WO2026002050A1 - Pulse generation apparatus, device, and system for neuromodulation - Google Patents

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 generating devices, equipment and systems for neural modulation Technical Field

This disclosure relates to the technical field of medical devices, and more specifically, to pulse generating devices, equipment, and systems for neuromodulation.

Background Technology

Neuromodulation technology is a technique that uses electrical or magnetic signals to stimulate nerve tissue, thereby altering the electrical activity of nerve cells and influencing human physiological functions.

However, existing pulse signals used for neuromodulation often suffer from charge imbalance, requiring the use of extra pulses to balance them, which can cause secondary damage and affect the effectiveness of neuromodulation.

Summary of the Invention

This disclosure aims to solve at least one aspect of the aforementioned technical problems.

In a first aspect, embodiments of this disclosure provide a pulse generator for neural modulation, comprising:

A pulse generating unit is used to be electrically connected to at least one electrode; the at least one electrode is used to be positioned at a predetermined location on the target object.

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

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.

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

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 is in the range of 10 microseconds to 1000 microseconds, the amplitude of the first pulse signal is in the range of 0.1 volts to 10.5 volts, and the frequency of the first pulse signal is in the range of 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 of the second pulse signal is in the range of 10 microseconds to 1000 microseconds, the amplitude of the second pulse signal is in the range of 0.1 volts to 10.5 volts, and the frequency of the second pulse signal is in the range of 1 to 1500 Hz.

In a second aspect, embodiments of this disclosure provide a pulse generating device, comprising: at least one electrode, and a pulse generating device for neural modulation as described in the first aspect;

Each electrode is provided with at least one electrode contact for outputting a first pulse signal or a second pulse signal.

In one possible implementation, for epilepsy, at least one electrode includes at least one deep electrode and/or at least one cortical electrode;

Deep electrodes are used to be implanted at predetermined locations deep within the target brain, while cortical electrodes are used to be implanted at predetermined locations in the target brain cortex.

The pulse generation unit is electrically connected to at least one deep electrode and at least one dermal electrode to generate a target pulse signal;

The control unit is electrically connected to the pulse generation unit and is used to control the pulse generation unit to generate a corresponding target pulse signal according to the pre-stored initial pulse generation information when epilepsy is detected in the target object. The target pulse signal is then output to the target area of the target object through at least one deep electrode and/or at least one cortical electrode. The initial pulse generation information includes pulse parameter information and electrode information. The initial pulse generation information is the pulse generation information determined by the terminal device based on the target object's EEG digital signal. The electrode information represents the information of the deep electrode and/or cortical electrode used to output the target pulse signal. The target area includes the lesion area of the epilepsy.

In one possible implementation, 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 connection contact point for electrical connection with the pulse generation unit, and the other end of which is provided with at least one first electrode contact point.

Each first electrode contact is used to output a first pulse signal or a second pulse signal, and/or to sense electroencephalogram (EEG) signals.

In one possible implementation, 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 second electrode contact is used to output a first pulse signal or a second pulse signal, and/or to sense EEG signals.

In one possible implementation, the control unit is further configured to acquire electroencephalogram (EEG) signals output from at least one deep electrode and/or at least one cortical electrode, and when it is determined that the target object has epilepsy based on the EEG signals, determine an adjusted target region based on the EEG signals, determine adjusted pulse generation information based on the adjusted target region, and control the pulse generation unit to generate a corresponding target pulse signal based on the adjusted pulse generation information.

In one possible implementation, the control unit is specifically used for:

If the area of the target region is greater than the first threshold, then control a set of first electrode contacts of at least one deep electrode and/or a set of second electrode contacts of at least one dermal electrode to output the target pulse signal.

If the area of the target region is greater than the second threshold, then 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 are controlled to output the target pulse signal; the second threshold is greater than the first threshold.

In one possible implementation, applied to Parkinson's disease, at least one electrode includes at least one deep electrode, implanted at a predetermined location deep within the brain of the target subject; each deep electrode includes at least one electrode contact, each electrode contact being used to output pulse signals and/or sense electroencephalogram (EEG) signals;

The pulse generation unit is electrically connected to at least one deep electrode to generate a target pulse signal;

The control unit is electrically connected to the pulse generation unit and is used to acquire EEG signals output from the electrode contacts of at least one deep electrode, 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 generation unit to generate a target pulse signal based on the pulse generation information, and output the target pulse signal to the target area of the target object through at least one deep electrode; 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, and the target area includes the lesion area of Parkinson's disease.

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 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.

In one possible implementation, for pain relief, at least one electrode is placed in a target area of the target object, the target area including the pain area and/or the spinal cord;

The pulse generating unit is electrically connected to at least one electrode and is used to generate a target pulse signal;

The control unit is used to control the pulse generation 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.

In one possible implementation, 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.

Thirdly, embodiments of this disclosure provide a pulse generation system, including: a terminal device and a pulse generation device according to the second aspect;

The terminal device is communicatively connected to the control unit. 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. The contact information is used to indicate 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 based on the pulse generation information, and to output the target pulse signal to at least one electrode.

In one possible implementation, 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 ways: acquiring multiple sample target regions and the field strength distribution information corresponding to each sample target region; training the 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.

In one possible implementation, the pulse generating device is applied to Parkinson's disease, and the terminal device is also used to acquire the EEG digital signal sent from the control unit, convert the EEG digital signal into an EEG image through predetermined software, extract and display the spectral changes corresponding to the β band of the EEG from the EEG image using predetermined software, display a control interface for inputting pulse generation information, and in response to the input operation of pulse generation information on the control interface, acquire the pulse generation information and send the pulse generation information to the control unit.

In one possible implementation, the control interface also includes signal acquisition controls;

The terminal device is also used 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 acquire, in response to a request for acquisition of EEG signals, EEG signals output from the electrode contacts of at least one deep electrode.

In one possible implementation, the pulse generating device is used to relieve pain, and the pulse generating system also includes an adjustment device for sending adjustment information to the control unit, so that the control unit determines pulse generating information based on the adjustment information and controls the pulse generating unit to generate a target pulse signal based on the pulse generating 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.

The beneficial effects of the technical solutions provided in this disclosure are:

The pulse generating device for neuromodulation disclosed in this embodiment controls a pulse generating unit to generate a target pulse signal and output the target pulse signal to at least one electrode. This allows at least one electrode to output the target pulse signal to a target region of the target object. By simultaneously outputting first and second pulse signals of opposite polarity, neuromodulation of the target region is achieved. Because the first and second pulse signals have opposite polarities, this facilitates charge balance within the stimulation field, especially during the synchronous output phase. This also ensures the stimulation effect and avoids the secondary damage caused by using extra pulses to balance the charge in existing technologies, thus guaranteeing the neuromodulation effect.

Attached Figure Description

To more clearly illustrate the technical solutions in the embodiments of this disclosure, the accompanying drawings used in the description of the embodiments of this disclosure will be briefly introduced below.

Figure 1 is a schematic diagram of the frame of a pulse generating device provided in an embodiment of this disclosure;

Figure 2 is a schematic diagram of the frame of a pulse generator for neural modulation provided in an embodiment of this disclosure;

Figure 3 is a schematic diagram of the frame of another pulse generation device for neural modulation provided in an embodiment of this disclosure;

Figure 4 is a schematic diagram of the structure of a deep electrode provided in an embodiment of this disclosure;

Figure 5 is a schematic diagram of the structure of a cortical electrode provided in an embodiment of this disclosure;

Figure 6 is a schematic diagram of the frame of a pulse generating unit provided in an embodiment of this disclosure;

Figure 7 is a schematic diagram of the structure of a deep electrode provided in an embodiment of the present disclosure, in which two sets of first electrode contacts output target pulse signals to form stimulation field strength and cross field strength;

Figure 8 is a schematic diagram of a pulse generation system provided in an embodiment of this disclosure;

Figure 9 is a schematic diagram of the frame of a terminal device provided in an embodiment of this disclosure;

Figure 10 is a schematic diagram of the structure of a pulse generation device for epilepsy provided in an embodiment of this disclosure;

Figure 11 is a schematic diagram of another pulse generation system provided in an embodiment of this disclosure;

Figure 12 is a schematic diagram of the frame of a pulse generation device for Parkinson's disease provided in an embodiment of this disclosure;

Figure 13 is a schematic diagram of a set of electrode contacts of a deep electrode provided in an embodiment of this disclosure;

Figure 14 is a schematic diagram of another deep electrode provided in an embodiment of this disclosure;

Figure 15 is a schematic diagram of another deep electrode provided in an embodiment of this disclosure;

Figure 16 is a schematic diagram of a pulse generation system provided in an embodiment of this disclosure;

Figure 17 is a schematic diagram of the structure of a pulse generator for relieving pain provided in an embodiment of this disclosure;

Figure 18 is a schematic diagram of the waveform structure of a target pulse signal provided in an embodiment of this disclosure;

Figure 19 is a schematic diagram of the structure of an electrode needle provided in an embodiment of this disclosure;

Figure 20 is a schematic diagram of the structure of an electrode patch provided in an embodiment of this disclosure;

Figure 21 is a schematic diagram of a pulse generation system provided in an embodiment of this disclosure.

Figure label:
1-Pulse generation system;
10-Pulse Generator;
110 - Pulse generator, 111 - Pulse generation unit, 1111 - Signal conversion module
1112 - First pulse generating module, 1113 - Second pulse generating module, 112 - Control unit;
120-Electrode; 1201-Electrode needle; 1202-Electrode rod; 1203-Electrode patch; 121-Deep electrode; 1211-Electrode outer tube; 1212-First connecting contact point; 1213-First electrode contact point; 122-Cortical electrode; 1221-Connecting wire; 1222-Electrode patch; 1223-Second connecting contact point; 1224-Second electrode contact point;
130 - Magnet sensing module;
20 - Terminal equipment; 210 - Display device; 220 - Server; 30 - Programmable controller; 40 - Charging coil; 50 - Magnet; 60 - Adjustment device.

Detailed Implementation

The embodiments of this disclosure are described below with reference to the accompanying drawings. It should be understood that the embodiments described below with reference to the accompanying drawings are exemplary descriptions for explaining the technical solutions of the embodiments of this disclosure, and do not constitute a limitation on the technical solutions of the embodiments of this disclosure.

Those skilled in the art will understand that, unless specifically stated otherwise, the singular forms “a,” “an,” “the,” and “the” used herein may also include the plural forms. It should be further understood that the terms “comprising” and “including” as used in embodiments of this disclosure mean that the corresponding feature can be implemented as the presented feature, information, data, step, operation, element, and/or component, but do not exclude implementation as other features, information, data, step, operation, element, component, and/or combinations thereof supported by the art. It should be understood that when we say that an element is “connected” or “coupled” to another element, the one element may be directly connected or coupled to the other element, or it may mean that the one element and the other element are connected through an intermediate element. Furthermore, “connected” or “coupled” as used herein may include wireless connection or wireless coupling. The term “and/or” as 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.”

To make the objectives, technical solutions, and advantages of this disclosure clearer, the embodiments of this disclosure will be described in further detail below with reference to the accompanying drawings.

Research has shown that neuromodulation technology is a technique that uses electrical or magnetic signals to stimulate nerve tissue, thereby altering the electrical activity of nerve cells and influencing human physiological functions. This technology has been widely used in the medical field, such as deep brain stimulation (DBS) for treating Parkinson's disease and epilepsy, and spinal cord stimulation (SCS) for treating chronic pain.

However, there are still some shortcomings in terms of the precision and effectiveness of treatment. For example, the accuracy of neuromodulation treatment largely depends on the localization of the lesion and the precise implantation of the electrode. However, in reality, sometimes the source of the lesion in the patient is not obvious, or with the passage of time after implantation, the patient's own movement and other factors, the electrode implantation position may shift, which will greatly reduce the accuracy of the treatment.

