Stimulation methods for electromagnetically or electrically controlled spontaneous breathing

Abstract

The present invention relates to an electrical stimulation device for stimulating one or more nerves and / or muscles of a living organism with electrical signals, comprising: a) the electrical stimulation apparatus has at least one signal output device, whereby the generated electrical stimulation signal can be supplied to at least one nerve and / or one muscle; b) the electrical stimulation apparatus has at least one control device, the at least one control device being configured to activate the at least one signal output device in such a manner that a stimulation signal output by the at least one signal output device is capable of generating muscle contractions in the organism, whereby respiration of the organism can be influenced in a goal-directed manner. The present invention relates to an electrical stimulation device having the following characteristics.

Description

[Technical field]

[0001] The present invention relates to a stimulation method for electromagnetically or electrically controlled spontaneous breathing. [Background technology]

[0002] Principles of ventilation Respiration occurs to maintain gas exchange, i.e., the simultaneous intake of oxygen and expulsion of carbon dioxide to sustain life.

[0003] Ventilation therapy ranges from assisted inspiration to completely mechanical inspiration to prevention of exhalation, depending on the nature and severity of the disease. In cases of respiratory pump fatigue, the respiratory muscles are relaxed during inspiration, or in cases of impaired gas exchange, exhalation is prevented to prevent further loss of gas exchange surface. As the severity of lung damage increases, the oxygen fraction during inspiration is increased, as well as the pressure to prevent exhalation.

[0004] If exhalation is not prevented adequately and in a timely manner during the course of the disease, then in the context of widespread lung damage in ARDS (Acute Respiratory Distress Syndrome) a very pronounced impairment of gas exchange occurs. The required work of breathing then increases significantly and eventually the respiratory muscles are unable to compensate. With increasing fatigue, respiratory failure progresses and breathing becomes faster and shallower. In addition to inspiration, expiration must then be treated together by ventilation.

[0005] Ventilation can be synchronously assisted with spontaneous breathing or controlled and independent of autonomous breathing. In the case of controlled ventilation, the breathing frequency, tidal volume or ventilation pressure are controlled and the breathing time ratio between inspiration and expiration is also predefined. In addition, there are forms of ventilation that allow autonomous breathing independent of ventilation and many mixed forms. A special form of respiratory therapy is called high-flow oxygen therapy, in which gas mixtures are used at high flows through nasal cannulas or masks.

[0006] Depending on the method of managing the airway, the terms invasive or non-invasive ventilation are adopted. When the airway is managed and ventilated by an endotracheal tube, it is called invasive ventilation. When ventilation is performed without a tube, it is called non-invasive ventilation or NIV. With negative pressure ventilation, NIV can be performed without airway access, but with positive pressure ventilation, airway access is always required. NIV with positive pressure can be performed through a ventilation helmet or with a mask that seals the entire face, the mouth and nose, or just the nose. Principles of Airway Management In the absence of protective reflexes, for example in anesthesia or coma, the airway is managed using a tube. The airway is then intended to be protected against aspiration, i.e. against the ingress of gastric contents into the trachea, which can also lead to ARDS. Intubation is also performed when the patient cannot tolerate NIV any longer or when NIV is unsuccessful. As soon as the lung damage expands and high ventilation pressures and high oxygen fractions are required, NIV with positive pressure ventilation becomes unsafe and even very dangerous beyond certain limits. Even the slipping of the mask, removal of the helmet, or the interruption required in NIV for intubation with current technology can result in inadequate gas exchange with life-threatening oxygen deficiency.

[0007] The intermediate stage of airway management encompasses what are called supraglottic airways or SGAs, such as the laryngeal mask, which has been used millions of times in anesthesia or emergency situations. Here, no hose is inserted into the trachea through the glottis, instead the larynx is enclosed and sealed from the outside and ventilation can be performed. Gastric juices can be drained through a hose built into the larynx. All guidelines on airway management recommend the immediate insertion of an SGA if intubation fails and positive pressure ventilation through a mask is also not possible. However, compared to an endotracheal tube, the degree of airway management provided with an SGA is lower and reaches its limits at high ventilation pressures and high oxygen fractions. The airway can be partially closed by the glottis or completely closed by the roof of the larynx or by a displacement of the SGA, with the result that the patient's life is also seriously endangered, especially when the oxygen requirement is high. Principles of Lung Injury In the case of widespread lung damage or ARDS, exhalation is especially important because ARDS necessarily involves pathological changes such as loss of gas exchange surface due to collapse of lung areas, increased permeability between capillaries and alveoli, and / or viral infection of lung cells, such that surface active components or surfactants can no longer stabilize the alveoli during exhalation. However, blood continues to circulate through the collapsed, non-ventilated lung areas, oxygen uptake decreases, and life-threatening oxygen deficiency develops despite oxygen administration. This was recognized as early as 1967 by those who first described ARDS, who also recognized that the collapse during exhalation could be counterbalanced by providing ventilation. Since then, positive pressure ventilation during exhalation has been used to try to prevent the collapse of damaged lung areas. This is called positive end-expiratory pressure or PEEP. The higher the PEEP, the higher the level at which exhalation is prevented and maintained. Therefore, the respiratory state also shifts to inspiration, resulting in an increase in expiratory reserve volume (ERV) and a decrease in inspiratory reserve volume (IRV) (Figures 3 to 5). Current situation and problems the invention aims to solve The more invasive the treatment method, the more adverse effects and complications associated with the treatment, so that currently the lungs, respiratory and other organ systems are further damaged by the therapy itself. Moreover, modern therapeutic procedures are becoming more and more complex and susceptible to errors, and therefore more and more highly specialized personnel are required. For this reason, intensive care medicine in particular is the most expensive area in today's health care system, and in some countries, this has led to a decrease in intensive care capacity and a decrease in the availability of treatment facilities. Obviously, the risk of death of ventilated patients varies greatly from country to country.

[0008] Comparing European countries, Germany has the highest number of intensive care beds per capita, but the quality of care varies considerably. Even in Germany, there are significant differences in survival rates for ventilated patients between different levels of hospital care, and in the case of extensive lung damage (ARDS), the differences are even greater: for more than 50 years now, at least 50% of ARDS patients have not survived ventilation outside of specialized centers. Mortality rates for ventilated patients without ARDS are 31% in non-university hospitals, which is 50% higher than in university hospitals. For ventilated ARDS patients, not only is the mortality rate twice as high in non-university hospitals compared to university hospitals, but the mortality difference is also twice as high. The independent risk of death for ARDS is even three times higher (ref. 1).

[0009] One of the main problems is invasive positive pressure ventilation with an endotracheal tube. Even so-called lung-protective ventilation further damages already damaged lungs and respiratory muscles, as well as other organ systems. Moreover, invasive positive pressure ventilation with an endotracheal tube causes a whole chain reaction of life-threatening complications. Mainly because of the tube, up to 50% of patients who are invasively ventilated develop further lung inflammation and further damage to the lungs as well as other organ systems. As a result, analgesic sedation is required for shielding and attenuation, since the endotracheal tube further activates prominent defense reflexes. This has many side effects and leads to further serious complications. Thus, in most cases, overhang occurs, which prolongs the duration of ventilation and therefore frequently causes ventilation-related complications. In addition, sedation can considerably impair circulatory function, especially when combined with positive pressure ventilation, and therefore requires the continuous administration of drugs that support circulation. These so-called catecholamines can consequently weaken blood circulation in the organs and accelerate the dysfunction of some organ systems. Ventilated patients with very extensive pulmonary involvement are often treated in the prone position and therefore require particularly deep sedation.

[0010] Ventilation can also be performed without a tube. However, it may be difficult to adapt this so-called non-invasive ventilation efficiently enough to the severity of the lung injury to avoid collapse of lung areas and increased respiratory failure. The ensuing increase in respiratory drive causes stronger and deeper breaths, which in turn causes further lung injury. Summary of the Invention [Problem to be solved by the invention]

[0011] Object of the invention It is an object of the present invention to make available a device, a method and a computer program with which the aforementioned problems can at least be alleviated. [Means for solving the problem]

[0012] Description of the invention A person controls spontaneous breathing exclusively by himself, deliberately or subconsciously. However, autonomous breathing, in contrast to spontaneous breathing, can be controlled by electromagnetic or electrical stimulation. The respiratory muscles can be controlled non-invasively in a painless manner so that sufficient ventilation can be achieved by electromagnetic stimulation (Ref. 2). The phrenic nerve can also be directly stimulated by implanted electrodes. However, in contrast to electromagnetic stimulation, electrical stimulation, which is performed non-invasively through the skin, externally, without implanted electrodes, is painful using modern techniques. Novel techniques for painless electrical stimulation are under development. Thus, conventionally, electromagnetic stimulation is the only way autonomous breathing can be directly controlled non-invasively and painlessly.

[0013] This ventilation method developed by the inventors therefore represents the most natural form of non-invasive artificial ventilation. In contrast to all forms of negative and positive pressure ventilation, electromagnetically controlled autonomous ventilation is the only form of ventilation in which the patient can be ventilated by natural pressure fluctuations in the chest and abdomen. With this novel form of ventilation, the existing conflict between lung-protective ventilation and diaphragm-protective ventilation can be eliminated, since the lungs and diaphragm can be effectively and gently ventilated under electromagnetic breathing. By individually controlling autonomous breathing, both inappropriate and excessive respiratory efforts and the complications associated with these can be avoided.

[0014] Electromagnetic or electrical ventilation can be performed independently of spontaneous breathing, with or without spontaneous breathing, or in synchronization with spontaneous breathing. Depending on the disease and respiratory disorder, autonomous breathing can be appropriately modified, controlled and / or monitored by seven different electromagnetic or electrical stimulation patterns, classified into three groups.

[0015] In addition to electromagnetic or electrical stimulation of the phrenic nerve in the neck, stimulation can also be applied to higher or more peripherally located nerve structures, allowing targeted control of abdominal and thoracic breathing.

