CN113908395B - Waking-promoting instrument - Google Patents
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- CN113908395B CN113908395B CN202111191701.4A CN202111191701A CN113908395B CN 113908395 B CN113908395 B CN 113908395B CN 202111191701 A CN202111191701 A CN 202111191701A CN 113908395 B CN113908395 B CN 113908395B
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
- A61M2021/0072—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus with application of electrical currents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M21/00—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis
- A61M2021/0005—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus
- A61M2021/0083—Other devices or methods to cause a change in the state of consciousness; Devices for producing or ending sleep by mechanical, optical, or acoustical means, e.g. for hypnosis by the use of a particular sense, or stimulus especially for waking up
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Abstract
The embodiment of the application discloses an awakening instrument, which comprises: the device comprises a first electric stimulation module, a second electric stimulation module, an interaction module, an electric stimulation signal generation module and a power supply module. The first electric stimulation module is used for stimulating the median nerve according to the first electric stimulation signal; the second electrical stimulation module is used for stimulating the vagus nerve according to the second electrical stimulation signal; the interaction module is used for receiving the control instruction transmitted by the user and sending the control instruction to the electric stimulation generation module; the electric stimulation signal generation module is used for generating a first electric stimulation signal and a second electric stimulation signal according to the control instruction, and the power supply module is used for supplying power to each module. Based on the wake-promoting instrument provided by the application, the median nerve and the vagus nerve of the patient can be stimulated simultaneously when the instrument is used for treating the patient, so that the beneficial effects of the median nerve stimulation and the vagus nerve stimulation are combined to comprehensively influence the patient, the stimulation intensity of a specific brain region of the patient is improved, and the electric stimulation signals can be transmitted to a plurality of brain regions of the patient.
Description
Technical Field
The application belongs to the technical field of medical instruments, and particularly relates to an awakening instrument.
Background
Coma is the most serious disturbance of consciousness due to the high inhibition of the cortical and subcortical reticulum, a clinically critical condition, which is mainly manifested by complete loss of consciousness, loss of voluntary movements, and dullness or loss of response to external stimuli, but the patient also has breathing and heartbeats. Generally, the longer the coma time, the less chance of waking up. The golden period that promotes patient recovery during the first two months of coma. The treatment schemes for coma and arousal so far are various, such as medicines, operation treatment, music treatment, electric stimulation and the like. The electric stimulation method is safe and effective, and is a hot spot for research and application at present.
The median nerve belongs to the peripheral nervous system of the human body, is distributed at the positions from the arms to the palms on the two sides of the human body, occupies a large area in the central dominant region, and is a peripheral portal of the central nerve. The electric stimulation is carried out on the median nerve of the patient, and the electric stimulation signal can be transmitted to the central nervous system of the patient through the median nerve-spinal nerve-cervical marrow-brain stem-thalamus-cortex area pathway, so as to trigger the excitatory effect, activate the restrained neurons and the uplink reticular activation system and promote the patient to wake up. The existing researches show that the stimulation of the median nerve on two sides or the single stimulation of the median nerve on the right side can promote the awakening of patients suffering from traumatic brain coma, and simultaneously has better awakening effect on non-traumatic coma (hemorrhagic cerebral apoplexy, hypertensive brain, cerebrovascular accidents and the like), and the awakening rate can reach 66%.
The process of performing the electrical stimulation only stimulates the median nerve of the patient, and there is a problem in that the stimulation intensity is insufficient for a specific brain region of the patient, or the electrical stimulation signal cannot be transmitted to the target brain region.
Disclosure of Invention
The first aspect of the application provides an arousal instrument comprising: the device comprises a first electric stimulation module, a second electric stimulation module, an interaction module, an electric stimulation signal generation module and a power supply module.
The first electric stimulation module is used for stimulating the median nerve according to the first electric stimulation signal;
The second electrical stimulation module is used for stimulating the vagus nerve according to a second electrical stimulation signal;
The interaction module is used for receiving a control instruction transmitted by a user and sending the control instruction to the electric stimulation generation module;
the electric stimulation signal generation module is used for generating the first electric stimulation signal and the second electric stimulation signal according to the control instruction, transmitting the first electric stimulation signal to the first electric stimulation module and transmitting the second electric stimulation signal to the second electric stimulation module;
The power supply module is used for supplying power to the first electric stimulation module, the second electric stimulation module, the interaction module and the electric stimulation signal generation module;
The first electric stimulation module, the second electric stimulation module, the interaction module and the power supply module are respectively and electrically connected with the electric stimulation signal generation module.