Furthermore, current neuromodulation products primarily rely on a single channel for waveform generation, which limits their flexibility to some extent. For example, waveform generation through a single channel results in a relatively limited treatment modality, with fixed stimulation sites and ranges, making it impossible to flexibly adjust the stimulation based on the patient's specific condition.

The pulse generation device, equipment, and system for neural modulation disclosed herein are intended to solve the above-mentioned technical problems of the prior art.

Referring to Figure 1, this disclosure provides a schematic diagram of the framework of a pulse generating device 10. As shown in Figure 1, the pulse generating device 10 includes: at least one electrode 120, and a pulse generating device 110 for neural modulation according to this disclosure.

Optionally, the electrode 120 can be implanted in a predetermined location deep within the brain or in a predetermined location in the cerebral cortex.

Referring to Figure 2, this disclosure provides a schematic diagram of the framework of a pulse generator 110 for neural modulation. As shown in Figure 2, the pulse generator 110 for neural modulation includes a pulse generator unit 111 and a control unit 112.

The pulse generating unit 111 is used to be electrically connected to at least one electrode 120; the at least one electrode 120 is used to be positioned at a predetermined location on the target object.

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

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.

Specifically, the pulse generating unit 111 is used to generate a target pulse signal and output the target pulse signal to at least one electrode 120.

The pulse generating device 110 for neuromodulation in this embodiment controls the pulse generating unit 111 to generate a target pulse signal and output the target pulse signal to at least one electrode 120 via the control unit 112. This allows the at least one electrode 120 to output the target pulse signal to the target area of the target object. By simultaneously outputting first and second pulse signals of opposite polarity, neuromodulation of the target area is achieved. Because the first and second pulse signals have opposite polarities, the opposite polarity of the pulse signals largely achieves charge balance within the stimulation field, especially during the synchronous output phase of the first and second pulse signals. This ensures the stimulation effect while avoiding secondary damage caused by using extra pulses to balance the charge in existing technologies, thus guaranteeing the neuromodulation effect.

In some embodiments, the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal; the pulse signal parameters include pulse width, amplitude, and frequency; or,

The pulse width, amplitude, and frequency of the first pulse signal are different from at least one of the pulse width, amplitude, and frequency of the second pulse signal.

Optionally, if the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, then the first pulse signal and the second pulse signal are bidirectional symmetrical pulse signals, which can ensure charge balance.

Optionally, the pulse width, amplitude, and frequency of the first pulse signal may all be different from those of the second pulse signal, or at least one of the pulse width, amplitude, and frequency may be different.

In this embodiment of the invention, if the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, charge balance can be achieved within the formed stimulation field. If the pulse signal parameters of the first pulse signal are different from those of the second pulse signal, the stimulation intensity at a certain local location can be adjusted within the formed stimulation field to achieve the distribution of different stimulation amounts to the stimulation target. Based on effective stimulation, the amount of stimulation given is reduced, avoiding the harm of excess pulses to the patient and facilitating the low-power operation of the device.

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, or a sine 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, or a sine wave.

In some embodiments, 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 are the same as those of the second pulse signal, including pulse width, amplitude and frequency.

Specifically, in a set of effective stimulation waveforms, the waveforms of the first and second pulse signals are not limited to square waves; they can also be triangular waves, trapezoidal waves, sine waves, etc. The waveforms of the first and second pulse signals may be different, and even the waveforms of multiple first pulse signals or multiple second pulse signals may differ. Different waveforms will also produce different stimulation field strengths. The greater the slope of the stimulation waveform, the faster the neuron's response. However, for local neural clusters, the response can be very complex. In practical applications, different waveforms can be considered to achieve the effect of activating/inhibiting neurons.

Studies have found that the resting potential of neurons is -70mV, and the threshold voltage for enabling neurons to transmit electrical signals is -50 to -55mV. Conversely, to block electrical signal transmission, the neuronal potential must not exceed -55mV. Therefore, for local neural tissue around the contact point, the amplitude can be determined based on the size of the tissue and the area to be activated. The pulse width needs to be determined based on the signal transmission characteristics corresponding to the disease. The frequency range is determined based on the refractory period of neuronal electrical signal transmission, which is approximately 3ms. Theoretically, stimulation exceeding 330 Hz will not have a significant impact on neurons.

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

Optionally, 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 volts, 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 volts, 2 volts, 5 volts, 7 volts, 10.5 volts, etc., and the frequency can be 1 Hz, 500 Hz, 1000 Hz, 1500 Hz, etc.

In some embodiments, the time interval between two adjacent pulses of the first pulse signal is in the range of 0 milliseconds to 100 milliseconds; and/or, the time interval between two adjacent pulses of the second pulse signal is in the range of 0 milliseconds to 100 milliseconds.

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

In practice, neurons enter a refractory period after transmitting a signal. During this period, stimulating neurons will not elicit a response. Therefore, stimulating neurons at appropriate intervals can achieve the desired effect, conserve energy, and avoid unnecessary side effects. There is a certain time interval T between the end of one stimulus and the beginning of the next, and the length of this interval T may be the same or different for multiple stimulus gaps.

Referring to Figure 3, this disclosure provides a schematic diagram of another pulse generation device 110 for neural modulation. As shown in Figure 3, the pulse generation unit 111 further includes a signal conversion module 1111.

The signal conversion module 1111 is electrically connected to the control unit 112 and is used to be electrically connected to at least one electrode 120. The signal conversion module 1111 is used to preprocess the EEG signal output by at least one electrode 120, convert the preprocessed EEG signal into a digital EEG signal, and send the digital EEG signal to the control unit 112. The digital EEG signal is used to determine the target pulse signal.

Optionally, signal preprocessing includes signal processing methods such as filtering and amplification. The control unit 112 can determine the target pulse signal based on the EEG digital signal.

In the pulse generating device 10 of this embodiment, each electrode 120 is provided with at least one electrode contact for outputting a first pulse signal or a second pulse signal; at least one electrode 120 includes at least one deep electrode 121 and/or at least one cortical electrode 122; the deep electrode 121 is used for implantation at a predetermined location deep in the brain of the target object, and the cortical electrode 122 is used for implantation at a predetermined location in the cerebral cortex of the target object.

The deep electrode 121 of this embodiment is implanted deep into the 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 practical applications, the appropriate electrode can be selected according to different situations.

Referring to Figure 4, this embodiment of the present disclosure provides a schematic diagram of the structure of a deep electrode 121. As shown in Figure 4, the electrode contacts include a first electrode contact 1213. The deep electrode 121 includes an electrode outer tube 1211, one end of which is provided with at least one first connection contact 1212 for electrical connection with a pulse generating unit 111, and the other end of which is provided with at least one first electrode contact 1213.

Each first electrode contact 1213 is used to output a first pulse signal or a second pulse signal, and/or sense electroencephalogram (EEG) signals.

As an example, as shown in Figure 4, one end of the electrode outer tube 1211 is provided with at least two first contact points 1212 for electrical connection 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.

Specifically, the unipolar stimulation mode is a deep electrode 121 where at least one first electrode contact 1213 outputs a pulse signal, and the bipolar stimulation mode is a deep electrode 121 where at least two first electrode contacts 1213 output pulse signals.

Referring to Figure 5, this embodiment of the present disclosure provides a schematic diagram of the structure of a cortical electrode 122. As shown in Figure 5, the electrode contact includes a second electrode contact 1224. The cortical electrode 122 includes a connecting wire 1221 and an electrode patch 1222 that are fixedly connected. One end of the connecting wire 1221 is provided with at least one second connecting contact 1223 for electrical connection with a pulse generating unit 111. The electrode patch 1222 is disposed at the other end of the connecting wire 1221 and includes at least one second electrode contact 1224.

Each second electrode contact 1224 is used to output a first pulse signal or a second pulse signal, and/or sense electroencephalogram (EEG) signals.

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

In some embodiments, the first electrode contact 1213 is an annular contact arranged around the circumference of the electrode outer tube 1211; or, at least two first electrode contacts 1213 are spaced apart along the circumference of the electrode outer tube 1211; and/or, at least two first electrode contacts 1213 are spaced apart along the axial direction of the electrode outer tube 1211.

In practical applications, traditional electrodes use ring-shaped contacts, while directional electrodes employ more stimulation contacts. This allows for more precise control of current distribution, enabling directional stimulation of specific functions of target nuclei. The distribution of electrode contacts, the spacing between them, and the width of the contacts can vary, resulting in different electrode models that are selected based on clinical needs.

The power supply for the pulse generator 110 for neural modulation in this embodiment can be a dual current source. Because a single current source provides multiple field strength stimuli with each field strength being identical, while a dual current source allows for arbitrary setting of the two electric field strengths, thus providing greater flexibility for configurations requiring different stimulus field strengths.

Referring to Figure 6, this embodiment of the present disclosure provides a schematic diagram of the framework of a pulse generation unit 111. As shown in Figure 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.

A portion of the electrode contacts are electrically connected to the first pulse generating module 1112, and another portion of the electrode contacts are electrically connected to the second pulse generating module 1113.

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. The first pulse signal and the second pulse signal are generated at different electrode contacts, respectively and simultaneously. Alternatively, the first pulse signal can be generated at the electrode contacts, and the second pulse signal can be generated at the stimulator housing.

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

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

Specifically, at least one first pulse signal and at least one second pulse signal constitute a set of effective stimulation waveforms. In practical applications, the target area can be stimulated by at least one set of effective stimulation waveforms, thereby achieving neural modulation.

The pulse generating device 10 of this embodiment includes a pulse generating device 110 for neural modulation. For a detailed functional description of the pulse generating device 10, please refer to the description of the pulse generating device 110 for neural modulation shown above, which will not be repeated here.

The pulse generating device 10 of this disclosure embodiment can employ at least two current paths, each current path can generate a target pulse signal separately and simultaneously, the target pulse signal is composed of a first pulse signal and a second pulse signal with equal or unequal magnitude (pulse width, amplitude, frequency) and opposite polarity.

The generation of the first and second pulse signals can create various forms of stimulation field strength between the electrode and the target area, and the spatial diversity of the stimulation field strength can improve the spatial accuracy of the stimulation. It can also achieve dynamic controllability of the stimulation without changing the electrode position, and can output pulse signals at multiple electrode contacts, simultaneously obtaining at least two stimulation field strengths, thereby enabling the synergistic effect of at least two stimulation field strengths on the target area.

This disclosure allows for the generation of multiple stimulation field strengths based on the patient's condition or the different contact points of the stimulation electrodes. These multiple stimulation field strengths can partially overlap, with the overlapping areas enhancing the stimulation. Furthermore, when the electrode 120 is displaced, precise stimulation and adjustable stimulation areas can be achieved by adjusting the position of the field strength, replacing the need for craniotomy to replace or adjust the electrodes. Therefore, this disclosure enables flexible movement of the stimulation target area within the brain without moving the electrodes.

Referring to Figure 7, this embodiment of the present disclosure provides a schematic diagram of the structure of a deep electrode 121 where two sets of first electrode contacts 1213 output target pulse signals to form a stimulation field strength and a cross field strength. As shown in Figure 7, the two sets of first electrode contacts 1213 of the deep electrode 121 output target pulse signals. In each set 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 target pulse signals output by the two sets of first electrode contacts 1213 form two stimulation field strengths. The overlapping field strength of the two stimulation field strengths forms a cross field strength, which covers the target area and can enhance the stimulation of the target area.

In practical applications, the number of deep electrodes 121 and the number of first electrode contacts 1213 for outputting pulse signals from the deep electrode 121 can be determined based on factors such as the size and location of the target area and the required field strength. For example, a group of first electrode contacts 1213, three groups of first electrode contacts 1213, or more groups of first electrode contacts 1213 from the same deep electrode 121 can be used to output the target pulse signal.

