Electromagnetic initiation device and method for actuating target tissue

Abstract

An electromagnetic triggering device for actuating a target tissue of a human or animal body via a muscle or nervous system of a human or animal body, comprising an electromagnetic field generator having a coil design structure configured to generate an electromagnetic field having a target shape; a mounting device for holding the coil design structure of the electromagnetic field generator at the human or animal body; a sensor component configured to detect actuation of the target tissue; an electromagnetic field adjustment mechanism configured to automatically adjust the position of the electromagnetic field generated by the coil design structure and adjust the field strength of the electromagnetic field generated by the coil design structure; and a calibration unit communicating with the sensor component and the electromagnetic field adjustment mechanism. Also disclosed is a method for manufacturing an electromagnetic triggering device and a method for actuating a target tissue of a human or animal body via a muscle or nervous system of a human or animal body.

Description

Technical Field

[0001] The present invention relates to an electromagnetic initiation device according to the preamble of claim 1 and more particularly to a method of manufacturing such a device, a method of actuating a target tissue and the use of such a device. Background Art

[0002] In medicine, it is known that actuating a patient's target tissue is advantageous for many purposes. For example, in a hospital's intensive care unit, it may be desirable to actuate the diaphragm of a ventilated patient to prevent the disadvantages of diaphragm failure. Results show that within the first 18-69 hours of mechanical ventilation, atrophy of the diaphragm muscle fibers has occurred, and during this period, the muscle fiber cross-section decreases by more than 50%. Therefore, the purpose is to repeatedly actuate the diaphragm while providing artificial or mechanical ventilation to the patient, so that the function of the diaphragm can be maintained, or at least to actuate the diaphragm during the weaning period to support the effective recovery of independent respiratory function.

[0003] To achieve such actuation of tissue in a patient, it is known to stimulate the tissue directly or indirectly by stimulating specific parts of the nervous system. For example, a target tissue that is muscle tissue can be actuated by providing electrical pulses directly to the tissue or nerves associated with the tissue. More specifically, it is known that the diaphragm can be actuated by stimulating the phrenic nerve, for example, at the patient's neck.

[0004] In this context, US 2016 / 0310730 A1 describes a device for reducing ventilation-induced diaphragmatic deactivation in a patient receiving ventilation support from a mechanical ventilator (MV). The device includes an electrode array of a first and a second type, the electrode array including a plurality of electrodes configured to stimulate the patient's phrenic nerve, and at least one controller, the controller identifying the type of the electrode array from at least two different types and generating a stimulation signal to stimulate the patient's phrenic nerve based on the identified electrode type. Such electrode-based stimulation is not very reliable with movement or repositioning of the patient, and the feasible stimulation depth may be significantly limited by bone or fat tissue. In addition, electrode stimulation is reported to cause more pain to the patient than electromagnetic stimulation.

[0005] Therefore, there is a need for a system that allows for more convenient and efficient operation with less irritating side effects. Summary of the invention

[0006] According to the invention, this need is solved by an electromagnetic initiation device as defined by the features of independent claim 1, by a method for manufacturing an electromagnetic initiation device as defined by the features of independent claim 27, by a method for actuating a target tissue in a human or animal body as defined by the features of independent claim 51 and by the use as defined by the features of independent claims 67 to 69. Preferred embodiments are subject matter of the dependent claims.

[0007] In one aspect, the present invention is an electromagnetic initiation device for actuating a target tissue of a human or animal body via a muscle system or a nervous system of a human or animal body, the device comprising (i) an electromagnetic field generator having a coil design structure, the coil design structure being configured to generate a spatial electromagnetic field having a target shape; (ii) a mounting device for holding the coil design structure of the electromagnetic field generator at the human or animal body; (iii) a sensor component configured to detect actuation of the target tissue; (iv) an electromagnetic field adjustment mechanism configured to automatically adjust the position of the electromagnetic field generated by the coil design structure; and (v) a calibration unit communicating with the sensor component and the electromagnetic field adjustment mechanism. The coil design structure described herein may be or include at least two coils or at least one conical or otherwise curved or convex coil, or at least one small coil, i.e., a coil small enough to generate a sharp electromagnetic field, such as a coil with a diameter of less than 3 cm. The target shape of the electromagnetic field described herein may include a peak formed by the spatial electromagnetic field. The electromagnetic field generator may also be referred to as an electromagnetic field generator. The target shape of the electromagnetic field may be achieved by making the electromagnetic field a locally constrained target electric field (e.g., having a peak). The target shape may be adapted to act on the tissue region that is the region of the nerve that is to be activated / induced / actuated under the action of the electromagnetic field, which may be achieved, for example, by a peak in the electromagnetic field (the focal region). The target shape may generally be any shape of the electromagnetic field or time-varying electric field component that allows effective stimulation of one or more target nerves while minimizing other undesirable co-stimulatory effects on surrounding, overlying or nearby tissue or nerves. A peak shape is an example of this, as it maximizes the effect on the focal region and minimizes the effect on areas outside of that region.

[0008] Thus, tissue may refer to any type of human tissue, including but not limited to skin or muscle tissue (ie, diaphragm fibers).

[0009] The parameters of the voltage or current waveform applied by the generator to the coil affect the temporal characteristics / features of the electromagnetic field, including pulse shape, amplitude / amplitude, width, polarity and repetition frequency; the duration of the sweep or pulse series and the intervals therebetween; the total number of pulses; the intervals between stimulation sessions and the total number of sessions will affect the field strength and determine whether the target area or target tissue can be actuated / activated and at what intensity or "dose" the actuation / activation of the target area or target tissue is achieved. The electromagnetic field can be generated by the electromagnetic field generator in a single pulse or as a series. Therefore, a single pulse involves the generation of an electromagnetic field in a relatively short time and with a relatively long interruption between two pulses. Typically, a single pulse is provided at a frequency below 10 Hz (e.g., such as below 5 Hz), or a single pulse is manually initiated by a user or practitioner. The time width of a single pulse is about 10 μs to 300 μs. Such a pulse can actuate nerves and muscles and can be recognized by the patient or a sensor. In particular, such a single pulse can cause a single twitch of a muscle. In contrast, when generated in a series, the electromagnetic field is generated continuously or in the form of a sequence of pulses that follow one another more quickly. Such pulses can be provided at a frequency in the range between about 15 Hz and about 30 Hz. In particular, the series can achieve actuation of nerves or muscles, thereby causing tonic contraction or actuation. Advantageously, the series is provided by increasing the intensity (field strength) and / or frequency until the target intensity and frequency are obtained ("ramp protocol"). In this way, sudden twitches or discomfort can be reduced. All these parameters can be summarized under the term "temporal characteristics / temporal features / time-varying characteristics (temporal characteristics)" or "temporal parameters (temporal parameters)" of the electromagnetic field. These temporal parameters can be manually adjusted via an input interface or automatically controlled by a regulating mechanism.

[0010] The temporal characteristics and spatial distribution of the electromagnetic field can be adjusted in a manner that achieves the desired actuation (actuation feedback) of the target area. Therefore, the actuation feedback (signal) refers to a signal indicating appropriate characteristics of target tissue actuation, for example, a signal that reaches or exceeds a target value (threshold), a signal that presents a certain curve pattern or shape, a signal that satisfies a certain known algorithm to represent appropriate target tissue actuation with a desired intensity, or any combination thereof. The actuation feedback (signal) may particularly include feedback related in particular to the desired muscle actuation intensity that should be achieved before the adjustment mechanism stops changing. Appropriate actuation feedback signal characteristics can be specified by the user via an input interface or detected by an algorithm, for example.

[0011] The calibration unit of the electromagnetic initiation device according to the present invention is configured to (a) control the electromagnetic field adjustment mechanism to automatically change the position of the electromagnetic field generated by the coil design structure; (b) receive an actuation feedback signal from the sensor member after the sensor member detects the actuation of the target tissue; and (c) upon receiving the actuation feedback signal, control the electromagnetic field adjustment mechanism to automatically stop changing the position of the electromagnetic field generated by the coil design structure. Automatically stopping the change of the position of the electromagnetic field and the resulting field strength allows the electromagnetic field to be provided relatively quickly and accurately to effectively and safely actuate the target tissue. It can also prevent any unexpected changes in the configuration / configuration of the electromagnetic field after finding a suitable position. The field strength can also be referred to as the magnitude of the electromagnetic field.

[0012] The target tissue may be or include any muscle, muscle structure or part thereof that can be actuated via the nervous system. In particular, it may be a diaphragm or diaphragm. The nervous system may include or may be a single or multiple nerves, such as, in particular, the phrenic nerve. Therefore, in many applications, it is advantageous to repeatedly stimulate the nervous system or nerves, in particular the phrenic nerve. The coil design structure of the electromagnetic field generator allows the electromagnetic field to be shaped or customized according to the intended application of the device. In particular, the target shape may be formed so that it is relatively sharp. This allows specialized stimulation of the nervous system or a specific part thereof. In particular, it allows specific stimulation of nerves such as the phrenic nerve, and allows reduction or prevention or optimization of stimulation of other tissues such as other nerves or tissues near, around or above the target nerve. Therefore, such common stimulation should be avoided whenever it may occur. The process of locating the target nerve may also be supported by ultrasound imaging technology. In order to stimulate one or two phrenic nerves in the neck, a coil design structure may be provided, the coil design structure being characterized by a double coil that generates a focal electric field region, a plurality of coils that generate a plurality of focal electromagnetic regions, a conical coil, a parabolic coil, a small circular coil or a coil that is curved or convex in any form, or any combination thereof.

[0013] The mounting device may be configured to hold the coil design of the electromagnetic field generator at a specific target location of the human or animal body. In particular, such a target location may be a location where the electromagnetic field generated by the coil can reach a target part of the nervous system. The term "held at" used in conjunction with the mounting device may relate to the coil design being in contact with the body or in close proximity to the body. The position and orientation of the coil design may thereby be predetermined or different.

[0014] The term "in communication with" used in connection with the calibration unit may relate to any connection between elements that allows communication, such as transferring or exchanging information or data. The elements may communicate by being connected to each other by wire or wirelessly.