[0016] The stated object of the present invention is achieved by an electrostimulation device as claimed in claim 1. This object is additionally achieved by a method for stimulating one or more nerves and / or muscles of an organism with electrically, electromagnetically and / or magnetically generated stimulation signals, which stimulation signals are supplied to at least one nerve and / or one muscle of the organism, in such a way that muscle contractions of the organism are generated in a target-directed manner, which muscle contractions target-directedly influence the respiration of the organism. This object is further achieved when a computer program is executed on a computer with program coding means configured to perform such a method.

[0017] In particular, one, some or all of the following features of the electro-stimulation device and / or method steps are provided herein:

[0018] The intensity of the stimulation signal output by the at least one signal output device may be varied in steps and / or uniformly over the respiratory cycle of the organism, as will be explained further below in the section on stimulation method 1. In this case, the stimulation signal may be determined with the aim of minimizing the energy input to the lung tissue and diaphragm tissue of the organism in particular.

[0019] To at least partially prevent exhalation, the intensity of the stimulation signal output by the at least one signal output device may be maintained at a high level during exhalation of the organism, at which the muscle contraction generated by the stimulation signal is greater than zero, but at least such that at the end of exhalation, up to 75% of the inspiratory reserve volume is still present in the lungs, as further explained in this regard in the section on stimulation method 2 below.

[0020] By setting the parameters of the stimulation signal output by the at least one signal output device, the breathing of the organism can be controlled or adjusted to a predefined value, value range and / or time variation of breathing depth, as further explained in this regard in the section Stimulation Method 3 below.

[0021] By setting the parameters of the stimulation signal output by at least one signal output device, the respiration of the organism can be controlled or adjusted to a respiration frequency higher than 40 respiration cycles / min. In this way, stimulation of the movement of secretions can be performed. In this connection, further explanation is given below in the section Stimulation method 4, Stimulation of the movement of secretions. With this function, it is possible in particular to control or adjust higher than 60 respiration cycles / min. For example, 200-300 respiration cycles / min are possible with low amplitude muscle stimulation.

[0022] By setting the parameters of the stimulation signal output by at least one signal output device, the breathing of the organism can be controlled or adjusted to a breathing depth that is too low for the gas exchange that sustains the organism's life for a limited period of time. In this way, the organism's breathing movement is also performed without sufficient breathing, i.e. the volume of air flowing into and out of the lungs is insufficient. In this way, for example, the movement of secretions can be stimulated or the respiratory muscles can be trained.

[0023] Complete exhalation can be prevented by setting the parameters of the stimulation signal output by at least one signal output device so that the exhalation period (duration of the expiratory phase) of the organism is 0.2 to 1.3 times the inhalation period (duration of the inhalation phase). In addition, the intensity of the stimulation signal can be increased compared to the normal breathing cycle in order to generate the highest volumetric flow rate during exhalation. In this way, exhalation can be forced or accelerated or a cough stimulation can be performed. In this connection, further explanations are given below in the section Stimulation method 4, Cough stimulation. The duration of the inhalation phase used as a reference for this purpose can be, for example, the duration of the inhalation phase of the same breathing cycle, the average of the durations of several previous inhalation phases or a standard value of the duration of the inhalation phase determined for the respective organism.

[0024] By setting the parameters of the stimulation signal output by the at least one signal output device, the characteristics of the respiratory cycle can be controlled to predetermined target characteristics of the respiratory cycle, as further explained in this regard in the section Stimulation Method 4 below.

[0025] By setting the parameters of the stimulation signal output by the at least one signal output device, it is possible to adjust the characteristics of the breathing cycle to predefined target characteristics of the breathing cycle depending on measurements of the current characteristics of the breathing cycle of the living being, for example determined continuously by at least one sensor, as will be explained further in this regard below in the section on stimulation method 4.

[0026] For both of the aforementioned functions, the target characteristic may in particular be a characteristic that avoids damage to the lungs. In particular, self-destructive breathing patterns of the organism may be avoided in this way. The control device may also be configured to limit the respiratory volume flow rate, the respiratory movement and / or the transpulmonary pressure to a predetermined maximum value using the stimulation signal.

[0027] The parameters of the stimulation signal output by the at least one signal output device can be changed depending on the current measured value of the spontaneous breathing pulse of the living organism, in particular in a manner synchronous with the spontaneous breathing pulse. In this way, the spontaneous breathing pulse of the living organism can be blocked or changed. The measured value can be continuously measured by at least one spontaneous breathing impulse sensor capable of detecting the spontaneous breathing impulse of the living organism. In this connection, further explanation is given below in the section on stimulation method 5. The spontaneous breathing impulse sensor can be designed as a nerve impulse sensor capable of detecting the nerve impulse signal of the living organism that controls the breathing of the living organism. It is also possible that the signal output device for outputting the stimulation signal simultaneously forms a nerve impulse sensor, for example in the case of electromagnetic stimulation. For example, such a signal output device can be designed as a coil or a coil arrangement. The nerve impulses can also be detected with a coil or a coil arrangement.

[0028] Intra-abdominal pressure is the pressure within an organism's abdominal cavity.

[0029] The pressure inside the abdominal cavity (intracerebrospinal pressure, IAP) increases with inspiration and decreases with expiration. Thus, during spontaneous breathing, a pressure difference occurs between the thoracic and abdominal cavities. The respiratory muscles can cause small but strong pressure fluctuations in the abdominal cavity. These pressure fluctuations affect the function of the abdominal organs.

[0030] By setting the parameters of the stimulation signal output by at least one signal output device, it is possible to control or regulate the intraperitoneal pressure of the organism to a predefined value, value range and / or time variation. In this way, the intraperitoneal pressure can be influenced in a goal-directed manner. For example, by this means, the blood circulation in certain organs can be improved. For example, positive influences on the abdominal organs can be achieved. As with spontaneous breathing, the stimulation creates a natural pressure difference between the thoracic and abdominal cavities, which can also induce natural but strong pressure fluctuations in the abdominal cavity, which positively affect the function of the abdominal organs, for example, bowel movements and other bowel functions, the blood supply of the organs, or lymphatic drainage. This can decisively contribute to an improved prognosis. For example, relying on the existing intraperitoneal pressure achieved by the contraction of the diaphragm, the depth and duration of inspiration, as well as the level and duration of expiration, can be controlled in a goal-directed manner.

[0031] Thus, the stimulation can be target-directedly controlled not only for the depth and duration of inspiration, but also for the level and duration of expiration, depending on the existing intra-abdominal pressure that is influenced by breathing. If the intra-abdominal pressure rises to the point that the blood circulation of the abdominal organs is impaired, for example in intra-abdominal hypertension (IAP>1200 Pa (12 mbar)), the stimulation can be weakened accordingly, not only for inspiration but also for expiration.

[0032] By setting the parameters of the stimulation signal output by at least one signal output device, a goal-directed excitation of the respiratory nerves and / or respiratory center can be performed. In this way, the respiratory nerves and / or respiratory center are only activated in a goal-directed manner without significantly affecting the respiratory muscles. In particular, this does not cause sufficient stimulation of the respiratory muscles for gas exchange to sustain the life of the organism. This can be achieved, for example, if the intensity of the stimulation signal is low and muscle contraction is virtually nonexistent. In this way, the respiratory nerves and respiratory center can still be activated and / or activity can be maintained.

[0033] Ventilation weakens the work of breathing of the respiratory muscles, which are passive in ventilation and in which respiratory nerve activity is diminished or may even disappear altogether. This applies to both the efferent motor neurons that activate the muscles and the afferent sensory nerve pathways that detect the degree and rate of muscle contraction and the corresponding positional changes and report this to the respiratory center for feedback.

[0034] In addition to the activity of the efferent and afferent nerve pathways, the activity of neurons in the respiratory center in the brainstem region also decreases accordingly during ventilation. The activity of the respiratory center weakens after only a few minutes of ventilation time. After ventilation has stopped, it is possible to activate the respiratory center consciously, i.e. by the cerebral cortex, but breathing then feels difficult, even if it is not. When spontaneous breathing is fully restored in a healthy organism, a short time after ventilation has stopped, natural, autonomous spontaneous breathing is restored and is controlled by the respiratory center.

[0035] With this stimulation method for activating and / or maintaining activity of the respiratory nerves and respiratory reflexes, it is intended that the efferent neurons, i.e., motor nerve pathways and the afferent neurons, i.e., sensory nerve pathways, involving the neurons of the respiratory center in the brainstem region are activated and / or maintained active. As with the control, training, etc. of secretion movement and coughing, this stimulation method does not require sufficient breathing to maintain gas exchange.

[0036] By setting the parameters of the stimulation signal output by at least one signal output device, the characteristics of the respiratory cycle can be controlled or adjusted to a predetermined target characteristic of the respiratory cycle over a number of respiratory cycles, then the respiratory cycle of the organism is not affected over a number of respiratory cycles, and then the characteristics of the respiratory cycle can be controlled or adjusted again to the predetermined target characteristic of the respiratory cycle over a number of respiratory cycles. In this regard, further explanation is given below in the section on stimulation method 6.

[0037] By setting the parameters of the stimulation signal output by at least one signal output device, it is possible to excite muscle contractions of the respiratory muscles of the organism that are not necessary for the gas exchange carried out by the organism's breathing over a number of breathing cycles, thus generating additional muscle training. In this way, a goal-directed muscle training of the respiratory muscles can be performed. In this connection, further explanations are given in section 7 of the stimulation method below, in particular in 7.1, 7.5 and 7.6. With this type of stimulation, the effect on the actual breathing depth is either absent or too small for the gas exchange to sustain the organism's life. The purpose of this stimulation is the training of the respiratory muscles, which training does not impair the respiratory system, in particular the lung tissue and the diaphragm muscle strength.

[0038] By setting the parameters of the stimulation signal output by the at least one signal output device, it is possible to control or adjust the breathing state to an increased value and / or to move the breathing state to an inspiration phase, as will be explained further in this regard in section 7.2 Stimulation Method below.

