A pulse generator and a control method thereof

Abstract

The present application relates to the field of medical equipment, and particularly to a pulse generator and a control method thereof. The pulse generator of the present application uses the same pulse output circuit to send the same pulse output signal to the deep brain stimulation circuit and the vagus nerve stimulation circuit, so that the pulse generator can send the vagus nerve stimulation electrical signal to stimulate the vagus nerve and send the deep brain stimulation electrical signal to stimulate the deep brain. Since the deep brain stimulation electrical signal and the vagus nerve stimulation electrical signal are synchronously started based on the same pulse output signal, the two can be coordinated according to certain rules to achieve better therapeutic effect.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a pulse generator and its control method. Background Technology

[0002] Vagus nerve stimulation (VNS) has shown positive and effective therapeutic effects on a variety of clinical conditions. Domestic and international studies have demonstrated that VNS can treat refractory epilepsy, and as an adjunct treatment for refractory depression, traumatic brain injury, cerebral ischemia, and immune regulation disorders; it has even improved learning and cognitive function in some patients. Clinically, VNS is closely associated with neurological diseases, while deep brain stimulation (DBS) can also treat refractory epilepsy and depression. Multiple studies have shown a close relationship between VNS and DBS, and simultaneous use of both can lead to better therapeutic effects. There are precedents abroad of using a single DBS and VNS stimulator for combined treatment, but using two separate machines makes it difficult to guarantee the connection between VNS and DBS stimulation. Summary of the Invention

[0003] In view of this, the purpose of this invention is to provide a pulse generator that can perform both vagus nerve stimulation and deep brain stimulation, and coordinate the two in a certain way to achieve better therapeutic effects.

[0004] On one hand, embodiments of the present invention provide a pulse generator, the pulse generator comprising: a deep brain stimulation circuit for emitting deep brain stimulation electrical signals; and a vagus nerve stimulation circuit for emitting vagus nerve stimulation electrical signals; and a pulse output circuit connected to the deep brain stimulation circuit and the vagus nerve stimulation circuit respectively, for emitting the same pulse output signal to the deep brain stimulation circuit and the vagus nerve stimulation circuit.

[0005] Furthermore, the pulse generator further includes: a first output circuit connected to the deep brain stimulation circuit for transmitting the deep brain stimulation electrical signal; and a first electrode connected to the first output circuit for stimulating target points in the brain.

[0006] Furthermore, the pulse generator also includes: an EEG acquisition electrode for acquiring EEG signals; an EEG analysis circuit for real-time detection of whether the EEG signals are abnormal and for issuing an EEG abnormality signal when EEG abnormalities occur; and an input circuit connected to the EEG acquisition electrode and the EEG analysis circuit respectively, for inputting the EEG signals into the EEG analysis circuit.

[0007] Furthermore, the pulse generator also includes a system circuit, which is connected to the pulse output circuit and the EEG analysis circuit respectively, and is used to control the pulse output circuit to emit pulses in response to abnormal EEG signals emitted by the EEG analysis circuit.

[0008] Furthermore, the pulse generator also includes: a second output circuit connected to the vagus nerve stimulation circuit for transmitting the vagus nerve stimulation electrical signal; and a second electrode connected to the second output circuit for stimulating the vagus nerve target point.

[0009] Furthermore, the deep brain stimulation circuit includes a first control circuit, which generates the deep brain stimulation electrical signal after receiving the pulse output signal; the vagus nerve stimulation circuit includes a second control circuit, which generates the vagus nerve stimulation electrical signal after receiving the pulse output signal.

[0010] Furthermore, after receiving the pulse output signal, the first control circuit and the second control circuit respectively adjust the pulse output signal parameters so that the deep brain stimulation electrical signal and the vagus nerve stimulation electrical signal are output synchronously or alternately.

[0011] Furthermore, the pulse generator also includes a power supply, which is connected to both the pulse output circuit and the system circuit to provide electrical energy to both circuits.

[0012] Furthermore, the power supply includes: a first power supply connected to the pulse output circuit to provide power to the pulse output circuit; and a second power supply connected to the system circuit to provide power to the system circuit.

[0013] Furthermore, the system circuit is connected to the first power supply and the second power supply respectively, for monitoring the power level of the first power supply; the pulse generator further includes: a connection circuit, connected to the first power supply, the second power supply and the system circuit respectively, for connecting the second power supply to the first power supply under the control of the system circuit when the power level of the first power supply is lower than a predetermined threshold, to provide over-discharge protection for the first power supply.

[0014] Furthermore, the pulse generator also includes an emergency connection circuit, which is connected to the second power supply and the pulse output circuit respectively, and is configured to be turned on when an emergency is entered, so that the second power supply supplies power to the pulse output circuit.

