Device for treating cerebral apoplexy
By designing a device that includes controller, driver and stimulation electrode assembly, using wireless energy supply and resonant coupling technology, the problem of precise control of stimulation current and complete implantation in the prior art is solved, and efficient and safe therapeutic effects for stroke patients are achieved.
Patent Information
- Application Number
- PCT/CN2024/137296
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-07
- Filing Date
- 2024-12-06
- Publication Date
- 2025-06-12
AI Technical Summary
The prior art cannot achieve precise control of stimulation currents when treating stroke, and traditional equipment cannot be fully implanted into the body. External battery power supply requires large-volume batteries and needs to be replaced regularly, and radio frequency power supply is likely to cause radiation damage.
A device including a transmitting end and a receiving end is designed. The transmitting end includes a controller and a driver component, and the receiving end includes a stimulation electrode component, which supplies power to the stimulation electrode component through wireless energy supply, realizes bipolar electrical stimulation, and transmits energy through resonant coupling.
Accurate bipolar electrical stimulation of the sphenopal palatine ganglia is achieved, ensuring therapeutic effect and human safety, and through wireless energy supply and resonant coupling technology, energy transmission efficiency and device implantability are improved.
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Figure CN2024137296_12062025_PF_FP_ABST
Abstract
Description
A device for treating stroke
[0001] This application claims priority to the Chinese invention patent application with application number CN202311668485.7, filing date December 7, 2023, and invention title: A device for treating stroke. Technical Field
[0002] The present application relates to the field of medical devices, in particular to medical devices in the cross-technical field combined with electricity, and specifically to a device for treating stroke. Background Art
[0003] "Stroke", also known as "stroke", is an acute cerebrovascular disease and is currently the leading cause of death in China. In addition to preventive medications with significant side effects, medical treatment currently also uses interventional surgery. Preclinical studies have found that in an acute ischemic stroke model, stimulating this ganglion can increase collateral blood flow in the brain, stabilize the blood-brain barrier, and reduce the area of infarction. Preliminary randomized clinical studies have also found that stimulating the sphenopalatine ganglion has potential benefits for patients with ischemic stroke. The sphenopalatine ganglion is generally considered to be the main therapeutic target.
[0004] Neuromodulation is a specific treatment for this disease and has been widely used. Neuromodulation is performed using electrical stimulation to induce moderate dilation of the blood vessels in the sphenopalatine ganglion and increase blood flow to the brain. There are currently three common stimulation methods: voltage stimulation mode, current stimulation mode, and charge stimulation mode. In terms of existing technologies, the voltage stimulation mode directly applies the stimulation voltage to the human body load, and adjusts the voltage to change the stimulation intensity; the current stimulation mode injects a current of a given intensity into the human body load for stimulation, and controls the current to control the stimulation intensity; the charge stimulation mode injects the charge stored in the capacitor into the human body load for stimulation, and changes the stimulation intensity by switching the capacitor group.
[0005] For example, U.S. patent document US20180132947A1 discloses an implantation and delivery system of a neurostimulator, including an implant impedance sensing electrode, an auxiliary impedance sensing electrode, a first and a second wire electrically coupled to the implant impedance sensing electrode and the auxiliary impedance sensing electrode, respectively, and an impedance-based navigation circuit, including: a voltage generator configured to apply a current between the implant impedance sensing electrode and the auxiliary impedance sensing electrode through the wire, an impedance sensor configured to measure the impedance between the implant impedance sensing electrode and the auxiliary impedance sensing electrode based on the application of the current, and a position tracker configured to determine the position of the implantable neurostimulator in the large neural canal based on changes in the measured impedance.
[0006] Existing voltage stimulators cannot accurately control the stimulation current, which can easily cause damage to human tissue; charge stimulators need to set the total stimulation charge by switching capacitor groups, and the capacitor groups used are large in area, making them unable to be fully implanted; traditional current stimulators cannot accurately control the stimulation current within a wide stimulation voltage range and can no longer meet the needs of various application scenarios.
