EP4359063A1 - Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement - Google Patents

Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement

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Publication number
EP4359063A1
EP4359063A1 EP22737819.7A EP22737819A EP4359063A1 EP 4359063 A1 EP4359063 A1 EP 4359063A1 EP 22737819 A EP22737819 A EP 22737819A EP 4359063 A1 EP4359063 A1 EP 4359063A1
Authority
EP
European Patent Office
Prior art keywords
stimulation
breathing
living
respiratory
stimulation signals
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22737819.7A
Other languages
German (de)
English (en)
Inventor
Konstantinos Raymondos
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Stimit AG
Original Assignee
Stimit AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stimit AG filed Critical Stimit AG
Publication of EP4359063A1 publication Critical patent/EP4359063A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/3611—Respiration control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36135—Control systems using physiological parameters
    • A61N1/36139—Control systems using physiological parameters with automatic adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/40—Applying electric fields by inductive or capacitive coupling ; Applying radio-frequency signals

Definitions

  • the invention relates to an electrical stimulation device and a method for stimulating one or more nerves and/or muscles of a living being with electrical signals.
  • Ventilation therapy is carried out with supportive to fully mechanical inhalation and prevention of exhalation.
  • the respiratory muscles are relieved during inhalation or, in the event of gas exchange disorders, the further loss of gas exchange surface is counteracted by preventing exhalation.
  • the severity of the lung damage increases, not only does the pressure to prevent exhalation increase, but also the percentage of oxygen during inhalation.
  • a special form of respiratory therapy is the so-called "high-flow oxygen therapy", in which a gas mixture is used at a high flow rate through a nasal cannula or mask.
  • NIV non-invasive ventilation
  • invasive ventilation Ventilation without a tube
  • positive pressure ventilation there should always be an airway access.
  • NIV can be done with positive pressures via a respirator helmet or with a mask that encloses the entire face, mouth and nose, or just the nose.
  • Airway protection with a tube takes place in the absence of protective reflexes, for example in the case of anesthesia or coma. This is intended to protect the airways against aspiration, i.e. the entry of stomach contents into the trachea, which can also cause ARDS.
  • Intubation is also performed when NIV is no longer tolerated by the patient or is unsuccessful. As soon as high ventilation pressures and high proportions of oxygen are required due to increasing lung damage, NIV positive pressure administration becomes too unsafe and even very dangerous above a certain limit. Even the slipping of a mask, the removal of a helmet or a necessary NIV interruption for intubation with current techniques can then lead to insufficient gas exchange with a life-threatening lack of oxygen.
  • SGA supraglottic airways
  • laryngeal mask which are used millions of times in anesthesia or emergencies, represent an intermediate stage in securing the airway.
  • no tube is inserted through the glottis into the trachea, but the larynx is enclosed from the outside and sealed in such a way that ventilation can take place.
  • Gastric fluid can be guided past the larynx via an integrated tube. All airway management guidelines recommend the introduction of an SGA as soon as intubation is unsuccessful and positive pressure ventilation via the mask is also not possible.
  • the degree of airway protection with an SGA is lower and at high ventilation pressures and a high proportion of oxygen they reach their limits.
  • the airway can be obstructed by a partially or completely closing glottis, the larynx or a slipping SGA, which also poses a life-threatening risk to the patient, especially when there is a high oxygen requirement.
  • ARDS recognized this in 1967 and they also recognized how they could counteract the collapse during expiration with ventilation: Since then, attempts have been made to prevent the collapse of damaged lung areas through positive ventilation pressure during expiration. This is referred to as “positive end-expiratory pressure” or PEEP.
  • PEEP positive end-expiratory pressure
  • sedation can have a very significant impact on circulatory functions, so that drugs that support the circulatory system should be administered continuously.
  • catecholamines in turn reduce blood flow to the organs and can accelerate the failure of several organ systems.
  • Patients who require ventilation and have very severe lung damage are often treated in the prone position, which means that they require particularly deep sedation.
  • Ventilation can also take place without a tube. However, it can then be difficult to adapt this so-called non-invasive ventilation to the severity of the lung damage efficiently enough to treat collapsing lung areas and to avoid increasing respiratory insufficiency. The increased respiratory drive that then occurs with intensified and deepened breathing then also damages the lungs.
  • the present invention is therefore based on the object of providing devices, methods and computer programs with which the aforementioned problems can at least be reduced.
  • the ventilation method according to the present invention represents a natural form of non-invasive artificial respiration.
  • electromagnetically controlled self-respiration is the only form of ventilation with which natural pressure fluctuations in the chest and abdomen can be ventilated.
  • current conflicts between ventilation that protects the lungs and diaphragm can be resolved, since the lungs and diaphragm can be ventilated both effectively and gently with electromagnetic breathing. Individual control of self-breathing can help to avoid both too little and too much breathing effort and the complications associated with it.
  • Electromagnetic or electrical respiration can be carried out in the absence of, but also in the presence of, spontaneous respiration, and in this case can be carried out both independently and synchronously with spontaneous respiration. About seven different - divided into three groups - electromagnetic or electrical stimulation patterns can be Depending on the illness and respiratory disorder, the patient's own breathing may be changed, controlled and/or monitored.
  • the object is achieved according to the invention by an electrostimulation device according to claim 1.
  • the object is also achieved by a method for stimulating one or more nerves and/or muscles of a living being with electrically, electromagnetically and/or magnetically generated stimulation signals which in at least a nerve and / or a muscle of the living being are fed and thereby targeted muscle contractions are generated in the living being, through which the breathing of the living being is specifically influenced.
  • the object is also achieved by a computer program with program code means set up to carry out such a method when the computer program is run on a computer.
  • the present invention provides an electrostimulation device for stimulating one or more nerves and/or muscles of a living being with electrically, electromagnetically and/or magnetically generated stimulation signals.
  • the electrostimulation device has at least one signal output device through which electrically, electromagnetically and/or magnetically generated stimulation signals can be fed into at least one nerve and/or muscle.
  • the electrical stimulation device also has at least one control device which is set up to control the at least one signal emitting device in such a way that the stimulation signals emitted by the at least one signal emitting device can be used to generate muscle contractions in the living being, through which the breathing of the living being can be specifically influenced.
  • the electrostimulation device has at least one signal output device, by means of which electrically, electromagnetically and/or magnetically generated stimulation signals can be fed into at least one nerve and/or muscle.
  • the electrical stimulation device also has at least one control device, which is set up to control the at least one signal delivery device in such a way that the stimulation delivered by the at least one signal delivery device onssignals muscle contractions can be generated in the living being, through which the breathing of the living being can be specifically influenced.
  • the strength of the stimulation signals emitted by the at least one signal emission device can be changed in several steps and/or uniformly over the course of a breathing cycle of the living being. This can be achieved, for example, by controlling the electromagnetic field.
  • the control includes varying the amplitude or intensity and the frequency of the electromagnetic or electric field. Further explanations are given below in the section on stimulation method 1.
  • the stimulation signals can be determined in particular with the aim of minimizing the energy input into the tissue of the lungs and diaphragm of the living being.
  • An electromagnetic field generator or electric field generator may include a magnetic stimulator having one or more coils.