According to the wake-up instrument provided by the first aspect of the embodiment of the application, optionally, the interaction module comprises an interaction panel, and the interaction panel comprises an operation button, an output indicator light and a waveform display screen.
Based on the wake-up apparatus provided in the first aspect of the embodiment of the present application, optionally, the interaction module includes: a communication module, the communication module comprising: any one or more of a Bluetooth module, a WiFi module or a zigbee module.
According to the wake-up instrument provided in the first aspect of the embodiment of the present application, optionally, the electrical stimulation signal generating module includes: a microprocessor and RLC switching circuit;
the microprocessor is used for analyzing the control instruction and controlling the RLC conversion circuit;
The RLC conversion circuit is used for converting voltage input provided by the power supply module into current output;
the microprocessor is further configured to generate the first electrical stimulation signal and the second electrical stimulation signal as a function of the current output.
According to the wake-up instrument provided in the first aspect of the embodiment of the present application, optionally, the microprocessor is further configured to adjust parameters of the first electrical stimulation signal and the second electrical stimulation signal, where the parameters include: waveform, frequency, pulse width, on-off ratio.
According to the wake-up instrument provided in the first aspect of the embodiment of the present application, optionally, the electrical stimulation signal generating module further includes: the phase modulation module is used for modulating the phase of the optical signal,
The phase modulation module is used for adjusting the first electric stimulation signal and the second electric stimulation signal according to the control instruction so as to generate a phase difference between the first electric stimulation signal and the second electric stimulation signal.
According to the wake-up instrument provided in the first aspect of the embodiment of the present application, optionally, the first electrical stimulation module includes: a first sub-electrode and a second sub-electrode;
During use of the wake-up instrument, the first sub-electrode and the second sub-electrode may be disposed on a single side of a patient's body or on both sides of the patient's body;
According to the wake-up promoting instrument provided by the first aspect of the embodiment of the application, optionally, during the use process of the wake-up promoting instrument, the second electric stimulation module is arranged at the position of the concha and/or the position of the tragus of the patient.
According to the wake-up meter provided in the first aspect of the embodiment of the present application, optionally, the communication module is configured to connect with a mobile control device in a wired or wireless manner,
The mobile control device is used for carrying out data interaction with the wake-up instrument and controlling the wake-up instrument.
According to the wake-up instrument provided in the first aspect of the embodiment of the present application, optionally, the phase difference includes: in-phase, quadrature or anti-phase.
From the above technical solutions, the embodiment of the present application has the following advantages: the application provides a wake-up promoting instrument, which comprises: the device comprises a first electric stimulation module, a second electric stimulation module, an interaction module, an electric stimulation signal generation module and a power supply module. The first electric stimulation module is used for stimulating the median nerve according to the first electric stimulation signal; the second electrical stimulation module is used for stimulating the vagus nerve according to the second electrical stimulation signal; the interaction module is used for receiving the control instruction transmitted by the user and sending the control instruction to the electric stimulation generation module; the electric stimulation signal generation module is used for generating a first electric stimulation signal and a second electric stimulation signal according to the control instruction, transmitting the first electric stimulation signal to the first electric stimulation module, and transmitting the second electric stimulation signal to the second electric stimulation module. The power supply module is used for supplying power to the first electric stimulation module, the second electric stimulation module, the interaction module and the electric stimulation signal generation module. The first electric stimulation module, the second electric stimulation module, the interaction module and the power supply module are respectively and electrically connected with the electric stimulation signal generation module. Based on the wake-promoting instrument provided by the application, the median nerve and the vagus nerve of the patient can be stimulated simultaneously when the instrument is used for treating the patient, so that the beneficial effects of the median nerve stimulation and the vagus nerve stimulation are combined to comprehensively influence the patient, the stimulation intensity of a specific brain region of the patient is improved, and the electric stimulation signals can be transmitted to a plurality of brain regions of the patient.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only embodiments of the present application, and that other drawings can be obtained according to the provided drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic view of an embodiment of an awakening device according to the present application;
FIG. 2 is a schematic diagram of an embodiment of an wake-up meter control system according to the present application;
fig. 3 is a schematic flow chart of an embodiment of a method for using the wake-up instrument according to the present application.
Detailed Description
In order to better understand the solution of the present application, the following description of the solution of the embodiment of the present application will be clear and complete, and it is obvious that the described embodiment is only a part of the embodiment of the present application, not all the embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present application without making any inventive effort, shall fall within the scope of the present application.