[0007] In addition, none of the existing solutions can be fully implanted in the body. External battery power supply requires large batteries and needs to be replaced regularly. Ultrasonic power supply requires energy conversion, which is inefficient and complex, and the energy conversion components are large. Radio frequency power supply can easily cause radiation damage and cause irreversible damage to the human body. Therefore, none of the existing solutions are suitable for the current requirements of fully implantable and precisely controllable stimulators. Summary of the Invention
[0008] In order to solve the above technical problems existing in the prior art, the present application provides a device for treating stroke, comprising a transmitting end and a receiving end, wherein the transmitting end comprises a controller and a driver component, and the receiving end comprises a stimulation electrode component; wherein,
[0009] The controller includes a host computer, a signal generating circuit, a power management circuit, and a filtering and amplifying circuit, and is configured to set treatment parameters. The controller is electrically connected to the driver assembly;
[0010] The driver assembly includes a first resonant matching circuit and a transmitting coil, and is configured to supply power to the stimulation electrode assembly via a wireless power supply;
[0011] The stimulation electrode assembly includes a stimulation electrode and a micro-coil receiving circuit connected to the stimulation electrode. The stimulation electrode assembly is configured to be surgically implanted into the palatal canal of the human oral cavity, and the micro-coil receiving circuit is configured to be attached to the side of the tooth; "attachment" in this application refers to temporary attachment during the treatment process, which can be removed after the treatment is completed. This attachment can be fixed with accessories, such as adhesive attachments such as glue, or it can be achieved by other methods in the prior art; the side of the tooth in this application actually defines a position that is more convenient to fix, and it is not necessarily the inside or outside of the tooth. A surface on the tooth that can be fixed can also be considered as the "side of the tooth" here. The above should not be used as a limitation on the scope of protection of this application.
[0012] The microcoil receiving circuit is composed of a receiving coil, a second resonant matching circuit, a demodulation circuit, and a bipolar electrical stimulation circuit;
[0013] The bipolar electrical stimulation circuit includes an H-bridge circuit and a current mirror circuit; the output direction of the H-bridge circuit is controlled by a logic circuit according to the restored stimulation voltage; currents in positive and negative directions can be generated between the stimulation electrodes;
[0014] The receiving end is configured to convert the received high-frequency signal into a low-frequency signal through AM demodulation by a rectifier bridge and a passive low-pass filter, specifically a square wave with a high level of ±2 to +20V and a low level of -0.5 to -10V;
[0015] The device can make the amount of positive and negative charges flowing through the human body roughly equal by controlling the duration and amplitude of the high level and the low level by the host computer, thereby ensuring the stimulation effect and human safety.
[0016] Furthermore, the wireless power supply method is selected from at least one of magnetic coil coupling, resonant coupling, or PT coupling. The "at least one" mentioned here means that one of the above methods can be selected individually or in combination, or used alternately or in combination in different scenarios in the device.
[0017] Furthermore, the stimulation waveform parameters are completely set by the host computer. The signal generating circuit includes a single-chip microcomputer and a DDS chip. The DDS chip is configured to generate a signal waveform set by the host computer. The signal waveform is an AM (amplitude modulation) waveform with a carrier frequency of 5 to 15 MHz, preferably 8 to 12 MHz; its envelope wave is a square wave with a frequency of 1 Hz to 10 kHz; the signal is amplified into a modulated waveform with a peak-to-peak value below 30 V through a filtering and amplifying circuit.
[0018] Furthermore, the second coil matching network resonant matching circuit sets the resonant frequency to the frequency of the signal generated by the signal generating circuit through specific capacitance and coil parameters.
[0019] In one embodiment, the micro-coil receiving circuit converts the received high-frequency signal into a low-frequency signal through AM demodulation of a rectifier bridge and a passive low-pass filter, including a high-level and a low-level square wave; at the high level and the low level, the two bridge arms of the H-bridge circuit of the micro-coil receiving circuit are respectively turned on to achieve bipolar electrical stimulation of the human body.
