CN113730809B - Non-invasive vagus nerve combined sacral nerve stimulation device - Google Patents
Non-invasive vagus nerve combined sacral nerve stimulation device Download PDFInfo
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
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- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/3603—Control systems
- A61N1/36034—Control systems specified by the stimulation parameters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
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Abstract
The invention discloses a non-invasive vagus nerve combined sacral nerve stimulation device in the technical field of medical equipment, which comprises an internal controller, wherein the internal controller is connected with a vagus nerve stimulation link used for generating vagus nerve stimulation signals and a sacral nerve stimulation link used for generating sacral nerve stimulation signals, the vagus nerve stimulation link and the sacral nerve stimulation link are combined, and the non-invasive combined nerve stimulation used for realizing vagus nerve stimulation and sacral nerve stimulation is realized. The invention adopts a non-invasive nerve stimulation mode, is more acceptable for patients, has higher clinical treatment compliance, can select a vagus nerve stimulation mode singly, a sacral nerve stimulation module singly or a vagus nerve and sacral nerve stimulation mode jointly according to specific needs, has better treatment effect on functional gastrointestinal diseases by jointly using the vagus nerve and the sacral nerve stimulation mode, is beneficial to improving the illness state of the patients and improves the life quality of the patients.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a non-invasive vagus nerve combined sacral nerve stimulation device.
Background
Functional gastroenteropathy is a functional gastroenteropathy which mainly shows chronic or recurrent digestive tract symptoms but does not have organic change, and clinical manifestations mainly include related symptoms of gastrointestinal tract (including pharynx, esophagus, stomach, biliary tract, small intestine, large intestine and anus), and other functional symptoms such as insomnia, anxiety, depression and the like are often accompanied. Functional gastroenteropathy includes functional dyspepsia, irritable bowel syndrome, chronic primary constipation, and other various disease types. In recent years, researchers have found that an imbalance between the autonomic nervous system, i.e., the sympathetic and parasympathetic nervous systems, distributed in the gastrointestinal tract may cause dysfunction of the gastrointestinal tract in studies on the pathogenesis of functional gastrointestinal diseases, and thus participate in the pathogenesis of gastrointestinal diseases such as irritable bowel syndrome.
The vagus nerve, the longest nerve in the human body, is the principal component of parasympathetic nerves and can connect the central nervous system to the body by innervating the internal organs of the gastrointestinal tract. Recent studies have found that vagal nerve stimulation can affect the inflammatory state of the body through its afferent and efferent nerves. In one aspect, vagal nerve stimulation may reduce inflammatory responses of the gastrointestinal tract through the thalamus-pituitary-adrenal axis and cholinergic anti-inflammatory pathways; on the other hand, the vagus nerve stimulation can improve the depression of the functional gastroenteropathy patient and the inflammation caused by other mood factors, thereby having better treatment effect on the functional gastroenteropathy. For example, chinese patent CN101687095A "autonomic nerve stimulation for treating gastrointestinal disorders" employs an implantable method of coupling at least one electrode to at least one portion of the vagus nerve of a gastrointestinal patient, applying electrical signal stimulation to at least one portion of the vagus nerve via the electrode to treat gastrointestinal disorders, and specifically uses an electrical stimulation therapy provided by an Implantable Medical Device (IMD).
Because the existing nerve stimulating electrode for treating gastroenteropathy is invasive, the invasive nerve stimulating therapy mode is more unacceptable for patients, and the therapy is greatly limited.
The sacral nerve is the nerve of the sacrum, which is located below the nerve of the lumbar vertebra, on both sides of the sacrum. The digestive system is innervated by the central nervous system through the vagus nerve, thoracolumbar pathways, and sacral nerves, which in turn innervate the enteric nervous system and the final effector system to affect the modulation of various functions of the digestive system. The sacral nerve stimulation uses the sacral nerve as a target point, and utilizes the electrode to emit current stimulation, thereby exerting the effect of improving important diseases of the sacral nerve and achieving the effect of improving intestinal functions. The research shows that the sacral nerve stimulation can effectively strengthen gastrointestinal motility and relieve local symptoms of constipation, and has an effect on treating symptoms such as constipation when a functional gastrointestinal patient is ill.
