Electromagnetic or Electrically Controlled Spontaneous Breathing Stimulation Method

Abstract

The present invention relates to an electrical stimulation device for stimulating one or more nerves and / or muscles of a living body with an electrical signal. The electrical stimulation device has the following features. a) The electrical stimulation apparatus has at least one signal output device, via which an electrical stimulation signal can be supplied to at least one nerve and / or muscle. b) the electrical stimulation apparatus has at least one control device configured to operate the at least one signal output device such that a stimulation signal output by the at least one signal output device is capable of generating muscular contractions in a living organism, thereby targetably influencing the respiration of said living organism.

Description

[Technical field]

[0001] Technical Field

[0001] The present invention relates to an electrical stimulation appliance and method for stimulating one or more nerves and / or muscles of a living body using electrical signals.

[0002] prior art Principles of ventilation

[0002] Respiration is performed to maintain gas exchange, ie the supply of oxygen to sustain life and the simultaneous exhalation of carbon dioxide.

[0003]

[0003] Depending on the nature and severity of the disease, ventilation therapy is performed with a completely mechanical support of inhalation and with the prevention of exhalation. In case of exhaustion of the respiratory pump, the respiratory muscles relax during inhalation, and in case of gas exchange disorders, the further loss of gas exchange area is mitigated by the prevention of exhalation. As the severity of lung damage increases, not only the pressure is increased to prevent exhalation, but also the oxygen fraction during inhalation.

[0004]

[0004] During the course of the disease, if exhalation is not prevented sufficiently and in time, a very pronounced gas exchange disorder occurs in the context of widespread lung damage ARDS (Acute Respiratory Distress Syndrome). A significant increase in the work of breathing is then required, which, ultimately, can no longer be compensated for by the respiratory muscles. As the exhaustion increases, respiratory failure develops and breathing becomes faster and shallower. Inhalation, and then exhalation together, must be treated by an artificial respirator.

[0005]

[0005] Ventilation can be performed in a synchronized manner to support spontaneous breathing, or it can be controlled independently of autonomous breathing. When controlling ventilation, the respiratory rate, tidal volume, or ventilation pressure is controlled, and the breathing time ratio between inhalation and exhalation is also predetermined. In addition, there are forms of ventilation that allow autonomous breathing independent of ventilation, and many mixed forms. One special form of respiratory treatment is called high-flow oxygen therapy, which uses a high flow of gas mixtures through a nasal cannula or mask.

[0006]

[0006] Depending on how the airway is secured, the terms invasive or non-invasive ventilation are employed. When the airway is secured by a tracheal tube and ventilation is performed through the latter, this is called invasive ventilation. When ventilation is performed without a tube, this is called non-invasive ventilation or NIV. With negative pressure ventilation, NIV can be performed without airway access, whereas with positive pressure ventilation, airway access must always be present. NIV with positive pressure can be performed through a ventilation helmet or with a mask that covers the whole face, mouth and nose, or encloses only the nose.

[0007] Principles of Airway Management

[0007] For example, in the case of anesthesia or coma, if there is no protective reflex, a tube is used to secure the airway. In this way, an attempt is made to secure the airway against inhalation, i.e. against the ingress of gastric contents into the trachea, which may also lead to the development of ARDS. Intubation is also performed when the patient can no longer tolerate NIV or when NIV remains unsuccessful. As lung damage increases and high ventilation pressures and high oxygen fractions are required, NIV with positive pressure ventilation quickly becomes unsafe and, after a certain limit, very dangerous. Then, with the current technology, the shifting of the mask or removal of the helmet for intubation leads to inadequate gas exchange, and the necessary interruptions in NIV can also lead to inadequate gas exchange and life-threatening oxygen deprivation.

[0008]

[0008] An intermediate stage in airway management involves what are called supraglottic airways or SGAs, such as laryngeal masks. These have been used millions of times in anesthesia or emergency situations. Here, a hose is not inserted into the trachea through the glottis, but instead the larynx is enclosed and sealed from the outside so that ventilation can be performed. Gastric juices can be drained at the larynx through an integrated hose. All airway guidelines recommend the immediate insertion of an SGA if intubation fails and positive pressure ventilation by mask is not possible. However, compared to an endotracheal tube, the degree of airway management provided by an SGA is less, and its limitations are known at high ventilation pressures and high oxygen fractions. The airway can be blocked by partial or complete closure of the glottis, by the roof of the larynx, or by the sliding of the SGA, which can equally seriously endanger the patient's life, especially when oxygen demand is high. Principles of Lung Injury

[0009]

[0009] In the case of extensive lung damage or ARDS, exhalation is especially important because the latter is accompanied by the following pathological changes: collapsing of lung areas, resulting in loss of gas exchange area, because of increased permeability between the capillaries and the alveoli, and / or viral infection of lung cells, meaning that the surface-active substance or surfactant there can no longer stabilize the alveoli during exhalation. However, blood continues to circulate through the collapsed and unventilated 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 collapse could be countered during exhalation by providing ventilation. Since then, positive ventilation pressure has been used during exhalation to prevent 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. This shifts the respiratory state to inhalation, resulting in an increase in expiratory reserve volume (ERV) and a decrease in inspiratory reserve volume (IRV) (Figures 3 to 5).

[0010] Current position and issues to be resolved

[0010] The lungs, respiratory system, and other organ systems are now more damaged by the treatments themselves, due to the increased side effects and complications associated with the treatments as a result of their increasing invasiveness. Furthermore, modern treatment methods are increasingly complex and error-prone, and therefore require an increasing number of highly specialized personnel. For this reason, intensive care medicine in particular is by far the most costly sector in today's health care system. In some countries, this has led to a reduction in intensive care capacity and a decrease in the availability of treatment sites. It is clear that the risk of death for patients on ventilators varies greatly between different countries.

[0011]

[0011] In a comparison of European countries, Germany has by far the largest number of intensive care beds per population. However, the quality of care varies widely. Even in Germany, there are significant differences in survival rates for ventilated patients at different levels of inpatient care. For acute respiratory distress syndrome (ARDS), the differences are even greater: for over 50 years, at least 50% of ARDS patients have not been able to be taken off ventilator (survive ventilation) outside of specialized centers. Mortality rates for ventilated patients without ARDS are 31% outside university hospitals, which is 50% higher than in university hospitals. For ventilated patients with ARDS, not only the mortality rate but also the mortality difference is doubled in non-university hospitals compared to university hospitals. The independent risk of dying from ARDS is three times higher. See [1].

[0012]

[0012] One of the main problems is invasive positive pressure ventilation with a tracheal tube. Even so-called lung-protective ventilation further damages the already damaged lungs and respiratory muscles, as well as other organ systems. Moreover, this triggers a whole chain reaction of life-threatening complications. Mainly because of the tube, up to 50% of patients on invasive ventilation also develop lung inflammation, which causes further damage to the lungs as well as other organ systems. In addition, the endotracheal tube activates significant defense reflexes, which in turn require sedation for shielding and damping. This has many side effects and leads to further serious complications. That is, overhangs often occur, which prolong the duration of ventilation and therefore frequently cause ventilation-related complications. In addition, sedation significantly impairs circulatory function, especially in combination with positive pressure ventilation, so drugs that support circulation must be administered continuously. These so-called catecholamines, in turn, can reduce blood flow in organs and accelerate the failure of various organ systems. Patients on ventilators with very extensive lung damage are often treated in the prone position, and as a result, they require particularly deep sedation.

[0013]

[0013] Ventilation can also be performed without the use of tubes. However, it can then be difficult to adapt this so-called non-invasive ventilation efficiently enough to the severity of the lung damage to avoid collapsing lung areas and increasing respiratory failure. An increase in respiratory drive then occurs, leading to more intense and deeper breathing, which in turn leads to further damage to the lungs. Summary of the Invention [Problem to be solved by the invention]

[0014] Object of the invention

[0014] It is therefore an object of the present invention to make available an appliance, a method and a computer program which are able to at least alleviate the problems mentioned above. [Means for solving the problem]

[0015] Introduction of the invention

[0015] We control our spontaneous breathing by ourselves, either intentionally or unconsciously. However, in contrast to spontaneous breathing, autonomous breathing can be controlled by electromagnetic or electrical stimulation. The respiratory muscles can be controlled non-invasively and painlessly, such that sufficient ventilation can be achieved by electromagnetic stimulation. See [2]. The phrenic nerve can also be stimulated directly via implanted electrodes. However, when done non-invasively without implanted electrodes, applying electrical stimulation externally through the skin using today's technology is painful, in contrast to electromagnetic stimulation. New technologies are under development that allow painless electrical stimulation. Thus, electromagnetic stimulation has been the only way that autonomous breathing can be controlled non-invasively, painlessly, and directly until now.

[0016]

[0016] The ventilation method according to the invention represents a natural form of non-invasive artificial ventilation. In contrast to all forms of negative as well as positive pressure ventilation, electromagnetically controlled autonomous ventilation is the only form of ventilation that allows the patient to be ventilated by natural pressure variations in the chest and abdomen. This new form of ventilation allows the existing conflict between lung-protective ventilation and diaphragm-protective ventilation to be resolved, because both the lungs and the diaphragm can be ventilated efficiently and gently under electromagnetic breathing. By individual control of autonomous breathing, both inappropriate and excessive respiratory efforts and the associated complications can be avoided.

[0017]

[0017] Electromagnetic or electrical ventilation can be performed in both the absence and presence of spontaneous breathing, and in these cases can be performed independently of and in synchronization with spontaneous breathing. By dividing seven different electromagnetic or electrical stimulation patterns into three groups, autonomous breathing can be appropriately modified, controlled, and / or monitored according to diseases and respiratory disorders.

[0018] In addition to electromagnetic or electrical stimulation of the phrenic nerve in the neck region, stimulation can also occur in higher or peripherally located neural structures, allowing targeted control of abdominal and thoracic breathing.

[0019]

[0019] According to the present invention, this object is achieved by an electrical stimulation device according to claim 1. Additionally, this object is achieved by a method for stimulating one or more nerves and / or muscles of a living organism by means of electrically, electromagnetically and / or magnetically generated stimulation signals, which are supplied to at least one nerve and / or one muscle of the living organism, thus generating targeted muscle contractions in the living organism, which targeted muscle contractions affect the respiration of the living organism. Furthermore, this object is achieved by a computer program, which, when executed on a computer, is configured* for performing such a method.

[0020]

[0020] The present invention provides an electrical stimulation device for stimulating one or more nerves and / or muscles of a living body with electrically, electromagnetically and / or magnetically generated stimulation signals.

[0021]

[0021] The electrical stimulation apparatus has at least one signal output device, by means of which an electrically, electromagnetically and / or magnetically generated stimulation signal can be provided to at least one nerve and / or muscle. The electrical stimulation apparatus also has at least one control device, which is configured to control the at least one signal output device such that the stimulation signal output from the at least one signal output device can be used to generate muscle contractions in a living organism, thereby specifically influencing the respiration of the living organism.

[0022]

[0022] The electrical stimulation apparatus has at least one signal output device, by means of which an electrically, electromagnetically and / or magnetically generated stimulation signal can be provided to at least one nerve and / or muscle, and also has at least one control device, which is configured to control the at least one signal output device such that the stimulation signal output from the at least one signal output device can be used to generate muscle contractions in a living organism, thereby specifically influencing the respiration of the living organism.

[0023]

[0023] Specifically, we provide one, several, or all of the following features of electrical stimulation devices and method steps:

[0024]

[0024] The strength of the stimulation signal output by at least one signal output device can be modified in various steps and / or uniformly over the respiratory cycle of the living body. This can be achieved, for example, by activation of the electromagnetic field. This activation includes changing the amplitude or intensity and frequency of the electromagnetic or electric field. This is explained in more detail below in the section on stimulation method 1. The stimulation signal can be determined in this case, in particular with a view to minimizing the energy input into the lung and diaphragm tissues of the living body.