The terms "first," "second," "third," "fourth" and the like in the description and in the claims and in the above drawings, if any, are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments described herein may be implemented in other sequences than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.
Coma is the most serious disturbance of consciousness due to the high inhibition of the cortical and subcortical reticulum, a clinically critical condition, which is mainly manifested by complete loss of consciousness, loss of voluntary movements, and dullness or loss of response to external stimuli, but the patient also has breathing and heartbeats. For coma caused by craniocerebral injury, the coma time is positively correlated with the death rate, and the longer the coma time, the smaller the awake probability. The golden period that promotes patient recovery during the first two months of coma. The treatment schemes for coma and arousal so far are various, such as medicines, operation treatment, music treatment, electric stimulation and the like. The electric stimulation method is safe and effective, and is a hot spot for research and application at present.
The median nerve belongs to the peripheral nervous system of the human body, is distributed at the positions from the arms to the palms on the two sides of the human body, occupies a large area in the central dominant region, and is a peripheral portal of the central nerve. The electric stimulation is carried out on the median nerve, and the stimulation signal can be conducted upwards to the central nervous system through the median nerve-spinal nerve-cervical marrow-brain stem-thalamus-cortex area pathway, so as to trigger the excitatory effect, activate the restrained neurons and the ascending reticular activation system and promote the awakening. The median nerve stimulation technique is simple to operate, safe, noninvasive and less in side effect. The existing researches show that the stimulation of the median nerve on two sides or the single stimulation of the median nerve on the right side can promote the awakening of patients suffering from traumatic brain coma, and simultaneously has better awakening effect on non-traumatic coma (hemorrhagic cerebral apoplexy, hypertensive brain, cerebrovascular accidents and the like), and the awakening rate can reach 66%.
The vagus nerve is the 10 th pair of brain nerves of the human brain, and is the pair with the longest travel and the widest distribution. The vagus nerve auricle branch is the branch with the shallowest distribution of the vagus nerve on the body surface, and the auricular collet, the tragus and the external auditory canal are all provided with rich vagus nerve endings, wherein the distribution proportion of the vagus nerve of the auricular collet is 100%. Electrical stimulation of these ear locations activates the vagal afferent nerve. Studies have shown that percutaneous ear vagal nerve stimulation can activate the bridge brain blue patch noradrenergic system, which is a key component of the reticular activation system; at the same time, the orexin and the receptor thereof can be increased, and the orexin energy signal is enhanced, and the signal participates in promoting arousal. Currently, clinical studies have demonstrated the feasibility of the stimulation of the vagal nerve in the treatment of coma.
The median nerve stimulation and the vagus nerve stimulation can achieve the effect of promoting the wake of the comatose patient, but the action mechanisms of the median nerve stimulation and the vagus nerve stimulation are different, and the scope of the application of the median nerve stimulation and the vagus nerve stimulation to the comatose patient is different. It has been reported clinically that some comatose patients do not respond to median nerve stimulation, but do have an awake-promoting response to vagal nerve stimulation. Currently, there is no effective means to identify which neural stimulus a patient responds to, and if validated at the cost of time, the golden period of waking up is easily missed. The device for promoting the waking up of the coma can effectively improve the waking up rate of the coma by combining the median nerve stimulation and the vagus nerve stimulation.
Referring to fig. 1, an embodiment of the wake-up apparatus provided by the present application includes: a first electrical stimulation module 101, a second electrical stimulation module 102, an interaction module 103, an electrical stimulation signal generation module 104, and a power module 105.
The first electrical stimulation module 101 is configured to stimulate the median nerve according to the first electrical stimulation signal, and specifically, the first electrical stimulation module 101 may include one or more electrode pads, and in actual use, the first electrical stimulation module 101 may be disposed at a median nerve position on two sides of an arm of the patient, or disposed at a median nerve position on one side of the arm of the patient and near the median nerve position on the side of the arm, so that a unilateral median nerve stimulation or a bilateral median nerve stimulation may be performed on the patient, where one preferred stimulation mode is a unilateral nerve stimulation is performed on a right side of the arm of the patient. It is to be understood that the first electro-stimulation module 101 may be in the form of an electrode pad disposed outside the skin, or may be in the form of an inlet body, which may be specific according to the actual situation, and is not limited herein.
The first electrical stimulation signal is obtained through pre-modulation, specifically, the first electrical stimulation signal may be a current signal or a voltage signal, the size of which may be determined according to the physical condition of the patient, and parameters such as waveform, frequency, on-off ratio, duration and the like of the first electrical stimulation signal may be modulated, and specific modulation modes and processes may be determined according to actual conditions, which are not limited herein.
