EP4294500A1

EP4294500A1 - Stimulation methods for an electromagnetically or electrically controlled spontaneous respiration

Info

Publication number: EP4294500A1
Application number: EP22708867.1A
Authority: EP
Inventors: Konstantinos Raymondos
Original assignee: Stimit AG
Current assignee: Stimit AG
Priority date: 2021-02-17
Filing date: 2022-02-16
Publication date: 2023-12-27
Also published as: US20240123226A1; WO2022175317A1; CA3208404A1

Abstract

The invention relates to an electrostimulation device for stimulating one or more nerves and/or muscles of a living being with electrical signals, said device having the following features: a) the electrostimulation device has at least one signal-emitting unit, by means of which electrical stimulation signals can be fed into at least one nerve and/or one muscle; b) the electrostimulation device has at least one control unit, which is designed to actuate the at least one signal-emitting unit in such a way that muscle contractions can be generated in the living being by the stimulation signals emitted by the at least one signal-emitting unit, and respiration by the living being can be influenced in a targeted manner by means of said muscle contractions.

Description

Stimulation methods for electromagnetically or electrically controlled self-respiration

Basics of ventilation

Breathing takes place to maintain gas exchange, i.e. for a life-sustaining border oxygen supply with simultaneous exhalation of carbon dioxide.

Depending on the type and severity of the disease, ventilation therapy is carried out with supportive to fully mechanical inhalation and prevention of exhalation. When the respiratory pump is exhausted, the respiratory muscles are relieved during inhalation or, in the event of gas exchange disorders, the further loss of gas exchange surface is counteracted by preventing exhalation. As the severity of the lung damage increases, not only does the pressure to prevent exhalation increase, but also the percentage of oxygen during inhalation.

If exhalation is not prevented sufficiently and in good time during the course of the disease, very pronounced gas exchange disorders develop as part of pronounced lung damage or ARDS (“A-cute Respiratory Distress Syndrome”).

The then required, significantly increased work of breathing can ultimately no longer be compensated for by the respiratory muscles. With increasing exhaustion, respiratory insufficiency develops, breathing becomes faster and shallower. Now both the inhalation and the exhalation through the ventilation must be treated in combination.

Ventilation can be synchronized to support one's own spontaneous breathing or be controlled independently of one's own breathing. During controlled ventilation the breathing rate, the tidal volume or the ventilation pressure are checked and the breathing time ratio between inhalation and exhalation is also specified. In addition, there are forms of ventilation that allow self-breathing independently of the ventilation and numerous mixed forms. A special form of respiratory therapy is the so-called "high-flow oxygen therapy", in which a gas mixture is used at a high flow rate through a nasal cannula or mask.

Depending on how the airway is secured, one speaks of "invasive" or "non-invasive" ventilation. If the airway is secured via a trachea hose (tube) and ventilated via it, this is referred to as "invasive ventilation". Ventilation without a tube is referred to as "non-invasive ventilation" or "NIV". With negative pressure ventilation, NIV can be performed without airway access, while with positive pressure ventilation, airway access is always required. Here, NIV can be done with positive pressures via a respirator helmet or with a mask that encloses the entire face, mouth and nose, or just the nose.

Basics of airway management

The airway is secured with a tube if there is a lack of protective reflexes, for example in the case of anesthesia or coma. This is intended to protect the airways against aspiration, i.e. the entry of stomach contents into the trachea, which can also cause ARDS. Intubation is also performed when NIV is no longer tolerated by the patient or is unsuccessful. As soon as high ventilation pressures and high proportions of oxygen are required with increasing lung damage, NIV positive pressure testing becomes too unsafe and even very dangerous above a certain limit. Even the slipping of a mask, the removal of a helmet or a necessary NIV interruption for intubation with current techniques can then lead to insufficient gas exchange with a life-threatening lack of oxygen.

The so-called “supraglottic airways” or “SGA”, such as the larynx mask, which are used by the millions in anesthesia or emergencies, represent an intermediate stage in securing the airway. In this case, no tube is inserted through the glottis into the trachea, but the larynx from the outside enclosed and sealed in such a way that it can be ventilated. Gastric fluid can be guided past the larynx via an integrated tube. All airway management guidelines recommend the introduction of an SGA as soon as intubation is unsuccessful and positive pressure ventilation via the mask is also not possible. Compared to a tube in the trachea, however, the degree of airway protection with an SGA is lower and they reach their limits at high ventilation pressures and a high oxygen content. The airway can be obstructed by a partially or completely closing glottis, the larynx or a slipping SGA, which also poses a life-threatening risk to the patient, especially when there is a high oxygen requirement.

Fundamentals of Lung Injury

In the case of pronounced lung damage or ARDS, exhalation is particularly important, since the following pathological changes are present here: Gas exchange surface is lost due to collapsing lung areas, because increased permeability between blood capillaries and pulmonary alveoli and/or virus infection of the lung cells causes the surface-active cells there Substance "Surfactant" can no longer stabilize the alveoli during exhalation. However, collapsed, non-ventilated areas of the lung continue to be supplied with blood, less oxygen is absorbed and, despite the administration of oxygen, a life-threatening lack of oxygen develops. The people who first described ARDS recognized this in 1967 and they also recognized how they could use ventilation to counteract the collapse during expiration: since then, attempts have been made to prevent the collapse of damaged lung areas through positive ventilation pressure during expiration. This is referred to as “positive end-expiratory pressure” or PEEP. The higher the PEEP, the higher the level at which exhalation is prevented and maintained. Accordingly, the position of breathing is also shifted into inspiration, thereby increasing the expiratory reserve volume (ERV) and decreasing the inspiratory reserve volume (IRV) (Figures 3 to 5).

Current situation and problem

An increasing invasiveness of the treatment methods resulted in more therapy-related, undesirable effects and complications, so that currently Lungs, breathing and other organ systems are also significantly damaged by the therapy itself. In addition, the more modern therapeutic measures were also becoming more and more expensive, complicated and error-prone, which meant that more and more highly specialized professionals were needed. Mainly because of this, intensive care medicine is by far the most cost-intensive area in the healthcare system today, which in some countries has led to a reduction in intensive care capacities and a reduced availability of therapy places. It is obvious that the mortality risk of mechanically ventilated patients differs significantly between different countries.

Although Germany has by far the most intensive care beds per inhabitant in a European comparison, the quality of care differs significantly. Even in Germany, there are major differences in the survival of ventilated patients between clinics with different levels of care: In the case of pronounced lung damage (ARDS), the differences are increasing significantly and for more than 50 years at least half of ARDS patients outside of specialized centers have not survived ventilation. The mortality rate of ventilated patients without ARDS is 31% in non-university clinics, 50% higher than in university clinics. In the case of ventilated patients with ARDS, not only did the mortality double in the non-university hospitals, but also the mortality difference compared to the university hospitals. The independent risk of dying with ARDS even tripled (1).

One of the main problems is invasive positive pressure ventilation via the tracheal tube. Even the so-called “lung-protective ventilation” not only damages the already damaged lungs and respiratory muscles, but also other organ systems. It also sets in motion a whole chain reaction of life-threatening complications. Mainly because of the tube, up to half of the invasively ventilated patients also develop pneumonia, which not only further damages the lungs but also other organ systems. The tube in the trachea also activates pronounced protective reflexes, making analgosedation necessary for shielding and cushioning. This has numerous side effects and other serious complications. Overhangs often occur, which lengthen the ventilation period and thus cause ventilation-related complications more frequently. In addition, especially in combination with positive pressure ventilation, the sedation impairs the circulatory functions considerably, so that drugs that support the circulatory system have to be administered continuously. These so-called catecholamines reduce the blood flow to the organs and can accelerate the failure of several organ systems. Patients who require ventilation and who have severe lung damage are often treated in the prone position, which means that they need particularly deep sedation.

Ventilation can also take place without a tube. However, it can then be difficult to adapt this so-called non-invasive ventilation to the severity of the lung damage efficiently enough to avoid collapsing areas of the lungs and increasing respiratory insufficiency. The increased respiratory drive that then occurs with intensified and deepened breathing then also damages the lungs.

object of the invention

The invention is based on the object of specifying devices, methods and computer programs with which the aforementioned problems can be at least redu ed.

Description of the invention

We control our spontaneous breathing exclusively ourselves - voluntarily or subconsciously. In contrast to spontaneous breathing, however, self-breathing can be controlled by electromagnetic or electrical stimulation. The respiratory muscles can be controlled non-invasively and painlessly in such a way that adequate ventilation can be achieved via electromagnetic stimulation (2). The phrenic nerve (N. phrenicus) can also be directly stimulated via implanted electrodes. Non-invasive without implanted electrodes, however, electrical stimulation from outside via the skin is painful with current technology, in contrast to electromagnetic stimulation. New techniques for painless electrical stimulation are under development. So far, electromagnetic ventilation is the only method that can be used to control self-breathing non-invasively, painlessly and directly. This ventilation method developed by us is therefore the most natural form of non-invasive artificial respiration. In contrast to all forms of positive and negative pressure ventilation, electromagnetically controlled self-breathing is the only form of ventilation that uses natural pressure fluctuations in the chest and abdomen to ventilate the patient can be. With this new form of ventilation, existing conflicts between ventilation that protects the lungs and diaphragm can be resolved, since the lungs and diaphragm can be ventilated both effectively and gently with electromagnetic breathing. Individual control of self-breathing can prevent both too little and too much effort to breathe and the complications associated with it.

Electromagnetic or electrical ventilation can be carried out in the absence of, but also in the presence of, spontaneous breathing, and in this case can be carried out both independently and synchronized with spontaneous breathing. Using seven different electromagnetic or electrical stimulation patterns - divided into three groups - depending on the disease and respiratory disorder, the patient's own breathing can be changed, controlled and/or monitored.