[0025]

[0025] The electromagnetic field generator or electric field generator may include a magnetic stimulator having one or more coils. The field generator generates a sequence of a continuous train of multiple impulses of the electromagnetic field or electric field. During inspiration, i.e., inhalation, the intensity of the electromagnetic or electric impulses may be higher than during expiration, i.e., exhalation. During expiration, the intensity of the electromagnetic or electric pulses may be essentially zero, which may lead to passive expiration. The intensity of the electromagnetic or electric pulses may also be maintained at a particular level, which may lead to expiration with some residual level of diaphragmatic contraction. By gently increasing or decreasing the intensity, for example, by creating a ramp, the transition between inspiration and expiration may be made more physiological.

[0026]

[0026] In the context of the present invention, the term "train" refers to a sequence of multiple electromagnetic or electrical impulses, typically generated at a frequency of about 15-40 Hz.

[0027]

[0027] The term "impulse" or "impulses" in the context of the present invention refers to a relatively short supply of an electromagnetic field. The impulse can be applied in the form of a sine wave or in other impulse shapes. In this case, each of the impulses of the train preferably has substantially the same impulse time width, which is relatively short, as mentioned above. In particular, the time width or bandwidth of the impulse is preferably in the range of about 150 microseconds to about 300 microseconds. The duration of the train in the inhalation phase, the duration between trains in the exhalation phase, and the slope are adjustable. Typically, the duration of the train in the inhalation phase is 1 to 3 seconds, and the duration between trains in the exhalation phase is 2 to 5 seconds. Exhalation can be passive or stimulated.

[0028]

[0028] In order to at least partially prevent exhalation, the intensity of the stimulation signal output by at least one signal output device can be maintained at a high level during exhalation of the living body. At this level, the muscle contraction caused by the stimulation signal is not only greater than zero, but also high enough that at the end of exhalation, at least up to 75% of the inspiratory reserve volume is still present in the lungs. This inspiratory reserve volume can usually be determined with the aid of a current sensor or by a ventilator. This will be explained in more detail below in the section titled Stimulation Method 2.

[0029]

[0029] By setting the parameters of the stimulation signal output by at least one signal output device, the respiration of the living body can be controlled or regulated to a predefined value, range of values ​​and / or time variation of respiration depth, as will be explained in more detail below in the section entitled Stimulation Method 3.

[0030]

[0030] Parameters include the strength and frequency of the electromagnetic field, and the duration and intensity of stimulated or unstimulated inhalation or exhalation.

[0031]

[0031] Higher electromagnetic field strength can produce a higher inhalation flow rate, i.e. a more vigorous, quicker and faster inhalation, due to the more vigorous contraction of the diaphragm. A longer train period can prolong the contraction of the diaphragm, i.e. a larger total flow rate over time. In other words, the amount of inhalation can be controlled by adjusting the strength and duration of the diaphragm contraction. The length of the pause between the inhalation and exhalation phases, or the length of the low intensity exhalation phase, determines the duration of exhalation. The strength during exhalation determines the respiratory mean, i.e. PEEP. Deep breaths usually have a high tidal volume.

[0032]

[0032] By setting the parameters of the stimulation signal output by at least one signal output device, the breathing of the living body can be controlled or regulated to a number of breathing cycles greater than 40 per minute. For example, 40 nerves are stimulated per minute. In this way, a stimulation of mobilization of secretions can be performed. After a certain time, this increased breathing rate can be reduced to a normal number of breathing cycles, i.e., 10-12 per minute. This will be explained in more detail below in the chapter Stimulation method 4, Stimulation of mobilization of secretions. In this function, specifically, the breathing cycles can be controlled or regulated to a number of more than 60 per minute. For example, low amplitude muscle stimulation allows 200-300 breathing cycles per minute.

[0033]

[0033] By setting the parameters of the stimulation signal output by at least one signal output device, the breathing of the living body can be controlled or regulated for a limited period of time to a breathing depth that is too low for the living body's life-sustaining gas exchange. In this way, the respiratory movement of the living body can also be performed without sufficient breathing, i.e. an insufficient amount of air flows into and out of the lungs. In this way, for example, secretory recruitment can be stimulated or respiratory muscles can be trained.

[0034]

[0034] By setting the parameters of the stimulation signal output by at least one signal output device, the duration of the exhalation (duration of the expiratory phase) of the organism can be shortened to 0.2-1.3 times the duration of the inhalation (duration of the inhalation phase) to prevent complete exhalation. In addition, the strength of the stimulation signal can be increased to generate a maximum volumetric flow rate during exhalation compared to a normal breathing cycle. In this way, exhalation can be forced or accelerated or cough stimulation can be performed. This is explained in more detail below in the chapter 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 typical value of the inhalation phase duration determined for the respective organism.

[0035]

[0035] By setting the parameters of the stimulation signal output by the at least one signal output device, the characteristics of the breathing cycle can be controlled to predetermined target characteristics of the breathing cycle, as will be explained in more detail below in the section entitled Stimulation Method 4.

[0036]

[0036] By setting the parameters of the stimulation signal output by at least one signal output device, for example as a function of current measurements of the characteristics of the respiratory cycle of the living body, determined continuously by at least one sensor, it is possible to regulate the characteristics of the respiratory cycle to predetermined target characteristics of the respiratory cycle, as will be explained in more detail below in the chapter entitled Stimulation method 4.

[0037]

[0037] For both of the above functions, it is envisaged that the target characteristic may in particular be a characteristic that avoids damage to the lungs. In particular, self-harming breathing patterns of the organism may be avoided in this way. The control device may also be configured to limit the respiratory volumetric flow rate, the respiratory effort and / or the transpulmonary pressure to a predefined maximum value by the stimulation signal.

[0038]

[0039] The parameters of the stimulation signal output by the at least one output device can be modified as a function of a current measurement value of the spontaneous breathing impulse of the living body, in particular in synchronism with the spontaneous breathing impulse. In this way, the spontaneous breathing impulse of the living body can be blocked or modified. The measurement value can be determined continuously by the at least one spontaneous breathing impulse sensor. The spontaneous breathing impulse sensor can detect the spontaneous breathing impulse of the living body. This is explained in more detail below in the chapter Stimulation method 5. The spontaneous breathing impulse sensor can be designed as a nerve impulse sensor and can detect the nerve impulse signal of the living body that controls the breathing of the living body. It is also possible, for example in the case of electromagnetic stimulation, for the signal output device to form the nerve impulse sensor, which simultaneously outputs the stimulation signal. For example, such a signal output device can be designed as a coil or a coil arrangement. The nerve impulses can also be detected by means of a coil or a coil arrangement.

[0039]

[0040] Intraperitoneal pressure is the pressure within the abdominal cavity of a living body.

[0040]

[0041] The pressure in the abdominal cavity (intracerebrospinal pressure, IAP) increases with inhalation and decreases with exhalation. This means that during spontaneous breathing, a pressure difference occurs between the thoracic and abdominal cavities. The respiratory muscles can generate short but strong pressure fluctuations in the abdominal cavity. These pressure fluctuations affect the function of the abdominal organs.

[0041]

[0042] By setting the parameters of the stimulation signal output by at least one signal output device, it becomes 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 targetedly influenced. For example, the blood flow in certain organs can be improved by this means. For example, favorable effects can be achieved on the abdominal organs. As in spontaneous breathing, the stimulation creates a natural pressure difference between the thoracic and abdominal cavities, and also natural but strong pressure fluctuations in the abdominal cavity, which have a favorable effect on the functions of the abdominal organs, for example intestinal motility and other intestinal functions, organ blood supply or lymph drainage. This can decisively contribute to an improved prognosis. Depending on the existing intraperitoneal pressure, for example caused by the contraction of the diaphragm, the depth and duration of inspiration, but also the level and duration of exhalation can be targeted and controlled.

[0042]

[0043] That is, as a function of the existing intra-abdominal pressure influenced by breathing, the stimulation can be targeted and controlled not only for the depth and duration of inhalation, but also for the level and duration of exhalation. For example, if the intra-abdominal pressure in intra-abdominal hypertension (IAP>12 mbar) becomes so high that blood flow in the abdominal organs is impeded, the stimulation can be reduced accordingly, not only for inhalation but also for exhalation.

[0043]

[0044] By setting the parameters of the stimulation signal output by at least one signal output device, it is possible to achieve targeted excitation of the respiratory nerves and / or respiratory center. In this way, only the respiratory nerves and / or respiratory center are activated. This does not have any perceptible effect on the respiratory muscles. In particular, this does not cause sufficient stimulation of the respiratory muscles for the life-sustaining gas exchange of the living body. This can be achieved, for example, when the intensity of the stimulation signal is so low that almost no muscle contraction occurs. In this way, the respiratory nerves and respiratory center can still be activated and / or their activity can be maintained.

[0044]

[0045] Mechanical ventilation reduces the respiratory work of the respiratory muscles. Respiratory movements are passive with the ventilator, and respiratory nerve activity weakens and may disappear completely. This applies to both the efferent motor neurons that activate the muscles, and the afferent sensory pathways, which detect the range and rate of muscle contraction and the corresponding positional changes, and report this to the respiratory center for feedback.

[0045]

[0046] In addition to the activity of the efferent and afferent neural pathways, the activity of neurons in the respiratory center in the brainstem region is also appropriately reduced during ventilation. The respiratory center reduces its activity after only a few minutes of ventilation time. After ventilation has stopped, it is possible to consciously activate the respiratory center, i.e., through the cerebral cortex, but breathing will now feel intense, even if it is not. Shortly after ventilation has stopped and spontaneous breathing has been fully reestablished in a healthy organism, natural autonomous spontaneous breathing resumes and is controlled by the respiratory center.

[0046]

[0047] This stimulation method of activating and / or maintaining the activity of the respiratory nerves and respiratory reflexes is intended to activate and / or maintain the activity of efferent and afferent neurons, i.e., motor and sensory neural pathways and neurons of the respiratory center in the brainstem region. As in conditioning, training, secretion mobilization, coughing, etc., this stimulation method also requires that there is not enough breathing to maintain gas exchange.

[0047]

[0048] By setting the parameters of the stimulation signal output by at least one signal output device, it is possible to control or regulate the characteristics of the respiratory cycle to a predetermined target characteristic of the respiratory cycle over a number of respiratory cycles, then not affect the respiratory cycle of the living body over a number of respiratory cycles, and then control or regulate the characteristics of the respiratory cycle to the predetermined target characteristic of the respiratory cycle again over a number of respiratory cycles, as will be explained in more detail below in the section entitled Stimulation Method 6.

[0048]

[0049] By setting the parameters of the stimulation signal output by at least one signal output device, it is possible to cause muscular contractions of the respiratory muscles of the living organism over a number of respiratory cycles. These muscular contractions are not necessary for the gas exchange that would occur by the breathing of the living organism, i.e. produce an extra muscle training. In this way, muscle training of the targeted respiratory muscles can be performed. This is explained in more detail below in chapter Stimulation method 7, in particular in 7.1, 7.5 and 7.6. With this type of stimulation, the actual depth of breathing is not affected, i.e. it is only affected by a very low amplitude, which is too low for the life-sustaining gas exchange of the living organism. The purpose of this stimulation is training of the respiratory muscles, which does not harm the respiratory organs, in particular the lung tissue and the diaphragm muscles.

[0049]

[0050] By setting the parameters of the stimulation signal output by the at least one signal output device, it is possible to control or regulate the breathing state to higher values ​​and / or to shift the breathing state to an inspiration phase, as will be explained in more detail below in the chapter Stimulation method 7.2.