[0015] By configuring the calibration unit according to the present invention, the electromagnetic field generator can be automatically oriented and adjusted, i.e., calibrated, so that the nervous system is stimulated to specifically / particularly actuate the target tissue. In particular, the intensity of the electromagnetic field generated and the orientation of its target shape can be automatically changed until the nervous system is stimulated so that the sensor receives a signal that the target tissue is actuated. In this configuration, the nervous system is specifically / particularly stimulated and due to the target shape of the electromagnetic field, side effects such as stimulation of other parts of the nervous system can be reduced or minimized. Moreover, the system can react to the patient's movement and automatically redirect for the new position of the target nerve. Thus, the calibration unit, the electromagnetic field adjustment mechanism and the sensor component can be formed as an automatic feedback system implemented in the electromagnetic initiation device.

[0016] In this way, the electromagnetic initiation device according to the present invention allows automatic, convenient and efficient operation and, more specifically, allows simple, precise and specific / exclusive positioning of the portion of the nervous system to be stimulated to actuate the target tissue. By automatically calibrating the device, a considerably higher accuracy can be obtained compared to manual positioning of the relevant portion of the nervous system and usability can be improved. In addition, the device allows reducing side effects in the stimulation of the nervous system.

[0017] Preferably, the mounting device comprises a repositioning structure configured to automatically change the position of the coil design structure of the electromagnetic field generator relative to the human or animal body when the coil design structure of the electromagnetic field generator is held at the human or animal body. The term "position" used in conjunction with the automatic change achieved by the repositioning structure may relate to position, orientation, formed shape, or the like, and combinations thereof. The position may be changed by tilting, moving, repositioning, changing shape, or the like. In this way, the orientation of the electromagnetic field may be effectively and accurately adjusted.

[0018] Therefore, the electromagnetic field adjustment mechanism preferably includes a repositioning structure of the mounting device, and the calibration unit is preferably configured to automatically change the position of the electromagnetic field by triggering the repositioning structure to automatically change the position of at least two electromagnetic coils relative to the human or animal body. The repositioning structure of the mounting device preferably includes a tilting mechanism as a joint, which is configured to tilt the coil design structure of the electromagnetic field generator relative to the human or animal body when the coil design structure of the electromagnetic field generator is held at the human or animal body. This allows effective adaptation of the position and / or orientation to adjust the electromagnetic field and thus stimulate the nervous system. In particular, in neck applications with longitudinally related phrenic nerves, tilting the coil design structure with a peak around the longitudinal axis at the neck surface, combined with changing the field strength / field intensity, can allow all the degrees of freedom required to locate the phrenic nerve. In addition to the joint, the tilting mechanism can be any suitable mechanism for tilting the coil design structure.

[0019] Alternatively or additionally, the electromagnetic field generator preferably comprises a repositionable conductive element located in the electromagnetic field generated by the coil design.Such a conductive element allows for selective and effective adjustment of the electromagnetic field.

[0020] Thus, the electromagnetic field adjustment mechanism preferably comprises a conductive element of the electromagnetic field generator, and the calibration unit is preferably configured to automatically change the position of the electromagnetic field by causing the electromagnetic field adjustment mechanism to automatically reposition the conductive element in the electromagnetic field. The conductive element preferably comprises a conductive shaft. Such a shaft can be a simple and effective embodiment for accurately adjusting the electromagnetic field or its target shape. In this context, the term "shaft" can refer to any suitable rod-like structure, such as a rod, a rod, a stick, a stem, a column, etc.

[0021] Preferably, the electromagnetic field generator comprises a coil array comprising a coil design structure. In particular, the array may consist of three or more coils. Such an array allows for more complex shaping and movement of the electromagnetic field, in particular its target shape.

[0022] Thus, the electromagnetic field adjustment mechanism preferably comprises a coil array of an electromagnetic field generator, and the calibration unit is preferably configured to automatically change the position of the electromagnetic field by causing the electromagnetic field adjustment mechanism to automatically allow different coil combinations of the coil array. The coils in the coil array are preferably overlapped. Preferably, the coil array of the electromagnetic field generator is arranged to generate a plurality of electromagnetic fields each having a target shape, and the coil array is arranged so that the plurality of electromagnetic fields overlap and generate cumulative intensity. By this cumulative intensity, a more precise and well-defined locally confined target electric field can be generated so that the nervous system can be accurately stimulated.

[0023] Preferably, the sensor member comprises at least one electrode configured to be attached to a human or animal body such that it senses activity of the target tissue. Such an electrode can effectively detect actuation of the target tissue so that a calibration process can be stopped and / or proper function of the actuation can be monitored.

[0024] Additionally or alternatively, the sensor member preferably comprises a flow sensor having an adapter connectable to a respiratory system of a human or animal body, the flow sensor being configured to detect changes in air flow caused by activity of the target tissue. As used herein, the term "flow sensor" relates to any device that allows detection of air movement, in particular detection of changes in air movement that result in pressure changes. Typically, a flow sensor measures the number of times a fixed volume is filled with a fluid within a specific time frame, the force or pressure generated in a flowing fluid stream, or the velocity of a fluid in a known area. In particular, the adapter may be configured to connect to the airway of a respiratory system. The flow sensor may be integrated with the electromagnetic initiation device, for example in one unit. The flow sensor may also be included in another unit such as an associated ventilation device, etc.

[0025] Thus, the adapter of the flow sensor of the sensor member is configured to be connected to the mouth and / or nose of a human or animal body. The term "connection" as used herein relates to any direct connection or any indirect connection via another element. For example, the adapter may be indirectly connected to the mouth and / or nose via a tube.

[0026] Additionally or alternatively, the sensor member preferably includes an accelerometer and / or a gyroscope and / or a strain gauge on the patient's chest to detect diaphragmatic contraction. In addition, an esophageal catheter or other type of catheter can be used as a sensor member to detect the actuation of the diaphragm. A catheter measuring the compound muscle action potential (CMAP) of the diaphragm can be used as a sensor member. A catheter in the esophagus measuring the electrical activity of the diaphragm can be used as a sensor member. Diaphragm EMG measurement using a catheter can be used. A trans-diaphragmatic pressure sensor as a catheter can be used as a sensor member to measure gastric pressure (Pga) and esophageal pressure (Pes), sensor type: balloon catheter and pressure transducer / sensor, which requires a small balloon catheter to be inserted into the esophagus and stomach to assess intrathoracic pressure and intra-abdominal pressure, respectively. Alternatively, ultrasound monitoring can be used as a sensor member to detect the actuation of the diaphragm. In addition, blood oxygen quantification measurement results can be used as an indication of inspiratory activity / diaphragmatic actuation. An elastic strip or band (around the chest or other expansion structure) can also be used as a sensor member to detect actuation of the diaphragm; changes in the cross-section of the strip or band can be used as an indication of muscle or diaphragm contraction. Electrodes on the target muscle or diaphragm for measuring action potentials (e.g., electroencephalograms) can be used as sensor members to detect diaphragm actuation. For example, a skin EMG meter for the diaphragm can be used as a sensor member, whereby the diaphragm EMG is monitored using surface electrodes located between the seventh and ninth intercostal spaces in the anterior axillary line. A mechanical stretch sensor on the skin that measures chest deformation can be used as a sensor member. For example, an electrical impedance tomography device in the form of a band that measures lung volume can be used as a sensor member.

[0027] Preferably, the mounting device is configured to hold the coil design structure at the neck of a human or animal body so that the electromagnetic field generated by the coil design structure of the electromagnetic field generator can reach the phrenic nerve of the nervous system of the human or animal body. Such an embodiment allows effective stimulation of the phrenic nerve and actuation of the diaphragm.

[0028] Therefore, the mounting device preferably includes an arcuate member, which can be arranged around the neck of a human or animal body at a certain distance, and the two coils of the electromagnetic field generator are held at the arcuate member of the mounting device. The coil design structure can be moved along the arcuate member. Alternatively, the arcuate member can be equipped with a coil array. Such an arcuate member allows relatively high flexibility in repositioning the coil and / or the electromagnetic field. The arcuate member is preferably equipped with an approach channel. The channel can be implemented as a recess, a slot, a through hole, etc. Such a channel allows the human or animal body to be approached, particularly in the area where the electromagnetic field is applied. In this way, for example, a catheter can be placed in the neck area to stimulate the phrenic nerve.

[0029] Preferably, the electromagnetic initiation device includes a tracker configured to detect movement of the human or animal body relative to the coil design of the electromagnetic field generator and automatically change the position of the electromagnetic field to compensate for the detected movement of the human or animal body relative to the coil design of the electromagnetic field generator. This arrangement ensures proper operation even when the body moves to a certain extent.

[0030] Preferably, the electromagnetic field adjustment mechanism is configured to automatically adjust the field strength of the electromagnetic field generated by the coil design structure, and the calibration unit is configured to control the electromagnetic field adjustment mechanism to automatically change the field strength of the electromagnetic field generated by the coil design structure, and control the electromagnetic field adjustment mechanism to automatically stop changing the field strength of the electromagnetic field generated by the coil design structure when receiving the actuation feedback. This arrangement allows for effective adjustment and dimensioning of the electromagnetic field or its target shape to achieve appropriate stimulation.

[0031] Preferably, the electromagnetic field adjustment mechanism is configured to automatically adjust the time characteristics of the electromagnetic field, and the calibration unit is configured to control the electromagnetic field adjustment mechanism to automatically change the time characteristics of the electromagnetic field and optionally control the electromagnetic field adjustment mechanism to automatically stop changing the time characteristics of the electromagnetic field generated by the coil design structure when receiving actuation feedback.

[0032] Thus, the electromagnetic initiation device preferably comprises an alarm unit, wherein the tracker is connected to the alarm unit and is configured to activate the alarm unit when the detected movement exceeds the range that can be compensated by changing the position of the spatial electromagnetic field generated by the two coils via the electromagnetic field adjustment mechanism. The alarm may be an audible signal, a visual signal or a tactile signal, or any combination thereof.

[0033] Preferably, the electromagnetic field generator is also configured to automatically adjust transient field characteristics, such as the pulse form, pulse duration, pulse frequency, interval time between series, etc. of the electromagnetic field generated by the coil design structure, and the calibration unit is configured to control the electromagnetic field adjustment mechanism to automatically change the transient field characteristics of the electromagnetic field generated by the coil design structure and control the electromagnetic field generator to automatically stop changing the transient field characteristics of the electromagnetic field generated by the coil design structure when receiving actuation feedback.

[0034] Preferably, the sensor member comprises a pressure sensor having an adapter connectable to the respiratory system of a human or animal body, the pressure sensor being configured to detect pressure changes caused by the activity of the target tissue. The adapter of the pressure sensor of the sensor member may be configured to be connected to the mouth and / or nose of the human or animal body. The pressure sensor may be integrated with the electromagnetic initiation device, for example, in one unit. The pressure sensor may also be included in another unit such as an associated ventilation device or the like. Such an arrangement allows detection of actuation of the target tissue causing the patient to breathe.

