WO2019154834A1

WO2019154834A1 - Electro-magnetic induction apparatus and method of operating such apparatus

Info

Publication number: WO2019154834A1
Application number: PCT/EP2019/052869
Authority: WO
Inventors: Ronja MÜLLER-BRUHN
Original assignee: Mueller Bruhn Ronja
Priority date: 2018-02-06
Filing date: 2019-02-06
Publication date: 2019-08-15
Also published as: CA3090045A1; US20210361964A1; BR112020015992A2; BR112020015997A2; AU2019217570A1; US20210361939A1; JP2021513449A; EP3749414A1; CN111918696A; CN111936189A; JP2021513448A; WO2019154839A1; AU2019217572A1; WO2019154837A1; KR20200141437A; KR20200143671A; EP3749401A1; CA3090028A1

Abstract

An electro-magnetic induction apparatus (6) for activating a muscular structure in a human or animal body via its muscular or neural system, comprising an electromagnetic field generator (8) with a coil configured to generate an electro-magnetic field, a mouthpiece (7) configured to keep the respiratory passages clear in order to rectify a breathing difficulty, and an electro-magnetic field adjustment mechanism configured to adjust the field strength of the electro-magnetic field.

Description

DESCRI PTI ON

Title

ELECTRO-MAGNETIC INDUCTION APPARATUS AND METHOD OF OPERATING SUCH

APPARATUS

Technical Field

[0001] The present invention relates to an electro-magnetic induction apparatus and more particularly to a method of operating such an apparatus and a use of such an apparatus.

Background Art

[0002] In accidental or illness situations, it happens that affected persons stop breathing due to various causes. In an early emergency treatment it is therefore often desired to provide the patient with air into his respiratory system to achieve survival or reanimation. For that purpose it is known to use ventilation machines. Such ventilation machines typically comprise a mouthpiece to be attached to the mouth and/or nose of the patient. The mouthpiece is connected to a pump which usually is controlled by an electronic system.

[0003] Even though such ventilation machines may be appropriate in many applications they also have some disadvantages. For example, typically ventilation machines are comparably bulky such that they can not conveniently be brought close to the patient. Further, if the respiratory system and particularly a respiratory passage or upper respiratory tract thereof is fully or partially blocked the ventilation may be hindered or reduced. Such blocking may also happen when the ventilation machine is in operation already. Still further, typically it is aimed to induce spontaneous breathing of the patient as quick as possible. It is known, that natural breathing and heart beating can interrelate or mutually influence each other (e.g. if the heart is re-animated, the breathing function is more likely to start gain as well), therefore a positive effect of spontaneous patient breathing on heart beat function is possible as well. A re- animation of the patient to breathe spontaneously can therefore have a positive effect on re- animating the heart as well. Such spontaneous breathing is not or to a limited extent only supported by actively pumping air into the respiratory system.

[0004] Therefore, there is a need for a system allowing to conveniently and effectively re- animating the patient’s breathing function, e.g. by inducing an artificial breathing of patient in emergency situations.

Disclosure of the Invention [0005] According to the invention this need is settled by an electro-magnetic induction apparatus as it is defined by the features of independent claim 1 , by a method of operating such an apparatus as it is defined by the features of independent claim 28, and by a use as it is defined by the features of independent claim 30. Preferred embodiments are subject of the dependent claims.

[0006] In one aspect, the invention is an electro-magnetic induction apparatus for activating a muscular structure in a human or animal body via its muscular or neural system. The electro- magnetic induction apparatus comprises an electro-magnetic field generator, a mouthpiece and an electro-magnetic field adjustment mechanism. The electro-magnetic field generator can also be referred to as electro-magnetic field creator. The electro-magnetic field generator has a coil configured to generate an electro-magnetic field. The mouthpiece is configured to keep the respiratory passages clear in order to rectify a breathing difficulty. The electro-magnetic field adjustment mechanism is configured to adjust the field strength of the electro-magnetic field.

[0007] The field strength of the electro-magnetic field can also be referred as intensity of the electro-magnetic field. It can cover the field strength in the narrow sense as well as temporal characteristics of the electro-magnetic field generated by the electro-magnetic field generator via the coil. It can depend on the temporal parameters of the voltage or current waveform applied to the coil via a generator including pulse shape, amplitude or magnitude, width, polarity, and repetition frequency; duration of and interval between bursts or trains of pulses; total number of pulses; and interval between stimulation sessions and total number of sessions have, amongst others; the intensity has an effect on if and to which extent a target area or target tissue can be activated. The intensity of the resulting electro-magnetic field can also be adjusted by just adjusting one of these parameters, e.g. the magnitude or amplitude.

[0008] The electro-magnetic field can be generated by the electro-magnetic field generator in single pulses or as a train. Thereby, single pulses relate to the generation of the electro- magnetic field over a comparably short time and with a comparably long interruption between two subsequent pulses. Typically, single pulses are provided at frequencies lower than 10 Hz such as, e.g. at 5 Hz or below, or single pulses are initiated by the user or practitioner. The single pulses can have a time width of about 10 to 300 ps. Such pulses can activate nerves and muscles and are identifiable by the patient or by a sensor. In particular, such single pulses may cause a single convulsion of a muscle. In contrast thereto, when being generated in a train, the electro-magnetic field is either continuously generated or in sequences of pulses comparably quickly following each other. Such pulses can be provided in a frequency range of in between about 15 Hz and about 30 Hz. In particular, a train may achieve to activate a nerve or muscle such that a tetanic contraction or activation is induced. Advantageously, the train is provided by increasing the intensity (field strength) and/or frequency until a target intensity and frequency is achieved (ramp protocol). All of these parameters are summarized under the term“temporal characteristics” or “temporal parameters” of the electro-magnetic field. These temporal parameters can be adjusted manually via an input interface or be controlled automatically by an adjustment mechanism.