The second electrical stimulation module 102 is configured to stimulate the vagus nerve according to the second electrical stimulation signal; specifically, the second electrical stimulation module 102 may include one or more electrode pads, and in actual use, the second electrical stimulation module 102 may be disposed at a position where the vagus nerve of the ear of the patient is distributed, where the position may be a concha position or a tragus position, or the electrode pads may be selectively disposed at both the concha position and the tragus position of the patient, so as to apply stimulation to both positions at the same time, and the specific manner of disposing the second electrical stimulation module may be determined according to the actual situation, which is not limited herein.
The second electrical stimulation signal is obtained through pre-modulation, specifically, the second electrical stimulation signal may be a voltage signal or a current signal, the size of which may be determined according to the physical condition of the patient, and parameters such as waveform, frequency, on-off ratio, duration and the like of the second electrical stimulation signal may be modulated, and specific modulation modes and processes may be determined according to actual conditions, which are not limited herein.
The interaction module 103 is configured to receive a control instruction transmitted by a user, and send the control instruction to the electrical stimulation generating module. The specific interaction module may be an interaction module that receives an action signal, such as a switch, a button, a knob, or an indicator light, and the user may perform a corresponding action through the interaction module, and further control the wake-up apparatus through a specific action, such as pressing the switch, rotating the knob, etc., and in the actual use process, the interaction module 103 may include a plurality of interaction modules and be used to control different types of parameters, respectively, and it is understood that the interaction module 103 may also include a display module that is used to display information to the user, such as a display screen, a display light, etc., where the specific situation may be according to the actual situation, and the application is not limited herein.
It should be noted that the interaction module may also include an interaction module for receiving and sending an electrical signal, such as a bluetooth module, a WiFi module, or a zigbee module, and specifically, taking the bluetooth module as an example, when in use, the wake-up promoting device may establish bluetooth connection with a terminal device such as a mobile phone or a tablet computer used by a user through the bluetooth module to receive a control signal sent by the user through the terminal device such as the mobile phone or the tablet computer, where the bluetooth module may be a low energy bluetooth module (BLE, bluetooth Low Energe) specifically may be determined according to an actual situation, and is not limited herein.
It will be appreciated that the present device in actual use may have both an interaction component for receiving and transmitting electrical signals and an interaction component for receiving motion signals, or any one of the above, depending on the actual situation, and is not limited herein.
The electrical stimulation signal generation module 103 is configured to generate a first electrical stimulation signal and a second electrical stimulation signal according to the control instruction, transmit the first electrical stimulation signal to the first electrical stimulation module, and transmit the second electrical stimulation signal to the second electrical stimulation module; the specific electric stimulation signal generating module 103 may include a microprocessor and a circuit structure for completing the corresponding functions, where the microprocessor can complete the operations of fetching instructions, executing instructions, exchanging information with an external memory and a logic component, and the like, and is an operation control part of the microcomputer. It can form a micro-control unit together with the memory and the peripheral circuit chip. The micro control unit (Microcontroller Unit; MCU), also called as single chip Microcomputer (SINGLE CHIP Microcomputer) or single chip Microcomputer, properly reduces the frequency and specification of the CPU (Central Process Unit; CPU), integrates the peripheral interfaces of memory (Timer), USB, A/D conversion, etc. on a single chip to form a chip-level computer, and performs different combination control for different application occasions. Corresponding instructions can be pre-burnt in the actual implementation process, so that the electric stimulation signal generating module can generate the first electric stimulation signal and the second electric stimulation signal according to the control instructions, and specifically, the process of generating the corresponding electric stimulation signals according to the control instructions can refer to the prior art, and details are not repeated here.
The power module 104 is configured to supply power to the first electrical stimulation module 101, the second electrical stimulation module 102, the interaction module 103, and the electrical stimulation signal 104 generation module. Specifically, the power module 104 may be a storage battery pack formed by a plurality of storage batteries, or may be a power socket connected to a power grid, where the power module is used to supply power to other constituent modules of the wake-up promoting instrument, and the specific power module form may be according to practical situations, and is not limited herein.
The first electrical stimulation module 101, the second electrical stimulation module 102, the interaction module 103 and the power module 104 are electrically connected with the electrical stimulation signal generation module 105 respectively. So as to transmit energy and signals to enable the wake-up instrument to work normally.