  • the field generator generates a sequence of consecutive trains of multiple pulses of the elec romagnetic or electric field.
  • inspiration i.e. inhalation
  • the intensity of the electromagnetic or electrical impulses can be higher than during expiration, i.e. exhalation.
  • expiration the intensity of the electromagnetic or electrical impulses can be essentially zero, which can lead to passive expiration, or maintained at a certain level, which can lead to expiration with some residual level of diaphragm contraction.
  • the transition between inspiration and expiration can be smoothed out and made more physiological by gently increasing or decreasing intensities, e.g. B. by creating ramps.
  • train refers to a sequence of several electromagnetic or electrical pulses.
  • the pulses are typically generated at a frequency of about 15 - 40 Hz.
  • pulse or “pulses” in the context of the invention refers to a comparatively brief provision of the electromagnetic field.
  • a pulse can be applied in the form of a sine wave or other pulse shape.
  • each of the multiple pulses of the trains preferably has an essentially identical pulse time width, which, as mentioned, is comparatively short.
  • the time width or bandwidth of the pulses is preferably in a range from about 150 microseconds to about 300 microseconds.
  • the duration of the train in the inspiration phase, the duration between the trains in the expiration phase and the ramp are adjustable. Typically, the duration of the trains in the inspiration phase is 1-3 seconds; the expiratory phase is 2-5 seconds. Expiration can be passive or stimulated.
  • the strength of the stimulation signals emitted by the at least one signal output device can be kept at an elevated level during expiration of the living being, at which the muscle contraction generated by stimulation signals is greater than zero, but at least as high is that up to 75% of the inspiratory reserve volume is still in the lungs at the end of expiration.
  • the volume can typically be determined using a flow sensor or a ventilator. Further explanations are given below in the section on stimulation method 2.
  • the breathing of the living being can be controlled or regulated to a predetermined value, value range and/or temporal change in breathing depth by setting parameters of the stimulation signals emitted by the at least one signal emission device. Further explanations are given below in the section on stimulation method 3.
  • the parameters include the intensity and the frequency of the electromagnetic field, and the duration and intensity of the stimulated or non-stimulated inspiration or expiration.
  • a higher intensity of the electromagnetic field can generate a higher flow or more intensive, rapid, faster inhalation through more intensive contraction of the diaphragm.
  • a longer duration of the train can lead to a longer lasting contraction of the diaphragm or a greater sum of the flow over time.
  • the inspired volume can be controlled by adjusting the intensity and duration of the diaphragmatic contraction.
  • the length of the pauses between the inspiration and expiration phase or the length of the expiration phase with less intensity determine the duration of expiration.
  • the intensity during expiration determines the respiratory mean, i.e. PEEP.
  • a deep breath typically has a high tidal volume.
  • the breathing of the living being can be stopped controlled or regulated to a respiratory rate of more than 40 respiratory cycles/minute, e.g. the nerve is stimulated 40 times per minute.
  • the increased respiratory rate may, after a time, reduce to the normal breathing cycles, ie 10 to 12 times per minute.
  • secretion mobilization stimulation secretion mobilization stimulation.
  • more than 60 breathing cycles/minute can be controlled or regulated with this function. For example, 200 to 300 breathing cycles/minute with a low amplitude of muscle stimulation are possible.
  • the breathing of the living being can be controlled or regulated for a limited period of time to a breathing depth that is too low for a life-sustaining gas exchange of the living being. In this way, a breathing movement of the living being can also be carried out without sufficient breathing, d. H. the volumes of air flowing in and out of the lungs are insufficient. This can, for example, stimulate secretion mobilization or train the respiratory muscles.
  • the parameters of the stimulation signals emitted by the at least one signal output device By setting the parameters of the stimulation signals emitted by the at least one signal output device, complete expiration can be prevented by increasing the expiration time (duration of the expiration phase) of the living being to 0.2 to 1.3 times the inhalation time (duration of the inspiration phase) is shortened.
  • the strength of the stimulation signals can be increased compared to normal breathing cycles in order to generate a maximum flow rate during exhalation.
  • exhalation can be forced or accelerated or a cough stimulated. Further explanations are given below in the section on stimulation method 4, cough stimulation.
  • the duration of the inspiration phase used as a reference can be, for example, the duration of the inspiration phase of the same breathing cycle, or an average of the duration of several previous inspiration phases, or a typical value of the duration of the inspiration phase determined for the living being in question.
  • the characteristics of the breathing cycles can be controlled to predetermined target characteristics of the breathing cycles. Further explanations are given below in the section on stimulation method 4.
  • the characteristic data of the respiratory cycles can be regulated to a predetermined target -Respiratory cycle characteristics are performed. Further explanations are given below in the section on stimulation method 4.
  • the target characteristic data can in particular be characteristic data that avoid damage to the lungs.
  • a self-damaging breathing pattern of the living being can be avoided in this way.
  • the control device can also be set up to use the stimulation signals to limit the volume flow of respiration, the respiratory movements and/or the transpulmonary pressures to a predetermined maximum value.
  • Parameters of the stimulation signals emitted by the at least one signal output device can be changed as a function of current measured values of the spontaneous breathing pulses of the living being, in particular synchronized with the spontaneous breathing pulses. In this way, the spontaneous breathing impulse of the living being can be blocked or changed.
  • the measured values can be continuously determined by at least one spontaneous breathing impulse sensor, by means of which the spontaneous breathing impulses of the living being can be detected. Further explanations are given below in the section on stimulation method 5.
  • the spontaneous respiration impulse sensor can be designed as a nerve impulse sensor, by means of which the nerve impulse signals of the living being controlling the breathing of the living being can be detected.
  • the signal output device for outputting the stimulation signals to form the nerve impulse sensor at the same time.
  • a signal output device can be designed as a coil or coil arrangement.
  • the nerve impulse can also be recorded with a coil or coil arrangement.
  • the intra-abdominal pressure is the pressure in the subject's abdominal cavity.
  • the pressure in the abdominal cavity (“intrabdominal pressure”, IAP) is increased by inhalation and decreased by exhalation.
  • Spontaneous breathing creates pressure gradients between the chest and abdominal cavity.
  • the respiratory muscles can ge, but also cause increased pressure fluctuations in the abdominal cavity. These pressure fluctuations affect the functions of the abdominal organs.
  • the intra-abdominal pressure of the living being can be controlled or regulated to a predetermined value, value range and/or change over time by setting parameters of the stimulation signals emitted by the at least one signal emission device.
  • the intra-abdominal pressure can be specifically influenced. This can, for example, improve blood circulation in certain organs.
  • positive influences on the abdominal organs can be triggered.
  • the stimulation creates natural pressure gradients between the chest and abdominal cavity and natural but also increased pressure fluctuations in the abdominal cavity can be caused, which favorably improve the functions of the abdominal organs - such as intestinal motility and other intestinal functions, organ perfusion or lymphatic drainage influence. This can make a decisive contribution to improving the prognosis.
  • the depth and duration of inhalation, but also the level and duration of exhalation can be controlled in a targeted manner.