[0020] In one embodiment, the single chip microcomputer reads the waveform parameters sent by the host computer, performs format conversion according to the communication protocol of the DDS chip, and controls the DDS chip to output the waveform.
[0021] In one embodiment, the power management circuit uses a 220V AC to ±15V DC switching power supply to power the power amplifier of the filter amplifier circuit; and converts the +15V voltage into 3.3V through a low-voltage difference voltage regulator chip, and converts it into -3.3V through a charge pump to power other parts of the controller.
[0022] In one embodiment, the transmitting end uses a PCB printed coil with a large coil area of 3 to 40 cm 2 The receiving end uses an FPC printed circuit board coil, the coil area is small, the area is 0.5 to 3 cm 2 The use of coupled coils of this structure for energy transmission can improve energy transmission efficiency. The high transmission efficiency (generally better than 60%) is insensitive to changes in the center position of the transmitting and receiving coils and has good frequency selectivity.
[0023] In one embodiment, a single stimulation pulse includes a positive stimulation pulse and a negative stimulation pulse, whose current intensities are +I and -I respectively, wherein the current intensity I is 1-3 mA.
[0024] Preferably, the duration of the single stimulation pulse width is 150 to 550 μs.
[0025] In one embodiment, the output direction of the H-bridge circuit is controlled by a logic circuit according to the restored stimulation voltage; the single-side bridge arm of the H-bridge circuit is controlled by the same set of logic signals. When a high level is input, the upper PMOS is cut off and the lower NMOS is turned on, and the current flows back from this side of the bridge arm; when a low level is input, the current flows out from this side of the bridge arm; thereby, current in positive and negative directions can be generated between the stimulation electrodes.
[0026] Preferably, the two MOSFETs of the unilateral bridge arm in the H-bridge circuit cannot be turned on at the same time. Taking into account the differences in devices, the bridge may experience an instantaneous short circuit when switching states, causing abnormal heating. In order to circumvent this problem, the gate loop of the MOSFET is asymmetric, which prolongs its conduction time, thereby ensuring that the two MOSFETs of the unilateral bridge arm cannot be turned on at the same time. The resistors connected in parallel on the cathode and anode provide a discharge path for the gate-drain capacitance of the MOSFET when the bridge is in action, accelerate the switching of the output current direction, and suppress the voltage fluctuations of the electrode. The design of the H-bridge circuit realizes the precise switching of the current direction through the logic control module, thereby ensuring the bipolar output and stability of the electrical stimulation.
[0027] This application is to develop an implantable neurostimulation product that can promote vascular compensation around cerebral ischemia in stroke patients by electrically stimulating the sphenopalatine ganglion, thereby achieving the purpose of treating stroke.
[0028] The method of using the device for treating stroke developed by this application is as follows:
[0029] (1) Before starting stimulation, the coil of the external driver assembly is attached to the face through a specific position coupling, so that the position of the coil on the face corresponds to the position of the stimulation assembly in the implant port to optimize the magnetic coil coupling efficiency;
[0030] (2) implanting a receiving coil and a stimulating electrode assembly into the oral cavity of a human body through minimally invasive surgery, and ensuring that the assembly stably receives the wireless power supply signal; the coil circuit connected to the stimulating electrode needle is attached to the side of the tooth;
[0031] (3) Setting the electrical stimulation parameters through an external controller generates a bipolar electrical stimulation signal with a balance of positive and negative currents, thereby improving the electrical stimulation effect and human safety;
[0032] (4) After preparation, the external power supply is turned on, and the electrical stimulation is stably applied to the sphenopalatine ganglion through wireless energy transmission of a specific frequency.
[0033] The advantages and beneficial effects of the technical solution of this application are as follows:
[0034] (1) In this application, the system is used for sphenopalatine ganglion stimulation therapy, with the transmitter attached to the face, the receiving electrode implanted into the human body through surgery, and the receiving coil attached to the side of the teeth.
