Electrical stimulation assisted breathing device and method

Abstract

The invention relates to the technical field of electrical stimulation devices, and particularly discloses an electrical stimulation assisted breathing device and method, and the device comprises an acquisition module, a control module, an information output module, an inspiratory muscle stimulation module, and an expiratory muscle stimulation module. The acquisition module is used for acquiring breathing time parameters; the control module is used for analyzing and processing the preset breathing time parameters or / and the real-time breathing time parameters to obtain inspiration muscle stimulation parameters and expiration muscle stimulation parameters, and sending out inspiration and expiration prompt instructions; the information output module is used for sending out a prompt signal based on the inspiration and expiration prompt instruction; the inspiratory muscle stimulation module and the expiratory muscle stimulation module are respectively used for outputting waveforms based on the inspiratory muscle stimulation parameters and the expiratory muscle stimulation parameters. According to the device, the breathing electrical stimulation rhythm can be adjusted more intelligently and dynamically, and a patient can be guided to conduct breathing rehabilitation training; and a comprehensive working mode is provided, and the applicable scene is richer.

Description

Technical Field

[0001] The present invention relates to the technical field of electrical stimulation devices, and in particular to an electrical stimulation breathing-assisted device and method. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease characterized by persistent, irreversible airflow limitation. The disease can cause many symptoms, such as dyspnea and rapid shallow breathing. COPD not only affects the patient's comfort, but also causes a series of health problems. For example, it may cause insufficient oxygen supply to the patient's body, which in turn induces symptoms such as cyanosis and systemic hypoxia. In severe cases, it can also increase the burden on the heart, which may cause complications such as right ventricular hypertrophy and cor pulmonale.

[0003] Traditional respiratory function training, such as abdominal breathing and pursed lip breathing, is often used for respiratory rehabilitation. This type of training can help patients deepen their breathing and reduce their respiratory rate. However, these traditional methods require guidance from professional medical staff and long-term training before patients can truly master them. Because their training takes a long time and takes a long time to take effect, patients often find it difficult to persist.

[0004] External electrical stimulation of the phrenic nerve and abdominal muscles causes passive contraction of the respiratory muscles. It does not require the patient to actively work, reduces oxygen consumption, can quickly improve respiratory function, enhance the strength and endurance of the respiratory muscles, and can also train and restore the patient's autonomous breathing ability, becoming a new idea for respiratory therapy. The key and difficulty in its implementation lies in the fact that the electrical stimulation of the phrenic nerve and abdominal muscles must be coordinated with each other and must be synchronized with the patient's breathing. However, the current electrical stimulation devices cannot dynamically adjust the rhythm of respiratory electrical stimulation according to the patient's condition, and cannot effectively guide patients to perform respiratory rehabilitation training. Summary of the invention

[0005] In response to the above problems, the first purpose of the present invention is to provide an electrical stimulation assisted breathing device, which can more intelligently and dynamically adjust the respiratory electrical stimulation rhythm, helping to guide patients to perform respiratory rehabilitation training; it also has a comprehensive working mode and is more applicable to a richer range of scenarios.

[0006] The second object of the present invention is to provide a method for electrically stimulating breathing assistance.

[0007] The first technical solution adopted by the present invention is: an electrical stimulation assisted breathing device, comprising an acquisition module, a control module, an inspiratory muscle stimulation module and an expiratory muscle stimulation module; The acquisition module is used to acquire a breathing time parameter, or to calculate the breathing time parameter by acquiring a patient's physiological signal; the breathing time parameter includes a preset breathing time parameter and / or a real-time breathing time parameter; The control module is used to receive the breathing time parameter, calculate the guided breathing time parameter based on the breathing time parameter, and perform analysis and processing based on the breathing time parameter and / or the guided breathing time parameter to obtain the inspiratory muscle stimulation parameter and the expiratory muscle stimulation parameter; The inspiratory muscle stimulation module is used to stimulate the inspiratory muscle or the nerve controlling the inspiratory muscle during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameters; The expiratory muscle stimulation module is used to stimulate the expiratory muscle or the nerve controlling the expiratory muscle during at least a part of the expiratory phase based on the expiratory muscle stimulation parameters.

[0008] Preferably, the breathing time parameters include but are not limited to one or more of the following parameters: inspiration start time, inspiration end time, inspiration time, exhalation start time, exhalation end time, exhalation time, and respiratory rate; The inspiratory muscle stimulation parameters include but are not limited to one or more of the inspiratory muscle stimulation start time, inspiratory muscle stimulation stop time, pulse frequency, pulse width, pulse amplitude, and duty cycle; The expiratory muscle stimulation parameters include, but are not limited to, one or more of expiratory muscle stimulation start time, expiratory muscle stimulation stop time, pulse frequency, pulse width, pulse amplitude, and duty cycle.

[0009] Preferably, the control module includes a first working mode, wherein: An analysis and processing is performed based on the preset breathing time parameter to obtain a first inspiratory muscle stimulation parameter and a first expiratory muscle stimulation parameter.

[0010] Preferably, the control module includes a second working mode, wherein: An analysis is performed based on the real-time respiratory time parameter to obtain a second inspiratory muscle stimulation parameter and a second expiratory muscle stimulation parameter.

