CN103055417B - A kind of noinvasive transcutaneous electrostimulation instrument - Google Patents

Abstract

The invention discloses a non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapy instrument, which includes a real-time monitoring module for monitoring the respiratory condition, used for real-time monitoring of the respiratory condition of the monitored object when it is in a sleeping state, and obtaining sleep parameters; the electrical stimulation signal A generating module, used to provide at least two electrical stimulation modes; a non-implantable percutaneous electrode, used to conduct the chronic frequency-variable electrical stimulation signal to the diaphragm or genioglossus of the monitored subject; or transfer the acute electrical stimulation The signal is transmitted to the diaphragm or genioglossus of the monitored subject. The non-invasive percutaneous frequency-variable electrical stimulation multifunctional respiratory therapeutic instrument of the present invention integrates multiple functions such as acute diaphragm pacing, chronic frequency-variable diaphragm electrical stimulation, acute genioglossus electrical stimulation, and chronic frequency-variable genioglossus electrical stimulation. Prevent double action.

Description

A non-invasive transcutaneous electrical stimulator

technical field

The invention relates to the treatment of diaphragm fatigue and obstructive sleep apnea hypopnea syndrome (OSAHS) caused by chronic obstructive pulmonary disease (chronic obstructive pulmonary disease, COPD), especially relates to a non-invasive transcutaneous electrical stimulation instrument.

Background technique

Both COPD and OSAHS are clinically common and frequently-occurring diseases, and both involve certain skeletal muscles related to breathing. Respiratory muscle exercise for COPD patients can improve their oxygenation at night, relieve dyspnea and improve respiratory muscle function, while improving their activity and quality of life. External diaphragm pacing (External Diaphragm Pacemaker, EDP) is a more effective way to exercise respiratory muscles. At present, EDP therapy uses continuous 2.5Hz or 10Hz electrical stimulation combined with physiological frequency (40Hz) chronic electrical stimulation, which can well prevent and treat diaphragmatic fatigue in COPD, and can better improve diaphragmatic function. For patients with OSAHS, the increased upper airway resistance due to upper airway relaxation and stenosis is the initiating factor leading to OSAHS, and the abnormal function of the genioglossus muscle and the stenosis of the upper airway caused by the posterior fall of the tongue root are one of the main reasons. The length-tension curve of the tongue muscle is stronger than that of normal people, that is, it can effectively reopen the upper airway and stop the occurrence of obstructive respiratory events, and the increase of the myoelectric activity of the genioglossus muscle can significantly improve the stability of the upper airway. Therefore, improving the function of upper airway dilating muscles is the key to effective and reasonable treatment of this disease. There is a transcutaneous non-invasive bidirectional current pulse stimulation device developed in China based on this. When apnea is detected during sleep, it can immediately give the patient electrical stimulation according to the initial program to promote the contraction of the genioglossus muscle, immediately improve ventilation, and stop breathing. pause.

However, the above two diseases may exist at the same time, which is called overlap syndrome. At present, the therapeutic apparatus for these two diseases has a single function, that is, it can only provide one kind of electrical stimulation for one disease, and the electrical stimulation mode of the above-mentioned percutaneous non-invasive bidirectional current pulse stimulation instrument is for acute short-term symptomatic treatment, and only temporarily The effect of opening the airway and restoring breathing has no long-term therapeutic effect, and treatment cannot improve the contractility and anti-fatigue ability of the genioglossus muscle, let alone prevent the occurrence of apnea events. Therefore, there is an urgent need for a multifunctional electrical stimulator that combines the electrical stimulation treatment functions of diaphragm muscle fatigue and OSAHS into one.

Contents of the invention

In view of this, the present invention provides a non-invasive transcutaneous electrical stimulation instrument, which can give the monitored object a chronic variable frequency electrical stimulation signal or an acute electrical stimulation signal by providing a chronic variable frequency electrical stimulation mode and an acute electrical stimulation mode. Simultaneously give the monitored object chronic variable-frequency electrical stimulation signals and acute electrical stimulation signals, that is, the therapeutic device can not only give suitable chronic variable-frequency electrical stimulation or acute electrical stimulation to the diaphragm of the monitored object with COPD, but also give patients with OSAHS The suitable chronic variable-frequency electrical stimulation or acute electrical stimulation of the genioglossus muscle of the monitored object integrates the functions of diaphragm muscle fatigue and OSAHS electrical stimulation treatment, and solves the problem of single function of the existing electrical stimulation treatment equipment.

The present invention solves the above technical problems by the following technical means:

The invention provides a non-invasive transcutaneous electrical stimulator, comprising:

The real-time monitoring module is used for real-time monitoring of the breathing condition of the monitored object when it is in a sleep state, and obtains sleep parameters;

The electrical stimulation signal generation module is used to provide at least two electrical stimulation modes, and when the monitored object is not in a sleep state, start the chronic variable frequency electrical stimulation mode to generate a chronic variable frequency electrical stimulation signal, or when the monitored object is in the When in a sleep state, analyze and judge whether the breathing condition of the monitored subject is normal according to the sleep parameter analysis obtained by real-time monitoring, and if not, start the acute electrical stimulation mode to generate an acute electrical stimulation signal;

A plurality of non-implantable percutaneous electrodes for conducting the chronic variable frequency electrical stimulation signal to the diaphragm and/or genioglossus of the monitored subject; or conducting the acute electrical stimulation signal to the monitored subject diaphragm and/or genioglossus.