[0035] (2) In this application, multiple parameters of the electrical stimulation waveform can be adjusted by setting the host computer. The electrical stimulation waveform and energy are wirelessly transmitted through the coil in a resonant coupling manner, which is stable and efficient.
[0036] (3) The receiving circuit in this application implements a bipolar electrical stimulation function, ensuring charge balance during stimulation. By controlling the duration and amplitude of the high and low levels on the host computer, the amount of positive and negative charge flowing through the sphenopalatine canal tissue can be roughly equal, thereby ensuring the stimulation effect and human safety.
[0037] (4) Since human body impedance varies from person to person, the current brought about when voltage is applied will be significantly different due to individual differences. The treatment of stroke is to quickly change the nerve potential, thereby causing a rapid recovery of blood supply and blood flow, so as to help the patient's brain restore blood supply during the golden treatment period and prevent subsequent paralysis and local necrosis. This application uses current control technology to eliminate the differences in human body impedance, ensure that a certain amount of charge is injected into the sphenopalatine nerve, and ensure that the nerve potential can be effectively improved, thereby achieving the treatment goal.
[0038] The above description is only an overview of the technical solution of the present application. In order to more clearly understand the technical means of the present application so that it can be implemented in accordance with the contents of the specification, and to make the above and other purposes, features and advantages of the present application more obvious and easy to understand, the following is a detailed description of the preferred embodiments of the present application in conjunction with the accompanying drawings.
[0039] Based on the detailed description of the specific embodiments of the present application in conjunction with the accompanying drawings below, those skilled in the art will become more aware of the above and other objects, advantages and features of the present application. BRIEF DESCRIPTION OF THE DRAWINGS
[0040] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings required for the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present application. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without inventive work. In all drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn according to the actual scale.
[0041] FIG1 is an overall system block diagram of the device of the present application.
[0042] FIG2 is a flowchart of the program of the single chip microcomputer of the present application.
[0043] FIG3 is a block diagram of the filter amplifier circuit in this application.
[0044] FIG4 is a topological structure of a coil matching network in this application.
[0045] FIG5 is an overall functional block diagram of the receiving end circuit in this application.
[0046] FIG6 is a circuit diagram of a voltage detection circuit in the present application.
[0047] FIG7 is a circuit diagram of an H-bridge in this application.
[0048] FIG8 is a waveform diagram of a single stimulation pulse of the present application. DETAILED DESCRIPTION
[0049] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. In the following description, specific details such as specific configurations and components are provided only to help fully understand the embodiments of the present application. Therefore, it should be clear to those skilled in the art that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present application. In addition, for clarity and brevity, the description of known functions and structures has been omitted in the embodiments.
[0050] It should be understood that references throughout this specification to "one embodiment" or "this embodiment" mean that a particular feature, structure, or characteristic associated with the embodiment is included in at least one embodiment of the present application. Therefore, the appearance of "one embodiment" or "an embodiment" throughout this specification does not necessarily refer to the same embodiment. Furthermore, these particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0051] In addition, the present application may repeat reference numerals and / or letters in different examples. This repetition is for the purpose of simplicity and clarity and does not in itself indicate the relationship between the various embodiments and / or settings discussed.
[0052] The term "and / or" in this article is merely a description of the association relationship between associated objects, indicating that three relationships may exist. For example, A and / or B can mean: A exists alone, B exists alone, and A and B exist at the same time. The term "and / or" in this article describes another type of association object relationship, indicating that two relationships may exist. For example, A / and B can mean: A exists alone, and A and B exist alone. In addition, the character " / " in this article generally indicates that the previous and subsequent associated objects are in an "or" relationship.
[0053] The term "at least one" in this article is merely a description of the association relationship between associated objects, indicating that three relationships may exist. For example, at least one of A and B can mean: A exists alone, A and B exist at the same time, and B exists alone.