[0009] The muscular structure can particularly be the diaphragm and/or a respiratory muscle. The neural system can particularly comprise the Phrenic nerve via which the diaphragm can be activated.

[0010] The electro-magnetic induction apparatus can be used in severe or urgent cases such as for reanimation of a patient. For example, in a situation where a patient stops breathing and a fast re-animation is crucial the importance of side effects is comparably low. The crucial issue is to re-activate the breathing of the patient to keep him alive or unimpaired. For example, when reanimating a patient by getting him to breath spontaneously again, it is less important that only or specifically the Phrenic nerve is stimulated as long as it can be guaranteed that it is stimulated at all. Therefore, side-effects like pain or stimulation of other nerves may be accepted since more crucial effects are to achieve. Therefore, in order to quickly localize and stimulate the Phrenic nerve the electro-magnetic field can be comparably broad and unspecific. However, in such emergency situation it can be of higher importance that the respiratory system of the patient is kept open or accessible which is achieved by the mouthpiece specifically configured. This mouthpiece can be quickly applicable to the patient when stimulating the Phrenic nerve.

[0011] Thus, the electro-magnetic induction apparatus according to the invention allows for efficiently and quickly activating the muscular structure such as the diaphragm for reanimation or other emergency purposes.

[0012] Preferably, the electro-magnetic field generator comprises coil design having the coil. The coil design described herein can be or comprise at least two coils including the coil, at least one cone shaped coil being the coil, or any curved or bulged coil or a circular coil being the coil or an array of coils. Such coil design allows for providing a shaped or customized electro- magnetic field in compliance with the intended application of the apparatus which can be beneficial for stimulating the neural system or the Phrenic nerve.

[0013] Preferably, the electro-magnetic field has a targeted shape. The targeted shape of the electro-magnetic field can be achieved by the electro-magnetic field being a spatial or locally constrained, targeted electric field, e.g., having a peak. It can be adapted to be active in a target area being the nerve area that shall be activated with the electromagnetic-field, which can be for example achieved by the peak in the electro-magnetic field (focality area). The time dependence and spatial distribution of the electro-magnetic field and the field strength can be tuned in such a way that the desired activation of the target area is achieved. This allows for specifically stimulating the neural system or a specific portion thereof. In particular, it allows for specifically stimulating a nerve such as the Phrenic nerve and for lowering or preventing stimulation of other tissue such as other nerves neighboring the targeted nerve. Thus, whereas in emergency situations where reanimation is aimed such side effects are of less importance it can anyway be desired to avoid or reduce such co-stimulations whenever possible. In order to stimulate both Phrenic nerves at a neck, the coil design can be provided with a double coil generating a focal e-field area, a parabolic coil or a large coils such as a coil having a diameter of more than 3 cm or a small circular coil such as a coil having a diameter of less than 3 cm.

[0014] Preferably, the mouthpiece comprises a tubus or tube such as a magill-tube, an oxford- non-kinking-tube, a woodbridge-tube, a Kuhn-tube or the like. Such tubus can efficiently be provided into the respiratory system of the patient. In particular, such tubus can be forwarded into the trachea of the patient. Like this, the respiratory system can efficiently be kept open during operation of the apparatus.

[0015] Preferably, the electro-magnetic induction apparatus comprises a steering unit configured to generate repetitive electro-magnetic inductions. Such steering unit can be implemented alternatively or additionally to configuring the electro-magnetic field generator to generate repetitive electro-magnetic inductions.

[0016] Thereby, repetitive electro-magnetic inductions preferably are activating impulses or pulses with a regular frequency. The frequency can be in a range of, e.g., 10 to 50 cycles per minute. A stimulation protocol may include magnetic field intensities of 1 tesla to 4 tesla on double coil surface, repetitive stimulation impulses applied in a frequency of 10 Hz to 50 Hz (+/- 10 Hz) over a duration of between 0,2 seconds and 3 seconds (on-times), followed by pauses of minimum 1 second to 4 seconds before this protocol is repeated again. Also the electro- magnetic pulses can be repeated at a frequency in a range of about 10 Hz to about 30 Hz or preferably in a range of about 20 Hz to about 25 Hz. The single pulses can have a time width in a range of about 10 ps to about 300 ps. The configuration of the provision of the electro- magnetic pulses can be embodied by a processing unit, e.g., running a sophisticated software.

[0017] Preferably, the electro-magnetic induction apparatus comprises a mounting arrangement holding the coil of the electro-magnetic field generator at the human or animal body. The mounting arrangement can be embodied to hold the coil design of the electro-magnetic field generator in a specific target position at the human or animal body. In particular, such target position may be a position in which a target portion of the neural system can be reached by the electro-magnetic field created by the coils. The term“holding at” as used in connection with the mounting arrangement can relate to the coil or coil design being in contact with the body or in close distance to it. The position and orientation of the coil or coil design can thereby be predefined or distinct. [0018] Thereby, the mounting arrangement preferably is configured to hold the coil of the electro-magnetic field generator at a neck of the human or animal body. In particular, the coil or coil design can be held by the mounting arrangement such that the Phrenic nerve of the neural system of the human or animal body can be reached by the preferably locally constrained, targeted electric field of the electro-magnetic field generated by the coil or coil design of the electro-magnetic field generator. Such an embodiment allows for efficiently stimulating the Phrenic nerve and to activate the diaphragm.

[0019] Preferably, the electro-magnetic induction apparatus comprises a sensor member configured to detect an activation of a target tissue of the human or animal body and a calibration unit in communication with the sensor member and with the electro-magnetic field adjustment mechanism, wherein the electro-magnetic field adjustment mechanism is configured to automatically adjust a field strength of the electro-magnetic field generated by the coil of the electro-magnetic field generator and the calibration unit is configured to control the electro- magnetic field adjustment mechanism to automatically vary the field strength of the electro- magnetic field generated by the coil design, to receive an activation feedback signal from the sensor member upon detection of the activation of the target tissue, and to control the electro- magnetic field adjustment mechanism to automatically keep the field strength of the electro- magnetic field generated by the coil when the activation feedback signal is received.