[0015] Furthermore, the emergency connection circuit is connected to the system circuit, and the system circuit controls the emergency connection circuit to disconnect in response to the emergency connection circuit being connected for a predetermined time or starting to charge.

[0016] Furthermore, in response to the emergency connection circuit being connected for a predetermined time, the system circuit activates a low-power ultra-long standby mode and sends an alarm notification to a third party.

[0017] Furthermore, the power supply also includes a wireless charging unit for receiving electrical energy wirelessly.

[0018] Furthermore, the pulse generator also includes: a housing; a first top cover, which is sealed to the housing; a second top cover, which is sealed to the housing; a circuit board disposed inside the housing, and the pulse output circuit disposed on the circuit board.

[0019] On the other hand, embodiments of the present invention also provide a control method for the above-mentioned pulse generator, the method comprising: a pulse output circuit sending the same pulse output signal to a deep brain stimulation circuit and a vagus nerve stimulation circuit; the deep brain stimulation circuit controlling the output of a deep brain stimulation electrical signal after receiving the pulse output signal, and the vagus nerve stimulation circuit controlling the output of a vagus nerve stimulation electrical signal after receiving the pulse output signal.

[0020] The pulse generator in this embodiment of the invention uses the same pulse output circuit to send the same pulse output signal to the deep brain stimulation circuit and the vagus nerve stimulation circuit. This allows the pulse generator to send both vagus nerve stimulation signals and deep brain stimulation signals. Furthermore, since the deep brain stimulation signals and vagus nerve stimulation signals are synchronously activated based on the same pulse output signal, they can coordinate with each other according to a certain pattern to achieve better therapeutic effects. Attached Figure Description

[0021] The above and other objects, features and advantages of the present invention will become clearer from the following description of embodiments of the invention with reference to the accompanying drawings, in which:

[0022] Figure 1 This is a schematic diagram of the overall structure of the pulse generator according to an embodiment of the present invention;

[0023] Figure 2 This is a schematic diagram of the internal structure of the pulse generator according to an embodiment of the present invention;

[0024] Figure 3 This is a modular schematic diagram of the internal circuit structure of the pulse generator according to an embodiment of the present invention;

[0025] Figure 4This is a modular schematic diagram of the specific internal circuit structure of the pulse generator according to an embodiment of the present invention;

[0026] Figure 5 This is a schematic diagram of the power connection scheme of the pulse generator according to an embodiment of the present invention;

[0027] Figure 6 This is a schematic diagram of the control steps of the pulse generator according to an embodiment of the present invention;

[0028] Figure 7 This is a schematic diagram of the control steps of a pulse generator according to another embodiment of the present invention;

[0029] Figure 8 This is a schematic diagram of the power management steps of the pulse generator according to an embodiment of the present invention;

[0030] Figure 9 This is a schematic diagram of the pulse generator in use according to an embodiment of the present invention;

[0031] Figure 10 This is a schematic diagram of the pulse generator in use according to another embodiment of the present invention.

[0032] Legend: 1. Shell; 2. First top cover; 21. Deep brain stimulation circuit; 211. First control circuit; 22. First output circuit; 221. First electrode; 223. EEG acquisition electrode; 224. Input circuit; 225. EEG analysis circuit; 3. Second top cover; 31. Vagus nerve stimulation circuit; 311. Second control circuit; 32. Second output circuit; 321. Second electrode; 4. Power supply; 41. First power supply; 42. Second power supply; 43. Wireless charging unit; 5. Circuit board; 51. Pulse output circuit; 52. System circuit; 53. Connection circuit; 54. Emergency connection circuit. Detailed Implementation

[0033] The present invention is described below based on embodiments, but the invention is not limited to these embodiments. In the detailed description of the invention below, certain specific details are described in detail. Those skilled in the art will fully understand the invention even without these details. To avoid obscuring the essence of the invention, well-known methods, processes, flows, elements, and circuits are not described in detail.

[0034] Furthermore, those skilled in the art should understand that the accompanying drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0035] Furthermore, it should be understood that in the following description, "circuit" refers to a conductive loop consisting of at least one element or sub-circuit connected by electrical or electromagnetic connections. When an element or circuit is said to be "connected" to another element or "connected" between two nodes, it can be directly coupled or connected to another element, or there may be intermediate elements. The connection between elements can be physical, logical, or a combination thereof. Conversely, when an element is said to be "directly coupled to" or "directly connected" to another element, it means that there are no intermediate elements between them.