[0050]

[0051] By setting the parameters of the stimulation signal output by the at least one signal output device, it is possible to regulate the breathing of the living body 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 which continuously detects the measured value of the breathing depth of the living body. This is explained in more detail below in the chapters Stimulation method 3 and 7.3.

[0051]

[0052] By setting the parameters of the stimulation signal output by the at least one signal output device, it is possible to limit the breathing depth and / or the volumetric flow rate during the inspiration phase to a predefined maximum value, as will be explained in more detail below in the chapters Stimulation methods 4 and 7.4.

[0052]

[0053] By setting the parameters of the stimulation signal output by at least one signal output device, it is possible to limit the volumetric flow rate during the expiratory phase to a predetermined maximum value and / or to reduce it with respect to the average intrinsic volumetric flow rate of the organism during the expiratory phase.

[0053]

[0054] By setting the parameters of the stimulation signal output by the at least one signal output device, it is possible to shorten the duration of the expiratory phase with respect to the average intrinsic duration of the expiratory phase of the living body, in particular by the stimulation signal, which makes it possible to prevent the living body from completely expelling, i.e. to keep at least a certain residual amount of air in the lungs.

[0054]

[0055] During the breathing 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, thus minimizing the energy input into the tissues of the living body.

[0055]

[0056] The throughflow control actuator is pneumatically and / or electrically coupled to the respiratory system of the organism, thereby allowing the volumetric flow rate of airflow into and / or out of the organism to be adjusted. The throughflow control actuator can be variably activated during the breathing cycle to at least temporarily limit or reduce the volumetric flow rate during the inhalation and / or exhalation phases. The throughflow control actuator can comprise, for example, an electrically operable valve in a breathing mask or a hose. The throughflow control actuator can be an electric actuator that can stimulate the organism's larynx, for example by electromagnetic laryngeal stimulation. In this way, for example during exhalation, a desired defined resistance to the exhaled airflow can be generated, thereby keeping the airways and alveoli open.

[0056]

[0057] The control device can be connectable to a ventilator via an interface. The ventilator is configured to ventilate the living body by generating a variable positive and / or negative pressure, and the control device is configured to exchange data with the control device of the ventilator. The advantage of this is that the control device of the electrical stimulation device can use data, in particular measurements anywhere present in the ventilator, such as volumetric flow rate, breathing depth, etc. Thus, such sensors are not required in the electrical stimulation device.

[0057]

[0058] By appropriately adapting the intensity of the stimulation signal output by at least one stimulation device, it is possible to bring about a deep inhalation at the beginning of the breathing cycle. The advantage of this is, for example, in the case of stimulation method 2, that this opens the lungs and performs a recruitment stimulation accordingly. In the case of cough stimulation, it is for example advantageous to take in a maximum amount of air into the lungs, facilitating the stimulation of the cough, because a large amount of air is available to generate a high volumetric flow rate in the exhalation.

[0058]

[0059] For example, by appropriately adapting the intensity of the stimulation signal output by the at least one signal output device, it is possible to carry out a cough stimulation when the first deep inhalation in a breathing cycle is caused, and following this deep inhalation, by setting the parameters of the stimulation signal output by the at least one signal output device, one or more partial exhalations are caused, for example by a shortened exhalation period and / or an increased intensity of the stimulation signal compared to an average exhalation, for example by completely preventing exhalation, for example by a shortened exhalation period of 0.2 to 1.3 times the inhalation period. In addition, the intensity of the stimulation signal can also be increased compared to a normal breathing period in order to generate a maximum volumetric flow rate during exhalation. In particular, following a deep inhalation, and by appropriately adapting the intensity of the stimulation signal output by the at least one signal output device, it is possible to generate several such exhalations, with a shortened exhalation period and / or a maximum volumetric flow rate, without intermediate inhalations.

[0059]

[0060] Moreover, it has the advantage that such a cough stimulation occurs directly and in time after the stimulation of secretion recruitment. As mentioned above, by setting the parameters of the stimulation signal output, the at least one signal output device can stimulate secretion recruitment in order to control or regulate the breathing of the living body to a breathing rate of more than 40 respiratory cycles per minute.

[0060]

[0061] Based on the output stimulation signal, it is possible to alternately stimulate purely thoracic breathing, purely abdominal breathing or a combination of both. The intensity of the stimulation of abdominal and thoracic breathing can be adapted independently of each other. In this way, thoracic and abdominal breathing can be stimulated independently of each other. By increasing the activation in the thorax, shifting the breathing state to inhalation and continuously preventing exhalation, the total cross-sectional area of ​​the diaphragm can be greatly expanded throughout the entire respiratory cycle. In this way, breathing can be performed much more effectively, independently of thoracic breathing, with much less respiratory movement and therefore much less stress on the lungs and diaphragm.

[0061]

[0062] Here, an electrically, electromagnetically and / or magnetically generated stimulation signal can be provided by a signal output device to at least one nerve and / or one muscle. The strength of the stimulation signal can be determined, for example, by voltage or current amplitude, power, amplitude of a magnetic variable and / or short-term average value of one or more such variables. For example, the signal provided to the signal output device to generate the stimulation signal can be an alternating voltage or current signal or other pulsed signal sequence.

[0062]

[0063] The signal output device can in principle be any desired signal output device or a combination of different signal output devices capable of providing such an electrical stimulation signal to at least one nerve and / or one muscle, i.e. the signal output device can directly excite the muscle with an electrical signal to cause it to contract and / or indirectly excite the muscle by electrical stimulation of the corresponding nerve, thereby inducing a contraction of the muscle. For example, the signal output device can have an implanted electrode, which is implanted at a suitable place in the body of the living subject, via which the stimulation signal is provided directly into the body.

[0063]

[0064] In an advantageous embodiment, the signal output device has a signal output element that can be placed externally on the living body and therefore does not need to be implanted. In this way, invasive processes 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. By such coils, a magnetic field can be supplied to the living body, which in turn leads to an induced current in the body, which can generate a desired electrical stimulation signal in at least one nerve and / or one muscle. For this purpose, for example, coils or coil configurations according to WO2019 / 154837A1 or WO2020 / 079266A1 can be used.

[0064]

[0065] The signal output element may also include electrodes. The electrodes may be placed on the body of the living body, for example fastened to the skin. The electrodes may electrically couple the electrical signal to the body. Yet another possibility is that the signal element may have capacitive electrodes, via which the electrical stimulation signal may be supplied to the living body by capacitive coupling, i.e. without electrical contact with the living body.

[0065]

[0066] The electrical stimulation device can in principle be configured to stimulate any desired nerve, thereby affecting the breathing of the living body in a targeted manner. This includes not only the stimulation of the respiratory muscles in the neck region, but also the stimulation of the nerve roots, as well as the stimulation of nerves in brain regions, for example nerves in the brain stem and / or cerebellum. For example, the electrical stimulation device can be designed to stimulate one or more of the following nerves: the phrenic nerve, one or more intercostal nerves, the first, second and third motor neurons, provided that they are capable of inducing respiratory movements.

[0066]

[0067] In order to achieve the desired effect on the respiration of the living body by means of the stimulation signal, the signal output device or its signal output element is designed so that it can be appropriately and safely positioned in a suitable location on the living body. For example, for stimulation of the diaphragm it can be positioned in the region of the phrenic nerve close to the head and / or for stimulation of thoracic respiration it can be positioned in the region of one or more intercostal nerves. For this purpose, the signal output element is adapted with respect to its shape and nature to this suitable positioning on the living body.

[0067]

[0068] The control device can be configured to store the characteristics of one or more breaths of a living organism, for example by means of a control device having a parameter memory, in which typical characteristics of such organisms or characteristics of an individual organism to be treated are pre-stored. In this case, the electrical stimulation device can also be designed without a measuring device, in particular without feedback of a measuring signal in the sensing of the control circuit.

[0068]

[0069] The electrical stimulation device may also have a measuring device with one or more sensors, by means of which characteristics of the respiratory cycle of the living body are detected at specific times or continuously and fed to the control device, where the characteristics may be stored, at least temporarily. Further characteristics of the respiratory cycle, which are predefined in the control device, may also be stored in the parameter memory, as described above.

[0069]

[0070] The control device may be specifically designed as an electronic control device having a computer, by means of which the individual functions of the electrical stimulation device are controlled, and a computer program may be stored in the control device, and the corresponding functions are programmed so that the computer executes the computer program.

[0070]

[0071] When referring to a computer, the latter may be configured to execute a computer program, for example in the software sense, which may be designed as a conventional computer, such as a PC, laptop, notebook, tablet or smartphone, or as a microprocessor, microcontroller or FPGA, or as a combination of such elements.

[0071]

[0072] When we talk about regulation, it differs from control in the sense that regulation involves the feedback of a measured or internal value, which in turn influences the generated regulated output value in the sense of a closed loop control circuit. In control, the variable is purely controlled without such feedback.

[0072]

[0073] When the expression "depth of respiration" is used, it includes not only the actual depth of respiration but also the apparent depth of respiration of the organism. The actual depth of respiration is determined by the size of the tidal volume, which is actually exchanged with the environment during exhalation. The tidal volume is the amount of air that is inhaled and exhaled, i.e. ventilated, with each breath. The apparent depth of respiration is determined by the size of the tidal volume. The tidal volume is considered to occur when unobstructed breathing is possible, by inferring the movement of the respiratory muscles. In most cases, the apparent depth of respiration corresponds to the actual depth of respiration. However, the actual depth of respiration may deviate considerably from the apparent depth of respiration if the airway is, for example, completely or partially obstructed and / or if the lungs show pathological changes.

[0073]

[0074] The actual breathing depth of the organism can be detected based on different variables, for example based on the amplitude of the tidal volume and / or 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 air-filled space of the lung and the pressure at the outer edge of the lung between the two pleura. It is therefore the difference between the intrapulmonary pressure and the intrathoracic pressure, or in other words, the difference between the alveolar pressure and the pleural pressure. The alveolar pressure can only be detected indirectly, through measurements in the airways or in the ventilatory system. The pleural pressure corresponds approximately to the pressure in the esophagus. The transpulmonary pressure can be determined, for example, by measurements of the pressure in the ventilatory system of the organism or the pressure in the esophagus. The transpulmonary pressure is therefore the difference between the ventilation pressure minus the esophageal pressure.

[0074]

[0075] The apparent breathing depth can be detected based on different variables, for example by detecting the movement of the organism, for example the movement in the chest and / or abdomen induced by muscle contraction. Another possibility of detecting or characterizing the apparent breathing depth is to determine the electrical and / or mechanical energy or force required to generate the breathing movement of the organism. This energy or force is required to breathe at a certain volumetric flow rate. Thus, the apparent breathing depth can be determined, at least approximately, based on the intensity of the stimulation signal output by at least one signal output device.

[0075]

[0076] The respiratory volumetric flow rate indicates how much air is actually inhaled or exhaled by the organism per unit time. The respiratory cycle includes an inhalation phase (also called inhalation or inspiration for short) followed immediately by an exhalation phase (also called exhalation or expiration for short). At the end of inhalation at rest, there is a possible lung volume that can still be inhaled, the inspiratory reserve volume (IRV). At the end of exhalation at rest, there is a possible lung volume that can still be exhaled, the expiratory reserve volume (ERV). That is, breathing at rest takes place in a defined respiratory state between the inhalation reserve and the expiratory volume (Figures 3 and 4).

[0076]

[0077] If exhalation during resting breathing is at least partially prevented in each respiratory cycle, the respiratory state transitions to inhalation, where the expiratory reserve increases and the inspiratory reserve decreases (Figure 5). This transition due to the prevention of exhalation occurs by: 1. slowing the respiratory flow during exhalation, and / or 2. keeping exhalation at a defined level, and / or 3. shortening the exhalation time.