[0035] The electromagnetic initiation device according to the present invention and its preferred embodiments can be advantageously used for transcutaneous electromagnetic initiation / induction / stimulation of the phrenic nerve for diagnostic purposes to assess diaphragmatic function or sleep apnea syndrome or other forms of sleep-disordered breathing.

[0036] Alternatively, the electromagnetic initiation device according to the present invention and its preferred embodiments can be advantageously used for repeated regular / periodic percutaneous electromagnetic initiation / induction / stimulation of the phrenic nerve for therapeutic purposes in patients without spontaneous breathing, for example for resuscitation and life maintenance of patients with inoperative or impaired respiratory centers, such as sedated patients, intensive care patients or anesthetized patients. The repeated regular / periodic initiation can in particular stimulate ten to fifty times per minute. Inoperative respiratory centers may be caused by the intake of drugs or opioids. This use may involve the immediate treatment of patients with loss of stimulation due to interruption of the connection between the respiratory center and the diaphragm, such as paraplegic patients after an accident, application in patients with loss of stimulation due to sedation or respiratory depression, or application in patients who are mechanically ventilated without triggering.

[0037] The electromagnetic initiation device according to the present invention and its preferred embodiments can also be advantageously used for repeated percutaneous electromagnetic induction / stimulation / initiation of the phrenic nerve for therapeutic use in patients with at least partially intact phrenic nerves, without spontaneous diaphragmatic contraction or insufficient spontaneous diaphragmatic contraction. These therapeutic applications may include, for example, treating or avoiding diaphragmatic weakness in mechanically ventilated patients, avoiding or treating lung infections in mechanically ventilated patients, avoiding or treating lung damage or other positive pressure-related complications, for COPD patients, resuscitating and maintaining life in patients with impaired respiratory center function (e.g., caused by drugs or opioids), for treating sleep apnea syndrome and other forms of sleep-disordered breathing; treating patients with idiopathic diaphragmatic paralysis, neuromuscular atrophy or ALS patients, and treating hypercapnia. For these applications, it may be useful to design the coil positioning mechanism in the following way: the patient lies on a pillow or mattress whose shape adapts to the patient's anatomical structure. This can be a vacuum pillow, in which the patient's head can be fixed in place after evacuation. The coil is fixed to a holder, which is mounted to a mattress or bed or the holder is located on the mattress below the vacuum pillow. An automatic adjustment mechanism is included at the coil holder for changing the direction of stimulation. The adjustment mechanism and coil structure may be surrounded by a cleanable or disposable cover to protect the patient from mechanical coil movement and to protect the coil mechanism from contamination.

[0038] Preferably, the calibration unit is configured to (i) control the electromagnetic field generator to generate the electromagnetic field in pulses while being able to change the position of the electromagnetic field generated by the coil design structure, and (ii) control the electromagnetic field generator to generate the electromagnetic field in series when stopping the change of the position of the electromagnetic field generated by the coil design structure. By separating the provision of pulses when adjusting the position of the electromagnetic field from the provision of a series to stimulate the target tissue, it is possible to achieve optimized actuation of the target tissue according to its purpose. In particular, in order to make the electromagnetic field have an appropriate position, the position of the target tissue or the nerves associated with it must be determined. For this purpose, short pulses are sufficient and the discomfort to the patient is also less. In contrast, in order to stimulate the target tissue, such as the diaphragm that causes breathing, a series may be more effective because contraction within an appropriate time can be effectively achieved.

[0039] Therefore, the calibration unit is preferably configured to control the electromagnetic field generator to generate an electromagnetic field in the form of a series, the series having a field strength that is initially lower than the locally confined target electromagnetic field in the form of a pulse and then gradually increases. In particular, the field strength of the series may be initially slightly lower to avoid discomfort, then gradually increase until the desired muscle contraction intensity is reached, and finally, the field strength of the series may be higher than the field strength of the pulse. In this way, it can be ensured that the target tissue is safely stimulated after finding the correct position of the electromagnetic field.

[0040] Preferably, the actuation feedback signal includes multiple responses to the actuation of the target tissue, each response is associated with a specific position of the electromagnetic field generated by the coil design structure and a specific field strength, and the calibration unit is configured to control the electromagnetic field adjustment mechanism to adjust the position and the final field strength of the electromagnetic field to the most suitable response or the most desired signal feature in the multiple responses of the actuation feedback signal when the actuation feedback signal is received. As used herein, the term "most suitable" can particularly relate to the intensity of the response. In particular, the most suitable response can be the strongest response. Additionally or alternatively, the most suitable response can also be determined by other response characteristics. In this way, the best or most effective position and the final field strength of the electromagnetic field can be determined and adjusted. In particular, by first collecting multiple responses for multiple positions and final field strengths and selecting the strongest or most suitable response, the configuration / configuration of the electromagnetic field can be optimized. The term "strong" related to the response can relate to the intensity or intensity of the activity of the target tissue. Such an intensity or intensity can be related to the intensity or intensity of the signal provided by the sensor member.

[0041] Preferably, the actuation feedback signal comprises a plurality of responses to actuation of the target tissue, each response being associated with a specific position of a target region of the electromagnetic field generated by the coil design structure, and the calibration unit is configured to control the electromagnetic field adjustment mechanism so as to: adjust the position of the electromagnetic field to a specific position associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal when the actuation feedback signal is received; and / or adjust the temporal field characteristics / time-varying field characteristics (temporal field characteristics) to a specific position and time setting (temporal settings) associated with a most appropriate one of the plurality of responses of the actuation feedback signal when the actuation feedback signal is received; and / or adjust the temporal field characteristics to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal when the actuation feedback signal is received.

[0042] On the other hand, the present invention is a method for manufacturing an electromagnetic initiation device, which is used to actuate a target tissue of a human or animal body via a muscle system or a nervous system of a human or animal body. The method includes: (i) assembling (ia) an electromagnetic field generator having a coil design structure configured to generate a spatial electromagnetic field having a target shape, (ib) a mounting device for holding the coil design structure of the electromagnetic field generator at a human or animal body, and (ic) a sensor component configured to detect actuation of the target tissue to the electromagnetic initiation device; (ii) assembling (ii.a) an electromagnetic field adjustment mechanism configured to automatically adjust the position of the electromagnetic field generated by the coil design structure and (ii.b) a calibration unit communicating with the sensor component and the electromagnetic field adjustment mechanism to the electromagnetic initiation device, and configuring the calibration unit to (iii.a) control the electromagnetic field adjustment mechanism to automatically change the position of the electromagnetic field generated by the coil design structure, (iii.b) receive an actuation feedback signal from the sensor component after the sensor component detects the actuation of the target tissue, and (iii.c) control the electromagnetic field adjustment mechanism to automatically stop changing the position of the electromagnetic field generated by the coil design structure when the actuation feedback is received.

[0043] The method according to the invention allows to efficiently manufacture the electromagnetic initiation device according to the invention and its preferred embodiments. Thus, the effects and benefits described above in conjunction with the electromagnetic initiation device according to the invention can be achieved.

[0044] Preferably, the mounting device is provided with a repositioning structure, which is configured to automatically change the position of the coil design structure of the electromagnetic field generator relative to the human body or animal body when the coil design structure of the electromagnetic field generator is held at the human body or animal body. Therefore, the electromagnetic field adjustment mechanism is preferably provided with the repositioning structure of the mounting device, and the calibration unit is preferably configured to automatically change the position of the electromagnetic field by inducing the repositioning structure to automatically change the position of the at least two electromagnetic coils relative to the human body or animal body. There are at least two electromagnetic coils relative to the human body or animal body. The repositioning structure of the mounting device is preferably provided with a tilting mechanism such as a joint, which is configured to tilt the coil design structure of the electromagnetic field generator relative to the human body or animal body when the coil design structure of the electromagnetic field generator is held at the human body or animal body.

[0045] Preferably, the electromagnetic field generator is provided with a repositionable conductive element located in the electromagnetic field generated by the coil design structure. Thus, the electromagnetic field adjustment mechanism is preferably provided with the conductive element of the electromagnetic field generator, and the calibration unit is preferably configured to change the position of the electromagnetic field by inducing the electromagnetic field adjustment mechanism to automatically reposition the position of the conductive element in the electromagnetic field. The conductive element is preferably provided with a conductive axis.

[0046] Preferably, the electromagnetic field generator is provided with a coil array including a coil design structure. Thus, the electromagnetic field adjustment mechanism is preferably provided with a coil array of the electromagnetic field generator, and the calibration unit is preferably configured to automatically change the position of the electromagnetic field by causing the electromagnetic field adjustment mechanism to automatically allow different coil combinations of the coil array. The coils of the coil array are preferably overlapped. Preferably, the coil array of the electromagnetic field generator is arranged to generate a plurality of electromagnetic fields each having a target shape, and the coil array is arranged so that the plurality of electromagnetic fields overlap and generate cumulative intensity.

[0047] Preferably, the sensor member is provided with at least one electrode configured to be attached to a human or animal body such that it can sense activity of a target tissue.

[0048] Preferably, the sensor member is provided with a flow sensor having an adapter connectable to the respiratory system of a human or animal body, the flow sensor being configured to detect changes in gas flow caused by the activity of the target tissue. Therefore, the adapter of the flow sensor of the sensor member is preferably configured to be connectable to the mouth and / or nose of a human or animal body.

[0049] Preferably, the mounting device is configured to hold the coil design structure at the neck of the human or animal body so that the electromagnetic field generated by the coil design structure of the electromagnetic field generator can reach the phrenic nerve of the nervous system of the human or animal body. Therefore, the mounting device is preferably provided with an arc-shaped member, which can be arranged around the neck of the human or animal body at a certain distance, and the two coils of the electromagnetic field generator are held at the arc-shaped member of the mounting device. The arc-shaped member is preferably equipped with an access channel.

[0050] Preferably, the method further comprises the step of assembling a tracker into the electromagnetic initiation device, wherein the tracker is configured to detect movement of a human or animal body relative to the coil design structure of the electromagnetic field generator and automatically change the position of the electromagnetic field to compensate for the detected movement of the human or animal body relative to the coil design structure of the electromagnetic field generator.