[0036] Unless the context explicitly requires it, words such as "including" or "contains" in the instruction manual should be interpreted as including rather than exclusive or exhaustive; that is, meaning "including but not limited to".

[0037] In the description of this invention, it should be understood that the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0038] like Figure 3 As shown, the pulse generator of this embodiment includes a deep brain stimulation circuit 21, a vagus nerve stimulation circuit 31, and a pulse output circuit 51. The deep brain stimulation circuit 21 is used to generate a deep brain stimulation electrical signal; the vagus nerve stimulation circuit 31 is used to generate a vagus nerve stimulation electrical signal. The pulse output circuit 51 is connected to both the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31, and sends the same pulse output signal to both circuits, causing them to start synchronously. Understandably, the pulse output signal can serve as a start signal to synchronously activate the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31. The deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31 each complete the DA conversion and adjust the pulse width, frequency, amplitude, phase, and other parameters of the stimulation signal to output the stimulation signal. Alternatively, the pulse output signal can first complete the DA conversion to serve as the original stimulation signal, and then the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31 each adjust the pulse width, frequency, amplitude, phase, and other parameters of the stimulation signal to output the final stimulation signal.

[0039] After the pulse output circuit 51 sends the same pulse output signal to the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31, the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31 respectively send deep brain stimulation electrical signals and vagus nerve stimulation electrical signals based on the pulse output signal to stimulate the target points of the brain and vagus nerve. In this embodiment, the same pulse output circuit 51 sends the same pulse output signal to the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31, so that the pulse generator can send both vagus nerve stimulation electrical signals for vagus nerve stimulation and deep brain stimulation electrical signals for deep brain stimulation. Since the deep brain stimulation electrical signals and vagus nerve stimulation electrical signals are started synchronously based on the same pulse output signal, they can cooperate according to a certain pattern. For example, they can be synchronized or coordinated according to a certain period after phase adjustment to achieve better therapeutic effects.

[0040] like Figure 1 and Figure 2 As shown, in one specific embodiment, the pulse generator comprises a housing 1, a first top cover 2, a second top cover 3, and a circuit board 5. The first top cover 2 and the second top cover 3 are respectively sealed to the housing 1, and the circuit board 5 is disposed inside the housing 1. A deep brain stimulation circuit 21, a vagus nerve stimulation circuit 31, and a pulse output circuit 51 are disposed on the circuit board 5. Specifically, the housing 1 is made of titanium or titanium alloy, and the first top cover 2 and the second top cover 3 are made of polyurethane or epoxy resin, which has good corrosion resistance and biocompatibility. During use, the pulse generator needs to be implanted into the human body; the housing 1 and the first and second top covers 2 and 3, which are sealed to it, can protect the internal circuitry.

[0041] like Figure 4 As shown, in one specific embodiment, the pulse generator further includes a first output circuit 22 and a first electrode 221. The first output circuit 22 is connected to the deep brain stimulation circuit 21 and is used to transmit deep brain stimulation electrical signals. The first electrode 221 is connected to the first output circuit 22 and is implanted in the brain to stimulate target points in the brain. When the pulse generator is in use, the pulse output circuit 51 emits a pulse output signal. After receiving the pulse output signal, the deep brain stimulation circuit 21 generates a deep brain stimulation electrical signal, and then outputs the deep brain stimulation electrical signal through the first output circuit 22 to the first electrode 221. The first electrode 221 then stimulates the target points in the brain, thereby achieving the treatment of the disease.

[0042] In some optional embodiments, the pulse generator further includes an EEG acquisition electrode 223, an EEG analysis circuit 225, and an input circuit 224. The EEG acquisition electrode 223 is used to acquire EEG signals. The EEG analysis circuit 225 is used to detect abnormalities in the EEG signals in real time and issue an abnormal EEG signal when abnormalities occur. The input circuit 224 is connected to both the EEG acquisition electrode 223 and the EEG analysis circuit 225, and is used to input the EEG signals into the EEG analysis circuit 225. In this embodiment, the EEG acquisition electrode 223 needs to be implanted into the cerebral cortex before use. During use, the EEG acquisition electrode 223 can acquire EEG signals from the cerebral cortex, and then transmit the EEG signals to the EEG analysis circuit 225 through the input circuit 224. This embodiment, by acquiring EEG signals, can determine whether the patient is in a state of illness, thus enabling the pulse generator to promptly activate the electrical stimulation function when the patient has an attack, providing timely treatment.