[0020] The activation feedback (signal) can refer to a signal that indicates appropriate characteristics of target tissue activation, e.g. a signal that reaches or exceeds a target value (threshold), a signal that exhibits a certain curve pattern or shape, a signal that fulfills a certain algorithm known to represent appropriate target tissue activation in the desired strength, or any combination thereof. The activation feedback (signal) may comprise feedback in particular about a desired muscle activation strength that shall be reached before the adjustment mechanism stops variation. The appropriate activation feedback signal characteristics can for example be defined by a user via an input interface or be detected by algorithms.

[0021] Preferably, the sensor member comprises at least one electrode configured to be attached to the human or animal body such that it senses an activity of the target tissue. Such an electrode can efficiently detect activation of the target tissue such that the calibration process can stopped and/or a proper functioning of the activation can be monitored.

[0022] Additionally or alternatively, the sensor member preferably comprises a flow sensor having an adaptor connectable to a respiratory system of the human or animal body, the flow sensor being configured to detect an air flow change induced by an activity of the target tissue. The term “flow sensor” as used herein relates to any device allowing for detecting an air movement and, in particular, change of the air movement resulting in a pressure change. Typically, flow sensors measure the number of times a fixed volume is filled by the fluid within a specific time frame, a force or pressure produced in the flowing stream of the fluid or a velocity of the fluid over a known area. The adaptor can particularly be configured to be connected to an airway of the respiratory system. The flow sensor can be integral with the electro-magnetic induction device, e.g. in one unit. It can also be comprised in another unit such as an associated ventilation machine or the like.

[0023] Thereby, the adaptor of the flow sensor of the sensor member preferably is configured to be connected to a mouth and/or a nose of the human or animal body. The term“connected” as used herein relates to any direct connection or indirect connection via another element. For example, the adaptor can be indirectly connected to the mouth and/or nose via a tube.

[0024] Additionally or alternatively, the sensor member preferably comprises accelerators and/or gyroscopes and/or strain gauges, on the chest of the patient to detect diaphragm contractions. Also, an oesophagus catheter or other types of catheters may be used as a sensor member to detect activation of the diaphragm. A catheter to measure compound muscle action potentials (CMAP) of diaphragm may be used as a sensor member. A catheter in esophagus that measures the electrical activity of the diaphragm may be used as a sensor member. EMG measurement of diaphragm using catheter may be used. A transdiaphragmatic pressure sensor as catheter may be used as a sensor member, measuring gastric pressure (Pga) and esophagus pressure (Pes), sensor type: balloon catheter and pressure transducer, this requires the placement of small balloon-tipped catheters into the esophagus and stomach to assess intrathoracic and intra-abdominal pressures, respectively. Or, ultrasound monitoring may be used as a sensor member to detect diaphragm activations. Further, oxymetry measures may be used as indicators about inhalation activities/ diaphragm activation. Also elastic bands/ belts (around chest or other expanding structures) may be used as a sensor member to detect diaphragm activations; cross-section changes in bands/ belts can serve as indicators for muscle/ diaphragm contractions. Electrodes on target muscles/ diaphragm to measure action potentials (e.g. electroenzephalograms) can be used as a sensor member to detect diaphragm activation. For example, cutaneous EMG measurement of diaphragm may be used as sensor member, whereby diaphragmatic EMG is monitored with a surface electrode positioned between the seventh and ninth intercostal spaces in the anterior axillary line. Mechanical stretch sensors on skin measuring thorax deformation may be used as a sensor member. Electrical impedance tomography, e.g. in form of a belt measuring lung volume, may be used as a sensor member.

[0025] The term“in communication” as used in connection with the calibration unit can relate to any connection of elements allowing to communicate such as to transfer or exchange information or data. The elements can be in communication by being in wired or wireless connection with each other. [0026] Thereby, the calibration unit preferably is configured to automatically vary a position of the electro-magnetic field generated by the coil in addition to its field strength and/or temporal characteristics. By such configuration of the calibration unit, the electro-magnetic field generator can automatically be orientated and adjusted, i.e. calibrated, such that the neural system is stimulated to specifically activate a target tissue such as a diaphragm or a Phrenic nerve. In particular, the strength and orientation of the electro-magnetic field created can be automatically varied until the neural system is stimulated such that the sensor receives a signal of the target tissue being activated. In that configuration, the neural system is specifically stimulated and due to the targeted shape of the electro-magnetic field the side effects such as stimulation of other portions of the neural system can be lowered or minimized. Moreover, the system can react to patient movements, and automatically re-orient towards the new location of the target nerve or tissue. Thereby, the calibration unit, the electro-magnetic field adjustment mechanism and the sensor member can form an automated feedback system implemented in the electro-magnetic induction apparatus.

[0027] Like this, the electro-magnetic induction apparatus allows for an automatic, convenient and efficient operation and, more particular, for a simple, precise and specific localization of the portion of the neural system to be stimulated for activating the target tissue. By automatically calibrating the device, a considerable higher accuracy can be achieved compared to a manual localization of the relevant portion of the neural system, and usability can be improved. Additionally, such apparatus allows for reducing the side effects in stimulation of the neural system.

[0028] Preferably, the sensor member comprises a flow sensor detecting flow changes in the mouthpiece. The term“flow sensor” as used herein relates to any device or structure allowing for detection of an air movement and, in particular, change of the air movement resulting in a pressure change. Typically, flow sensors measure the number of times a fixed volume is filled by the fluid within a specific time frame, a force or pressure produced in the flowing stream of the fluid or a velocity of the fluid over a known area. The mouthpiece can particularly be configured to be connected to an airway of the respiratory system. The flow sensor can be integral with the electro-magnetic induction apparatus, e.g. in one unit with the mouthpiece. It can also be comprised in another unit.