  • the stimulation can specifically control the depth and duration of inhalation, but also the level and duration of exhalation, as a function of prevailing intra-abdominal pressures that are influenced by breathing. If the intra-abdominal pressure, for example in the case of intra-abdominal hypertension (IAP > 12 mbar), is so high that blood flow to the abdominal organs is impaired, the stimulation during inhalation and exhalation can be reduced accordingly.
  • IAP intra-abdominal hypertension
  • a targeted stimulation of the respiratory nerves and/or the respiratory center can be carried out by setting parameters of the stimulation signals emitted by the at least one signal emission device. This only activates the respiratory nerves and/or the respiratory center in a targeted manner, without leading to a noticeable effect on the respiratory muscles.
  • the respiratory muscles are not stimulated in a way that is sufficient for a life-sustaining border gas exchange of the living being. This can be achieved, for example, by the strength of the stimulation signals being so low that there are almost no muscle contractions. With this, respiratory nerves and the respiratory center can still be activated and/or their activity maintained.
  • Ventilation reduces the work of breathing of the respiratory muscles.
  • the respiratory movements are passive during ventilation, the activity of the respiratory nerves decreases and can even disappear completely. This applies both to the efferent motoneurons, which control the muscles, and to the afferent, sensory nerve pathways, which record the extent and speed of the muscle contraction and the corresponding change in position and report this back to the respiratory center for feedback.
  • the activity of the neurons in the respiratory center in the brainstem area also decreases accordingly during ventilation.
  • the respiratory center reduces its activity after just a few minutes of ventilation. After stopping ventilation, one can then consciously - i.e. via the cerebral cortex - control the respiratory center, but breathing is now perceived as strenuous, although it is not. After a short period of time, after stopping ventilation and complete resumption of spontaneous breathing in healthy living beings, natural, autonomous spontaneous breathing takes place again, which is controlled by the respiratory center.
  • the efferent and also the afferent neurons - i.e. the motor and sensory nerve tracts with the neurons of the respiratory center in the brainstem area - are to be activated and/or their activity is to be maintained .
  • conditioning, training, secretion mobilization and coughing, etc. there should also be insufficient breathing to maintain gas exchange with this stimulation method.
  • the characteristic data of the breathing cycles can be controlled or regulated to predetermined target characteristic data of the breathing cycles, after which there is no influence over a large number of breathing cycles carry out the breathing cycles of the living being and then carry out a control or regulation of the characteristic data of the breathing cycles to predetermined target characteristic data of the breathing cycles again over a large number of breathing cycles. Further explanations are given below in the section on stimulation method 6.
  • the at least one signal output device stimulation signals can be adjusted parameters of the output by the at least one signal output device stimulation signals over a variety of Respiratory cycles muscle contractions of the respiratory musculature of the living being are stimulated which are not necessary for the gas exchange of the living being to be carried out by breathing and thereby cause additional muscle training.
  • Targeted muscle training of the respiratory muscles can be carried out here. Further explanations on this are given below in section stimulation method 7, in particular 7.1, 7.5, 7.6. With this type of stimulation, the actual breathing depth is not affected, or only with such a small amplitude that is too small for a life-sustaining gas exchange of the living being.
  • the aim of this stimulation is to train the respiratory muscles, while the training is designed to be harmless to the respiratory organs, especially to the lung tissue and diaphragm muscle.
  • the breathing position can be controlled or regulated to an increased value and/or the breathing position can be shifted into the inspiration phase. Further explanations are given below in section stimulation method 7.2.
  • the living being's respiration can be regulated to a predetermined value, value range and/or temporal change in the respiratory depth using current measured values of the respiratory depth.
  • a breathing depth sensor can be used for this purpose, by means of which continuously measured values of the breathing depth of the living being are recorded. Further explanations are given below in the section on stimulation methods 3 and 7.3.
  • the breathing depth and/or the volume flow in the inspiration phase can be limited to a predetermined maximum value. Further explanations are given below in the section on stimulation methods 4 and 7.4.
  • the volume flow in the expiration phase can be limited to a predetermined maximum value and/or reduced compared to the average intrinsic volume flow of the living being in the expiration phase.
  • the duration of the expiration phase can be reduced compared to the average intrinsic duration of the expiration phase of the living being.
  • the stimulation signals can be used to prevent the living being from breathing out completely, ie at least a certain amount of residual air can be retained in the lungs.
  • the strength of the stimulation signals emitted by the at least one signal emission device can be increased in the course of a breathing cycle in the inspiration phase and reduced again in the expiration phase. In this way, the energy input into the living being's tissue can be minimized.
  • a flow control actuator that is pneumatically and/or electrically coupled to the respiratory system of the living being and by means of which the volume flow of the airflow flowing into and/or out of the living being can be adjusted can be variably controlled in the course of a breathing cycle such that the flow control actuator limits or reduces the volume flow in the inspiration phase and/or the expiration phase at least temporarily.
  • the flow control actuator may comprise an electrically operable valve in a breathing mask or hose.
  • the flow control actuator may be an electrical actuator capable of stimulating the subject's larynx, e.g., by electromagnetic larynx stimulation. As a result, a desired, defined resistance to the flow of exhaled air can be generated during exhalation, for example, which keeps the airways and alveoli open.
  • the control device can be connected via an interface to a ventilator that is set up to ventilate the living being by generating variable positive pressure and/or negative pressure, the control device being set up for data exchange with a control device of the ventilator.
  • a ventilator that is set up to ventilate the living being by generating variable positive pressure and/or negative pressure
  • the control device being set up for data exchange with a control device of the ventilator.
  • a deep inhalation can first be induced in the breathing cycle.
  • this is Onsmethode 2 is advantageous, for example, in order to thereby open the lungs and accordingly carry out a recruitment stimulation.
  • this can be advantageous, for example, in order to take up a maximum of air volume in the lungs, which is beneficial for cough stimulation because a lot of air is available for generating a high volume flow during exhalation.
  • Cough stimulation can be carried out, for example, by first causing a deep inhalation in the respiratory cycle by appropriately adjusting the strength of the stimulation signals emitted by the at least one signal emission device and then following the deep inhalation by setting parameters of the stimulation signals emitted by the at least one signal output device to evoke one or more partial expirations with an expiration duration that is shorter than the average expiration and/or an increased intensity of the stimulation signals, e.g. by preventing complete expiration, e.g. by reducing the expiration duration to 0.2 up to 1.3 times the inhalation time.
  • the strength of the stimulation signals can be increased compared to normal breathing cycles in order to generate maximum volumetric flow during expiration.
  • the secretion mobilization stimulation can be induced by adjusting the parameters of the stimulation signals emitted by the at least one signal output device by controlling or regulating the breathing of the living being to a respiratory rate of more than 40 respiratory cycles/minute.
  • electromagnetically and/or magnetically generated stimulation signals can be fed into at least one nerve and/or muscle by the signal output device.
  • the strength of the stimulation signals can be determined, for example, by the voltage or current amplitude, the electrical power, the amplitude of a magnetic parameter and/or a short-term average value of one or more such variables.
  • the signals fed into the signal output device for generating the stimulation signals can be alternating voltage or alternating current signals or other pulse-like signal sequences.