[0011] Preferably, when the acquisition module is unable to acquire the real-time breathing time parameters in real time, the preset breathing time parameters or the previously acquired real-time breathing time parameters are filtered to obtain estimated breathing time parameters; and the estimated breathing time parameters are analyzed and processed to obtain the second inspiratory muscle stimulation parameters and the second expiratory muscle stimulation parameters.

[0012] Preferably, the control module includes a third working mode, wherein: The guided breathing time parameter is calculated based on the breathing time parameter; and the guided breathing time parameter is analyzed and processed to obtain a third inspiratory muscle stimulation parameter and a third expiratory muscle stimulation parameter that vary with time.

[0013] Preferably, the guided breathing time parameters include but are not limited to one or more of breathing frequency, inhalation start time, inhalation end time, inhalation time, exhalation start time, exhalation end time, and exhalation time that vary with time.

[0014] Preferably, the respiratory frequency varying with time is calculated by the following formula: Fn=Fs-△F×△T; Where Fn is the respiratory frequency that changes with time; Fs is the initial respiratory frequency; △F is the decreasing step of the respiratory frequency as the treatment time changes; △T is the changing treatment time.

[0015] Preferably, it further comprises an information output module, the information output module is used to receive the inhalation or exhalation prompt instruction issued by the control module, and to issue an inhalation prompt signal when the inspiratory muscles are stimulated, and to issue an exhalation prompt signal when the expiratory muscles are stimulated; and The control module is also used to send the patient's physiological signal and the breathing time parameter and / or the guided breathing time parameter to the information output module, and display the information through the information output module.

[0016] The second technical solution adopted by the present invention is: an electrical stimulation assisted breathing method, comprising the following steps: S100: Acquire a breathing time parameter, or acquire a patient's physiological signal and calculate the breathing time parameter according to the patient's physiological signal; the breathing time parameter includes a preset breathing time parameter and / or a real-time breathing time parameter; S200: Calculating a guided breathing time parameter based on the breathing time parameter; and performing analysis and processing based on the breathing time parameter and / or the guided breathing time parameter to obtain an inspiratory muscle stimulation parameter and an expiratory muscle stimulation parameter; S300: stimulating the inspiratory muscles or the nerves controlling the inspiratory muscles during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameters; and stimulating the expiratory muscles or the nerves controlling the expiratory muscles during at least part of the expiratory phase based on the expiratory muscle stimulation parameters.

[0017] Beneficial effects of the above technical solution: The electrical stimulation assisted breathing device disclosed in the present invention can more intelligently and dynamically adjust the electrical stimulation rhythm of breathing, which helps to guide patients to perform respiratory rehabilitation training; it also has a comprehensive working mode and is more applicable to a variety of scenarios. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A schematic structural diagram of an electrical stimulation breathing-assisted device provided in accordance with an embodiment of the present invention. DETAILED DESCRIPTION

[0019] The following detailed description of the embodiments of the present invention is further described in detail in conjunction with the accompanying drawings and examples. The detailed description of the following embodiments and the accompanying drawings are used to exemplarily illustrate the principles of the present invention, but cannot be used to limit the scope of the present invention, that is, the present invention is not limited to the preferred embodiments described, and the scope of the present invention is defined by the claims.

[0020] In the description of the present invention, it should be noted that, unless otherwise specified, “plurality” means two or more than two; the terms “first”, “second”, etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance; for ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0021] Embodiment 1 like Figure 1 As shown, one embodiment of the present invention provides an electrical stimulation assisted breathing device, including an acquisition module, a control module, an information output module, an inspiratory muscle stimulation module and an expiratory muscle stimulation module; The acquisition module is used to acquire preset breathing time parameters before stimulating the inspiratory muscles and the expiratory muscles; and to acquire real-time breathing time parameters during the process of stimulating the inspiratory muscles and the expiratory muscles; The control module is used to receive a first acquisition instruction, a second acquisition instruction or / and a guided training instruction issued by a user; and based on the first acquisition instruction, call the acquisition module to obtain a preset breathing time parameter, based on the second acquisition, call the acquisition module to obtain a real-time breathing time parameter, and calculate the guided breathing time parameter based on the guided training instruction; and analyze and process based on the preset breathing time parameter, the real-time breathing time parameter or / and the guided breathing time parameter to obtain the inspiratory muscle stimulation parameter and the expiratory muscle stimulation parameter; and issue an inhalation and exhalation prompt instruction based on the inspiratory muscle stimulation parameter and the expiratory muscle stimulation parameter; and also includes sending the preset breathing time parameter, the real-time breathing time parameter or / and the guided breathing time parameter to the information output module; The information output module is used to receive and display the preset breathing time parameter, real-time breathing time parameter and / or guided breathing time parameter sent by the control module; and receive the inhalation and exhalation prompt instructions, and send an inhalation prompt signal when the inhalation muscle is stimulated based on the inhalation prompt instruction, and send an exhalation prompt signal when the expiratory muscle is stimulated based on the exhalation prompt instruction; The inspiratory muscle stimulation module is used to output a waveform during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameters to stimulate the inspiratory muscle or the nerve that controls the inspiratory muscle; The expiratory muscle stimulation module is used to output a waveform during at least part of the expiratory phase based on the expiratory muscle stimulation parameters to stimulate the expiratory muscle or the nerve that controls the expiratory muscle.

[0022] (1) Obtain module; The acquisition module is used to acquire preset breathing time parameters before stimulating the inspiratory muscles and the expiratory muscles; and to acquire real-time breathing time parameters during the process of stimulating the inspiratory muscles and the expiratory muscles.