[0077]

[0078] The functions described below are executed by a control device and can be designed, for example, as functions of a computer program or of several computer programs or computer program modules. If these functions are executed by a control device, the latter can execute the corresponding functions automatically. Also, many functions of the electrical stimulation device can be set by the user and / or manually controlled. This also includes functions that can be executed at will by the control device.

[0078]

[0079] The invention therefore also relates to a method for stimulating one or more nerves and / or muscles of a living organism by means of such an electrical stimulation device with electrically, electromagnetically and / or magnetically generated stimulation signals, the functions mentioned above being performed manually, for example by modifying the intensity of the stimulation signal output by at least one signal output device, and also by a computer program executing such a method.

[0079]

[0080] With regard to respiratory monitoring, feedback and control, the following may additionally be provided:

[0080]

[0081] For stimulation control, various monitoring parameters and feedback mechanisms can be used. For this purpose, as in conventional ventilators, it is possible to detect one, several or all of the following respiratory parameters: parameters of the body's gas exchange, such as oxygen intake and carbon dioxide output, respiratory impulse, respiratory rate, tidal volume, respiratory rate, levels of exhalation and inhalation. The monitoring can also distinguish between thoracic and abdominal breathing and detect them separately.

[0081]

[0082] A specific role is played by parameters, both for the regulation during the stimulation and for the effect achieved after this stimulation, which indicate the transition between heavy and gentle breathing, i.e. the increase in respiratory drive. These include, for example, the quotient of respiratory rate and tidal volume (RSB or shallow rapid ventilation index), the P0.1 value, the respiratory flow strength (quotient of tidal volume and inspiration time), and the extent of the pressure fluctuations in the esophagus or across the diaphragm in a defined range, for example 4-8 mbar.

[0082]

[0083] In addition, spontaneous electrical activity of the phrenic nerve can also be detected, for example, electromagnetically, by electroneurography (ENG) and used for feedback. Spontaneous electrical activity of the phrenic nerve represents a direct measure of central nervous respiratory activity and can be detected, 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 for controlling stimulation.

[0083]

[0084] Also, certain electromyography patterns can indicate the onset of fatigue. In order to be able to use the electromyography signal of the diaphragm as a direct measure of electrical muscle activity for electromagnetic or electrical respiratory feedback and control, electromyography of spontaneous activity can be performed during the pauses between stimulations. In contrast, artifacts caused by electromagnetic stimulation can make measurements difficult or impossible. Now, by special stimulation algorithms, certain intervals of muscle activity can be detected without artifacts and can then be used to control other stimulations. 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. Furthermore, by directly coupling the devices to each other, it is also possible to perform filtering of the electromagnetic signals. For example, electromyography monitoring of the achieved muscle activity can also be performed between stimulations, which allows direct feedback.

[0084]

[0085] The relationship between electrical stimulation and the resulting mechanical muscle activity depends on the force-length and force-velocity ratios, i.e. on the thoracic volume and shape, but also on the pathological process. For example, during disease progression, the diaphragm force may decrease even though the electrical muscle stimulation increases. Monitoring the diaphragm force is therefore advantageous, especially for feedback to control the training stimulation. Besides indirect parameters such as RSB and P0.1 values, ultrasound measurements of diaphragm movement and thickening can provide an indirect indication of diaphragm force. The standard method, which has been used for many years, detects the diaphragm force indirectly through pressure fluctuations between the thoracic and abdominal cavities. The phrenic nerve is stimulated with electromagnetic standard stimuli and the resulting transdiaphragmatic pressure fluctuations are measured by balloon catheters in the esophagus and stomach. From this the diaphragm force can be determined.

[0085]

[0086] Further advantageous features and method steps are described in detail below.

[0086]

[0087] Group 1: Lung-dependent irritation 1) Lung-sparing stimulation for low-energy transfer 2) Recruitment and stabilization stimuli to open collapsed lung regions and maintain open regions 3) Lung-protective stimulation to control tidal volume Group 2: Respiratory-related stimuli 4) Control stimulation to control harmful autonomic breathing 5) Modulation stimulation to modify spontaneous breathing Group 3: conditioning and training stimuli 6) Conditioning stimulation to implement improved breathing patterns 7) Training stimuli for training respiratory muscles

[0087]

[0088] Group 1: Lung-dependent irritation

[0088]

[0089] Pulmonary relaxation stimulation - Stimulation method 1

[0089]

[0090] A gentle and particularly low-energy breath is achieved by a pattern of gradually increasing impulse stimulation intensity during inhalation and decreasing impulse stimulation intensity during exhalation. In this way, rapid respiratory movements are avoided, thereby minimizing energy transfer to the lung tissue and lung damage caused by breathing itself. This principle is based on the newly developed breathing pattern of flow-controlled ventilation (FCV) (3) (see also PCT / EP2017 / 052001).

[0090]

[0091] In this flow-controlled form of ventilation, the conflict between lung-sparing and diaphragm-sparing ventilation is very pronounced, because 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 can promote simultaneous autonomous breathing, i.e., preservation of respiratory muscles and their strength in FCV.

[0091]

[0092] During natural spontaneous breathing, the diaphragm is active during exhalation. This activity, called expiratory braking, brakes exhalation and stabilizes the lungs. This natural activity of the diaphragm during exhalation decreases as expiratory resistance increases. This lung-relaxing stimulus provides a reduced intensity stimulus during the exhalation phase as well. Complete exhalation is only very short and is completely avoided (see stabilizing stimulus under stimulation method 2). This relieves the collapse of lung tissue. In this way, not only dysfunction in gas exchange is prevented, but also the increase in respiratory drive and the increasing respiratory insufficiency associated with harmful spontaneous breathing patterns can be prevented.

[0092]

[0093] In addition, the conditioning effect of this form of stimulation results in training this gentle breathing pattern (see conditioning stimulation under stimulation method 6). Furthermore, it maintains and trains both the strength and muscle mass of the respiratory muscles, which is very important especially during normal ventilation and especially during flow-controlled ventilation (FCV) (see training stimulation under stimulation method 7.1).

[0093]

[0094] Recruitment and stabilization stimulation - stimulation method 2

[0094]

[0095] Stimulation method 2, coupled with the prevention and / or slowing down of exhalation (see above), sometimes induces a deep sigh. By preventing and / or slowing down exhalation, this stimulation method restores collapsed lung areas and stabilizes the lungs, thus preventing renewed collapse.

[0095]

[0096] In the restorative stimulation, it is possible to set not only the depth of inhalation, but also the duration of the inhalation phase and even the duration of the exhalation phase, i.e., to increase the efficiency of the restorative stimulation, the breathing time ratio can also be changed, the maximum inhalation time can be extended and the exhalation time can be shortened.

[0096]

[0097] In stabilizing stimulation, the end of exhalation can be held at different levels depending on the requirements by direct stimulation of the respiratory muscles (expiratory hold). As explained under stimulation method 1, the speed of exhalation can be further slowed down, for example by reducing the intensity of the stimulation impulse during exhalation, similar to the natural expiratory brake explained above. In addition, collapse of lung areas can likewise be prevented by modifying the breathing time ratio. By modifying the stimulation time in stabilizing stimulation, the inhalation time can be extended and the exhalation phase shortened, as explained above for recruitment stabilization. If stimulation in the exhalation phase is not possible or is only possible to an insufficient extent, complete exhalation can be prevented by prematurely starting the electromagnetic or electrical stimulation of inhalation (expiratory cut). Here, as already mentioned above, accurate breathing monitoring, in particular of the breathing state, is advantageous in order to be able to accurately determine the correct time for inhalation.

[0097]

[0098] In addition, a dynamic adapted increase in the expiratory resistance can be optionally combined with a stabilizing stimulus, which results in a further slowdown of expiratory flow and thus further stabilization of the lungs during the expiratory phase. This can be combined with and synchronized with the stimulus during expiratory flow. Thus, during spontaneous expiratory flow, the increase in expiratory resistance is very naturally performed by the vocal cords, which open again during inhalation. The increase in expiratory resistance reduces the natural diaphragm activity for expiratory braking.

[0098]

[0099] This stimulation method 2 also mitigates the increased respiratory work and drive caused by increased lung collapse, preventing further lung damage associated with self-damaging spontaneous respiration (see also control stimulation on the next page). Thus, recovery and stabilization stimulation can indirectly reduce or even prevent not only increased work of breathing and harmful respiratory effort, but also high tidal volume ventilation.

[0099]

[0100] Lung protection stimulation-stimulation method 3

[0100]

[0101] By stimulation during inhalation, the breathing depth is regulated, for example, so that a gentle tidal volume of 6 ml / kg ideal weight is breathed and / or the transpulmonary pressure of 5 mbar is not exceeded. For this purpose, feedback can be performed between the measurements of the tidal volume, the transpulmonary pressure or the corresponding correlates, and the stimulation intensity, so that the stimulation can be adapted to the tidal volume and / or the transpulmonary pressure achieved. Moreover, this is not only done for subsequent breaths, but instead, the ongoing stimulation can also be directly controlled already by monitoring and feedback. That is, the intensity of the ongoing stimulation can be weakened and / or the stimulation duration can be shortened, for example, so that the defined tidal volume of 6 ml / kg ideal weight and / or the transpulmonary pressure of 5 mbar is not exceeded. This is very important, especially during spontaneous breathing (see stimulation methods 4 and 5, Control and Modulated Stimulation).

[0101]

[0102] Moreover, in pathological conditions with high levels of carbon dioxide exhalation, adequate ventilation must also be ensured. Besides the restoration and maintenance of the gas exchange surface area and the level of tidal volume, this is achieved by a properly adapted respiratory rate. The respiratory rate is determined not only by the incidence of the stimulation, but also by the ratio between inhalation and exhalation mentioned above, i.e. the respiratory time ratio, which can be set by the corresponding stimulation time.

[0102]

[0103] Group 2: Respiratory-related stimuli

[0103]

[0104] Control Stimulation - Stimulation Method 4

[0104]

[0105] Independent of spontaneous breathing, this electromagnetic or electrical stimulation method achieves a more gentle autonomic respiratory control over the lungs, even when spontaneous breathing follows a completely different, possibly even harmful, pattern. Thus, if the respiratory drive and effort increase, for example, when the work of breathing is excessive and fatigue is increasing, the stimulation can provide targeted counter-control. Here, the enhanced, rapid, and deeper breathing inflicts damage to the already damaged lungs, as well as to the already weakened and similarly previously damaged respiratory muscles. The increased lung damage as well as diaphragm damage resulting from self-inflicted spontaneous breathing is called patient-self inflicted lung injury (P-SILI).

[0105]

[0106] This stimulation method allows the control of autonomous breathing so that respiratory muscle overload and P-SILI can be reduced or even prevented. Electromagnetic or electrical stimulation is the only method so far that allows the control of autonomous breathing, i.e. it is the best non-invasive method, independent of spontaneous breathing and the patient's will, and without the use of drugs.

[0106]

[0107] To control this stimulation method, feedback mechanisms can be used that take into account important features of spontaneous breathing and / or the autonomous breathing that ultimately occurs together with the stimulation. Here, tidal volume, transpulmonary pressure, respiratory rate, respiratory state, and indirect properties of respiratory drive are particularly important, allowing an individual and flexible adaptation of the stimulation.

[0107]

[0108] Special forms of regulatory stimuli: secretion mobilization and coughing

[0108]

[0109] These two methods of respiratory muscle stimulation are similarly performed independently of spontaneous breathing and satisfy a specific function independent of breathing: thus, secretions are intended to be mobilized from the peripheral airways to the central airways, then mobilized by coughing, and finally cleared from the airways.