[0039] By setting the parameters of the stimulation signal output by the at least one signal output device, the breathing of the living organism can be adjusted to a predefined value, value range and / or time variation of the breathing depth based on the current measured value of the breathing depth. For this purpose, a breathing depth sensor can be used that continuously detects the measured value of the breathing depth of the living organism. In this regard, further explanation is given below in the stimulation methods 3 and 7.3 sections.

[0040] By setting the parameters of the stimulation signal output by the at least one signal output device, the breathing depth and / or the volumetric flow during the inspiration phase can be limited to a predefined maximum value, as will be explained further in this regard in sections Stimulation methods 4 and 7.4 below.

[0041] By setting the parameters of the stimulation signal output by at least one signal output device, the volumetric flow rate during the expiratory phase can be limited to a predetermined maximum value and / or reduced compared to the average intrinsic volumetric flow rate of the organism during the expiratory phase.

[0042] By setting the parameters of the stimulation signal output by the at least one signal output device, the duration of the expiratory phase can be shortened compared to the average inherent duration of the expiratory phase of the organism, in particular, complete exhalation of the organism can be prevented by the stimulation signal, i.e. at least a certain residual amount of air can be preserved in the lungs.

[0043] Over a respiratory cycle, the intensity of the stimulation signal output by the at least one signal output device can be increased during the inspiration phase and decreased again during the expiration phase, in this way the energy input into the tissue of the organism can be minimized.

[0044] A throughflow control actuator pneumatically and / or electrically coupled to the organism's respiratory system and capable of adjusting the volumetric flow rate of air inflow and / or outflow of the organism can be variably activated over the breathing cycle in such a way that the throughflow control actuator at least temporarily limits or reduces the volumetric flow rate in the inspiration phase and / or in the expiration phase. The throughflow control actuator can, for example, comprise an electrically actuable valve in a breathing mask or breathing hose. The throughflow control actuator can be an electrical actuator that can stimulate the organism's larynx, for example by electromagnetic laryngeal stimulation. In this way, for example during expiration, a defined and desired resistance to the expiratory airflow can be generated, which keeps the airways and alveoli open.

[0045] The control device is connectable via an interface to a ventilator configured to ventilate an organism by generating variable positive and / or negative pressure and is configured to exchange data with the control device of the ventilator. This has the advantage that the control device of the electro-stimulation apparatus can use data, in particular measurements present with the ventilator, such as measurements of volumetric flow rate, breathing depth, etc. Thus, such sensors are not required in the electro-stimulation apparatus.

[0046] By appropriately adapting the intensity of the stimulation signal output by the at least one stimulation device, a deep inspiration can be brought about at the beginning of the breathing cycle, which in the case of the stimulation method 2 can be advantageous, for example, to open the lungs with a deep inspiration at the beginning and to perform incremental stimulation accordingly. In the case of cough stimulation, bringing about a deep inspiration at the beginning of the breathing cycle can be advantageous, for example, to obtain a maximum volume of air in the lungs and to facilitate a cough stimulation, since a large amount of air is available to generate a large volume flow rate in the expiration.

[0047] For example, by appropriately adapting the intensity of the stimulation signal output by the at least one signal output device, it is possible to perform a cough stimulation when a deep inspiration is provided at the beginning of a breathing cycle, and after a deep inspiration, by setting the parameters of the stimulation signal output by the at least one signal output device, for example by preventing a complete exhalation or by providing one or more partial exhalations with a shortened exhalation period and / or an increased intensity of the stimulation signal compared to an average exhalation, for example by providing an exhalation period that is 0.2 to 1.3 times the inhalation period. In addition, the intensity of the stimulation signal may be increased compared to a normal breathing cycle in order to generate the highest volumetric flow rate during exhalation. In particular, after a deep inspiration, by appropriately adapting the intensity of the stimulation signal output by the at least one signal output device, several such exhalations can be generated with shortened exhalation periods and / or with the highest volumetric flow rate, without an inspiration being generated in between.

[0048] It is further advantageous to perform such a cough stimulation immediately after stimulating the movement of secretions. As previously described, the movement of secretions may be stimulated by setting parameters of the stimulation signal output by at least one signal output device to control or regulate the breathing of the organism to a breathing frequency higher than 40 respiratory cycles / minute.

[0049] Based on the output stimulation signal, pure thoracic breathing, pure abdominal breathing or a combination thereof can be alternately stimulated. The intensity of the stimulation of abdominal breathing and the intensity of the stimulation of thoracic breathing can be adapted independently of each other. In this way, thoracic breathing and abdominal breathing can be stimulated independently of each other. Thus, the activation of the thorax is improved and the respiratory state is transferred to inspiration, and the total cross-sectional area of ​​the diaphragm can be significantly increased throughout the entire respiratory cycle by continuously preventing expiration. In this way, breathing can now be performed much more effectively, independently of thoracic breathing, with much less respiratory effort and therefore much less stress on the lungs and diaphragm.

[0050] An electrically, electromagnetically and / or magnetically generated stimulation signal can now be supplied by a signal output device to at least one nerve and / or one muscle. The strength of the stimulation signal can be defined, for example, by the magnitude of the voltage or current, the power, the magnitude of a magnetic variable, and / or the short-term average value of one or more such variables. For example, the signal supplied to the signal output device to generate the stimulation signal can be an alternating voltage or current signal, or other pulsed signal train.

[0051] The signal output device can in principle be any desired signal output device or a combination of several signal output devices, by which such an electrical stimulation signal can be supplied to at least one nerve and / or one muscle. In this way, by the signal output device, a muscle can be excited to contract directly by an electrical signal and / or indirectly by electrical stimulation of a corresponding nerve, which can excite a muscle contraction. For example, the signal output device can have an implanted electrode, which is implanted in a suitable position in the body of the living being and supplies the stimulation signal directly to the body.

[0052] In an advantageous embodiment, the signal output device has a signal output element, which can be placed outside the organism and therefore does not need to be implanted. In this way, invasive steps can be avoided. For example, the signal output element can have one or more electric coils, by which an electric signal can be inductively supplied to at least one nerve and / or one muscle. Such coils can supply a magnetic field to the organism, which generates an induced current inside the body, generating a desired electric stimulation signal in at least one nerve and / or one muscle. For this purpose, coils or coil arrangements can be used, for example, according to WO 2019 / 154837 A1 or WO 2020 / 079266 A1.

[0053] The signal output element may also comprise electrodes that are positioned on the body of the organism, for example secured to the skin, and that can galvanically couple an electrical signal to the body.Furthermore, the signal element may have capacitive electrodes through which the electrical stimulation signal can be supplied to the organism by capacitive coupling, i.e. without galvanic contact with the organism.

[0054] The electrical stimulation device can in principle be configured to stimulate any desired nerve to target-directedly affect the respiration of an organism. This includes not only the stimulation of the respiratory muscles in the neck region, but also the stimulation of nerve roots and even nerves in brain regions, for example the brainstem and / or the cerebellum. For example, the electrical stimulation device can be designed to stimulate one or more of the nerves, such as the phrenic nerve, one or more intercostal nerves, the first, second and third motor neurons, as long as they are capable of activating the respiratory movement.

[0055] For the desired influence of the respiration of the living being by the stimulation signal, the signal output device or its signal output element is designed so that it can be appropriately and safely placed in a suitable position in the living being, for example in the region of the phrenic nerve near the head to stimulate the diaphragm and / or in the region of one or more intercostal nerves to stimulate thoracic breathing, for which purpose the signal output element is adapted in terms of shape and properties to this suitable position in the living being.

[0056] The control device may for example have a parameter memory for storing one or more respiratory characteristics of an organism, in which it may be configured to prestore representative characteristics of such organisms or characteristics of individual organisms to be treated. In this case, the electrostimulation device may also be designed without a measuring device, in particular without feedback of the measuring signal in the sense of a control circuit.

[0057] The electrical stimulation device may also have a measuring device with one or more sensors, whereby characteristics of the respiratory cycle of the organism are sensed at a certain time or continuously and provided to the control device. In this case, the characteristics may be stored at least temporarily in the control device. Furthermore, further characteristics of the respiratory cycle, predefined in the control device, may be stored in a parameter memory as described above.

[0058] The control device may in particular be designed as an electronic control device having a computer which controls the individual functions of the electro-stimulation device, and a computer program may be stored in the control device which programs the corresponding functions so that the computer executes the computer program.

[0059] When a computer is mentioned, the corresponding functions may be configured to execute a computer program, for example in the software sense. The computer may be designed as a conventional computer, for example a PC, a laptop, a notebook, a tablet or a smartphone, or as a microprocessor, a microcontroller or an FPGA, or as a combination of such elements.

[0060] When regulation is mentioned, it differs from control in the sense that it involves the feedback of measurements or internal values, whereby the output values ​​produced by regulation are influenced in the sense of a closed-loop control circuit, whereas in the case of control, variables are purely controlled without such feedback.

[0061] When the expression "respiratory depth" is used, it also includes the actual respiratory depth and the apparent respiratory depth of an organism. The actual respiratory depth is defined by the size of the tidal volume actually exchanged with the environment during expiration. The tidal volume is the volume of air inhaled and exhaled, i.e. the volume of air ventilated per breath. The apparent respiratory depth is defined by the size of the tidal volume that would be expected to result from the movement of the respiratory muscles if breathing could be performed unhindered. In many cases, the apparent respiratory depth should correspond to the actual respiratory depth. However, the actual respiratory depth may deviate considerably from the apparent respiratory depth, for example, when the airways are totally or partially obstructed and / or the lungs show pathological changes.