In addition to electromagnetic or electrical stimulation of the phrenic nerve in the neck area, higher or more peripheral neuronal structures can also be stimulated. This allows targeted control of abdominal and chest breathing.

The object of the invention mentioned is achieved by an Elektrostimulationsvor device according to claim 1. The object is also achieved by a method for stimulating one or more nerves and / or muscles of a living being with electrically, electromagnetically and / or magnetically generated stimulation signals, which in at least be fed into a nerve and/or a muscle of the living being and thereby specifically generate muscle contractions in the living being, through which the breathing of the living being is specifically influenced. The object is also achieved by a computer program with program code means designed to carry out such a method when the computer program is executed on a computer. In particular, one, several or all of the following functions of the electrostimulation device and/or method steps are provided.

The strength of the stimulation signals emitted by the at least one signal output device can be changed in several steps and/or uniformly over the course of a breathing cycle of the living being. Further explanations are given below in the section on stimulation method 1. The stimulation signals can be determined in particular with the aim of minimizing the energy input into the tissue of the living being's lungs and diaphragm.

In order to at least partially prevent exhalation, the strength of the stimulation signals emitted by the at least one signal output device can be kept at an increased level during exhalation of the living being, at which the muscle contraction generated by the stimulation signals is greater than zero, but is at least as high as that up to 75% of the inspiratory reserve volume is still in the lungs at the end of expiration. Further explanations are given in the section on stimulation method 2 below.

The respiration of the living being can be controlled or regulated to a predetermined value, value range and/or temporal change in the respiratory depth by setting parameters of the stimulation signals emitted by the at least one signal emission device. Further explanations are given below in the section on stimulation method 3.

The breathing of the living being can be controlled or regulated to a breathing rate of more than 40 breathing cycles/minute by setting parameters of the stimulation signals emitted by the at least one signal output device. This allows secretion mobilization stimulation to be carried out.

Further explanations are given below in the section on stimulation method 4, secretion mobilization stimulation. With this function, in particular, more than 60 breathing cycles/minute can be controlled or regulated. For example, 200 to 300 breathing cycles/minute with a low amplitude of muscle stimulation are possible. By setting parameters of the stimulation signals emitted by the at least one signal output device, the living being's respiration can be controlled or regulated for a limited period of time to a breathing depth that is too low for a life-sustaining gas exchange of the living being. In this way, a breathing movement of the living being can also be carried out without sufficient breathing, ie the air volumes flowing into and out of the lungs are insufficient. This can, for example, stimulate secretion mobilization or train the respiratory muscles.

By setting the parameters of the stimulation signals emitted by the at least one signal output device, complete expiration can be prevented by increasing the expiration time (duration of the expiration phase) of the living being to 0.2 to 1.3 times the inhalation time (duration of the inspiration phase ) is shortened. In addition, the strength of the stimulation signals can be increased compared to normal breathing cycles in order to generate maximum volumetric flow during expiration. This can be used to force or accelerate exhalation or to stimulate a cough. Further explanations are given below in section Stimulation method 4, Cough stimulation. The duration of the inspiration phase used as a reference can be, for example, the duration of the inspiration phase of the same breathing cycle, or an average of the duration of several previous inspiration phases, or a typical value of the duration of the inspiration phase determined for the living being in question.

By setting parameters of the stimulation signals emitted by the at least one signal output device, the characteristics of the respiratory cycles can be controlled to predetermined target characteristics of the respiratory cycles. Further explanations are given below in the section on stimulation method 4.

By setting parameters of the stimulation signals emitted by the at least one signal output device depending on current measured values of characteristic data of the living being's breathing cycles, which are continuously determined, for example, by means of at least one sensor, the characteristic data can be regulated of the respiratory cycles to predetermined target characteristics of the respiratory cycles who performed the. Further explanations are given below in the section on stimulation method 4.

For both of the functions mentioned above, the target characteristic data can in particular be such characteristic data that avoid damage to the lungs. In particular, a self-damaging breathing pattern of the living being can be avoided in this way. The control device can also be set up to use the stimulation signals to limit the volume flow of respiration, the respiratory movements and/or the transpulmonary pressures to a predetermined maximum value.

Parameters of the stimulation signals emitted by the at least one signal output device can be changed as a function of current measured values of the living being's spontaneous breathing pulses, in particular synchronized with the spontaneous breathing pulses. In this way, the spontaneous breathing pulse of the living being can be blocked or changed. The measured values can be continuously determined by at least one spontaneous breathing impulse sensor, by which the spontaneous breathing impulses of the living being can be detected. Further explanations are given below in the section on stimulation method 5. The spontaneous breathing impulse sensor can be designed as a nerve impulse sensor, by means of which nerve impulse signals of the living being that control the breathing of the living being can be detected. It is also possible, for example in the case of electromagnetic stimulation, for the signal delivery device for delivering the stimulation signals to form the nerve impulse sensor at the same time. For example, such a signal output device can be designed as a coil or coil arrangement. The nerve impulse can also be detected with a coil or coil arrangement.

Intra-abdominal pressure is the pressure in the living being's abdominal cavity.

Inhalation increases the pressure in the abdominal cavity (intrabdominal pressure, IAP) and exhalation decreases it. This creates a pressure gradient between the chest and abdominal cavity during spontaneous breathing. The respiratory muscles can cause small but also increased pressure fluctuations in the abdominal cavity. These pressure fluctuations affect the functions of the abdominal organs. The intra-abdominal pressure of the living being can be controlled or regulated to a predetermined value, value range and/or change over time by setting parameters of the stimulation signals emitted by the at least one signal emission device. In this way, the intra-abdominal pressure can be specifically influenced. This can, for example, improve blood circulation in certain organs. For example, positive influences on the abdominal organs can be triggered. As with spontaneous breathing, the stimulation creates natural pressure gradients between the chest and abdominal cavity and natural, but also increased pressure fluctuations in the abdominal cavity can be caused, which favorably improve the functions of the abdominal organs - such as intestinal motility and other intestinal functions, organ blood circulation or lymphatic drainage influence. This can make a decisive contribution to improving the prognosis. For example, depending on the prevailing intra-abdominal pressures caused by diaphragm contractions, the depth and duration of inhalation, but also the level and duration of exhalation, can be controlled in a targeted manner.

Depending on the prevailing intra-abdominal pressures influenced by breathing, the stimulation can specifically control the depth and duration of inhalation, but also the level and duration of exhalation. If the intra-abdominal pressure, for example in the case of intra-abdominal hypertension (IAP > 12 mbar), is so high that blood flow to the abdominal organs is impaired, the stimulation during inhalation and exhalation can be reduced accordingly.

A targeted stimulation of the respiratory nerves and/or the respiratory center can be carried out by setting parameters of the stimulation signals emitted by the at least one signal emission device. This only activates the respiratory nerves and/or the respiratory center in a targeted manner, without leading to a noticeable effect on the respiratory muscles. In particular, the respiratory muscles are not stimulated in this way in a way that is sufficient for a life-sustaining gas exchange of the living being. This can be realized, for example, by the strength of the stimulation signals being so low that there are almost no muscle contractions. With this, respiratory nerves and the respiratory center can still be activated and/or their activity maintained. Ventilation reduces the work of breathing of the respiratory muscles. The respiratory movements are passive during ventilation, the activity of the respiratory nerves decreases and can even disappear completely. This applies both to the efferent motor neurons, which control the muscles, and to the afferent, sensory nerve pathways, which record the extent and speed of the muscle contraction and the corresponding change in position and report this back to the respiratory center for feedback.

In addition to the activity of the efferent and afferent nerve tracts, the activity of the neurons in the respiratory center in the brainstem area also decreases during ventilation. The respiratory center reduces its activity after just a few minutes of ventilation. After stopping ventilation, you can then consciously - i.e. via the cerebral cortex - control the respiratory center, but breathing is now perceived as strenuous, although it is not. After a short time, after the ventilation has stopped and spontaneous breathing has resumed completely in healthy living beings, natural, autonomous spontaneous breathing takes place again, which is controlled by the respiratory center.

With this stimulation method for activating and/or maintaining the activity of respiratory nerves and respiratory reflexes, the efferent and afferent neurons - i.e. the motor and sensory nerve tracts with the neurons of the respiratory center in the brainstem area - are to be activated and/or their activity is to be maintained. As with conditioning, training, secretion mobilization and coughing, etc., this stimulation method does not require sufficient respiration to maintain gas exchange.

By setting parameters of the stimulation signals emitted by the at least one signal output device over a large number of breathing cycles, the characteristic data of the breathing cycles can be controlled or regulated to predetermined target characteristic data of the breathing cycles, after which there is no influencing of the breathing cycles over a large number of breathing cycles To carry out living being and then to carry out a control or regulation of the characteristic data of the respiratory cycles to predetermined target characteristic data of the respiratory cycles again over a large number of breathing cycles. Further explanations are given below in the section on stimulation method 6. By setting parameters of the stimulation signals emitted by the at least one signal emitting device, muscle contractions of the living being's respiratory muscles can be stimulated over a large number of breathing cycles, which are not necessary for the gas exchange to be carried out by the living being through respiration and thereby cause additional muscle training. Targeted muscle training of the respiratory muscles can be carried out here. Further explanations in this regard are given below in section stimulation method 7, in particular 7.1, 7.5, 7.6. With this type of stimulation, the actual breathing depth is not influenced or only with such a small amplitude that is too small for a life-sustaining gas exchange of the living being. The aim of this stimulation is a training of the respiratory muscles, the training being designed harmless to the respiratory organs, in particular harmless to the lung tissue and the diaphragm muscle.