[0023] The preset breathing time parameters (i.e., the breathing time parameters obtained in advance) are: the breathing time parameters obtained before the inspiratory muscle and expiratory muscle stimulation is implemented; the real-time breathing time parameters (i.e., the breathing time parameters obtained in real time) are: the breathing time parameters obtained during the implementation of the inspiratory muscle and expiratory muscle stimulation; that is, when the start of breathing is monitored, the breathing time parameters are started to be obtained, and the inspiratory muscle stimulation is output in real time, and when exhaling, the expiratory muscle stimulation is output in real time; the preset breathing time parameters and the real-time breathing time parameters include but are not limited to one or more combinations of the following parameters: inhalation start time, inhalation end time, inhalation time, exhalation start time, exhalation end time, exhalation time, respiratory frequency, etc.

[0024] The preset breathing time parameters and the real-time breathing time parameters can be obtained through one or more methods including sensors, memories, interfaces or user interfaces; the patient's physiological signals can also be obtained through sensors or interfaces, and the preset breathing time parameters and the real-time breathing time parameters can be calculated based on the patient's physiological signals; the patient's physiological signals include but are not limited to respiratory activity signals, muscle electrical activity signals, etc.

[0025] The sensor includes one or more of a piezoelectric sensor, an acceleration sensor, an electromyographic sensor, a gas flow sensor, a pressure sensor, and a millimeter wave radar; The piezoelectric chip sensor has a piezoelectric effect, and when it is subjected to pressure, it will produce a charge change; the piezoelectric chip sensor is built into the wearable device, and the patient fixes the wearable device on the chest and / or abdomen; when a person breathes, the rise and fall of the chest and abdomen will exert pressure on the piezoelectric chip sensor, and the piezoelectric chip sensor converts this mechanical pressure into an electrical signal. With the periodic change of chest and abdominal pressure during breathing, the electrical signal generated by the piezoelectric chip sensor also presents corresponding periodic changes, thereby reflecting information such as the frequency and depth of breathing; for example, when inhaling, the expansion of the chest and abdomen increases the pressure on the piezoelectric chip sensor, and when exhaling, the pressure decreases, and the electrical signal will change accordingly.

[0026] The respiratory signal is collected by attaching the acceleration sensor to the belly and chest surfaces of the subject; during the breathing process, the chest and abdomen will have regular ups and downs, and this movement has acceleration changes; the acceleration sensor converts this acceleration change into an electrical signal, and then analyzes the characteristics such as the respiratory frequency.

[0027] The EMG sensor works by capturing electrical signals from muscles, which are generated by muscle cells when they receive nerve impulses. The EMG sensor can convert these weak electrical signals into analyzable data. In respiratory acquisition, the EMG sensor can be placed on the patient's chest or abdomen to capture the activity of the respiratory muscles.

[0028] The gas flow sensor is used to obtain the flow in the breathing circuit, and has a fast response time and airflow direction detection function, so that the inhalation and exhalation stages can be quickly identified.

[0029] The pressure sensor converts the airway pressure into an electrical signal, thereby analyzing and determining the inhalation and exhalation process.

[0030] The millimeter-wave radar is widely used in the field of respiratory and heart rate acquisition because of its characteristics such as being unaffected by light and being able to penetrate clothes. The millimeter-wave radar detects the human body by emitting electromagnetic waves and receives echoes for signal processing. It can identify human breathing movements without wearing or touching the body, and analyze and measure parameters such as respiratory frequency.

[0031] The memory is used to store preset breathing time parameters and real-time breathing time parameters; the memory includes but is not limited to: SRAM, SDRAM, ROM, EPROM, EEPROM, FLASH, etc.

[0032] The interface can be used to obtain patient physiological signals, preset breathing time parameters and real-time breathing time parameters from other devices (such as a ventilator); the interface includes but is not limited to: USB, CAN, I2C, SPI, UART, etc.

[0033] The user interface includes but is not limited to hardware components, such as a touch screen, buttons, keyboard, mouse, etc., and software components, such as a graphical user interface (GUI), sound recognition software, gesture recognition software, etc. The user can set parameters such as the inspiratory muscle / expiratory muscle stimulation time (0.5 seconds to 2 seconds), the inspiratory muscle / expiratory muscle activation delay time (0.1 seconds to 2 seconds), the respiratory rate (5 times / minute to 40 times / minute), the inspiratory time (0.5 seconds to 5 seconds), and the exhalation time (0.5 seconds to 12 seconds) through the user interface.