[0054] It should also be noted that, in this document, relational terms such as "first" and "second" are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, "include," "comprises," or any other variations thereof are intended to cover non-exclusive inclusion.
[0055] Example 1
[0056] This embodiment introduces the system structure of a device for treating stroke.
[0057] FIG1 shows a system block diagram of a device for treating stroke. The system mainly includes a transmitter and a receiver. The transmitter includes a controller and a driver component, and the receiver is a stimulation electrode component.
[0058] The controller includes a host computer, a signal generating circuit, a power management circuit, and a filtering and amplifying circuit, and is used to set treatment parameters. The controller is electrically connected to the driver assembly;
[0059] The driver assembly includes a first resonant matching circuit and a transmitting coil, and supplies power to the stimulation electrode assembly via a wireless power supply method;
[0060] The stimulation electrode assembly includes a stimulation electrode and a micro-coil receiving circuit connected to the stimulation electrode. The stimulation electrode can be surgically implanted into the palatal canal of the human oral cavity, and the micro-coil receiving circuit is attached to the side of the tooth.
[0061] The microcoil receiving circuit is composed of a receiving coil, a second resonant matching circuit, a demodulation circuit, and a bipolar electrical stimulation circuit; wherein the bipolar electrical stimulation circuit includes an H-bridge circuit and a current mirror circuit.
[0062] The second resonant matching circuit sets the resonant frequency to the frequency of the signal generated by the signal generating circuit through specific capacitance and coil parameters.
[0063] In one embodiment, the transmitter connects to a host computer via a single-chip microcomputer, forwarding instructions from the host computer to a DDS chip to generate a pre-defined signal waveform. This signal waveform is an AM (amplitude modulation) waveform with a carrier frequency of approximately 10 MHz and an envelope wave with a frequency of 1 Hz to 10 kHz. Parameters such as the high and low voltage levels and the duty cycle of the square wave are adjustable. The signal is then amplified by a filter amplifier circuit and a power amplifier circuit, transforming it into a modulated waveform with a peak-to-peak value below 30 V. A resonant matching circuit sets the resonant frequency to the frequency of the DDS-generated signal using specific capacitor and coil parameters. The large coil at the transmitter is aligned with the center of the small coil at the receiver, wirelessly transmitting the stimulation waveform from outside the body to inside the body. The power management circuit uses a 220 V AC to ±15 V DC switching power supply to power the power amplifier. The +15 V voltage is converted to 3.3 V using a low-dropout voltage regulator chip and then to -3.3 V using a charge pump to power other components.
[0064] In one embodiment, the receiving end converts the received high-frequency signal into a low-frequency signal through AM demodulation of a rectifier bridge and a passive low-pass filter - a square wave with a high level of +2 to +20V, preferably +6 to 10V, and a low level of -0.5 to -10V, preferably -2 to -4V. At high and low levels, the two bridge arms of the H-bridge module of the circuit are turned on respectively, achieving bipolar electrical stimulation of the human body. The current mirror circuit is used to stabilize the stimulation current. By controlling the duration and amplitude of the high and low levels on the host computer, the amount of charge flowing through the human body in the positive and negative directions can be made roughly equal, thereby ensuring the stimulation effect and human safety.
[0065] Example 2
[0066] Figure 2 is a flowchart of the microcontroller program described in this application. This program, based on an STM32 microcontroller, primarily reads waveform parameters sent from a host computer via the serial port, converts the format according to the DDS chip's communication protocol, and controls the DDS chip's waveform output. The program's implementation is divided into three parts: initialization, serial port data reading, and waveform writing and playback.
[0067] The initialization section initializes the GPIO port, serial port, timer, and AD9910 chip. When writing data, it reads the parameters received via the serial port interrupt and sets the DDS chip's state accordingly. The states are categorized as cyclic stimulation, single stimulation, and paused stimulation. Parameters such as carrier frequency, high-level amplitude, low-level amplitude, and high-level duty cycle are written to the DDS chip's RAM. The DDS automatically replays the waveform based on the data in RAM. If a single stimulation is requested, the power amplifier chip is controlled and shut down after the single stimulation is complete.