By setting parameters of the stimulation signals emitted by the at least one signal output device, the breathing position can be controlled or regulated to an increased value and/or the breathing position can be shifted into the inspiration phase. Further explanations are given below in section stimulation method 7.2.

By setting parameters of the stimulation signals emitted by the at least one signal output device, the living being's respiration can be regulated to a predetermined value, value range and/or temporal change in the respiratory depth using current measured values of the respiratory depth. For this purpose, a breathing depth sensor can be used, which continuously measures the breathing depth of the living creature. Further explanations are given below in the section on stimulation methods 3 and 7.3.

By setting parameters of the stimulation signals emitted by the at least one signal emission device, the breathing depth and/or the volume flow in the inspiration phase can be limited to a predetermined maximum value. Further explanations are given below in the section on stimulation methods 4 and 7.4. By setting parameters of the stimulation signals emitted by the at least one signal output device, the volume flow in the expiration phase can be limited to a predetermined maximum value and/or reduced compared to the average intrinsic volume flow of the living being in the expiration phase.

By setting parameters of the stimulation signals emitted by the at least one signal output device, the duration of the expiration phase can be reduced compared to the average intrinsic duration of the living being's expiration phase. In particular, the stimulation signals can be used to prevent the living being from breathing out completely, i. H. at least a certain amount of residual air can be retained in the lungs.

The strength of the stimulation signals emitted by the at least one signal output device can be increased in the course of a breathing cycle in the inspiration phase and reduced again in the expiration phase. In this way, the energy input into the living being's tissue can be minimized.

A flow control actuator that is pneumatically and/or electrically coupled to the respiratory system of the living being and by means of which the volumetric flow of the air flow flowing into and/or out of the living being can be adjusted can be controlled variably in the course of a breathing cycle in such a way that the flow Control actuator of the volume flow in the inspiration phase and / or the expiration phase is at least temporarily limited or reduced. For example, the flow control actuator may comprise an electrically operable valve in a breathing mask or hose. The flow control actuator may be an electrical actuator capable of stimulating the subject's larynx, e.g., by electromagnetic larynx stimulation. As a result, a desired, defined resistance to the flow of exhaled air can be generated during exhalation, for example, which keeps the airways and alveoli open.

The control device can be connected via an interface to a ventilator that is set up to ventilate the living being by generating variable positive pressure and/or negative pressure, the control device being set up for data exchange with a control device of the ventilator. This has the advantage that the control device of the electrical stimulation device can access data, in particular measured values, which are already present in the ventilator, such as measured values for volume flow, breathing depth and the like. Accordingly, such sensors are then not necessary in the electrostimulation device.

By appropriately adjusting the strength of the stimulation signals emitted by the at least one signal emission device, a deep inhalation can initially be induced in the respiratory cycle. In the case of stimulation method 2, this is advantageous, for example, in order to open the lungs and carry out recruitment stimulation accordingly. In the case of cough stimulation, this can be advantageous, for example, in order to take in a maximum of air volume in the lungs, which is beneficial for cough stimulation because a lot of air is available to generate a high volume flow during expiration.

Cough stimulation can be carried out, for example, by first causing a deep inhalation in the breathing cycle by appropriately adjusting the strength of the stimulation signals emitted by the at least one signal-emitting device and then following the deep inhalation by setting parameters of the stimulation signals generated by the at least one One or more partial expirations with an expiration duration that is shorter than the average expiration and/or an increased intensity of the stimulation signals, e.g. by preventing complete expiration, e.g. by reducing the expiration duration to 0.2 to 1 .3 times the inhalation time is reduced. In addition, the strength of the stimulation signals can be increased compared to normal breathing cycles in order to generate maximum volumetric flow during expiration. It is possible, in particular, to generate several such exhalations with a shortened exhalation duration and/or maximum volume flow following a deep inhalation by appropriately adjusting the strength of the stimulation signals emitted by the at least one signal emission device, without inhaling being generated in between. It is also advantageous to carry out such a cough stimulation immediately after a secretion mobilization stimulation. As mentioned, the secretion mobilization stimulation can be induced by adjusting the parameters of the stimulation signals emitted by the at least one signal output device by controlling or regulating the living being's respiration to a respiratory rate of more than 40 respiratory cycles/minute.

Pure chest breathing, pure abdominal breathing or a combination of these can be stimulated by the stimulation signals that are emitted. Since the strengths of the stimulation of abdominal breathing and chest breathing can be independently adjustable. In this way, chest breathing and abdominal breathing can be stimulated independently. Thus, through increased activation in the chest area with a shift in the position of breathing into inhalation and with continued prevention of exhalation, the total cross-section of the diaphragm can be significantly enlarged during the entire respiratory cycle. As a result, it is now possible to breathe much more effectively, independently of thoracic breathing, with much smaller and thus much gentler breathing movements for both the lungs and the diaphragm.

Electrically, electromagnetically and/or magnetically generated stimulation signals can be fed into at least one nerve and/or muscle by the signal delivery device. The strength of the stimulation signals can be determined, for example, by the voltage or current amplitude, the electrical power, the amplitude of a magnetic parameter and/or a short-term average value of one or more such parameters. For example, the signals fed into the signal output device for generating the stimulation signals can be AC voltage or AC signals or other pulse-like signal sequences.

In principle, the signal delivery device can be any desired signal delivery device, or a combination of several signal delivery devices, by means of which such electrical stimulation signals can be fed into at least one nerve and/or muscle. The signal delivery device can thus stimulate a muscle to contract directly by electrical signals and/or indirectly by electrical stimulation of the corresponding nerve, which can stimulate muscle contraction. For example, the signal output device can be implanted electro have those that are implanted at the appropriate point in the body of the living being and through which the stimulation signals are fed directly into the body.

In an advantageous embodiment, the signal output device has signal output elements that can be arranged on the outside of the living being and therefore do not have to be implanted. In this way, invasive steps can be avoided. For example, the signal output elements can have one or more electrical coils, through which inductive electrical signals can be fed into the at least one nerve and/or muscle. Magnetic fields are fed into the living being through such coils, which in turn lead to induced currents in the body, by means of which the desired electrical stimulation signals can be generated in at least one nerve and/or one muscle. For example, coils or coil arrangements according to WO 2019/154837 A1 or WO 2020/079266 A1 can be used for this purpose.

The signal delivery elements can also include electrodes attached to the body of the living being, which are to be attached to the skin, for example, through which electrical signals can be galvanically coupled into the body. As a further possibility, the signal elements can have capacitive electrodes, through which the electrical simulation signals can be fed into the living being by means of capacitive coupling, i.e. without galvanic contact with the living being.

In principle, the electrical stimulation device can be set up to stimulate any nerve with which the breathing of the living being can be influenced in a targeted manner. This also includes the stimulation of the auxiliary respiratory muscles in the neck area, but also the stimulation of the nerve roots, as well as nerves in the brain area, e.g. in the brainstem and/or in the cerebrum. For example, the electrical stimulation device can be designed to stimulate one or more of the following nerves: Phrenic nerve, one or more intercostal nerves, first, second, third motoneuron, insofar as these can trigger breathing movements.

The signal output device or its signal output elements are designed in such a way that they can be conveniently and safely arranged at the appropriate position on the living being, for example for stimulating the diaphragm in the area of the phrenic nerve near the head and/or for stimulating chest breathing in the area of one or more of the intercostal nerves. For this purpose, the signal delivery elements are adapted to this corresponding positioning on the living being in terms of their shape and nature.

The control device can be set up, for example, to store characteristic data of one or more breaths of a living being, in that the control device has a parameter memory in which typical characteristic data of such living beings or characteristic data of the individual living being to be treated are stored in advance. In this case, the electrical stimulation device can also be designed without a measuring device and in particular without feedback of measured signals in the sense of a control loop.

The electrical stimulation device can also have a measuring device with one or more sensors, by means of which characteristic data of the breathing cycles of the living being are recorded at specific points in time or continuously and are fed to the control device. In this case, the characteristic data can be stored at least temporarily in the control device. In addition, additional characteristics of respiratory cycles determined in advance can be stored in a parameter memory in the control device, as described above.

The control device can be formed out in particular as an electronic control device which has a computer through which the individual functions of the electrostimulation device are controlled. A computer program can be stored in the control device, in which the corresponding functions are programmed and are executed by the computer executing the computer program.

If a computer is mentioned, it can be set up to run a computer program, eg in the sense of software. The computer can be designed as a commercially available computer, for example as a PC, laptop, notebook, tablet or smartphone, or as a microprocessor, microcontroller or FPGA, or as a combination of such elements. Where regulation is mentioned, regulation differs from control in that regulation has feedback of measured or internal values, with which the generated output values of the regulation are in turn influenced in the sense of a closed control loop. In the case of a controller, a variable is simply controlled without such feedback.

Insofar as the term "breathing depth" is used, this term includes the actual breathing depth as well as the apparent breathing depth of the living being. Actual depth of breath is determined by the amount of tidal volume exchanged with the environment during respiration. The tidal volume is the amount of air that is inhaled and exhaled, i.e. ventilated, per breath. The apparent depth of breathing is determined by the amount of tidal volume that would be expected to occur due to the movement of the respiratory muscles if breathing could be performed freely. In many cases the apparent depth of breath will correspond to the actual depth of breath. However, if, for example, the airways are completely or partially blocked and/or the lungs are pathologically altered, the actual depth of breath can deviate significantly from the apparent depth of breath.