[0034] (2) Control module; The control module is used to receive a first acquisition instruction, a second acquisition instruction or / and a guided training instruction issued by a user; and based on the first acquisition instruction, start working mode one, call the acquisition module to obtain a preset breathing time parameter; based on the second acquisition instruction, start working mode two, call the acquisition module to obtain a real-time breathing time parameter; based on the guided training instruction, start working mode three, calculate the guided breathing time parameter; and analyze and process based on the preset breathing time parameter, the real-time breathing time parameter or / and the guided breathing time parameter to obtain the inspiratory muscle stimulation parameter and the expiratory muscle stimulation parameter, including: The user selects the working mode of the electrical stimulation assisted breathing device according to the patient's condition: 1) When the patient is conscious and can cooperate with the electric stimulation assisted breathing device for synchronous breathing training, the user selects working mode 1: the user inputs a first acquisition instruction through the input interface of the electric stimulation assisted breathing device; the control module is used to receive the first acquisition instruction input by the user, and call the acquisition module to obtain a preset breathing time parameter or a patient's physiological signal; if it is a patient's physiological signal, the preset breathing time parameter is calculated based on the patient's physiological signal; the control module analyzes and processes the preset breathing time parameter to obtain a first inspiratory muscle stimulation parameter and a first expiratory muscle stimulation parameter; the first inspiratory muscle stimulation parameter includes parameters such as the first start and stop time of the inspiratory muscle stimulation module (i.e., the inspiratory muscle stimulation start time and the inspiratory muscle stimulation stop time); the first expiratory muscle stimulation parameter includes parameters such as the first start and stop time of the expiratory muscle stimulation module (i.e., the expiratory muscle stimulation start time and the expiratory muscle stimulation stop time); the pulse frequency, pulse width, pulse amplitude, duty cycle, etc.

[0035] 2) When the patient is in an unconscious state and is using a ventilator, the user selects working mode 2: the user inputs a second acquisition instruction through the input interface of the electrical stimulation assisted breathing device; the control module is used to receive the second acquisition instruction input by the user, and call the acquisition module to obtain real-time breathing time parameters or patient physiological signals; if it is a patient physiological signal, the real-time breathing time parameters are calculated based on the patient physiological signals; the control module analyzes and processes the real-time breathing time parameters to obtain second inspiratory muscle stimulation parameters and second expiratory muscle stimulation parameters; the second inspiratory muscle stimulation parameters include the second start and stop time, pulse frequency, pulse width, pulse amplitude, duty cycle and other parameters of the inspiratory muscle stimulation module; the second expiratory muscle stimulation parameters include the second start and stop time, pulse frequency, pulse width, pulse amplitude, duty cycle and other parameters of the expiratory muscle stimulation module; If the acquisition module of the electrical stimulation assisted breathing device cannot obtain the real-time breathing time parameters in real time, the preset breathing time parameters or the previously acquired real-time breathing time parameters are subjected to sliding average filtering or median filtering to obtain estimated breathing time parameters; the estimated breathing time parameters are analyzed and processed to obtain the second inspiratory muscle stimulation parameters and the second expiratory muscle stimulation parameters; the estimated breathing time parameters include but are not limited to one or more combinations of the following parameters: inhalation start time, inhalation end time, inhalation time, exhalation start time, exhalation end time, exhalation time, respiratory frequency, etc.

[0036] 3) When the patient is in the state of just being separated from the ventilator and the respiratory rate is greater than the set threshold (for example, 20 times / minute), and can cooperate with the electric stimulation assisted breathing device for synchronous breathing training, the user selects working mode three: the user inputs the guided training instruction through the input interface of the electric stimulation assisted breathing device; the control module is used to receive the guided training instruction input by the user, calculate the guided breathing time parameter based on the guided training instruction, and analyze and process the guided breathing time parameter to obtain the third inspiratory muscle stimulation parameter and the third expiratory muscle stimulation parameter; the third inspiratory muscle stimulation parameter includes the inspiratory muscle stimulation module The third start and stop time, pulse frequency, pulse width, pulse amplitude, duty cycle and other parameters; the third expiratory muscle stimulation parameters include the third start and stop time, pulse frequency, pulse width, pulse amplitude, duty cycle and other parameters of the expiratory muscle stimulation module; as the respiratory frequency that changes with time in the guided breathing time parameter gradually decreases, the time interval between start and stop in the third start and stop time of the inspiratory muscle stimulation module / expiratory muscle stimulation module gradually becomes longer, that is, the operating frequencies of the inspiratory muscle stimulation module and the expiratory muscle stimulation module are also gradually decreasing, so as to achieve synchronous training of the electrical stimulation assisted breathing device and the patient's breathing.

[0037] The above-mentioned pulse frequency, pulse width, pulse amplitude, duty cycle and other parameters are preset values; when it is necessary to increase the stimulation intensity of the inspiratory muscles to improve the respiratory function, the control module will increase the pulse amplitude according to the instructions input by the user through the interface. The above-mentioned analysis and processing of each breathing time parameter is mainly to calculate the start and stop time of the expiratory muscle stimulation module and the inspiratory muscle stimulation module according to the inspiration start time, inspiration end time, inspiration time, exhalation start time, exhalation end time and exhalation time in the breathing time parameters.

[0038] The step of calculating the guided breathing time parameter based on the guided training instruction includes: The guided breathing time parameter is calculated based on the starting value of the breathing time parameter, the target value of the breathing time parameter and the treatment time; the starting value of the breathing time parameter is obtained by performing sliding average filtering or median filtering on the previously acquired real-time breathing time parameter (i.e., the estimated breathing time parameter), and the breathing frequency in the estimated breathing time parameter is recorded as the initial breathing frequency; the target value of the breathing time parameter is clinical experience data, or the target value of the breathing time parameter is obtained by multiplying the estimated breathing time parameter by a coefficient a, and the range of the coefficient a is between 0 and 1; The calculation process of the guided breathing time parameter is, for example: the breathing frequency corresponding to the target value of the breathing time parameter is recorded as Fe, unit: times / minute; the initial breathing frequency (obtained by performing sliding average filtering or median filtering on the previously acquired real-time breathing time parameters to obtain the corresponding initial breathing frequency) is recorded as Fs, unit: times / minute; the treatment time is recorded as T, unit: minute; then the decreasing step of the breathing frequency changing with the treatment time is: △F=(Fs-Fe) / (T-1) or △F=Fs(1-a) / (T-1); based on this breathing frequency step and the changing treatment time △T, the breathing frequency Fn=Fs-△F×△T that changes with time is calculated; and other guided breathing time parameters are calculated therefrom, and the guided breathing time parameters include but are not limited to the breathing frequency that changes with time, the start time of inspiration, the end time of inspiration, the inhalation time, the start time of exhalation, the end time of exhalation, the exhalation time, the etc.