[0029] Alternatively, the sensor member can comprises a flow sensor having an adaptor connectable to a respiratory system of the human or animal body, the flow sensor being configured to detect an air flow change induced by an activity of the muscular structure. Thereby, the adaptor of the flow sensor of the sensor member preferably is configured to be connected to a mouth and/or a nose of the human or animal body. The term“connected” as used herein relates to any direct connection or indirect connection via another element. For example, the adaptor can be indirectly connected to the mouth and/or nose via a tube. [0030] The sensor member preferably comprises a pressure sensor detecting pressure changes in the mouthpiece. The pressure sensor can be integral with the electro-magnetic induction apparatus and particularly with its mouthpiece. It can also be comprised in another unit. Such an arrangement allows for efficiently detecting an activation of the target tissue resulting in a respiration of the patient.

[0031] Preferably, the mounting arrangement comprises a repositioning structure configured to automatically change a position of the coil design of the electro-magnetic field generator relative to the human or animal body when being held at the human or animal body. The term“position” as used in connection with the automatic changing by the repositioning structure can relate to a location, orientation, form-shaping or the like and combinations thereof. The position can be changed by tilting, shifting, relocating, reshaping or similar actions. Like this, the orientation of the electric-magnetic field can efficiently and precisely be adjusted.

[0032] Thereby, the electro-magnetic field adjustment mechanism comprises the repositioning structure of the mounting arrangement and the calibration unit is configured to automatically vary the position of the electro-magnetic field by inducing the repositioning structure to automatically change the position of the at least two electro-magnetic coils relative to the human or animal body. The repositioning structure of the mounting arrangement preferably comprises a tilting mechanism such as a joint configured to tilt the coil or coil design of the electro-magnetic field generator relative to the human or animal body when being held at the human or animal body. This allows for an efficient adaptation of the position and/or orientation to adjust the electro-magnetic field in order to stimulate the neural system. Besides a joint the tilting mechanism can be any suitable structure to tilt the coil or coil design.

[0033] Preferably, the electro-magnetic field generator comprises a repositionable conductive element located in the electro-magnetic field generated by the coil or coil design. Such a conductive element allows for an alternative efficient adjustment of the electro-magnetic field.

[0034] Thereby, the electro-magnetic field adjustment mechanism preferably comprises the conductive element of the electro-magnetic field generator and the calibration unit is configured to automatically vary the position of the electro-magnetic field by inducing the electro-magnetic field adjustment mechanism to automatically reposition the conductive element in the electro- magnetic field. The conductive element preferably comprises a conductive shaft. Such a shaft may be a simple and efficient embodiments for precisely adjust the electro-magnetic field. In this context the term“shaft” may relate to any suitable rod-like structure such as a bar, a pole, a stick, a stem, a post or the like.

[0035] Preferably, the electro-magnetic field generator comprises an array of coils including the coil design. The array can consist of three or more coils. Such array allows for more sophisticatedly shaping and moving the electro-magnetic field and particularly its targeted shape.

[0036] Thereby, the electro-magnetic field adjustment mechanism comprises the array of coils of the electro-magnetic field generator and the calibration unit is configured to automatically vary the position of the electro-magnetic field by inducing the electro-magnetic field adjustment mechanism to automatically empower different coil combinations of the array of coils. The coils of the array of coils preferably overlap. The array of coils of the electro-magnetic field generator preferably are arranged to generate a plurality of electro-magnetic fields each having a targeted shape, the array of coils being arranged such that the plurality of electro-magnetic fields overlap and generate an accumulated intensity. With such accumulated intensity, a more precise and well defined targeted electric field can be generated such that the neural system, such as the Phrenic nerve, or the diaphragm can be precisely stimulated.

[0037] Preferably, the sensor member comprises at least one electrode configured to be attached to the human or animal body such that it senses an activity of the muscular structure and particularly of the diaphragm. Such an electrode can efficiently detect activation of the muscular structure such that the calibration process can stopped and/or a proper functioning of the activation can be monitored.

[0038] Preferably, the mounting arrangement is configured to hold the coil design at the neck of the human or animal body such that a Phrenic nerve of the neural system of the human or animal body can be reached by the electro-magnetic field generated by the coil or coil design of the electro-magnetic field generator. Such an embodiment allows for efficiently stimulating the Phrenic nerve and to activate the diaphragm.

[0039] Thereby, the mounting arrangement preferably comprises an arc member arrangable in distance around the neck of the human or animal body, the coil of the electro-magnetic field generator being held at the arc member of the mounting arrangement. The coil or coil design can be movable along the arc member. Or, the arc member can be equipped with the array of coils. The arc member can also hold the sensor member or any further sensor member.

[0040] Preferably, the electro-magnetic field creator is configured to generate repetitive electro- magnetic inductions with a gradually increasing amplitude and/or with a gradually increasing field strength.

[0041] Preferably, the electro-magnetic induction apparatus comprises an input interface, allowing a user to keep the stimulator settings, such as, e.g., keep intensity/amplitude and stop variation of intensity/amplitude, when an appropriate breathing response from the patient is detected. [0042] In another aspect, the invention is a method of operating an electro-magnetic induction apparatus as described above. The method comprises the steps of: (i) removing residuals from a mouth of a patient, (ii) placing the mouthpiece of the electro-magnetic induction apparatus in or on the mouth and trachea of the patient, (iii) placing the electro-magnetic field generator of the electro-magnetic induction apparatus on an anterolateral neck adjacent to the posterior body of the sternomastoid muscle at the level of the cricoid cartilage, or another suitable body location, (iv) increasing the field strength of the electro-magnetic field generated by the electro- magnetic field generator of the electro-magnetic induction apparatus until respiratory signals are detected, (v) stopping the increasing of the electro-magnetic field generated by the electro- magnetic field generator of the electro-magnetic induction apparatus, and (vi) repeatedly providing pulses of the electro-magnetic field generated by the electro-magnetic field generator of the electro-magnetic induction apparatus with the same electro-magnetic field strength and/or temporal characteristics.