[0109]

[0110] Secretion mobilization stimulation: This stimulation method allows secretion to be mobilized from the periphery to the central trigger, for example by frequent, short, rapid, forced ejections.

[0110]

[0111] Stimulation of cough: this stimulation method can be carried out immediately after the recruitment of secretions in order to mobilize the recruited secretions more effectively and in particular to be able to "blow them out". For this purpose, there is a short cough or a series of short coughs after a fairly long inhalation. As in the case of a natural cough, forced expulsion is more effective, i.e. it increases the pressure in the lungs, if the initiation of expulsion is against an increase in airway resistance. This short, synchronized increase in expulsion resistance can be achieved by synchronizing an artificial resistance and / or by constriction of the vocal cords caused by stimulation of the laryngeal nerve.

[0111]

[0112] Modulation stimulation - stimulation method 5

[0112]

[0113] In contrast to the control stimulation (see stimulation method 4 above), the modulated stimulation is not performed independently of the spontaneous breathing, but instead as a function of the spontaneous breathing impulse. Instead of the autonomous breathing being controlled completely independent of the spontaneous breathing, the spontaneous breathing pulse is therefore always taken into account, even when there is partial or complete control of the natural spontaneous breathing and only a weak or even non-existent respiratory impulse.

[0113]

[0114] Synchronization types

[0114]

[0115] Therefore, the spontaneous breathing impulse must be detected so that electromagnetic or electrical stimulation can be synchronized with it. The modulation stimulation can be synchronized with the aid of standard methods of detecting the spontaneous breathing pulse, such as pressure, flow, or temperature variations in the air stream, or with the aid of body sensors, such as the Grasby capsule or muscle activity sensors. However, synchronization with the actual nerve impulse before the onset of spontaneous inspiration is much more accurate. Ventilation synchronized with the nerve impulse is called neurally assisted or neurally adjusted ventilatory assist (NAVA). Here, the nerve impulse is detected by a sensor in the esophagus close to the diaphragm. See [4].

[0115]

[0116] However, the actual nerve impulses can also be detected by non-invasive electromagnetic means, either directly at the stimulation site on the neck, peripherally, or centrally at the site of origin of the nerve impulses in the brainstem region.

[0116]

[0117] Dispensing level modulation

[0117]

[0118] Spontaneous breathing can then be altered in synchronization with the modulated stimulation, as in the previously described stimulation methods 1-3. This can be done by stimulation throughout the entire respiratory cycle, as in the lung relaxation stimulation, to achieve a more gentle spontaneous breathing. Depending on the disease and spontaneous breathing pattern, modulated stimulation as described under stimulation method 2 can also be performed only during the exhalation phase, to stabilize the lungs at different levels by preventing and / or delaying exhalation.

[0118]

[0119] Modulation of tidal volume

[0119]

[0120] However, depending on the requirements, stimulation can also be provided synchronously only during the inhalation phase, so as to allow for intermittent, very deep, sustained breathing to re-open collapsed lung areas, as explained under stimulation method 2. Furthermore, in case of insufficient shallow breathing, stimulation during spontaneous inhalation can also allow for a sufficiently deep breath with a corresponding tidal volume. For this purpose, besides the detection of the respiratory impulses as also explained under lung-protective stimulation (see stimulation method 3 above), feedback on the respiratory volume and / or transpulmonary pressure is also advantageous here.

[0120]

[0121] Furthermore, it is possible to prevent excessively deep breathing with excessive tidal volumes that would damage the lungs by "taking over" or inhibiting the spontaneous nerve impulse. Such taking over can be performed by targeted stimulation of the phrenic nerve just before the spontaneous nerve impulse, so that the spontaneous impulse cannot be delivered during the absolute refractory period of the nerve, but can only be delivered in an attenuated form during the relative refractory period.

[0121]

[0122] As already mentioned above, excessive spontaneous breathing tidal volumes can also be indirectly avoided by shifting the breathing state to inhalation and preventing exhalation. A feedback mechanism using tidal volume measurements, as previously explained for lung protective stimulation (stimulation method 3), is used here as well.

[0122]

[0123] Modulation of breathing rate

[0123]

[0124] The previous form of stimulation did not change the spontaneous breathing rate. However, if the spontaneous breathing rate is too high or too low, the spontaneous breathing rate can be directly and / or indirectly influenced and controlled by electromagnetic or electrical stimulation. As a result, a smooth transition to independent breathing is controlled and regulated by the corresponding feedback mechanism by detecting the spontaneous breathing rate.

[0124]

[0125] That is, the extent and incidence of the stimulation can be adapted individually according to the spontaneous breathing depth and incidence. If the spontaneous breathing rate is too fast, it can be indirectly slowed down by extending the inhalation and / or exhalation phases and finally superimposed with a lower rate. It is also possible to reduce the breathing rate by individual deep breathing by activating the respiratory reflex.

[0125]

[0126] As with conventional backup ventilation, if breathing is too slow or has stopped, the respiratory rate is increased directly by electromagnetically or electrically controlled autonomous breathing. If breathing gradually decreases, for example, as the depth of coma increases, a corresponding number of stimulations can achieve an adequate respiratory rate early, even before insufficient gas exchange with oxygen deficiency occurs due to intermittent breathing.

[0126]

[0127] Modulation in response to intraperitoneal pressure

[0127]

[0128] The pressure in the abdominal cavity (intracerebrospinal pressure IAP) increases with inspiration and decreases with expiration, i.e., a natural pressure difference occurs between the thoracic and abdominal cavities, as in the case of spontaneous breathing. Stimulation of the respiratory muscles can not only bring about natural but also enhance pressure variations in the abdominal cavity, influencing the functions of abdominal organs, e.g. intestinal motility, organ blood supply or lymph drainage, and furthermore can decisively contribute to improving the prognosis of ventilated patients.

[0128]

[0129] This means that as a function of the existing intra-abdominal pressure influenced by breathing, the stimulation can be targeted and controlled not only for the depth and duration of inhalation, but also for the level and duration of exhalation, e.g., in intra-abdominal hypertension (IAP>12 mbar) where the intra-abdominal pressure is so high that it impedes the blood flow in the abdominal organs, the stimulation can be reduced accordingly, especially in exhalation.

[0129]

[0130] Group 3: conditioning and training stimuli

[0130]

[0131] Conditioning Stimulation - Stimulation Method 6

[0131]

[0132] All five stimulation methods described above can also be used exclusively as conditioning to improve spontaneous breathing. Here, intermittent stimulation is performed with variable stimulation periods, but only a few breaths may be sufficient. The conditioning stimulation trains a defined spontaneous breathing pattern either by modulation of spontaneous autonomous breathing or as autonomous breathing controlled by stimulation methods 1 to 5 described above.

[0132]

[0133] The conditioning stimulus can be controlled and augmented by direct feedback based on the detection and measurement of autonomous breathing: breathing nature, level of exhalation, depth of inspiration, tidal volume, and respiratory rate are measured and the conditioning stimulus adapted accordingly.

[0133]

[0134] Redistribution of respiratory activity to the region of the respiratory muscles, as occurs in positive pressure ventilation, is thereby prevented, and even fatigue or decline of the autonomic respiratory activity under conventional ventilation is avoided, since peripheral nerve activity with corresponding afferent impulses from the respiratory muscles can be maintained by stimulation.

[0134]

[0135] In "pauses" without conditioning stimuli, spontaneous breathing can proceed normally. However, normal ventilation can also take place, or spontaneous breathing can be assisted by electromagnetic or electrical stimulation, and in this case, too, autonomous breathing can be modulated as described above, in contrast to the conditioning stimuli. In these pauses, a check is made to see whether, to what extent, and especially for how long the conditioning stimuli have influenced the spontaneous autonomous breathing. Then, depending on the changes made, a feedback mechanism makes it possible to individually adapt the nature, occurrence rate, duration, and especially the intervals of the conditioning stimuli.

[0135]

[0136] The conditioning respiration produced by the conditioning stimulus, like the training stimuli described below, must meet certain requirements (see below).

[0136]

[0137] Training Stimulation - Stimulation Method 7

[0137]

[0138] Muscle degradation begins after only a few hours during positive pressure ventilation, and muscle strength declines even earlier and very rapidly: muscle biopsies taken after only 2 hours of ventilation demonstrated a strength loss of approximately 35% in isolated muscle fibers [5].

[0138]

[0139] Muscle deterioration and weakening are additionally exacerbated by severe disease processes, especially inflammation. If the weakened muscles are only inadequately relieved by ventilation, an increased respiratory drive develops, leading to greater and eventually overstretched respiratory effort, weakening and damaging the muscles as well as the already damaged lungs. A high level of respiratory effort represents the most important factor for damage to the diaphragm muscles. The scale between too little and too high levels of respiratory effort is very narrow and can also vary greatly between and within individuals. As a result of reduced strength and muscle deterioration, the weakened respiratory muscles eventually are no longer able to ensure sufficient autonomous breathing. Respiratory failure develops with the breathing patterns already described above. Breathing becomes rapid, shallow, and intense, causing further damage to the already damaged lungs as well as the respiratory muscles. The cessation of ventilation constitutes the largest portion of the total ventilation period and is therefore critically determined by the restoration of muscle strength suitable for adequate spontaneous breathing, together with the rebuilding of muscle mass required.

[0139]

[0140] The electromagnetic or electrical stimulation training methods described below are intended to strengthen the respiratory muscles so that they can be built and existing muscles can be weakened and their deterioration prevented, where further damage to the lungs and respiratory muscles must be minimized or avoided as much as possible.

[0140]

[0141] A restorative, preventative, and preemptive form of training

[0141]

[0142] By using electromagnetic or electrical stimulation, the device can: 1. retrain degraded respiratory muscles or retrain weakened muscles; 2. prevent muscle deterioration or weakening; and / or 3. strengthen muscles before the expected muscle loss, before the expected degradation or strengthening occurs.

[0142]

[0143] Thus, training can be restorative, preventative, and / or preemptive. 1) Following deterioration and / or weakening of respiratory muscles due to conventional ventilation and disease processes, restorative training stimuli are used to rebuild muscles and / or restore strength. 2) During conventional ventilation and disease processes, muscle deterioration and / or strength loss is mitigated by a preventative training stimulus. 3) Anticipatory training stimuli to build respiratory muscles and / or strength prior to anticipated increased load and / or anticipated respiratory muscle deterioration or weakening due to conventional ventilation or disease processes.

[0143]

[0144] Intensity of training stimulus

[0144]

[0145] Since electromagnetic or electrical stimulation provides sufficient ventilation (1), it is assumed that this stimulation intensity during inhalation is also suitable for preventing muscle deterioration, just as normal spontaneous breathing also prevents muscle deterioration and loss of muscle strength. In many cases, a lower stimulation intensity is also suitable for preventing muscle deterioration, for example if used properly and frequently during conventional ventilation. More intense stimulation can correspondingly build up respiratory muscles and / or muscle strength, or even fewer stimulations can be more effective in preventing muscle deterioration and / or loss of muscle strength.

[0145]

[0146] For training at high stimulation intensities, stimulation during ejection is of particular importance (see below).