Based on the above principles, the pulse generating device 10 of this embodiment can involve different field strength distributions and intensity changes according to the patient's actual condition and the selection of stimulation sites, thereby achieving dynamic controllability of stimulation. The stimulation field strength generated by the waveform can be generated independently at intervals, or it can be partially overlapping with different local intensities.

The pulse generating device 10 of this disclosure can also simultaneously obtain stimulation field strength at multiple points through the synergistic effect of multiple pathways, thereby achieving multi-point synergistic stimulation. This synergistic stimulation mode can make full use of the interaction between different points, bringing more precise and effective neuromodulation effects to patients.

The pulse generating device 10 of this disclosure employs a deep electrode 121 and/or cortical electrode 122 design, achieving precise stimulation of the nervous system through accurate control of stimulation parameters. Compared with traditional neurostimulators, this disclosure embodiment offers higher stimulation efficacy and safety, while reducing unnecessary energy consumption and potential impact on surrounding tissues.

The pulse generating device 10 of this disclosure provides an innovative design for deep electrodes 121 and/or cortical electrodes 122. By precisely controlling the parameters of the first and second pulse signals, it achieves accurate stimulation of the nervous system. This design has high flexibility and adjustability, can meet different treatment needs, and provides a new solution for the treatment and rehabilitation of nervous system diseases.

Referring to Figure 8, this disclosure provides a schematic diagram of the framework of a pulse generation system 1. As shown in Figure 8, the pulse generation system 1 includes a terminal device 20 and a pulse generation device 10 according to this disclosure.

The terminal device 20 is communicatively connected to the control unit 112. The terminal device 20 is used to send pulse generation information to the control unit 112. 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. The pulse signal parameters include the pulse width, amplitude, and frequency. The contact information is used to indicate the electrode contacts of the electrode 120 that outputs the corresponding pulse signal.

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

In some embodiments, when the control unit 112 determines the presence of an abnormal neural signal based on the EEG digital signal sent by the signal conversion module 1111 of the pulse generation unit 111, it sends the EEG digital signal to the terminal device 20.

Referring to Figure 9, this embodiment of the present disclosure provides a schematic diagram of the framework of a terminal device 20. As shown in Figure 9, the terminal device 20 includes a display device 210 and a server 220. The terminal device 20 is used to generate brainwaves from EEG digital signals through the debugging software of the server 220, and to display the brainwaves on the display device 210. In response to the pulse generation information obtained through the debugging software, the terminal device 20 sends the pulse generation information to the control unit 112.

In practical applications, when the pulse generator 10 detects an abnormal neural signal, it can store a filtered, amplified, and converted digital EEG signal according to a pre-set scheme. These stored digital EEG signals are transmitted to the server 220 of the closed-loop neurostimulator debugging and management software 5. The server 220 can read the digital EEG signals and generate EEG waveforms on the software for doctors to analyze. After analyzing the patient's EEG data, doctors can adjust the stimulation scheme in the debugging software and save it back to the pulse generator 10.

As an example, electroencephalogram (EEG) signals are acquired via cortical electrodes 122 and deep electrodes 121. The acquired EEG signals are transmitted to a signal conversion module 1111, and then via an analog switch in the signal conversion module 1111 to the amplification circuit. The amplification circuit removes DC and interference signals through high-pass and low-pass filtering, and amplifies the EEG signals. The amplified EEG signals are then converted into digital EEG signals via analog-to-digital (A/D) conversion in the signal conversion module 1111. The digital EEG signals are processed by an algorithm in the control unit 112 to determine the presence of abnormal neural signals. If the determination result indicates the presence of abnormal neural signals, a stimulation pulse is generated according to preset pulse signal parameters in the control unit 112, and transmitted to the lesion area via electrodes 120 for neuromodulation.

In some embodiments, the terminal device 20 is further configured to determine the target region for neuromodulation based on the EEG digital signal, determine the field strength distribution information corresponding to the target region based on the target region 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 ways: acquiring multiple sample target regions and the field strength distribution information corresponding to each sample target region; training the 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.

Optionally, the field strength distribution generated by the target pulse signal generated by the control unit 112 based on the pulse generation information can cover the target area and realize neural modulation of the target area.

In practical applications, to achieve the best neuromodulation effect, the pulse signal design of the pulse generation system 1 provided in this embodiment also involves optimizing and adjusting the pulse signal parameters. This optimization and adjustment can be performed based on the patient's specific condition, individual differences, and real-time feedback during treatment.

The pulse generation system 1 of this embodiment 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 strength distribution model between pulse signal parameters and neuromodulation effects based on machine learning algorithms by learning and analyzing a large amount of patient treatment data. During treatment, the system can set the strength and distribution of the stimulation field strength according to the patient's real-time physiological signals and treatment feedback, or according to the distance between the stimulation site and the electrode contact, to automatically adjust parameters such as the amplitude, width, and interval of the pulse signal for personalized and precise treatment. Alternatively, a suitable stimulation field strength can be selected for precise stimulation based on the location of the stimulation site and the electrode contact.

The pulse generation system 1 of this embodiment can also realize remote adjustment of pulse signal parameters through the terminal device 20 and the control unit 112. Doctors or therapists can remotely control the system to adjust the pulse signal parameters of the neurostimulator in real time to adapt to changes during the patient's treatment. This remote adjustment function not only improves the convenience and flexibility of treatment, but also allows doctors or therapists to more easily monitor the patient's treatment and adjust the treatment plan in a timely manner.

The pulse generation system 1 of this disclosure includes a pulse generation device 10. For a detailed functional description of the pulse generation system 1, please refer to the description of the corresponding pulse generation device 10 shown above, which will not be repeated here.

By applying the embodiments of this disclosure, at least the following beneficial effects can be achieved:

(1) In this embodiment, the control unit 112 controls the pulse generation unit 111 to generate a target pulse signal and output the target pulse signal to at least one electrode 120, so that at least one electrode 120 outputs the target pulse signal to the target area of the target object. This is achieved by simultaneously outputting a first pulse signal and a second pulse signal with opposite polarities, thereby modulating the target area neurally. Because the first and second pulse signals have opposite polarities, the opposite polarity of the pulse signals largely achieves charge balance within the stimulation field, especially during the synchronous output phase of the first and second pulse signals. This also ensures the stimulation effect and avoids the secondary damage caused by using extra pulses to balance the charge in existing technologies, thus guaranteeing the neural modulation effect.

(2) The pulse generation unit 111 of this embodiment includes a first pulse generation module 1112 and a second pulse generation module 1113, which can generate a first pulse signal and a second pulse signal respectively. This reduces the requirements of the circuit of the pulse generation device 110 for nerve modulation. Moreover, the first pulse generation module 1112 and the second pulse generation module 1113 can be controlled independently. Using the first pulse generation module 1112 and the second pulse generation module 1113 can double the stimulation effect. However, the first pulse generation module 1112 and the second pulse generation module 1113 require less current/voltage, thereby making the design of the pulse generation device 110 for nerve modulation of this embodiment more flexible and adjustable.

(3) In this embodiment, the first pulse signal and the second pulse signal have the same start time, which can prolong the charge balance effect time to a certain extent, resulting in a better charge balance effect. At the same time, in this embodiment, the charge balance effect time and the effective stimulation time can be performed at the same time, which can achieve the balance of excess charge while effectively stimulating, ensuring that the tissue is protected from damage by excess charge.

(4) The embodiments of this disclosure use first pulse signals and second pulse signals with opposite polarities, and the first pulse signals and second pulse signals have the same start 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 there is a certain interval between the positive and negative pulse signals of the bipolar pulse signal), the embodiments of this disclosure can shorten the stimulation refractory period, generate multiple sets of stimulation within the same stimulation duration, and can regulate the target tissue more quickly and shorten the regulation time.

As an example, the first embodiment of this application provides a pulse generating device and pulse generating system for epilepsy, which will be described in detail below.

Epilepsy is a chronic brain disorder characterized by recurrent seizures. It is caused by abnormal electrical activity in the brain's neurons, and seizures are characterized by their recurrence and brevity. Causes of epilepsy include muscle contractions, developmental disorders of the cerebral cortex, brain tumors, head trauma, central nervous system infections, and may also be related to genetics. Epilepsy can occur at any age, but it is relatively common in children and the elderly. It is estimated that epilepsy affects more than 70 million people worldwide, with an incidence rate in China between 5 and 7 per 1,000, and approximately 400,000 to 600,000 new cases diagnosed annually.

The main manifestation of epilepsy is sudden, unexplained seizures. The symptoms vary, but the manifestations of each seizure in the same patient are similar. Symptoms may include momentary loss of consciousness and falling, abnormal sensation in the limbs, hallucinations, repetitive words or single syllables, and spinning of the body or eyes.

There is no specific treatment for epilepsy; the primary treatment is medication, aiming to control the condition, reduce seizure frequency, and ultimately achieve seizure-free periods with minimal side effects, restoring or nearing a normal quality of life. During medication, patients must regularly monitor their blood drug levels to adjust the regimen. A patient's lifestyle also directly impacts the disease's condition; therefore, improving lifestyle habits, such as maintaining good sleep, avoiding excessive fatigue and stress, and avoiding excessive alcohol consumption and smoking, are also important measures for preventing epileptic seizures.

Before a seizure, some patients can sense that they are about to have one. These premonitions may include abnormal sensations in the limbs or other inexplicable sensations. Some people may also experience changes in taste, smell, or hearing. Others may experience blurred vision.

These early symptoms are not necessarily related to epileptic seizures, but these premonitions can help patients prepare for a seizure in advance. These include taking anti-epileptic medication beforehand, avoiding dangerous environments, and taking precautions to prevent injury during a seizure.

The pulse generator and pulse generation system for epilepsy provided in this embodiment aim to solve at least one of the above-mentioned technical problems related to epilepsy.

Referring to Figure 8, this disclosure provides a schematic diagram of the structure of a pulse generation system 1. As shown in Figure 8, the pulse generation system 1 includes: a terminal device 20 and a pulse generation device 10 for epilepsy as described in this disclosure.

Referring to Figure 10, this disclosure provides a schematic diagram of the structure of a pulse generating device 10 for epilepsy. As shown in Figure 10, the pulse generating device 10 for epilepsy includes: at least one deep electrode 121, at least one cortical electrode 122, a pulse generating unit 111, and a control unit 112.

Optionally, the terminal device 20 is communicatively connected to the control unit 112. The terminal device 12 is used to acquire and display the EEG digital signal of the target object, display an input interface for inputting initial pulse generation information, and in response to the input operation of the initial pulse generation information on the input interface, acquire the initial pulse generation information and send the initial pulse generation information to the control unit 112.

At least one deep electrode 121 is implanted at a predetermined location deep within the brain of the target subject; at least one cortical electrode 122 is implanted at a predetermined location in the cerebral cortex of the target subject; a pulse generation unit 111 is electrically connected to both the at least one deep electrode 121 and the at least one cortical electrode 122, and the pulse generation unit 111 is used to generate a target pulse signal.

The control unit 112 is electrically connected to the pulse generation unit 111. When the target object is detected to have epilepsy, the control unit 112 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 area of the target object through at least one deep electrode 121 and/or at least one cortical electrode 122. The initial pulse generation information includes pulse parameter information and electrode information. The initial pulse generation information is the pulse generation information determined by the terminal device 20 according to the target object's EEG digital signal. The electrode information represents the information of the deep electrode 121 and/or cortical electrode 122 used to output the target pulse signal. The target area includes the lesion area of epilepsy.

Specifically, the control unit 112 controls the target pulse signal generated by the pulse generation unit 111 to cover the target area according to the initial pulse generation information, which can regulate epilepsy symptoms safely and effectively.

Optionally, the control unit 112 can determine, based on the electrode information, which deep electrode 121 and/or dermal electrode 122 needs to output a pulse signal in order to output a target pulse signal to the target area.