[0051] Preferably, the electromagnetic field adjustment mechanism is configured to automatically adjust the field strength of the electromagnetic field generated by the coil design structure, and the calibration unit is configured to control the electromagnetic field adjustment mechanism to automatically change the field strength of the electromagnetic field generated by the coil design structure, and control the electromagnetic field adjustment mechanism to automatically stop changing the field strength of the electromagnetic field generated by the coil design structure when receiving actuation feedback.

[0052] Therefore, the method preferably comprises: assembling an alarm unit into the electromagnetic initiation device, wherein the tracker is connected to the alarm unit and configured to activate the alarm unit when the detected movement exceeds the compensation range that can be achieved by changing the position of the electromagnetic field generated by the two coils via the electromagnetic field adjustment mechanism. The alarm can be an audible signal, a visual signal or a tactile signal, or any combination thereof.

[0053] Preferably, the method includes the following steps: configuring the calibration unit to (i) control the electromagnetic field generator to generate the electromagnetic field in a pulsed form while being able to change the position of the electromagnetic field generated by the coil design structure; and (ii) control the electromagnetic field generator to generate the electromagnetic field in a series form when stopping the change of the position of the electromagnetic field generated by the coil design structure.

[0054] Therefore, the method preferably comprises the step of configuring the calibration unit to control the electromagnetic field generator to generate the electromagnetic field in a series having a field strength that is initially lower than the electromagnetic field in pulse form and that gradually increases thereafter.

[0055] Preferably, the actuation feedback signal comprises a plurality of responses to actuation of the target tissue, each response being associated with a specific position of the electromagnetic field generated by the coil design structure, and the calibration unit is configured to control the electromagnetic field adjustment mechanism so as to: adjust the position of the electromagnetic field to a specific position associated with the strongest or most appropriate one of the multiple responses of the actuation feedback signal when the actuation feedback signal is received; and / or adjust the time field characteristic / time-varying field characteristic to a specific position and time setting associated with the most appropriate one of the multiple responses of the actuation feedback signal when the actuation feedback signal is received; and / or adjust the time field characteristic to a specific position and time setting associated with the most appropriate response characteristic of the multiple responses of the actuation feedback signal when the actuation feedback signal is received.

[0056] Preferably, the actuation feedback signal comprises a plurality of responses to actuation of the target tissue, each response being associated with a specific position of a target area of ​​the electromagnetic field generated by the coil design structure, including configuring the calibration unit to control the electromagnetic field adjustment mechanism to adjust the position of the electromagnetic field to a specific position associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal when the actuation feedback signal is received.

[0057] Preferably, the method includes configuring the electromagnetic field regulating mechanism to automatically adjust the time characteristics / time properties / time-varying characteristics / time-related characteristics of the electromagnetic field, and configuring the calibration unit to control the electromagnetic field regulating mechanism to automatically change the time characteristics of the electromagnetic field and optionally control the electromagnetic field regulating mechanism to automatically stop changing the time characteristics of the electromagnetic field generated by the coil design structure when receiving actuation feedback.

[0058] On the other hand, the present invention is a method for actuating a target tissue of a human or animal body via the muscle system or nervous system of the human or animal body, comprising: (i) positioning a coil design structure at the human or animal body; (ii) generating a spatial electromagnetic field having a target shape with the aid of the coil design structure; (iii) sensing actuation of the target tissue; (iv) adjusting the position of the electromagnetic field generated by the coil design structure; (v) automatically changing the position of the electromagnetic field generated by the coil design structure; (vi) evaluating actuation feedback obtained by sensing actuation of the target tissue; and (vii) automatically stopping the change of the position of the electromagnetic field generated by the coil design structure when actuation is detected by sensing actuation of the target tissue.

[0059] Such a method allows to effectively actuate the target tissue. This may be useful, for example, to prevent any drawbacks caused by not being able to use the target tissue. In particular, when used in ventilation applications, such a method may prevent the inoperativeness of the diaphragm due to not using the diaphragm during ventilation. More specifically, the method according to the invention allows to achieve the effects and benefits described above in conjunction with the electromagnetic initiation device according to the invention.

[0060] Thus, automatically changing the position of the electromagnetic field preferably comprises automatically changing the position of at least two electromagnetic coils relative to the human or animal body.Automatically changing the position of the electromagnetic field preferably comprises automatically repositioning the conductive element in the electromagnetic field.

[0061] Preferably, the electromagnetic field generator comprises a coil array comprising a coil design structure. Thus, automatically changing the position of the electromagnetic field comprises automatically allowing / granting different coil combinations of the coil array. The coils of the coil array preferably overlap. Preferably, the coil array of the electromagnetic field generator is arranged to generate a plurality of electromagnetic fields, each having a locally confined target electric field, the coil array being arranged so that the plurality of electromagnetic fields overlap and generate cumulative strengths.

[0062] Preferably, sensing actuation of the target tissue comprises attaching at least one electrode to the human or animal body.

[0063] Preferably, sensing the actuation of the target tissue comprises connecting a flow sensor to the respiratory system of the human or animal body and detecting changes in air flow caused by the activity of the target tissue. Thereby, the flow sensor is preferably connected to the mouth and / or nose of the human or animal body.

[0064] Preferably, positioning the coil design structure at the human or animal body comprises holding the coil design structure at the neck of the human or animal body such that the electromagnetic field generated by the coil design structure can reach the phrenic nerve of the nervous system of the human or animal body. Advantageously, both sides of the neck are involved in the actuation of the diaphragm. In particular, two electromagnetic initiation devices may be placed in parallel at the neck such that the phrenic nerve can be stimulated on both sides. Preferably, the two devices are coupled / connected so as to be able to cooperate in a synchronized or matched manner.

[0065] Preferably, the method includes automatically adjusting the field strength of the electromagnetic field generated by the coil design structure, automatically changing the field strength of the electromagnetic field generated by the coil design structure, and automatically stopping the change of the field strength of the electromagnetic field generated by the coil design structure when actuation of the target tissue is sensed.

[0066] Preferably, the method comprises generating the electromagnetic field in pulses while varying the position of the electromagnetic field generated by the coil design, and generating the electromagnetic field in series while ceasing to vary the position of the electromagnetic field generated by the coil design.

[0067] Therefore, the method preferably comprises generating the electromagnetic field in a series having a field strength which is initially lower than the electromagnetic field in pulse form and which then gradually increases.

[0068] Preferably, the actuation feedback signal includes multiple responses to actuation of the target tissue, each response being associated with a specific position of the electromagnetic field generated by the coil design structure, and, upon receiving the actuation feedback signal, the position of the electromagnetic field is adjusted to the specific position associated with the strongest or most appropriate response among the multiple responses of the actuation feedback signal.

[0069] The electromagnetic field generators of all embodiments described herein are advantageously configured to provide electromagnetic field pulses with adjustable field strength and frequency. In this way, sudden convulsions of the patient or a specific body part can be prevented. This can improve the convenience and efficiency of stimulation.

[0070] Preferably, the actuation feedback signal comprises a plurality of responses to actuation of the target tissue, each response being associated with a specific position of a target area of ​​the electromagnetic field generated by the coil design structure, and the position of the electromagnetic field is adjusted to a specific position associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal when the actuation feedback signal is received; and / or the time field characteristic / time-varying field characteristic is adjusted to a specific position and time setting associated with a most appropriate one of the plurality of responses of the actuation feedback signal when the actuation feedback signal is received; and / or the time field characteristic is adjusted to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal when the actuation feedback signal is received.

[0071] Preferably, the method comprises adjusting a temporal characteristic of the electromagnetic field and changing the temporal characteristic of the electromagnetic field and optionally, upon receiving actuation feedback, ceasing to change the temporal characteristic of the electromagnetic field generated by the coil design. BRIEF DESCRIPTION OF THE DRAWINGS

[0072] The electromagnetic initiation device according to the invention as well as the process according to the invention and the method according to the invention are described in more detail below by means of exemplary embodiments and with reference to the accompanying drawings, in which:

[0073] Figure 1 A first embodiment of a ventilation device having a first embodiment of an electromagnetic initiation device according to the present invention is shown;

[0074] Figure 2 Shows Figure 1 An electromagnetic field generator of an electromagnetic initiating device;

[0075] Figure 3 Shown by Figure 1 The space electromagnetic field generated by the electromagnetic initiation device;

[0076] Figure 4 A second embodiment of a ventilation device having a second embodiment of an electromagnetic initiation device according to the present invention is shown;

[0077] Figure 5 The electromagnetic field generator of the third embodiment of the electromagnetic initiation device according to the present invention is shown in a tilted state;

[0078] Figure 6 Shown in a non-tilted state Figure 5 An electromagnetic field generator;

[0079] Figure 7 A third embodiment of a ventilation device having a fourth embodiment of an electromagnetic initiation device according to the present invention is shown;

[0080] Figure 8 A fifth embodiment of the electromagnetic initiation device according to the present invention is shown;

[0081] Fig. 9 shows a spatial electromagnetic field generated by a sixth embodiment of an electromagnetic initiation device according to the present invention;

[0082] Fig.10 A flow chart showing a first embodiment of a method for actuating a target tissue of a human or animal body via a muscle system or a nervous system of a human or animal body according to the present invention;

[0083] Fig.11A flow chart showing a second embodiment of a method of actuating a target tissue of a human or animal body via a muscular system or a nervous system of a human or animal body according to the present invention; and

[0084] Fig.12 A flow chart showing a third embodiment of a method according to the present invention for actuating a target tissue of a human or animal body via a muscular system or a nervous system of the human or animal body. DETAILED DESCRIPTION

[0085] In the following description, certain terms are used for convenience, and these terms are not intended to limit the present invention. The terms "right", "left", "upward", "downward", "below" and "upper" refer to directions in the drawings. The terms include the terms explicitly mentioned and their derivatives and terms with similar meanings. Similarly, spatial relative terms such as "under...", "below", "down", "above", "up", "proximal", "distal" and the like can be used to describe the relationship between one element or feature shown in the figure and another element or feature. These spatially relative terms are intended to include different positions and orientations of the device in use or operation in addition to the positions and orientations shown in the drawings. For example, if the device in the drawings is turned over, the elements described as "below" or "below" other elements or features will be "above" or "above" the other elements or features. Therefore, the exemplary term "below" can include positions and orientations above and below. The device can be oriented in other ways (rotated 90 degrees or other orientations), and the spatial relative descriptions used here are interpreted accordingly. Similarly, the description of movement along and around various axes includes various special device positions and orientations.