[0043] The increasing can be stopped immediately or with a defined delay to allow for a more supramaximal stimulation. Particularly, the Phrenic nerve can be identified or found by providing increasing single pulses of the electro-magnetic field generated by the electro-magnetic field generator. This may induce a twitch of the diaphragm which can lead to a detectable flow or pressure change, typically having a peak shape. Thereby, the respiratory signals detected can, e.g., be such short flows or strokes of breath. Once the Phrenic nerve is located and found, the pulses of the electro-magnetic field generated by the electro-magnetic field generator of the electro-magnetic induction apparatus can be provided at a frequency in a range of about 10 Hz to about 30 Hz or preferably in a range of about 20 Hz to about 25 Hz. The pulses can have a width or length in a range of about 160 ps to about 300 ps. Such pulses at such frequency can be beneficial for an efficient breathing support wherein sudden convulsion or twitching can be prevented.

[0044] The method according to the invention allows for efficiently achieving the effects and benefits of the electro-magnetic induction apparatus and its preferred embodiments described above.

[0045] Preferably, the method further comprises: placing a sensor member, preferably having electrodes and/or accelerators and/or gyroscopes and/or strain gauges, on the chest of the patient to detect diaphragm contractions. Also, an oesophagus catheter or other types of catheters may be used as a sensor member to detect activation of the diaphragm. A catheter to measure compound muscle action potentials (CMAP) of diaphragm may be used as a sensor member. A catheter in esophagus that measures the electrical activity of the diaphragm may be used as a sensor member. EMG measurement of diaphragm using catheter may be used. A transdiaphragmatic pressure sensor as catheter may be used as a sensor member, measuring gastric pressure (Pga) and esophagus pressure (Pes), sensor type: balloon catheter and pressure transducer, this requires the placement of small balloon-tipped catheters into the esophagus and stomach to assess intrathoracic and intra-abdominal pressures, respectively. Or, ultrasound monitoring may be used as a sensor member to detect diaphragm activations. Further, oxymetry measures may be used as indicators about inhalation activities/ diaphragm activation. Also elastic bands/ belts (around chest or other expanding structures) may be used as a sensor member to detect diaphragm activations; cross-section changes in bands/ belts can serve as indicators for muscle/ diaphragm contractions. Electrodes on target muscles/ diaphragm to measure action potentials (e.g. electroenzephalograms) can be used as a sensor member to detect diaphragm activation. For example, cutaneous EMG measurement of diaphragm may be used as sensor member, whereby diaphragmatic EMG is monitored with a surface electrode positioned between the seventh and ninth intercostal spaces in the anterior axillary line. Mechanical stretch sensors on skin measuring thorax deformation may be used as a sensor member. Electrical impedance tomography, e.g. in form of a belt measuring lung volume, may be used as a sensor member.

[0046] In a further other aspect, the electro-magnetic induction apparatus according to the invention or any of its preferred embodiments described above is used for repetitive regular transcutanous electro-magnetic induction of a Phrenic nerve for therapeutic use in patients with no spontaneous breath, for example for reanimation and keeping alive patients who have no or an impaired function of a respiratory center. The repetitive regular induction can be in particular ten to fifty stimuli per minute. The no or impaired function of the respiratory center can result from drugs or opioid consumption, or form an accident. The use can be involved in an immediate therapy for patients with missing stimulus due to interrupted connection between respiratory center and diaphragm such as, e.g., paraplegic patients after accidents, for use in patients with missing stimulus due to sedation or respiratory depression, or for use in mechanically ventilated patients without trigger.

[0047] The electro-magnetic field apparatus of all embodiments described herein advantageously is configured to provide pulses of electromagnetic fields, with adjustable field strength and frequency. Like this, sudden convulsion of the patient or of specific body parts can be prevented. This can increase convenience and efficiency of the stimulation.

Brief Description of the Drawings

[0048] The electro-magnetic induction apparatus according to the invention as well as the method and use according to the invention are described in more detail hereinbelow by way of exemplary embodiments and with reference to the attached drawings, in which:

Fig. 1 shows some parts of a first embodiment of an electro-magnetic induction apparatus according to the invention;

Fig. 2 shows other parts of the electro-magnetic induction apparatus of Fig. 1 ; Fig. 3 shows an electro-magnetic field generator of a second embodiment of an electro- magnetic induction apparatus according to the invention in a non-tilted state;

Fig. 4 shows the electro-magnetic field generator of the electro-magnetic induction apparatus of Fig. 3 in a tilted state;

Fig. 5 shows an electro-magnetic field generated by the electro-magnetic induction apparatus of Fig. 3;

Fig. 6 shows some parts of a third embodiment of an electro-magnetic induction apparatus according to the invention;

Fig. 7 shows an electro-magnetic field generated by a fourth embodiment of an electro- magnetic induction apparatus according to the invention; and

Fig. 8 shows flow scheme of an embodiment of a method of operating an electro-magnetic induction apparatus according to the invention.

Description of Embodiments

[0049] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms“right”,“left”,“up”,“down”,“under" and“above" refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as "beneath", "below", "lower", "above", "upper", "proximal", "distal", and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.

[0050] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.

[0051] Fig. 1 and Fig. 2 show an embodiment of an electro-magnetic induction apparatus 6 for activating a muscular structure in a human or animal body via its muscular or neural system according to the invention. It comprises, on one hand, a mouthpiece 7 as can be seen in Fig. 1 and, on the other hand, an electro-magnetic field generator 8 and an electro-magnetic field adjustor 9 as electro-magnetic field adjustment mechanism as can be seen in Fig. 2.