From the above technical solutions, the embodiment of the present application has the following advantages: the application provides a wake-up promoting instrument, which comprises: the device comprises a first electric stimulation module, a second electric stimulation module, an interaction module, an electric stimulation signal generation module and a power supply module. The first electric stimulation module is used for stimulating the median nerve according to the first electric stimulation signal; the second electrical stimulation module is used for stimulating the vagus nerve according to the second electrical stimulation signal; the interaction module is used for receiving the control instruction transmitted by the user and sending the control instruction to the electric stimulation generation module; the electric stimulation signal generation module is used for generating a first electric stimulation signal and a second electric stimulation signal according to the control instruction, transmitting the first electric stimulation signal to the first electric stimulation module, and transmitting the second electric stimulation signal to the second electric stimulation module. The power supply module is used for supplying power to the first electric stimulation module, the second electric stimulation module, the interaction module and the electric stimulation signal generation module. The first electric stimulation module, the second electric stimulation module, the interaction module and the power supply module are respectively and electrically connected with the electric stimulation signal generation module. Based on the wake-promoting instrument provided by the application, the median nerve and the vagus nerve of the patient can be stimulated simultaneously when the instrument is used for treating the patient, so that the beneficial effects of the median nerve stimulation and the vagus nerve stimulation are combined to comprehensively influence the patient, the stimulation intensity of a specific brain region of the patient is improved, and the electric stimulation signals can be transmitted to a plurality of brain regions of the patient.
Based on the embodiment of the wake-up instrument provided in fig. 1 described above, the interactive module may optionally include an interactive panel including operating buttons, output indicator lights, and a waveform display screen. The operation button is used for controlling parameters of currents output by the first electric stimulation module and the second electric stimulation module, and specifically can respectively control parameters such as waveforms, frequencies, on-off ratios, duration and the like of the first electric stimulation signal and the second electric stimulation signal, and phase differences between the first electric stimulation signal and the second electric stimulation signal. The output indicator lamp is used for prompting whether the current wake-up instrument is in a working state or not, and the waveform display screen is used for displaying waveforms of the first electric stimulation signal and the second electric stimulation signal.
Based on the embodiment of the wake-up instrument provided in fig. 1, the interaction module may optionally include: a communication module, the communication module comprising: any one or more of a Bluetooth module, a WiFi module or a zigbee module. The communication module is used for being connected with a mobile control device in a wired or wireless mode, and the mobile control device is used for carrying out data interaction with the waking-promoting instrument and controlling the waking-promoting instrument. Specifically, the wake-up instrument control system established based on the communication module may refer to fig. 2, including: the wake-up promoting instrument 201, the mobile control device 202, the cloud server 203 and the personal computer (PC, personal Computer) 204, wherein a data connection is established between the wake-up promoting instrument 201 and the mobile control device 202 through a communication module so as to perform data interaction, and a connection is established between the mobile control device 202, the cloud server 203 and the personal computer 204 through a wired or wireless network so as to perform data interaction, and the specific form can be determined according to practical situations and is not limited herein.
The mobile control device can have a parameter setting function, a phase setting function, a channel parameter inquiring function and a device electric quantity monitoring function, so that an operator can conveniently operate the wake-up promoting instrument through the mobile control end. The mobile control device may connect to the cloud server and record and synchronize patient data, such as synchronized stimulation records and case records. In other embodiments, the system can also query cloud data through a PC end to check, change and other operations on the usage record and the case record of the waking device.
Based on the embodiment of the wake-up meter provided in fig. 1, the electrical stimulation signal generating module may further comprise: a microprocessor and RLC switching circuit; the microprocessor is used for analyzing the control instruction and controlling the RLC conversion circuit; the RLC conversion circuit is used for converting voltage input provided by the power supply module into current output; the microprocessor is further configured to generate the first electrical stimulation signal and the second electrical stimulation signal as a function of the current output. Based on the structure, the first electric stimulation signal and the second electric stimulation signal output by the waking-promoting instrument are current signals, and compared with voltage signals, the current signals reduce deviation caused by human body impedance, and are high in reliability and good in safety.