[0043] In one specific embodiment, the pulse generator further includes a system circuit 52. The system circuit 52 is connected to both the pulse output circuit 51 and the EEG analysis circuit 225, and is used to control the pulse output circuit 51 to emit pulses in response to abnormal EEG signals emitted by the EEG analysis circuit 225. The EEG signals collected by the EEG acquisition electrodes 223 are input to the EEG analysis circuit 225 via the input circuit 224, and then the processing results are transmitted to the system circuit 52 via the EEG analysis circuit 225. The EEG analysis circuit 225 can be implemented using a programmable controller such as a microcontroller. The EEG analysis circuit 225 has a program for detecting EEG signals, capable of detecting whether the EEG signals are abnormal. During use, the pulse output circuit 51 of the implanted pulse generator is initially in standby mode, while the EEG analysis circuit 225 performs real-time detection of whether the EEG signals are abnormal. If the EEG signals are normal, the standby mode remains unchanged. When the EEG analysis circuit 225 detects an abnormal EEG signal, it sends an abnormal EEG signal to the system circuit 52. The system circuit 52 then sends a control signal to the pulse output circuit 51, causing it to output a pulse signal. This causes the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31 to output vagus nerve stimulation signals based on the pulse output signal, thus providing deep brain stimulation and vagus nerve stimulation treatment to the patient. This embodiment, through the above method, can automatically treat the patient based on their condition, maximizing the timing of treatment and ensuring timely intervention. Simultaneously, it prevents the pulse generator from stimulating the patient when they are not experiencing an attack, improving the user experience and reducing the power consumption and lifespan of the pulse generator.

[0044] In one specific embodiment, the pulse generator further includes a second output circuit 32 and a second electrode 321. The second output circuit 32 is connected to the vagus nerve stimulation circuit 31 and is used to transmit vagus nerve stimulation electrical signals. The second electrode 321 is connected to the second output circuit 32 and is used to stimulate the vagus nerve. The second electrode 321 is implanted on the vagus nerve. When the pulse generator is activated, the pulse output circuit 51 begins to output a pulse output signal. After receiving the pulse output signal, the vagus nerve stimulation circuit 31 outputs a vagus nerve stimulation electrical signal according to the pulse output signal. The vagus nerve stimulation electrical signal is output to the second electrode 321 through the second output circuit 32, and the second electrode 321 stimulates the target point of the vagus nerve to treat the patient using vagus nerve stimulation therapy.

[0045] In one specific embodiment, the deep brain stimulation circuit 21 includes a first control circuit 211, which generates a deep brain stimulation electrical signal upon receiving a pulse output signal. The vagus nerve stimulation circuit 31 includes a second control circuit 311, which generates a vagus nerve stimulation electrical signal upon receiving a pulse output signal. Both the first control circuit 211 and the second control circuit 311 can be implemented using a programmable controller such as a microcontroller. Since the pulse output circuit 51 outputs the same pulse output signal to both the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31, the first control circuit 211 and the second control circuit 311 will receive the pulse output signal at the same time and react to it simultaneously. Based on this, the pulse width, frequency, amplitude, phase, and other parameters of the deep brain stimulation electrical signal and the vagus nerve stimulation electrical signal are determined by the control programs in the first control circuit 211 and the second control circuit 311. Therefore, by storing associated control programs in the first control circuit 211 and the second control circuit 311, a certain coordination relationship can be established between the deep brain stimulation electrical signals and the vagus nerve stimulation electrical signals. Furthermore, in some embodiments, the first control circuit 211 and the second control circuit 311 can each store multiple sets of control programs, enabling the deep brain stimulation and vagus nerve stimulation to switch between different coordination modes or to be performed relatively independently, thereby meeting more diverse treatment needs.

[0046] Specifically, after receiving the pulse output signal, the first control circuit 211 and the second control circuit 311 respectively begin to call the control program to generate deep brain stimulation electrical signals and vagus nerve stimulation electrical signals. Furthermore, by calling different control programs, the signal parameters of the deep brain stimulation electrical signals and vagus nerve stimulation electrical signals can be adjusted, enabling the pulse generator to operate in three different modes.

[0047] Mode 1: Independent Stimulation Mode. In this mode, the first control circuit 211 and the second control circuit 311 independently call the program to perform stimulation, and there is no correlation between the parameters of vagus nerve stimulation and deep brain stimulation.

[0048] Mode Two: Coordinated Stimulation Mode. In this mode, the first control circuit 211 and the second control circuit 311 invoke a specific program to coordinate the output of deep brain stimulation electrical signals and vagus nerve stimulation electrical signals. For example, the first control circuit 211 and the second control circuit 311 generate two parameter-correlated electrical pulse signals, which serve as vagus nerve stimulation electrical signals and deep brain stimulation electrical signals, respectively, and can be output synchronously or alternately. This mode enables deep brain stimulation and vagus nerve stimulation to proceed according to a certain pattern, thereby achieving better therapeutic effects.