In this embodiment, at least one deep electrode 121 and at least one cortical electrode 122 are provided on the head of the target subject. A pulse generating unit 111 is electrically connected to both the deep electrode 121 and the cortical electrode 122. When the control unit 112 detects epilepsy in the target subject, it can control the pulse generating unit 111 to generate a corresponding target pulse signal based on pre-stored initial pulse generation information. This target pulse signal is then output to the target area of the target subject through at least one deep electrode 121 and/or at least one cortical electrode 122, thereby achieving treatment of the epileptic lesion area. The pre-stored initial pulse generation information in this embodiment is obtained by examining the target subject. The pulse generation information determined on the terminal device 20 based on the target subject's EEG digital signals can effectively regulate the target subject's epilepsy, avoiding the high risks and side effects associated with drug treatment or surgical treatment.

The pulse generator 10 for epilepsy according to this disclosure can be used in conjunction with devices such as an electroencephalogram (EEG) machine to monitor the patient's neurological activity in real time, providing data support for precise control of pulse signals. For example, the pulse generator 10 for epilepsy can acquire the patient's brain waves in advance, analyze the brain waves, and analyze and judge based on the characteristics of abnormal brain waves (such as the type, frequency, amplitude, waveform, etc. of abnormal brain waves) to output the optimal stimulation pulse signal. Before implantation of the pulse generator 10 for epilepsy, the optimal stimulation waveform is input into the pulse generator 10 for epilepsy. In this way, after implantation, the optimal stimulation pulse signal matched to the patient can be used directly for treatment, resulting in good control of epilepsy symptoms and saving doctors time in adjusting various parameters, trial and error time, and patient adaptation time.

In some embodiments, 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.

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

The pulse signal parameters of the first pulse signal are the same as those 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.

Optionally, if the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, then the first pulse signal and the second pulse signal are bidirectional symmetrical pulse signals, which can ensure charge balance.

Optionally, the pulse width, amplitude, frequency, and current of the first pulse signal may all be different from those of the second pulse signal, or at least one of the pulse width, amplitude, frequency, and current may be different.

Optionally, the waveform of the first pulse signal includes any one of the following: a rectangular wave, a triangular wave, a trapezoidal wave, or a sine wave; the waveform of the second pulse signal includes any one of the following: a rectangular wave, a triangular wave, a trapezoidal wave, or a sine wave.

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 are the same as those of the second pulse signal.

Specifically, in a set of effective stimulation waveforms, the waveforms of the first and second pulse signals are not limited to square waves; they can also be triangular waves, trapezoidal waves, sine waves, etc. The waveforms of the first and second pulse signals may be different, and even the waveforms of multiple first pulse signals or multiple second pulse signals may differ. Different waveforms will also produce different stimulation field strengths. The greater the slope of the stimulation waveform, the faster the neuron's response. However, for local neural clusters, the response can be very complex. In practical applications, different waveforms can be considered to achieve the effect of activating/inhibiting neurons.

Studies have found that the resting potential of neurons is -70mV, and the threshold voltage for enabling neurons to transmit electrical signals is -50 to -55mV. Conversely, to block electrical signal transmission, the neuronal potential must not exceed -55mV. Therefore, for local neural tissue around the contact point, the amplitude can be determined based on the size of the tissue and the area to be activated. The pulse width needs to be determined based on the signal transmission characteristics corresponding to the disease. The frequency range is determined based on the refractory period of neuronal electrical signal transmission, which is approximately 3ms. Theoretically, stimulation exceeding 330 Hz will not have a significant impact on neurons.

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 0.01 volts to 10 volts, a frequency ranging from 2 Hz to 333 Hz, and a current ranging from 0.5 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 450 microseconds, the amplitude ranges from 0.01 volts to 10 volts, the frequency ranges from 2 Hz to 333 Hz, and the current ranges from 0.5 mA to 25.5 mA.

Optionally, 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 Hz, 100 Hz, 200 Hz, 333 Hz, etc., and the current can be 0.5 mA, 10 mA, 15 mA, 25.5 mA, 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 Hz, 100 Hz, 200 Hz, 333 Hz, etc., and the current can be 0.5 mA, 10 mA, 15 mA, 25.5 mA, etc.

In some embodiments, the time interval between two adjacent pulses of the first pulse signal is in the range of 0 milliseconds to 55 milliseconds; and/or, the time interval between two adjacent pulses of the second pulse signal is in the range of 0 milliseconds to 55 milliseconds.

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

As shown in Table 1, an embodiment of pulse signal parameters is illustrated, which can include a pulse width of 160 microseconds, an amplitude of 0.01 volts to 10 volts, a frequency of 200 Hz, and a current of 1 milliampere.

Table 1:

Optionally, the pulse width is typically used in the range of 60-90 milliseconds, with an output range of 20-450 milliseconds; the amplitude is typically used in the range of 2-3 volts, with an output range of 0-10 volts; the frequency is typically 130 Hz, with low-frequency stimulation at 60-80 Hz and high-frequency stimulation at 130-150 Hz, with an output range of 2-255 Hz; and the current is typically used in the range of 1.3-2 mA, with an output range of 0.5-25.5 mA.

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, etc., and the current can be 1.3 mA, 1.7 mA, 2 mA, etc.

Referring to Figure 4, this embodiment of the present disclosure provides a schematic diagram of the structure of a deep electrode 121. As shown in Figure 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 contact point 1212 for electrical connection with a 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 to output a first pulse signal or a second pulse signal, and/or sense electroencephalogram (EEG) signals.

As an example, as shown in Figure 4, one end of the electrode outer tube 1211 is provided with at least two first contact points 1212 for electrical connection 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.

Referring to Figure 5, this embodiment of the present disclosure provides a schematic diagram of the structure of a cortical electrode 122. As shown in Figure 5, the cortical electrode 122 includes a connecting wire 1221 and an electrode patch 1222 that are fixedly connected. One end of the connecting wire 1221 is provided with at least one second contact point 1223 for electrical connection with a pulse generating unit 111. The electrode patch 1222 is disposed at the other end of the connecting wire 1221 and includes at least one second electrode contact 1224. Each second electrode contact 1224 is used to output a first pulse signal or a second pulse signal, and/or sense electroencephalogram (EEG) signals.

Optionally, each first contact point 1212 is electrically connected to a first electrode contact point 1213, and each second contact point 1223 is electrically connected to a second electrode contact point 1224.

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

In some embodiments, each deep electrode 121 includes 4-8 first electrode contacts 1213, with a distance of 8-12 mm between two adjacent first electrode contacts 1213; and/or, each dermal electrode 122 includes 4-8 second electrode contacts 1224, with a distance of 8-12 mm between two adjacent second electrode contacts 1224.

Referring to Figure 6, this embodiment of the present disclosure provides a schematic diagram of the framework 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 first electrode contact 1213 of each deep electrode 121 is electrically connected to the first pulse generating module 1112, and another portion of the first electrode contact 1213 is electrically connected to the second pulse generating module 1113;

A portion of the second electrode contacts 1224 of each cortical electrode 122 are electrically connected to the first pulse generating module 1112, and another portion of the second electrode contacts 1224 are electrically connected to the second pulse generating module 1113.

Optionally, the electrode information represents information about the first electrode contact 1213 of each deep electrode 121 and/or the second electrode contact 1224 of each cortical electrode 122 used to output the target pulse signal. Therefore, the electrode information is information about the electrode contacts of the deep electrodes 121 and/or cortical electrodes 122 that are needed in epilepsy treatment.

This disclosure allows for the generation of multiple stimulation field strengths based on the patient's condition or the different contact points of the stimulation electrodes. These multiple stimulation field strengths can partially overlap, with the overlapping areas enhancing the stimulation. Furthermore, when the electrodes shift, the position of the field strength can be adjusted to achieve precise stimulation and an adjustable stimulation area, replacing the need for craniotomy to replace or adjust the electrodes. Therefore, this disclosure enables flexible movement of the stimulation target area within the brain without moving the electrodes.

In some embodiments, the control unit 112 is further configured to acquire electroencephalogram (EEG) signals output from at least one deep electrode 121 and/or at least one cortical electrode 122, and when it is determined that the target object has epilepsy based on the EEG signals, determine an adjusted target region based on the EEG signals, determine adjusted pulse generation information based on the adjusted target region, and control the pulse generation unit 111 to generate a corresponding target pulse signal based on the adjusted pulse generation information.

Optionally, before implanting the pulse generation device 10 for epilepsy, the doctor can implant multiple SEEG electrodes in the patient's head. These multiple SEEG electrodes are implanted for a short period of time. EEG signals are collected from these SEEG electrodes, and the location of the lesion is confirmed based on these EEG signals, thereby determining the target area.

After the pulse generator 10 for epilepsy is implanted in the patient's head, the lesion area of the patient's epilepsy may change due to the development of the disease, such as the lesion becoming larger or smaller, or the addition of new lesions, which will change the target area that needs to be treated. As a result, the pulse generation information needs to be readjusted in order to provide targeted treatment according to the patient's condition.

The control unit 112 can acquire electroencephalogram (EEG) signals output from at least one deep electrode 121 and/or at least one cortical electrode 122. Therefore, when the target subject experiences epilepsy, the control unit can determine an adjusted target region based on the EEG signals. The adjusted target region includes the epileptic lesion area. Furthermore, the control unit can determine adjusted pulse generation information based on the adjusted target region, i.e., determine new pulse parameter information and electrode information. The electrode information represents the information of the deep electrode 121 and/or cortical electrode 122 used to output the target pulse signal. This information may include contact point selection, monopolar stimulation mode, bipolar stimulation mode, stimulation orientation, characteristics, distribution, and strength of the stimulation field.

Optionally, the EEG signal can be converted into a digital EEG signal after signal preprocessing such as signal amplification and filtering, so that the control unit 112 can determine whether epilepsy has occurred.

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

Specifically, in a set of first electrode contacts 1213, one first electrode contact 1213 outputs a first pulse signal, and the other first electrode contact 1213 outputs a second pulse signal.

Specifically, in a set of second electrode contacts 1224, one second electrode contact 1224 outputs a first pulse signal, and the other second electrode contact 1224 outputs a second pulse signal.

Alternatively, in embodiments of this disclosure, only the amplitude, pulse width, frequency, and current may be adjusted, while the waveform remains fixed and needs to be adjusted during treatment.

Depending on the target area and the required stimulation intensity, select the corresponding contact to output pulses. For example, if a set of electrode contacts is selected to output pulses, a field strength is formed around that set of electrode contacts, which is suitable for cases where the lesion or the range of the attack is small. If the lesion or the range of the attack is large, two sets of spaced electrode contacts can be selected to output pulses simultaneously, thus forming an elliptical field strength between the two sets of spaced electrode contacts.

Optionally, the second threshold and the first threshold are determined based on practical experience, meaning that in this embodiment of the disclosure, at least one set of electrode contacts can be matched to work simultaneously according to the size of the target area. The overlapping area of the electric field strengths of the two sets of electrode contacts can cover the target area, thereby enhancing the electric field strength of the target area.

Optionally, the first pulse signal and the second pulse signal are generated at different electrode contacts, respectively and simultaneously. Alternatively, the first pulse signal can be generated at the electrode contact, and the second pulse signal can be generated at the housing of the deep electrode 121.

Optionally, the unipolar stimulation mode is a deep electrode 121 where at least one first electrode contact 1213 outputs a pulse signal, and the bipolar stimulation mode is a deep electrode 121 where at least two first electrode contacts 1213 output pulse signals.

In some embodiments, the control unit 112 is specifically configured to: if the target region 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 region; if the target region 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 region; if the target region is located in both the deep brain and 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 region.

The embodiments disclosed herein can determine the appropriate electrode to use based on the specific location where epilepsy occurs, thus making it applicable to various epilepsy patients.