[0039] The control module is also used to control the waveform output of the inspiratory muscle stimulation module and the expiratory muscle stimulation module based on the inspiratory muscle stimulation parameters and the expiratory muscle stimulation parameters; and to send inhalation and exhalation prompt instructions to the information output module based on the first inspiratory muscle stimulation parameter and the first expiratory muscle stimulation parameter, the third inspiratory muscle stimulation parameter and the third expiratory muscle stimulation parameter; and send the patient's physiological signals, preset breathing time parameters, real-time breathing time parameters, estimated breathing time parameters and guided breathing time parameters to the information output module, and display the information through the information output module.

[0040] The control module includes a central processing unit (CPU), a communication function module, a memory and a power management unit; wherein the central processing unit is responsible for executing various control algorithms for calculating estimated breathing time parameters, guided breathing time parameters, processing patient physiological signals and / or preset breathing time parameters, real-time breathing time parameters and making decisions; outputting inspiratory muscle stimulation parameters and expiratory muscle stimulation parameters; the communication function module is used to send patient physiological signals, preset breathing time parameters, real-time breathing time parameters, estimated breathing time parameters and guided breathing time parameters to the information output module, and to send inhalation and exhalation prompt instructions to the information output module, and the communication function module includes but is not limited to CAN, I2C, SPI, UART; the memory includes flash memory and RAM, etc., which are used to store program codes and running data; the power management unit is used to ensure the normal operation of each component inside the module and provide the required voltage and current.

[0041] (3) Information output module; The information output module includes a display screen, an LED light, a voice amplifier, a speaker, etc.

[0042] The information output module is used to receive the patient's physiological signals, preset breathing time parameters, real-time breathing time parameters, estimated breathing time parameters and guided breathing time parameters sent by the control module, and display the patient's physiological signals as graphics or waveforms, and display the preset breathing time parameters, real-time breathing time parameters, estimated breathing time parameters and guided breathing time parameters on the screen.

[0043] The information output module is also used to receive the inhalation and exhalation prompt instructions, and to send an inhalation prompt signal when the inhalation muscles are stimulated based on the inhalation prompt instruction, and to send an exhalation prompt signal when the expiratory muscles are stimulated based on the exhalation prompt instruction.

[0044] The inhalation prompt signal is an auditory prompt, a visual prompt or a sensory prompt related to inhalation; the auditory prompt is "inhale", "inhale" or "Inhale" etc.; The visual prompt may be emitted by an LED light in green, yellow or red, etc.; or an animation that can serve as a prompt for the inhalation action, such as a mouth gradually opening, gas entering the mouth or lungs, etc., or other graphics, such as a flower gradually growing larger, etc.; The sensory prompt can be generated by a certain stimulation signal to prompt inhalation.

[0045] The exhalation prompt signal is an auditory prompt, a visual prompt or a sensory prompt related to exhalation; the auditory prompt is “Hu”, “Exhale” or “Exhale”, etc.; The visual prompt may be emitted by an LED light in green, yellow or red, etc.; or an animation that can serve as a prompt for exhalation, such as a mouth gradually closing, gas exhaled from the mouth or lungs, etc., or other graphics, such as a flower gradually shrinking, etc.; The sensory prompt can be generated by a certain stimulation signal to prompt exhalation.

[0046] (4) Inspiratory muscle stimulation module and expiratory muscle stimulation module; The inspiratory muscle stimulation module is used to output a waveform during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameters to stimulate the inspiratory muscle or the nerve that controls the inspiratory muscle; The expiratory muscle stimulation module is used to output a waveform during at least part of the expiratory phase based on the expiratory muscle stimulation parameters to stimulate the expiratory muscle or the nerve that controls the expiratory muscle.

[0047] Among them, the inspiratory muscles include but are not limited to: diaphragm, external intercostal muscles, sternocleidomastoid muscles, back muscles, chest muscles, etc.; the nerves that control the inspiratory muscles include but are not limited to: phrenic nerves, intercostal nerves, thoracic nerves, accessory nerves and cervical plexus branches, etc.

[0048] The expiratory muscles include but are not limited to: internal intercostal muscles, external oblique muscles, internal oblique muscles, transverse abdominal muscles, etc.; the nerves that control the expiratory muscles include but are not limited to: intercostal nerves, thoracic nerves, lumbar nerves, etc.

[0049] The circuit composition structure of the inspiratory muscle stimulation module and the expiratory muscle stimulation module is the same, mainly including a power supply, a pulse generating circuit, a stimulation intensity adjustment circuit, an isolation circuit, etc.