However, the present nerve stimulation treatment of gastrointestinal diseases is single signal stimulation, and how to combine vagal nerve stimulation and sacral nerve stimulation to realize comprehensive nerve stimulation, and performing single nerve stimulation when needed is a problem faced in the industry.
Disclosure of Invention
In order to overcome the deficiencies of the prior art, the present invention provides a non-invasive vagal nerve united sacral nerve stimulation device.
The technical scheme of the invention is as follows:
A non-invasive vagal nerve united sacral nerve stimulation device comprising an internal controller, wherein the internal controller is connected to a vagal nerve stimulation link for generating vagal nerve stimulation signals, a sacral nerve stimulation link for generating sacral nerve stimulation signals, the vagal nerve stimulation link and the sacral nerve stimulation link being united for effecting non-invasive united neural stimulation of vagal nerve stimulation and sacral nerve stimulation.
The invention according to the above-mentioned solution is characterized in that the internal controller is connected to a stimulus current signal generator,
The stimulation current signal generator comprises a first stimulation current signal generator, a second stimulation current signal generator and a third stimulation current signal generator, wherein the first stimulation current signal generator is used for generating a vagus nerve stimulation signal, and the second stimulation current signal generator and the third stimulation current signal generator are used for generating a sacral nerve stimulation signal.
Further, the first stimulation current signal generator is connected with the vagus nerve stimulation electrode through a first relay, and the second stimulation current signal generator and the third stimulation current signal generator are both connected with the corresponding sacral nerve stimulation electrode through a second relay.
Still further, the sacral nerve stimulating electrode comprises a first sacral nerve stimulating electrode and a second sacral nerve stimulating electrode, the first sacral nerve stimulating electrode is connected with the second stimulating current signal generator through the second relay, and the second sacral nerve stimulating electrode is connected with the third stimulating current signal generator through the second relay.
Further, the vagus nerve stimulating electrode and the sacral nerve stimulating electrode are detachable electrodes, the detachable electrodes comprise electrode heads and leads, and the electrode heads are connected with electrode channel holes on the noninvasive vagus nerve combined sacral nerve stimulating device through the leads.
The invention according to the above scheme is characterized in that the vagal nerve stimulation signal is a continuous pulse cluster with constant interval, which comprises alternating pulse signal areas and signal off areas.
Further, the time length of the pulse signal area is smaller than the time length of the signal closing area.
Further, the pulse signal duty ratio of the continuous pulse cluster is 25% -50%.
The invention according to the above-described aspect is characterized in that the sacral nerve stimulation signal is a bi-directional rectangular pulse.
Further, in the process of obtaining the perception threshold of the vagal nerve stimulation signal or the perception threshold of the sacral nerve stimulation signal:
(1) Firstly, setting the current intensity of the stimulation current of the vagus nerve stimulation signal or the sacral nerve stimulation signal as an initial value, and giving stimulation of a reference time;
(2) Obtaining subjective tingling or itching of a patient, reducing the current intensity by 50% for repeated stimulation if the subjective tingling or itching is felt, and increasing the current intensity by 50% and for repeated stimulation if the subjective tingling or itching is felt;
(3) Repeating step (2) until at least 4 results with stinging or itching sensation are obtained, and the 4 results with stinging or itching sensation are positioned after the results without stinging or itching sensation;
(4) The current intensity at this time is recorded as the perception threshold of the vagal nerve stimulation signal or the perception threshold of the sacral nerve stimulation signal.
The invention according to the scheme has the beneficial effects that:
The invention adopts a non-invasive nerve stimulation mode, is more acceptable to patients, has higher clinical treatment compliance and provides greater convenience for clinical treatment.
The invention can select a vagus nerve stimulation mode, a sacral nerve stimulation module or a vagus nerve and sacral nerve stimulation mode according to specific requirements, has stronger controllability for users and meets the treatment requirements of patients with different diseases and different disease stages of the same patient; and the combined use of the vagus nerve and the sacral nerve stimulation mode has better treatment effect on the functional gastrointestinal diseases, is beneficial to improving the illness state of patients and improves the life quality of the patients.