Beneficial effects of implementing the present invention: the present invention starts the chronic variable frequency electrical stimulation mode to generate a chronic variable frequency electrical stimulation signal through the electrical stimulation generation module when the monitored object is not in a sleep state, and the chronic variable frequency electrical stimulation signal is generated through a non-implanted percutaneous electrode. The electrical stimulation signal is transmitted to the diaphragm and/or genioglossus of the monitored subject, that is, the chronic variable frequency electrical stimulation signal is given to the monitored subject suffering from COPD and/or OSAHS to continuously variable frequency electrical stimulation of the diaphragm and/or genioglossus , so as to promote the transformation of the diaphragm/genioglossus muscle fiber type, and also enhance its contractility and fatigue resistance; or when the monitored subject is in a sleep state, the real-time monitoring module is used to monitor the respiratory status of the monitored subject, and when the subject is breathing When the situation is abnormal, the acute electrical stimulation mode is activated by the electrical stimulation generation module to generate acute electrical stimulation signals, and then the non-implanted percutaneous electrodes transmit them to the diaphragm and/genioglossus, that is, the acute electrical stimulation signals are given Real-time pacing of the diaphragm of the monitored object suffering from COPD and/or OSAHS, and/or acute electrical stimulation of the genioglossus muscle, so that the monitored object can immediately resume breathing and avoid abnormal situations such as suffocation; that is to say, the utility model The non-invasive transcutaneous electrical stimulation multifunctional therapeutic device can not only give continuous variable frequency electrical stimulation or instant pacing to the monitored subject's diaphragm, but also can give the monitored subject continuous variable frequency electrical stimulation or acute electrical stimulation to the genioglossus muscle. , it can also give chronic variable frequency electric stimulation therapy/acute electric stimulation therapy to the diaphragm and genioglossus of the monitored object at the same time, that is, the non-invasive transcutaneous electric stimulation multifunctional therapeutic instrument of the present invention combines the functions of diaphragm muscle fatigue and OSAHS electric stimulation therapy function; and the non-invasive transcutaneous electrical stimulation multifunctional therapeutic instrument of the present utility model provides the monitored object suffering from OSAHS with the genioglossus muscle acute electrical stimulation, and also gives the diaphragm continuous frequency conversion electrical stimulation, so that it can play an auxiliary role in strengthening To open the airway and enhance the therapeutic effect of OSAHS, that is, the non-invasive percutaneous electrical stimulation multifunctional therapeutic instrument of the present invention integrates acute diaphragmatic pacing, chronic frequency-variable diaphragmatic electrical stimulation, acute genioglossus electrical stimulation, frequency-variable genioglossus electrical stimulation, etc. It is multi-functional. It can not only terminate apnea events and reverse hypoxia through acute electrical stimulation therapy, but also improve the contractility and anti-fatigue ability of diaphragm and genioglossus muscle through frequency conversion electrical stimulation therapy. It has dual effects of treatment and prevention.

Description of drawings

The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

FIG. 1 is a functional block diagram of an embodiment of a non-invasive transcutaneous electrical stimulator of the present invention.

Detailed ways

The present invention will be described in detail below in conjunction with the accompanying drawings.

Because both COPD and OSAHS can achieve the therapeutic effect by electrically stimulating the relevant respiratory muscles, for example, COPD can electrically stimulate its diaphragm, OSAHS can electrically stimulate its genioglossus, and EDP can even assist in strengthening the open airway, To enhance the therapeutic effect of OSAHS, the non-invasive percutaneous electrical stimulation apparatus of the present invention is obtained by combining the electrical stimulation treatment of diaphragm fatigue with the electrical stimulation treatment of OSAHS. The non-invasive transcutaneous electrical stimulator of the present invention will be described in detail below in conjunction with accompanying drawing 1 and specific embodiments.

Referring to FIG. 1 , it is a functional block diagram of an embodiment of a noninvasive transcutaneous electrical stimulator of the present invention. During specific implementation, the noninvasive transcutaneous electrical stimulator 1 of this embodiment includes a real-time monitoring module 11, and the electrical stimulation signal Generating module 12, and several non-implantable transcutaneous electrodes 13, wherein, real-time monitoring module 11, is used for real-time monitoring the breathing condition of monitored object when sleeping state, obtains the sleep parameter of this monitored object, and outputs to electric circuit Stimulation signal generation module 12; the electrical stimulation signal generation module 12 is used to provide at least two electrical stimulation modes, the at least two electrical stimulation modes include chronic variable frequency electrical stimulation mode and acute electrical stimulation mode, and when the monitored object is not in When in a sleep state, start the chronic variable frequency electrical stimulation mode to generate a chronic variable frequency electrical stimulation signal, and output it to the non-implantable percutaneous electrode 13, or when the monitored object is in a sleeping state, monitor the sleep signal obtained in real time according to the above-mentioned real-time monitoring module 11. Parameter analysis determines whether the breathing condition of the monitored object is normal, and if it is not normal, the acute electrical stimulation mode is started to generate an acute electrical stimulation signal, and is output to the non-implantable percutaneous electrode 13; the non-implantable percutaneous electrode 13 , for conducting the chronic frequency-variable electrical stimulation signal generated by the electrical stimulation signal generation module 12 to the diaphragm and/or genioglossus of the monitored object, or conducting the acute electrical stimulation signal generated by the electrical stimulation signal generation module 12 To the diaphragm and/or genioglossus of the subject being monitored. During specific implementation, the chronic variable-frequency electrical stimulation signal in this embodiment adopts a continuous 2.5Hz/10Hz compound physiological frequency pulse train of 40Hz.