Further, the microprocessor may be further configured to adjust parameters of the first electrical stimulation signal and the second electrical stimulation signal, where the parameters include: waveform, frequency, pulse width, on-off ratio. Wherein for a first electrical stimulation signal for stimulating the median nerve, the adjustable parameter categories include: waveform, frequency, pulse width, on/off ratio, duration, and monophasic/biphasic mode, etc. Wherein the waveform comprises sine wave, triangular wave, sawtooth wave and square wave; the pulse width is a characteristic parameter of a square wave. Monophasic/biphasic mode refers to electrical stimulation of positive and negative polarity directionality. Frequency is an important parameter for achieving stimulation regulation. Upon application of electrical stimulation, brain tonic activity may be modulated around the frequency of the external stimulus. Studies have shown that the frequency of the gamma band is important for learning, memory and information processing capabilities. Whereas 40Hz is considered to be the frequency most important for sensory and perceptual combinations. When using median nerve stimulation for coma promotion, the frequency is generally within the two gamma bands of 40Hz or 35 Hz. These two frequencies have been demonstrated in a number of studies to achieve the coma-promoting function. Nerve stimulation often uses a segmented stimulation mode, where stimulation output is stopped after a period of time, and stimulation is output after a period of time. The on/off ratio is two time parameters, and the on/off ratio is respectively used for indicating the output and the stop time length of the stimulation current in one period. In the case of median nerve stimulation, 20s on and 40s off are commonly used, i.e. 20s of current output and 40s of current output are not. There are also 20s on and 50s off. The duration is the time from the start to the stop of the stimulus, including the time the current is stopped. When the medicine is used for unconsciousness and wake-up, the duration is generally about 6 to 10 hours. When the two parameters are set, a certain current actual output time is ensured, and a better treatment effect can be achieved. For example, a 20s on/40s off mode duration of 6 hours, the current actually output for 2 hours; the 20s on/60s off mode lasts the same 6 hours, and the current is actually output for 1.5 hours. When the stimulus waveform is a square wave, the pulse width of the square wave needs to be set. The parameter frequently used for waking up is 300us, which has been proven to be effective in previous studies. It will be appreciated that the actual parameter settings of each category may be adjusted according to the actual condition of the patient, and are not limited herein. Monophasic/biphasic mode refers to monophasic and biphasic output current waveforms, the current of which is always positive, i.e. greater than 0, and current always flows from positive to negative. The current of the biphasic waveform is positive and negative, and polarity inversion occurs between the positive electrode and the negative electrode.
For the second electrical stimulation signal used to stimulate the vagus nerve, the vagus nerve stimulation output is typically a square wave, with adjustable parameters such as frequency, pulse width, on/off ratio, and monophasic/biphasic mode. The meaning of each parameter is similar to the description corresponding to the first electrical stimulation signal, and will not be repeated here. It will be appreciated that the actual parameter settings of each category may be adjusted according to the actual condition of the patient, and are not limited herein.
Further, the electrical stimulation signal generation module may further include: the phase modulation module is used for adjusting the first electric stimulation signal and the second electric stimulation signal according to the control instruction so as to generate a phase difference between the first electric stimulation signal and the second electric stimulation signal. The phase difference can be adjusted to any value of 0-180 degrees. The specific phase difference can be in-phase (0 °), quadrature (90 °) or anti-phase (180 °)
The phase is one of important information of human brain nerve oscillation, and the phase difference of external stimulus can generate different modulation effects on the nerve oscillation of brain areas, so as to improve the cognitive ability, pain feeling, emotion and other aspects. Externally applied electrical stimulation can affect the neural oscillation of the brain itself, and phase locking is one of them. That is, under the influence of external stimulus, the frequency of the cranial nerve oscillation is gradually adjusted to be close to the frequency value of the external stimulus, and at the same time, a constant phase is maintained. When the phases of the two signals remain at a constant phase difference, the two signals are coherent signals. The phase-adjustable coherent signal has several special phase differences of in-phase, quadrature and anti-phase. Phase coherence is a feature that measures the phase relationship of two signals. When two different electrical stimulations are used for controlling the brain nerves, a modulation effect is generated on the phase coherence of a target brain region. Modulation of phase coherence may improve brain function. For example, the gamma wave phase coherence of 40Hz between two hemispheres of the brain is modulated, so that the perception of fuzzy motion stimulation can be enhanced. The non-invasive ear vagus nerve stimulation and the non-invasive median nerve stimulation are applied to the comatose patient at the same time, and the most suitable phase difference between the two types of stimulation can be continuously adjusted and found according to the actual condition and feedback observation condition of the patient, so that the stimulation intensity of signals in a specific brain area is enhanced, the propagation depth of the stimulation is enhanced, and the patient is promoted to wake up.