[0049] The aforementioned synchronous output can adjust the phase between deep brain stimulation electrical signals and vagus nerve stimulation electrical signals, so that the two signals can stimulate simultaneously or with a relative delay. Because there is a certain parameter matching relationship in pulse width, frequency, amplitude or phase, it is called synchronous output.

[0050] The aforementioned alternating output can alternate between deep brain stimulation electrical signals and vagus nerve stimulation electrical signals according to a certain cycle. Therefore, there may be no coordination relationship between stimulation parameters. Instead, stimulation can be performed alternately by controlling the output time of the two signals separately. The alternating output method can avoid or reduce the side effects caused by continuous stimulation of a single target.

[0051] Mode 3: Cross-stimulation Mode. In this mode, the first control circuit 211 and the second control circuit 311, by invoking specific programs, can generate at least two different deep brain stimulation electrical signals and at least two different vagus nerve stimulation electrical signals, respectively. The at least two different deep brain stimulation electrical signals have the same frequency but may have different contact combinations, amplitudes, and / or pulse widths, and are periodically alternated for deep brain stimulation. Similarly, the at least two different vagus nerve stimulation electrical signals have the same frequency but may have different contact combinations, amplitudes, and / or pulse widths, and are periodically alternated for vagus nerve stimulation. Furthermore, the at least two deep brain stimulation programs and the at least two vagus nerve stimulation programs can have a cooperative relationship, such as a phase coordination relationship between the stimulation signals, to achieve alternating therapeutic effects. Through cross-stimulation, multiple signals can be alternately used to stimulate the brain and the vagus nerve, thereby avoiding or reducing the neurological side effects caused by continuous single stimulation signals.

[0052] In one specific embodiment, the pulse generator further includes a power supply 4. The power supply 4 is connected to both the pulse output circuit 51 and the system circuit 52, providing power to both. Specifically, the power supply 4 can be a battery, comprising two batteries: a first power supply 41 and a second power supply 42. Specifically, if the pulse output signal is used as the initial stimulation signal, the first power supply 41 only needs to be connected to the pulse output circuit 51 to provide power to it, and the pulse output circuit 51 indirectly provides power to the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31. If the pulse output signal is used only as a start signal, the first power supply 41 can be connected to the pulse output circuit 51, the deep brain stimulation circuit 21, and the vagus nerve stimulation circuit 31 respectively. The second power supply 42 is connected to the system circuit 52 to provide power to it. Since the pulse output circuit 51 consumes relatively large amounts of power, this embodiment separates the power supply for the system circuit 52 from that for the pulse output circuit 51. This ensures that even when the first power supply 41 is depleted, the second power supply can still power the system circuit 52, guaranteeing system operation and providing the prerequisite for activating emergency mode when necessary. Furthermore, dividing the power supply 4 into a first power supply 41 and a second power supply 42 reduces the size of the power supply batteries; using two standardized batteries for both the first power supply 41 and the second power supply 42 reduces the cost of manufacturing dedicated batteries and also reduces the overall size of the pulse generator.

[0053] Figure 5 This is a schematic diagram of the power connection scheme for the pulse generator according to an embodiment of the present invention. This embodiment optimizes the power connection scheme to achieve better power management. Other structures and functions are the same as in the above embodiments and will not be repeated here. Figure 5As shown, in some optional embodiments, the system circuit 52 is connected to the first power supply 41 and the second power supply 42 respectively, for monitoring the power level of the first power supply 41. The pulse generator also includes a connection circuit 53, which is connected to the first power supply 41, the second power supply 42 and the system circuit 52 respectively, for switching the second power supply 42 to the first power supply 41 under the control of the system circuit 52 when the power level of the first power supply 41 is lower than a predetermined threshold, thus providing over-discharge protection for the first power supply 41. Specifically, the connection circuit 53 can consist of a control switch and wires. The control switch is normally open and will only close when it receives a control signal from the system circuit 52, thus connecting the connection circuit. Since the first power supply 41 supplies power to the pulse output circuit 51 and the stimulation circuit, and the second power supply supplies power to the system circuit 52, and the power consumption of the pulse output circuit 51 and the stimulation circuit is relatively larger than that of the system circuit 52, the second power supply 42 will still have residual power when the first power supply 41 is depleted. Therefore, to prevent the first power supply 41 from over-discharging and causing battery damage after its power is depleted, this embodiment includes a connection circuit 53. When the first power supply 41 has sufficient power, the switch on the connection circuit 53 is normally open, and the connection circuit 53 is not energized. When the system circuit 52 detects that the power of the first power supply 41 is lower than a predetermined threshold, the system circuit 52 will issue a closing command to the normally open switch on the connection circuit 53, causing the connection circuit 53 to be turned on and connecting the second power supply 42 to the first power supply 41, thus providing over-discharge protection for the first power supply 41.