Referring to Fig. 1, in the present embodiment, the real-time monitoring module 11 includes a heat-sensitive mouth and nose airflow sensor 111, which is used to monitor the nostril and oral breathing airflow of the monitored subject when he is in a sleep state, and obtain the nostril and oral breathing signal of the monitored subject; Thoracic and abdominal respiration sensor 112, for monitoring the chest and abdomen movement when the monitored subject is in a sleeping state, and obtaining the chest and abdominal respiration signal of the monitored subject; and a transcutaneous blood oxygen saturation sensor 113, for monitoring that the monitored subject is in a sleeping state In this embodiment, the real-time monitoring module 11 monitors the breathing signal (including nostril oral breathing signal and chest and abdomen breathing signal) and blood oxygen concentration parameters are sleep parameters. In this embodiment, only when the monitored subject is in a sleeping state, the real-time monitoring module 11 monitors the breathing condition of the monitored subject in real time, so as to obtain sleep parameters. The real-time monitoring in this embodiment includes real-time monitoring of the initial respiratory condition of the monitored subject in a sleeping state, and also includes real-time monitoring of the respiratory condition of the monitored subject in the acute electrical stimulation mode.

In this embodiment, the sleep breathing condition of the monitored subject includes abnormality and normality; abnormality means that when the monitored subject is in a sleep state, his or her breathing is apnea or tends to apnea, or the blood oxygen concentration is lower than the normal value.

Referring to FIG. 1 , in this embodiment, the non-implantable percutaneous electrodes 13 include diaphragm pacing electrodes 131 for receiving the chronic frequency-variable electrical stimulation signals or acute electrical stimulation signals generated by the electrical stimulation signal generation module 122, and conduct it to the diaphragm of the monitored object; the genioglossus electrode 132 is used to receive the chronic variable frequency electrical stimulation signal or the acute electrical stimulation signal generated by the above-mentioned electrical stimulation signal generation module 122, and conduct it to the monitored object's Genioglossus.

Referring to Fig. 1, in this embodiment, the electrical stimulation signal generating module 12 specifically includes a memory 123, a programmable microprocessor 121 and an electrical stimulation signal generator 122, and the electrical stimulation signal generator 122 includes several first output channels and several second output channels. Two output channels, the first output channel is electrically connected to the genioglossus electrode 132, and the second output channel is electrically connected to the diaphragm pacing electrode; wherein, the memory 123 is used to store the chronic variable frequency electrical stimulation preset by the monitored object or medical personnel Signal parameters, the chronic frequency-variable electrical stimulation signal parameters include gating parameters for gating the first output channel and/or the second output channel; the programmable microprocessor 121 is used to provide at least two electrical stimulation modes, and when When the monitored object is not in a sleep state, obtain the preset parameters of the chronic variable frequency electrical stimulation signal to trigger the electrical stimulation signal generator 122 to generate a corresponding chronic variable frequency electrical stimulation signal, or when the monitored object is in a sleep state, according to the real-time monitoring module 11 Analyze the sleep parameters obtained by real-time monitoring to determine whether the breathing condition of the monitored object is normal. If not, generate corresponding acute electrical stimulation signal parameters according to the sleep parameters obtained by real-time monitoring, and trigger the electrical stimulation signal parameters according to the acute electrical stimulation signal parameters. The stimulation signal generator 122 generates a corresponding acute electrical stimulation signal, and the acute electrical stimulation signal parameters include gating parameters for gating the first output channel and/or the second output channel; and the electrical stimulation signal generator 122 is used for Generate a corresponding chronic variable frequency electrical stimulation signal according to the preset chronic variable frequency electrical stimulation signal parameters, and gate the first output channel and/or the second output channel corresponding to the gating parameters in the chronic variable frequency electrical stimulation signal parameters, and then pass through the The first output channel and/or the second output channel output the chronic variable frequency electrical stimulation signal to the corresponding genioglossus muscle electrode 132 and/or diaphragm muscle pacing electrode 131, or the acute electrical stimulation signal generated by the programmable microprocessor 121 The stimulation signal parameters generate corresponding acute electrical stimulation signals, and gate the first output channel and/or the second output channel selected by the gating parameters in the acute electrical stimulation signal parameters, and then pass through the first output channel and/or the second output channel The two output channels output the acute electrical stimulation signal to the genioglossus muscle electrode 132 and/or the diaphragm muscle pacing electrode 131 . In this embodiment, the memory 123 and the programmable microprocessor 121 are integrated together, which can be implemented in the form of a single-chip microcomputer, that is, the single-chip microcomputer is used to control the electrical stimulation mode, and the degree of intelligence is high, and all parameters have been fully digitally adjusted. , and can be displayed through the display module of the microcontroller. At the same time, due to the use of a powerful single-chip microcomputer as the control core, the peripheral circuits are reduced, so the reliability is greatly improved and the volume is reduced. It is very convenient to use through the full digital panel adjustment. Of course, the electrical stimulation signal generator 123 can also be integrated together.