Drawings
FIG. 1 is a system block diagram of the present invention;
FIG. 2 is a flow chart of an implementation of the present invention;
FIG. 3 is a schematic representation of a vagal nerve stimulation site according to the present invention;
FIG. 4 is a schematic of a vagal nerve stimulation signal;
Fig. 5 is a schematic view of a sacral nerve stimulation site;
fig. 6 is a schematic diagram of a sacral nerve stimulation signal.
Detailed Description
The invention is further described below with reference to the drawings and embodiments:
As shown in fig. 1, a non-invasive vagal nerve combined sacral nerve stimulation device includes an internal controller and a nerve stimulation link coupled to the internal controller, the nerve stimulation link including a vagal nerve stimulation link for generating vagal nerve stimulation signals, a sacral nerve stimulation link for generating sacral nerve stimulation signals, the vagal nerve stimulation link and the sacral nerve stimulation link being combined for effecting non-invasive combined nerve stimulation of vagal nerve stimulation and sacral nerve stimulation. The sacral nerve stimulation link is used for generating sacral nerve stimulation, and the sacral nerve stimulation plays a similar anti-inflammatory role as a vagal nerve stimulation system in inhibiting corresponding pro-inflammatory cytokines and increasing anti-inflammatory cytokines, and the effect of single nerve stimulation is enhanced through the nerve regulation combined stimulation with similar target effect.
The internal controller is connected with the stimulation current signal generator, wherein the internal controller is used for controlling the operation of the whole non-invasive vagus nerve combined sacral nerve stimulation device, and can also receive the control signal of the external control end to realize the regulation and control of the corresponding function.
The non-invasive vagus nerve combined sacral nerve stimulation device further comprises a power supply, wherein the power supply is respectively connected with the internal controller and the stimulation current signal generator and supplies power for the internal controller and the stimulation current signal generator. The internal controller and the stimulation current signal generator are separately powered by a power source, and the power source is charged through an external charging socket.
The external control end is connected with the internal controller and is used for receiving the control signal of the external control end, wherein the external control end is intelligent mobile equipment, such as a tablet or a mobile phone. Specifically, the external control end is in wireless connection with the internal controller (such as Bluetooth, etc.), and the external control end sends signals of a set stimulation mode, a set stimulation parameter (such as stimulation frequency, waveform, duration, etc.) and the like to the internal controller in a wireless transmission mode, and the internal controller realizes the regulation and control of corresponding functions.
In the invention, the stimulation current signal generator comprises a first stimulation current signal generator, a second stimulation current signal generator and a third stimulation current signal generator, wherein the first stimulation current signal generator is used for generating a vagus nerve stimulation signal so as to realize the vagus nerve stimulation function; the second and third stimulation current signal generators are configured to generate a sacral nerve stimulation signal for performing a sacral nerve stimulation function.
In order to realize the control of the corresponding nerve stimulation function, the first stimulation current signal generator is connected with the vagus nerve stimulation electrode through the first relay, and the second stimulation current signal generator and the third stimulation current signal generator are both connected with the corresponding sacral nerve stimulation electrode through the second relay. The internal controller analyzes after receiving the control instruction of the external control end, precisely controls the first stimulation current signal generator, the second stimulation current signal generator and the third stimulation current signal generator to generate corresponding stimulation currents, and simultaneously controls the first relay and the second relay to act to realize the opening and closing of different stimulation branches.
Such as: when the first relay is opened (on, the same as the next one) and the second relay is closed (off, the same as the next one), the non-invasive vagus nerve combined sacral nerve stimulation device only outputs vagus nerve stimulation signals, and a vagus nerve stimulation mode is realized; when the first relay is closed and the second relay is opened, the non-invasive vagus nerve combined sacral nerve stimulation device only outputs a sacral nerve stimulation signal, so that a sacral nerve stimulation mode is realized; when the first relay and the second relay are simultaneously opened, the vagus nerve stimulation signal and the sacral nerve stimulation signal are simultaneously output, and a vagus nerve combined sacral nerve stimulation mode is realized.