[0062] The actual breathing depth of an organism can be detected based on different variables, such as, for example, the tidal volume and / or the magnitude of the transpulmonary pressure (TPP). The level of the tidal volume depends on the level of the transpulmonary pressure. The transpulmonary pressure is the pressure difference between the pressure in the air-filled space of the lungs and the pressure at the outer edge of the lungs between the two pleura. The transpulmonary pressure is therefore the difference between the intrapulmonary pressure and the intrathoracic pressure, or in other words, the difference between the intraalveolar pressure and the intrathoracic pressure. The intraalveolar pressure can only be detected indirectly by measurements in the airway or ventilation system. The intrathoracic pressure corresponds approximately to the pressure in the esophagus. The transpulmonary pressure can be determined, for example, by measuring the pressure in the ventilation system or in the esophagus of the organism. The transpulmonary pressure is then the difference between the ventilation pressure and the esophageal pressure.

[0063] The apparent respiration depth may be detected based on various variables, for example by detecting the organism's movements, such as chest and / or abdominal movements caused by muscle contractions. Another possibility for detecting or characterizing the apparent respiration depth is to determine the electrical and / or mechanical energy or force required to generate the organism's respiratory movement to generate a respiratory volumetric flow rate. Thus, the apparent respiration depth may be determined, at least approximately, based on the strength of the stimulation signal output by at least one signal output device.

[0064] The respiratory volumetric flow rate indicates the amount of air that an organism actually inhales or exhales per unit time. The respiratory cycle includes an inhalation phase (also called inspiration or inspiration for short) followed immediately by an exhalation phase (also called expiration or exhalation for short). At the end of resting inspiration there is an inspiratory reserve volume (IRV), which is the lung volume that can still be inhaled. At the end of resting expiration there is an expiratory reserve volume (ERV), which is the lung volume that can still be exhaled. Thus, at rest breathing takes place in a state of breathing defined between the inspiratory reserve volume and the expiratory reserve volume (Figures 3 and 4).

[0065] During resting breathing, when exhalation is at least partially prevented in each respiratory cycle, the respiratory state transitions to inspiration, where expiratory reserve increases and inspiratory reserve decreases (Figure 5). Such transitions in respiratory state are achieved by preventing exhalation by: 1. slowing the respiratory flow during exhalation, 2. maintaining exhalation at a defined level, and / or 3. shortening the exhalation time.

[0066] The functions described below are performed by a control device and may be designed, for example, as functions of a computer program(s) or computer program modules. Where a function is performed by a control device, the control device may perform the corresponding function automatically. Many functions of the electro-stimulation device may also be set and / or controlled manually by a user. This includes functions that may be optionally performed by a control device.

[0067] The invention therefore also relates to a method for stimulating one or more nerves and / or muscles of a living organism using stimulation signals generated electrically, electromagnetically and / or magnetically by such an electrostimulation apparatus, in which the specified functions are performed manually, such as, for example, modulating the intensity of the stimulation signal output by at least one signal output device, and to a computer program for carrying out such a method.

[0068] For respiratory monitoring, feedback and control the following may further be provided:

[0069] Various monitoring parameters and feedback mechanisms may be used to control stimulation. For this purpose, as in conventional ventilation, one, some or all of the following may be sensed: parameters of gas exchange, such as oxygen intake and carbon dioxide release, and respiratory parameters, such as respiratory impulse, respiratory frequency, tidal volume, respiratory rate, levels of expiration and inspiration, of the organism. This monitoring may also be capable of sensing separately, distinguishing between thoracic and abdominal breathing.

[0070] A particular role plays both in the adjustments during stimulation and in the effects achieved after stimulation, the parameters that dictate the transition between enhanced and relaxed breathing and thus the increase in respiratory drive. These include, for example, the quotient of respiratory frequency and tidal volume (RSB or rapid superficial breathing index), the P0.1 value, the strength of the respiratory flow (quotient of tidal volume and inspiration time) and the degree of pressure fluctuations in the esophagus or across the diaphragm, within a defined range, for example, of 400-800 Pa (4-8 mbar).

[0071] In addition, spontaneous electrical activity of the phrenic nerve can also be sensed, for example electromagnetically as well, using an electroneurogram (ENG) and used for feedback. Spontaneous electrical activity of the phrenic nerve represents a direct measurement of central nerve respiratory activity and can be sensed, for example, by the number of impulses per breath, impulse frequency during peak inspiratory flow, or average activity over 0.1 seconds, and used for feedback and stimulation control.

[0072] Certain electromyographic patterns can also indicate the onset of fatigue. Electromyographic testing of spontaneous activity can be performed during rest periods between stimulations, so that the diaphragm electromyographic signal can be used as a direct measure of electrical muscle activity for electromagnetic or electrical respiratory feedback and control. In contrast, artifacts caused by electromagnetic stimulation can make measurements difficult or impossible. Now, with special stimulation algorithms, muscle activity can be detected at regular intervals without artifacts and then used to control further stimulation. This control takes into account the fact that spontaneous activity is neither too low nor too high, for example not exceeding 8% of maximum activity. Moreover, instruments directly coupled to each other can also allow filtering of electromagnetic signals. For example, electromyographic monitoring of the realized muscle activity is possible even during stimulation, thereby allowing direct feedback.

[0073] The relationship between electrical stimulation and the resulting mechanical muscle activity depends on the force-to-length and force-to-velocity ratios, and therefore on the volume and shape of the thorax, as well as on the pathological process. For example, during the course of a disease, the diaphragm force may decrease even though the electrical muscle stimulation increases. Monitoring the diaphragm force is therefore particularly advantageous for feedback purposes to control the training stimulus. In addition to indirect parameters such as RSB and P0.1 values, ultrasound measurements of the diaphragm movement and thickening can provide indirect indicators of diaphragm force. In the standard method, which has been used for many years, the diaphragm force is indirectly sensed by the pressure fluctuations between the thoracic and abdominal cavities. The phrenic nerve is stimulated with an electromagnetic standard stimulus, and the resulting transdiaphragmatic pressure fluctuations are measured by balloon catheters in the esophagus and stomach. From this, the diaphragm force can be determined.

[0074] Further advantageous features and method steps are described in detail below. Group 1: Lung-dependent stimulation 1. Lung-sparing stimulation for low-energy delivery 2. Stimulation of recruitment and stabilization to open collapsed lung areas and maintain open areas 3. Lung-protective stimulation to control tidal volume Group 2: Respiratory-related irritation 4. Controlled Stimulation to Control Noxious Autonomic Breathing 5. Modulation Stimuli to Regulate Spontaneous Breathing Group 3: Conditioning and training stimuli 6. Coordination stimulation to implement improved breathing patterns 7. Training stimuli for training respiratory muscles Group 1: Lung-dependent stimulation Lung preservation stimulation-stimulation method 1 Gentle, particularly low-energy breathing is achieved by a pattern of stepwise increasing impulse stimulation intensity during inspiration and decreasing impulse stimulation intensity during expiration. In this way, sudden respiratory movements are avoided, thereby minimizing energy transfer to the lung tissue and lung damage caused by the breathing itself. This principle is based on the newly developed breathing pattern of flow-controlled ventilation (FCV) (ref. 3) (see also PCT / EP2017 / 052001).

[0075] In this flow-controlled ventilation, the conflict between lung-sparing ventilation and diaphragm-sparing ventilation is very pronounced, since spontaneous breathing should not be possible during FCV. However, stimulation method 1 can be synchronized with FCV. Such synchronization between electromagnetic or electrical stimulation and FCV simultaneously promotes autonomous breathing, thus allowing the preservation of respiratory muscles and their strength in FCV.

[0076] During natural spontaneous breathing, the diaphragm is also active during expiration. This activity, called expiratory inhibition, inhibits expiration and stabilizes the lungs. When expiratory resistance increases, this natural activity of the diaphragm during expiration decreases. This lung-sparing stimulation also results in a stimulation of decreasing intensity during the expiratory phase. Complete expiration is very short or avoided altogether (see stabilizing stimulation with stimulation method 2). This opposes the collapse of lung tissue. In this way, it is possible to prevent not only impaired gas exchange, but also increased respiratory failure due to increased respiratory drive and harmful spontaneous breathing patterns.

[0077] In addition, as a result of the conditioning effect of this type of stimulation, this gentle breathing pattern is trained (see conditioning stimulation with stimulation method 6). Furthermore, both the strength and the muscle mass of the respiratory muscles are maintained and trained, which is particularly important during conventional ventilation and especially during flow-controlled ventilation (FCV) (see training stimulation with stimulation method 7.1). Titration and Stabilization Stimulation - Stimulation Method 2 Stimulation method 2 results in occasional deep exhalations combined with the prevention and / or slowing of exhalation (see above). This stimulation method reinforces the collapsed lung areas and stabilizes the lungs by preventing and / or slowing of exhalation. In this way, renewal of the collapse is prevented.

[0078] In incremental stimulation, it is possible to set the duration of the inhalation and exhalation phases as well as the depth of inspiration. Thus, to improve the efficiency of incremental stimulation, the time ratio of breathing can be changed, the time of maximum inspiration can be extended and the time of expiration can be shortened.

[0079] In stabilizing stimulation, the end of expiration can be held at various levels by direct stimulation of the respiratory muscles, depending on the demands (expiratory hold). As explained in stimulation method 1, for example by reducing the intensity of the stimulation impulse during expiration, the rate of expiration can be further slowed down, similar to the natural expiratory inhibition mentioned above. Similarly, by varying the breathing time ratio, the collapse of the lung areas can be further prevented. By varying the stimulation time in stabilizing stimulation, it is possible to prolong the inspiration time and shorten the expiratory phase, as explained above with respect to incremental stabilization. In the expiratory phase, if stimulation is not possible or the degree of stimulation possible is insufficient, complete expiration can also be prevented by starting the electromagnetic or electrical stimulation of inspiration earlier (expiratory truncation). Now, as mentioned above, a close monitoring of the breathing, and in particular the breathing state, is advantageous, since the exact time for inspiration can be precisely established.

[0080] In addition, the stabilization stimulation can be optionally combined with a dynamically adapted increase in expiratory resistance, which results in further slowing of exhalation and thus further stabilization of the lungs during the expiratory phase. This can be performed synchronously in combination with the stimulation during exhalation. During spontaneous exhalation, the increase in expiratory resistance is achieved quite naturally by the vocal folds reopening during inspiration. The increase in expiratory resistance weakens the natural activity of the diaphragm for expiratory inhibition.