[0054] In some optional embodiments, the pulse generator also includes an emergency connection circuit 54. The emergency connection circuit 54 is connected to the second power supply 42, the pulse output circuit 51, and the stimulation circuit, respectively, and is configured to activate upon entering an emergency state, allowing the second power supply 42 to supply power to the pulse output circuit 51 and the stimulation circuit. Specifically, the emergency connection circuit 54 can also consist of a control switch and wires. The control switch is normally open and only closes upon receiving an emergency state signal, activating the emergency connection circuit. Since the first power supply 41 powers the pulse output circuit 51 and the stimulation circuit, and the second power supply powers the system circuit 52, and the power consumption of the pulse output circuit 51 and the stimulation circuit is relatively greater than that of the system circuit 52, the second power supply 42 will still have residual power when the first power supply 41 is depleted. At this time, the system circuit 52 can continue to operate normally, but the pulse output circuit 51 and the stimulation circuit can no longer output pulse signals. If the patient suddenly falls ill at this time, timely treatment will be impossible. Therefore, the pulse generator in this embodiment is also equipped with an emergency connection circuit 54. When not in an emergency state, the switch on the emergency connection circuit 54 is normally open, and the emergency connection circuit 54 is not connected. When the first power supply 41 is depleted, if the patient suddenly falls ill, the emergency state can be entered manually or by the system circuit 52. When the emergency state is entered, the switch on the emergency connection circuit 54 closes, the emergency connection circuit is connected, and the second power supply 42 is connected to the pulse output circuit 51 and the stimulation circuit. The pulse output circuit 51 and the stimulation circuit use the remaining power in the second power supply 42 to emit pulse output signals to achieve emergency treatment for the patient.

[0055] In some optional implementations, the emergency connection circuit 54 is connected to the system circuit 52. The system circuit 52 controls the emergency connection circuit 54 to disconnect when the connection time reaches a predetermined duration or charging begins. Since the remaining power in the second power supply 42 is limited, the emergency state cannot be used for an extended period. To prevent damage from over-discharge of the second power supply 42, the system circuit 52 can be preset to allow the emergency state to remain active for a duration of 48 hours. When the connection time of the emergency connection circuit 54 reaches this predetermined time, the system circuit 52 will control the emergency connection circuit 54 to disconnect. Furthermore, the user should charge the pulse generator as soon as possible after activating the emergency state. If the user starts charging within the duration of the emergency state, such as within 48 hours, the system circuit 52 will detect the start of charging and also control the emergency connection circuit 54 to disconnect. Since the first power supply 41's power is restored after charging, it returns to the initial state where the first power supply 41 supplies power to the pulse output circuit 51. Through the above-described settings, this embodiment enables flexible control of emergency situations, avoids excessive discharge of the second power supply 42, protects the second power supply 42, and ensures that the system circuit 52 can maintain normal operation.

[0056] In some optional implementations, system circuit 52, in response to the emergency connection circuit 54 being connected for a predetermined time, activates a low-power ultra-long standby mode and sends an alarm notification to a third party. If the emergency connection circuit 54 remains connected for a predetermined time, such as 48 hours, and the user does not charge the pulse generator within those 48 hours, system circuit 52, after disconnecting the emergency connection circuit 54, controls the pulse generator to enter a low-power ultra-long standby mode to prevent damage to the pulse generator. Simultaneously, system circuit 52 sends an alarm notification to a third party, alerting the patient's family, guardian, pulse generator after-sales personnel, or the pulse generator manufacturer, enabling them to promptly receive information about insufficient power in the pulse generator and recharge or replace it in time, reducing the probability of danger to the patient.

[0057] like Figure 2 As shown, in some optional embodiments, the power supply 4 also includes a wireless charging unit 43 for wirelessly receiving electrical energy. Since pulse generators are typically implanted in the body, they cannot be wired for charging. If the power supply 4 runs out of power, it can only be replaced surgically with a new pulse generator or a new battery, causing significant discomfort to the user. Therefore, this embodiment incorporates a wireless charging unit 43 on the power supply 4, allowing for wireless charging of the internally implanted power supply 4 from outside the body using a wireless charger. This greatly facilitates the use of the pulse generator and reduces user discomfort.

[0058] Figure 6 This is a schematic diagram of the control steps of a pulse generator according to an embodiment of the present invention. In this embodiment, the pulse generator is controlled according to the following... Figure 6 The steps shown are as follows:

[0059] S51: The pulse output circuit 51 sends the same pulse output signal to the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31.