The sacral nerve stimulating electrode comprises a first sacral nerve stimulating electrode and a second sacral nerve stimulating electrode, the first sacral nerve stimulating electrode is connected with the second stimulating current signal generator through the second relay, and the second sacral nerve stimulating electrode is connected with the third stimulating current signal generator through the second relay. The vagus nerve stimulating electrode and the sacral nerve stimulating electrode are detachable electrodes, the detachable electrodes comprise electrode heads and leads, and the electrode heads are connected with electrode channel holes on the noninvasive vagus nerve combined sacral nerve stimulating device through the leads. When the electrode head or the lead wire needs to be replaced, the electrode head or the lead wire can be directly replaced, and the product cost is fully saved.
The invention realizes different stimulation modes, namely a non-invasive vagus nerve stimulation mode, a non-invasive sacral nerve stimulation mode and a non-invasive vagus nerve combined sacral nerve stimulation mode by the operation of different stimulation current signal generators and the action of corresponding relays. When the stimulation mode is vagal nerve combined sacral nerve stimulation, corresponding parameters such as stimulation frequency, stimulation time and stimulation waveform of vagal nerve and sacral nerve stimulation are set, and the corresponding vagal nerve and sacral nerve stimulation positions are placed, the treatment effect on functional gastrointestinal diseases can be achieved, at the moment, the sacral nerve stimulation plays a similar anti-inflammatory effect as a vagal nerve stimulation system in terms of inhibiting corresponding pro-inflammatory cytokines and increasing anti-inflammatory cytokines, and the effect of single nerve stimulation is enhanced through nerve regulation combined stimulation with similar target effect. Of course, the present invention is not limited thereto. The treatment requirements of patients with different diseases and different disease stages of the same patient can be met through the adjustment of the stimulation mode and the stimulation mode parameters.
1. Vagus nerve stimulation signal
As shown in fig. 4, the vagal nerve stimulation signal is a continuous pulse cluster with constant intervals, which includes alternating pulse signal regions (on time in the figure) and signal off regions (off time in the figure).
The time length of the pulse signal area is smaller than that of the signal closing area, specifically, the time length of the pulse signal area is 30-60s, and the time length of the signal closing area is 60-120s. The duty ratio of the pulse signal of the continuous pulse cluster is 25% -50%, the pulse width of the continuous pulse cluster is 250-500 mu s, and the pulse frequency is 25HZ.
In the process of acquiring the perception threshold value of the vagus nerve stimulation signal, the invention comprises the following steps:
(1) Firstly, setting the current intensity of the stimulation current of the vagus nerve stimulation signal or the sacral nerve stimulation signal as an initial value, and giving percutaneous ear vagus nerve stimulation (transcutaneous auricular vagus nerve stimulation, taVNS) with a reference time;
(2) Obtaining subjective tingling or itching of a patient, reducing the current intensity by 50% for repeated stimulation if the subjective tingling or itching is felt, and increasing the current intensity by 50% and for repeated stimulation if the subjective tingling or itching is felt;
(3) Repeating step (2) until at least 4 results with stinging or itching sensation are obtained, and the 4 results with stinging or itching sensation are positioned after the results without stinging or itching sensation;
(4) The current intensity at this time is recorded as the perception threshold of the vagal nerve stimulation signal.
The current intensity of the minimum perception threshold of the vagal nerve stimulation signal obtained according to the above steps is <5mA.
2. Sacral nerve stimulation signals
As shown in fig. 6, the sacral nerve stimulation signal is a bi-directional rectangular pulse comprising periodically alternating pulse wave sets, each pulse wave set comprising a cathodic pulse wave and an anodic pulse wave. The pulse width of the cathode pulse wave and the anode pulse wave is 100 mu s, and the pulse frequency of the pulse wave group is 10-120HZ.
Since the action potential is generated after depolarization of the cathode phase, and the anode phase immediately following it hinders the generation of the action potential, in order to avoid such an anode blocking effect, a phase interval of 600 mus is provided between each anode pulse wave and its preceding cathode pulse wave.