Based on the embodiment of the wake-up meter provided in fig. 1 above, optionally, the first electrical stimulation module comprises: a first sub-electrode and a second sub-electrode; during use of the wake-up instrument, the first sub-electrode and the second sub-electrode may be disposed on a single side of a patient's body or on both sides of the patient's body; in particular. If bilateral median nerve stimulation is performed, the first sub-electrode and the second sub-electrode are respectively arranged at the median nerve points of the left and right forearm wrist joints of the patient; if the body of the patient is stimulated on one side, the right side of the body of the patient is generally selected to be stimulated, at this time, the first sub-electrode can be arranged at the median nerve point of the wrist joint of the right forearm, and the second sub-electrode can be arranged at the position 4-5cm away from the upper electrode on the right arm, so that a large enough electric field is formed to electrically stimulate the deep nerve of the patient.
Based on the embodiment of the wake-up instrument provided in fig. 1, the second electrical stimulation module may optionally include one or more sub-electrodes, where the one or more sub-electrodes may be disposed in a concha or tragus position of the patient, or may be disposed in both the concha and tragus positions of the patient. It is understood that the sub-electrodes included in the second electrical stimulation module may also be disposed at a location where other vagus nerves are distributed, such as a cervical vagus nerve or a concha cavity, so that the vagus nerve is stimulated more comprehensively and the vagus nerve is activated to a greater extent. The specific placement position of the sub-electrodes may be determined according to practical situations, and is not limited herein.
In order to facilitate understanding of the function and structure of the wake-up apparatus provided by the present application, the following provides a method for using the wake-up apparatus provided by the present application, so as to further describe the wake-up apparatus provided by the present application, and concretely referring to fig. 3, the method for using the wake-up apparatus provided by the present application includes:
301. Cleaning.
Specifically, the cleaning process includes wiping the skin of the patient where the electrode is to be applied with alcohol or a skin-specific scrub to remove skin oils and exfoliate the stratum corneum and enhance the skin conductivity.
302. A first electro-stimulation module is placed.
Specifically, the first electric stimulation module is placed at the median nerve of a patient, and if bilateral median nerve stimulation is performed, the electrodes are respectively placed at the median nerve points of the left and right forearm wrist joints; if the right median nerve stimulation is performed, one electrode is positioned at the median nerve point of the right forearm wrist joint, and the other electrode is positioned on the right arm at a distance of 4-5cm from the upper electrode, so that a large enough electric field is ensured to electrically stimulate the deep nerve. The placement position of the first electrical stimulation module may refer to the content included in the foregoing corresponding embodiment of fig. 1, and will not be described herein.
303. A second electro-stimulation module is placed.
Specifically, the second electrical stimulation module is placed on the concha boat portion of the patient to perform stimulation, or the concha boat and the tragus portion of the patient are selected to perform stimulation at the same time, and the placement position of the second electrical stimulation module may refer to the content included in the corresponding embodiment of fig. 1, which is not described herein.
304. And adjusting parameters of the wake-up promoting instrument.
Specifically, the adjusted parameters include:
(1) Parameters of the first electrical stimulation signal are adjusted. The adjustable parameters include waveform, frequency, pulse width, on/off ratio and duration. Wherein the waveform comprises sine wave, triangular wave, sawtooth wave and square wave; the pulse width is a characteristic parameter of a square wave. Single phase/biphasic mode. The specific parameter adjustment manner and rule may refer to the content included in the foregoing corresponding embodiment of fig. 1, which is not described herein.
(2) And adjusting parameters of the second electric stimulation signal, wherein the adjustable parameters include frequency, pulse width, on/off ratio and single-phase/double-phase mode. The specific parameter adjustment manner and rule may refer to the content included in the foregoing corresponding embodiment of fig. 1, which is not described herein.
(3) The magnitude of the current is determined. For median nerve stimulation and vagus nerve stimulation, the magnitude of the current needs to be determined according to the bearing degree of the patient. The current level is required to be less than the pain threshold of the patient (pain cannot be felt or the brain pain mechanism will be activated). For unconscious patients, the physical condition of the patient is generally monitored by matching with an electrocardiograph, a blood pressure and other instruments. The current increases slowly from 0mA upwards, and a larger value is determined under the condition that the indexes of the patient such as electrocardio, blood pressure and the like do not change obviously. Experiments and clinical experience show that under the condition of sufficient frosting, the current of the median nerve stimulation is generally 15-20 mA for adults and 10-15 mA for children; the current level of vagal nerve stimulation is typically between 0.5mA and 3 mA.