[0052] Turning to Fig. 1 , the mouthpiece 7 has a tubus 71 which is provided into a mouth of a patient 56. The tubus 71 is shaped in accordance with the anatomy of the respiratory system of the patient 56 and, particularly, to a portion thereof in the area of his neck 526. More specifically, the shape of the tubus 71 is designed in correspondence with the oral cavity, the Pharynx and eventually the Trachea of the patient 56.

[0053] As depicted in Fig. 2, the electro-magnetic field generator 8 has a housing 82 in which a pair of coils 81 is arranged as coil design. The coils 81 are configured to generate an electro- magnetic field. From the housing 82 a handle 82 extends which can be gripped by an operator of the electro-magnetic induction apparatus 6. The electro-magnetic field adjustor 9 is configured to adjust the field strength of the electro-magnetic field generated by the coils 81.

[0054] In use of the electro-magnetic induction apparatus 6, particularly in an emergency situation where the patient 56 is to be reanimated, the tubus 71 is advanced through the mouth of the patient 56 to keep the respiratory passages clear in order to rectify a breathing difficulty. Then the electro-magnetic field generator 8 is positioned at the neck 527 of the patient 56. The electro-magnetic field adjustor 9 now activates the coils 81 which, in turn, create a comparably broad and unspecific electro-magnetic field. The operator moves the coils 81 and the electro- magnetic field generator 8 varies the field strength of the electro-magnetic field until the Phrenic nerve is stimulated and breathing is induced by activating the diaphragm as muscular structure of the patient 56.

[0055] The electro-magnetic induction apparatus 6 is embodied particularly simple and robust. Like this, operation can be comparably efficient and specifically suitable for emergency situations, where re-animation of the patient 56 has highest priority and side effects or discomfort of the patient is less relevant.

[0056] However, for a more sophisticated application an electro-magnetic field generator 219 can be designed and operated as shown Fig. 3, Fig. 4 and Fig. 5 depicting a second embodiment of an electro-magnetic induction apparatus according to the invention. The electro- magnetic field generator 219 comprises a housing in which two coils 21 19 are positioned as coil design. The coils 2119 are fixed to each other such that they can be moved or manipulated together as one unit. The coils 21 19 are connected to cables 2139 at their lateral end sides. Starting from the coils 2119, the cables 2139 are redirected by respective pulleys 2129 and guided through an opening out of the housing. The cables 2139 together with the pulleys 2129 establish a tilting mechanism configured to tilt the coils 2119.

[0057] In Fig. 4 the coils 21 19 are depicted in a tilted state in which the left coil 21 19 is higher than the right coil 21 19. For changing the tilting of the coils 21 19, one of the cables 2139 can be pulled. As can be seen in Fig. 3, for moving the coils 21 19 back to a straight position, the left cable 2139 is pulled such that the coils 21 19 are rotated counter-clockwise.

[0058] As can particularly be seen in Fig. 5, when operated, the two coils 21 19 generate an electro-magnetic field 212 towards a neck 52 of a patient. The electro-magnetic field 212 has a targeted shape with a target area 213 at which the electro-magnetic field 212 maximally extends into the neck 52.

[0059] The second embodiment of an electro-magnetic induction apparatus further has a controller as a processing unit with a calibration unit, a flow sensor integrated in a mouthpiece and a field adjustment unit of an electro-magnetic field adjustment mechanism. The controller is in communication with the sensor member and the tilting mechanism via respective wires. The calibration unit is configured to manipulate the tilting mechanism to automatically vary the position of the electro-magnetic field 212 generated by the coils 21 1 and the controller to vary the field strength of the electro-magnetic field. The aim of varying field strength and position of the electro-magnetic field 212 is to adjust the electro-magnetic field 212 such that it specifically stimulates a Phrenic nerve 53 of the patient 5 as can be best seen in Fig. 5. Upon stimulation of the Phrenic nerve 53, a diaphragm of the patient is activated. Thereby, an airflow or breathing is induced which is sensed by the flow sensor.

[0060] In use, the coils 2119 are connected to a neck of the patient wherein the coils 21 19 can be tilted or rotated relative to the neck. During calibration of the electro-magnetic induction apparatus the calibration unit automatically tilts the coils 21 19 relative to the neck by pulling the cables 2139. Thereby, the electromagnetic field 212 and particularly its target area 213 are moved correspondingly. In addition to that, the calibration unit varies the field strength of the electro-magnetic field 212 until the Phrenic nerve is in within the target area 213 and thereby stimulated.

[0061] The calibration unit is further configured to receive an activation feedback signal from the flow sensor upon detection of activation of the diaphragm or upon detection of the airflow. Additionally, it is configured to stop variation of the electro-magnetic field 212 and the controller to stop variation of the field strength of the electro-magnetic field 212 when the activation feedback is received. [0062] In Fig. 6 components of a third embodiment of an electro-magnetic induction apparatus 27 according to the invention is shown. The electro-magnetic induction apparatus 27 comprises a mounting arrangement 227 with an arc member 2217 to which coils 21 17 of an electro- magnetic field generator 217 are mounted as coil design. The arc member 2217 is positioned around a neck 527 of a patient 57. The coils 21 17 can be moved along the arc member 2217 and thereby around the neck 527 of the patient 57. Additionally, the coils 21 17 can turn about the arc member 2217. By these movements of the coils 21 17 an electro-magnetic field and, in particular, a target area thereof can be moved around and in the neck 527 for stimulating a Phrenic nerve or both Phrenic nerves of the patient 57.