[0086] To avoid repetition in the drawings and the description of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omitting an aspect from the description or drawings does not mean that the aspect is lost in the embodiments containing the aspect. Instead, the aspect may be omitted for clarity and to avoid lengthy descriptions. In this context, the following applies to the remainder of this specification: if a drawing includes reference numerals that are not described in the directly related part of the specification for the sake of clarity, reference may be made to the previous or subsequent parts of the specification. In addition, for reasons of clarity, if reference symbols are not provided for all features of a component in a drawing, reference is made to other drawings showing the same component. Similar reference numerals in two or more drawings represent the same or similar elements.

[0087] Figure 1A first embodiment of a ventilation device 1 is shown, which has a first embodiment of an electromagnetic induction device 2 (hereinafter also referred to as an EMI device) according to the present invention. The EMI device 2 comprises an electromagnetic field generator 21 having two coils 211 as a coil design structure. The coils 211 are located in a common plane and are configured to generate a spatial electromagnetic field 212. Figure 3 As can be seen in particular in FIG. 5 , when in operation, the two coils 211 generate an electromagnetic field 212 towards the neck 52 of the patient 5. The electromagnetic field 212 has a central target shape with a focal region 213 where the electromagnetic field 212 extends maximally into the neck 52.

[0088] Back to Figure 1 , the EMI device 2 has a mounting device 22, a neck arc 221 of which is arranged on the neck 52 of the patient 5 and fixed to the bed 51 on which the patient 5 lies. The neck arc 221 is provided with a joint 222 as a repositioning structure of the electromagnetic field adjustment mechanism of the EMI device 2. The joint 222 holds the coil 211 at the neck 52 of the patient 5.

[0089] The ventilation device 1 further comprises a ventilator 11 as a flow generator, from which a ventilation tube 13 extends. The EMI device 2 has a mouthpiece 12 which serves as an adapter, i.e., as a catheter interface of the ventilation device 1. The mouthpiece 12 is applied to the mouth in the form of an entry point for the respiratory system of the patient 5. The ventilation tube 13 is connected to a flow sensor 41 of the sensor member 4 of the EMI device 2.

[0090] The EMI device 2 also has a controller 3 as a processing unit, which has a calibration unit 31 and a field adjustment unit 32 of the electromagnetic field adjustment mechanism. The controller 3 communicates with the flow sensor 41 and the connector 222 via respective lines 33.

[0091] The calibration unit 31 is configured to manipulate the joint 222 to automatically change the position of the focal area 213 of the electromagnetic field 212 generated by the coil 211 and the controller 3 to change the field strength of the electromagnetic field. The purpose of changing the field strength and position of the electromagnetic field 212 is to adjust the electromagnetic field 212 so that it specifically stimulates the phrenic nerve 53 of the patient 5, such as Figure 3 After stimulating the phrenic nerve 53, the diaphragm of the patient 5 is actuated. Thereby, airflow or breathing is caused which is sensed by the flow sensor 41.

[0092] The calibration unit 31 is configured to receive an actuation feedback signal from the flow sensor 41 after the actuation of the diaphragm is detected or after the airflow is detected. In addition, the calibration unit is configured to stop the change of the focal area 213 of the electromagnetic field 212 and the position of the controller 3 to stop the change of the field strength of the electromagnetic field 212 when the actuation feedback is received.

[0093] The ventilator 11 is configured to deliver air to the respiratory system of the patient 5 through the mouthpiece 12. Thus, the controller 3 is configured to control the ventilator 11 to deliver air to the respiratory system according to a breathing regimen specified in the controller 3. In particular, the controller 3 regulates the actuation of the diaphragm in coordination with the breathing regimen, so that the actuation of the diaphragm via the phrenic nerve 53 cooperates with the ventilation of the patient 5.

[0094] exist Figure 2 , the coil 211 of the electromagnetic field generator 21 is shown in more detail. As can be seen, the coil 211 is connected to the neck arc 221 via the joint 222. Figure 2 As shown by the arrow in , the joint 222 can be tilted via the controller 3 so that the coil 211 can also be tilted or rotated together. During the calibration of the EMI device 2, the calibration unit 31 automatically tilts the coil 211 relative to the neck 52 of the patient 5 by moving the joint 222. As a result, the electromagnetic field 212, especially the focal area 213 of its target shape, moves accordingly. In addition, the calibration unit 31 changes the field strength of the electromagnetic field 212 until the phrenic nerve is in the focal area 213 and is thereby stimulated.

[0095] The EMI device 2 is also equipped with a tracker 23 configured to detect the movement of the patient 5 relative to the coil 211 and automatically cause a change in the position of the electromagnetic field 212 to compensate for the detected movement of the patient 5. The tracker 23 communicates with an alarm unit. When the detected movement exceeds the compensation range that can be achieved by changing the position of the electromagnetic field 212, the alarm unit is activated.

[0096] The controller 3 is equipped with a wireless adapter for connecting to a mobile device such as a smartphone, tablet computer, etc. as an input interface. When the mobile device is connected, the operator can input an appropriate cycle breathing regimen suitable for treating the patient 5. The breathing regimen is implemented so that the controller 3 causes operation in a predetermined patient-specific manner. Thereby, the ventilator 11 delivers air to the respiratory system of the patient 5 via the mouthpiece 12 by applying a cycle of delivering air to the respiratory system of the patient 5 and exhausting air from the respiratory system according to the breathing regimen. In addition, the EMI device 2 actuates the diaphragm just before the start of one of the cycles of each breathing regimen.

[0097] Figure 4A second embodiment of a ventilation device 10 is shown, which has a second embodiment of an EMI device 20 according to the present invention. The EMI device 20 includes an electromagnetic field generator 210 having two coils 2110. The coils 2110 are configured to generate a spatial electromagnetic field having a target shape. The EMI device 20 also has a mounting device 220 with a strap 2210. The strap 2210 has an adhesive and is attached to the neck 520 of the patient 50.

[0098] The EMI device 20 is equipped with a shaft 2220 as a repositionable element, which extends toward the coil 2110 and can tilt the electromagnetic field around the axis of the shaft.

[0099] The ventilation apparatus 10 includes a ventilator 110 as a flow generator, from which a ventilation tube 130 extends. The EMI device 20 has a mouthpiece 120 as an adapter or as a catheter interface of the ventilation apparatus 10. The mouthpiece 120 is applied to the mouth as an entry site into the respiratory system of the patient 50.

[0100] The EMI device 20 has a controller 30 as a processing unit, which has a calibration unit 310 and a field adjustment unit 320 of an electromagnetic field adjustment mechanism. On the body of the patient 50, a sensor member 40 for detecting the actuation of the diaphragm includes a plurality of electrodes 410. The controller 30 communicates with the electrodes 410 and a magnetic stimulator 325, which is connected to the shaft 2220 via corresponding wires 330.

[0101] The calibration unit 310 is configured to automatically change the position of the electromagnetic field in space by automatically triggering the field adjustment unit 320 to reposition the axis 2220 and by automatically changing the electromagnetic field field strength. In particular, the axis 2220 affects the alignment of the electromagnetic field around the axis of the axis, thereby affecting the position of the target area. Therefore, by moving the axis 2220, the electromagnetic field can be repositioned. Like this, the electromagnetic field can be moved within the neck 520 of the patient 50. In particular, the calibration unit 310 is configured to change the position of the electromagnetic field and change the field strength of the electromagnetic field. Like this, the electromagnetic field can be adjusted so that it specifically stimulates the phrenic nerve of the patient 50. Once the phrenic nerve is stimulated, the diaphragm of the patient 50 is actuated, and the actuation is sensed by the electrode 410.

[0102] The calibration unit 310 is configured to receive an actuation feedback signal from the electrode 410 when actuation of the diaphragm is detected. In addition, the calibration unit is configured to stop changing the position of the electromagnetic field and control the controller 30 to stop changing the field strength of the electromagnetic field when the actuation feedback is received. The ventilator 110 is configured to deliver air to the respiratory system of the patient 50 through the mouthpiece 120. The controller 30 is configured to control the ventilator 110 so that its delivery of air to the respiratory system conforms to the breathing regimen specified in the controller 30. In particular, the controller 30 adjusts the actuation of the diaphragm in coordination with the breathing regimen so that the actuation of the diaphragm via the phrenic nerve cooperates with the ventilation and breathing of the patient 50.

[0103] The controller 30 is equipped with a wireless adapter as an input interface to connect to a mobile device such as a smartphone, tablet computer, etc. When the mobile device is connected, the operator can input an appropriate cycle breathing scheme suitable for treating the patient 50. The breathing scheme is implemented so that the controller 30 causes ventilation and phrenic nerve stimulation in a predetermined and patient-specific manner. Thus, the ventilator 110 delivers air to the respiratory system of the patient 50 via the mouthpiece 120 by applying a cycle of delivering air to the respiratory system of the patient 50 and exhausting air from the respiratory system according to the breathing scheme. In addition, the EMI device 20 actuates the diaphragm just before the start of one of the cycles of each breathing scheme.

[0104] exist Figure 5 , an electromagnetic field generator 219 of a third embodiment of an EMI device according to the present invention is shown. The electromagnetic field generator 219 comprises a housing in which two coils 2119 are positioned. The coils 2119 are fixed to each other so that they can be moved or manipulated together as a unit. The coils 2119 are connected to cables 2139 at their lateral end sides. Starting from the coils 2119, the cables 2139 are redirected by corresponding pulleys 2129 and guided out of the housing via an opening.

[0105] exist Figure 5 In the embodiment, the coil 2119 is in an inclined state, wherein the left coil 2119 is higher than the right coil 2119. To change the inclination of the coil 2119, one of the cables 2139 can be pulled. Figure 6 As can be seen in FIG, to move the coil 2119 back to the straight position, the left cable 2139 is pulled, causing the coil 2119 to rotate counterclockwise.

[0106] Figure 7A third embodiment of a ventilation device 18 is shown, which has a fourth embodiment of an EMI device 28 according to the present invention. The EMI device 28 includes an electromagnetic field generator 218, which has two coils 2118 as a coil design structure. The electromagnetic field generator 218 has a housing 2128, and a shaft 2228 of a mounting device 228 extends into the housing 2128. The shaft 2228 is coupled to a shaft driver 2238, and once the electromagnetic field is generated by the coil 2118, the shaft 2238 can be moved in the electromagnetic field under the action of the shaft driver 2238.

[0107] The ventilation device 18 comprises a ventilator from which a ventilation tube is connected via a flow sensor 418 of the sensor member 48 to a mouthpiece 128 as an adapter or a catheter interface of the ventilation device 18. The mouthpiece 128 is applied to the mouth of the patient 58, which serves as an entry site for the patient's respiratory system.