  • the signal delivery device can basically be any signal delivery device, or a combination of several signal delivery devices, through which such electrical stimulation signals can be fed into at least one nerve and/or a muscle.
  • the signal delivery device can thus stimulate a muscle to contract directly by electrical signals and/or indirectly by electrical stimulation of the corresponding nerve, which can stimulate muscle contraction.
  • the signal output device can have implanted electrodes, which are implanted at a corresponding point in the body of the living being and through which the stimulation signals are fed directly into the body.
  • the signal emitting device has signal emitting elements that can be arranged on the outside of the living being and accordingly do not have to be implanted.
  • the signal output elements can have one or more electrical coils, through which electrical signals can be fed inductively into the at least one nerve and/or muscle. Magnetic fields are fed into the living being through such coils, which in turn lead to induced currents in the body, by means of which the desired electrical stimulation signals can be generated in at least one nerve and/or one muscle.
  • coils or coil arrangements according to WO 2019/154837 A1 or WO 2020/079266 A1 can be used for this purpose.
  • the signal delivery elements can also comprise electrodes attached to the body of the living being, to be attached to the skin, for example, by which can galvanically couple electrical signals into the body.
  • the signal elements can have capacitive electrodes, through which the electrical simulation signals can be fed into the living being by means of capacitive coupling, ie without galvanic contact with the living being.
  • the electrostimulation device can be set up for stimulating basically any nerves with which the breathing of the living being can be influenced in a targeted manner. This also includes the stimulation of the auxiliary respiratory muscles in the neck area, but also the stimulation of the nerve roots, as well as nerves in the brain area, eg in the brainstem and/or in the cerebrum.
  • the electrical stimulation device can be designed for stimulating one or more of the following nerves: phrenic nerve, one or more intercostal nerves, first, second, third motor neuron, insofar as these can trigger breathing movements.
  • the signal delivery device or its signal delivery elements are designed in such a way that they can be conveniently and safely arranged at the appropriate position of the living being, for example for stimulating the diaphragm in the area near the head of the Phrenic Nerve and/or for stimulating chest breathing in the area of one or more of the Intercostal Nerves.
  • the signal delivery elements are adapted to this corresponding positioning on the living being in terms of their shape and nature.
  • the control device can be set up, for example, to store characteristic data of one or more breaths of a living being, in that the control device has a parameter memory in which typical characteristic data of such living beings or characteristic data of the individual living being to be treated are stored beforehand .
  • the electrical stimulation device can also be designed without a measuring device and in particular without feedback of measured signals in the sense of a control loop.
  • the electrical stimulation device can also have a measuring device with one or more sensors, by means of which characteristic data of the breathing cycles of the living being are recorded at specific points in time or continuously and are fed to the control device.
  • the characteristic data can be buffered at least temporarily in the control device.
  • additional characteristic data of breathing cycles determined in advance can be stored in a parameter memory in the control device, as described above.
  • the control device can be designed in particular as an electronic control device that has a computer that controls the individual functions of the electrostimulation device.
  • a computer program can be stored in the control device, in which the corresponding functions are programmed and are executed by the computer running the computer program.
  • a computer can be set up to run a computer program, e.g. in the sense of software.
  • the computer can be designed as a commercially available computer, e.g. as a PC, laptop, notebook, tablet or smartphone, or as a microprocessor, microcontroller or FPGA, or as a combination of such elements.
  • regulation differs from control in that regulation has feedback of measured or internal values, with which the generated output values of the regulation are in turn influenced in the sense of a closed control loop. In the case of a controller, a variable is simply controlled without such feedback.
  • breathing depth this term includes the actual breathing depth as well as the apparent breathing depth of the living being.
  • Actual depth of breath is determined by the amount of tidal volume actually exchanged with the environment during respiration.
  • the tidal volume is the amount of air that is inhaled and exhaled, i.e. ventilated, per breath.
  • the apparent depth of breathing is determined by the magnitude of the tidal volume that would be expected to occur due to the movement of the respiratory muscles if breathing could be performed freely. In many cases the apparent depth of breath will correspond to the actual depth of breath. If, for example, the airways are completely or partially blocked and/or the lungs are pathologically altered, the actual depth of breath can deviate significantly from the apparent depth of breath.
  • the actual breathing depth of the living being can be detected using different variables, for example using the tidal volume and/or the amplitude of the transpulmonary pressure (abbreviated TPD, or TPP, “transpulmonary pressure”).
  • TPD transpulmonary pressure
  • the level of the tidal volume depends on the level of the transpulmonary pressure.
  • the transpulmonary pressure is the pressure difference between the air-filled space of the lungs and the pressure at the outer edge of the lungs between the both layers of the pleura. It is therefore the difference between the intrapulmonary and intrapleural pressures, or to put it another way, it is the difference between the alveolar pressure and the pleural pressure.
  • the alveolar pressure can only be recorded indirectly via measurements in the airways or in a ventilation system.
  • the pleural pressure corresponds approximately to the pressure in the esophagus.
  • the transpulmonary pressure can be determined, for example, by measuring the pressures in the respiratory system and in the esophagus of the subject. The transpulmonary pressure is then the difference between ventilation pressure and esophagus pressure.
  • the apparent depth of respiration can be detected using different quantities, e.g. by detecting the movement of the living being triggered by muscle contraction, for example movement in the chest area and/or abdominal area.
  • Another possibility for detecting or characterizing the apparent breathing depth is the determination of the necessary electrical and/or mechanical energy or force for generating breathing movements of the living being, which is required for generating a volume flow of respiration.
  • the apparent breathing depth can therefore be determined, at least approximately, based on the strength of the stimulation signals emitted by the at least one signal emission device.
  • a breathing cycle comprises an inhalation phase (also called inhalation or inspiration for short) and an immediately following exhalation phase (also called exhalation or expiration for short).
  • inhalation phase also called inhalation or inspiration for short
  • exhalation phase also called exhalation or expiration for short
  • IOV inspiratory reserve volume
  • ESV expiratory reserve volume
  • control device can be designed, for example, as functions of a computer program or separate computer programs or computer program modules. Insofar as the functions are executed by the control device, this can automatically execute the corresponding functions.
  • a large number of functions of the electrostimulation device can also be set and/or controlled manually by the user. This also includes functions that can optionally be performed by the control device.
  • the invention therefore also relates to methods for stimulating one or more nerves and/or muscles of a living being with electrically, electromagnetically and/or magnetically generated stimulation signals using such an electrostimulation device in which the functions mentioned are performed manually, for example the change the strength of the stimulation signals emitted by the at least one signal emission device, and a computer program for carrying out such a method.
  • Various monitoring parameters and feedback mechanisms can be provided for stimulation control. Similar to conventional ventilation, one, several or all parameters of the living being's gas exchange such as oxygen uptake and carbon dioxide release and respiratory parameters such as respiratory pulse, respiratory rate, tidal volume, respiratory rate, exhalation and inhalation levels can be recorded for this purpose.
  • the monitoring can also differentiate between chest and abdominal breathing and record them separately.
  • Parameters that indicate the transitions between intensified and relaxed breathing and thus an increase in the drive to breathe play a special role both for the adjustment during the stimulation and for the effects achieved after the stimulation.