The actual breathing depth of the living being can be recorded using different parameters, eg using the tidal volume and/or the amplitude of the transpulmonary pressure (abbreviated TPD, or TPP, "transpulmonary pressure"). The level of the tidal volume depends on the level of the transpulmonary pressure. The transpulmonary pressure is the pressure difference between the air-filled space of the lungs and the pressure at the outer edge of the lungs between the two layers of the pleura. It is therefore the difference between intrapulmonary and intrapleural pressure, or in other words it is the difference between alveolar pressure and pleural pressure. The alveolar pressure can only be recorded indirectly via measurements in the airways or in a ventilation system. The pleural pressure corresponds approximately to the pressure in the esophagus. The transpulmonary pressure can be determined, for example, by measuring the pressures in the respiratory system and in the esophagus of the subject. The transpulmonary pressure is then the difference between ventilation pressure and esophagus pressure. The apparent depth of breath can be recorded using different variables, for example by recording the movement of the living being triggered by muscle contraction, for example movement in the chest area and/or abdominal area. Another possibility for detecting or characterizing the apparent breathing depth is the determination of the necessary electrical and/or mechanical energy or force for generating breathing movements of the living being, which is required for generating egg nes volume flow of respiration. The apparent breathing depth can therefore be determined at least approximately based on the strength of the stimulation signals emitted by the at least one signal-emitting device.

The respiration volume flow indicates how much air volume is actually inhaled or exhaled by the living being per unit of time. A breathing cycle comprises an inhalation phase (also called inhalation or inspiration for short) and an immediately following exhalation phase (also called exhalation or expiration for short). At the end of a resting inspiration, there is still a possible lung volume that could still be inspired, the inspiratory reserve volume (IRV). At the end of an exhalation at rest, there is still a possible lung volume that could still be exhaled, the expiratory reserve volume (ERV). Resting breathing therefore takes place in a certain breathing length between the inspiratory and expiratory reserve volume (Figures 3, 4).

If, during resting breathing, exhalation is at least partially prevented in each breathing cycle, the position of breathing shifts into inhalation. Here, the expiratory reserve volume is increased and the inspiratory reserve volume is reduced (FIG. 5). Such a shift in the position of breathing by preventing exhalation occurs 1. by slowing down the respiratory flow during exhalation and/or 2. by holding exhalation at a certain level and/or 3. by shortening the exhalation time.

The functions described below, which are executed by the control device, can be embodied, for example, as functions of a computer program or separate computer programs or computer program modules. Insofar as the functions are carried out by the control device, this can carry out the corresponding functions automatically. A variety of functions the electrostimulation device can also be adjusted and/or controlled manually by the user. This also includes functions that can optionally be performed by the control device.

The invention therefore also relates to a method for stimulating one or more nerves and/or muscles of a living being with electrically, electromagnetically and/or magnetically generated stimulation signals using such an electrostimulation device in which the functions mentioned are performed manually, for example changing the strength the stimulation signals emitted by the at least one signal emission device, and a computer program for carrying out such a method.

With regard to breath monitoring, feedback and control, the following can also be provided.

Various monitoring parameters and feedback mechanisms can be provided for stimulation control. Similar to conventional ventilation, one, several or all parameters of the living being's gas exchange such as oxygen uptake and carbon dioxide release and respiratory parameters such as respiratory impulse, respiratory rate, tidal volume, respiratory rate, exhalation and inhalation level can be recorded for this purpose. The monitoring can also differentiate between chest and abdominal breathing and record them separately.

Parameters that indicate transitions between intensified and relaxed breathing and thus an increase in the respiratory drive play a special role both for the adjustment during the stimulation and for the effects achieved after the stimulation. These include, for example, the quotient of respiratory rate and tidal volume (RSB, "rapid shallow breathing index"), the so-called P0.1 value, the respiratory flow rate (ratio of tidal volume and inspiration time) and pressure fluctuations in the esophagus within a certain range e.g. 4 to 8 mbar or the extent of transdiaphragmatic pressure fluctuations.

In addition, the spontaneous electrical activity of the phrenic nerve can also be recorded electromagnetically with an electroneurogram (ENG), for example, and be used for feedback. The electrical, spontaneous phrenic nerve activity is a direct measure of the central neural respiratory activity and can be recorded, for example, via the number of pulses per breath, the pulse frequency during the peak inspiratory flow or the mean activity over 0.1 seconds and used for feedback and control of the stimulation are used.

Certain electromyographic patterns can also indicate the onset of exhaustion. In order to be able to use electromyographic signals from the diaphragm as a direct measure of electrical muscle activity for feedback and control of electromagnetic or electrical respiration, electromyography of spontaneous activity can be performed during the stimulation pauses. On the other hand, artefacts caused by the electromagnetic stimulation can make a measurement more difficult or impossible. Here, special stimulation algorithms can enable artefact-free recording of muscle activity through fixed pauses, which can then be used to control further stimulation. This control takes into account that the spontaneous activity is neither too low nor too high, e.g. does not exceed 8% of the maximum activity. In addition, devices that are directly coupled to one another can also enable filtering of the electromagnetic signals. In this way, an electromyographic monitoring of the muscle activity achieved can also take place during the stimulation, which enables direct feedback.

The relationship between electrical stimulation and the resulting mechanical muscle activity depends on the force-length and force-velocity ratio and thus on the volume and shape of the thorax, but also on the course of the disease. For example, as the disease progresses, diaphragm strength can decrease, although electrical muscle stimulation increases. Therefore, monitoring the force of the diaphragm is particularly advantageous for the feedback to control the training stimulations. In addition to indirect parameters such as RSB and P0.1 value, ultrasound measurements of movements and thickening of the diaphragm can give an indirect indication of diaphragm force. In the standard method that has been used for many years, the force of the diaphragm is measured indirectly via pressure fluctuations between the chest and abdomen. The phrenic nerve is thereby with a standard electromagnetic stimulus and the resulting transdiaphragmatic pressure fluctuations measured via a balloon catheter in the esophagus and stomach. From this, the diaphragm force can be determined.

Further advantageous functions and method steps are explained in detail below.

Group 1: lung-dependent stimulations

1. Lung-sparing stimulation for low energy transfer

2. Recruitment and stabilization stimulation to open collapsed lung areas and maintain opened areas

3. Lung protective stimulation to control tidal volume

Group 2: Respiratory stimulation

4. Control stimulation to control harmful self-breathing

5. Modulation stimulation to change spontaneous breathing

Group 3: conditioning and training stimulations

6. Conditioning stimulation to train an improved breathing pattern

7. Traininqsstimulation for training the respiratory muscles

Group 1: Lung-dependent stimulation Lung-sparing stimulation - stimulation method 1

Gentle and above all low-energy breathing is achieved by a pattern with gradually increasing stimulation strength of the impulses during inhalation and decreasing stimulation strength of the impulses during exhalation. This avoids sudden breathing movements and thus minimizes the transfer of energy to the lung tissue and the lung damage caused by the breathing itself. The principle is based on the breathing pattern of the newly developed flow-controlled ventilation (FCV) (3) (see also PCT/EP2017/052001).

With this flow-controlled form of ventilation, the conflict between ventilation that protects the lungs and the diaphragm is very pronounced, since spontaneous breathing is not permitted during FCV. However, stimulation method 1 can be synchronized with FCV. Such synchronization between electromagnetic or electrical stimulation and FCV can promote simultaneous self-breathing - and thus maintenance of the respiratory muscles and their muscle strength in FCV. The diaphragm is also active during natural spontaneous breathing during exhalation. This activity, called “expiratory braking”, slows down exhalation and stabilizes the lungs. This natural diaphragmatic activity during exhalation decreases as expiratory resistance increases. This stimulation, which is gentle on the lungs, is also used during the exhalation phase with decreasing intensity. A complete exhalation takes place only very briefly or is avoided completely (see below stabilization stimulation with stimulation method 2). This counteracts a collapse of the lung tissue. This not only prevents a gas exchange disorder, but also an increasing respiratory insufficiency with increased respiratory drive with harmful spontaneous breathing patterns.

In addition, this gentle breathing pattern is trained through the conditioning effect of this form of stimulation (see below, conditioning stimulation - stimulation method 6). In addition, both muscle strength and muscle mass of the respiratory muscles are maintained and trained, which is particularly important during conventional ventilation and especially in flow-controlled ventilation (FCV) (see below Training stimulation, stimulation method 7.1.).

Recruitment and stabilization stimulation - stimulation method 2

Stimulation method 2 causes isolated, deep sighs in combination with prevention and/or slowing down (see above) of exhalation. This stimulation method recruits collapsed lung areas and stabilizes the lungs by preventing and/or delaying expiration. This will prevent it from collapsing again.

In addition to the depth of the inhalation, the duration of the inhalation and exhalation phases can also be set for recruitment stimulation. For example, to increase efficiency during recruitment stimulation, the respiratory time ratio can be changed and the maximum inhalation time can be lengthened and the exhalation time shortened.

With stabilization stimulation, the end of exhalation can be kept at different levels as required by direct stimulation of the respiratory muscles become (“expiratory hold”). As described under stimulation method 1, the rate of expiration can also be slowed down, for example, by reducing the intensity of the stimulation impulses during expiration - similar to the natural "expiratory braking" mentioned above. The collapse of lung areas can also be prevented by changing the breathing time ratio. By changing the stimulation times, the inhalation time can be lengthened and the exhalation phase shortened in the stabilization stimulation as described above for the recruitment stimulation. If stimulation in the exhalation phase is not possible or only possible to an insufficient extent, complete exhalation can be prevented by starting electromagnetic or electrical stimulation of inhalation earlier ("expiratory cut"). As already mentioned above, precise monitoring of respiration and in particular of the respiratory position is advantageous here in order to be able to precisely determine the correct time for inhalation.

In addition, the stabilization stimulation can also be combined with an optionally dynamically adjusted increase in expiration resistance, which also slows expiration further and thus additionally stabilizes the lungs in the expiration phase. This can be done in combination and synchronously with the stimulation during expiration. During spontaneous exhalation, the resistance to exhalation increases naturally due to the vocal folds, which open again during inhalation. By increasing the resistance to exhalation, the natural activity of the diaphragm for “expiratory braking” decreases.