[0108] The EMI device 28 has a controller 38 as a processing unit, which has a calibration unit and a field adjustment unit. The housing 2128 of the electromagnetic field generator 218, the shaft driver 2238 and the controller 38 are attached to the patient 58, and in particular, the electromagnetic field generator 218 is attached to the patient's neck 528. Thereby, an adhesive for mounting the device 228 is used. The controller 38 communicates with the flow sensor 418 and the shaft driver 2238 by means of a line 338.

[0109] Ventilation equipment 18 and combination Figure 4 The described ventilation device 10 operates accordingly.

[0110] exist Figure 8 A fifth embodiment of the EMI device 27 according to the present invention is shown in FIG. The EMI device 27 is implemented similarly to the EMI device described above with reference to the previous figures. However, the mounting device 227 includes an arcuate member 2217, and the coil 2117 of the electromagnetic field generator 217 is mounted on the arcuate member 2217 as a coil design structure. The arcuate member 2217 is positioned around the neck 527 of the patient 57. The coil 2117 can move along the arcuate member 2217 and can therefore move around the neck 527 of the patient 57. In addition, the coil 2117 can rotate around the arcuate member 2217. Through these movements of the coil 2117, the spatial electromagnetic field, especially its target shape, can be moved around and in the neck 527 to find and stimulate the phrenic nerve of the patient 57.

[0111] Fig. 9The electromagnetic field generated by the coil of the electromagnetic field generator of the sixth embodiment of the EMI device according to the present invention is shown. In particular, the electromagnetic field generator includes two pairs of coils, wherein the two pairs of coils are perpendicular to each other. Therefore, the first pair of coils generates a first electromagnetic field 2126 having a target shape with a first focal area 2136. The second pair of coils generates a second electromagnetic field 2146 having a target shape with a second focal area 2156. Since the first pair of coils is perpendicular to the second pair of coils, the first electromagnetic field and the second electromagnetic field overlap at their respective focal areas 2136, 2156. In this way, an intensity accumulation area 2166 is formed at the site where the focal areas 2136, 2156 overlap. The phrenic nerve 536 is located in the intensity accumulation area 2166.

[0112] Fig.10 A first embodiment of a method of actuating a target tissue in a human or animal body via the muscular system or nervous system of the human or animal body according to the present invention is shown. The first method can be performed, for example, by using Figure 1 The electromagnetic initiation device 2 shown is used for execution.

[0113] In a first step 101, a coil is placed on a human or animal body near a target nerve. For example, the coil can be positioned at the neck so as to be close to the phrenic nerve. In a second step 102, a spatial electromagnetic field having a target shape is generated by means of the coil. In a third step 103, it is sensed whether the target tissue associated with the target nerve is actuated. If it is the case of actuation, in a fourth step 104, the position of the coil and the strength of the electromagnetic field are stabilized or maintained, and the target nerve is repeatedly stimulated.

[0114] If actuation of the target tissue is not sensed in the third step 103, the position of the electromagnetic field and the field strength of the electromagnetic field are automatically changed in a series of sub-steps as follows: In a first sub-step 103i, the position of the coil is adjusted by tilting the coil to a predetermined degree. Then, in a second sub-step 103ii, it is sensed again whether the target tissue is actuated. If it is the case that it is actuated, the fourth step 104 is performed as described above. If actuation is not sensed again, the field strength of the electromagnetic field is adjusted in the third sub-step 103iii. Thereafter, in a fourth sub-step 103iv, it is sensed again whether the target tissue is actuated. If it is the case that it is actuated, the method is continued in the fourth step 104 as described above. If actuation is not sensed again, the sequence of these sub-steps is repeated.

[0115] exist Fig.11 In the figure, a second embodiment of the method of actuating a target tissue of a human or animal body via the muscular system or nervous system of the human or animal body according to the invention is shown. The second method is similar to the first method described above, and includes tracking of the movement of the part involved, especially the body.

[0116] In particular, in a first step 201, a coil is placed on a human or animal body near a target nerve. In a second step 202, a tracker is positioned near the target tissue so that the target tissue is in the monitoring area of ​​the tracker. In a third step 203, a spatial electromagnetic field having a target shape is generated by means of the coil. In a fourth step 204, it is sensed whether the target tissue associated with the target nerve is actuated. If it is the case of actuation, in a fifth step 205, the position of the coil and the strength of the electromagnetic field are stabilized or maintained, and the target nerve is repeatedly stimulated.

[0117] If actuation of the target tissue is not sensed in the fourth step 204, the position of the electromagnetic field and the field strength of the electromagnetic field are automatically changed in a series of sub-steps as follows: In a first sub-step 204i, the position of the coil is adjusted by tilting the coil to a predetermined degree. Then, in a second sub-step 204ii, it is sensed again whether the target tissue is actuated. If it is the case that it is actuated, the fifth step 205 is performed as described above. If actuation is not sensed again, the field strength of the electromagnetic field is adjusted in a third sub-step 204iii. Thereafter, in a fourth sub-step 204iv, it is sensed again whether the target tissue is actuated. If it is the case that it is actuated, the method is continued in the fifth step 205 as described above. If actuation is not sensed again, the sequence of these sub-steps is repeated.

[0118] After stopping the automatic change of the coil and stabilizing the electromagnetic field in step 205, it is monitored in a sixth step 206 whether the tracker indicating body movement is repositioned. If no repositioning is detected, the method continues at step 205. However, if repositioning is detected, an alarm is provided in an eighth step 208.

[0119] Fig.12 A third embodiment of a method of actuating a target tissue in a human or animal body via the muscular system or nervous system of the human or animal body according to the present invention is shown. The third method is similar to the second method described above, involving automatic resetting of the electromagnetic field when a repositioning of the body relative to the coil is detected.

[0120] In particular, in a first step 301, a coil is placed near a target nerve on a human or animal body. In a second step 302, a tracker is positioned near the target tissue so that the target tissue is within the monitoring area of ​​the tracker. In a third step 303, an initial electromagnetic field having a target shape is generated by means of the coil. In a fourth step 304, it is sensed whether the target tissue associated with the target nerve is actuated. If it is the case of actuation, in a fifth step 305, the position of the coil and the strength of the electromagnetic field are stabilized or maintained, and the target nerve is repeatedly stimulated.

[0121] If actuation of the target tissue is not sensed in the fourth step 304, the position of the electromagnetic field and the field strength of the electromagnetic field are automatically changed in a series of sub-steps as follows: In a first sub-step 304i, the position of the coil is adjusted by tilting the coil to a predetermined degree. Then, in a second sub-step 304ii, it is sensed again whether the target tissue is actuated. If it is the case of actuation, the fifth step 305 is performed as described above. If actuation is not sensed again, the field strength of the electromagnetic field is adjusted in a third sub-step 304iii. Thereafter, in a fourth sub-step 304iv, it is sensed again whether the target tissue is actuated. If it is the case of actuation, the method is continued in the fifth step 305 as described above. If actuation is not sensed again, the sequence of these sub-steps is repeated.

[0122] After stopping the automatic change of the coil and stabilizing the electromagnetic field in step 305, it is monitored in a sixth step 306 whether the tracker indicating body movement is repositioned. If no repositioning is detected, the method continues at step 305. But if repositioning is detected, in an eighth step 308, the position of the coil and the field strength of the electromagnetic field are reset to the same initial position and field strength as in steps 301 and 303. Thereafter, in a ninth step 309, the coil is re-tilted and the electromagnetic field is readjusted to the expected position and field strength according to the detected repositioning. Thus, the amount and direction of the repositioning are taken into account. Thereafter, the method continues at sub-step 304ii of the sub-step sequence.

[0123] This specification and the drawings illustrating various aspects and embodiments of the present invention should not be considered as limiting the claims defining the protected invention. In other words, although the present invention has been shown and described in detail in the drawings and the preceding description, such illustration and description should be considered illustrative or exemplary rather than restrictive. Various mechanical, compositional, structural, electrical and operational changes may be made without departing from the spirit and scope of this specification and claims. In some cases, well-known circuits, structures and techniques are not shown in detail so as not to make the present invention difficult to understand. Therefore, it should be understood that those of ordinary skill in the art may make changes and modifications within the scope and spirit of the following claims. In particular, the present invention encompasses other embodiments having any combination of the features of the different embodiments described above and below.

[0124] The present disclosure also covers all other features shown in the drawings, even though they may not have been described individually in the preceding or following description. Furthermore, a single alternative of the embodiments described in the drawings and the description and a single alternative of their features may be abandoned from the subject matter of the present invention or from the disclosed subject matter. The present disclosure includes subject matter consisting of the features defined in the claims or exemplary embodiments as well as subject matter containing said features.

[0125] Furthermore, in the claims, the term "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality. A single unit or step may perform the functions of a plurality of features recited in the claims. The mere fact that specific measures are recited in mutually different dependent claims does not mean that the combination of these measures cannot be used advantageously. The terms "substantially / roughly", "about", "approximately", etc. in conjunction with an attribute or value particularly also clearly define the attribute or clearly define the value, respectively. The term "about" in the context of a given numerical value or range refers to a value or range within 20%, within 10%, within 5% or within 2% of a given value or range, for example. Components described as connected or connected may be directly connected electrically or mechanically, or they may be indirectly connected via one or more intermediate components. Any figure marks in the claims should not be interpreted as limiting the scope of protection.

Claims

1. An electromagnetic triggering device (2; 20; 27; 28) for actuating a target tissue of a human or animal body via a muscle system or a nervous system of a human or animal body, wherein the target tissue is a diaphragm of a human or animal body, the electromagnetic triggering device comprising: With coil design structure (211; 2110; An electromagnetic field generator (21; 210; 217; 218; 219) having a coil design structure configured to generate a spatial electromagnetic field (212; 2126, 2146) having a target shape (213; 2136, 2156); A mounting device (22; 220; 227; 228) for holding a coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) on a human or animal body, wherein the mounting device (22; 220; 227; 228) is configured to be able to hold the coil design structure (211; 2110; 2117; 2118; 2119) on a human or animal body. 8; 2119) is held at the neck (52; 520; 527; 528) of a human or animal body so that the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) can reach the phrenic nerve (53; 536) of the nervous system of the human or animal body; A sensor member (4; 40; 48) configured to detect actuation of a diaphragm of a human or animal body; An electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) configured to automatically adjust the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); and A calibration unit (31; 310; 38) in communication with the sensor member (4; 40; 48) and the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219), wherein the calibration unit (31; 310; 38) is configured to: Controlling the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically change the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); receiving an actuation feedback signal from the sensor component (4; 40; 48) after the sensor component (4; 40; 48) detects actuation of the diaphragm of a human or animal body; and When the actuation feedback signal is received, the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) is controlled to automatically stop changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119).