[0081] This stimulation method 2 also counteracts the increased work of breathing and respiratory drive resulting from increased lung collapse, preventing the associated further lung damage from self-destructive spontaneous breathing (see also control stimulation on the next page). Thus, recruitment and stabilization stimulation can indirectly reduce or even prevent not only the increase in the work of breathing and harmful respiratory effort, but also ventilation with large tidal volumes. Lung protection stimulation-stimulation method 3 The breathing depth is adjusted by means of stimulation during inspiration so that a gentle tidal volume, for example 6 ml / kg of ideal body weight, is breathed and / or the transpulmonary pressure of 500 Pa (5 mbar) is not exceeded. For this purpose, feedback can be made between the measured value of the tidal volume, the measured value of the transpulmonary pressure, or a corresponding correlation value, and the stimulation intensity, so that the stimulation can be adapted to the realized tidal volume and / or transpulmonary pressure. This is then not only done for subsequent breaths, but also by monitoring and feedback, the stimulation already in progress can be directly controlled. Thus, the ongoing stimulation intensity can be attenuated and / or the stimulation duration can be shortened, so that for example a tidal volume of 6 ml / kg defined for the ideal body weight and / or a transpulmonary pressure of 500 Pa (5 mbar) is not exceeded. This is particularly important during spontaneous breathing (see controlled and modulated stimulation, stimulation methods 4 and 5).

[0082] Moreover, even in pathological conditions with high levels of carbon dioxide exhalation, it is necessary to ensure sufficient ventilation. This is achieved by a properly adapted breathing frequency, in addition to the gradual increase and maintenance of the gas exchange surface and the level of tidal volume. The breathing frequency is defined not only by the occurrence of stimuli, but also by the ratio between the aforementioned inhalation and exhalation (the breathing time ratio, which can be set by the corresponding stimulation time). Group 2: Respiratory-related irritation Control Stimulation - Stimulation Method 4 This electromagnetic or electrical stimulation method provides the lungs with a gentler, controlled, autonomous breathing, independent of spontaneous breathing, even though the spontaneous breathing follows a completely different, possibly harmful, pattern. Thus, when the respiratory drive and effort increases, for example due to excessive work of breathing and increased fatigue, the stimulation can provide a goal-directed counter-control. Here, the enhanced, fast, deep breathing causes damage to the already injured lungs, and also damages the already weakened and similarly previously injured respiratory muscles. This increased lung damage, as well as diaphragm damage as a result of self-injurious spontaneous breathing, is referred to as Patient-Induced Lung Injury (P-SILI).

[0083] With this stimulation method, autonomous breathing can be controlled so that respiratory muscle overload and P-SILI can be reduced and even prevented. So far, electromagnetic or electrical stimulation is the only method by which autonomous breathing can be controlled and even optimized non-invasively and without drugs, independent of spontaneous breathing and the patient's will.

[0084] To control this stimulation method, a feedback mechanism may be used that takes into account important characteristics of spontaneous breathing and / or autonomous breathing that ultimately occurs together with the stimulation, where tidal volume, transpulmonary pressure, respiratory frequency, respiratory state and indirect characteristics of respiratory drive are particularly important to allow for flexible individual adaptation of the stimulation. Special forms of control stimuli: secretion movement and coughing These two methods of respiratory muscle stimulation are also performed independently of spontaneous breathing and fulfill a specific function independent of breathing, which is intended to move secretions from the peripheral airways to the central airways and then to be removed by coughing and finally from the airways. Stimulation of secretion movement: Using this stimulation method, secretions can be moved from peripheral to central airways, for example, by frequent short, rapid, forced expiration. Cough stimulation: this stimulation method can be performed immediately after the displacement of secretions, so as to displace the displaced secretions even more effectively and, above all, to be able to "cough them out". For this purpose, after a fairly long inspiration, there is a short cough or a series of short coughs. Forced expiration is more effective if, as in the case of a natural cough, the start of expiration is performed against an increased airway resistance, thus allowing the pressure in the lungs to increase. This short, synchronized increase in expiratory resistance can be achieved by a synchronized artificial resistance and / or a constriction of the vocal folds brought about by stimulation of the laryngeal nerve. Modulated Stimulation - Stimulation Method 5 In contrast to the control stimulation (see stimulation method 4 above), the modulation stimulation is performed as a function of the spontaneous breathing impulse, without being independent of the spontaneous breathing. Autonomic breathing is not controlled completely independent of the spontaneous breathing, and thus a partial or complete control of natural spontaneous breathing is performed, where the spontaneous breathing impulse is always taken into account, even if the respiratory impulse is weak or absent. Synchronization types Therefore, the spontaneous breathing impulse must be detected so that electromagnetic or electrical stimulation can be synchronized to it. Modulation stimulation can be synchronized with the aid of standard methods of detecting the spontaneous breathing pulse, such as variations in airflow pressure, flow rate, or temperature, or with body sensors such as the Graseby capsule or muscle activity sensors. However, synchronization with the actual nerve impulse that precedes the onset of spontaneous inspiration is much more accurate, and ventilation synchronized with the nerve impulse is referred to as neural assistance or neurally adjusted ventilatory assistance (NAVA). Here, the nerve impulse is detected by a sensor in the esophagus near the diaphragm (Ref. 4).

[0085] However, actual nerve impulses can also be sensed by non-invasive electromagnetic means, either peripherally, just above the stimulation site in the neck, or centrally, at the site of origin of the nerve impulses in the brainstem region. Breath level modulation Spontaneous breathing can then be changed synchronously with the modulation stimulation, as in the above stimulation methods 1 to 3. This can be done by stimulation throughout the respiratory cycle, such as lung-sparing stimulation, to achieve gentler spontaneous breathing. Depending on the disease and spontaneous breathing pattern, the modulation stimulation described in stimulation method 2 can also be performed only in the expiratory phase, to stabilize the lungs at different levels, by preventing and / or delaying exhalation. Modulation of tidal volume However, if required, stimulation can also be delivered synchronously only during the inspiration phase, so that collapsed lung areas can be reopened by intermittent very deep sustained breathing, as described in stimulation method 2. Furthermore, in cases of insufficient, superficial breathing, stimulation during spontaneous inspiration can also allow sufficient depth of breathing with a corresponding tidal volume. For this purpose, in addition to sensing the respiratory pulse, as also described in lung-protective stimulation (see stimulation method 3 above), feedback on the respiratory volume and / or transpulmonary pressure is also advantageous here.

[0086] Furthermore, it is possible to prevent breathing too deeply with excessive tidal volumes that would damage the lungs by "taking over" or inhibiting the spontaneous nerve impulse. Such a takeover can be achieved by stimulation targeted to the phrenic nerve just before the natural nerve impulse, so that the natural impulse cannot be delivered during the absolute refractory period of the nerve, but only in an attenuated form during the relative refractory period.

[0087] As mentioned above, excessive spontaneous tidal volumes can also be indirectly avoided by shifting the breathing state to inspiration and preventing expiration. A feedback mechanism using tidal volume measurement, as explained above in lung protective stimulation (stimulation method 3), is used here as well. Modulation of breathing frequency In previous stimulation methods of modulated stimulation, the spontaneous breathing frequency was not changed. However, if the spontaneous breathing frequency is too fast or too slow, it can be directly and / or indirectly influenced and controlled by electromagnetic or electrical stimulation. The resulting smooth transition to controlled autonomous breathing is regulated by sensing the spontaneous breathing frequency and a corresponding feedback mechanism.

[0088] Thus, the degree and rate of stimulation can be individually adapted according to the depth and rate of spontaneous breathing. If the spontaneous breathing frequency is too fast, it can be indirectly slowed down by lengthening the inspiratory and / or expiratory phases, and finally a lower frequency can be superimposed. The breathing frequency can also be indirectly slowed down by individual deep breathing due to an activated respiratory reflex.

[0089] As with conventional backup ventilation, if breathing is too slow or stops, the breathing frequency is increased directly using electromagnetically or electrically controlled autonomous breathing. If breathing slowly decreases, for example as the depth of coma increases, a sufficient breathing frequency can be achieved early by the corresponding stimulation frequency, before insufficient gas exchange due to oxygen deficiency occurs due to intermittent breathing. Modulation dependent on intraperitoneal pressure The pressure in the abdominal cavity (intracerebrospinal pressure, IAP) increases with inspiration and decreases with expiration. Thus, as in spontaneous breathing, a natural pressure difference exists between the thoracic and abdominal cavities. Stimulation of the respiratory muscles can result in natural as well as enhanced pressure variations in the abdominal cavity, influencing the functions of the abdominal organs, for example bowel motility, organ blood supply or lymphatic drainage, and contributing crucially to the prognosis of the ventilated patient.

[0090] Thus, the stimulation can be target-directedly controlled not only for the depth and duration of inspiration, but also for the level and duration of expiration, depending on the existing intra-abdominal pressure that is influenced by breathing. If the intra-abdominal pressure rises to the point that blood circulation of the abdominal organs is impaired, for example in intra-abdominal hypertension (IAP>1200 Pa (12 mbar)), the stimulation can be weakened accordingly, especially during expiration. Group 3: Conditioning and training stimuli Conditioned stimulation-stimulation method 6 All five of the above mentioned stimulation methods can also be used exclusively as conditioning of improved spontaneous breathing. Here, intermittent stimulation is performed with varying duration of stimulation, and even a few breaths may be sufficient. The conditioning stimulation trains the defined spontaneous breathing pattern with modulation of spontaneous autonomic breathing or as controlled autonomous breathing using the above mentioned stimulation methods 1 to 5.

[0091] The adaptive stimulus can be controlled and reinforced by direct feedback based on measurements of sensed autonomous breathing: breathing quality, level of expiration, depth of inspiration, tidal volume and breathing frequency are measured and adapted adaptive stimulus is implemented accordingly.