This stimulation method 2 also counteracts an increase in the work of breathing and the respiratory drive caused by increased lung collapse and prevents further lung damage associated with self-damaging spontaneous breathing (see also the next page for control stimulation). Recruitment and stabilization stimulation can thus indirectly increase the work of breathing and harmful respiratory effort, but also reduce or even prevent ventilation with high tidal volumes.

Lung protective stimulation - stimulation method 3 With the stimulation during inhalation, the breathing depth is regulated in such a way that a gentle tidal volume of, for example, 6 ml/kg ideal weight is breathed in and/or a transpulmonary pressure of 5 mbar is not exceeded. For this purpose, feedback can be provided between the measurement of the tidal volume, the transpulmonary pressure or corresponding correlates and the stimulation intensity, so that the stimulation can be adapted to the tidal volume achieved and/or the transpulmonary pressure. This then happens not only for the following breath, but can already directly control the ongoing stimulation via monitoring and feedback. In this way, the ongoing stimulation intensity can be weakened and/or the stimulation duration can be shortened so that a specific tidal volume of, for example, 6 ml/kg of ideal weight and/or a transpulmonary pressure of 5 mbar is not exceeded. This is particularly important during spontaneous breathing (see below for control and modulation stimulation, stimulation methods 4 and 5).

In addition, adequate ventilation must also be guaranteed in disease states with high levels of carbon dioxide exhalation. In addition to the recruitment and maintenance of the gas exchange area and the level of the tidal volume, this is achieved by an appropriately adapted respiratory rate. The respiratory rate is determined not only by the frequency of the stimulations, but also by the above-mentioned relationship between inhalation and exhalation - the respiratory time ratio - be what can be set by appropriate stimulation times.

Group 2: Respiratory stimulation Control stimulation - stimulation method 4

Independent of spontaneous breathing, this electromagnetic or electrical stimulation method achieves controlled breathing that is gentler on the lungs, even if spontaneous breathing follows a completely different, possibly even harmful, pattern. In this way, the stimulation can take targeted countermeasures if, for example, the respiratory drive and respiratory effort increase due to excessive breathing work and increasing exhaustion. Intensified, fast and deep breathing damages both an already damaged lung and the already damaged weakened and also pre-damaged respiratory muscles. This increasing damage to the lungs as well as to the diaphragm caused by self-damaging spontaneous breathing is referred to as patient-seif injured lung injury (P-SILI).

With this stimulation method, natural breathing can be controlled in such a way that overloading of the respiratory muscles and P-SILI can be reduced or even prevented. Electromagnetic or electrical stimulation is the only method to date that can be used non-invasively and without medication to control and thus optimize self-breathing independently of spontaneous breathing and the patient's will.

Feedback mechanisms can be used to control this stimulation method, which take into account important characteristics of spontaneous breathing and/or also of the natural breathing that ultimately takes place together with the stimulation. to be able to adjust the stimulation individually and flexibly.

Special form of control stimulation: secretion mobilization and coughing

These two methods of stimulating the respiratory muscles also take place independently of spontaneous breathing and fulfill special functions that are independent of breathing. This is intended to mobilize secretion from the peripheral into the central airways and further mobilize it through coughing and finally remove it from the airways.

Secretion mobilization stimulation: With this stimulation method, secretions can be mobilized from the peripheral to the central airways, e.g. with high-frequency, short and fast breaths.

Cough stimulation: This stimulation method can follow directly after the secretion mobilization stimulation in order to continue to effectively mobilize mobilized secretion and, above all, to be able to “cough it out”. For this purpose, after a longer inhalation, a short cough or a series of short coughs follows. The burst of exhalation becomes more effective when the beginning of exhalation, as in the case of natural coughing takes place against an increased airway resistance and thus the pressure in the lungs can be increased. This brief, synchronized increase in exhalation resistance can be achieved via synchronized artificial resistance and/or narrowing of the vocal folds caused by stimulation of the laryngeal nerves.

Modulation stimulation - stimulation method 5

In contrast to control stimulation (see stimulation method 4 above), modulation stimulation does not take place independently of spontaneous breathing, but as a function of the spontaneous respiratory impulse. Instead of complete self-breathing control independent of spontaneous breathing, there is partial or complete control of natural spontaneous breathing, in which the spontaneous breathing impulse is always taken into account - even if the breathing impulse is weak or not present at all.

forms of synchronization

The spontaneous respiratory impulse must therefore be detected so that an electromagnetic or electrical stimulation synchronized with it can take place. The modulation stimulation can be synchronized using the standard detection methods for the spontaneous respiratory impulse such as pressure, flow or temperature fluctuations in the respiratory stream or body sensors such as so-called Graseby capsules or muscle activity sensors. Much more precise, however, is the synchronization with one's own nerve impulse before spontaneous inhalation begins: Ventilation synchronized with the nerve impulse is referred to as neurally assisted or also as "neurally adjusted ventilatory assist" or "NAVA". The nerve impulse is recorded by a sensor in the esophagus near the diaphragm (4).

However, one's own nerve impulse can also be recorded non-invasively electromagnetically. This can either be done peripherally directly above the stimulation site on the neck - or centrally at the point of origin of the nerve impulse in the brainstem area.

Exhalation level modulation With the modulation stimulation, the spontaneous breaths can then be changed in a synchronized manner, as in the stimulation methods 1 to 3 described above. This can be done by stimulating the entire breathing cycle, as with lung-friendly stimulation, in order to achieve gentler spontaneous breathing. Depending on the disease and the spontaneous breathing pattern, the modulating stimulation, as described under stimulation method 2, can only take place in the exhalation phase in order to stabilize the lungs at different levels by preventing and/or delaying exhalation.

Modulation of tidal volume

However, it can also be stimulated as required and synchronized only in the inhalation phase in order to reopen collapsed lung areas as described under stimulation method 2 with a few intermittent, very deep and sustained breaths. A sufficient depth of respiration with a corresponding tidal volume can also be achieved through stimulation during spontaneous inhalation in the case of insufficient, shallow respiration. In addition to recording the respiratory impulse, feedback on the respiratory volumes and/or the transpulmonary pressures is also advantageous, as described for lung-protective stimulation (see stimulation method 3 above).

By "taking over" or inhibiting the spontaneous nerve impulse, too deep a breath with a lung-damaging, too large tidal volume can also be avoided. Such a takeover can take place through targeted stimulation of the phrenic nerve immediately before the natural nerve impulse, so that the natural impulse cannot be transmitted during the absolute refractory period of the nerve and can only be transmitted to a weaker extent in the relative refractory period.

As already mentioned above, an excessively large, spontaneously breathed tidal volume can also be prevented indirectly by preventing exhalation by shifting the respiratory position into inhalation. The feedback mechanisms described above for lung-protective stimulation (stimulation method 3) with measurement of the tidal volumes are also used here. Modulation of respiratory rate

With the previous forms of modulation stimulation, the spontaneous respiratory rate was not changed. However, if the frequency of spontaneous breathing becomes too fast or too slow, it can be directly and/or indirectly influenced and controlled by electromagnetic or electrical stimulation. The resulting smooth transitions to controlled self-breathing are regulated by recording the spontaneous breathing rate and corresponding feedback mechanisms.

The extent and frequency of the stimulation can be individually adjusted depending on the depth and frequency of spontaneous breathing. A spontaneous breathing frequency that is too fast is indirectly slowed down by longer inhalation and/or exhalation phases and finally a lower frequency can also be superimposed. The breathing frequency can also be slowed down indirectly by individual deep breaths via the breathing reflexes activated in this way.

Similar to conventional back-up ventilation, if breathing is too slow or stops, the respiratory rate is increased directly with electromagnetically or electrically controlled self-breathing. If breathing decreases slowly, e.g. with increasing coma depth, a sufficient breathing rate can be achieved early on by means of an appropriate stimulation frequency - even before insufficient gas exchange with lack of oxygen occurs due to interrupted breathing.

Modulation depending on the intra-abdominal pressures

Inhalation increases the pressure in the abdominal cavity (intrabdominal pressure, IAP) and exhalation decreases it. As with spontaneous breathing, the stimulation also creates natural pressure gradients between the chest and abdominal cavity. The stimulation of the respiratory muscles can cause natural but also increased pressure fluctuations in the abdominal cavity, which affect the functions of the abdominal organs - such as intestinal motility, organ perfusion or lymphatic drainage - and make a decisive contribution to the prognosis of ventilated patients. Depending on the prevailing intra-abdominal pressures influenced by breathing, the stimulation can specifically control the depth and duration of inhalation, but also the level and duration of exhalation. If the intra-abdominal pressure, for example in the case of intra-abdominal hypertension (IAP > 12 mbar), is so high that blood flow to the abdominal organs is impaired, the stimulation can be reduced accordingly, particularly during exhalation.

Group 3: conditioning and training stimulations conditioning stimulation - stimulation method 6

All of the 5 stimulation methods mentioned above can also be used exclusively to condition improved spontaneous breathing. Here, an intermittent stimulation with varying stimulation duration takes place, whereby only a few breaths can be sufficient. The conditioning stimulation trains a specific spontaneous breathing pattern - either with a modulation of spontaneous breathing or as controlled breathing with the stimulation methods 1 to 5 described above.

The conditioning stimulation can be controlled and intensified by direct feedback. The feedback takes place on the basis of measured values of the patient's own respiration. The type of breathing, the level of exhalation and the inhalation depth, the tidal volume and the respiratory rate are measured and a correspondingly adapted conditioning stimulation is carried out.

This prevents a redistribution of respiratory activity in the area of the auxiliary respiratory muscles that occurs during positive pressure ventilation. Fatigue or even a fading of one's own respiratory activity is also prevented under conventional ventilation, since the peripheral nerve activity with the corresponding afferent pulses from the respiratory muscles can be maintained by the stimulation.