(4) The phase difference of the stimulus is adjusted. The phase difference can be adjusted to any value of 0-180 degrees, and can be adjusted to be in-phase (0 degree), quadrature (90 degrees) or anti-phase (180 degrees) according to actual needs
It should be understood that there is no logical relationship in time sequence between the steps 102 to 104, and the implementation sequence of each step may be adjusted according to the actual situation in the implementation process, and this section is only described in this order for illustration purposes, and is not limited to the actual situation.
305. And starting the wake-up promoting instrument.
After the current is determined, the stimulation mode is confirmed again, and the electrode connection is correct, and then the stimulation can be started to be applied. The stimulus application period is generally 4 to 8 hours. After the stimulation is finished, the electrode is removed.
In the several embodiments provided in the present application, it should be understood that the disclosed systems, devices, and methods may be implemented in other manners. For example, the apparatus embodiments described above are merely illustrative, e.g., equivalent transformations of circuitry, partitioning of elements is merely one logical functional partitioning, and there may be additional partitioning aspects in actual implementation, e.g., multiple elements or components may be combined or integrated into another system, or some features may be omitted, or not implemented. Alternatively, the coupling or direct coupling or communication connection shown or discussed with each other may be an indirect coupling or communication connection via some interfaces, devices or units, which may be in electrical, mechanical or other form.
The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.
In addition, each functional unit in the embodiments of the present application may be integrated in one processing unit, or each unit may exist alone physically, or two or more units may be integrated in one unit. The integrated units may be implemented in hardware or in software functional units.
The foregoing description of the preferred embodiments of the invention is not intended to be limiting, but rather is intended to cover all modifications, equivalents, or alternatives falling within the spirit and principles of the invention.
Claims (8)
1. An arousal instrument, comprising: the device comprises a first electric stimulation module, a second electric stimulation module, an interaction module, an electric stimulation signal generation module and a power supply module;
the first electric stimulation module is used for stimulating the median nerve according to the first electric stimulation signal;
The second electrical stimulation module is used for stimulating the vagus nerve according to a second electrical stimulation signal;
The interaction module is used for receiving a control instruction transmitted by a user and sending the control instruction to the electric stimulation generation module;
the electric stimulation signal generation module is used for generating the first electric stimulation signal and the second electric stimulation signal according to the control instruction, transmitting the first electric stimulation signal to the first electric stimulation module and transmitting the second electric stimulation signal to the second electric stimulation module;
The power supply module is used for supplying power to the first electric stimulation module, the second electric stimulation module, the interaction module and the electric stimulation signal generation module;
The first electric stimulation module, the second electric stimulation module, the interaction module and the power supply module are respectively and electrically connected with the electric stimulation signal generation module;
The electrical stimulation signal generation module further includes: a phase modulation module;
The phase modulation module is used for adjusting the first electric stimulation signal and the second electric stimulation signal according to the control instruction so as to generate a phase difference between the first electric stimulation signal and the second electric stimulation signal;
the phase difference includes: in-phase, quadrature or anti-phase;
the wake-promoting instrument is used for simultaneously stimulating the median nerve and the vagus nerve.
2. The wake-up instrument of claim 1, wherein the interactive module comprises an interactive panel comprising operating buttons, output indicator lights, and a waveform display screen.
3. The wake-up instrument of claim 1, wherein the interaction module comprises: a communication module, the communication module comprising: any one or more of a Bluetooth module, a WiFi module or a zigbee module.
4. The wake-up instrument of claim 1, wherein the electrical stimulation signal generation module comprises: a microprocessor and RLC switching circuit;
the microprocessor is used for analyzing the control instruction and controlling the RLC conversion circuit;
The RLC conversion circuit is used for converting voltage input provided by the power supply module into current output;
the microprocessor is further configured to generate the first electrical stimulation signal and the second electrical stimulation signal as a function of the current output.
5. The wake-up instrument of claim 4, wherein the microprocessor is further configured to adjust parameters of the first electrical stimulation signal and the second electrical stimulation signal, the parameters comprising: waveform, frequency, pulse width, on-off ratio.
6. The wake-up instrument of claim 1, wherein the first electrical stimulation module comprises: a first sub-electrode and a second sub-electrode;
The first sub-electrode and the second sub-electrode may be disposed on a single side of the patient's body or on both sides of the patient's body during use of the wake-up instrument.
7. The wake-up instrument of claim 1, wherein the second electrical stimulation module is disposed at a concha and/or tragus position of the patient during use of the instrument.
8. The wake-up instrument of claim 3, wherein the communication module is configured to wirelessly connect to a mobile control device;
The mobile control device is used for carrying out data interaction with the wake-up instrument and controlling the wake-up instrument.
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