[0092] This prevents the redistribution of respiratory activity that occurs during positive pressure ventilation to the region of the respiratory muscles.Fatigue and degradation of the autonomous respiratory activity during conventional ventilation is also avoided, since peripheral nerve activity with corresponding afferent impulses from the respiratory muscles can be maintained by stimulation.

[0093] During "rest periods" without regulatory stimuli, spontaneous breathing can occur as normal. However, conventional ventilation can also be provided, or spontaneous breathing can be supported by electromagnetic or electrical stimuli, and again, as explained above, autonomous breathing can be modulated in contrast to regulatory stimuli. These rest periods are examined to ascertain whether, how much and especially the duration of the regulatory stimuli have an effect on spontaneous autonomous breathing. Depending on the changes achieved, the nature, frequency, duration and especially the intervals of the regulatory stimuli can be adapted individually via a feedback mechanism.

[0094] The conditioned breathing achieved by the conditioned stimulus, like the training stimulus described below, must meet certain requirements (see below). Training stimulus-stimulation method 7 During positive pressure ventilation, muscle deterioration begins after just a few hours, and muscle strength declines even earlier, very rapidly. Thus, muscle biopsies taken just 2 hours after ventilation showed a reduction in strength of approximately 35% in isolated muscle fibers (5).

[0095] Muscle deterioration and weakening are further exacerbated by the course of critical illness, especially by inflammation. If muscle weakening is only insufficiently alleviated by ventilation, the respiratory drive increases, resulting in high and eventually excessive respiratory efforts, further weakening and damaging the already damaged lungs as well as the muscles. High levels of respiratory effort represent the most important cause of damage to the diaphragm muscles. The degree of degree between too low and too high respiratory effort can be very narrow and can vary greatly between and within individuals. As a result of reduced strength and muscle deterioration, the weakened respiratory muscles are eventually no longer able to ensure sufficient autonomous breathing. Respiratory failure progresses with the breathing patterns already described above. Breathing becomes faster, shallower and stronger, causing further damage to the already damaged lungs as well as the respiratory muscles. Therefore, the cessation of ventilation, which takes up the greatest part of the entire ventilation period, is carefully determined by the restoration of adequate muscle strength for sufficient spontaneous breathing together with the rebuilding of the necessary muscle mass.

[0096] The electromagnetic or electrical stimulation training methods described below are intended to strengthen the respiratory muscles so that muscles can be built up and existing muscle loss and muscle deterioration can be prevented, where further damage to the lungs and respiratory muscles should be minimized or avoided as much as possible. Therapeutic, preventive and preemptive forms of training Respiratory muscles can be trained by electromagnetic or electrical stimulation to: 1. re-strengthen weakened or weakened respiratory muscles; 2. prevent muscle deterioration or weakening; and / or 3. strengthen muscles before expected deterioration or before expected loss of strength.

[0097] Thus, training can be therapeutic, preventative and / or preemptive, as follows: 1. Following deterioration and / or weakening of respiratory muscles due to conventional ventilation and disease treatments, therapeutic training stimulation is performed to rebuild muscles and / or restore muscle strength. 2. Muscle deterioration and / or strength loss during conventional ventilation and disease treatment is prevented by preventive training stimulation. 3. Respiratory muscles and / or strength are enhanced by a pre-emptive training stimulus prior to anticipated increased loading and / or deterioration or weakening of respiratory muscles due to conventional ventilation or disease treatment. Intensity of training stimulus Since electromagnetic or electrical stimulation results in sufficient ventilation (Ref. 1), it is assumed that this stimulation intensity during inspiration is suitable to prevent muscle deterioration, similar to how normal spontaneous breathing also prevents muscle deterioration and strength loss. In many cases, a lower stimulation intensity is also suitable to prevent muscle deterioration, if used with an appropriate frequency, for example during conventional ventilation. With a stronger stimulation, respiratory muscles and / or muscle strength may be correspondingly increased, or muscle deterioration and / or strength loss may be more effectively prevented with a lesser stimulation.

[0098] For training with high stimulation intensities, particular emphasis is placed on stimulation during expiration (see below). Smooth transitions in training stimulus patterns In the training stimuli, the following six transitions are smoothly performed: 1. A transition between a small number of very strong training stimuli and a large number of very weak training stimuli. 2. Transition between partial stimulation and stimulation over the entire respiratory cycle. 3. Transition between stimulation synchronized with spontaneous breathing and stimulation independent of spontaneous breathing. 4. The transition between stimuli that prevent muscle deterioration or loss of muscle strength and stimuli that promote muscle growth or strength. 5. Transition between training and conditioning stimuli. 6. Transition between training and ventilation stimuli. Training breathing requirements The training stimulus results in a corresponding training breath. Thus, the training pattern also focuses on the above-mentioned stimulation methods 1 to 4 and takes into account the relationships mentioned therein. Accordingly, the breath achieved in the training stimulus is also intended to meet the following four requirements:

[0099] Training breathing is 1. It should have a positive effect on the lungs and respiratory muscles without or with minimal further damage.

[0100] 2. It should not have further adverse effects, such as hyperventilation.

[0101] 3. It should not have a negative effect on spontaneous breathing; rather, it should have a positive effect as much as possible.

[0102] 4. Discomfort should be eliminated or reduced as much as possible. Electromagnetic or electrical training methods Therefore, according to the above-mentioned stimulation methods 1 to 6, there are the following six forms of training stimulation that allow strong training stimulation without harmful breathing.

[0103] 7.1.Lung preservation training stimulus 7.2. Strong training stimuli 7.3. Lung protection training stimulation 7.4. Training stimuli to avoid self-injury (P-SILI) 7.5. Modulation of the training stimulus 7.6. Adjustment of training stimuli 7.1.Lung preservation training stimulus The principle of gentle breathing with low energy transfer to the lung tissue described in stimulation method 1 also applies to training stimulation, even if it is only performed occasionally and after fairly long intervals. With this stimulation method, sudden and potentially harmful respiratory movements as described above are avoided by a gradual increase in the stimulation impulse during inspiration and a gradual decrease in the stimulation impulse during expiration. This is especially important for strong and frequent training stimulation (see 7.2 below). 7.2. Strong training stimuli This method can achieve rapid muscle strengthening or strength increase and / or effectively prevent muscle deterioration and strength loss with only a few strong stimuli. The crucial aspect of this stimulation type is that there is almost no breathing, despite the strong muscular activity of the respiratory muscles. As described above in stimulation method 2, this is achieved by shifting the breathing state to inspiration and preventing exhalation. In detail, holding the exhalation at a defined level (holding the exhalation) requires an increase in muscular effort. Thus, very strong training stimuli can be performed simultaneously with obvious contraction of the respiratory muscles in both the inspiration and expiration phases without resulting in strong breathing.

[0104] Here, the "breath holding" in both the inhalation and exhalation phases can be enhanced by appropriately extending the stimulation time in each respiratory cycle, while at the same time, as a secondary effect, the collapsed lung regions are opened and the ventilated lung regions are stabilized, as explained in the stimulation method 2 above.

[0105] This training method allows a very strong training stimulation of the respiratory muscles with only minor side effects and with lung protection. Even if the muscle activity is evident, it is possible to avoid not only self-injury (see 7.3-7.5 below), but also to avoid hyperventilation with corresponding side effects such as hypocapnia and the resulting dangerous pH shifts.

[0106] When stimulation during the expiratory phase is not possible or is inappropriate, the side effects and fatigue associated with hyperventilation can be avoided by a rest period that can be controlled by feedback. In addition, deep breathing can be mechanically restricted not only by straps and / or weights, but also by increasing airway resistance, and as a result, the training effect can be further enhanced.

[0107] As a result of the strong training stimulus, the device can be used for a significantly shorter period of time per patient and, as a result, can be used by several patients at short intervals.

[0108] An important aspect of this intense training is that, despite a pronounced stimulation corresponding to a strong contraction of the respiratory muscles, it does not result in deep breathing with rapid respiratory movements (see 7.1 above), large tidal volumes (see 7.3 below), and / or high transpulmonary pressures. 7.3. Lung protection training stimulation As explained in stimulation method 3 above, the breathing depth during inspiration is adjusted so that, also in this form of training, a moderate tidal volume is breathed and / or a moderate transpulmonary pressure is applied. This is very important, especially in the case of frequent training stimulation. By the aforementioned feedback between the measurement of tidal volume and the stimulation intensity, feedback on the breathing state can be further performed as explained above (see 7.2 above).

[0109] Thus, the stimulation intensity can be increased, while at the same time, even with a strong training stimulation, a lung-protective tidal volume of, for example, 6 ml / kg for ideal body weight and / or a transpulmonary pressure of 500 Pa (5 mbar) is not exceeded. Thus, by the interaction between the respiratory state and the tidal volume, as explained in 7.2 above, a strong training stimulation can be realized without harmful breathing.

[0110] In addition, it is possible to limit the tidal volume by shifting the breathing state to inspiration by increasing the expiratory resistance, which can be performed in conjunction and synchronously with the stimulation during expiration.

[0111] However, even with low stimulation intensities, large tidal volumes can be achieved. Lung-protective stimulation also prevents situations where harmful breathing would result with large tidal volumes, even with low stimulation intensities, independent of the respiratory state, which precludes the possibility that the training stimulation itself could damage the lungs, especially in the case of frequent stimulation. This is particularly important in spontaneous breathing, since in this case even small training stimulation in addition to spontaneous breathing can significantly strengthen the autonomous breathing that follows (see 7.4.-7.5 below). 7.4. Training stimuli to avoid self-injury (P-SILI) In addition to the three previously mentioned training stimulus patterns, which are intended to minimize or prevent further damage due to ventilation achieved during training, this training pattern is intended to avoid or minimize damage in the presence of spontaneous breathing.

[0112] Spontaneous breathing is taken into account so that the additional training stimulus does not result in deep and / or sudden inspiration. This is important, especially in the case of frequent repetitions, and can be achieved in various ways: during inspiration there is either no stimulus, or a stimulus such that the defined tidal volume is not exceeded, or inspiration is modulated accordingly.