[0068] Example 3
[0069] Figure 3 is a block diagram of the filter amplifier circuit at the transmitter in this application. Since the DDS chip is powered by a positive voltage, its output amplitude range is in the range of 0 to 1V. It is necessary to filter out the DC component of the signal and amplify its voltage. A second-order high-pass filter is designed using the operational amplifier chip LMH6612 to filter and amplify the DDS output. The chip has high bandwidth, low noise, and rail-to-rail characteristics. The filter adopts a Sallen-Key topology, which reduces the filter's demand for operational amplifier bandwidth. The filter can achieve high-pass filtering with a cutoff frequency of 10Hz and amplify the signal by a factor of 5.
[0070] In one embodiment, the amplified signal is input into a power amplifier circuit built using the THS3491 chip, which can amplify the signal to a maximum range of ±15V and provide up to 15W of energy. This chip features high operating voltage, high slew rate, and high gain-bandwidth product. This power amplifier chip uses current feedback amplifiers. To ensure frequency consistency of the signal, high-precision fixed-value resistors are used as the feedback resistors in the amplifier circuit. The chip requires good heat dissipation during operation, and the circuit board uses multiple metal heat sinks to dissipate heat from the circuit.
[0071] Example 4
[0072] Figure 4 shows the topology of the transmitter and receiver coil matching network. C1 and C2 are the matching capacitors for the transmitter and receiver, respectively. The transmitter uses adjustable capacitors, while the receiver uses high-precision NPO capacitors. L1 and L2 are the transmitter and receiver coils, respectively. The transmitter uses a printed PCB coil with a relatively large area of 3 to 40 cm. 2 The receiving end uses an FPC printed circuit board coil, which has a small area of 0.5 to 3 cm 2 The use of coupled coils of this structure for energy transmission has the following advantages: high energy transmission efficiency, insensitivity of the transmission efficiency to changes in the center positions of the transmitting and receiving coils, and good frequency selectivity.
[0073] Example 5
[0074] Figure 5 shows the overall functional block diagram of the receiving circuit. This circuit restores the stimulation waveform. The stimulation signal, modulated by AM onto a high-frequency sine wave, is input through the coupling coil. After rectification and detection, it is restored to the user-defined low-frequency waveform, the square wave described above. This waveform is then applied to the electrodes via an H-bridge to stimulate neural tissue.
[0075] Example 6
[0076] Figure 6 shows the schematic diagram of the voltage detection circuit. This circuit is a logic circuit composed of PMOS and NMOS transistors. This structure utilizes the turn-on voltage of field-effect transistors to compare the input voltage with a threshold value without requiring an additional power supply, and then controls the H-bridge to direct current to the appropriate electrodes. Furthermore, this structure inherently amplifies the signal, resulting in faster control signal execution compared to other solutions, capable of responding to microsecond stimulation pulses.
[0077] Example 7
[0078] Figure 7 shows the schematic diagram of an H-bridge circuit. The output direction of the H-bridge circuit is controlled by a logic circuit based on the recovered stimulation voltage. Each arm of the bridge is controlled by the same set of logic signals. When the input is high, the upper PMOS transistor is turned off and the lower NMOS transistor is turned on, allowing current to flow back through that arm. When the input is low, current flows out of that arm. This allows current to flow in both positive and negative directions between the two stimulation electrodes.
[0079] As shown in Figure 8, a single stimulation pulse consists of a positive stimulation pulse and a negative stimulation pulse, with current intensities of +I and -I, respectively, and pulse widths t1 and t3, respectively. The positive and negative pulses are separated by a non-stimulation time t2. The current intensity I is 1 to 3 mA, and the durations of pulse widths t1 and t3 are 150 to 550 μs. This single stimulation pulse can be used for single stimulation or multiple stimulation cycles.