The embodiments disclosed herein can also analyze the real-time acquired EEG signals and optimize the optimal stimulation pulse signals to truly achieve precise stimulation, high-efficiency stimulation, full-coverage stimulation, and personalized treatment.

Referring to Figure 11, this disclosure provides a schematic diagram of the framework of another pulse generation system 1. The pulse generation system 1 further includes a magnet 50 for a target object to wear, and the pulse generation device 10 for epilepsy further includes a magnet sensing module 130.

The magnet sensing module 130 is used to send an acquisition electrical signal to the control unit 112 when the magnet 50 is within a predetermined distance range of the magnet sensing module 130; the control unit 112 is also used to acquire and record the electroencephalogram (EEG) signals output from at least one deep electrode 121 and/or at least one cortical electrode 122 in response to receiving the acquisition electrical signal.

In practical applications, when an epilepsy patient anticipates an epileptic seizure, they can pass the magnet 50 across the location where the pulse generator 10 for epilepsy is implanted. The magnetically sensitive magnet sensing module 130 inside the pulse generator 10 can convert the sensed change in the magnetic field into an electrical signal that can be recognized by the control unit 112. After receiving the electrical signal, the control unit 112 records the corresponding electroencephalogram (EEG) signal.

Optionally, the pulse generating device 10 for epilepsy is fixed to the head of the target.

In some embodiments, the magnet sensing module 130 includes a Hall switch. The Hall switch is used to send a data acquisition electrical signal to the control unit 112 when a change in the magnetic field is sensed.

Alternatively, when a thin sheet of metal or semiconductor carrying an electric current is placed perpendicularly in a magnetic field, a potential difference is generated across the two ends of the sheet; this phenomenon is called the Hall effect. A Hall switch uses the Hall effect to sense changes in the magnetic field and outputs an electrical signal. The input of a Hall switch is characterized by the magnetic flux density B. When the value of B reaches a certain level (such as B1), the trigger inside the Hall switch flips, and the output level of the Hall switch also flips accordingly, thus outputting a signal representing a change in the magnetic field.

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

As an example, this disclosure provides a pulse generation method applied to a pulse generation system 1 of this disclosure. The pulse generation method includes:

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

(2) The control unit 112 stores the initial pulse generation information. When the target object is detected to have epilepsy, it controls the pulse generation unit 111 to generate the corresponding target pulse signal according to the pre-stored initial pulse generation information, and outputs the target pulse signal to the target area of the target object through at least one deep electrode 121 and/or at least one dermal electrode 122.

(3) The control unit 112 acquires the EEG signals output from at least one deep electrode 121 and/or at least one cortical electrode 122. When it is determined that the target object has epilepsy based on the EEG signals, the control unit 112 determines the adjusted target area based on the EEG signals, determines the adjusted pulse generation information based on the adjusted target area, and controls the pulse generation unit 111 to generate the corresponding target pulse signal based on the adjusted pulse generation information.

Optionally, the control unit 112 may further control a set of first electrode contacts 1213 of at least one deep electrode 121 and/or a set of second electrode contacts 1224 of at least one dermal electrode 122 to output a target pulse signal when the area of the target region is determined to be greater than a first threshold; and control at least two sets of first electrode contacts 1213 of at least one deep electrode 121 and/or at least two sets of second electrode contacts 1224 of at least one dermal electrode 122 to output a target pulse signal when the area of the target region is determined to be greater than a second threshold; wherein the second threshold is greater than the first threshold.

Optionally, the control unit 112 may also control at least one deep electrode 121 to output a target pulse signal to the target region when the target region is determined to be located in the deep brain of the target object; control at least one cortical electrode 122 to output a target pulse signal to the target region when the target region is determined to be located in the cerebral cortex of the target object; and control at least one deep electrode 121 and at least one cortical electrode 122 to output a target pulse signal to the target region when the target region is determined to be located in both the deep brain and cerebral cortex of the target object.

Optionally, the control unit 112 may also, in response to receiving the acquired electrical signal, acquire and record the electroencephalogram (EEG) signals output from at least one deep electrode 121 and/or at least one cortical electrode 122, determine the adjusted target region based on the EEG signals, determine the adjusted pulse generation information based on the adjusted target region, and control the pulse generation unit 111 to generate the corresponding target pulse signal based on the adjusted pulse generation information.

By applying the embodiments disclosed herein, at least the following beneficial effects can be achieved:

(1) In this embodiment, at least one deep electrode 121 and at least one cortical electrode 122 are provided on the head of the target object. The pulse generating unit 111 is electrically connected to both the deep electrode 121 and the cortical electrode 122. When the control unit 112 detects that the target object is experiencing epilepsy, it can control the pulse generating unit 111 to generate a corresponding target pulse signal based on the pre-stored initial pulse generation information. The target pulse signal is then output to the target area 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 epileptic lesion area. The pre-stored initial pulse generation information in this embodiment is used to examine the target object. The pulse generation information determined on the terminal device 20 based on the target object's EEG digital signal can effectively regulate the target object's epilepsy, avoiding the technical problems of high risk and significant side effects associated with drug treatment or surgical treatment.

(2) The target pulse signal of this embodiment includes a first pulse signal and a second pulse signal with opposite polarities, and the first pulse signal and the second pulse signal are output simultaneously. Since 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, especially during the synchronous output phase of the first pulse signal and the second pulse signal. At the same time, the stimulation effect is guaranteed, avoiding the secondary damage caused by using extra pulses to balance the charge in the prior art, thereby ensuring the neuromodulation effect.

(3) In this embodiment, the first pulse signal and the second pulse signal have the same start time, which can prolong the charge balance effect time to a certain extent, resulting in a better charge balance effect. At the same time, in this embodiment, the charge balance effect time and the effective stimulation time can be performed at the same time, which can achieve the balance of excess charge while effectively stimulating, ensuring that the tissue is protected from damage by excess charge.

(4) The embodiments of this disclosure use first pulse signals and second pulse signals with opposite polarities, and the first pulse signals and second pulse signals have the same start 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 there is a certain interval between the positive and negative pulse signals of the bipolar pulse signal), the embodiments of this disclosure can shorten the stimulation refractory period, generate multiple sets of stimulation within the same stimulation duration, and can regulate the target tissue more quickly and shorten the regulation time.

(5) This embodiment of the present disclosure allows for real-time monitoring and adjustment of pulse generation information based on the patient's condition. When the epileptic focus changes as the condition progresses, the control unit 112 can acquire EEG signals output from at least one deep electrode 121 and/or at least one cortical electrode 122. This allows for the determination of the adjusted target area based on the EEG signals when the target patient experiences epilepsy, and further determination of the adjusted pulse generation information based on the adjusted target area. This enables more convenient monitoring of the patient's treatment and timely adjustment of the treatment plan. Therefore, this embodiment of the present disclosure can analyze the real-time acquired EEG signals and optimize the optimal stimulation pulse signal, truly achieving precise stimulation, high-efficiency stimulation, full-coverage stimulation, and personalized treatment.

(6) The control unit 112 of this disclosure can determine at least one deep electrode 121 and/or at least one cortical electrode 122 to be used based on the location of the target area, thereby determining the corresponding electrode to be used based on the specific location of the epilepsy, which can be applied to various epilepsy patients and has strong applicability.

As an example, the second embodiment of this application provides a pulse generator and pulse generation system for Parkinson's disease, which will be described in detail below.

Parkinson's disease, also known as "tremor paralysis," is a neurodegenerative disease. The main cause is the degeneration and death of dopaminergic neurons in the substantia nigra, and it may be related to a variety of factors, including genetics, environment, and nervous system aging. It is generally accepted that aging is the most important factor in the development of Parkinson's disease, which has a significant high incidence in the elderly, with a slightly higher incidence in men than women.

The symptoms of Parkinson's disease vary, mainly manifesting as motor and non-motor symptoms. Motor symptoms include resting tremor, rigidity, bradykinesia, and postural instability. Non-motor symptoms mainly include constipation, olfactory dysfunction, sleep disturbances, autonomic dysfunction, and mental and cognitive impairments.

Parkinson's disease is a highly specific degeneration of dopamine-containing cells in the substantia nigra of the midbrain. Substantia nigra degeneration in Parkinson's disease leads to a lack of dopamine in the striatum. Effective control of PD is possible in patients within the first 5-7 years of treatment; thereafter, a series of common asthenic complications occur, collectively known as tardive dyskinesia.

Currently, society faces a situation of many patients, few doctors, and lengthy diagnosis times, hindering early detection, diagnosis, and treatment. Early diagnosis and disease progression analysis of Parkinson's disease are not easy. In particular, the internationally accepted methods for assessing the motor symptoms of Parkinson's disease are the Upton Depression Rating Scale (UPDRS) and the MDS-UPDRS. Each doctor manually observes and scores the patient's fluency in performing designated movements, providing a comprehensive assessment of the condition. This complete process is time-consuming and labor-intensive, increasing the burden on doctors, and is prone to errors due to varying doctor mental states.

Existing medications commonly cause side effects, such as motor complications (e.g., oscillations, wearing off phenomenon, and drug-induced motor difficulties), as well as nausea, daytime sleepiness, sleep attacks, orthostatic hypotension, or impulse control disorders. Symptomatic treatment of non-motor symptoms of Parkinson's disease (e.g., sleep disturbances, anxiety, and depression) is also available. However, to date, no approved treatments have been shown to protect neurons or alter the course of the disease. There is an urgent need for novel therapies that target the underlying causes of Parkinson's disease and, unlike symptomatic treatments, slow its continued progression.

The pulse generating device and pulse generating system disclosed herein for use in Parkinson's disease are intended to solve at least one of the above-mentioned technical problems related to Parkinson's disease.

Referring to Figure 8, this disclosure provides a schematic diagram of the framework of a pulse generation system 1. As shown in Figure 8, the pulse generation system 1 includes a terminal device 20 and a pulse generation device 10 for Parkinson's disease according to this disclosure.

Referring to Figure 12, this disclosure provides a schematic diagram of the framework of a pulse generating device 10 for Parkinson's disease. As shown in Figure 12, the pulse generating device 10 for Parkinson's disease includes at least one deep electrode 121, a pulse generating unit 111, and a control unit 112.

Terminal device 20 is communicatively connected to control unit 112. Terminal device 20 is used to acquire EEG digital signals sent from control unit 112, convert EEG digital signals into EEG images through predetermined software, extract and display the spectral changes corresponding to the β band of EEG waves from the EEG images using predetermined software, display a control interface for inputting pulse generation information, and in response to the input operation of pulse generation information on the control interface, acquire pulse generation information and send pulse generation information to control unit 112.

At least one deep electrode 121 is implanted at a predetermined location deep within the brain of the target subject; each deep electrode 121 includes at least one first electrode contact 1213, each first electrode contact 1213 being used to output pulse signals and/or sense electroencephalogram (EEG) signals.

The pulse generating unit 111 is electrically connected to at least one deep electrode 121, and the pulse generating unit 111 is used to generate a target pulse signal.

The control unit 112 is electrically connected to the pulse generation unit 111. The control unit 112 is used to acquire the EEG signal output from the first electrode contact 1213 of at least one deep electrode 121, convert the EEG signal into a digital EEG signal and send it to the terminal device 20, acquire the pulse generation information sent by the terminal device 20, 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 the target area of the target object through at least one deep electrode 121. The pulse generation information includes pulse parameter information and electrode information. The electrode information represents the information of the deep electrode 121 used to output the target pulse signal. The target area includes the lesion area of Parkinson's disease.

Specifically, the control unit 112 controls the target pulse signal generated by the pulse generation unit 111 to cover the target area according to the pulse generation information, thereby regulating Parkinson's disease safely and effectively.