[0050] The power supply is usually a stable DC power supply, provided by a battery or a rectified, filtered and stabilized AC power supply, which is used to power the digital logic and some low-power analog circuit parts in the circuit (i.e., pulse generation circuit, stimulation intensity adjustment circuit, isolation circuit); in addition, it also includes a high-voltage circuit that generates stimulation pulses, which is generated by a boost circuit; such as an inductor-based boost converter, which controls the conduction and shutdown of switching elements (such as MOSFET) to increase the lower DC voltage to tens of volts or even hundreds of volts to meet the voltage required for the stimulation pulse.

[0051] The pulse generating circuit is used to generate an electrical stimulation output waveform at the start time based on the inspiratory muscle stimulation parameters and the expiratory muscle stimulation parameters; the pulse generating circuit includes two circuit forms: constant voltage and constant current; the constant current type is a feedback circuit that adds current output on the basis of constant voltage to ensure that the current acting on the human body is constant and does not change with changes in external impedance; the output waveforms include triangular wave, square wave, trapezoidal wave, sine wave, step wave, exponential curve wave, etc.

[0052] The stimulation intensity adjustment circuit adopts a digital-to-analog conversion (DAC) circuit; the stimulation intensity adjustment circuit outputs the corresponding stimulation intensity based on the pulse amplitude in the inspiratory muscle stimulation parameters and the expiratory muscle stimulation parameters; the stimulation intensity adjustment circuit can be implemented by a DAC module integrated in the microcontroller or by using an external independent DAC chip; by changing the digital quantity input to the DAC, the output analog voltage can be accurately adjusted to control the stimulation intensity.

[0053] The isolation circuit is set up to ensure the safety of the user and prevent interference between circuits; optocouplers or transformers are commonly used isolation components (i.e., isolation circuits); for example, an optocoupler is used between the pulse generating circuit and the stimulation output end (i.e., the output end of the inspiratory muscle stimulation module or the expiratory muscle stimulation module), which transmits electrical signals through optical signals to achieve electrical isolation between the input and output sides, and the isolation voltage can reach several thousand volts; transformers can also be used to achieve isolation between the pulse generating circuit and the stimulation output end, or to isolate the power supply.

[0054] The acquisition module, control module, information output module, inspiratory muscle stimulation module and expiratory muscle stimulation module can be independent or combined; they can be implemented by hardware or software, or a combination thereof. Each module can be integrated into one device, or multiple independent modules can be connected by any communication means to form a combined device.

[0055] The present invention discloses an electrical stimulation assisted breathing device including the following working modes: Working mode one: the electrical stimulation assisted breathing device obtains preset breathing time parameters, and outputs a waveform via the inspiratory muscle stimulation module during at least part of the inspiratory phase corresponding to the preset breathing time parameters; and outputs a waveform via the expiratory muscle stimulation module during at least part of the expiratory phase corresponding to the breathing time parameters; and sends an inhalation prompt signal when the inspiratory muscles are stimulated, and sends an expiratory prompt signal when the expiratory muscles are stimulated; prompting the patient's breathing to be synchronized with the stimulation output of the electrical stimulation assisted breathing device.

[0056] Working mode two: the electrical stimulation assisted breathing device obtains real-time breathing time parameters (i.e., obtains breathing time parameters during the process of implementing inspiratory muscle and expiratory muscle stimulation). When the electrical stimulation assisted breathing device cannot obtain real-time breathing time parameters in real time, the estimated breathing time parameters are calculated; a waveform is output via the inspiratory muscle stimulation module during at least part of the time of the inspiratory phase corresponding to the estimated breathing time parameters, and a waveform is output via the expiratory muscle stimulation module during at least part of the time of the expiratory phase corresponding to the breathing time parameters.

[0057] Working mode three: The electrical stimulation assisted breathing device performs the operation of calculating the guided breathing time parameters based on the guided training instructions input by the user. The guided breathing time parameters can make the included respiratory frequency gradually decrease with the treatment time, and in the process of dynamic reduction of the respiratory frequency, a waveform is output via the inspiratory muscle stimulation module during at least part of the inspiratory phase corresponding to the guided breathing time parameters, and a waveform is output via the expiratory muscle stimulation module during at least part of the expiratory phase corresponding to the guided breathing time parameters; and an inhalation prompt signal is issued when the inspiratory muscles are stimulated, and an expiratory prompt signal is issued when the expiratory muscles are stimulated; prompting the patient's breathing to keep in sync with the stimulation output of the electrical stimulation assisted breathing device.

[0058] The above-mentioned output of the waveform via the inspiratory muscle stimulation module during at least part of the inspiratory phase includes: immediately starting to output the waveform via the inspiratory muscle stimulation module at the beginning of the inspiratory phase (i.e., the start time of inhalation), and after a preset inspiratory muscle stimulation time (e.g., 0.5 seconds to 2 seconds), the inspiratory muscle stimulation module stops outputting the waveform; or starting to output the waveform via the inspiratory muscle stimulation module after a start delay time (e.g., 0.1 seconds to 2 seconds) after the start of the inspiratory phase, and after a preset inspiratory muscle stimulation time (e.g., 0.5 seconds to 2 seconds), the inspiratory muscle stimulation module stops outputting the waveform; if the end time of the inspiratory phase (i.e., the end time of inhalation) is earlier than the end time of the preset inspiratory muscle stimulation time, the preset inspiratory muscle stimulation time is ignored, and the output of the waveform is stopped immediately at the end of the inspiratory phase.