[0080] In one embodiment, due to device variations, the bridge may experience a momentary short circuit when switching states, causing abnormal heating. To circumvent this issue, the MOSFET gate circuit is asymmetrical, extending its on-time and thus ensuring that both MOSFETs in a single bridge arm cannot be turned on simultaneously. The parallel resistors at the cathode and anode provide a discharge path for the MOSFET's gate-drain capacitance during bridge operation, accelerating the switching of the output current direction and suppressing voltage fluctuations at the electrodes.
[0081] Example 8
[0082] The device of the present application is used to treat stroke patients. The specific treatment process is as follows:
[0083] (1) Before starting stimulation, place the coil of the external driver assembly on the face;
[0084] (2) implanting a stimulation electrode needle into the palatal canal of the human oral cavity through minimally invasive surgery, and attaching the coil circuit connected to the stimulation electrode needle to the side of the tooth;
[0085] (3) The doctor uses an external controller to adjust multiple parameters of the electrical stimulation waveform so that the amount of charge flowing through the human body in the positive and negative directions is roughly equal;
[0086] (4) After preparation, the external power supply is turned on, and the electrical stimulation waveform and energy are stably and efficiently transmitted wirelessly to the stimulation needle through the coil in a resonant coupling manner to electrically stimulate the sphenopalatine ganglion.
[0087] For example, using a 2mA current intensity and 200μs or 500μs positive and negative current pulses can effectively restore blood flow to the brain within 5 minutes. Continuous rhythmic current stimulation therapy can alleviate stroke symptoms within the golden window of treatment.
[0088] The general course of treatment is 7 days, with stimulation for 20 to 60 minutes per day, which increases the patient's cerebral vascular perfusion and helps in the auxiliary treatment of ischemic stroke.
[0089] It should be understood that the above-mentioned specific embodiments of the present application are merely illustrative or explain the principles of the present application and do not constitute a limitation of the present application. Therefore, any modifications, equivalent substitutions, improvements, etc. made without departing from the spirit and scope of the present application should be included in the scope of protection of the present application. In addition, the claims attached hereto are intended to cover all variations and modifications that fall within the scope and boundaries of the appended claims, or the equivalent forms of such scope and boundaries.
Claims
1. A device for treating stroke, characterized in that: It includes a transmitting end and a receiving end, wherein the transmitting end includes a controller and a driver component, and the receiving end includes a stimulation electrode component; in, The controller includes a host computer, a signal generating circuit, a power management circuit, a filtering and amplifying circuit, and is configured to set treatment parameters, and the controller is electrically connected to the driver assembly; The driver assembly includes a first resonant matching circuit and a transmitting coil, and is configured to supply power to the stimulation electrode assembly via a wireless power supply; The stimulation electrode assembly includes a stimulation electrode and a micro-coil receiving circuit connected to the stimulation electrode, the stimulation electrode assembly is configured to be implanted into the palatal canal of the human oral cavity through surgery, and the micro-coil receiving circuit is configured to be attached to the side of the tooth; The micro-coil receiving circuit is composed of a receiving coil, a second resonant matching circuit, a demodulation circuit, and a bipolar electrical stimulation circuit; The bipolar electrical stimulation circuit includes an H-bridge circuit and a current mirror circuit; the output direction of the H-bridge circuit is controlled by a logic circuit according to the restored stimulation voltage; the stimulation electrodes are configured to generate currents in positive and negative directions; The receiving end is configured to convert the received high-frequency signal into a low-frequency signal through AM demodulation of a rectifier bridge and a passive low-pass filter, specifically a square wave with a high level of +2 to +20V and a low level of -0.5 to -10V; The device controls the duration and amplitude of the high level and the low level by the host computer so that the amount of charge flowing through the human body in the positive direction and the negative direction is roughly equal, thereby ensuring the stimulation effect and human body safety.