  • These include, for example, the quotient of respiratory rate and tidal volume (RSB, "rapid shallow breathing index”), the so-called P0.1 value, the respiratory flow rate (quotient of tidal volume and inspiration time) and pressure fluctuations in the esophagus in a certain range of e.g. 4 up to 8 mbar or the extent of transdiaphragmatic pressure fluctuations.
  • the spontaneous, electrical activity of the phrenic nerve can also be recorded electromagnetically with an electroneurogram (ENG), for example, and used for feedback.
  • ENG electroneurogram
  • the electrical, spontaneous phrenic nerve activity represents a direct measure of the central neural respiratory activity and can be recorded, for example, via the number of pulses per breath, the pulse frequency during the peak inspiratory flow or the mean activity over 0.1 seconds and used for feedback and control of the stimulation are used.
  • Certain electromyographic patterns can also indicate the onset of exhaustion.
  • electromyographic signals from the diaphragm as a direct measure of electrical muscle activity for feedback and control of electromagnetic or electrical respiration
  • electromyography of spontaneous activity can be performed during the stimulation pauses.
  • artifacts caused by the electromagnetic stimulation can make a measurement more difficult or impossible.
  • special stimulation algorithms can enable artefact-free recording of muscle activity through fixed pauses, which can then be used to control further stimulation. This control takes into account that the spontaneous activity is neither too low nor too high, ie does not exceed 8% of the maximum activity.
  • devices that are directly coupled to one another can also enable filtering of the electromagnetic signals.
  • an electromyographic monitoring of the muscle activity achieved can also take place during the stimulation, which enables direct feedback.
  • the relationship between electrical stimulation and the resulting mechanical muscle activity depends on the force-length and force-velocity ratio and thus on the volume and shape of the thorax, but also on the course of the disease. For example, as the disease progresses, the diaphragmatic force can decrease, although the electrical muscle stimulation increases. Therefore, monitoring the force of the diaphragm is particularly advantageous for the feedback to control the training stimulations.
  • ultrasonic measurements of movements and thickening of the diaphragm can give an indirect indication of diaphragm force.
  • the diaphragmatic force is recorded indirectly via pressure fluctuations between the chest and abdomen.
  • the phrenic nerve is stimulated with a standard electromagnetic stimulus and the resulting transdiaphragmatic paint pressure fluctuations measured via a balloon catheter in the esophagus and stomach. From this, the diaphragm force can be determined.
  • stimulation method 1 can be synchronized with FCV.
  • Such synchronization between electromagnetic or electrical stimulation and FCV can promote simultaneous self-breathing - and thus maintenance of the respiratory muscles and their muscle strength in FCV.
  • the diaphragm is also active during natural spontaneous breathing during expiration. This activity, known as “expiratory braking”, slows the exhalation and stabilizes the lungs. This natural diaphragm activity in the Exhalation decreases as expiratory resistance increases.
  • This stimulation which is gentle on the lungs, is also used during the exhalation phase with decreasing intensity. A complete exhalation takes place only very briefly or is avoided completely (see below stabilization stimulation with stimulation method 2). This counteracts a collapse of the lung tissue. This not only prevents gas exchange disorders, but also increasing respiratory insufficiency with increased respiratory drive and harmful spontaneous breathing patterns.
  • this gentle breathing pattern is trained through the conditioning effect of this form of stimulation (see below conditioning stimulation - stimulation method 6).
  • both muscle strength and muscle mass of the respiratory muscles are maintained and trained, which is particularly important during conventional ventilation and especially during flow-controlled ventilation (FCV) (see below Training stimulation, stimulation method 7.1.).
  • FCV flow-controlled ventilation
  • the stimulation method 2 causes isolated, deep sighs in combination with a prevention and/or slowing down (see above) of expiration. This stimulation method recruits collapsed lung areas and stabilizes the lungs by preventing and/or delaying expiration. This will prevent it from collapsing again.
  • the duration of the inhalation phase and the exhalation phase can also be set for the recruitment stimulation.
  • the respiratory time ratio can be changed and the time of maximum inspiration can be lengthened and the time of expiration shortened.
  • the end of exhalation can be held at different levels as required (“expiratory hold”) by direct stimulation of the respiratory muscles.
  • the rate of expiration can also be slowed down, for example by reducing the intensity of the stimulation impulses during expiration - similar to the natural "expiratory braking” mentioned above.
  • the collapse of lung areas can also be prevented by changing the breathing time ratio.
  • the inhalation time can be lengthened and the exhalation phase shortened during stabilization stimulation as described above for recruitment stimulation. If a stimulation If the exhalation phase is not or only insufficiently possible, complete exhalation can also be prevented by the earlier use of electromagnetic or electrical stimulation of inhalation ("expiratory cut").
  • precise monitoring of the respiration and in particular of the respiratory position is advantageous here in order to be able to precisely determine the correct point in time for inhalation.
  • the stabilization stimulation can also be combined with an optionally dynamically adapted increase in expiration resistance, as a result of which expiration is further slowed down and the lungs can thus be additionally stabilized in the expiration phase.
  • This can be done in combination and synchronously with the stimulation during expiration.
  • the exhalation resistance naturally increases due to the vocal folds, which open again during inhalation.
  • the natural activity of the diaphragm for "expiratory braking" decreases.
  • This stimulation method 2 also counteracts an increase in the work of breathing and the respiratory drive caused by increased lung collapse and prevents further lung damage associated with self-damaging spontaneous breathing (see also the next page, control stimulation).
  • the recruitment and stabilization stimulation can thus indirectly increase the work of breathing and harmful respiratory effort, but also reduce or even prevent ventilation with high tidal volumes.
  • Lung-protective stimulation stimulation method 3
  • the breathing depth is regulated such that a gentle tidal volume of, for example, 6 ml/kg of ideal weight inhaled and/or a transpulmonary pressure of 5 mbar is not exceeded.
  • feedback can be provided between the measurement of the tidal volume, the transpulmonary pressure or corresponding correlates and the stimulation intensity, so that the stimulation can be adapted to the tidal volume achieved and/or the transpulmonary pressure. This then not only happens for the following breath, but can already directly control the ongoing stimulation via monitoring and feedback.
  • the current stimulation intensity can be weakened and/or the stimulation duration shortened so that a certain tidal volume of, for example, 6 ml/kg ideal weight and/or a trans- pulmonary pressure of 5 mbar is not exceeded. This is particularly important during spontaneous breathing (see below for control and modulation stimulation, stimulation methods 4 and 5).
  • Group 2 Breath-related stimulations
  • Control stimulation - stimulation method 4
  • Electromagnetic or electrical stimulation is the only method to date that can be used non-invasively and without medication to control and thus optimize self-breathing independently of spontaneous breathing and the patient's will.
  • Secretion mobilization stimulation With this stimulation method, secretion can be mobilized from the peripheral to the central airways, e.g. by means of high-frequency, short and fast breaths.