[0063] Fig. 7 shows electromagnetic fields generated by coils of an electro-magnetic field generator of a fourth embodiment of an electro-magnetic induction apparatus according to the invention. In particular, the electro-magnetic field generator comprises two pairs of coils wherein the pairs are perpendicular to each other. Thus, a first pair of coils generates a first electro- magnetic field 2126 having a first targeted shape with a target area 2136. The second pair of coils generates a second electro-magnetic field 2146 having a second targeted shape with a target area 2156. Since the coils of the first pair are perpendicular to the coils of the second pair, the first electro-magnetic field and the second electro-magnetic field overlap at their respective target areas 2136, 2156. Like this, an area of accumulated intensity 2166 is created where the locally constrained, targeted electric fields 2136, 2156 overlap. A Phrenic nerve 536 is positioned in the area of accumulated intensity 2166 such that it is efficiently stimulated.

[0064] In Fig. 8 a method of operating an electro-magnetic induction apparatus as described above. The method comprises a step 101 of removing residuals from a mouth of a patient, a step 102 of placing the mouthpiece of the electro-magnetic induction apparatus in or on the mouth and trachea of the patient, a step 103 of placing the electro-magnetic field generator of the electro-magnetic induction apparatus on an anterolateral neck adjacent to the posterior body of the sternomastoid muscle at the level of the cricoid cartilage, or another suitable body location, a step 104 of placing a sensor member having electrodes on the chest of the patient to detect diaphragm contractions, a step 105 of increasing the field strength of the electro- magnetic field generated by the electro-magnetic field generator of the electro-magnetic induction apparatus until respiratory signals are detected, a step 106 of stopping the increasing of the electro-magnetic field generated by the electro-magnetic field generator of the electro- magnetic induction apparatus, and a step 107 of repeatedly providing pulses of the electro- magnetic field generated by the electro-magnetic field generator of the electro-magnetic induction apparatus with the same electro-magnetic field strength and/or temporal characteristics.

[0065] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting-the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.

[0066] The disclosure also covers all further features shown in the Figs individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.

[0067] Furthermore, in the claims the word "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 fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms“essentially”,“about”,“approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term“about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.

Claims

Claim 1 : An electro-magnetic induction apparatus (6) for activating a muscular structure in a human or animal body via its muscular or neural system, comprising an electro-magnetic field generator (8) with a coil (811 ; 2117; 2119) configured to generate an electro-magnetic field (212; 2126, 2146), a mouthpiece (7) configured to keep the respiratory passages clear in order to rectify a breathing difficulty, and an electro-magnetic field adjustment mechanism configured to adjust the field strength of the electro-magnetic field (212; 2126, 2146).

Claim 2: The electro-magnetic induction apparatus (6) of claim 1 , wherein the electro-magnetic field generator (8) comprises a coil design (811 ; 2117; 2119) having the coil (811 ; 2117; 2119).

Claim 3: The electro-magnetic induction apparatus (6) of claim 1 or 2, wherein the electro-magnetic field (212; 2126, 2146) has a targeted shape.

Claim 4: The electro-magnetic induction apparatus (6) of any one of the preceding claims 1 to 3, wherein the mouthpiece (7) comprises a tubus (71 ).

Claim 5: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the electro-magnetic field generator (8) is configured to generate repetitive electro-magnetic inductions.

Claim 6: The electro-magnetic induction apparatus (6) of claim 5, wherein repetitive electro-magnetic inductions are activating impulses with a regular frequency.

Claim 7: The electro-magnetic induction apparatus (6) of any one of the preceding claims, comprising a mounting arrangement holding the coil (811 ; 2117; 2119) of the electro-magnetic field generator (8) at the human or animal body. Claim 8: The electro-magnetic induction apparatus (6) of claim 7, wherein the mounting arrangement is configured to hold the coil (811 ; 2117; 2119) of the electro-magnetic field generator (8) at a neck (526; 527) of the human or animal body.

Claim 9: The electro-magnetic induction apparatus (6) of any one of the preceding claims, comprising

a sensor member configured to detect an activation of a target tissue of the human or animal body, and

a calibration unit in communication with the sensor member and with the electro-magnetic field (212; 2126, 2146) adjustment mechanism, wherein the electro-magnetic field (212; 2126, 2146) adjustment mechanism is configured to automatically adjust a field strength of the electro-magnetic field (212; 2126, 2146) generated by the coil (811 ; 2117; 2119) of the electro-magnetic field generator (8) and the calibration unit is configured to

control the electro-magnetic field (212; 2126, 2146) adjustment mechanism to automatically vary the field strength of the electro-magnetic field (212; 2126, 2146) generated by the coil design (811 ; 2117; 2119),

to receive an activation feedback signal from the sensor member upon detection of the activation of the target tissue, and

to control the electro-magnetic field (212; 2126, 2146) adjustment mechanism to automatically keep the field strength of the electro-magnetic field (212; 2126, 2146) generated by the coil (811 ; 2117; 2119) when the activation feedback signal is received.

Claim 10: The electro-magnetic induction apparatus (6) of claim 9, wherein the calibration unit is configured to automatically vary a position of the electro- magnetic field (212; 2126, 2146) generated by the coil (811 ; 2117; 2119) in addition to its field strength.

Claim 11 : The electro-magnetic induction apparatus (6) of claim 9 or 10, wherein the sensor member comprises a flow sensor detecting flow changes in the mouthpiece (7). Claim 12: The electro-magnetic induction apparatus (6) of claim 10 or 1 1 , wherein the sensor member comprises a pressure sensor detecting pressure changes in the mouthpiece (7).

Claim 13: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the mounting arrangement comprises a repositioning structure configured to automatically change a position of the coil design (81 1 ; 21 17; 21 19) of the electro-magnetic field generator (8) relative to the human or animal body when being held at the human or animal body.

Claim 14: The electro-magnetic induction apparatus (6) of claim 13, wherein the electro-magnetic field (212; 2126, 2146) adjustment mechanism comprises the repositioning structure of the mounting arrangement and the calibration unit is configured to automatically vary the position of the electro-magnetic field (212; 2126, 2146) by inducing the repositioning structure to automatically change the position of the at least two electro-magnetic coils (81 1 ; 21 17; 21 1 9) relative to the human or animal body.