[0059] The output of the waveform via the expiratory muscle stimulation module during at least part of the expiratory phase includes: immediately starting to output the waveform via the expiratory muscle stimulation module at the start time of the expiratory phase (i.e., the start time of exhalation), and after a preset expiratory muscle stimulation time (e.g., 0.5 seconds to 2 seconds), the expiratory muscle stimulation module stops outputting the waveform; or starting to output the waveform via the expiratory muscle stimulation module after a start-up delay time (e.g., 0.1 seconds to 2 seconds) after the start of the expiratory phase, and after a preset expiratory muscle stimulation time (e.g., 0.5 seconds to 2 seconds), the expiratory muscle stimulation module stops outputting the waveform; if the end time of the expiratory phase (i.e., the end time of exhalation) is earlier than the end time of the preset expiratory muscle stimulation time, the preset expiratory muscle stimulation time is ignored, and the output of the waveform stops immediately at the end of the expiratory phase.

[0060] For example, for patients who are still using a ventilator and need respiratory rehabilitation, the patient's consciousness may not be clear at this time and cannot cooperate well, so working mode two can be selected for treatment; in working mode two, the electric stimulation assisted breathing device can obtain the patient's real-time breathing time parameters in real time, and calculate the estimated breathing time parameters when the real-time breathing time parameters cannot be obtained in real time; the inspiratory muscle stimulation module outputs a waveform during at least part of the inspiratory phase corresponding to the estimated breathing time parameters, and the expiratory muscle stimulation module outputs a waveform during at least part of the expiratory phase corresponding to the estimated breathing time parameters. As the treatment progresses, the patient's respiratory function improves and he or she can be separated from the ventilator, but the breathing rate is relatively fast. At this time, working mode three can be selected for treatment. In working mode three, the electrical stimulation assisted breathing device calculates the guided breathing time parameters, and the breathing rate included in the guided breathing time parameters gradually decreases with the treatment time. During at least part of the inspiratory phase corresponding to the guided breathing time parameters, a waveform is output via the inspiratory muscle stimulation module, and an inhalation prompt signal is simultaneously output when the inspiratory muscles are stimulated. During at least part of the expiratory phase corresponding to the guided breathing time parameters, a waveform is output via the expiratory muscle stimulation module, and an exhalation prompt signal is simultaneously output when the expiratory muscles are stimulated. The patient is guided to perform respiratory treatment, and during the treatment, the breathing rate and the frequency of inspiratory muscle stimulation and expiratory muscle stimulation output are gradually and slowly reduced, so that the patient can adapt more easily, thereby improving the treatment effect. This avoids the patient's discomfort or affecting the treatment effect due to the large difference between the breathing rate of the electrical stimulation assisted breathing device and the patient's spontaneous breathing rate. After the patient's respiratory function is further improved, working mode 1 can be selected for treatment. In working mode 1, the electrical stimulation assisted breathing device outputs a waveform through the inspiratory muscle stimulation module according to the preset respiratory time parameters during at least part of the inspiratory phase corresponding to the preset respiratory time parameters, and simultaneously outputs an inhalation prompt signal when the inspiratory muscles are stimulated; outputs a waveform through the expiratory muscle stimulation module during at least part of the expiratory phase corresponding to the preset respiratory time parameters, and simultaneously outputs an expiratory prompt signal when the expiratory muscles are stimulated; this helps patients to carry out long-term consolidated respiratory rehabilitation.

[0061] Embodiment 2 An embodiment of the present invention provides a method for electrically stimulating assisted breathing, comprising the following steps: S100: receiving a first acquisition instruction, a second acquisition instruction or / and a guided training instruction issued by a user; based on the first acquisition instruction, acquiring a preset breathing time parameter before stimulating the inspiratory muscles and the expiratory muscles; based on the second acquisition instruction, acquiring a real-time breathing time parameter during the stimulation of the inspiratory muscles and the expiratory muscles; and performing calculation of the guided breathing time parameter based on the guided training instruction; S200: Analyze and process the preset breathing time parameter, the real-time breathing time parameter and / or the guided breathing time parameter to obtain an inspiratory muscle stimulation parameter and an expiratory muscle stimulation parameter, and issue an inhalation and exhalation prompt instruction based on the inspiratory muscle stimulation parameter and the expiratory muscle stimulation parameter; S300: outputting a waveform during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameter to stimulate the inspiratory muscle or the nerve that controls the inspiratory muscle; and outputting a waveform during at least part of the expiratory phase based on the expiratory muscle stimulation parameter to stimulate the expiratory muscle or the nerve that controls the expiratory muscle; And based on the inhalation cue instruction, an inhalation cue signal is issued when the inhalation muscles are stimulated, and based on the exhalation cue instruction, an exhalation cue signal is issued when the expiratory muscles are stimulated.

[0062] Furthermore, the step S300 also includes: displaying the patient's physiological signal and / or the preset breathing time parameter and the real-time breathing time parameter.

[0063] Those of ordinary skill in the art will appreciate that the units and algorithm steps of each example described in conjunction with the embodiments disclosed in the embodiments of the present invention can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of the present invention.

[0064] In the embodiments provided in the present application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are only schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation, such as multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of devices or units, which can be electrical, mechanical or other forms.

[0065] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0066] In addition, each functional unit in each embodiment of the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.