In the process of acquiring the perception threshold value of the sacral nerve stimulation signal, the invention comprises the following steps:
(1) Firstly, setting the current intensity of the stimulation current of the vagus nerve stimulation signal or the sacral nerve stimulation signal as an initial value, and giving stimulation of a reference time;
(2) Obtaining subjective tingling or itching of a patient, reducing the current intensity by 50% for repeated stimulation if the subjective tingling or itching is felt, and increasing the current intensity by 50% and for repeated stimulation if the subjective tingling or itching is felt;
(3) Repeating step (2) until at least 4 results with stinging or itching sensation are obtained, and the 4 results with stinging or itching sensation are positioned after the results without stinging or itching sensation;
(4) The current intensity at this time is recorded as the perception threshold of the sacral nerve stimulation signal.
The minimum perceived threshold current intensity of the sacral nerve stimulation signal obtained according to the above steps is <30mA.
As shown in fig. 2, 3 and 5, the method specifically comprises the steps of placing a stimulation electrode, connecting stimulation equipment, measuring a stimulation sensing threshold, setting stimulation parameters, starting stimulation, ending stimulation and the like in the process of performing non-invasive vagus nerve combined sacral nerve stimulation on a human body.
1. For vagus nerve
(1) Placing stimulation electrodes
The vagus nerve stimulation (taVNS) electrode placement part (the front wall of the left external auditory canal, namely the tragus) is rubbed by alcohol, scrub cream and alcohol in sequence so as to reduce the resistance of the stimulation part and make the stimulation part fully contacted with the stimulation electrode.
As shown in fig. 3, after the skin cleaning of the tragus is completed, the positive electrode of the vagus nerve stimulation is fixed outside the tragus, the negative electrode is arranged inside the tragus, the vagus nerve stimulation electrode is connected to the stimulation device, and the stimulation mode of the stimulation device is the vagus nerve combined sacral nerve stimulation mode through the external control end.
(2) Connection stimulation device
The external control end is connected with the internal controller and the corresponding stimulation electrode.
(3) Measuring stimulus perception threshold
The vagal nerve stimulation perception threshold is measured in the manner described above, and in one embodiment, the steps are as follows:
1) Setting the vagal nerve stimulation current to 3mA, giving taVNS stimulations (pulse width and frequency preset) for 1 s;
2) Inquiring whether the patient has stinging or itching feeling, if so, repeating the step 2 again with the current intensity reduced by 50%; if not, repeating the step 2 again with the current intensity increased by 50%;
3) The procedure described in step 2 is repeated until at least 4 answers "YES" are recorded, wherein the answer of "YES" 4 th must be after "NO". The intensity of the perceived threshold is the current intensity of the fourth "YES" answer.
Recording table for measuring perception threshold
| Intensity of current | 3mA | 1.5mA | 0.75mA | 1.1mA | 0.55mA | 0.825mA |
| Answer | Yes | Yes | No | Yes | No | Yes |
(4) Setting stimulation parameters
After determining the vagal nerve stimulation sensing threshold, the control end of the external device is used for setting taVNS stimulation parameters.
In this example, the stimulation time was set to 30min and the vagal nerve stimulation was repeated once in 12-24 hours.
Setting a stimulation current value as a perception threshold value, and setting the on period of 30-60 s; an off phase with a stimulation current value of zero and a time of 60-120 s; the duty cycle of the output stimulation current is 25-50%. Wherein the pulse width of the "on" and "off" phases is 250-500 mus, the stimulation frequency is 25Hz, and the current intensity of the minimum perceived current threshold is <5mA.
1. For sacral nerve
(1) Placing stimulation electrodes
The sacral nerve stimulation site is cleaned in the same manner as the vagal nerve stimulation site is wiped to reduce the resistance of the stimulation site and to make the stimulation site more fully contacted with the stimulation electrode.
As shown in fig. 5, the sacral nerve stimulation comprises two channels, channel 1 (Channel 1) and Channel2 (Channel 2), respectively, each Channel having two electrodes and four electrodes in total. The electrode placement part is as follows:
The positive electrode of Channel 1 is arranged on the right side of the back spine of the human body and between the thoracic vertebra T9 and the lumbar vertebra L2; the negative electrode is arranged on the right side of the median line of the front umbilicus lower abdomen of the human body;
the positive electrode of Channel 2 is arranged on the left side of the back spine of the human body and between the thoracic vertebra T9 and the lumbar vertebra L2; the negative electrode is arranged on the left side of the median line of the front umbilicus lower abdomen of the human body.