  • Cough stimulation This stimulation method can follow directly after the secretion mobilization stimulation in order to be able to further effectively mobilize mobilized secretion and, above all, also to be able to “cough it out”. For this purpose, after a longer inhalation, a short cough or a series of short coughs follows. The expiratory burst becomes more effective if, as with a natural cough, the exhalation begins against increased airway resistance and the pressure in the lungs can be increased. This brief, synchronized increase in exhalation resistance can be achieved via a synchronized artificial resistance and/or narrowing of the vocal folds caused by stimulation of the laryngeal nerves.
  • modulation stimulation does not take place independently of spontaneous breathing, but as a function of the spontaneous breathing impulse. Instead of complete self-breathing control independent of spontaneous breathing, there is partial or full control of natural spontaneous breathing, in which the spontaneous breathing impulse is always taken into account--even if the breathing impulse is weak or non-existent.
  • the spontaneous respiratory impulse should therefore be detected so that an electromagnetic or electrical stimulation synchronized with it can take place.
  • the modulation stimulation can be synchronized using the standard detection methods for the spontaneous respiratory impulse such as pressure, flow or temperature fluctuations in the respiratory stream or body sensors such as so-called Graseby capsules or muscle activity sensors.
  • the nerve impulse is recorded by a sensor in the esophagus near the diaphragm, see [4].
  • one's own nerve impulse can also be recorded non-invasively electromagnetically. This can be done either peripherally directly above the stimulation site on the neck - or centrally at the point of origin of the nerve impulse in the brain stem area.
  • the spontaneous breaths can then be changed in a synchronized manner with the modulation stimulation, as under the stimulation methods 1 to 3 described above. This can be done by stimulating the entire breathing cycle, as with lung-friendly stimulation, in order to achieve gentler spontaneous breathing.
  • the modulating stimulation as described under stimulation method 2
  • the spontaneous respiratory rate was not changed. However, if the frequency of spontaneous respiration becomes too fast or too slow, it can be directly and/or indirectly influenced and controlled by electromagnetic or electrical stimulation. The resulting smooth transitions to controlled self-breathing are regulated by recording the spontaneous breathing rate and corresponding feedback mechanisms.
  • the extent and frequency of stimulation can be adjusted individually depending on the depth and frequency of spontaneous breathing.
  • a spontaneous breathing rate that is too fast is indirectly slowed down by longer inhalation and/or exhalation phases, and finally a lower rate can also be superimposed.
  • the breathing frequency can also be slowed down indirectly by individual deep breaths via the breathing reflexes activated in this way.
  • IAP intra-abdominal pressure
  • the stimulation also creates natural pressure gradients between the chest and abdominal cavity.
  • the stimulation of the respiratory muscles can cause natural but also increased pressure fluctuations in the abdominal cavity, which affect the functions of the abdominal organs - such as intestinal motility, organ perfusion or lymphatic drainage - and make a decisive contribution to the prognosis of ventilated patients.
  • the stimulation can specifically control the depth and duration of inhalation, but also the level and duration of exhalation. Is the intrabdom- If, for example, in the case of intra-abdominal hypertension (IAP > 12 mbar), the pressure increases to such an extent that blood flow to the abdominal organs is impaired, the stimulation can be reduced accordingly, especially during exhalation.
  • IAP intra-abdominal hypertension
  • Conditioning stimulation stimulation method 6 All of the 5 stimulation methods mentioned above can also be used exclusively as conditioning for improved spontaneous breathing. This involves intermittent stimulation with varying stimulation durations, with just a few breaths also being sufficient.
  • the conditioning stimulation trains a specific spontaneous breathing pattern - either with a modulation of spontaneous breathing or as controlled breathing with the stimulation methods 1 to 5 described above.
  • the conditioning stimulation can be controlled and intensified by direct feedback.
  • the feedback takes place on the basis of recorded measured values of the patient's own respiration.
  • the type of breathing, the level of exhalation and the inhalation depth, the tidal volume and the respiratory rate are measured and a correspondingly adapted conditioning stimulation is carried out.
  • Muscle breakdown and weakening of muscle strength are additionally intensified by the severe course of the disease, in particular by inflammatory processes. If the weakened respiratory muscles are only insufficiently relieved by ventilation, an increased respiratory drive develops with high or ultimately too high breathing effort, which in particular further weakens and damages already damaged lungs, but also the muscles. The high respiratory effort is actually the most important factor for damage to the diaphragm muscles. The degree between too little and too much breathing effort can be very small and vary greatly both between and within individuals in the course of the disease. Due to reduced strength and muscle breakdown, the weakened respiratory muscles are no longer able to ensure sufficient self-breathing. A respiratory insufficiency develops with the breathing pattern already mentioned above.
  • the electromagnetically or electrically stimulated training methods described below are intended to strengthen the respiratory muscles in such a way that muscles are built up and both a reduction in the strength of the existing muscles and muscle breakdown can be prevented. Here, further damage to the lungs and respiratory muscles should be minimized or avoided as far as possible.
  • the respiratory muscles can be trained by electromagnetic or electrical stimulation in such a way that 1. degraded respiratory muscles are rebuilt or weakened muscles are strengthened again, 2. muscle breakdown or muscle weakness is prevented and/or 3. muscle build-up occurs before an expected reduction or strengthening occurs before an expected reduction in strength. Accordingly, training can be therapeutic, preventive and/or preemptive:
  • a therapeutic training stimulation is carried out in order to rebuild the musculature and/or restore muscle strength.
  • the respiratory musculature and/or muscle strength is built up through the peemptive training stimulation.
  • this stimulation intensity during inhalation is also suitable for preventing muscle breakdown - just as normal spontaneous breathing also prevents muscle breakdown and loss of strength .
  • a lower stimulation intensity is also suitable for preventing muscle breakdown if it is used accordingly frequently, for example during conventional ventilation.
  • respiratory muscles and/or muscle strength can be built up accordingly or muscle breakdown and/or a loss of strength can be prevented more effectively even with a few stimulations.
  • the training stimulation causes a corresponding training breathing. Therefore, the training patterns are also based on the stimulation methods 1 to 4 described above and take into account the relationships mentioned there. Accordingly, the following four requirements should also be met by the breathing effected during training stimulation:
  • Electromagnetic or electrical training methods [0152]
  • the following six forms of training stimulation result, which also allow intensive training stimulation without harmful breathing:
  • stimulation method 1 of gentle breathing with low energy transfer to the lung tissue also applies to training stimulation—even if it is only used occasionally and after longer intervals he follows.
  • This stimulation method sudden and potentially harmful breathing movements are avoided by gradually increasing the stimulation pulses during inspiration and gradually decreasing stimulation pulses during expiration, as described above. This is particularly important for intensive and frequent training stimulation (see below 7.2.).
  • the “holding of the breath” both in inhalation and in exhalation can be reinforced by correspondingly longer stimulation times in the respective respiratory cycles of the training effect.
  • This training method enables very intensive training stimulation of the respiratory muscles with few side effects and is gentle on the lungs, in which, despite pronounced muscle activity, not only self-damaging effects (see below 7.3-7.5) but also hyperventilation with corresponding side effects such as hypocapnia and consequently dangerous pH shifts are avoided can become.
  • stimulation in the exhalation phase is not possible or only insufficiently possible, then hyperventilation-related side effects and exhaustion can also be avoided by pauses that can be controlled via feedback.