In a specific embodiment, the programmable microprocessor 121 specifically includes a judgment unit, which is used to judge whether the breathing condition of the monitored subject is normal according to the sleep parameters obtained by the real-time monitoring module 11, and obtain a judgment result; When the judging result of the judging unit is that the breathing condition is abnormal, generate corresponding acute electrical stimulation signal parameters according to the sleep parameters, and trigger the electrical stimulation signal generator 122 to generate corresponding acute electrical stimulation signal parameters according to the acute electrical stimulation signal parameters; or When the chronic variable frequency electrical stimulation mode is activated, the preset parameters of the chronic variable frequency electrical stimulation signal are acquired to trigger the electrical stimulation signal generator 122 to generate a corresponding chronic variable frequency electrical stimulation signal. The memory includes a program storage unit and a data storage unit, the program storage unit is used to store various programs that need to be called during the entire processing process, and the data storage unit is used to store the chronic variable frequency electrical stimulation preset by the monitored object or medical staff Signal parameters; the memory can also include a non-volatile storage unit, which is used to store the acute electrical stimulation signal parameters generated by the programmable microprocessor 121 according to the sleep parameters obtained by real-time monitoring, and the monitored object is activated according to the acute electrical stimulation. Signal parameters Sleep parameters under acute electrical stimulation signals generated. In this embodiment, various parameters in the electrical stimulation process are stored in the memory, so that it has an automatic memory function, so that the parameters set at the last startup can be automatically executed at the next startup, which is more convenient to use. And because the processing programs stored in the memory can be modified at any time, so that the electrical stimulation signal parameters such as pacing parameters and pulse waveforms can be increased or adjusted according to the doctor's requirements, and product upgrades can be realized without changing the hardware. In this embodiment, the programmable microprocessor 121 is also used to control the shutdown of the acute electrical stimulation mode, that is, to output control signals to control the electrical stimulation When the signal generator 122 is turned off, the electrical stimulation signal generator 122 no longer generates acute electrical stimulation signals.

In this embodiment, some diaphragm pacing electrodes and some genioglossus electrodes 132 are arranged, and the electrical stimulation signal generator 122 also includes some first output channels and some second output channels, and the diaphragm pacing electrodes 131 correspond to the second The output channel, the genioglossus electrode 132 corresponds to the first output channel. And because the monitored object may suffer from one of COPD and OSAHS, may suffer from both. If the monitored subject only suffers from COPD, it is only necessary to give electrical stimulation to the diaphragm muscle, so the second output channel needs to be selected; Gate the first output channel; if the monitored subject suffers from COPD and OSAHS at the same time, you need to gate the first output channel and the second output channel at the same time, that is, you need to gate different outputs for different diseases and different electrical stimulation modes aisle. Therefore, in this embodiment, by setting corresponding gating parameters in the parameters of the chronic frequency-variable electrical stimulation signal and the parameters of the acute electrical stimulation signal, the electrical stimulation signal generator 122 can gating the corresponding output channels according to the gating parameters. For example, when it is necessary to give diaphragm electrical stimulation, the electrical stimulation signal generator 122 gates the second output channel connected to the diaphragm muscle pacing electrode 131 according to the gating parameters in the chronic variable frequency electrical stimulation signal parameters/acute electrical stimulation signal parameters, And output the chronic variable-frequency electrical stimulation signal/acute electrical stimulation signal to the diaphragm pacing electrode 131 through the second output channel. Similarly, when it is necessary to give genioglossus electrical stimulation, the first output channel connected to the genioglossus electrode 132 is selected according to the gating parameters in the chronic variable frequency electrical stimulation signal parameters/acute electrical stimulation signal parameters; When giving electrical stimulation to the genioglossus muscle and the diaphragm muscle, the second output channel connected to the diaphragm muscle pacing electrode 131 and the first output channel connected to the genioglossus muscle electrode 132 are selected respectively. In this embodiment, the parameters of the chronic frequency-variable electrical stimulation signal and the acute electrical stimulation signal also include the intensity, direction, time length and cycle of the electrical stimulation signal in the corresponding mode.

For the monitored subjects suffering from OSAHS, EDP can also play an auxiliary role in strengthening the open airway and enhancing the therapeutic effect of OSAHS, that is, when the real-time monitoring module 11 detects that the breathing condition is not In addition to stimulation therapy, chronic variable-frequency electrical stimulation of the diaphragm can also be performed at the same time, so as to restore the breathing of the monitored object and at the same time assist in strengthening the opening of the airway and enhance the therapeutic effect of OSAHS.

Therefore, in another specific embodiment, when the monitored subject is in a sleep state and it is determined that the breathing condition of the monitored subject is abnormal according to the analysis of sleep parameters, the electrical stimulation signal generation module 12 starts the generation of the acute electrical stimulation signal mode. At the same time, the chronic variable-frequency electrical stimulation mode can also be started, that is, the programmable microprocessor 121 can be used to generate acute electrical stimulation signal parameters according to the sleep parameters to trigger the electrical stimulation signal generator 122 to generate acute electrical stimulation signals, and at the same time, preset The parameters of the chronic variable frequency electrical stimulation signal are used to trigger the electrical stimulation signal generator 122 to generate a chronic variable frequency electrical stimulation signal; and the electrical stimulation signal generator 122 is used to generate the corresponding acute electrical stimulation signal according to the parameters of the acute electrical stimulation signal, and according to In the acute electrical stimulation signal parameters, the gating parameter gates the first output channel connected to the genioglossus electrode, and then the acute electrical stimulation signal is output to the genioglossus electrode 132 through the first output channel, and finally the genioglossus electrode 13 Conduct the acute electrical stimulation signal to the genioglossus of the monitored subject, and the electrical stimulation signal generator 122 is also used to generate a chronic variable frequency electrical stimulation signal according to the above-mentioned parameters of the chronic variable frequency electrical stimulation signal, and generate a chronic variable frequency electrical stimulation signal according to the chronic variable frequency electrical stimulation signal In the signal parameters, the gating parameter gates the second output channel connected to the diaphragm pacing electrode 131, and outputs the chronic variable frequency electrical stimulation signal to the diaphragm pacing electrode 131 through the second output channel, and then the diaphragm pacing electrode 131 will The chronic variable-frequency electrical stimulation signal is transmitted to the diaphragm of the monitored object. In this embodiment, by simultaneously giving the monitored subject an acute electrical stimulation of the genioglossus muscle and a continuous variable-frequency electrical stimulation of the monitored subject’s diaphragm, not only can breathing be restored, but at the same time, it can assist in strengthening the opening of the airway and enhance the therapeutic effect of OSAHS .