[0146]

[0147] Smooth transitions for training stimulus patterns

[0147]

[0148] The training stimuli had six smooth transitions. 1) A small number of very intense training stimuli, and a large number of very weak training stimuli. 2) Partial stimulation, and stimulation that occurs throughout the entire respiratory cycle. 3) Stimulation synchronized with spontaneous breathing and stimulation independent of spontaneous breathing. 4) Stimuli that prevent muscle deterioration or loss of strength, and stimulate muscle building or strength improvement. 5) Training and conditioning stimuli 6) Training and ventilation stimuli

[0148]

[0149] Training breathing requirements

[0149]

[0150] The training stimulus results in a corresponding training breath. Thus, the training pattern similarly focuses on the previously described stimulation methods 1 to 4 and further takes into account the relationships described here. Thus, the breath performed during the training stimulus is also intended to meet the following four requirements:

[0150]

[0151] Training breathing is 1) There must be no additional damage to the lungs and respiratory muscles, or there must be only a minimal amount of additional damage, and on the contrary there must be a positive effect on them. 2) Do not allow further adverse effects, such as hyperventilation, to occur. 3) There should be no adverse effect on spontaneous breathing; on the contrary, there should be as positive an effect on it as possible. 4) It must not cause discomfort or must cause the least discomfort possible.

[0151]

[0152] Electromagnetic or Electrical Training Methods

[0152]

[0153] Therefore, according to the stimulation methods 1 to 6 described above, there are six forms of training stimulation as follows, which also allow intensive training stimulation without causing harmful breathing. 7.1. Pulmonary relaxation training stimuli 7.2. Focused training stimuli 7.3. Lung-protective training stimulus 7.4. Training Stimuli to Avoid Self-Injurious Injury (P-SILI) 7.5. Modulated training stimuli 7.6. Conditioning and training stimuli

[0153]

[0154] 7.1. Pulmonary relaxation training stimuli

[0154]

[0155] The principle of gentle breathing with less energy transfer to the lung tissue, explained in stimulation method 1, also applies to training stimulation, even if it is only performed occasionally and after very long intervals. With this stimulation method, sudden and potentially harmful respiratory movements, as explained above, are avoided by a gradual increase in stimulation impulses during inhalation and a gradual decrease in stimulation impulses during exhalation. This is very important especially for intense and frequent training stimulation (see 7.2. below).

[0155]

[0156] 7.2. Focused training stimuli

[0156]

[0157] This method allows rapid muscle build-up and strength enhancement to be achieved and / or effectively prevents muscle deterioration and loss of strength with only a few intensive stimuli. A crucial aspect of this form of stimulation is that there is little breathing despite the intensive muscular activity of the respiratory muscles. As explained above in stimulation method 2, this is achieved by shifting the breathing state to inhalation and preventing exhalation. In particular, holding exhalation at a defined level (expiration retention) requires an increase in muscular effort. Thus, very intensive training stimuli can be performed simultaneously with a pronounced contraction of the respiratory muscles, without causing heavy breathing, both in the inhalation and exhalation phases.

[0157]

[0158] Here, the "holding of the respiration" in both the inhalation and exhalation phases can be enhanced by appropriately extending the stimulation time in each respiratory cycle. At the same time, as a secondary effect, the collapsed lung area is opened and the ventilated lung region is stabilized, as previously explained in the stimulation method 2.

[0158]

[0159] This training method allows a very intensive training stimulation of the respiratory muscles, with few side effects and protecting the lungs: despite the pronounced muscular activity, it is possible to avoid not only self-inflicted damage (see 7.3-7.5 below), but also the corresponding side effects such as hyperventilation and even hypocapnia, and, as a consequence, the dreaded pH shift.

[0159]

[0160] If stimulation is not possible during the exhalation phase, or possible but not appropriate, the side effects and fatigue associated with hyperventilation can also be avoided by pausing. Pausing can be controlled by feedback. In addition, deep breathing can also be restricted mechanically, by straps and / or weights, but also by increasing airway resistance, thus further enhancing the training effect.

[0160]

[0161] As a result of the focused training stimulus, the period of use per patient can be significantly reduced, so that the device can be made available to different patients at short intervals.

[0161]

[0162] An important aspect of this intensive training is to not generate deep breaths with sudden respiratory movements (see 7.1 above) and / or large tidal volumes (see 7.3 below) and / or high transpulmonary pressures, despite significant stimulation and corresponding strong contractions of the respiratory muscles.

[0162]

[0163] 7.3. Lung-protective training stimulus

[0163]

[0164] As explained above in stimulation method 3, the breathing depth during inhalation is also regulated in this form of training so that only gentle tidal volumes are breathed and / or gentle transpulmonary pressures are exercised. This is very important, especially in the case of frequent training stimulation. The aforementioned feedback between the measured tidal volume and the stimulation intensity allows additional feedback on the breathing state, as explained above (see 7.2. above).

[0164]

[0165] In this way, the stimulation intensity can be increased and at the same time, even in an intensive training stimulus, a tidal volume protecting a lung of, for example, 6 ml / kg ideal weight and / or a transpulmonary pressure of 5 mbar is not exceeded. As explained above in 7.2, the interaction between the breathing state and the tidal volume makes it possible to achieve an intensive training stimulus without dangerous breathing.

[0165]

[0166] In addition, by increasing the exhalation resistance, the respiratory state can be shifted to inhalation to a limited extent, thereby limiting the tidal volume, in combination with and in synchrony with the stimulation during exhalation.

[0166]

[0167] However, even at low stimulation intensities, high tidal volumes can be achieved. Also, independently of the respiratory state, lung-protective stimulation prevents situations in which dangerous breathing with high tidal volumes occurs, even at low stimulation intensities. This excludes the possibility of lung-damaging effects caused by the training stimulation itself, especially in the case of frequent stimulation. This is particularly important in spontaneous breathing, because in this case even low training stimulation considerably intensifies the autonomous breathing that is then taking place in addition to the spontaneous breathing (see 7.4.-7.5 below).

[0167]

[0168] 7.4. Training stimuli to avoid self-inflicted injury (P-SILI)

[0168]

[0169] Apart from the three previously mentioned training stimulus patterns intended to minimize or prevent additional damage caused by ventilation during training, this training pattern is intended to avoid or minimize damage in the presence of spontaneous breathing.

[0169]

[0170] The additional training stimulus takes into account spontaneous breathing so that it does not result in deep and / or sudden inhalations at all. This is especially important in the case of frequent repetitions and can be achieved in different ways: either there is no stimulus during inhalation, or the stimulus does not exceed a defined tidal volume, or the inhalation is modulated accordingly.

[0170]

[0171] In yet another pattern, in this training, the depth of spontaneous breathing, i.e. self-inflicted breathing, is also limited during exhalation, so that the respiratory state can be shifted to inhalation by preventing exhalation, as explained in stimulation method 2 and also in point 7.2.

[0171]

[0172] Therefore, spontaneous and / or autonomic breathing caused or altered by the stimulation must be detected so that the stimulation can be adapted individually and flexibly and, if necessary, spontaneous breathing can be modulated (see 7.5 below).

[0172]

[0173] 7.5. Modulated training stimuli

[0173]

[0174] Finally, there is a smooth transition between training and modulation stimuli in different combinations, as previously explained in stimulation method 5. That is, the stimulation can be individually adapted, taking into account the disease and its severity, so that the requirements of autonomic breathing and also the desired training effect can be achieved.

[0174]

[0175] The modulated training stimulation always takes into account the spontaneous breathing and therefore also changes it. Here, the stimulation is performed throughout the entire respiratory cycle or only in a part. In the case of partial stimulation, the training is performed only in the inhalation phase, only during exhalation, or in a part of these respiratory phases. Here, as explained several times before, exhalation is considered to be particularly important in order to make it possible to perform intensive training, to avoid the controlled autonomic breathing becoming too deep, and also to avoid the spontaneous breathing becoming too deep during training. Even in the case of shallow and rapid breathing due to fatigue of the respiratory muscles, the modulated stimulation can simultaneously perform training and achieve an improvement in the breathing pattern, as explained above in stimulation method 5. As fatigue increases, intervention must be sought as soon as possible to relieve the fatigued respiratory muscles. In the case of excessive fatigue, if it turns out that relaxation of the respiratory muscles by ventilation is necessary, preventive training stimulation can also reduce or prevent muscle deterioration at an early stage.

[0175]

[0176] 7.6. Conditioning and training stimuli

[0176]

[0177] The conditioning stimulus described above in stimulation method 6 also represents a form of training stimulus. However, the purpose of the conditioning stimulus is primarily the "practicing" or conditioning of a prescribed breathing pattern, not the training of the respiratory muscles. Thus, the conditioning training stimulus is performed when it is intended to additionally condition a prescribed breathing pattern, as a complement to the training of the respiratory muscles.

[0177]

[0178] Combination of stimulation functions

[0178]

[0179] Training stimuli can finally be combined with conditioning stimuli so that the requirements for appropriate adaptation of ventilation can also be met depending on the severity of the disease, lung damage and respiratory disorders.

[0179]

[0180] In the case of hypoxic lung injury, for example in the context of ARDS, stimulation during expiration assisted by expiratory hold, braking and cut stimulation patterns (see above and below) can stabilize the lung, protect it from excessively large tidal volumes, regulate the "holding" of expiration and simultaneously perform an intensive training of the respiratory muscles (see overview of expiratory stimulation).

[0180]

[0181] Overview of ejection stimulation

[0181]

[0182] Stimulation during exhalation is of utmost importance for: 1. lung stabilization, 2. lung protection, 3. conditioning of spontaneous breathing, and 4. intensive yet at the same time gentle training of the respiratory muscles.

[0182]

[0183] 1. Lung stabilization

[0183]

[0184] Stabilizing stimuli prevent lung collapse with corresponding gas exchange failure, as well as harmful collapse recruitment ventilation, hyperinflation of the ventilated lung, increased work of breathing, respiratory effort, P-SILI, and finally fatigue. Stabilizing stimuli can be performed in three different ways: 1. expiratory hold, 2. expiratory braking, and 3. expiratory cut, which can also be combined. 1) Breath retention: Preventing complete breathing out by holding the breath. 2) Expiratory braking: slowing down of exhalation by reducing the intensity of the stimulus. 3) Exhalation reduction: shortening the exhalation period.

[0184]

[0185] Finally, the level of exhalation is determined specifically by the nature of the damping and indirectly by the shortening of the exhalation time, as well as by the expiratory retention. In contrast to positive pressure ventilation, here there is no artificial pressure rise in the lungs, but also no artificial pressure drop in the abdominal cavity, as in the case of negative pressure ventilation.

[0185]

[0186] 2. Lung protection

[0186]

[0187] The more air is retained in the exhalation, the easier it is to transition the breathing state to inhalation and the more shallow the inhalation can be in the next breath. If the transition of the breathing state means that the inhalation cannot be made as deep, then high and therefore damaging tidal volumes cannot be reached purely mechanically. This applies to 1. spontaneous breathing, 2. electromagnetically or electrically controlled autonomous breathing, 3. electromagnetic or electrical training breathing, but also 4. conventional ventilation. In other words, the stimulation in the exhalation itself makes it possible to limit not only harmful spontaneous breathing, but also harmful electromagnetic or electrical ventilation, but also conventional ventilation with high tidal volumes.

[0187]

[0188] 3. Conditioning

[0188]

[0189] The conditioning stimuli aid in the performance of various expulsion strategies in a targeted manner, thereby more effectively learning the prescribed expulsion technique for subsequent spontaneous breathing.

[0189]

[0190] 4. Training

[0190]

[0191] The stimulation during exhalation allows for intensive training of the respiratory muscles by limiting inhalation with a transition of the respiratory state. This allows for a very intensive training stimulation, with a significant contraction of the respiratory muscles during both the inhalation and exhalation phases, because, despite the intensive muscular activity of the respiratory muscles, there is only a small amount of breathing. In this way, it is possible to avoid not only extensive training breathing, but also harmful spontaneous breathing during training, and the associated harmful effects and complications.