In the "pauses" without conditioning stimulation, normal, spontaneous breathing can take place. However, conventional ventilation can also take place, or spontaneous breathing assisted by electromagnetic or electrical stimulation, in which case portions of the patient's own breathing—also differing from the conditioning stimulation—can be modulated as described above. During these breaks it is checked whether, to what extent and, above all, how long-lasting the conditioning stimulation influenced spontaneous breathing. Depending on the changes brought about, the type, frequency, duration and, above all, the interval of the conditioning stimulation can be individually adjusted via feedback mechanisms.

The conditioning breathing effected by the conditioning stimulation must, like the training breathing described below, meet certain requirements (see below).

Training stimulation - stimulation method 7

During positive pressure ventilation, muscle breakdown begins after just a few hours, and muscle strength decreases rapidly and severely even earlier. Muscle biopsies were able to demonstrate a reduction in strength of the isolated muscle fibers of around 35% after just two hours of ventilation (5).

Muscle breakdown and weakening of muscle strength are heitsehen by the severe disease, especially reinforced by inflammatory processes.

If the weakened respiratory muscles are only insufficiently relieved by ventilation, an increased respiratory drive develops with high or ultimately too high breathing effort, which in particular further weakens and damages already damaged lungs, but also the muscles. The high breathing effort is actually the most important factor for damage to the diaphragm muscles. The degree between too little and too much breathing effort can be very small and vary greatly both between and within individuals in the course of the disease. Due to reduced strength and muscle breakdown, the weakened respiratory muscles are no longer able to ensure sufficient self-breathing. A respiratory insufficiency develops with the breathing pattern already mentioned above. Breathing becomes rapid, shallow and intensified, further damaging pre-damaged lungs but also the respiratory muscles. Weaning from ventilation, which accounts for the majority of the entire duration of ventilation, is accordingly largely determined by the return of sufficient muscle strength for adequate spontaneous breathing with the rebuilt muscle mass required for this. The electromagnetically or electrically stimulated training methods described below are intended to strengthen the respiratory muscles in such a way that muscles can be built up and both a reduction in the strength of the existing muscles and muscle breakdown can be prevented. Here, further damage to the lungs and respiratory muscles should be minimized or avoided as far as possible.

Therapeutic, preventive and preemptive forms of training

The respiratory muscles can be trained through electromagnetic or electrical stimulation in such a way that 1. worn-out respiratory muscles are built up again or weakened muscles are strengthened again, 2. muscle breakdown or muscle weakness is prevented and/or 3. muscle build-up before an expected breakdown or .A strengthening occurs before expected reduction in force.

Accordingly, therapeutic, preventive and/or preemptive training can be carried out:

1. After the breakdown and/or weakening of the respiratory musculature due to conventional ventilation and illness, a therapeutic training stimulation is carried out in order to rebuild the musculature and/or restore muscle strength.

2. During conventional ventilation and the course of the disease, muscle wasting and/or loss of strength is counteracted by preventive training stimulation.

3. Before an expected increased load and/or an expected reduction or weakening of the respiratory musculature through conventional ventilation or illness, the respiratory musculature and/or muscle strength is built up through the peemptive training stimulation.

Intensity of training stimulation

Since the electromagnetic or electrical stimulation causes sufficient ventilation (1), it can be assumed that this stimulation intensity during inhalation is also suitable for preventing muscle breakdown - just as normal spontaneous breathing also prevents muscle breakdown and loss of strength. In many cases a lower stimulation intensity is also suitable for preventing muscle breakdown if it is used correspondingly frequently, for example during conventional ventilation. With more intensive stimulation, respiratory muscles and/or muscle strength can be built up accordingly, or muscle breakdown and/or a loss of strength can be prevented more effectively with just a few stimulations.

For training with high stimulation intensity, stimulation during exhalation is of particular importance (see below).

Transitions for training stimulation patterns

In the case of training stimulation, there are six smooth transitions between...

1. ... few very intense and many very weak training stimulations.

2. ...a partial or complete respiratory cycle stimulation.

3. ...from a stimulation synchronized with spontaneous breathing to one independent of it.

4. ...a stimulation that prevents muscle breakdown or a reduction in strength and a stimulation that causes muscle growth or an increase in strength.

5. ...a training and a conditioning stimulation.

6. ...a training and a ventilation stimulation.

Training breathing requirements

The training stimulation causes a corresponding training breathing. The training patterns are therefore also based on the stimulation methods 1 to 4 described above and take into account the relationships mentioned there. Accordingly, the following four requirements should also be met by the breathing effected during training stimulation:

Training breathing should...

1. ...do little or no additional damage to the lungs and respiratory muscles, but on the contrary have a positive effect.

2. ... do not cause any other undesirable effects, such as hyperventilation. 3. ... do not negatively influence spontaneous breathing, but - if possible - positively influence it.

4. ... are not perceived as uncomfortable or only as little as possible.

Electromagnetic or electrical training methods

Thus, according to the stimulation methods 1 to 6 described above, the following six forms of training stimulation result, which also enable intensive training stimulation without harmful breathing:

7.1. Lung-friendly training stimulation

7.2. Intense training stimulation

7.3. Lung protective training stimulation

7.4. Self-harm (P-SILI) avoidant training stimulation

7.5. Modulating training stimulation

7.6. Conditioning training stimulation

7.1. Lung-friendly training stimulation

The principle of gentle breathing with low energy transfer to the lung tissue described for stimulation method 1 also applies to the training stimulation - even if it only occurs occasionally and after longer intervals. This pacing method avoids sudden and potentially harmful respiratory movements as described above by gradually increasing the pacing pulses on inspiration and decreasing the pacing pulses on expiration. This is particularly important for intensive and frequent training stimulation (see below 7.2.).

7.2. Intense training stimulation

With this method, muscle build-up or strength gain can be achieved more quickly and/or muscle breakdown or strength loss can be effectively prevented with only a small number of intensive stimulations. With this form of stimulation, it is crucial that, despite intensive muscle activity of the respiratory muscles, only little breathing takes place. This is achieved - as described above under stimulation method 2 - by shifting the position of breathing into inhalation while preventing exhalation. In particular, holding exhalation at a certain level (“expiratory hold”) requires increased muscular effort. Without causing intensive breathing, a very intensive training stimulation with pronounced contractions of the respiratory muscles can take place at the same time both in the inhalation and in the exhalation phase.

Here, the "holding of the breath" can be strengthened both in inhalation and in exhalation by correspondingly longer stimulation times in the respective breathing cycles of the training effect. As a side effect - as described above under stimulation method 2 - there is an opening of collapsed lung areas and a stabilization of ventilated lung areas.

This training method enables very intensive training stimulation of the respiratory muscles with few side effects and is gentle on the lungs. Despite pronounced muscle activity, not only self-damaging effects (see below 7.3-7.5) but also hyperventilation with corresponding side effects such as hypocapnia and the resulting dangerous pH shifts can be avoided.

If stimulation in the exhalation phase is not possible or only insufficiently possible, then hyperventilation-related side effects and exhaustion can also be avoided by pauses that can be controlled via feedback. In addition, deep breathing can also be mechanically limited by belts and/or weights, but also by increasing the airway resistance, which can further intensify the training effect.

Due to the intensive training stimulation, the duration of use per patient can be significantly reduced, which means that one device can be made available to several patients at short intervals.

The decisive factor in this intensive training is that, despite pronounced stimulation with correspondingly strong contractions of the respiratory muscles, no deeper breathing with sudden breathing movements (see above 7.1) and/or large tidal volumes (see below 7.3.) and/or large transpulmonary pressures is caused.

7.3. Lung protective training stimulation As described above under stimulation method 3, the breathing depth is also regulated for training stimulation during inhalation with this form of training so that a gentle tidal volume is breathed in and/or gentle transpulmonary pressure is exerted. This is particularly important in the case of frequent training stimuli. The above-mentioned feedback between the measurement of the tidal volume and the stimulation strength can also provide feedback on the breathing position as described above (see 7.2. above).

In this way, the stimulation intensity can be increased and at the same time a lung-protective tidal volume of, for example, 6 ml/kg of ideal weight and/or a transpulmonary pressure of 5 mbar is not exceeded, even with intensive training stimulation. As described above under 7.2, intensive training stimulation without harmful breathing can be made possible through an interaction between breathing position and tidal volume.

In addition, to a limited extent, increasing the resistance to exhalation can shift the respiratory length to inhalation, thereby limiting the respiratory volume. This can be done in combination and synchronously with the stimulation during expiration.

However, a high tidal volume can be achieved even with low stimulation levels. Regardless of the breathing position, the lung-protective training stimulation prevents harmful breathing with large tidal volumes from being caused even at low stimulation levels; This rules out the possibility of lung-damaging effects being caused by the training stimulation itself, particularly in the case of frequent stimulation. This is particularly important in the case of spontaneous breathing, because even a slight training stimulus in addition to a spontaneous breath can significantly increase the self-breathing that is then caused (see below 7.4. -7.5).

7.4. Self-harm (P-SILI) avoidant training stimulation

In addition to the above 3 training stimulation patterns that minimize or prevent additional damage from ventilation induced during training should, this training pattern should avoid or minimize damage in existing spontaneous breathing.

Spontaneous breathing is taken into account in such a way that additional training stimulation does not cause deep and/or sudden inspiration. This is particularly important in the case of frequent repetitions and can be achieved in different ways. Either there is no stimulation during inhalation, or only so little that a certain tidal volume is not exceeded, or inhalation is modulated accordingly.