[0067] If the functions are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, or the part that contributes to the prior art, or the part of the technical solution, can be embodied in the form of a software product. The computer software product is stored in a storage medium, including several instructions for a computer device (which can be a personal computer, server, or network device, etc.) to perform all or part of the steps of the method described in each embodiment of the present invention. The aforementioned storage medium includes: various media that can store program codes, such as USB flash drives, mobile hard disks, ROM, RAM, magnetic disks, or optical disks.

[0068] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. An electrical stimulation breathing-assisted device, characterized in that: It includes an acquisition module, a control module, an inspiratory muscle stimulation module and an expiratory muscle stimulation module; The acquisition module is used to acquire a breathing time parameter, or to calculate the breathing time parameter by acquiring a patient's physiological signal; the breathing time parameter includes a preset breathing time parameter and / or a real-time breathing time parameter; The control module is used to receive the breathing time parameter, calculate the guided breathing time parameter based on the breathing time parameter, and perform analysis and processing based on the breathing time parameter and / or the guided breathing time parameter to obtain the inspiratory muscle stimulation parameter and the expiratory muscle stimulation parameter; The inspiratory muscle stimulation module is used to stimulate the inspiratory muscle or the nerve controlling the inspiratory muscle during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameters; The expiratory muscle stimulation module is used to stimulate the expiratory muscle or the nerve controlling the expiratory muscle during at least a part of the expiratory phase based on the expiratory muscle stimulation parameters.

2. The electrical stimulation breathing-assisted device according to claim 1, characterized in that: The breathing time parameters include but are not limited to one or more of the following parameters: inspiration start time, inspiration end time, inspiration time, exhalation start time, exhalation end time, exhalation time, and respiratory rate; The inspiratory muscle stimulation parameters include but are not limited to one or more of inspiratory muscle stimulation start time, inspiratory muscle stimulation stop time, pulse frequency, pulse width, pulse amplitude, and duty cycle; The expiratory muscle stimulation parameters include, but are not limited to, one or more of expiratory muscle stimulation start time, expiratory muscle stimulation stop time, pulse frequency, pulse width, pulse amplitude, and duty cycle.

3. The electrical stimulation breathing assisted device according to claim 1, characterized in that: The control module includes a first working mode, wherein: An analysis and processing is performed based on the preset breathing time parameter to obtain a first inspiratory muscle stimulation parameter and a first expiratory muscle stimulation parameter.

4. The electrical stimulation breathing-assisted device according to claim 1, characterized in that: The control module includes a second working mode, wherein: An analysis is performed based on the real-time respiratory time parameter to obtain a second inspiratory muscle stimulation parameter and a second expiratory muscle stimulation parameter.

5. The electrical stimulation breathing-assisted device according to claim 4, characterized in that: When the acquisition module is unable to acquire the real-time breathing time parameters in real time, the preset breathing time parameters or the previously acquired real-time breathing time parameters are filtered to obtain estimated breathing time parameters; and the estimated breathing time parameters are analyzed to obtain the second inspiratory muscle stimulation parameters and the second expiratory muscle stimulation parameters.

6. The electrical stimulation breathing-assisted device according to claim 1, characterized in that: The control module includes a third working mode, wherein: The guided breathing time parameter is calculated based on the breathing time parameter; and the guided breathing time parameter is analyzed and processed to obtain a third inspiratory muscle stimulation parameter and a third expiratory muscle stimulation parameter that vary with time.

7. The electrical stimulation breathing-assisted device according to claim 6, characterized in that: The guided breathing time parameters include, but are not limited to, one or more of a breathing frequency that varies with time, an inhalation start time, an inhalation end time, an inhalation time, an exhalation start time, an exhalation end time, and an exhalation time.

8. The electrical stimulation breathing-assisted device according to claim 7, characterized in that: The respiratory rate that changes with time is calculated by the following formula: Fn=Fs-△F×△T; Where Fn is the respiratory frequency that changes with time; Fs is the initial respiratory frequency; △F is the decreasing step of the respiratory frequency as the treatment time changes; △T is the changing treatment time.

9. The electrical stimulation breathing-assisted device according to claim 1, characterized in that: It also includes an information output module, which is used to receive the inhalation or exhalation prompt instruction issued by the control module, and to issue an inhalation prompt signal when the inspiratory muscles are stimulated, and to issue an exhalation prompt signal when the expiratory muscles are stimulated; and The control module is also used to send the patient's physiological signal and the breathing time parameter and / or the guided breathing time parameter to the information output module, and display the information through the information output module.

10. An electrical stimulation assisted breathing method, characterized in that: The following steps are involved: S100: Acquire a breathing time parameter, or acquire a patient's physiological signal and calculate the breathing time parameter according to the patient's physiological signal; the breathing time parameter includes a preset breathing time parameter and / or a real-time breathing time parameter; S200: Calculating a guided breathing time parameter based on the breathing time parameter; and performing analysis and processing based on the breathing time parameter and / or the guided breathing time parameter to obtain an inspiratory muscle stimulation parameter and an expiratory muscle stimulation parameter; S300: stimulating the inspiratory muscles or the nerves controlling the inspiratory muscles during at least part of the inspiratory phase based on the inspiratory muscle stimulation parameters; and stimulating the expiratory muscles or the nerves controlling the expiratory muscles during at least part of the expiratory phase based on the expiratory muscle stimulation parameters.

Images