[0060] S52: After receiving the pulse output signal, the deep brain stimulation circuit 21 controls the output of a deep brain stimulation electrical signal, and the vagus nerve stimulation circuit 31 controls the output of a vagus nerve stimulation electrical signal after receiving the pulse output signal.

[0061] Figure 7 This is a schematic diagram of the control steps of a pulse generator according to another embodiment of the present invention. This embodiment optimizes the working steps of the above embodiment to achieve the function of EEG acquisition and feedback. In this embodiment, the pulse generator is controlled according to... Figure 7 The steps shown are as follows:

[0062] S61: The EEG acquisition electrode 223 acquires EEG signals and transmits them to the EEG analysis circuit 225;

[0063] S62: EEG analysis circuit 225 monitors brain waves;

[0064] S63: EEG analysis circuit 225 determines whether the brainwave signal is abnormal;

[0065] If the brainwave signal is normal, return to the previous step S61 and continue to collect brainwaves.

[0066] If the brainwave signal is abnormal, proceed to the next step S64;

[0067] S64: The pulse output circuit 51 sends the same pulse output signal to the deep brain stimulation circuit 21 and the vagus nerve stimulation circuit 31.

[0068] S65: After receiving the pulse output signal, the deep brain stimulation circuit 21 controls the output of a deep brain stimulation electrical signal, and the vagus nerve stimulation circuit 31 controls the output of a vagus nerve stimulation electrical signal after receiving the pulse output signal.

[0069] In some alternative embodiments, the power supply circuit of the pulse generator described above is configured as follows: Figure 5 Connect the power supply as shown. And follow the instructions as follows: Figure 8 The power management steps shown manage power usage. The specific steps are as follows:

[0070] S71: System circuit 52 detects the power level of the first power supply 41;

[0071] S72: Determine whether the power of the first power supply 41 is lower than a predetermined threshold;

[0072] If the power of the first power supply 41 is not lower than the predetermined threshold, then return to the previous step S71 and continue to detect the power of the first power supply 41.

[0073] If the power of the first power source 41 is lower than a predetermined threshold, proceed to the next step S73.

[0074] S73: Connecting circuit 53 connects the second power supply 42 to the first power supply 41, providing over-discharge protection for the first power supply 41;

[0075] S74: Determine whether to activate emergency status;

[0076] If the emergency state is not activated, return to the previous step S73;

[0077] If an emergency state is activated, proceed to the next step S75;

[0078] S75: Emergency connection circuit 54 is turned on, connecting the second power supply 42 to the pulse output circuit 51, so that the pulse output circuit 51 can use the power of the second power supply 42 to generate a pulse output signal.

[0079] S76: Determine whether the emergency connection circuit 54 has been connected for the predetermined time;

[0080] If the predetermined time is reached, proceed to step S78;

[0081] S78: Disable emergency status, force the low-power ultra-long standby mode to be enabled, and send an alarm notification to a third party;

[0082] In step S76 above, if it is determined that the predetermined time has not been reached, then proceed to step S77.

[0083] S77: Determines whether charging has started;

[0084] If charging has not started, return to step S75 and remain in emergency status;

[0085] If charging begins, proceed to step S79;

[0086] S79: Close the emergency status and return to the initial state;

[0087] The above initial state is the state when the first power supply 41 has sufficient power, that is, the first power supply powers the pulse output circuit 51 and the stimulation circuit, and the second power supply 42 powers the system circuit 52.

[0088] Figure 9 This is a schematic diagram of the pulse generator in use according to an embodiment of the present invention, such as... Figure 9 As shown, the pulse generator in this embodiment may include two first electrodes 221 and a second electrode 321. The two first electrodes 221 can simultaneously stimulate different parts of the brain, or, by setting two sets of first control circuits 211 in the deep brain stimulation circuit 21, the two first electrodes 221 can output different deep brain stimulation electrical signals respectively. In practical use, the pulse generator needs to be surgically implanted in the chest area; the two first electrodes 221 are implanted in the brain, with specific target locations including: hippocampus, subthalamic nucleus, medial globus pallidus, anterior thalamic nucleus (ANT), cerebellum, substantia nigra, and cerebral cortex; the second electrode 321 is implanted on the vagus nerve. Deep brain stimulation and vagus nerve stimulation therapy can then be performed.