[0191]

[0192] Further advantageous embodiments of the invention will become apparent from the following description of exemplary embodiments of the invention with the aid of schematic drawings. The invention is explained in more detail below in particular on the basis of exemplary embodiments and with reference to the attached drawings, in which: [Brief description of the drawings]

[0192] [Figure 1] 1 illustrates the use of an electrical stimulation device on a living body. [Diagram 2] 1 shows the in vivo use of an electrical stimulation device in conjunction with a positive pressure ventilator. [Diagram 3] A time diagram of respiratory status is shown. [Figure 4] A time diagram of respiratory status is shown. [Diagram 5] A time diagram of respiratory status is shown. [Figure 6] This shows the change in intrapulmonary air volume over time during the respiratory cycle. [Figure 7] 1 shows the change in transpulmonary pressure over time during the respiratory cycle. [Figure 8] The electromagnetic field during the inspiration phase is shown with a pulse train for stimulation, the onset of the train being in a ramp shape. [Figure 9] The electromagnetic field during the inspiration phase is shown with the pulse train for stimulation, the leading and trailing edges of the train being in a ramp shape. [Figure 10]The electromagnetic field during the inspiration phase is shown with a pulse train for stimulation, the rise and fall of the train being in a ramp shape, and pulses of reduced intensity between the trains. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0193] Method(s) of implementing the invention

[0193] Certain terms are used in the following description for convenience, but are not intended to be limiting. The words "right", "left", "lower", and "upper" refer to directions in the drawings to which they refer. Terms such as "inward", "outward", "below", "above", "left", and "right" are used to describe the placement of designated parts relative to one another, the movement of designated parts relative to one another, and directions toward or away from the geometric center of the invention and its named parts as shown in the drawings. These spatial relationships also include positions and orientations other than those shown in the drawings. For example, if the parts shown in the drawings are rotated, an element or structure described as "lower" would become "upper". The terms include the words expressly set forth above, derivatives thereof, and words of similar meaning.

[0194]

[0194] In order to avoid repetition in the drawings of various aspects and representative embodiments and the related description, it should be understood that certain features are common to the various aspects and representative embodiments. If an aspect is omitted in the description or figures, it is not implied that this aspect is absent in the related representative embodiment. On the contrary, such omission may serve for clarity and to avoid repetition. In this context, the following definitions apply throughout the rest of the description. When reference numbers are included in a figure for the purpose of clarifying the figure, but are not mentioned in the directly related description text, reference is made to their description in the description of the immediately preceding figure. In addition, when a reference number that is not included in the related figure is mentioned in the description directly belonging to the figure, reference is made to the immediately preceding and subsequent figures. Similar reference numbers in two or more figures represent similar or identical elements.

[0195]

[0195] Figure 1 shows a living body 1 in a supine position. To make things clear, advantageous stimulation positions of the phrenic nerve 2 and the intercostal nerve 3 are shown on the living body 1. In this exemplary embodiment, it is assumed that the phrenic nerve 2 is intended to be stimulated by electromagnetic stimulation.

[0196]

[0196] Fig. 1 shows an electrical stimulation device 4. The electrical stimulation device 4 is connected by electrical wiring to a signal output element 10, for example a coil, for providing a magnetic field in a living organism 1. By means of the signal output element 10, the electrical stimulation device can generate a stimulation signal in the living organism. This stimulation signal can generate muscle contractions and thus affect the respiration of the living organism 1 in a targeted manner.

[0197]

[0197] The electrical stimulation device 4 can be designed, for example, as a computer-controlled electrical stimulation device. It comprises a computer 5, a stimulation signal generator 6, a memory 7 and an operating element 8. In addition, a display device for displaying operating data can also be present. In the memory 7, a computer program is stored, by means of which some or all of the functions of the electrical stimulation device 4 can be performed. The computer 5 executes the computer program in the memory 7. Thus, the stimulation signal generator 6 outputs a corresponding stimulation signal to the signal output device 10, by means of which a desired magnetic field is generated. The aforementioned functions for ventilation of the living body 1 by the stimulation signal, or the process performed by the user, can be influenced by the user through the operating element 8, for example by setting the parameters of the respiratory cycle.

[0198]

[0198] The artificial ventilation of the living body 1 by electrical stimulation can be controlled by any desired element. If certain parameters are also to be regulated, one or more measured values ​​of the characteristics of the respiratory cycle of the living body 1 are supplied to the electrical stimulation device 4. For example, it is expedient to detect the volumetric flow rate inhaled by the living body 1 and the volumetric flow rate exhaled. This can be done, for example, by means of a facial mask 13, in which a flow sensor is arranged. The facial mask 13 or the flow sensor have no practical effect on the respiratory flow. However, a quantitative variable characterizing the volumetric flow rate can be detected and supplied to the electrical stimulation device 4. An evaluation of the sensor signals can be carried out, for example, by a computer 5.

[0199]

[0199] The electrical stimulation 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 provided to the electrical stimulation device 4 without the electrical stimulation device 4 having to be equipped with its own sensors.

[0200]

[0200] Figure 2 shows an electrical stimulation device 4 for use on a living organism 1 in conjunction with a positive pressure ventilator 11. The ventilator 11 has an air delivery unit 18, via which air can be suctioned from the environment through a port 19 and further supplied to the airway of the living organism 1 by means of a breathing mask 13 through an air line 12. The breathing mask 13 or the air line 12 can have a defined leakage port 14. Inside the ventilator 11, a pressure sensor 16 and a volumetric flow sensor 17, for example a pneumotachograph, are connected to the air line 12. The ventilator 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 a desired volumetric flow curve and / or pressure curve in the respiratory tract of the living organism 1 via the breathing mask 13.

[0201]

[0201] It will be seen that the electrical stimulation device 4 is connected to the ventilator 11 via an interface 9. The interface 9 provides the electrical stimulation device 4 with corresponding measured values ​​and, optionally, additional values ​​calculated within the ventilator 11 and relating to the characteristics of the respiratory cycle of the living body. In this way, the electrical stimulation device 4 receives, for example, current measured values ​​of pressure and volume flow of the respiratory cycle of the living body 1.

[0202]

[0202] Figures 3 to 5 each show various respiratory cycles plotted over time t for various respiratory states. The volume of air V located in the lungs in each case is plotted on the vertical axis.

[0203]

[0203] Figure 3 shows the respiratory state with the tidal volume at rest during breathing (AZV) and at the maximum possible exhalation. This is intended to show the normal respiratory state at rest during breathing, and the end-expiratory lung volume (ERV). Here, the inspiratory reserve volume (IRV) is also characterized, shown in Figure 4 by the maximum possible inhalation volume. Finally, Figure 5 shows the transition of the respiratory state from breathing to inhalation at rest during breathing. This is characterized by the respiratory tidal volume at rest going to an increased ERV and a decreased IRV.

[0204]

[0204] The respiratory progressions shown in Figures 3 to 5 can be suitably controlled or regulated by the electrical stimulation device 4 according to the invention and the method according to the invention, i.e. by providing a corresponding stimulation signal by the electrical stimulation device to at least one nerve and / or one muscle of the living body 1, which results in a corresponding muscular contraction of the respiratory muscles, which finally results in the respiratory cycle shown.

[0205]

[0205] Figures 6 and 7 show in an expanded view the respiratory cycle. It consists of an inhalation phase I and an exhalation phase E. Figure 6 shows the volume of air V over time, while Figure 7 shows the transpulmonary pressure TPP over time. It can be seen that the inhalation phase I according to Figure 6 starts at the lower vertex and ends at the upper vertex. The exhalation phase E starts at the upper vertex and ends at the next lower vertex of the curve. The progression graph of the pressure TPP is out of phase with respect to the progression graph of the volume V.

[0206]

[0206] The electrical stimulation device 4 can generate, for example, the profile graphs of the respiratory cycle as shown in Figures 6 and 7. According to the selected function, the duration of the inhalation phase and / or the duration of the exhalation phase can be influenced separately. The amplitude of the volume profile and / or the pressure profile can also be influenced separately, as well as the respective positions of the maxima and minima of the curve profile.

[0207]

[0207] Figure 8 shows an electromagnetic field with trains for stimulation in the inspiration phase, the leading edge of the trains is in a ramp shape. Each train contains a pulse, the series of pulses increasing in intensity from a minimum to a preset value. This allows a non-invasive or gentle initiation of stimulation, because the pulses do not immediately stimulate the nerve at the preset value. Between the trains there is a pause of about 1-3 seconds. During the pause there are no stimulation pulses. Here ejection is not assisted by stimulation.

[0208]

[0208] Figure 9 shows the electromagnetic field with a stimulation train during the inspiration phase, with a ramp shape on the rise and fall of the train, which allows a non-invasive and gentle start as well as a gentle end to the stimulation.

[0209]

[0209] Figure 10 shows an electromagnetic field as shown in Figure 9, with stimulating trains during the inspiration phase. In addition, the pulses between trains are attenuated in intensity, and this attenuation also assists in expiration. This assistance is beneficial for particularly sick patients, as it prevents their lungs from fully contracting during expiration, preventing the lungs from "sticking".

[0210]

[0210] Although the present invention has been shown and described in detail by the drawings and related descriptions, it should be understood that the drawings and the detailed description are illustrative and representative, and do not limit the present invention. In order not to obscure the invention, in certain examples, well-known structures and techniques may not be shown or described in detail. It is understood that changes and modifications may be made by those skilled in the art without departing from the scope of the following claims. In particular, the present invention also includes within its scope other representative embodiments having any combination of structures that may deviate from the combination of structures explicitly described.

[0211]

[0211] The present disclosure also includes embodiments having any combination of features described or shown above or below for different embodiments. The disclosure also includes individual structures in the figures, even if they are shown in relation to other structures in the figures and / or are not described above or below. Also, alternatives to the embodiments described in the figures and descriptions, and individual alternatives to these structures, can be excluded from the subject matter of the invention or the purpose of the disclosure. The present disclosure also includes embodiments that exclusively include features described in the claims or representative embodiments, and embodiments that include other additional features.

[0212] Hereinafter, the term "comprising" and its derivatives do not exclude other elements or steps. Similarly, the indefinite articles "a" or "an" and their derivatives do not exclude a large number. The functions of the various features recited in the claims can be realized by units or steps. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Terms such as "substantially," "about," "approximately," and the like, associated with a property or value specifically define exactly that property or exactly that value as well. In terms of a given numerical value or range, the terms "about" and "approximately" can refer to a value or range that is within 20%, within 10%, within 5%, or within 2% of that given value or range. The computer program can be stored and / or distributed on a suitable medium, for example an optical storage medium, or a fixed medium supplied together with or as part of other hardware. It may also be distributed in other forms, such as over the Internet or other wired or wireless telecommunications systems. In particular, the computer program may be, for example, a computer program product stored on a computer readable medium and designed to execute to implement a method, in particular the method according to the invention. Any reference signs in the claims shall not be construed as limiting the scope of the claims.

[0213]

[0213] References [1] Raymondos K, Dirks T, Quintel M, Molitoris U, Ahrens J, Dieck T, Johanning K, Henzler D, Rossaint R, Putensen C, Wrigge H, Wittich R, Ragaller M, Bein T, Beiderlinden M, Sanmann M, Rabe C, Schlechtweg J, Holler M, Frutos-Vivar F, Esteban A, Hecker H, Rosseau S, von Dossow V, Spies C, Welte T, Piepenbrock S, Weber-Carstens. Outcome of acute respiratory distress syndrome in university and non-university hospitals in Germany. Crit Care 2017; 21(1): 122. [2] Sander BH, Dieck T, Homrighausen F, Tschan CA, Steffens J, Raymondos K. Electromagnetic ventilation: first evaluation of a new method for artificial ventilation in humans. Muscle Nerve 2010; 42(3):305-10. [3] Schmidt J, Wenzel C, Spassov S, Borgmann S, Lin Z, Wollborn J, Weber J, Haberstroh J, Meckel S, Eiden S, Wirth S, Schumann S. Flow-Controlled Ventilation Attenuates Lung Injury in a Porcine Model of Acute Respiratory Distress Syndrome: A Preclinical Randomized Controlled Study. Crit Care Med 2020; 48(3):e241-e248. [4] Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural Control of Mechanical Ventilation in Respiratory Failure. Nat Med 1999;5(12):1433-6. [5] Welvaart WN, Paul MA, Stienen GJ, van Hees HW, Loer SA, Bouwman R, Niessen H, de Man FS, Witt CC, Granzier H, Vonk-Noordegraaf A, Ottenheijm CA. Selective diaphragm muscle weakness after contractile inactivity during thoracic surgery. Ann Surg. 2011; 254(6):10449.