(2) Connection stimulation device
After the cleaning of the sacral nerve stimulation part is completed, the sacral nerve stimulation electrode is connected with the stimulation device, and the external control end is connected with the internal controller.
(3) Measuring stimulus perception threshold
The vagal nerve stimulation perception threshold is measured in the manner described above, and in one particular embodiment, the output current is set to 30mA, and 30s of sacral nerve stimulation (pulse width and frequency preset) is administered; the remaining steps are the same as taVNS stimulus-perception threshold determination and are not described in detail herein.
(4) Setting stimulation parameters
After the sacral nerve stimulation sensing threshold is determined, setting the sacral nerve stimulation parameters through an external control terminal.
In this embodiment, specific sacral nerve stimulation parameters may be set as: the stimulation time was 60min, and the stimulation was repeated once in 24 hours.
The positive pulse width and the negative pulse width are 100 mu s; setting the delay time between two phase pulses, namely the phase interval to be 600 mu s; the stimulation frequency is set to 10-120Hz, and the stimulation current intensity is required to be less than 30mA, so that the patient feels but does not cause muscle contraction.
After the vagus nerve stimulation and the sacral nerve stimulation parameters are determined, the stimulation electrodes are connected, a stimulation instruction is wirelessly transmitted to the stimulation device through the external control end, and stimulation is applied to the patient until the stimulation is finished.
The invention can realize the combined application of the vagal nerve stimulation and the sacral nerve stimulation, and realize three freely selected stimulation modes of the vagal nerve stimulation, the sacral nerve stimulation and the vagal nerve combined sacral nerve stimulation, and can meet the treatment requirements of patients with different diseases and different disease stages of the same patient through the adjustment of the stimulation modes and the parameters of the stimulation modes; meanwhile, the vagus nerve combined sacral nerve stimulation treatment system can play a better role in treating the functional gastroenteropathy patient, improve the illness state of the patient and improve the life quality of the patient.
In addition, the invention can realize non-invasive nerve regulation in time, is more acceptable for patients, has higher compliance in clinical treatment and provides greater convenience for clinical treatment.
It will be understood that modifications and variations will be apparent to those skilled in the art from the foregoing description, and it is intended that all such modifications and variations be included within the scope of the following claims.
While the invention has been described above with reference to the accompanying drawings, it will be apparent that the implementation of the invention is not limited by the above manner, and it is within the scope of the invention to apply the inventive concept and technical solution to other situations as long as various improvements made by the inventive concept and technical solution are adopted, or without any improvement.
Claims (5)
1. A non-invasive vagal nerve united sacral nerve stimulation device comprising an internal controller, wherein the internal controller is connected to a vagal nerve stimulation link for generating vagal nerve stimulation signals, a sacral nerve stimulation link for generating sacral nerve stimulation signals, the vagal nerve stimulation link and the sacral nerve stimulation link being united for effecting a non-invasive united neural stimulation of vagal nerve stimulation and sacral nerve stimulation;
The internal controller is connected with a stimulation current signal generator, the stimulation current signal generator comprises a first stimulation current signal generator, a second stimulation current signal generator and a third stimulation current signal generator, the first stimulation current signal generator is used for generating a vagus nerve stimulation signal, and the second stimulation current signal generator and the third stimulation current signal generator are used for generating a sacral nerve stimulation signal;
The first stimulation current signal generator is connected with the vagus nerve stimulation electrode through a first relay, and the second stimulation current signal generator and the third stimulation current signal generator are connected with the corresponding sacral nerve stimulation electrode through a second relay;
The sacral nerve stimulation electrode comprises a first sacral nerve stimulation electrode and a second sacral nerve stimulation electrode, the first sacral nerve stimulation electrode is connected with the second stimulation current signal generator through the second relay, and the second sacral nerve stimulation electrode is connected with the third stimulation current signal generator through the second relay;
In the process of acquiring the perception threshold of the vagal nerve stimulation signal or the perception threshold of the sacral nerve stimulation signal:
(1) Firstly, setting the current intensity of the stimulation current of the vagus nerve stimulation signal or the sacral nerve stimulation signal as an initial value, and giving stimulation of a reference time;
(2) Obtaining subjective tingling or itching of a patient, reducing the current intensity by 50% for repeated stimulation if the subjective tingling or itching is felt, and increasing the current intensity by 50% and for repeated stimulation if the subjective tingling or itching is felt;
(3) Repeating step (2) until at least 4 results with thorn pain or itching sensation are obtained, and the 4 th results with thorn pain or itching sensation are positioned after the results without thorn pain or itching sensation;
(4) Recording that the current intensity at the moment is a perception threshold of the vagal nerve stimulation signal or a perception threshold of the sacral nerve stimulation signal;
the vagus nerve stimulation signal is a continuous pulse cluster with constant interval, and comprises alternating pulse signal areas and signal closing areas; setting a stimulation current value at a pulse signal area stage as a perception threshold; the stimulus current value at the signal off-zone stage is set to zero.