The non-invasive transcutaneous electrical stimulator of this embodiment uses the electrical stimulation signal generation module 12 to start the chronic variable frequency electrical stimulation mode to generate a chronic variable frequency electrical stimulation signal when the monitored object is not in a sleep state, and passes the non-implantable transcutaneous electrode 13 Conduct the chronic frequency-variable electrical stimulation signal to the diaphragm or genioglossus of the monitored subject, that is, to give continuous 2.5Hz/10Hz composite 40Hz to the diaphragm and/or genioglossus of the monitored subject suffering from COPD and/or OSAHS Electrical stimulation can make its muscle fibers restructure appropriately, improve contractility and fatigue resistance, thereby preventing the collapse and stenosis of the upper airway; Monitor the breathing condition of the subject, and when the breathing condition is abnormal, the electrical stimulation signal generating module 12 starts the acute electrical stimulation mode to generate an acute electrical stimulation signal, and then conducts it to the diaphragm through the non-implantable percutaneous electrode 13 And/genioglossus muscle, that is, to give the diaphragm muscle and/or genioglossus muscle suitable electrical stimulation signal of the monitored subject suffering from COPD and/or OSAHS for electrical stimulation treatment, so that the non-invasive transcutaneous electrical stimulation instrument of the present invention not only It can give continuous variable-frequency electrical stimulation/immediate pacing to the monitored subject's diaphragm, and can also give continuous variable-frequency electrical stimulation/acute electrical stimulation to the monitored subject's genioglossus muscle, and can also give the monitored subject's diaphragm and genioglossus muscle at the same time Continuous variable-frequency electrical stimulation/acute electrical stimulation, that is, the non-invasive percutaneous electrical stimulation apparatus of the present invention combines the functions of diaphragm muscle fatigue and OSAHS electrical stimulation treatment. On the other hand, the non-invasive transcutaneous electrical stimulator of this embodiment can also generate acute electrical stimulation signals according to sleep parameters through the electrical stimulation signal generation module 12. While performing acute electrical stimulation treatment on the monitored subjects suffering from OSAHS, it also uses The electrical stimulation signal generation module 12 generates a chronic frequency-variable electrical stimulation signal according to the preset parameters of the chronic variable-frequency electrical stimulation signal, so as to give the monitored subject suffering from OSAHS acute electrical stimulation to the genioglossus muscle and at the same time give continuous frequency-variable electrical stimulation to the diaphragm , thus achieving the dual effects of prevention and treatment while terminating apnea and restoring breathing.

To sum up, the non-invasive transcutaneous electrical stimulation multifunctional therapeutic instrument of this embodiment integrates the functions of acute diaphragm pacing, chronic frequency conversion diaphragm electrical stimulation, acute genioglossus electrical stimulation, and frequency conversion genioglossus electrical stimulation. Acute electrical stimulation therapy terminates apnea events, reverses hypoxia, and can improve the contractility and fatigue resistance of diaphragm and genioglossus through frequency conversion electrical stimulation therapy, which has dual effects of treatment and prevention. The non-invasive transcutaneous electrical stimulator of this embodiment will be described in detail below in conjunction with working principles and specific embodiments.