Claims

1. An electrical stimulation device for stimulating one or more nerves and / or muscles of a living body with an electrically, electromagnetically, and / or magnetically generated stimulation signal, comprising: a) the electrical stimulation device having at least one signal output device, through which an electrically, electromagnetically, and / or magnetically generated stimulation signal can be supplied to at least one nerve and / or muscle; b) the electrical stimulation device having at least one control device, the control device being configured to operate the at least one signal output device such that the stimulation signal output by the at least one signal output device can generate muscle contraction in the living body, thereby affecting the breathing of the living body by targeting it. An electrical stimulation device characterized by this.

2. The nerve stimulation device according to claim 1, wherein the control device is configured to modify the intensity of the stimulation signal output by the at least one signal output device in several steps and / or uniformly over the breathing cycle of the living body. A nerve stimulation device characterized by this.

3. The nerve stimulation device according to claim 1, wherein the control device is configured to maintain the intensity of the stimulation signal output by the at least one signal output device at a high level during the exhalation phase of the living body, at which level the muscle contraction generated by the stimulation signal is greater than zero but high enough that at least 75% of the pre-inspiratory volume still remains in the lungs at the end of exhalation. A nerve stimulation device characterized by this.

4. The nerve stimulation device according to claim 1, wherein by setting the parameters of the stimulation signal output by the at least one signal output device, the control device is configured to control or regulate the breathing of the living body to a predetermined value, range of values, and / or temporal variation of breathing depth. A nerve stimulation device characterized by this.

5. The nerve stimulation device according to claim 1, wherein by setting the parameters of the stimulation signal output by the at least one signal output device, the control device is configured to control or regulate the breathing of the living body to a breathing rate higher than 40 breathing cycles per minute. A nerve stimulation device characterized by this. **Claim 6** The nerve stimulation device according to claim 1, wherein the control device is configured to control or regulate the respiration of the living body to a respiration depth that is too low for the life-sustaining gas exchange of the living body in a limited time period by setting parameters of the stimulation signal output by the at least one signal output device. **Claim 7** The nerve stimulation device according to claim 1, wherein the control device is configured to prevent complete exhalation by shortening the period of the exhalation phase of the living body to 0.2 to 1.3 times the period of the inhalation phase by setting parameters of the stimulation signal output by the at least one signal output device. **Claim 8** The nerve stimulation device according to claim 1, wherein the control device is configured to control the characteristics 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. **Claim 9** The nerve stimulation device according to claim 1, wherein a current measured value of the characteristics of the respiratory cycle of the living body is continuously determined by at least one sensor and supplied to the control device, and the control device is configured to regulate the characteristics of the respiratory cycle to a predetermined target characteristic of the respiratory cycle as a function of the measured value by setting parameters of the stimulation signal output by the at least one signal output device. **Claim 10** The nerve stimulation device according to claim 1, wherein a current measured value of the spontaneous respiration impulse is continuously determined by at least one spontaneous respiration impulse sensor capable of detecting the spontaneous respiration impulse of the living body and supplied to the control device, and the control device is configured to modify the parameters of the stimulation signal output by the at least one signal output device as a function of the measured value of the spontaneous stimulation impulse, in particular, in synchronization with the spontaneous stimulation impulse. **Claim 11** A nerve stimulation device according to claim 1, wherein the control device is configured to control or regulate the intra-abdominal pressure of the living body to a predetermined value, value range, and / or temporal change by setting parameters of the stimulation signal output by the at least one signal output device.

12. A nerve stimulation device according to claim 1, wherein the control device is configured to focus on and excite the respiratory nerves and / or the respiratory center by setting parameters of the stimulation signal output by the at least one signal output device.

13. A nerve stimulation device according to claim 1, wherein the control device controls or regulates the characteristics of the respiratory cycle to predetermined target characteristics of the respiratory cycle over a number of respiratory cycles, then does not affect the respiratory cycle of the living body over a number of respiratory cycles, and then again controls or regulates the characteristics of the respiratory cycle to the predetermined target characteristics of the respiratory cycle over a number of respiratory cycles.

14. A nerve stimulation device according to claim 1, wherein the control device is configured to induce muscle contractions of the respiratory muscles of the living body that are not necessary for gas exchange to be performed by the respiration of the living body over a number of respiratory cycles, and thus perform muscle training.

15. A nerve stimulation device according to claim 1, wherein the control device is configured to control or regulate the respiratory state to a higher value and / or shift the respiratory state to an inhalation phase by setting parameters of the stimulation signal output by the at least one signal output device.

16. The nerve stimulation device according to claim 1, wherein a current measured value of the respiratory depth is continuously determined by at least one respiratory depth sensor capable of detecting a measured value of the respiratory depth of the living body and supplied to the control device, and by setting parameters of the stimulation signal output by the at least one signal output device, the control device is configured to regulate the respiration of the living body based on the measured value of the respiratory depth to a predetermined value, value range, and / or temporal change of the respiratory depth. A nerve stimulation device characterized by this.

17. The nerve stimulation device according to claim 1, wherein by setting parameters of the stimulation signal output by the at least one signal output device, the control device is configured to limit the respiratory depth and / or volumetric flow rate in the inspiration phase to a predetermined maximum value. A nerve stimulation device characterized by this.

18. The nerve stimulation device according to claim 1, wherein by setting parameters of the stimulation signal output by the at least one signal output device, the control device limits the volumetric flow rate in the expiration phase to a predetermined maximum value and / or is configured to decrease it in relation to the average specific volumetric flow rate of the living body in the expiration phase. A nerve stimulation device characterized by this.

19. The nerve stimulation device according to claim 1, wherein by setting parameters of the stimulation signal output by the at least one signal output device, the control device is configured to shorten the period of the expiration phase in relation to the average specific period of the expiration period of the living body. A nerve stimulation device characterized by this.

20. The nerve stimulation device according to claim 1, wherein over a respiratory cycle, the control device is configured to increase the intensity of the stimulation signal output by the at least one signal output device in the inspiration phase and lower it again in the expiration phase. A nerve stimulation device characterized by this.

21. The nerve stimulation device according to claim 1, wherein the control device is configured to variably operate a through-flow control actuator, the through-flow control actuator is aerodynamically and / or electrically coupled to the respiratory system of the living body, and the through-flow control actuator is configured to at least temporarily limit or reduce the volumetric flow rate in the inhalation phase and / or the exhalation phase, such that the volumetric flow rate of the air flow flowing into and / or out of the living body is adjustable over a respiratory cycle by the through-flow control actuator. A nerve stimulation device characterized by this.

22. The nerve stimulation device according to claim 1, wherein the spontaneous respiration impulse sensor is designed as a nerve impulse sensor capable of detecting a nerve impulse signal of the living body that controls the respiration of the living body. A nerve stimulation device characterized by this.

23. The nerve stimulation device according to claim 1, wherein the control device is connectable to a ventilator via an interface, the ventilator is configured to ventilate the living body by generating a variable positive pressure and / or negative pressure, and the control device is configured to be capable of data exchange with a control device of the ventilator. A nerve stimulation device characterized by this.

24. The nerve stimulation device according to claim 1, wherein the control device is configured to store characteristics of one or more respiratory cycles of the living body that quantitatively characterize each respiratory cycle. A nerve stimulation device characterized by this.

25. The nerve stimulation device according to claim 1, wherein the control device is configured to cause a deep inhalation first in the respiratory cycle by appropriately adapting the intensity of the stimulation signal output by the at least one signal output device. A nerve stimulation device characterized by this.

26. The nerve stimulation device according to claim 25, wherein following the deep inhalation, by setting the parameters of the stimulation signal output by the at least one signal output device, the control device is configured to shorten the expiratory period and / or increase the intensity of the stimulation signal compared to the average exhalation, to cause one or more partial exhalations. A nerve stimulation device characterized by this.

27. A nerve stimulation device according to claim 25, wherein the control device is configured to stimulate secretagogue mobilization and cause a deep inhalation following the stimulation of the secretagogue by setting parameters of the stimulation signal output by the at least one signal output device.

28. A nerve stimulation device according to any one of claims 1 to 27, wherein the control device is configured to alternately stimulate pure thoracic breathing, pure abdominal breathing, or a combination thereof based on the output stimulation signal, and the intensities of the stimulation of the abdominal breathing and the thoracic breathing are adaptable independently of each other.

29. A method of stimulating one or more nerves and / or muscles of a living body with an electrically, electromagnetically, and / or magnetically generated stimulation signal, comprising: a) supplying an electrically, electromagnetically, and / or magnetically generated stimulation signal to at least one nerve and / or muscle; b) activating the stimulation signal to cause muscle contraction in the living body, thereby affecting the breathing of the living body in a targeted manner. A method having the above steps.

30. The method according to claim 29, further comprising modifying the intensity of the stimulation signal in several steps and / or uniformly over the breathing cycle of the living body.

31. The method according to claim 29, further comprising maintaining the intensity of the stimulation signal at a higher level during the exhalation phase of the living body, at which level the muscle contraction generated by the stimulation signal is greater than zero but high enough so that at least 75% of the pre-inspiratory volume remains in the lungs at the end of exhalation.

32. The method according to claim 29, further comprising setting parameters of the stimulation signal to control or regulate the breathing of the living body to a predetermined value, range of values, and / or temporal change of breathing depth.

33. The method according to claim 29, further comprising setting parameters of the stimulation signal to control or regulate the breathing of the living body to a breathing rate higher than 40 breathing cycles per minute.

34. The method according to claim 29, further comprising the step of setting parameters of the stimulation signal to control or regulate the respiration of the living body to a respiration depth that is too low for the life-sustaining gas exchange of the living body within a limited time period.

35. The method according to claim 29, further comprising the step of setting parameters of the stimulation signal to prevent complete exhalation by shortening the period of the exhalation phase of the living body to 0.2 to 1.3 times the period of the inhalation phase.

36. The method according to claim 29, further comprising the step of setting parameters of the stimulation signal to control the characteristics of the respiratory cycle to predetermined target characteristics of the respiratory cycle.

37. The method according to claim 29, further comprising continuously determining a measured value of the characteristics of the respiratory cycle of the living body by at least one sensor; setting parameters of the stimulation signal to regulate the characteristics of the respiratory cycle to predetermined target characteristics of the respiratory cycle as a function of the measured value; and including.

38. The method according to claim 29, further comprising detecting spontaneous respiration impulses of the living body by at least one spontaneous respiration impulse sensor and continuously determining a current measured value of the spontaneous respiration impulses; changing parameters of the stimulation signal, in particular in synchronization with the spontaneous respiration pulses, in response to the measured values of the spontaneous respiration pulses; and including.

39. The method according to claim 29, further comprising setting parameters of the stimulation signal to control or regulate the intra-abdominal pressure of the living body to a predetermined value, value range, and / or temporal change.

40. The method according to any one of claims 29 to 39, further comprising the step of setting parameters of the stimulation signal to focus on and excite the respiratory nerves and / or the respiratory center.

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