[0089] Figure 10 This is a schematic diagram of the pulse generator in use according to another embodiment of the present invention, as shown below. Figure 10As shown, the pulse generator in this embodiment includes a first electrode 221, a second electrode 321, and an EEG acquisition electrode 223. During use, the pulse generator needs to be surgically implanted in the chest area; the first electrode 221 is implanted in the brain, specifically in locations such as the hippocampus, subthalamic nucleus, medial globus pallidus, anterior thalamic nucleus (ANT), cerebellum, substantia nigra, and the patient's cerebral cortex; the EEG acquisition electrode 223 is implanted in the cerebral cortex; and the second electrode 321 is implanted on the vagus nerve. Deep brain stimulation, vagus nerve stimulation therapy, and EEG acquisition can then be performed.

[0090] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. For those skilled in the art, the present invention can be modified and varied in various ways. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principle of the present invention should be included within the scope of protection of the present invention.

Claims

1. A pulse generator, characterized in that, The pulse generator includes: Deep brain stimulation circuit (21), used to generate deep brain stimulation electrical signals; and Vagus nerve stimulation circuit (31) is used to generate vagus nerve stimulation electrical signals; The pulse output circuit (51) is connected to the deep brain stimulation circuit (21) and the vagus nerve stimulation circuit (31) respectively, and sends the same pulse output signal to the deep brain stimulation circuit (21) and the vagus nerve stimulation circuit (31); The deep brain stimulation circuit (21) includes a first control circuit (211), and the vagus nerve stimulation circuit (31) includes a second control circuit (311). The first control circuit (211) is used to generate and control the output of the deep brain stimulation electrical signal after receiving the pulse output signal; The second control circuit (311) is used to generate and control the output of the vagus nerve stimulation electrical signal after receiving the pulse output signal; The first control circuit (211) and the second control circuit (311) are configured to output the deep brain stimulation electrical signal and the vagus nerve stimulation electrical signal in three different modes selected from the following: independent stimulation mode, coordinated stimulation mode and cross-stimulation mode, wherein the coordinated stimulation mode is the synchronous output or alternating output of the deep brain stimulation electrical signal and the vagus nerve stimulation electrical signal.

2. The pulse generator according to claim 1, characterized in that, The pulse generator also includes: The first output circuit (22) is connected to the deep brain stimulation circuit (21) and is used to transmit the deep brain stimulation electrical signal; and The first electrode (221) is connected to the first output circuit (22) and is used to stimulate target points in the brain.

3. The pulse generator according to claim 1, characterized in that, The pulse generator also includes: Electroencephalogram (EEG) acquisition electrode (223) is used to acquire EEG signals; The electroencephalogram (EEG) analysis circuit (225) is used to detect whether the EEG signal is abnormal in real time and to issue an abnormal EEG signal when the EEG is abnormal. The input circuit (224) is connected to the EEG acquisition electrode (223) and the EEG analysis circuit (225) respectively, and is used to input the EEG signal into the EEG analysis circuit (225).

4. The pulse generator according to claim 3, characterized in that, The pulse generator also includes: The system circuit (52) is connected to the pulse output circuit (51) and the EEG analysis circuit (225) respectively, and is used to control the pulse output circuit (51) to emit pulses in response to the abnormal EEG signal emitted by the EEG analysis circuit (225).

5. The pulse generator according to claim 1, characterized in that, The pulse generator also includes: The second output circuit (32) is connected to the vagus nerve stimulation circuit (31) and is used to transmit the vagus nerve stimulation electrical signal; and The second electrode (321) is connected to the second output circuit (32) and is used to stimulate the target point of the vagus nerve.

6. The pulse generator according to claim 4, characterized in that, The pulse generator also includes: The power supply (4) is connected to the pulse output circuit (51) and the system circuit (52) respectively, and provides electrical energy to the pulse output circuit (51) and the system circuit (52).

7. The pulse generator according to claim 6, characterized in that, The power supply (4) also has a wireless charging unit (43) for receiving electrical energy wirelessly.

8. The pulse generator according to claim 1, characterized in that, The pulse generator also includes: Shell (1); The first top cover (2) is sealed to the housing (1) and is used to connect the first electrode (221); The second top cover (3) is sealed to the housing (1) and is used to connect the second electrode (321); A circuit board (5) is disposed inside the housing (1), and the pulse output circuit (51) is disposed on the circuit board (5).

9. A control method for a pulse generator as described in claim 1, characterized in that, The method includes: The pulse output circuit (51) sends the same pulse output signal to the deep brain stimulation circuit (21) and the vagus nerve stimulation circuit (31); After receiving the pulse output signal, the deep brain stimulation circuit (21) controls the output of the deep brain stimulation electrical signal, and the vagus nerve stimulation circuit (31) controls the output of the vagus nerve stimulation electrical signal after receiving the pulse output signal.

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