2. The electromagnetic initiation device (2; 20; 27; 28) according to claim 1, wherein: The mounting device (22; 220; 227; 228) comprises a repositioning structure (222; 2129, 2139), which is configured to automatically change the position of the coil design structure of the electromagnetic field generator relative to the human body or animal body when the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is held at the human body or animal body.

3. The electromagnetic initiation device (2; 20; 27; 28) according to claim 2, wherein: The electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) comprises a repositioning structure (222; 2129, 2139) of the mounting device (22; 220; 227; 228), and the calibration unit (31; 310; 38) is configured to automatically change the position of the electromagnetic field (212; 2126, 2146) by causing the repositioning structure (222; 2129, 2139) to automatically change the position of the coil design structure (211; 2110; 2117; 2118; 2119) relative to the human body or animal body.

4. The electromagnetic initiation device (2; 20; 27; 28) according to claim 2 or 3, wherein: The repositioning structure (222; 2129, 2139) of the mounting device (22; 220; 227; 228) includes a tilting mechanism, which is configured to tilt the coil design structure of the electromagnetic field generator relative to the human body or animal body when the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is held on the human body or animal body.

5. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The electromagnetic field generator (21; 210; 217; 218; 219) includes a repositionable conductive element located in the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119).

6. The electromagnetic initiation device (2; 20; 27; 28) according to claim 5, wherein: The electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) includes a conductive element of the electromagnetic field generator (21; 210; 217; 218; 219), and the calibration unit (31; 310; 38) is configured to automatically change the position of the electromagnetic field (212; 2126, 2146) by inducing the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically reposition the conductive element in the electromagnetic field (212; 2126, 2146).

7. The electromagnetic initiation device (2; 20; 27; 28) according to claim 5 or 6, wherein: The conductive element (2220; 2228) includes a conductive shaft.

8. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The electromagnetic field generator (21; 210; 217; 218; 219) comprises a coil array (211; 2110; 2117; 2118; 2119) including the coil design structure (211; 2110; 2117; 2118; 2119).

9. The electromagnetic initiation device (2; 20; 27; 28) according to claim 8, wherein: The electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) comprises the coil array (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219), and the calibration unit (31; 310; 38) is configured to automatically change the position of the electromagnetic field (212; 2126, 2146) by triggering the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically allow different coil combinations of the coil array (211; 2110; 2117; 2118; 2119).

10. The electromagnetic initiation device (2; 20; 27; 28) according to claim 8 or 9, wherein: The coils (211; 2110; 2117; 2118; 2119) of the coil array (211; 2110; 2117; 2118; 2119) overlap.

11. The electromagnetic initiation device (2; 20; 27; 28) according to any one of claims 8 to 10, wherein: The coil array (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is arranged to generate a plurality of electromagnetic fields, each electromagnetic field having a target shape (213; 2136, 2156), and the coil array (211; 2110; 2117; 2118; 2119) is arranged so that the plurality of electromagnetic fields overlap and generate cumulative intensities (2166).

12. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The sensor member (4; 40; 48) comprises at least one electrode configured to be attached to a human or animal body such that it can sense the activity of a diaphragm muscle of the human or animal body.

13. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The sensor component (4; 40; 48) comprises a flow sensor (41; 418) having an adapter (12; 120) connectable to a respiratory system of a human or animal body, the flow sensor (41; 418) being configured to detect air flow changes caused by the activity of the diaphragm of the human or animal body.

14. The electromagnetic initiation device (2; 20; 27; 28) according to claim 13, wherein: The adapter (12; 120) of the flow sensor (41; 418) of the sensor member (4; 40; 48) is configured to be connectable to the mouth and / or nose of a human or animal body.

15. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The mounting device (22; 220; 227; 228) comprises an arc-shaped member (2217) which can be arranged around the neck (52; 520; 527; 528) of a human or animal body at a certain distance, and the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is held at the arc-shaped member (2217) of the mounting device.

16. The electromagnetic initiation device (2; 20; 27; 28) according to claim 15, wherein: The arc-shaped member (2217) is provided with an access channel.

17. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) is configured to automatically adjust the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), and the calibration unit (31; 310; 38) is configured to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically change the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119).

18. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The electromagnetic field regulating mechanism (21; 210; 217; 218; 219) is configured to automatically adjust the time characteristics of the electromagnetic field (212; 2126, 2146), and the calibration unit (31; 310; 38) is configured to control the electromagnetic field regulating mechanism (21; 210; 217; 218; 219) to automatically change the time characteristics of the electromagnetic field (212; 2126, 2146).

19. An electromagnetic initiation device (2; 20; 27; 28) according to any of the preceding claims, comprising a tracker (23), which is configured to detect the movement of a human or animal body relative to the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) and to automatically change the position of the electromagnetic field (212; 2126, 2146) to compensate for the detected movement of the human or animal body relative to the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219).

20. Electromagnetic initiation device (2; 20; 27; 28) according to the preceding claim 19, comprising an alarm unit, wherein The tracker (23) is connected to the alarm unit and is configured to activate the alarm unit when the detected movement exceeds the range that can be compensated by changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) via the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219).

21. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The sensor member (4; 40; 48) comprises a pressure sensor having an adapter connectable to a respiratory system of a human or animal body, the pressure sensor being configured to detect pressure changes caused by the activity of a diaphragm muscle of the human or animal body.

22. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The calibration unit (31; 310; 38) is configured as follows: While changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), controlling the electromagnetic field generator (21; 210; 217; 218; 219) to generate the electromagnetic field (212; 2126, 2146) in a pulsed form; and When the change of the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) is stopped, the electromagnetic field generator (21; 210; 217; 218; 219) is controlled to generate the electromagnetic field (212; 2126, 2146) in a series.

23. The electromagnetic initiation device (2; 20; 27; 28) according to claim 22, wherein: The calibration unit (31; 310; 38) is configured to control the electromagnetic field generator (21; 210; 217; 218; 219) to generate an electromagnetic field (212; 2126, 2146) in the form of a series, the series having a field strength that is initially lower than the electromagnetic field (212; 2126, 2146) in the form of a pulse and then gradually increases.

24. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The actuation feedback signal includes multiple responses to the actuation of the diaphragm of a human or animal body, each response being associated with a specific position of a target area (213; 2136, 2156) of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), and the calibration unit (31; 310; 38) is configured to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to adjust the position of the target area (213; 2136, 2156) of the electromagnetic field (212; 2126, 2146) to a specific position associated with the strongest or most appropriate response among the multiple responses of the actuation feedback signal when the actuation feedback signal is received.

25. An electromagnetic initiation device (2; 20; 27; 28) according to any one of the preceding claims, wherein: The actuation feedback signal comprises a plurality of responses to actuation of the diaphragm of a human or animal body, each response being associated with a specific position of an electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), and the calibration unit (31; 310; 38) is configured to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) so as to: upon receiving the actuation feedback signal, adjust the position of the electromagnetic field (212; 2126, 2146) to a specific position associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal; and / or upon receiving the actuation feedback signal, adjust the time field characteristic to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal; and / or upon receiving the actuation feedback signal, adjust the time field characteristic to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal.

26. The electromagnetic initiation device (2; 20; 27; 28) according to claim 4, wherein: The tilting mechanism is a joint (222).

27. The electromagnetic initiation device (2; 20; 27; 28) according to claim 17, wherein: The calibration unit (31; 310; 38) is also configured to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically stop changing the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) when receiving an actuation feedback signal.

28. The electromagnetic initiation device (2; 20; 27; 28) according to claim 18, wherein: The calibration unit (31; 310; 38) is also configured to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically stop changing the time characteristics of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) when receiving an actuation feedback signal.

29. A method of manufacturing an electromagnetic initiation device (2; 20; 27; 28) for actuating a target tissue of a human or animal body via the muscular system or nervous system of a human or animal body, wherein the target tissue is the diaphragm of a human or animal body, the method comprising: An electromagnetic field generator (21; 210; 217; 218; 219), a mounting device (22; 220; 227; 228), a sensor member (4; 40; 48) configured to detect actuation of a diaphragm of a human or animal body, an electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) and a calibration unit (31; 310; 38) are assembled to the electromagnetic initiation device, wherein the electromagnetic field generator has a coil design structure (211; 2110; 2117) configured to generate a spatial electromagnetic field (212; 2126, 2146) having a target shape (213; 2136, 2156); 2118; 2119), the mounting device holds the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) on the human or animal body, the electromagnetic field adjustment mechanism is configured to automatically adjust the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), the calibration unit communicates with the sensor member (4; 40; 48) and the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219), and The calibration unit is configured as: Controlling the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically change the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); receiving an actuation feedback signal from the sensor component after the sensor component (4; 40; 48) detects actuation of the diaphragm of a human or animal body; Upon receiving an actuation feedback signal, controlling the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically stop changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); and The mounting device (22; 220; 227; 228) is constructed to be able to hold the coil design structure (211; 2110; 2117; 2118; 2119) at the neck (52; 520; 527; 528) of a human or animal body, so that the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) can reach the phrenic nerve (53; 536) of the nervous system of the human or animal body.

30. The method according to claim 29 comprises providing the mounting device (22; 220; 227; 228) with a repositioning structure (222; 2129, 2139), the repositioning structure being configured to automatically change the position of the coil design structure of the electromagnetic field generator relative to the human body or animal body when the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is held at the human body or animal body.

31. The method according to claim 30 comprises providing the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) with a repositioning structure (222; 2129, 2139) of the mounting device (22; 220; 227; 228) and configuring the calibration unit (31; 310; 38) to automatically change the position of the electromagnetic field (212; 2126, 2146) by inducing the repositioning structure (222; 2129, 2139) to automatically change the position of the coil design structure (211; 2110; 2117; 2118; 2119) relative to the human or animal body.

32. The method according to claim 30 or 31 comprises providing a tilting mechanism for the repositioning structure (222; 2129, 2139) of the mounting device (22; 220; 227; 228), the tilting mechanism being configured to tilt the coil design structure of the electromagnetic field generator relative to the human body or animal body when the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is held thereon.