2. The device for treating stroke according to claim 1, characterized in that: The wireless energy supply method is selected from at least one of magnetic coil coupling, resonance coupling or PT coupling.
3. The device for treating stroke according to claim 1, characterized in that: The stimulation waveform parameters are set by the host computer. The signal generating circuit includes a single-chip microcomputer and a DDS chip. The DDS chip is configured to generate a signal waveform set by the host computer. The signal waveform is an amplitude modulated AM waveform with a carrier frequency of 5 to 15 MHz, and its envelope wave is a square wave with a frequency of 1 Hz to 10 kHz. The signal is amplified into a modulated waveform with a peak-to-peak value below 30 V through a filtering and amplifying circuit.
4. The device for treating stroke according to claim 3, characterized in that: The second resonant matching circuit sets the resonant frequency to the frequency of the signal generated by the signal generating circuit through specific capacitance and coil parameters.
5. The device for treating stroke according to claim 4, characterized in that: The micro-coil receiving circuit converts the received high-frequency signal into a low-frequency signal through AM demodulation of a rectifier bridge and a passive low-pass filter, including a high-level and a low-level square wave; at the high level and the low level, the two bridge arms of the H-bridge circuit of the micro-coil receiving circuit are respectively turned on to achieve bipolar electrical stimulation of the human body.
6. The device for treating stroke according to claim 5, characterized in that: The transmitting end uses a PCB printed coil, the coil area is relatively large, the area is 3 to 40 cm 2 The receiving end uses a FPC printed circuit board coil, the coil area is small, the area is 0.5 to 3 cm 2 .
7. The device for treating stroke according to claim 3, characterized in that: The single chip microcomputer reads the waveform parameters sent by the host computer, performs format conversion according to the communication protocol of the DDS chip, and controls the DDS chip to output the waveform.
8. The device for treating stroke according to claim 1, characterized in that: The power management circuit uses a 220V AC to ±15V DC switching power supply to power the power amplifier of the filter amplifier circuit; and converts the +15V voltage therein to 3.3V through a low voltage difference voltage regulator chip, and converts it to -3.3V through a charge pump to power other parts of the controller.
9. The device for treating stroke according to claim 1, characterized in that: A single stimulation pulse includes a positive stimulation pulse and a negative stimulation pulse, and the current intensities thereof are +I and -I respectively, wherein the current intensity I is 1 to 3 mA.
10. The device for treating stroke according to claim 9, characterized in that: The duration of the single stimulation pulse width is 150 to 550 μs.
11. The device for treating stroke according to claim 1, characterized in that: The single-side bridge arm of the H-bridge circuit is controlled by the same set of logic signals. When a high level is input, the upper PMOS is cut off and the lower NMOS is turned on, and the current flows back from this side of the bridge arm; when a low level is input, the current flows out from this side of the bridge arm, thereby generating current in positive and negative directions between the stimulation electrodes.
12. The device for treating stroke according to claim 11, characterized in that: The two MOSFETs of a single-side bridge arm in the H-bridge circuit cannot be turned on at the same time.
13. A device for treating stroke, characterized in that: The device is configured to electrically stimulate the sphenopalatine ganglion via a stimulating motor component, thereby promoting vascular compensation around cerebral ischemia in stroke patients, thereby achieving the purpose of treating stroke.
14. A device for treating stroke according to any one of claims 1 to 13, characterized in that: The method of using the device is as follows: (1) Place the coil of the external driver assembly on the face; (2) implanting the stimulation electrode assembly into the palatine canal of the human oral cavity through minimally invasive surgery, and attaching the coil circuit connected to the stimulation electrode needle to the side of the tooth; (3) adjusting multiple parameters of the electrical stimulation waveform through an external controller so that the amount of charge flowing through the human body in the positive and negative directions is approximately equal; (4) Turn on the external power supply, and the electrical stimulation waveform and energy are stably and efficiently transmitted to the stimulation needle through the coil wirelessly in a resonant coupling manner to electrically stimulate the sphenopalatine ganglion.
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