[0113] In a further pattern, as described in stimulation method 2 and item 7.2, in this training, during expiration, the breathing state can be shifted to inspiration by preventing expiration so that the depth of spontaneous breathing is limited and therefore also self-injurious breathing is limited.

[0114] It is therefore necessary to detect spontaneous and / or autonomous breathing, which is caused or altered by stimulation, so that stimulation can be flexibly adapted individually and, if necessary, spontaneous breathing can be modulated (see 7.5 below). 7.5. Modulation of the training stimulus Finally, there is a smooth transition in the various combination situations between training and modulation stimulation, as explained above in stimulation method 5. Thus, the stimulation can be individually adapted to meet the requirements of autonomous breathing and also the desired training effect, taking into account the disease and the severity of the disease.

[0115] A modulating training stimulus always takes into account the spontaneous breathing and therefore also changes the spontaneous breathing. Here, the stimulation is carried out over the entire respiratory cycle or only partially. In the case of partial stimulation, training is achieved only during the inhalation phase, only during exhalation or during parts of these respiratory phases. Here, as explained several times above, exhalation assumes a particular importance so as to be able to provide a strong training and to avoid the controlled autonomous breathing becoming too deep and also to avoid too deep spontaneous breathing during training. Even in situations where the respiratory muscles are fatigued with shallow and rapid breathing, the modulating stimulation can simultaneously provide training and improve the breathing pattern as explained in stimulation method 5 above. As fatigue increases, intervention should be sought as soon as possible to rescue the fatigued respiratory muscles. In cases of extreme fatigue, rescue of the respiratory muscles by ventilation may be required, and preventive training stimulation can limit or even prevent muscle deterioration early. 7.6. Adjustment of training stimuli The conditioning stimulation described in stimulation method 6 above also represents a form of training stimulation. However, the main purpose of conditioning stimulation is not training of the respiratory muscles but "practice" or adjustment of a defined breathing pattern. Therefore, conditioning training stimulation is performed when adjustment of a defined breathing pattern is further intended as a complement to training of the respiratory muscles. Combination of stimulation functions Training stimuli can finally be combined with conditioning stimuli so that the requirements of an appropriately adapted ventilation can also be met depending on the severity of the disease, the lung injury and the respiratory disorder. For example, in the case of hypoxemic lung injury in the context of ARDS, stimulation during expiration with the assistance of expiratory hold, inhibition and truncated stimulation patterns (see above and below) can stabilize the lungs, protect them from excessive tidal volumes, regulate the expiratory "hold" and at the same time provide a strong training of the respiratory muscles (see overview of expiratory stimulation). Overview of Exhalation Stimuli Stimulation during expiration is of central importance for: 1. lung stabilization; 2. lung protection; 3. regulation of spontaneous breathing; and 4. strong, yet gentle, training of the respiratory muscles. 1. Lung stabilization Stabilizing stimuli prevent lung collapse with corresponding gas exchange impairment and also prevent harmful collapse incremental ventilation, hyperexpansion of the ventilated lung, increased work of breathing, respiratory effort, P-SILI, and ultimately fatigue. Stabilizing stimuli can be performed in three different ways, which can also be combined: 1. holding of expiration, 2. inhibition of expiration, and 3. truncation of expiration. 1. Breath retention: Preventing complete exhalation by holding the breath. 2. Inhibition of expiration: slowing down of expiration by reducing the intensity of the stimulus. 3. Expiratory truncation: shortening of the expiratory period.

[0116] Finally, the expiratory level is determined in particular by the retention of expiratory air, but also by the nature of the inhibition and, indirectly, by the shortening of expiratory time. In contrast to positive pressure ventilation, here there is no artificial pressure increase in the lungs, but also no artificial decrease in pressure in the abdominal cavity, as is the case with negative pressure ventilation. 2.Lung protection The more air is retained in the exhalation, the more the breathing state shifts to inhalation and is no longer deep breathing, and can be inhaled again. If the transition of the breathing state means that deep breathing is not possible, high and therefore harmful tidal volumes cannot be realized purely mechanically. This affects 1. spontaneous breathing, 2. electromagnetically or electrically controlled autonomous breathing, 3. electromagnetic or electrically trained breathing, but also 4. conventional ventilation. Thus, even the stimulation of the exhalation itself can limit harmful spontaneous breathing, and harmful electromagnetic or electrical ventilation, but also conventional ventilation with large tidal volumes. 3. Adjustment The conditioning stimuli support the practice of different expiratory movements in a goal-directed manner, thereby enabling more effective learning of a defined expiratory technique for subsequent spontaneous breathing. 4.Training The stimulation in exhalation allows for strong training of the respiratory muscles by shifting the breathing state and restricting the inhalation. This allows for a very strong training stimulation with a significant contraction of the respiratory muscles in both the inhalation and exhalation phases, since there is only slight breathing despite the strong muscular activity of the respiratory muscles. In this way, it is possible to avoid extensive training breathing, and also to avoid harmful spontaneous breathing during training, as well as the associated adverse effects and complications. Example Embodiments The invention is explained in more detail below on the basis of exemplary embodiments and with reference to the figures. [Brief description of the drawings]

[0117] [Figure 1] FIG. 1 is a diagram illustrating the use of an electrical stimulation device on a living organism. [Diagram 2] FIG. 2 illustrates the use of an electrical stimulation device in conjunction with positive pressure ventilation on an organism. [Diagram 3] FIG. 3 is a diagram showing a time chart of a respiratory state. [Figure 4] FIG. 4 is a diagram showing a time chart of a respiratory state. [Diagram 5] FIG. 5 is a diagram showing a time chart of a respiratory state. [Figure 6] FIG. 6 is a diagram showing the change in air volume in the lungs over time during the respiratory cycle. [Figure 7] FIG. 7 is a graph showing the change in transpulmonary pressure over time during the respiratory cycle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0118] 1 shows an organism 1 in a supine position. For clarity, advantageous stimulation positions of the phrenic nerve 2 and the intercostal nerve 3 in the organism 1 are shown. In the present exemplary embodiment, it is assumed that the phrenic nerve 2 is intended to be stimulated by electromagnetic stimulation.

[0119] 1 shows an electrical stimulation device 4 connected by electrical lines to a signal output element 10, e.g. a coil, for supplying a magnetic field to an organism 1. By means of the signal output element 10, the electrical stimulation device can generate a stimulation signal for the organism, which can generate muscle contractions that can have a target-directed influence on the respiration of the organism 1.

[0120] The electrostimulation device 4 may for example be designed as a computer-controlled electrostimulation device. The electrostimulation device 4 comprises a computer 5, a stimulation signal generator 6, a memory 7 and an operating element 8. A display device for displaying operational data may additionally be present. Some or all of the functions of the electrostimulation device 4 may be performed by a computer program stored in the memory 7. The computer 5 executes the computer program of the memory 7. In this way, the stimulation signal generator 6 outputs a corresponding stimulation signal to a signal output device 10 which generates a desired magnetic field. The aforementioned functions for ventilation of the living being 1 by the stimulation signal or procedures performed by the user may be influenced by the user via the operating element 8, for example by setting parameters of the breathing cycle.

[0121] Artificial ventilation by electrical stimulation of the organism 1 can be controlled by the described elements. If certain parameters are also to be adjusted, the electrical stimulation device 4 must be supplied with one or more measurements of the characteristics of the respiratory cycle of the organism 1. For example, it may be convenient to sense the volumetric flow inhaled and exhaled by the organism 1. This can be achieved, for example, by a face mask 13 on which a flow sensor is arranged. The face mask 13 or the flow sensor have substantially no influence on the respiratory flow rate. However, a quantitative variable characterizing the volumetric flow rate can be sensed and supplied to the electrical stimulation device 4. The sensor signals can be evaluated, for example, by a computer 5.

[0122] The electrostimulation device 4 may additionally have an interface 9 for connection to other devices, for example for data exchange with other devices. In this way, further measured values ​​can be supplied to the electrostimulation device 4 without the electrostimulation device 4 having to be equipped with sensors of its own.

[0123] 2 shows the use of an electrical stimulation device 4 on an organism 1 in association with a positive pressure ventilation device 11. By means of an air delivery unit 18 of the ventilation device 11, air can be drawn from the environment through a port 19 and supplied by means of a breathing mask 13 through an air line 12 to the airways of the organism 1. The breathing mask 13 or the air line 12 can have a defined leak 14. Inside the ventilation device 11, a pressure sensor 16 and a volumetric flow sensor 17, for example a pneumotachometer, are connected to the air line 12. The ventilation device 11 has its own control unit 15, to which the sensors 16, 17 are connected. The control unit 15 operates the air delivery unit 18 according to a predefined algorithm, thus generating, via the breathing mask 13, a desired volumetric flow curve and / or pressure curve in the respiratory tract of the organism 1.

[0124] It will be seen that the electro-stimulation device 4 is connected to the ventilation device 11 via its interface 9. By means of the interface 9 the electro-stimulation device 4 is provided with corresponding measurement values ​​and optional further values ​​related to properties of the breathing cycle of the organism calculated inside the ventilation device 11. In this way the electro-stimulation device 4 receives for example current measurement values ​​of the pressure and volume flow of the breathing cycle of the organism 1.

[0125] 3 to 5 show several respiratory cycles for various respiratory states, each plotted against time t. The volume of air V in the lungs in each case is plotted on the ordinate.

[0126] Figure 3 shows a respiratory state with tidal volume (AZV) during breathing at rest and maximum possible expiration, which is intended to show normal respiratory states during breathing at rest and end expiratory reserve volume (ERV). Inspiratory reserve volume (IRV) is also characterized here and is shown in Figure 4 by maximum possible inspiration. Finally, Figure 5 shows a transition of respiratory states from breathing at rest to inspiration, where the tidal volume during breathing at rest is characterized by being at increased ERV and decreased IRV.