Optionally, the electrode information includes information about the deep electrode 121 and information about the first electrode contact 1213. The control unit 112 can determine which first electrode contact 1213 of which deep electrode 121 needs to output a pulse signal based on the electrode information, so as to output a target pulse signal to the target area.

Specifically, each first electrode contact 1213 of the deep electrode 121 can output only a pulse signal, or it can sense only an EEG signal, or it can output a pulse signal and sense an EEG signal at different time periods respectively.

Optionally, before converting the EEG signal into a digital EEG signal, the control unit 112 can also perform signal preprocessing on the EEG signal, including signal processing methods such as filtering and amplification.

Optionally, the pulse generating device 10 for Parkinson's disease is fixed to the head of the target object.

In this embodiment of the pulse generating device 10 for Parkinson's disease, at least one deep electrode 121 is implanted at a predetermined location deep within the brain of the target subject. Each deep electrode 121 includes at least one first electrode contact 1213, which is used to output pulse signals and/or sense electroencephalogram (EEG) signals. This allows the control unit 112 to acquire the EEG signals output from the first electrode contact 1213 of at least one deep electrode 121, convert the EEG signals into digital EEG signals, and send them to the terminal device 20. This allows the doctor to analyze the target subject's condition based on the digital EEG signals received by the terminal device 20, thereby determining pulse generation information. The control unit 112 acquires the pulse generation information sent by the terminal device 20, controls the pulse generating unit 111 to generate a target pulse signal based on the pulse generation information, and outputs the target pulse signal to the target area of the target subject through at least one deep electrode 121, thereby achieving treatment of the lesion area of Parkinson's disease.

The pulse generating device 10 for Parkinson's disease in this embodiment treats the target subject by outputting pulse signals through a deep electrode 121 implanted in the target subject's head. The target pulse signal is obtained based on the pulse generation information of the target subject's electroencephalogram (EEG) signal, ensuring treatment effectiveness. Furthermore, the target subject's EEG signal is acquired through at least one deep electrode 121, allowing real-time acquisition of the target subject's EEG signal without the need for additional equipment, saving manpower and resources. Therefore, this embodiment, by acquiring EEG signals and outputting pulse signals through the deep electrode 121, can specifically regulate Parkinson's disease in the target subject, ensuring treatment effectiveness.

Furthermore, the pulse generation device 10 for Parkinson's disease in this embodiment can periodically check the condition of the target subject and adjust the pulse generation information for treatment in a timely manner based on the target subject's electroencephalogram (EEG) signals, thereby further ensuring the treatment effect.

In some embodiments, 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.

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

The pulse signal parameters of the first pulse signal are the same as those 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.

Optionally, if the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, then the first pulse signal and the second pulse signal are bidirectional symmetrical pulse signals, which can ensure charge balance.

Optionally, the pulse width, amplitude, frequency, and current of the first pulse signal may all be different from those of the second pulse signal, or at least one of the pulse width, amplitude, frequency, and current may be different.

In this embodiment of the invention, if the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, charge balance can be achieved within the formed stimulation field. If the pulse signal parameters of the first pulse signal are different from those of the second pulse signal, the stimulation intensity at a certain local location can be adjusted within the formed stimulation field to achieve the distribution of different stimulation amounts to the stimulation target. Based on effective stimulation, the amount of stimulation given is reduced, avoiding the harm of excess pulses to the patient and facilitating the low-power operation of the device.

Specifically, in a set of effective stimulation waveforms, the waveforms of the first and second pulse signals are not limited to square waves; they can also be triangular waves, trapezoidal waves, sine waves, etc. The waveforms of the first and second pulse signals may be different, and even the waveforms of multiple first pulse signals or multiple second pulse signals may differ. Different waveforms will also produce different stimulation field strengths. The greater the slope of the stimulation waveform, the faster the neuron's response. However, for local neural clusters, the response can be very complex. In practical applications, different waveforms can be considered to achieve the effect of activating/inhibiting neurons.

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 Hz to 260 Hz, and a current ranging from 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 ranges from 20 microseconds to 450 microseconds, the amplitude ranges from 0 volts to 10.5 volts, the frequency ranges from 1 Hz to 260 Hz, and the current ranges from 1 mA to 30 mA.

Optionally, 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 Hz, 100 Hz, 150 Hz, 260 Hz, etc., and the current can be 1 mA, 10 mA, 20 mA, 30 mA, 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 Hz, 100 Hz, 150 Hz, 260 Hz, etc., and the current can be 1 mA, 10 mA, 20 mA, 30 mA, etc.

Referring to Figure 4, this embodiment of the present disclosure provides a schematic diagram of the structure of a deep electrode 121. As shown in Figure 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 a 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 electrically connected to a corresponding connecting contact 1112 via a wire.

As an example, as shown in Figure 4, one end of the electrode outer tube 1211 is provided with at least two connection contact points 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 two first electrode contacts 1213.

Optionally, the unipolar stimulation mode is a deep electrode 121 where at least one first electrode contact 1213 outputs a pulse signal, and the bipolar stimulation mode is a deep electrode 121 where at least two first electrode contacts 1213 output pulse signals.

In some embodiments, the first electrode contact 1213 is an annular contact arranged around the circumference of the electrode outer tube 1211; or, at least two first electrode contacts 1213 are spaced apart along the circumference of the electrode outer tube 1211; and/or, at least two first electrode contacts 1213 are spaced apart along the axial direction of the electrode outer tube 1211.

This disclosure allows for the generation of multiple stimulation field strengths based on the patient's condition or the different contact points of the stimulation electrodes. These multiple stimulation field strengths can partially overlap, with the overlapping areas enhancing the stimulation. Furthermore, when the electrodes shift, the position of the field strength can be adjusted to achieve precise stimulation and an adjustable stimulation area, replacing the need for craniotomy to replace or adjust the electrodes. Therefore, this disclosure enables flexible movement of the stimulation target area within the brain without moving the electrodes.

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 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 to the first pulse generation module 1112, and the other first electrode contact 1213 is electrically connected to the second pulse generation module 1113.

Specifically, at least one first pulse signal and at least one second pulse signal constitute a set of effective stimulation waveforms. In practical applications, the target area can be stimulated by at least one set of effective stimulation waveforms, thereby achieving the regulation of Parkinson's symptoms.

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

Referring to Figure 13, this embodiment of the present disclosure provides a structural schematic diagram of a group of first electrode contacts 1213 of a deep electrode 121. As shown in Figure 13, the first electrode contacts 1213 are arranged circumferentially along the outer electrode tube 1211 to form a group of first electrode contacts 1213. The number of first electrode contacts 1213 in each group is 2-4. In the embodiment shown in Figure 13, four first electrode contacts 1213 are used as an example.

Optionally, at least two sets of first electrode contacts 1213 are provided at intervals along the axial direction of the outer electrode tube 1211, and the length of the first electrode contacts 1213 along the axial direction of the outer electrode tube 1211 is 0.5 mm to 1.5 mm.

Referring to Figure 14, this disclosure provides another structural schematic diagram of a deep electrode 121. As shown in Figure 14, the length of the first electrode contact 1213 along the axial direction of the electrode outer tube 1211 is L1, and the value of L1 can be 0.5 mm, 1 mm, or 1.5 mm, etc.

In some embodiments, the first electrode contact 1213 is elliptical, with a circumferential length of 0.8 mm to 1 mm along the outer electrode tube 1211 and an axial length of 0.5 mm to 0.7 mm along the outer electrode tube 1211.

The distance between two adjacent first electrode contacts 1213 along the circumferential axis of the outer electrode tube 1211 is 0.6 mm to 0.8 mm.

Optionally, the circumferential length of the outer electrode tube 1211 can be 0.8 mm, 0.9 mm, 1 mm, etc. The axial length of the outer electrode tube 1211 can be 0.5 mm, 0.6 mm, 0.7 mm, etc.; the distance between two adjacent first electrode contacts 1213 along the circumferential axis of the outer electrode tube 1211 can be 0.6 mm, 0.7 mm, 0.8 mm, etc.

Referring to Figure 15, this disclosure provides a schematic diagram of another deep electrode 121. As shown in Figure 15, the distance L2 between two adjacent first electrode contacts 1213 along the circumferential axis of the electrode outer tube 1211 can be 0.75 mm.

Referring to Figure 6, this embodiment of the present disclosure provides a schematic diagram of the structure of a pulse generation unit 111. As shown in Figure 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.

Of the two adjacent first electrode contacts 1213, one first electrode contact 1213 is electrically connected to the first pulse generating module 1112, and the other first electrode contact 1213 is electrically connected to the second pulse generating module 1113.

The pulse generation system 1 of this disclosure includes a pulse generation device 10 for Parkinson's disease. For a detailed functional description of the pulse generation system 1, please refer to the description of the pulse generation device 10 for Parkinson's disease shown above, which will not be repeated here.

The pulse generation system 1 of this embodiment treats the target subject by outputting pulse signals through a deep electrode 121 implanted in the target subject's head. The target pulse signal is obtained based on the pulse generation information for targeted treatment given by the target subject's electroencephalogram (EEG) signal, ensuring treatment effectiveness. Furthermore, the target subject's EEG signal is acquired through at least one deep electrode 121, allowing for real-time acquisition of the target subject's EEG signal without the need for additional equipment, saving manpower and resources. Therefore, the pulse generation system 1 of this embodiment, by acquiring EEG signals and outputting pulse signals through the deep electrode 121, can provide targeted regulation of the target subject's Parkinson's disease, ensuring treatment effectiveness. In addition, the pulse generation system 1 of this embodiment allows for periodic monitoring of the target subject's condition, enabling timely adjustment of the pulse generation information based on the target subject's EEG signal, further guaranteeing treatment effectiveness.

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

The deep electrode 121 of this embodiment can acquire EEG signals in real time or under the control of the control unit 112. This allows doctors to regularly examine Parkinson's patients through the terminal device 20. The pulse generation information can be adjusted through the EEG signals, and targeted treatment can be carried out according to the development of the Parkinson's patient's condition to ensure treatment effectiveness and save equipment and manpower.

Referring to Figure 16, this embodiment of the present disclosure provides a schematic diagram of the structure of a pulse generation system 1. As shown in Figure 16, the pulse generation system 1 further includes: a programmable controller 30; the programmable controller 30 is connected to the control unit 112 via Bluetooth, and the programmable controller 30 is connected to the terminal device 20 via a data cable; the control unit 112 is used to send EEG digital signals to the programmable controller 30; the programmable controller 30 is used to send EEG digital signals to the terminal device 20.

Referring to Figure 16, the pulse generation system 1 also includes a charging coil 40; the programmable controller 30 performs electromagnetic resonant coupling transmission through the charging coil 40 to wirelessly charge the pulse generation device 10 used for Parkinson's disease.

Optionally, the programmable device 30 can be a patient programmable device that uses its own battery to wirelessly charge the pulse generator 10 used for Parkinson's disease through electromagnetic resonant coupling transmission via the charging coil 40.

As an example, this disclosure provides a pulse generation method applied to a pulse generation system 1 of this disclosure. The pulse generation method includes:

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

(2) The terminal device 20 acquires the EEG digital signal sent from the control unit 112, converts the EEG digital signal into an EEG image through predetermined software, and extracts and displays the spectral changes corresponding to the β band of the EEG from the EEG image using predetermined software. It displays a control interface for inputting pulse generation information, and in response to the input operation of pulse generation information on the control interface, acquires pulse generation information and sends the pulse generation information to the control unit 112.

(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 the target area of the target object through at least one deep electrode 121.