2. The non-invasive vagal nerve associated sacral nerve stimulation device of claim 1 wherein the vagal nerve stimulation electrode and the sacral nerve stimulation electrode are detachable electrodes comprising an electrode head and a lead, the electrode head being connected to an electrode access hole on the non-invasive vagal nerve associated sacral nerve stimulation device by the lead.
3. The non-invasive vagal nerve united sacral nerve stimulation device of claim 1 wherein the length of time of the pulsed signal zone is less than the length of time of the signal-off zone.
4. The non-invasive vagal nerve united sacral nerve stimulation device of claim 1 wherein the pulse signal duty cycle of the continuous pulse train is 25% -50%.
5. The non-invasive vagal nerve complex sacral nerve stimulation device of claim 1 wherein the sacral nerve stimulation signal is a bi-directional rectangular pulse.
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| US20020055688A1 (en) * | 2000-05-18 | 2002-05-09 | Jefferson Jacob Katims | Nervous tissue stimulation device and method |
| US10441780B2 (en) * | 2005-11-10 | 2019-10-15 | Electrocore, Inc. | Systems and methods for vagal nerve stimulation |
| US9403001B2 (en) * | 2009-03-20 | 2016-08-02 | ElectroCore, LLC | Non-invasive magnetic or electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders |
| US11511109B2 (en) * | 2011-03-10 | 2022-11-29 | Electrocore, Inc. | Non-invasive magnetic or electrical nerve stimulation to treat gastroparesis, functional dyspepsia, and other functional gastrointestinal disorders |
| WO2014110071A2 (en) * | 2013-01-08 | 2014-07-17 | ElectroCore, LLC | Non-invasive vagus nerve stimulation devices and methods to treat or avert atrial fibrillation |
| EP3145584B1 (en) * | 2014-05-23 | 2022-02-16 | electroCore, Inc. | Systems for vagal nerve stimulation |
| WO2016197039A1 (en) * | 2015-06-05 | 2016-12-08 | The Johns Hopkins University | Method and device for sacral nerve stimulation |
| CA3030029A1 (en) * | 2016-07-08 | 2018-01-11 | Cala Health, Inc. | Systems and methods for stimulating n nerves with exactly n electrodes and improved dry electrodes |
| CN107789733B (en) * | 2017-11-23 | 2020-06-19 | 清华大学 | Electric pulse stimulation system, control method and control method of electric pulse stimulation signal |
| MX2020005470A (en) * | 2017-11-27 | 2020-11-09 | Coda Biotherapeutics Inc | Compositions and methods for neurological diseases. |
| JP2021521985A (en) * | 2018-04-27 | 2021-08-30 | サルーダ・メディカル・ピーティーワイ・リミテッド | Nerve stimulation of mixed nerves |
| BR112020023522A2 (en) * | 2018-05-18 | 2021-02-09 | Musc Foundation For Research Development | method of improving oromotor skills, cranial nerve stimulation system and method of improving muscle rehabilitation |
| CA3095342A1 (en) * | 2018-07-03 | 2020-01-09 | Boston Scientific Neuromodulation Corporation | Spinal cord stimulation system modelling relationships between stimulation parameters for automatic customization of sub-perception therapy |
| EP3893988A4 (en) * | 2018-12-13 | 2022-09-07 | Livanova USA, Inc. | Neuromodulation therapy for auto-immune and inflammatory disorders |
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