[0127] The respiratory profiles shown in Figures 3 to 5 can be suitably controlled or adjusted by the electrical stimulation device 4 according to the present invention and the method according to the present invention, i.e. by the electrical stimulation device a corresponding stimulation signal is supplied to at least one nerve and / or one muscle of the organism 1, resulting in a corresponding muscular contraction of the respiratory muscles, ultimately resulting in the respiratory cycle shown.

[0128] Figures 6 and 7 show an expanded view of the respiratory cycle. The respiratory cycle consists of an inhalation phase I and an exhalation phase E. Figure 6 shows the air volume V over time, and Figure 7 shows the transpulmonary pressure TPP over time. According to Figure 6 it can be seen that the inhalation phase I starts with a lower apex and ends with an upper apex. The exhalation phase E starts with an upper apex of the curve and ends with a subsequent lower apex. The profile of the pressure TPP is phase shifted with respect to the profile of the air volume V.

[0129] The electrostimulation device 4 can for example generate the profiles of the breathing cycle shown in Figures 6 and 7. The duration of the inspiration phase and / or the duration of the expiration phase are influenced separately depending on the selected function. The amplitude of the air volume profile and / or the pressure profile as well as the respective positions of the maxima and minima of the curve profile are influenced separately. literature 1.Raymondos K, Dirks T, Quintel M, Molitoris U, Ahrens J, Dieck T, Johanning K, Henzler D, Rossaint R, Puttensen 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. Crit Care 2017;21(1):122.

[0130] 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.

[0131] 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.

[0132] 4.Sinderby C、Navalesi P、Beck J、Skrobik Y、Comtois N、Friberg S、Gottfried SB、Lindstrom L。Neural Control of Mechanical Ventilation in Respiratory Failure。Nat Med 1999;5(12):123–363.

[0133] 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、diaphragmatic contractual diaphragm after mutation inactivity during thoracic surgery. Ann Surg. 2011; 254(6):1044-9。

Claims

1. 1. An electrical stimulation device for stimulating one or more nerves and / or muscles of a living organism using electrically, electromagnetically and / or magnetically generated stimulation signals, comprising: The electrostimulation device has the following features (a) and (b): (a) the electro-stimulation device has at least one signal output device by which an electrically, electromagnetically and / or magnetically generated stimulation signal can be supplied to at least one nerve and / or one muscle; (b) the electro-stimulation apparatus has at least one control device configured to activate the at least one signal output device such that the stimulation signal output by the at least one signal output device is capable of generating muscular contractions in the organism, thereby targetably influencing respiration of the organism. The electrostimulation device may further comprise any one, more than one or all of the following features (c), (d), (e), (f), (g), (h), (i), (j), (k) and (l): (c) the control device is configured to keep the intensity of the stimulation signal output by the at least one signal output device at an increased level during an exhalation phase of the organism, where the muscle contraction generated by the stimulation signal is greater than zero, but at least such that at the end of exhalation, up to 75% of the inspiratory reserve volume is still present in the lungs. (d) the control device is configured to control or regulate the breathing of the living being to a predetermined value, range of values ​​and / or temporal change in breathing depth by setting parameters of the stimulation signal output by the at least one signal output device; (e) the control device is configured to control or regulate the respiration of the organism to a respiration frequency greater than 40 respiratory cycles / minute by setting parameters of the stimulation signal output by the at least one signal output device. (f) the control device is configured to prevent complete exhalation by setting parameters of the stimulation signal output by the at least one signal output device to cause a duration of an exhalation phase of the organism to be 0.2 to 1.3 times a duration of an inhalation phase. (g) the control device is configured to control a characteristic of the respiratory cycle to a predetermined target characteristic of the respiratory cycle by setting parameters of the stimulation signal output by the at least one signal output device. (h) a current measurement value of the spontaneous breathing impulse is continuously determined by at least one spontaneous breathing impulse sensor capable of sensing the spontaneous breathing impulse of the living organism and is provided to the control device, the control device being configured to modify parameters of the stimulation signal output by the at least one signal output device in response to the measurement value of the spontaneous breathing impulse, in particular in a manner synchronous with the spontaneous breathing impulse. (i) the control device is configured to control or regulate the intra-abdominal pressure of the organism to a predetermined value, range of values ​​and / or change over time by setting parameters of the stimulation signal output by the at least one signal output device; (j) the control device is configured to perform a goal-directed excitation of respiratory nerves and / or respiratory centers by setting parameters of the stimulation signal output by the at least one signal output device; (k) the control device is configured to excite muscular contractions of respiratory muscles of the organism that are not necessary for the gas exchange performed by the breathing of the organism, over a plurality of respiratory cycles, by setting parameters of the stimulation signal output by the at least one signal output device, thus generating muscle training. (l) the control device is configured to control or adjust a respiratory state to an increased value and / or transition the respiratory state into the inhalation phase by setting parameters of the stimulation signal output by the at least one signal output device.

2. 2. The electrostimulation apparatus of claim 1, characterized in that the control device is configured to vary the intensity of the stimulation signal output by the at least one signal output device in stages and / or uniformly over the respiratory cycle of the organism.

3. 3. The electrostimulation apparatus of claim 1 or 2, characterized in that the control device is configured to control or regulate the respiration of the organism to a breathing depth that is too low for life-sustaining gas exchange of the organism for a limited period of time by setting parameters of the stimulation signal output by the at least one signal output device.

4. 4. An electrostimulation apparatus as claimed in any one of claims 1 to 3, characterized in that current measurements of characteristics of the respiratory cycle of the living organism are continuously determined by at least one sensor and supplied to the control device, and the control device is configured to adjust the characteristics of the respiratory cycle towards a predetermined target characteristic of the respiratory cycle in dependence on the measurements by setting parameters of the stimulation signal output by the at least one signal output device.

5. 5. An electrostimulation apparatus as claimed in any one of claims 1 to 4, characterized in that the control device is configured to control or adjust the characteristic of the respiratory cycle to a predetermined target characteristic of the respiratory cycle over a number of respiratory cycles by setting parameters of the stimulation signal output by the at least one signal output device, thereafter having no effect on the respiratory cycle of the living organism over a number of respiratory cycles, and thereafter controlling or adjusting the characteristic of the respiratory cycle again to the predetermined target characteristic of the respiratory cycle over a number of respiratory cycles.

6. 6. An electrostimulation apparatus as claimed in any one of claims 1 to 5, characterized in that a current measurement value of the breathing depth is continuously determined by at least one breathing depth sensor capable of detecting a measurement value of the breathing depth of the living organism and supplied to the control device, and the control device is configured to adjust the breathing of the living organism to a predetermined value, range of values ​​and / or temporal changes of the breathing depth by setting parameters of the stimulation signal output by the at least one signal output device based on the measurement value of the breathing depth.

7. 7. An electrostimulation apparatus according to any one of claims 1 to 6, characterized in that the control device is configured to limit the breathing depth and / or the volumetric flow rate during the inspiration phase to a predetermined maximum value by setting parameters of the stimulation signal output by the at least one signal output device.

8. 8. An electrostimulation apparatus according to any one of claims 1 to 7, characterized in that the control device is configured to limit the volumetric flow rate during the expiratory phase to a predetermined maximum value and / or to reduce it compared to the average intrinsic volumetric flow rate of the organism during the expiratory phase by setting parameters of the stimulation signal output by the at least one signal output device.

9. 9. An electrostimulation apparatus according to any one of claims 1 to 8, characterized in that the control device is configured to shorten the duration of the expiratory phase compared to an average intrinsic duration of the expiratory phase of the organism by setting parameters of the stimulation signal output by the at least one signal output device.

10. 10. An electro-stimulation apparatus according to any one of claims 1 to 9, characterized in that the control device is configured to increase the intensity of the stimulation signal output by the at least one signal output device over a breathing cycle during the inspiration phase and to decrease it again during the expiration phase.

11. 11. An electrostimulation apparatus as claimed in any one of claims 1 to 10, characterized in that the control device is configured to variably activate a through-flow control actuator pneumatically and / or electrically coupled to the respiratory system of the organism and capable of adjusting the volumetric flow rate of air inflow and / or outflow of the organism, over the respiratory cycle in such a way that the through-flow control actuator at least temporarily limits or reduces the volumetric flow rate during the inhalation phase and / or the exhalation phase.

12. 12. An electrostimulation device according to any one of claims 1 to 11, characterized in that the spontaneous breathing impulse sensor is designed as a nerve impulse sensor capable of detecting nerve impulse signals of the living organism that control the breathing of the living organism.

13. 13. An electrostimulation apparatus as claimed in any one of claims 1 to 12, characterized in that the control device is connectable via an interface to a ventilation apparatus configured to ventilate the living being by generating a variable positive and / or negative pressure and is configured for data exchange with a control device of the ventilation apparatus.

14. 14. An electrostimulation apparatus according to any one of claims 1 to 13, characterized in that the control device is configured to store characteristics quantitatively characterising each of one or more respiratory cycles of the organism.

15. 15. An electro-stimulation apparatus according to any one of claims 1 to 14, characterized in that the control device is configured to bring about an initial deep inspiration in the breathing cycle by appropriately adapting the intensity of the stimulation signal output by the at least one signal output device.

16. 16. The electrostimulation apparatus of claim 15, characterized in that the control device is configured to provide, after the deep inspiration, one or more partial exhalations with a shortened exhalation period and / or an increased intensity of the stimulation signal compared to an average exhalation, by setting parameters of the stimulation signal output by the at least one signal output device.

17. 17. The electro-stimulation device of claim 15 or 16, characterized in that the control device is configured to stimulate secretion movement and subsequently result in deep inspiration by setting parameters of the stimulation signal output by the at least one signal output device.

18. 18. An electrostimulation apparatus according to any one of claims 1 to 17, characterized in that the control device is configured to stimulate alternately pure thoracic breathing, pure abdominal breathing or a combination thereof based on the output stimulation signal, and in that the intensity of the stimulation of abdominal breathing and the intensity of the stimulation of thoracic breathing may be adaptable independently of each other.

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