When applied to the embodiments of this disclosure, at least the following technical effects can be achieved:

(1) The control unit 112 of this embodiment can acquire the EEG signal output from the first electrode contact 1213 of at least one deep electrode 121, convert the EEG signal into a digital EEG signal and send it to the terminal device 20. This allows doctors to analyze the target patient's condition based on the digital EEG 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 based on the pulse generation information, and outputs the target pulse signal to the target area of the target patient through at least one deep electrode 121, thereby achieving treatment of the lesion area of Parkinson's disease. In this embodiment, the target patient is treated by outputting a pulse signal from the deep electrode 121 implanted in the head of the target patient. The target pulse signal is obtained based on the targeted treatment pulse generation information given by the target patient's EEG signal, which can ensure the treatment effect. Moreover, the target patient's EEG signal is acquired through at least one deep electrode 121, so the target patient's EEG signal can be acquired in real time through the deep electrode 121, without the need for additional equipment to examine the target patient's EEG signal, saving manpower and resources. Therefore, this embodiment of the present disclosure acquires electroencephalogram (EEG) signals and outputs pulse signals through the deep electrode 121, which can be used to specifically regulate Parkinson's disease in the target subject and ensure the therapeutic effect.

(2) The target pulse signal of this embodiment includes a first pulse signal and a second pulse signal with opposite polarities, and the first pulse signal and the second pulse signal are output simultaneously. Since 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, especially during the synchronous output phase of the first pulse signal and the second pulse signal. At the same time, the stimulation effect is guaranteed, avoiding the secondary damage caused by using extra pulses to balance the charge in the prior art, thereby ensuring the neuromodulation effect.

(3) In this embodiment, the first pulse signal and the second pulse signal have the same start time, which can prolong the charge balance effect time to a certain extent, resulting in a better charge balance effect. At the same time, in this embodiment, the charge balance effect time and the effective stimulation time can be performed at the same time, which can achieve the balance of excess charge while effectively stimulating, ensuring that the tissue is protected from damage by excess charge.

(4) The embodiments of this disclosure use first pulse signals and second pulse signals with opposite polarities, and the first pulse signals and second pulse signals have the same start 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 there is a certain interval between the positive and negative pulse signals of the bipolar pulse signal), the embodiments of this disclosure can shorten the stimulation refractory period, generate multiple sets of stimulation within the same stimulation duration, and can regulate the target tissue more quickly and shorten the regulation time.

(5) The present invention can enable regular examination of the target's condition, timely adjustment of the pulse generation information for treatment based on the target's EEG signals, targeted treatment based on the development of Parkinson's disease, ensuring treatment effectiveness, and saving equipment and manpower.

As an example, the third embodiment of this application provides a pulse generating device and system for relieving pain, as well as a wearable device, which will be described in detail below.

Chronic pain is a major symptom of chronic injury. The pathology of chronic pain is widespread in everyone's body. Chronic pain is a symptom arising from chronic injury. Its occurrence also indicates a decline in physical condition or potential health crises in other parts of the body. The pain it causes can lead to sleep disturbances, loss of appetite, mental breakdown, even personality distortions and home unrest, causing many patients to choose suicide due to the unbearable long-term pain. It has a serious impact on the lives and quality of life of the elderly.

Cancer pain, in particular, is a sensation caused by the transmission of information about the need for repair or regulation at the site of pain to the central nervous system. It is one of the main causes of suffering for patients with advanced cancer. Among patients experiencing pain, 50% to 80% of the pain is not effectively controlled for various reasons.

Cancer pain can be categorized into three types: pain directly caused by the tumor (approximately 88%), pain caused by cancer treatment (approximately 11%), and pain indirectly caused by the tumor (approximately 1%). Clinically, a small number of cancer patients may experience pain unrelated to the tumor, such as lower back and leg pain in lung cancer patients due to concurrent disc herniation. Therefore, the cause of pain in cancer patients must be clearly diagnosed.

With the continuous development of technology, the medical field no longer relies solely on medication for patient treatment; it also utilizes various therapeutic devices, such as ultra-laser pain therapy devices, ultrasound therapy devices, and infrared therapy devices. Among these, ultra-laser pain therapy devices effectively treat inflammatory, neurological, and traumatic pain by irradiating the patient's ganglia, nerve trunks, nerve plexuses, pain points, and acupoints with laser light. This utilizes the photoelectric, photomagnetic, photochemical, photoimmunoassay, and photoenzymatic effects produced by light acting on the human body.

Ultrasound therapy devices use ultrasound waves to treat the human body. The ultrasound waves exert mechanical, thermal, and cavitation effects on human tissues, leading to accelerated blood flow, improved blood circulation, increased peristalsis of blood vessel walls, enhanced cell membrane permeability, ion redistribution, increased metabolism, decreased hydrogen ion concentration in tissues, increased pH value, muscle relaxation, decreased muscle tone, and reduced or alleviated pain. These changes in local tissues during ultrasound therapy can influence a specific stage of the body or the whole body through neurohumoral pathways, thus achieving a therapeutic effect.

Infrared therapy devices use the penetrating power of infrared rays to act on the treatment area. They can penetrate the skin and directly generate a thermal effect on muscles and subcutaneous tissues, accelerating blood circulation, increasing metabolism, reducing pain, increasing muscle relaxation, and producing a massage effect.

However, the above-mentioned pain treatment methods are mainly physical therapy for common and minor pain. They are not very effective for cancer pain or some chronic pain of unknown cause.

The pulse generating device and system for relieving pain, and the wearable device disclosed herein, are intended to solve at least one of the above-mentioned technical problems related to pain.

Referring to Figure 17, this embodiment of the present disclosure provides a schematic diagram of the structure of a pulse generator 110 for relieving pain. As shown in Figure 17, the pulse generator 110 for relieving pain includes: at least one electrode 120, a pulse generating unit 111, and a control unit 112.

At least one electrode 120 is disposed in the target area of the target object, each electrode 120 including at least one electrode contact, the target area including the pain area and/or the spinal cord.

The pulse generating unit 111 is electrically connected to at least one electrode and is used to generate a target pulse signal.

The control unit 112 is electrically connected to the pulse generating unit 111. The control unit 112 is used to control the pulse generating unit 111 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.

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.

The pain-relieving pulse generating device 110 of this embodiment places at least one electrode 120 in the target area of the target object. 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 area through at least one electrode 120 to stimulate the pain-related nerves in the target area. Therefore, by stimulating the pain-related nerves in the target area, this embodiment can interfere with or inhibit pain signals, thereby achieving the purpose of relieving pain.

Optionally, in embodiments of this disclosure, the Aβ fiber is stimulated by a target pulse signal, thereby closing the transmission gate and preventing the transmission of signals from small-diameter A-δ or C fibers.

Meanwhile, the target pulse signal used by the pain-relieving pulse generator 110 in this embodiment includes a first pulse signal and a second pulse signal with opposite polarities. Pulse signals with opposite polarities are beneficial to achieving charge balance within the stimulation field, especially during the synchronous output phase of the first pulse signal and the second pulse signal. At the same time, the stimulation effect is guaranteed, avoiding secondary damage caused by using extra pulses to balance the charge in the prior art, and ensuring the pain-relieving effect.

Referring to Figure 18, this embodiment of the present disclosure provides a waveform structure diagram of a target pulse signal. As an example, as shown in Figure 18, the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal. The polarities of a first pulse of the first pulse signal and a second pulse of the second pulse signal are opposite and symmetrical, that is, the first pulse signal and the second pulse signal are bidirectional symmetrical pulse signals, which can completely guarantee charge balance.

Optionally, the pulse width, amplitude, frequency, and current of the first pulse signal may all be different from those of the second pulse signal, or at least one of the pulse width, amplitude, frequency, and current may be different.

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 Hz to 100 kHz, and a 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.

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 Hz, 500 Hz, 50 kHz, 100 kHz, etc., and the current can be 0.01 mA, 10 mA, 15 mA, 25.5 mA, 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 Hz, 500 Hz, 50 kHz, 100 kHz, etc., and the current can be 0.01 mA, 10 mA, 15 mA, 25.5 mA.

In this embodiment of the invention, if the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, charge balance can be achieved within the formed stimulation field. If the pulse signal parameters of the first pulse signal are different from those of the second pulse signal, the stimulation intensity at a certain local location can be adjusted within the formed stimulation field to achieve the distribution of different stimulation amounts to the stimulation target. Based on effective stimulation, the amount of stimulation given is reduced, avoiding the harm of excess pulses to the patient and facilitating the low-power operation of the device.

In practice, neurons enter a refractory period after transmitting a signal. During this period, stimulating neurons will not elicit a response. Therefore, stimulating neurons at appropriate intervals can achieve the desired effect, conserve energy, and avoid unnecessary side effects. There is a certain time interval T between the end of one stimulus and the beginning of the next, and the length of this interval T may be the same or different for multiple stimulus gaps.

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

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

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, or a sine 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, or a sine wave.

In some embodiments, 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 are the same as those of the second pulse signal, including pulse width, amplitude and frequency.

Specifically, in a set of effective stimulation waveforms, the waveforms of the first and second pulse signals are not limited to square waves; they can also be triangular waves, trapezoidal waves, sine waves, etc. The waveforms of the first and second pulse signals may be different, and even the waveforms of multiple first pulse signals or multiple second pulse signals may differ. Different waveforms will also produce different stimulation field strengths. The greater the slope of the stimulation waveform, the faster the neuron's response. However, for local neural clusters, the response can be very complex. In practical applications, different waveforms can be considered to achieve the effect of activating/inhibiting neurons.

In some embodiments, the electrode contacts include a first electrode contact 1213.

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

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

Referring to Figure 19, the first electrode contact 1213 is an annular contact, arranged circumferentially around 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 mm-5 mm.

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

In some embodiments, the electrode contacts include a second electrode contact 1224.

Referring to Figure 20, this embodiment of the present disclosure provides a schematic diagram of the structure of an electrode patch 1203. As shown in Figure 20, at least one electrode includes at least one electrode patch 1203, which is attached to a target area; the electrode patch 1203 includes an electrode pad 1222, which includes at least one second electrode contact 1224; each second electrode contact 1224 is electrically connected to a pulse generating unit 111.

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

Referring to Figure 20, the second electrode contact 1224 is square, 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, and a plurality of second electrode contacts 1224 are arranged in at least one row on the electrode patch 1222.

Referring to Figure 6, this embodiment of the present disclosure provides a schematic diagram of the structure of a pulse generating unit 111. The pulse generating unit 111 includes a first pulse generating module 1112 for generating a first pulse signal and a second pulse generating module 1113 for generating a second pulse signal; a portion of the electrode contacts are electrically connected to the first pulse generating module 1112, and another portion of the electrode contacts are electrically connected to the second pulse generating module 1113.

The control unit 112 is also configured to output the target pulse signal to at least one set of electrode contacts of at least one electrode according to the target pulse signal generated by the control pulse generating unit 111; each set of electrode contacts includes two electrode contacts, one electrode contact being electrically connected to the first pulse generating module 1112 and the other electrode contact being electrically connected to the second pulse generating module 1113.

Optionally, of two adjacent electrode contacts, one electrode contact is electrically connected to the first pulse generating module 1112, and the other electrode contact is electrically connected to the second pulse generating module 1113.

Specifically, at least one first pulse signal and at least one second pulse signal constitute a set of effective stimulation waveforms. In practical applications, the target area can be stimulated by at least one set of effective stimulation waveforms, thereby achieving the purpose of relieving pain.

The embodiments disclosed herein can generate multiple stimulation field strengths based on each pain point in the patient's pain area, and the multiple stimulation field strengths can partially overlap, with the overlapping field strengths enhancing the stimulation.

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

This disclosure provides a wearable device, including: a connection structure and a pain-relieving pulse generator 110 according to this disclosure; the connection structure and the pain-relieving pulse generator 110 are detachably connected, and the connection structure is used to fix the connection to a predetermined position of a target object.

Optionally, the connection structure can be fixed to the waist, arms, legs, neck, or head of the target object.

In some embodiments, the connection structure includes a first connecting band and a second connecting band; both the first connecting band and the second connecting band are detachably connected to the pain-relieving pulse generating device 110; the first connecting band and the second connecting band are used to detachably form a ring.