  • deep breathing can also be mechanically limited by belts and/or weights, but also by increasing the airway resistance, which can further intensify the training effect.
  • the intensive training stimulation means that the duration of use per patient can be significantly reduced, which means that a device can be made available to several patients at short intervals.
  • the breathing depth is also regulated for a training stimulation in this form of training during inhalation in such a way that a gentle tidal volume is breathed in and/or a gentle transpulmonary pressure is exerted. This is particularly important with frequent training stimuli.
  • the above-mentioned feedback between the measurement of the tidal volume and the stimulation strength can also provide feedback on the breathing position as described above (see 7.2. above).
  • the stimulation strength can be increased and yet a lung-protective tidal volume of, for example, 6 ml/kg of ideal weight and/or a transpulmonary pressure of 5 mbar is not exceeded, even with intensive training stimulation.
  • intensive training stimulation without harmful breathing can be made possible through an interaction between breathing position and tidal volume.
  • an increase in the expiration resistance can also shift the respiratory length to inhalation, thereby limiting the tidal volume. This can be done in combination and synchronously with the stimulation during expiration.
  • the lung-protective training stimulation prevents harmful breathing with large tidal volumes from being caused even at low stimulation levels; This rules out the possibility that the training stimulation itself could cause damage to the lungs, particularly in the case of frequent stimulation. This is particularly important in the case of spontaneous breathing, since even a small amount of training stimulation in addition to a spontaneous breath can significantly increase the self-breathing that is then induced (see below 7.4. -7.5). 7.4. Training stimulation to avoid self-harm (P-SILI) In addition to the above-mentioned 3 training stimulation patterns, which are intended to minimize or prevent additional damage from the ventilation caused during training, this training pattern is intended to avoid or minimize damage when spontaneous breathing is present.
  • Spontaneous breathing is taken into account in such a way that an additional training stimulus does not induce deep and/or sudden inspirations. This is particularly important in the case of frequent repetitions and can be achieved in different ways. Either there is no stimulation during inhalation, or only so little that a certain tidal volume is not exceeded, or inhalation is modulated accordingly.
  • the stimulation method under 2 and also under 7.2. described prevention of exhalation the breathing position can be shifted into inhalation, so that in this training during exhalation, the depth of the spontaneous breaths and thus also self-damaging breathing is limited at the same time.
  • the spontaneous respiration and/or the self-respiration that takes place or is altered by the stimulation must be recorded so that the stimulation can be individually and flexibly adjusted and the spontaneous respiration modulated if necessary (see below 7.5).
  • the modulating training stimulation always takes spontaneous breathing into account and therefore also changes it. In this case, stimulation is provided over the entire respiratory cycle or only partially. With partial stimulation, you can train only in the inhalation phase, only during exhalation, or in parts of these breathing phases. As described above, exhalation is of particular importance here in order to be able to train intensively and to avoid both too deep, controlled breathing and too deep spontaneous breathing during training. Even when exhausted The tertiary respiratory muscles, in which shallow and rapid breathing eventually occurs, can be trained simultaneously with the modulating stimulation and an improved breathing pattern can be achieved as described above under stimulation method 5. With increasing exhaustion, based on defined limits, an intervention as early as possible should be aimed at in order to relieve the exhausted respiratory muscles. If, in the case of pronounced exhaustion, the respiratory muscles need to be relieved by ventilation, preventive training stimulation can limit or even prevent muscle breakdown at an early stage.
  • conditioning stimulation described above under stimulation method 6 also represents a form of training stimulation.
  • the primary goal of conditioning stimulation is not direct training of the respiratory muscles, but “training” or conditioning a specific breathing pattern. If, in addition to training the respiratory muscles, the conditioning of a specific breathing pattern is also to take place, then conditioning training stimulation takes place.
  • training stimulation can be combined with conditioning in such a way that the requirements of appropriately adapted ventilation can also be met.
  • stimulation during expiration with the aid of the "expiratory hold", “braking” and “cut” stimulation patterns (see above and below) can stabilize the lungs, protecting the lungs from excessively high levels Protect tidal volumes, train in conditioning to “hold” the exhalation and at the same time cause intensive training of the respiratory muscles (see also overview of exhalation stimulation).
  • the stimulation during exhalation is of central importance 1. for lung stabilization, 2. for lung protection, 3. for conditioning spontaneous breathing and 4. for intensive and yet at the same time gentle training of the respiratory muscles.
  • the stabilization stimulation prevents a collapse of the lung with the corresponding gas exchange disturbances and also prevents harmful collapse recruitment ventilation, overexpansion of the ventilated lung, an increase in the work of breathing, respiratory effort, P-SILI and finally exhaustion.
  • the stabilization stimulation can be carried out using three different methods: 1. the “expiratory hold”, 2. the “expiratory braking” and 3. the “expiratory cut”, which can also be combined:
  • the exhalation level is determined in particular by holding the exhalation, but also by the type of deceleration and indirectly by shortening the exhalation time.
  • positive pressure ventilation there is no unnatural increase in pressure in the lungs, but also no unnatural reduction in pressure in the abdomen as with negative pressure ventilation.
  • the conditioning stimulation specifically supports the practice of the various exhalation methods in order to learn a certain exhalation technique more effectively for the subsequent spontaneous breathing.
  • FIG. 2 shows the use of an electrostimulation device in connection with positive pressure respiration on a living being
  • Figs. 3 to 5 are timing diagrams of breathing positions; 6 shows the change in the volume of air in the lungs in a respiratory cycle over time;
  • FIG. 1 shows a living being 1 in a lying position. To clarify the situation, advantageous stimulation positions of the phrenic nerve 2 and the interconstal nerves 3 are shown on the living being 1 . In the present embodiment It was assumed that the phrenic nerve 2 should be stimulated by electromagnetic stimulation.
  • FIG. 1 shows an electrostimulation device 4 which is connected via electrical lines to signal output elements 10, e.g. coils, for feeding magnetic fields into the living being 1.
  • the electrical stimulation device can generate stimulation signals in the living being, which can be used to generate muscle contractions, through which the breathing of the living being 1 can be influenced in a targeted manner.
  • the electrostimulation device 4 can be designed, for example, as a computer-controlled electrostimulation device. It has a computer 5, a Stimu lation signal generating device 6, a memory 7 and 8 controls. There can also be a display device for displaying operating data. A computer program is stored in the memory 7 with which some or all of the functions of the electrostimulation device 4 can be carried out. The computer ner 5 processes the computer program in memory 7. As a result, corresponding stimulation signals are emitted via the stimulation signal generating device 6 to the signal output device 10, through which the desired magnetic fields are generated.
  • the previously described functions for the ventilation of the living being 1 by the stimulation signals or the methods to be carried out by the user can be influenced by the user via the operating elements 8, e.g. by setting parameters of respiratory cycles.