33. A method according to any one of claims 29 to 32, comprising providing the electromagnetic field generator (21; 210; 217; 218; 219) with a repositionable conductive element located in the electromagnetic field (212; 2126, 2146) generated by the coil design.

34. The method according to claim 33 comprises providing the electromagnetic field adjusting mechanism (21; 210; 217; 218; 219) with the conductive element of the electromagnetic field generator (21; 210; 217; 218; 219) and configuring the calibration unit (31; 310; 38) to automatically change the position of the electromagnetic field (212; 2126, 2146) by inducing the electromagnetic field adjusting mechanism (21; 210; 217; 218; 219) to automatically reposition the position of the conductive element in the electromagnetic field.

35. The method of claim 33, comprising providing the conductive element with a conductive axis.

36. A method according to any one of claims 29 to 35, comprising providing the electromagnetic field generator (21; 210; 217; 218; 219) with a coil array (211; 2110; 2117; 2118; 2119) comprising the coil design structure.

37. The method according to claim 36 comprises providing the electromagnetic field adjusting mechanism (21; 210; 217; 218; 219) with the coil array (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) and configuring the calibration unit (31; 310; 38) to automatically allow different coil combinations of the coil array to automatically change the electromagnetic field (212; 2126, 2146) by triggering the electromagnetic field adjusting mechanism (21; 210; 217; 218; 219).

38. The method according to claim 36 or 37, wherein: The coils (211; 2110; 2117; 2118; 2119) of the coil array (211; 2110; 2117; 2118; 2119) overlap.

39. The method according to any one of claims 36 to 38, comprising arranging the coil array (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) to generate a plurality of electromagnetic fields, each electromagnetic field having a target shape (213; 2136, 2156), the coil array (211; 2110; 2117; 2118; 2119) being arranged so that the plurality of electromagnetic fields overlap and produce cumulative intensities.

40. A method according to any one of claims 29 to 39, comprising providing the sensor member (4; 40; 48) with at least one electrode configured to be attached to a human or animal body such that it can sense activity of a target tissue.

41. The method according to any one of claims 29 to 40 comprises providing the sensor component (4; 40; 48) with a flow sensor (41; 418), the flow sensor having an adapter that can be connected to the respiratory system of a human or animal body, the flow sensor (41; 418) being configured to detect changes in air flow caused by activity of the target tissue.

42. A method according to claim 41, comprising configuring an adapter of the flow sensor (41; 418) of the sensor member (4; 40; 48) to be connectable to the mouth and / or nose of a human or animal body.

43. The method according to any one of claims 29 to 42 comprises providing the mounting device (22; 220; 227; 228) with an arc-shaped member which can be arranged around the neck (52; 520; 527; 528) of a human or animal body at a certain distance, and the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is held at the arc-shaped member of the mounting device.

44. The method of claim 43, wherein: The arc-shaped member is provided with an access channel.

45. A method according to any one of claims 29 to 44, comprising assembling a tracker into the electromagnetic initiation device, wherein: The tracker is configured to detect movement of a human or animal body relative to the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) and to automatically change the position of the electromagnetic field (212; 2126, 2146) to compensate for the detected movement of the human or animal body relative to the coil design structure (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219).

46. ​​The method according to any one of claims 29 to 45, comprising configuring an electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically adjust the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) and configuring the calibration unit (31; 310; 38) to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to Automatically change the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), and control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically stop changing the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) when receiving an actuation feedback signal.

47. The method of claim 45, comprising incorporating an alarm unit into the electromagnetic initiation device, wherein: The tracker is connected to the alarm unit and is configured to activate the alarm unit when the detected movement exceeds the range that can be compensated by changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) via the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219).

48. The method according to any one of claims 29 to 47, comprising configuring the calibration unit to: While changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), controlling the electromagnetic field generator (21; 210; 217; 218; 219) to generate the electromagnetic field (212; 2126, 2146) in a pulsed form; and When the change of the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) is stopped, the electromagnetic field generator (21; 210; 217; 218; 219) is controlled to generate the electromagnetic field (212; 2126, 2146) in a series.

49. The method according to claim 48 comprises configuring the calibration unit (31; 310; 38) to control the electromagnetic field generator (21; 210; 217; 218; 219) to generate an electromagnetic field (212; 2126, 2146) in the form of a series, the series having a field strength that is initially lower than the electromagnetic field (212; 2126, 2146) in the form of a pulse and then gradually increases.

50. The method according to any one of claims 29 to 49, wherein: The actuation feedback signal comprises a plurality of responses to actuation of a diaphragm of a human or animal body, each response being associated with a specific position of an electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), the method comprising configuring the calibration unit (31; 310; 38) to be able to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) so as to: upon receiving the actuation feedback signal, adjust the position of the electromagnetic field (212; 2126, 2146) to a specific position associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal; and / or upon receiving the actuation feedback signal, adjust the time field characteristic to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal; and / or upon receiving the actuation feedback signal, adjust the time field characteristic to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal.

51. The method according to any one of claims 29 to 50 comprises configuring the electromagnetic field regulating mechanism (21; 210; 217; 218; 219) to be capable of automatically adjusting the temporal characteristics of the electromagnetic field (212; 2126, 2146) and configuring the calibration unit (31; 310; 38) to be capable of controlling the electromagnetic field regulating mechanism (21; 210; 217; 218; 219) to automatically change the temporal characteristics of the electromagnetic field (212; 2126, 2146).

52. The method of claim 32, wherein: The tilting mechanism is a joint.

53. The method of claim 51, wherein: The calibration unit (31; 310; 38) is also configured to control the electromagnetic field adjustment mechanism (21; 210; 217; 218; 219) to automatically stop changing the time characteristics of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) when receiving actuation feedback.

54. A method of actuating a target tissue of a human or animal body via a muscular system or a nervous system of a human or animal body, wherein the target tissue is a diaphragm of a human or animal body, comprising: The coil design structure (211; 2110; 2117; 2118; 2119) is positioned at a human or animal body, wherein positioning the coil design structure (211; 2110; 2117; 2118; 2119) at a human or animal body comprises: holding the coil design structure (211; 2110; 2117; 2118; 2119) at a neck (52; 520; 527; 528) of the human or animal body so that an electromagnetic field (212; 2126, 2146) generated by the coil design structure can reach a phrenic nerve (53; 536) of a nervous system of the human or animal body; A spatial electromagnetic field (212; 2126, 2146) having a target shape (213; 2136, 2156) is generated by means of the coil design structure (211; 2110; 2117; 2118; 2119); sensing actuation of a diaphragm muscle of a human or animal body; Adjusting the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); Automatically changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); evaluating an actuation feedback signal obtained by sensing actuation of a diaphragm muscle of a human or animal body; as well as When actuation is detected by sensing actuation of the diaphragm of the human or animal body, changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) is automatically stopped.

55. The method of claim 54, wherein: Automatically changing the position of the electromagnetic field (212; 2126, 2146) includes automatically changing the position of the coil design structure (211; 2110; 2117; 2118; 2119) relative to the human or animal body.

56. The method of claim 54 or 55, wherein: Automatically changing the position of the electromagnetic field (212; 2126, 2146) includes automatically repositioning the conductive element within the electromagnetic field.

57. A method according to any one of claims 54 to 56, wherein: The electromagnetic field generator (21; 210; 217; 218; 219) comprises a coil array (211; 2110; 2117; 2118; 2119) including the coil design structure.

58. The method of claim 57, wherein: Automatically changing the position of the electromagnetic field (212; 2126, 2146) includes automatically allowing different coil combinations of the coil array.

59. The method according to claim 57 or 58, wherein: The coils (211; 2110; 2117; 2118; 2119) of the coil array (211; 2110; 2117; 2118; 2119) overlap.

60. The method of claim 57 or 58, wherein: The coil array (211; 2110; 2117; 2118; 2119) of the electromagnetic field generator (21; 210; 217; 218; 219) is arranged to generate a plurality of electromagnetic fields, each electromagnetic field having a target shape (213; 2136, 2156), and the coil array (211; 2110; 2117; 2118; 2119) is arranged so that the plurality of electromagnetic fields overlap and generate cumulative intensities.

61. The method according to any one of claims 54 to 60, wherein: Sensing actuation of a diaphragm of the human or animal body comprises attaching at least one electrode to the human or animal body.

62. The method according to any one of claims 54 to 61, wherein: Sensing actuation of the diaphragm of a human or animal body comprises: connecting a flow sensor (41; 418) to the respiratory system of the human or animal body; and detecting changes in air flow caused by the activity of the diaphragm of the human or animal body.

63. The method of claim 62, wherein: The flow sensor (41; 418) is connected to the mouth and / or nose of a human or animal body.

64. A method according to any one of claims 54 to 63, comprising: Automatically adjust the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); automatically change the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); and automatically stop changing the field strength of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) when sensing the actuation of the diaphragm of a human or animal body.

65. A method according to any one of claims 54 to 64, comprising: The electromagnetic field (212; 2126, 2146) is generated in a pulsed form while changing the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119); and the electromagnetic field (212; 2126, 2146) is generated in a series form when stopping the change of the position of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119).

66. A method according to claim 65, comprising generating the electromagnetic field (212; 2126, 2146) in a series having a field strength that is initially lower than the electromagnetic field (212; 2126, 2146) in pulse form and that gradually increases thereafter.

67. The method according to any one of claims 54 to 66, wherein: The actuation feedback signal comprises a plurality of responses to actuation of the diaphragm of a human or animal body, each response being associated with a specific position of a target area (213; 2136, 2156) of an electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119), and, upon receiving the actuation feedback signal, adjusting the position of the electromagnetic field (212; 2126, 2146) to a specific position associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal; and / or upon receiving the actuation feedback signal, adjusting the time field characteristic to a specific position and time setting associated with a most appropriate response among the plurality of responses of the actuation feedback signal; and / or upon receiving the actuation feedback signal, adjusting the time field characteristic to a specific position and time setting associated with a most appropriate response characteristic among the plurality of responses of the actuation feedback signal.

68. A method according to any one of claims 54 to 67, comprising: The temporal characteristics of the electromagnetic field (212; 2126, 2146) are adjusted and the temporal characteristics of the electromagnetic field (212; 2126, 2146) are changed.

69. The method of claim 68, further comprising ceasing to alter the temporal characteristics of the electromagnetic field (212; 2126, 2146) generated by the coil design structure (211; 2110; 2117; 2118; 2119) upon receipt of the actuation feedback signal.

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