the range of 1 mA to 30 mA; and / or, The pulse signal parameters of the second pulse signal include at least one of the following: the pulse width of the second pulse signal is in the range of 20 microseconds to 450 microseconds, the amplitude of the second pulse signal is in the range of 0 volts to 10.5 volts, the frequency of the second pulse signal is in the range of 1 Hz to 260 Hz, and the current of the second pulse signal is in the range of 1 mA to 30 mA.

11. The pulse generating device according to claim 3, wherein, For pain relief, at least one of the electrodes is disposed in a target area of ​​a target object, the target area including a painful area and / or the spinal cord; The pulse generating unit is electrically connected to at least one of the electrodes and is used to generate a target pulse signal; The control unit is used to control the pulse generating unit to generate a target pulse signal, and output the target pulse signal to the target area through at least one electrode to stimulate the pain-related nerves in the target area.

12. The pulse generating device according to claim 11, wherein, The pulse signal parameters of the first pulse signal include at least one of the following: pulse width ranging from 20 microseconds to 1000 microseconds, amplitude ranging from 0.01 volts to 15 volts, frequency ranging from 20 Hz to 100 kHz, and current ranging from 0.01 mA to 25.5 mA; and / or, The pulse signal parameters of the second pulse signal include at least one of the following: the pulse width ranges from 20 microseconds to 1000 microseconds, the amplitude ranges from 0.01 volts to 15 volts, the frequency ranges from 20 Hz to 100 kHz, and the current ranges from 0.01 mA to 25.5 mA.

13. A pulse generation system, wherein, include: Terminal equipment and pulse generating device as described in any one of claims 3-12; The terminal device is communicatively connected to the control unit, and the terminal device is used to send pulse generation information to the control unit; the pulse generation information includes pulse signal parameters of the first pulse signal, pulse signal parameters of the second pulse signal, contact information corresponding to the first pulse signal, and contact information corresponding to the second pulse signal; the pulse signal parameters include pulse width, amplitude, and frequency, and the contact information is used to represent the electrode contacts of the electrode that outputs the corresponding pulse signal; The control unit is used to control the pulse generation unit to generate a target pulse signal according to the pulse generation information, and to output the target pulse signal to at least one electrode.

14. The pulse generation system according to claim 13, wherein, The terminal device is also used to determine the target area for neuromodulation based on the EEG digital signal, determine the field strength distribution information corresponding to the target area based on the target area and the field strength distribution model, and determine the pulse generation information based on the field strength distribution information and the distribution of each electrode contact. The field strength distribution model is pre-trained at least in the following manner: acquiring multiple sample target regions and field strength distribution information corresponding to each sample target region; training a preset initial model based on the multiple sample target regions and the field strength distribution information corresponding to each sample target region to obtain the trained field strength distribution model.

15. The pulse generation system according to claim 13, wherein, The pulse generating device is applied to Parkinson's disease. The terminal device is also used to acquire EEG digital signals sent from the control unit, convert the EEG digital signals into EEG images using predetermined software, extract and display the spectral changes corresponding to the β band of the EEG from the EEG images using the predetermined software, display a control interface for inputting pulse generation information, and acquire the pulse generation information and send the pulse generation information to the control unit in response to the input operation of pulse generation information on the control interface.

16. The pulse generation system according to claim 15, wherein, The control interface also includes signal acquisition controls; The terminal device is also configured to send an EEG signal acquisition request to the control unit in response to a selection operation of the signal acquisition control; The control unit is also configured to, in response to the EEG signal acquisition request, acquire EEG signals output from the electrode contacts of at least one deep electrode.

17. The pulse generation system according to claim 13, wherein, The pulse generating device is used to relieve pain. The pulse generating system also includes an adjustment device, which is used to send adjustment information to the control unit, so that the control unit determines pulse generation information according to the adjustment information and controls the pulse generating unit to generate a target pulse signal according to the pulse generation information. The pulse generation information includes the pulse signal parameters of the first pulse signal, the pulse signal parameters of the second pulse signal, the contact information corresponding to the first pulse signal, and the contact information corresponding to the second pulse signal.

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