When the monitored object is not in a sleep state, the electrical stimulation generating module 12 starts the chronic frequency-variable electrical stimulation mode to generate a chronic variable-frequency electrical stimulation signal, that is, the programmable microprocessor 121 will store the monitored object or the chronic frequency-variable frequency preset by the medical staff. The electrical stimulation signal parameters are sent to the electrical stimulation signal generator 122 to trigger it to generate a chronic variable frequency electrical stimulation signal, then the electrical stimulation signal generator 122 generates a corresponding chronic variable frequency electrical stimulation signal according to the preset chronic variable frequency electrical stimulation signal parameters, and According to the gating parameters in the chronic variable frequency electrical stimulation signal parameters, the corresponding output channel is gated to output the generated chronic variable frequency electrical stimulation signal to the corresponding diaphragmatic muscle pacing electrode 131 and/or genioglossus muscle electrode 132, and then the diaphragmatic muscle is paced The electrode 131 and/or the genioglossus electrode 132 transmits the chronic variable-frequency electrical stimulation signal to the diaphragm and/or genioglossus of the monitored subject. For example, when the monitored subject suffering from COPD is not in a sleep state, the programmable microprocessor 121 sends the chronic variable frequency electrical stimulation signal parameters preset by the monitored subject or medical staff to the electrical stimulation signal generator 122 to trigger its generation. Chronic variable frequency electrical stimulation signal, the chronic variable frequency electrical stimulation signal parameters include the intensity, direction, time length and period of the chronic variable frequency electrical stimulation signal, and the second output connected to the diaphragm pacing electrode 131 on the gate electrical stimulation signal generator 122 The gating parameters of the channel; the electrical stimulation signal generator 122 generates a corresponding chronic variable frequency electrical stimulation signal according to the chronic variable frequency electrical stimulation signal parameters, and gates the second output channel, and then outputs the chronic variable frequency electrical stimulation signal to the diaphragm The pacing electrode 131; the diaphragm pacing electrode 131 conducts the chronic variable-frequency electrical stimulation signal output by the electrical stimulation signal generator 122 to the diaphragm of the monitored subject. And when the monitored subject suffering from SOAHS is not in a sleep state, its principle is the same as the above-mentioned principle, the difference is that after the electrical stimulation signal generator 122 generates a chronic frequency-variable electrical stimulation signal, it passes the chronic variable-frequency electrical stimulation signal through the first output channel. The variable-frequency electrical stimulation signal is output to the genioglossus muscle electrode 132, and the chronic variable-frequency electrical stimulation signal is transmitted to the genioglossus muscle of the monitored subject by the genioglossus muscle electrode 132. If when the monitored object suffers from the COPD and OSAHS at the same time, after the electrical stimulation signal generator 122 generates the chronic variable frequency electrical stimulation signal, the second output channel connected with the diaphragmatic muscle pacing electrode 131 is selected simultaneously, and the second output channel connected with the genioglossal electrode 131 is selected. The first output channel connected to the muscle electrode 132, and the chronic variable frequency electrical stimulation signal is output to the diaphragm pacing electrode 131 and the genioglossus muscle 132 respectively through these two channels, and then the diaphragm pacing electrode 131 and the genioglossus muscle electrode 132 are respectively conducted to the diaphragm and genioglossus of the monitored subject for electrical stimulation treatment.

When the monitored object is in a sleep state, the programmable microprocessor 121 analyzes and judges whether the monitored object's respiratory condition is normal according to the sleep parameters monitored by the real-time monitoring module 11, and if it is not normal, starts the acute electrical stimulation mode. The programming microprocessor 121 generates corresponding acute electrical stimulation signal parameters according to the sleep parameters obtained by the real-time monitoring, and the acute electrical stimulation signal parameters include the intensity, direction, time length and period of the acute electrical stimulation signal in the acute electrical stimulation mode, and Gating the gating parameters of the first output channel and/or the second output channel of the electrical stimulation signal generator 122, the electrical stimulation signal generator 122 generates a corresponding acute electrical stimulation signal according to the acute electrical stimulation signal parameters, and according to the above selection The corresponding output channel is gated through the parameters, and then the generated acute electrical stimulation signal is output to the corresponding diaphragmatic muscle pacing electrode 131 and/or genioglossus electrode 132 through the gated output channel, and finally, the diaphragmatic muscle pacing electrode 131 And/or the genioglossus electrode 132 conducts the acute electrical stimulation signal to the diaphragm and/or genioglossus of the monitored subject; When returning to normal after treatment, the programmable microprocessor 121 controls the acute electrical stimulation mode to be turned off, that is, no acute electrical stimulation signal is generated. The parameter triggers the electrical stimulation signal generator 122 to generate an acute electrical stimulation signal. For example, when a monitored subject suffering from COPD is in a sleep state, the programmable microprocessor 121 analyzes and judges whether the breathing condition of the monitored subject is normal according to the sleep parameter analysis obtained by the real-time monitoring module 11, and if it is not normal, then according to the The sleep parameters generate acute electrical stimulation signal parameters, and the acute electrical stimulation parameters include the intensity, direction, time length and period of the acute electrical stimulation signal in the acute electrical stimulation mode, and gate electrical stimulation signal generator 122 and diaphragm pacemaker electrode The gating parameters of the first output channel connected to 131; the electrical stimulation signal generator 122 generates corresponding acute electrical stimulation signals according to the acute electrical stimulation signal parameters, and gates the diaphragm connected to the diaphragm pacing electrode 131 according to the gating parameters. The first output channel outputs the generated acute electrical stimulation signal to the diaphragm pacing electrode 131 through the first output channel; the diaphragm pacing electrode 131 transmits the acute electrical stimulation signal to the diaphragm of the monitored subject. And when it is judged that the breathing condition of the monitored subject has returned to normal according to the sleep parameters obtained by real-time monitoring after the electrical stimulation treatment, the acute electrical stimulation mode is controlled to be turned off. When the monitored subject suffering from SOAHS is in a sleep state, its principle is the same as the above-mentioned principle, and the difference is that after the electrical stimulation signal generator 122 produces an acute electrical stimulation signal, it passes through the second electrical stimulation signal connected to the genioglossus electrode 132. The output channel outputs the acute electrical stimulation signal to the genioglossus muscle electrode 132, and the acute electrical stimulation signal is transmitted to the genioglossus muscle of the monitored subject through the genioglossus muscle electrode 132. And when the monitored object suffers from COPD and OSAHS at the same time, then the electrical stimulation signal generator 122 can output the acute electrical stimulation signal generated to the diaphragmatic muscle pacing electrode 131 and the geniotongue through the second output channel and the first output channel respectively. Muscle electrode 132, the diaphragm muscle and genioglossus muscle of the monitored object are simultaneously electrically stimulated by the diaphragm pacing electrode 131 and the genioglossus electrode 132.