In a further pattern, the stimulation method under 2 and also under 7.2. described prevention of exhalation, the breathing position must be shifted into inhalation, so that during exhalation, the depth of the spontaneous breaths and thus self-damaging breathing is limited at the same time.

Accordingly, the spontaneous breathing and/or the self-breathing that occurs or changes as a result of the stimulation must be recorded so that the stimulation can be individually and flexibly adjusted and, if necessary, the spontaneous breathing can be modulated (see below 7.5).

7.5. Modulating training stimulation

Finally, there are smooth transitions with different combinations between a training stimulation and a modulation stimulation, as described above under stimulation method 5. In this way, the stimulation can be individually adjusted taking into account the illness and the severity of the illness, so that both the requirements for self-breathing and the desired training effect can be met.

The modulating training stimulation always takes spontaneous breathing into account and therefore also changes it. This is stimulated over the entire respiratory cycle or only partially. With partial stimulation, you can train only in the inhalation phase, only during exhalation, or in parts of these breathing phases. Here- As described above, exhalation is of particular importance in order to be able to train intensively and to avoid both too deep, controlled breathing and too deep spontaneous breathing during training.

Even with exhausted respiratory muscles, which eventually result in shallow and rapid breathing, the modulating stimulation can be used to train at the same time and an improved breathing pattern can be achieved as described above under stimulation method 5. In the event of increasing exhaustion, based on defined limits, the aim should be to intervene as early as possible in order to relieve the exhausted respiratory muscles. If, in the case of pronounced exhaustion, the respiratory muscles need to be relieved by ventilation, preventive training stimulation can limit or even prevent muscle breakdown at an early stage.

7.6. Conditioning training stimulation

The conditioning stimulation described above under stimulation method 6 also represents a form of training stimulation. However, the primary goal of conditioning stimulation is not direct training of the respiratory muscles, but rather “training” or conditioning a specific breathing pattern. So if, in addition to training the respiratory muscles, conditioning of a specific breathing pattern is also to take place, then conditioning training stimulation takes place.

Combining stimulation functions

Depending on the severity of the disease, damage to the lungs and respiratory disorders, training stimulation can finally be combined with conditioning in such a way that the requirements of appropriately adapted ventilation can also be met. For example, in the case of hypoxemic lung damage as part of ARDS, stimulation during expiration with the help of the "expiratory hold", "braking" and "cut" stimulation patterns (see above and below) can stabilize the lungs, protect lungs from excessively high tidal volumes, conditioning to “hold” the exhalation and at the same time cause intensive training of the respiratory muscles (see overview of exhalation stimulation). Expiratory stimulation overview

The stimulation during exhalation is of central importance for 1. lung stabilization, 2. for lung protection, 3. for conditioning spontaneous breathing and 4. for intensive and yet at the same time gentle training of the respiratory muscles.

1. Lung stabilization

The stabilization stimulation prevents a collapse of the lung with corresponding gas exchange disturbances and also prevents harmful collapse recruitment ventilation, overexpansion of the ventilated lung, an increase in the work of breathing, respiratory effort, P-SILI and finally exhaustion. Stabilization stimulation can be done using three different methods:

1. the "expiratory hold", 2. the "expiratory braking" and 3. the "expiratory cut", which can also be combined:

1. Expiratory hold: Prevention of full exhalation by holding exhalation.

2. Expiratory braking: slowing down of exhalation through decreasing stimulation intensity.

3. Expiratory cut: shortening of the exhalation time.

The level of exhalation is determined in particular by holding the exhalation, but also by the type of deceleration and indirectly by shortening the exhalation time. In contrast to positive pressure ventilation, there is no unnatural increase in pressure in the lungs, but also no unnatural reduction in pressure in the abdomen as with negative pressure ventilation.

2. Lung protection

The more air is held in the exhalation, the more the position of breathing shifts into the inhalation and the less deeply one can then inhale again. If it is not possible to breathe in so deeply by shifting the length of the breath, then high and thus harmful tidal volumes cannot be achieved for purely mechanical reasons. This concerns 1. spontaneous breathing, 2. the electromagnetically or electrically controlled self-breathing, 3. electromagnetic or electrical training breathing, but also 4. even conventional ventilation. Thus, the stimulation during expiration alone enables harmful spontaneous breathing, but also harmful electromagnetic or electrical ventilation, as well as conventional ventilation with large tidal volumes, to be limited.

3. Conditioning

The conditioning stimulation specifically supports the practice of the various exhalation methods in order to learn a certain exhalation technique more effectively for the subsequent spontaneous breathing.

4. Workout

The stimulation during exhalation enables intensive training of the respiratory muscles by limiting inhalation by shifting the respiratory position. This enables a very intensive training stimulation with pronounced contractions of the respiratory muscles both in the inhalation and in the exhalation phase, since despite intensive muscle activity of the respiratory muscles only little is breathed. This avoids pronounced training breathing, but also harmful spontaneous breathing during training and the associated harmful effects and complications.

exemplary embodiments

The invention is explained in more detail below with reference to exemplary embodiments using drawings.

Show it

FIG. 1 shows the use of an electrostimulation device on a human being,

FIG. 2 shows the use of an electrostimulation device in connection with positive pressure respiration on a living being,

Figures 3 to 5 time diagrams of respiratory positions,

FIG. 6 the change in the air volume in the lungs in a breathing cycle over time,

FIG. 7 shows the change in the transpulmonary pressure in a breathing cycle over time.

FIG. 1 shows a living being 1 in a lying position. To clarify the situation, advantageous stimulation positions of the phrenic nerve 2 and the interconstal nerves 3 are shown on the living being 1 . In the present exemplary embodiment, it is assumed that the phrenic nerve 2 is to be stimulated by electromagnetic stimulation.

FIG. 1 shows an electrostimulation device 4, which is connected via electrical lines to signal-emitting elements 10, e.g. coils, for feeding magnetic fields into living being 1. The electrical stimulation device can generate stimulation signals in the living being via the signal delivery elements 10, which can be used to generate muscle contractions, through which the breathing of the living being 1 can be influenced in a targeted manner.

The electrical stimulation device 4 can be designed, for example, as a computer-controlled electrical stimulation device. It has a computer 5, a stimulation signal generating device 6, a memory 7 and 8 controls. There can also be a display device for displaying operating data. A computer program is stored in the memory 7, with which some or all of the functions of the electrical stimulation device 4 can be carried out. The computer 5 processes the computer program in the memory 7. In this way, corresponding stimulation signals are emitted via the stimulation signal generation device 6 to the signal emission device 10, through which the desired magnetic fields are generated. The functions described above for the ventilation of the living being sens 1 by the stimulation signals or the procedures to be carried out by the user can be influenced by the user via the operating elements 8, for example by setting parameters of breathing cycles.

The elements described can be used to control the artificial respiration of the living being 1 by electrostimulation. If certain parameters are also to be regulated, it is necessary for the electrostimulation device 4 to be supplied with one or more measured values of characteristics of breathing cycles of the living being 1 . For example, it can be useful to record the volume flow inhaled by the living being 1 and the volume flow exhaled. This can be done, for example, by means of a face mask 13 in which a flow sensor is arranged. The respiratory flow is practically not influenced by the face mask 13 or the flow sensor. However, quantitative variables that characterize the volume flow can be recorded and supplied to the electrical stimulation device 4 . The sensor signals can be evaluated by the computer 5, for example.

The electrostimulation device 4 can also have an interface 9 for connecting to other devices, e.g. for exchanging data with other devices. In this way, the electrostimulation device 4 can be supplied with further measured values without the electrostimulation device 4 having to be equipped with its own sensors.

Figure 2 illustrates the use of the electrostimulation device 4 on the living creature 1 in connection with a positive-pressure ventilator 11. The ventilator 11 has an air delivery unit 18 through which air is sucked in from the environment via a connection 19 and via an air line 12 by means a breathing mask 13 can be fed into the airways of the living being 1. The breathing mask 13 or the air line 12 can have a defined leakage 14 . With A pressure sensor 16 and a volume flow sensor 17 , for example a pneumotachograph, are connected to the air line 12 within the ventilator 11 . The ventilation device 11 has its own control unit 15 to which the sensors 16, 17 are connected. The control unit 15 controls the air delivery unit 18 according to predefined algorithms in order to generate desired volume flow curves and/or pressure curves in the respiratory organs of the living being 1 via the breathing mask 13 in this way.

It can be seen that the electrical stimulation device 4 is connected to the ventilator 11 via its interface 9 . The electrostimulation device 4 is supplied via the interface 9 with the corresponding measured values and possibly also additional values calculated internally in the ventilator 11 via characteristic data of the breathing cycles of the living being. In this way, the electrostimulation device 4 receives, for example, current measured values of the pressure and the volume flow of the breathing cycles of the living being 1.

In FIGS. 3 to 5, several breathing cycles are plotted against time t for different breathing positions. The air volume V in the lungs is plotted on the ordinate.

FIG. 3 shows the breathing position with tidal volumes during resting breathing (AZV) and a maximum possible exhalation, whereby the normal breathing position during resting breathing and the end-expiratory reserve volume (ERV) should be illustrated. The inspiratory reserve volume (IRV) is also marked here and is illustrated in FIG. 4 by the maximum possible inhalation. Finally, FIG. 5 shows the shift in the respiratory position during resting breathing into inhalation, which is characterized in that the tidal volumes of resting breathing occur with an increased ERV and reduced IRV.

The respiratory patterns shown in Figures 3 to 5 can be controlled accordingly by the fiction, contemporary electrostimulation device 4 and the inventive method, ie by the Elektrostimulationsvorrich device are corresponding stimulation signals in at least one nerve and / or fed to a muscle of the living being 1, whereby the corresponding muscle contractions of the respiratory muscles are generated, by which ultimately the respiratory cycles presented are caused.