  • the elements described can be used to control the artificial respiration of the living being 1 by electrostimulation. If certain parameters are also to be regulated, it is necessary for the electrostimulation device 4 to be supplied with one or more measured values of characteristics of breathing cycles of the living being 1 . For example, it can be useful to record the volume flow inhaled by the living being 1 and the volume flow exhaled. This can be done, for example, by means of a face mask 13 in which a flow sensor is arranged. The respiratory flow is practically not influenced by the face mask 13 or the flow sensor. However, quantitative variables that characterize the volume flow can be recorded and fed to the electrostimulation device 4 . The sensor signals can be evaluated by the computer 5, for example.
  • the electrostimulation device 4 can also have an interface 9 for connection to other devices, for example for data exchange with other devices. ten. In this way, the electrostimulation device 4 can be supplied with further measured values without the electrostimulation device 4 having to be equipped with its own sensors.
  • FIG. 2 illustrates the use of the electrostimulation device 4 on the living being 1 in connection with a positive-pressure ventilator 11.
  • the ventilator 11 has an air delivery unit 18 through which air is sucked in from the environment via a connection 19 and via an air line 12 can be fed into the respiratory tract of the living being 1 by means of a breathing mask 13 .
  • the breathing mask 13 or the air line 12 can have a defined leakage 14 .
  • Connected to the air line 12 within the ventilator 11 is a pressure sensor 16 and a volume flow sensor 17, such as a pneumotachograph.
  • the ventilator 11 has its own control unit 15 to which the sensors 16, 17 are connected.
  • the control unit 15 controls the air delivery unit 18 according to predetermined algorithms in order to generate desired volume flow profiles and/or pressure profiles in the respiratory organs of the living being 1 via the breathing mask 13 in this way.
  • the electrical stimulation device 4 is connected to the ventilator 11 via its interface 9 .
  • the electrical stimulation device 4 is supplied via the interface 9 with the corresponding measured values and possibly also with additional values calculated internally in the ventilator 11 via characteristic data of the living being's breathing cycles.
  • the electrostimulation device 4 receives, for example, current measured values of the pressure and the volume flow of the breathing cycles of the living being 1.
  • FIGS. 3 to 5 several breathing cycles are plotted over time t for different breathing positions.
  • the air volume V in the lungs is plotted on the ordinate.
  • FIG. 3 shows the breathing position with tidal volumes during resting breathing (AZV) and a maximum possible exhalation, whereby the normal breathing position during resting breathing and the end-expiratory reserve volume (ERV) should be illustrated.
  • the inspiratory reserve volume (IRV) is also marked here and is illustrated in FIG. 4 by the maximum possible inhalation.
  • FIG. 5 shows the shift in the respiratory position during resting breathing into inhalation, which is characterized in that the tidal volumes of resting breathing occur with an increased ERV and reduced IRV.
  • the respiratory patterns shown in FIGS. 3 to 5 can be correspondingly controlled or regulated by the electrostimulation device 4 according to the invention and the method according to the invention, i.e. the electrostimulation device feeds corresponding stimulation signals into at least one nerve and/or muscle of the living being 1 , whereby the corresponding muscle contractions of the respiratory muscles are generated, which ultimately result in the respiratory cycles shown.
  • FIGS. 6 and 7 show a breathing cycle in an enlarged representation.
  • the breathing cycle consists of an inspiration phase I and an expiration phase E.
  • FIG. 6 shows the air volume V over time
  • FIG. 7 shows the transpulmonary pressure TPP over time. It can be seen that the inspiration phase I begins at the lower apex according to FIG. 6 and ends at the upper apex.
  • the expiratory phase E begins at the upper apex and ends at the next lower apex of the curve.
  • the course of the pressure TPP is phase-shifted compared to the course of the volume V.
  • the profiles of the breathing cycles shown in FIG. 6 and FIG. 7, for example, can be generated by the electrostimulation device 4 .
  • the duration of the inspiration phase and/or the duration of the expiration phase can be influenced separately.
  • the amplitude of the volume curve and/or the pressure curve can also be influenced separately, as can the respective positions of the maxima and minima of the curves.
  • FIG. 8 shows an electromagnetic field with trains for stimulation in the inspiration phase, the increase in the train being ramp-shaped.
  • Each of the trains includes impulses, a series of impulses that increase in intensity from a minimum value to a predefined value. This enables a non-invasive or gentle start of the stimulation since the impulses do not immediately stimulate the nerve with the predefined value.
  • FIG. 9 shows an electromagnetic field with trains for stimulation in the inspiration phase, with not only the increase but also the descent of the train being ramp-shaped. This enables not only a non-invasive and gentle start, but also a gentle end to the stimulation.
  • FIG. 10 shows an electromagnetic field with trains for stimulation in the inspiration phase as shown in FIG.
  • the impulses between the trains are at a reduced intensity, which also supports exhalation through relaxation. This support is particularly helpful for sick patients so that their lungs do not contract completely when they exhale, which can prevent the lungs from "gluing together”.
  • the present disclosure also includes embodiments with any combination of features that are mentioned or shown above or below for different embodiments. It also includes individual features in the figures, even if they are shown there in connection with other features and/or are not mentioned above or below.
  • the alternatives of embodiments described in the figures and the description and individual alternatives their features can also be excluded from the subject matter of the invention or from the disclosed objects.
  • the disclosure includes embodiments that exclusively include the features described in the claims or in the exemplary embodiments, as well as those that include other additional features.
  • a computer program may be stored and/or distributed on any suitable medium, such as an optical storage medium or a fixed medium provided 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.
  • a computer program can be, for example, a computer program product stored on a computer-readable medium, which is designed to be executed in order to implement a method, in particular the method according to the invention. Any reference signs in the claims should not be construed as limiting the scope of the claims.

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Abstract

L'invention concerne un dispositif d'électrostimulation pour stimuler un ou plusieurs nerfs et/ou muscles d'un être vivant à l'aide de signaux électriques, ledit dispositif présentant les caractéristiques suivantes : a) le dispositif d'électrostimulation comprend au moins une unité d'émission de signaux au moyen de laquelle des signaux de stimulation électriques peuvent être émis dans au moins un nerf et/ou un muscle ; b) le dispositif d'électrostimulation comprend au moins une unité de commande qui est conçue pour actionner ladite unité d'émission de signaux, de telle sorte que des contractions musculaires peuvent être générées dans l'être vivant par les signaux de stimulation émis par ladite unité d'émission de signaux et la respiration de l'être vivant peut être influencée de manière ciblée au moyen desdites contractions musculaires.
EP22737819.7A 2021-06-23 2022-06-23 Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement Pending EP4359063A1 (fr)

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US20050261747A1 (en) * 2003-05-16 2005-11-24 Schuler Eleanor L Method and system to control respiration by means of neuro-electrical coded signals
US20210361964A1 (en) 2018-02-06 2021-11-25 Stimit Ag Ventilation machine and method of ventilating a patient
EP3866917A1 (fr) 2018-10-19 2021-08-25 Stimit AG Appareil facilitant la respiration et utilisation correspondante
US20230105270A1 (en) * 2019-12-19 2023-04-06 Stimit Ag Ventilation arrangement and treatment method
CA3208404A1 (fr) * 2021-02-17 2022-08-25 Konstantinos Raymondos Procedes de stimulation pour une respiration spontanee commandee electromagnetiquement ou electriquement

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