In another specific embodiment, when the monitored subject suffering from SOAHS is in a sleep state and his breathing condition is not normal, the electrical stimulation signal generation module 12 can also start the chronic variable frequency electrical stimulation mode while starting the acute electrical stimulation mode That is, the electrical stimulation signal generator 122 can also produce chronic variable-frequency electrical stimulation signals according to preset chronic variable-frequency electrical stimulation signal parameters while producing acute electrical stimulation signal parameters according to the programmable microprocessor 121, and According to the gating parameters in the acute electrical stimulation signal parameters and the gating parameters in the chronic variable frequency electrical stimulation signal parameters, the second output channel connected to the genioglossus muscle electrode 132 and the second output channel connected to the diaphragmatic muscle pacing electrode 131 are selected respectively. An output channel, and output the acute electrical stimulation signal to the genioglossus muscle electrode 132 through the first output channel, and output the chronic variable frequency electrical stimulation signal to the diaphragm electrode 131 through the second output channel; The tongue muscle electrode 132 transmits the acute electrical stimulation signal to the genioglossus muscle of the monitored subject for electrical stimulation treatment, and the electrode 131 transmits the chronic variable frequency electrical stimulation signal to the monitored subject's diaphragm for electrical stimulation treatment. And when it is judged that the breathing condition of the monitored object has returned to normal according to the sleep parameters obtained by real-time monitoring after the electrical stimulation treatment, the acute electrical stimulation mode and the chronic variable frequency electrical stimulation mode are controlled to be turned off.

If the monitored subject suffers from COPD and OSAHS at the same time, and it is monitored that he is in abnormal breathing, the acute electrical stimulation mode in the above method can be used, that is, the acute electrical stimulation signal is used to electrically stimulate the diaphragm and genioglossus respectively, and also The acute electrical stimulation mode in the above method can be combined with the chronic variable frequency electrical stimulation mode, that is, while the acute electrical stimulation signal is used to electrically stimulate the genioglossus muscle, the chronic variable frequency electrical stimulation method is used to electrically stimulate the diaphragm muscle.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention without limitation. Although the patent has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be carried out Modifications or equivalent replacements without departing from the spirit and scope of the technical solution of the present invention shall be covered by the claims of the present invention.

Claims (8)