FIGS. 6 and 7 show a breathing cycle in an enlarged view. The breathing cycle consists of an inspiration phase I and an expiration phase E. FIG. 6 shows the air volume V over time, and FIG. 7 shows the transpulmonary pressure TPP over time. It can be seen that the inspiration phase I begins at the lower peak according to FIG. 6 and ends at the upper peak. The expiratory phase E begins at the upper apex and ends at the next lower apex of the curve. The course of the pressure TPP is phase-shifted in comparison to the course of the volume V.

The profiles of the breathing cycles shown in FIG. 6 and FIG. 7, for example, can be generated by the electrostimulation device 4 . Depending on the selected function, the duration of the inspiration phase and/or the duration of the expiration phase can be influenced separately. The amplitude of the volume curve and/or the pressure curve can also be influenced separately, as can the respective positions of the maxima and minima of the curves.

literature

1. Raymondos K, Dirks T, Quintei M, Molitoris U, Ahrens J, Dieck T, Johanning K, Henzler D, Rossaint R, Putensen C, Wrigge H, Wittich R, Ragaller M, Bein T, Beiderlinden M, Sanmann M, Rabe C, Schlechtweg J, Holler M, Frutos-Vivar F, Esteban A, Hecker H, Rosseau S, von Dossow V, Spies C, Welte T, Piepenbrock S, Weber-Carstens. Outcome of acute respiratory distress syndrome in university and non-university hospitals in Germany. CritCare 2017; 21(1):122.

2. Sander BH, Dieck T, Homrighausen F, Tschan CA, Steffens J, Raymondos K. Electromagnetic ventilation: first evaluation of a new method for artificial ventilation in humans. Muscle Nerve 2010; 42(3):305-10.

3. Schmidt J, Wenzel C, Spassov S, Borgmann S, Lin Z, Wollborn J, Weber J, Haberstroh J, Meckel S, Eiden S, Wirth S, Schumann S. Flow-Controlled Ventilation Attenuates Lung Injury in a Porcine Model of Acute respiratory distress syndrome: A preclinical randomized controlled study. Crit Care Med 2020; 48(3):e241-e248.

4. Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural Control of Mechanical Ventilation in Respiratory Failure. Nat Med 1999;5(12):1433-6.

5. Welvaart WN, Paul MA, Stienen GJ, van Hees HW, Loer SA, Bouwman R, Niessen H, de Man FS, Witt CC, Granzier H, Vonk-Noordegraaf A, Ottenheijm CA. Selective diaphragm muscle weakness after contractile inactivity during thoracic surgery. Ann Surg. 2011; 254(6):1044-9.

Claims

patent claims

1. Electrostimulation device for stimulating one or more nerves and/or muscles of a living being with electrically, electromagnetically and/or magnetically generated stimulation signals, having the following features: a) the electrostimulation device has at least one signal output device through which electrically, electromagnetically and/or magnetically he generated stimulation signals can be fed into at least one nerve and/or a muscle, b) the electrical stimulation device has at least one control device which is set up to control the at least one signal output device in such a way that the stimulation signals emitted by the at least one signal output device cause muscle contractions in the living body beings can be generated through which the breathing of the living being can be influenced in a targeted manner.

2. Electrical stimulation device according to claim 1, characterized in that the control device is set up to change the strength of the stimulation signals emitted by the at least one signal output device in several steps and/or uniformly over the course of a breathing cycle of the living being.

3. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to keep the strength of the stimulation signals emitted by the at least one signal output device at an increased level during the expiration phase of the living being, at which the muscle contraction generated by the stimulation signals is greater than zero, but is at least as high that Up to 75% of the inspiratory reserve volume is still in the lungs at the end of expiration.

4. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to adjust the breathing of the living being to a predetermined value, value range and/or temporal change in breathing depth by setting parameters of the stimulation signals emitted by the at least one signal emission device to control or regulate.

5. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to control or to control the respiration of the living being to a respiratory rate of more than 40 respiratory cycles/minute by setting parameters of the stimulation signals emitted by the at least one signal emission device regulate.

6. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to control or regulate the breathing of the living being for a limited period of time to a breathing depth by setting parameters of the stimulation signals emitted by the at least one signal emission device is too low for a life-sustaining gas exchange of the living being.

7. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to prevent complete expiration by setting parameters of the stimulation signals emitted by the at least one signal emission device by reducing the duration of the expiration phase of the living being to 0.2 - up to 1.3 times the duration of the inspiration phase is reduced.

8. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to control the characteristic data by setting parameters of the stimulation signals emitted by the at least one signal emission device of the breathing cycles to predetermined target characteristics of the breathing cycles.

9. Electrostimulation device according to one of the preceding claims, characterized in that the control device is supplied with continuously determined, current measured values of characteristic data of the respiratory cycle of the living being by at least one sensor, wherein the control device is set up to set parameters by the at least stimulation signals emitted by a signal output device, depending on the measured values, to regulate the characteristic data of the respiratory cycles to predetermined target characteristic data of the respiratory cycles.

10. Electrostimulation device according to one of the preceding claims, characterized in that the control device is fed continuously determined, current measured values of the spontaneous breathing pulses by at least one spontaneous breathing pulse sensor, by which the spontaneous breathing pulses of the living being can be detected, the control device being set up for this purpose, parameters of the stimulation signals emitted by the at least one signal output device as a function of the measured values of the spontaneous breathing pulses, in particular synchronized with the spontaneous breathing pulses.

11 . Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to control or adjust the intra-abdominal pressure of the living being to a predetermined value, value range and/or change over time by setting parameters of the stimulation signals emitted by the at least one signal emission device regulate.

12. Electrical stimulation device according to one of the preceding claims, characterized in that the control device is set up to carry out targeted stimulation of the respiratory nerves and/or the respiratory center by setting parameters of the stimulation signals emitted by the at least one signal emission device

13. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to control or regulate the characteristic data of the respiratory cycles to a predetermined target by setting parameters of the stimulation signals emitted by the at least one signal emission device over a large number of respiratory cycles - Carry out characteristics of the breathing cycles, then carry out no influencing of the breathing cycles of the living being over a large number of breathing cycles and then carry out a control or regulation of the characteristics of the breathing cycles to predetermined target characteristics of the breathing cycles again over a large number of breathing cycles.

14. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to stimulate muscle contractions of the respiratory muscles of the living being by setting parameters of the stimulation signals emitted by the at least one signal emission device over a large number of breathing cycles, which are necessary for the Breathing to be carried out gas exchange of the living being are not necessary and thereby cause muscle training.

15. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to control or regulate the respiratory position to an increased value by setting parameters of the stimulation signals emitted by the at least one signal emission device and/or to switch the respiratory position to the postpone the inspiration phase.

16. Electrostimulation device according to one of the preceding claims, characterized in that continuously determined, current measured values of the respiratory depth are supplied to the control device by at least one respiratory depth sensor, by means of which measured values of the respiratory depth of the living being can be recorded, the control device being set up to by adjusting parameters of the stimulation signals emitted by the at least one signal output device, regulating the living being's respiration to a predetermined value, value range and/or temporal change in the respiratory depth based on the measured values of the respiratory depth.

17. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to limit the respiratory depth and/or the volume flow in the inspiration phase to a predetermined maximum value by setting parameters of the stimulation signals emitted by the at least one signal emission device.

18. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to limit the volume flow in the expiration phase to a predetermined maximum value and/or compared to that by setting parameters of the stimulation signals emitted by the at least one signal emission device to reduce the mean intrinsic volume flow of the living being in the expiratory phase.

19. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to reduce the duration of the expiration phase compared to the mean intrinsic duration of the expiration phase of the living being by setting parameters of the stimulation signals emitted by the at least one signal emission device.

20. Electrical stimulation device according to one of the preceding claims, characterized in that the control device is set up to increase the strength of the stimulation signals emitted by the at least one signal output device in the course of a breathing cycle in the inspiration phase and to decrease it again in the expiration phase.

21 . Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to have a flow control actuator which is pneumatically and/or electrically coupled to the respiratory system of the living being and by means of which the volume flow of the air flow flowing into and/or out of the living being can be adjusted is to be controlled variably in the course of a breathing cycle, such that by the flow control actuator limits or reduces the volume flow in the inspiration phase and/or the expiration phase at least temporarily.

22. Electrostimulation device according to one of the preceding claims, characterized in that the spontaneous breathing impulse sensor is designed as a nerve impulse sensor, by which the breathing of the living being can be detected by controlling nerve impulse signals of the living being.

23. Electrostimulation device according to one of the preceding claims, characterized in that the control device can be connected via an interface to a ventilator which is set up to ventilate the living being by generating variable positive pressure and/or negative pressure, the control device for data exchange with a control device of the ventilator is set up.

24. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to store characteristic data of one or more breathing cycles of the living being, which quantitatively characterize the respective breathing cycle.

25. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to initially bring about a deep inhalation in the respiratory cycle by appropriately adjusting the strength of the stimulation signals emitted by the at least one signal output device.

26. Electrostimulation device according to claim 25, characterized in that the control device is set up to, following the deep inhalation by setting parameters of the stimulation signals emitted by the at least one signal output device, one or more partial exhalations with an exhalation compared to the average shortened expiratory time and/or increased strength of the stimulation signals.

27. Electrostimulation device according to claim 25 or 26, characterized in that the control device is set up to cause a secretion mobilization stimulation by setting parameters of the stimulation signals emitted by the at least one signal output device and to cause deep inspiration following the secretion mobilization stimulation.

28. Electrostimulation device according to one of the preceding claims, characterized in that the control device is set up to stimulate selectively pure chest breathing, pure abdominal breathing or a combination thereof by the stimulation signals emitted, the strengths of the stimulation of abdominal breathing and chest breathing being independent of one another can be customizable.