Claim 15: The electro-magnetic induction apparatus (6) of claim 13 or 14, wherein the repositioning structure of the mounting arrangement comprises a tilting mechanism configured to tilt the coil (81 1 ; 21 17; 21 19) of the electro-magnetic field generator (8) relative to the human or animal body when being held at the human or animal body.

Claim 16: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the electro-magnetic field generator (8) comprises a repositionable conductive element located in the electro-magnetic field (212; 2126, 2146) generated by the coil (81 1 ; 21 17; 21 19).

Claim 17: The electro-magnetic induction apparatus (6) of claim 16, wherein the electro-magnetic field (212; 2126, 2146) adjustment mechanism comprises the conductive element of the electro-magnetic field generator (8) and the calibration unit is configured to automatically vary the position of the electro-magnetic field (212; 2126, 2146) by inducing the electro-magnetic field (212; 2126, 2146) adjustment mechanism to automatically reposition the conductive element in the electro-magnetic field (212; 2126, 2146).

Claim 18: The electro-magnetic induction apparatus (6) of claim 16 or 17, wherein the conductive element comprises a conductive shaft.

Claim 19: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the electro-magnetic field generator (8) comprises an array of coils (811 ; 2117; 2119) including the coil design (811 ; 2117; 2119).

Claim 20: The electro-magnetic induction apparatus (6) of claim 19, wherein the electro-magnetic field (212; 2126, 2146) adjustment mechanism comprises the array of coils (811 ; 2117; 2119) of the electro-magnetic field generator (8) and the calibration unit is configured to automatically vary the position of the electro- magnetic field (212; 2126, 2146) by inducing the electro-magnetic field (212; 2126, 2146) adjustment mechanism to automatically empower different coil combinations of the array of coils (811 ; 2117; 2119).

Claim 21 : The electro-magnetic induction apparatus (6) of claim 19 or 20, wherein coils (811 ; 2117; 2119) of the array of coils (811 ; 2117; 2119) overlap.

Claim 22: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the array of coils (811 ; 2117; 2119) of the electro- magnetic field generator (8) are arranged to generate a plurality of electro- magnetic fields (212; 2126, 2146) each having a targeted shape, the array of coils (811 ; 2117; 2119) being arranged such that the plurality of electro-magnetic fields (212; 2126, 2146) overlap and generate an accumulated intensity.

Claim 23: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the sensor member comprises at least one electrode configured to be attached to the human or animal body such that it senses an activity of the muscular structure.

Claim 24: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the sensor member comprises a flow sensor having an adaptor connectable to a respiratory system of the human or animal body, the flow sensor being configured to detect an air flow change induced by an activity of the target tissue.

Claim 25: The electro-magnetic induction apparatus (6) of claim 24, wherein the adaptor of the flow sensor of the sensor member is configured to be connected to a mouth and/or a nose of the human or animal body.

Claim 26: The electro-magnetic induction apparatus (6) of any one of claims 3 to

25, wherein the mounting arrangement is configured to hold the coil design (811 ; 2117; 2119) at the neck of the human or animal body such that a Phrenic nerve of the neural system of the human or animal body can be reached by the electro- magnetic field (212; 2126, 2146) generated by the coil design (811 ; 2117; 2119) of the electro-magnetic field generator (8).

Claim 27: The electro-magnetic induction apparatus (6) of claim 26, wherein the mounting arrangement comprises an arc member arrangable in distance around the neck of the human or animal body, the two coils (811 ; 2117; 2119) of the electro-magnetic field generator (8) being held at the arc member of the mounting arrangement.

Claim 28: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the electro-magnetic field creator (8) is configured to generate repetitive electro-magnetic inductions with a gradually increasing amplitude.

Claim 29: The electro-magnetic induction apparatus (6) of any one of the preceding claims, wherein the electro-magnetic field creator (8) is configured to generate repetitive electro-magnetic inductions with a gradually increasing field strength.

Claim 30: The electro-magnetic induction apparatus (6) of any one of the preceding claims, with an input interface, allowing a user to keep the stimulator settings when an appropriate breathing response from the patient is detected. Claim 31 : A method of operating an electro-magnetic induction apparatus (6) according to any one of the preceding claims, comprising

removing residuals from a mouth of a patient (56; 57), placing the mouthpiece (7) of the electro-magnetic induction apparatus (6) in or on the mouth and trachea of the patient (56; 57),

placing the electro-magnetic field generator (8) of the electro-magnetic induction apparatus (6) on an anterolateral neck adjacent to the posterior body of the sternomastoid muscle at the level of the cricoid cartilage, or another suitable body location,

increasing the field strength of the electro-magnetic field (212; 2126, 2146) generated by the electro-magnetic field generator (8) of the electro- magnetic induction apparatus (6) until respiratory signals are detected,

stopping the increasing of the electro-magnetic field (212; 2126, 2146) generated by the electro-magnetic field generator (8) of the electro-magnetic induction apparatus (6), and

repeatedly providing pulses of the electro-magnetic field (212; 2126, 2146) generated by the electro-magnetic field generator (8) of the electro- magnetic induction apparatus (6) with the same electro-magnetic field (212; 2126, 2146) field strength.

Claim 32: The method of claim 31 , further comprising placing a sensor member, preferably having electrodes and/or accelerators and/or gyroscopes and/or strain gauges, on the chest of the patient (56; 57) to detect diaphragm contractions.

Claim 33: Use of an electro-magnetic induction apparatus (6) according to any one of claims 1 to 30 for repetitive regular transcutanous electro-magnetic induction of a Phrenic nerve for therapeutic use in patients (56; 57) with no spontaneous breath, for example for reanimation and keeping alive patients (56; 57) who have no function of a respiratory center.