Optionally, the ends of the first connecting strip and the second connecting strip can be glued together to form an adjustable ring structure that can accommodate different patient sizes.

The wearable device of this disclosure embodiment places at least one electrode 120 in the target area of the target object. 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 area through at least one electrode 120 to stimulate the pain-related nerves in the target area. Therefore, this disclosure embodiment can stimulate Aβ fibers through the target pulse signal, thereby closing the transmission gate and preventing the transmission of signals from small-diameter A-δ or C fibers, thus interfering with or inhibiting pain signals and achieving the purpose of relieving pain.

Meanwhile, the wearable device in this embodiment uses a target pulse signal including a first pulse signal and a second pulse signal with opposite polarities. Pulse signals with opposite polarities are beneficial for achieving charge balance within the stimulation field, especially during the synchronous output phase of the first pulse signal and the second pulse signal. This also ensures the stimulation effect and avoids secondary damage caused by using extra pulses to balance the charge in the prior art, thus ensuring the pain relief effect.

Referring to Figure 21, this disclosure provides a schematic diagram of a pulse generation system 1. When the pulse generation device is used to relieve pain, the pulse generation system 1 may further include: an adjustment device 60 and a pain-relieving pulse generation device 110 according to this disclosure.

The adjustment device 60 is used to send adjustment information to the control unit 112, so that the control unit 112 determines pulse generation information according to the adjustment information and controls the pulse generation unit 111 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.

Optionally, contact information is used to indicate the electrode contacts of the electrode 120 that outputs the pulse signal.

Optionally, the regulating device 60 is communicatively or electrically connected to the control unit 112.

The pulse generation system 1 applied to the embodiments of this disclosure can achieve at least the following technical effects:

The pulse generation system 1 of this embodiment places at least one electrode 120 in the target area of the target object. 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 area through at least one electrode 120 to stimulate the pain-related nerves in the target area. The pulse generation system 1 of this embodiment can stimulate Aβ fibers through the target pulse signal, thereby closing the transmission gate and preventing the transmission of signals from small-diameter A-δ or C fibers, thus interfering with or inhibiting pain signals and achieving the purpose of relieving pain.

Meanwhile, the target pulse signals used in the pulse generation system 1 of this embodiment include a first pulse signal and a second pulse signal with opposite polarities. Pulse signals with opposite polarities are beneficial to achieving charge balance within the stimulation field, especially during the synchronous output phase of the first pulse signal and the second pulse signal. At the same time, the stimulation effect is guaranteed, avoiding secondary damage caused by using extra pulses to balance the charge in the prior art, and ensuring the effect of relieving pain.

In some embodiments, the adjustment device 60 includes an increase adjustment module and a decrease adjustment module, and the adjustment information includes increase information and decrease information.

The adjustment device 60 is used to send adjustment information (increase or decrease) to the control unit 112 in response to a selection operation for adding or decreasing the adjustment module; the control unit 112 is used to adjust the current pulse generation information to the next pulse generation information according to the pre-stored arrangement order of multiple pulse generation information in response to receiving the adjustment information; or, in response to receiving the decrease information, adjust the current pulse generation information to the previous pulse generation information according to the pre-stored arrangement order of multiple pulse generation information; the multiple pulse generation information is arranged in order of increasing field strength of the corresponding generated target pulse signal.

Optionally, multiple pre-stored pulse generation information can be preset. By setting different pulse signal parameters and different electrode contacts to output pulse information, different levels of stimulation can be achieved, and users can adjust them according to their needs.

Optionally, the increase adjustment module and the decrease adjustment module can be manually pressed adjustment buttons, or they can be corresponding adjustment controls. The adjustment device 60 includes a touch screen display, which includes increase adjustment controls and decrease adjustment controls to facilitate user selection and operation.

The adjustment device 60 of this embodiment adjusts the level of the output target pulse signal according to the needs of the target object, thereby allowing the user to flexibly control the field strength of the output target pulse signal. For example, when the user still feels some pain, they can press the increase adjustment module to increase the field strength of the output target pulse signal, further relieving the user's pain; simultaneously, when the user feels the pain has subsided, they can press the decrease adjustment module to decrease the field strength of the output target pulse signal, avoiding overstimulation. Therefore, the target pulse signal of this embodiment can be flexibly adjusted according to user needs, improving the user experience.

As an example, this disclosure provides a pulse generation method applied to a pulse generation system 1 of this disclosure. The pulse generation method includes:

(1) The control unit 112 controls the pulse generation unit 111 to generate a target pulse signal according to the initial pulse generation information, and outputs the target pulse signal to the target area through at least one electrode to stimulate the pain-related nerves in the target area.

Optionally, the initial pulse generation information is the default pulse generation information, and the user can further adjust it to the desired level using the adjustment device 60.

(2) Perform at least one of the following adjustment operations: In response to the selection operation of adding or lowering the adjustment module, the adjustment device 60 sends an increase information or a decrease information to the control unit 112; In response to receiving the increase information, the control unit 112 adjusts the current pulse generation information to the next pulse generation information according to the arrangement order of multiple pre-stored pulse generation information; or, In response to receiving the decrease information, adjusts the current pulse generation information to the previous pulse generation information according to the arrangement order of multiple pre-stored pulse generation information.

Optionally, the increase adjustment module and the decrease adjustment module can be manually pressed adjustment buttons, or they can be corresponding adjustment controls. The adjustment device 60 includes a touch screen display, which includes increase adjustment controls and decrease adjustment controls to facilitate user selection and operation.

By applying the embodiments disclosed herein, at least the following technical effects can be achieved:

(1) In this embodiment, at least one electrode 120 is placed in the target area of the target object. 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 area through at least one electrode 120 to stimulate the pain-related nerves in the target area. Therefore, this embodiment can stimulate Aβ fibers through the target pulse signal, thereby closing the transmission gate and preventing the transmission of signals from small-diameter A-δ or C fibers, thus interfering with or inhibiting the pain signal and achieving the purpose of relieving pain.

(2) The target pulse signal of this embodiment includes a first pulse signal and a second pulse signal with opposite polarities, and the first pulse signal and the second pulse signal are output simultaneously. Since 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, especially during the synchronous output phase of the first pulse signal and the second pulse signal. At the same time, the stimulation effect is guaranteed, avoiding the secondary damage caused by using extra pulses to balance the charge in the prior art, thereby ensuring the neuromodulation effect.

(3) In this embodiment, the first pulse signal and the second pulse signal have the same start time, which can prolong the charge balance effect time to a certain extent, resulting in a better charge balance effect. At the same time, in this embodiment, the charge balance effect time and the effective stimulation time can be performed at the same time, which can achieve the balance of excess charge while effectively stimulating, ensuring that the tissue is protected from damage by excess charge.

(4) The embodiments of this disclosure use first pulse signals and second pulse signals with opposite polarities, and the first pulse signals and second pulse signals have the same start 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 there is a certain interval between the positive and negative pulse signals of the bipolar pulse signal), the embodiments of this disclosure can shorten the stimulation refractory period, generate multiple sets of stimulation within the same stimulation duration, and can regulate the target tissue more quickly and shorten the regulation time.

(5) The adjustment device 60 of this embodiment adjusts the level of the output target pulse signal according to the needs of the target object, thereby enabling the user to flexibly control the field strength of the output target pulse signal. For example, when the user still feels some pain, they can press the increase adjustment module to increase the field strength of the output target pulse signal, further relieving the user's pain; at the same time, when the user feels the pain is relieved, they can press the decrease adjustment module to decrease the field strength of the output target pulse signal, avoiding overstimulation. Therefore, the target pulse signal of this embodiment can be flexibly adjusted according to user needs, improving the user experience.

It should be understood that although arrows indicate various operation steps in the flowcharts of the embodiments of this disclosure, the order in which these steps are implemented is not limited to the order indicated by the arrows. Unless explicitly stated herein, in some implementation scenarios of the embodiments of this disclosure, the implementation steps in each flowchart can be executed in other orders as required. Furthermore, some or all of the steps in each flowchart may include multiple sub-steps or multiple stages based on the actual implementation scenario. Some or all of these sub-steps or stages can be executed at the same time, and each sub-step or stage can also be executed at different times. In scenarios where execution times differ, the execution order of these sub-steps or stages can be flexibly configured as required, and the embodiments of this disclosure do not limit this.

In this disclosure, the terms "module" or "unit" refer to a computer program or part of a computer program that has a predetermined function and works with other related parts to achieve a predetermined goal, and can be implemented wholly or partially using software, hardware (such as processing circuitry or memory), or a combination thereof. Similarly, a processor (or multiple processors or memory) can be used to implement one or more modules or units. Furthermore, each module or unit can be part of an overall module or unit that includes the functionality of that module or unit.

The above description is only an optional implementation method for some implementation scenarios of this disclosure. It should be noted that for those skilled in the art, other similar implementation methods based on the technical concept of this disclosure without departing from the technical concept of this disclosure also fall within the protection scope of the embodiments of this disclosure.

Claims (17)

A pulse generator for neural modulation, comprising: A pulse generating unit is used to be electrically connected to at least one electrode; the at least one electrode is used to be positioned at a predetermined location on a 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 region of the target object; the target region is a region for neural modulation. 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. The pulse generating device for neural modulation according to claim 1 is characterized in that the waveforms of the first pulse signal and the second pulse signal are both rectangular, the pulse signal parameters of the first pulse signal are the same as those of the second pulse signal, and the pulse signal parameters include pulse width, amplitude and frequency. A pulse generating device, comprising: at least one electrode, and a pulse generating device 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. The pulse generating device according to claim 3, characterized in that, applied to 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 generation unit and is used to control the pulse generation 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 deep electrode and/or 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 the terminal device based on the EEG digital signal of the target object, the electrode information represents the information of the deep electrode and/or cortical electrode used to output the target pulse signal, and the target area includes the lesion area of the epilepsy. According to claim 4, the pulse generating device, 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. According to claim 4, the pulse generating device, wherein the electrode contacts include second electrode contacts; 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. According to claim 4, the pulse generating device, 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, determine an adjusted target region based on the EEG signals, determine adjusted pulse generation information based on the adjusted target region, and control the pulse generating unit to generate a corresponding target pulse signal based on the adjusted pulse generation information. According to claim 7, the pulse generating device, 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 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 are controlled to output the target pulse signal; the second threshold is greater than the first threshold. According to claim 3, the pulse generating device, applied to 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, each of the electrode contacts being 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 generation 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 generation 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 electrodes used to output the target pulse signal, and the target area includes the lesion area of Parkinson's disease. According to claim 9, the pulse generating device, 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. According to claim 3, the pulse generating device, for relieving pain, at least one of the electrodes is disposed in a target area of the target object, the target area including a pain 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. According to the pulse generating device of claim 11, 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 Hz to 100 kHz, and a 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. A pulse generation system, comprising: a terminal device and a pulse generation 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. According to the pulse generation system of claim 13, the terminal device is further configured to determine the target region for neuromodulation based on the EEG digital signal, determine the field strength distribution information corresponding to the target region based on the target region and the field strength distribution model, and determine the pulse generation information based on the field strength distribution information and the distribution of each of the electrode contacts; 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. According to claim 13, the pulse generation system is applied to Parkinson's disease, and the terminal device is further configured 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, in response to input operations for pulse generation information on the control interface, acquire the pulse generation information and send the pulse generation information to the control unit. According to the pulse generation system of claim 15, the control interface further includes a signal acquisition control; 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. According to claim 13, the pulse generating system is used to relieve pain, and the pulse generating system further includes an adjustment device for sending adjustment information to the control unit, so that the control unit determines pulse generating information according to the adjustment information and controls the pulse generating unit to generate a target pulse signal according to the pulse generating 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.