1. A non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapy instrument, is characterized in that, comprising: A real-time monitoring module (11), used for real-time monitoring of the breathing condition of the monitored object when it is in a sleep state, and obtaining sleep parameters; The electrical stimulation signal generation module (12) is used to provide at least two electrical stimulation modes, and when the monitored object is in a non-sleeping state, start the chronic variable frequency electrical stimulation mode to generate chronic variable frequency electrical stimulation signals, and send them to several non- The diaphragm pacing electrode (131) or the genioglossus electrode (132) in the implanted percutaneous electrode (13), or the diaphragm pacing electrode sent to the several non-implanted percutaneous electrodes (13) simultaneously (131) and genioglossus motor (132); or when the monitored subject is in a sleep state, analyze and judge whether the breathing condition of the monitored subject is abnormal according to the sleep parameter analysis obtained by real-time monitoring, if abnormal, then Start the acute electrical stimulation mode to generate an acute electrical stimulation signal, and send it to the diaphragm pacemaker electrode (131) or the genioglossus muscle electrode (132) in several non-implanted percutaneous electrodes (13), or send it to several non-implanted percutaneous electrodes (13) at the same time. Diaphragm pacing electrode (131) and genioglossus electrode (132) in the embedded percutaneous electrode (13), or when the monitored subject is in a sleep state, according to the sleep parameter analysis and judgment obtained by real-time monitoring Whether the respiratory condition of the monitored subject is abnormal, if abnormal, start the acute electrical stimulation mode to generate an acute electrical stimulation signal and send it to the genioglossus electrode (132), and at the same time, start the chronic variable frequency electrical stimulation mode to generate a chronic variable frequency electrical stimulation signal sent to the diaphragm electrode (131); Several non-implantable percutaneous electrodes (13), used for conducting the chronic frequency-variable electrical stimulation signal to the diaphragm and/or genioglossus of the monitored subject; or conducting the acute electrical stimulation signal to the Diaphragm and/or genioglossus of the monitored object, the non-implantable percutaneous electrode (13) includes: Diaphragm pacing electrode (131), used to receive the chronic frequency-variable electrical stimulation signal or acute electrical stimulation signal generated by the electrical stimulation signal generation module (12), and conduct it to the diaphragm of the monitored subject; The genioglossus electrode (132) is used to receive the chronic variable-frequency electrical stimulation signal or the acute electrical stimulation signal generated by the electrical stimulation signal generation module (12), and conduct it to the genioglossus muscle of the monitored subject. 2. The non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapeutic instrument as claimed in claim 1, wherein when the monitored subject suffering from OSAHS is in a sleep state, and it is judged that the patient is suffering from OSAHS according to the sleep parameters obtained by real-time monitoring When the respiratory condition of the monitored subject with OSAHS is abnormal, The electrical stimulation signal generation module (12) is used to start an acute electrical stimulation mode to generate an acute electrical stimulation signal, and output it to the genioglossus electrode (132) and the diaphragm pacing electrode (131); The genioglossus electrode (132) is used to conduct the acute electrical stimulation signal to the genioglossus of the monitored subject; The diaphragm pacing electrode (131) is used to conduct the acute electrical stimulation signal to the diaphragm of the monitored subject. 3. The non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapeutic instrument as claimed in claim 2, characterized in that, the electric stimulation generation module (12) is also used for determining the acute electric stimulation mode according to the sleep parameters When the respiratory condition of the monitored subject returns to normal, the acute electrical stimulation mode is turned off. 4. The non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapeutic apparatus as claimed in claim 2, characterized in that, the electric stimulation signal generating module (12) includes a memory, a programmable microprocessor (121) and an electric stimulation signal Generator (122), the electrical stimulation signal generator (122) includes several first and second output channels, the first output channel is electrically connected to the genioglossus electrode, and the second output channel is connected to the The diaphragm pacing electrodes are electrically connected, wherein, The memory is used to store preset parameters of the chronic frequency-variable electrical stimulation signal; the parameters of the chronic variable-frequency electrical stimulation signal include gating parameters corresponding to the first output channel and/or the second output channel; The programmable microprocessor (121) is used to provide at least two electrical stimulation modes, and when the monitored subject is in a non-sleeping state, obtain preset chronic variable frequency electrical stimulation signal parameters to trigger the electrical stimulation The signal generator generates a corresponding chronic variable-frequency electrical stimulation signal; or when the monitored subject is in a sleep state, analyze and judge whether the breathing condition of the monitored subject is abnormal according to the sleep parameters obtained through real-time monitoring, and if abnormal, then Generate acute electrical stimulation signal parameters according to the sleep parameters obtained by real-time monitoring to trigger the electrical stimulation signal generator to generate corresponding acute electrical stimulation signals; the acute electrical stimulation signal parameters include parameters corresponding to the first output channel and/or or the gating parameter of the second output channel; The electrical stimulation signal generator (122) is used to generate a corresponding chronic variable frequency electrical stimulation signal according to the preset chronic variable frequency electrical stimulation signal parameters, and gate the first parameter corresponding to the gating parameter among the chronic variable frequency electrical stimulation parameters. An output channel and/or a second output channel, and then output the chronic variable frequency electrical stimulation signal to the corresponding genioglossus electrode (132) and/or the diaphragm through the first output channel and/or the second output channel Pulse electrodes (131); or generate corresponding acute electrical stimulation signals according to the acute electrical stimulation signal parameters, and gate the first output channel and/or the second output channel corresponding to the gating parameters in the acute electrical stimulation signal parameters , and then output the acute electrical stimulation signal to the corresponding genioglossus muscle electrode (132) and/or diaphragm muscle pacing electrode (131) through the first output channel and/or the second output channel. 5. The non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapy instrument as claimed in claim 4, wherein when the monitored subject suffering from OSAHS is in a sleep state, and the sleep parameter analysis obtained according to real-time monitoring is used to determine the patient When the respiratory condition of the monitored subject with OSAHS is abnormal, The programmable microprocessor (121) is used to generate corresponding acute electrical stimulation signal parameters according to the sleep parameters obtained by real-time monitoring to trigger the electrical stimulation signal generator (122) to generate corresponding acute electrical stimulation signals; The gating parameters in the acute electrical stimulation signal parameters correspond to the first output channel and the second output channel of the electrical stimulation signal generator; The electrical stimulation signal generator (122) generates corresponding acute electrical stimulation signals according to the acute electrical stimulation signal parameters, and gates the first output channel and the second output channel corresponding to the gating parameters in the acute electrical stimulation signal parameters channel, and then output the acute electrical stimulation signal to the genioglossus muscle electrode (131) through the first output channel, and at the same time, output the acute electrical stimulation signal to the diaphragm pacing through the second output channel Electrodes (132). 6. The non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapeutic apparatus as claimed in claim 5, wherein the programmable microprocessor comprises: A judging unit, configured to judge whether the breathing condition of the monitored subject is abnormal according to the sleep parameters obtained through real-time monitoring by the real-time monitoring module (11), and obtain a judging result; A trigger unit, configured to generate an acute electrical stimulation signal parameter according to the sleep parameter to trigger the electrical stimulation signal generator (122) to generate a corresponding acute electrical stimulation signal when the judgment result of the judging unit is that the breathing condition is abnormal; And/or when the chronic variable frequency electrical stimulation mode is activated, acquiring the preset parameters of the chronic variable frequency electrical stimulation signal triggers the electrical stimulation signal generator (122) to generate a corresponding chronic variable frequency electrical stimulation signal. 7. The non-invasive transcutaneous transcutaneous frequency conversion electrical stimulation multifunctional respiratory therapeutic apparatus according to claim 5, wherein the memory is also used to store the acute electrical stimulation signal parameters, and obtained by real-time monitoring, according to the acute electrical stimulation signal parameters. The electrical stimulation signal parameter is the sleep parameter of the monitored object under the acute electrical stimulation signal generated. 8. The non-invasive percutaneous frequency conversion electric stimulation multifunctional respiratory therapeutic apparatus according to any one of claims 1 to 7, wherein the real-time monitoring module (11) comprises: A heat-sensitive oronasal airflow sensor (111), used to monitor the oronasal breathing airflow of the monitored object when it is in a sleep state, obtain the oronasal breathing signal of the monitored object, and output it to the electrical stimulation signal generation module (12); A thoracoabdominal respiration sensor (112), used to monitor the thoracoabdominal movement of the monitored object when it is in a sleeping state, obtain the thoracoabdominal respiration signal of the monitored object, and output it to the electrical stimulation signal generating module (12); The transcutaneous blood oxygen saturation sensor (113) is used to monitor the transcutaneous blood oxygen saturation of the monitored subject in a sleeping state, and output to the electrical stimulation signal generating module (12).