Stimulation devices for stimulating nerves

Abstract

The present invention discloses a stimulation device for safely stimulating first and second nerves in a human or animal body to activate target cells in the human or animal body, the stimulation device comprising: a first coil unit configured to be placed on the human or animal body to stimulate the first nerve; a second coil unit configured to be placed on the human or animal body to stimulate the second nerve, the first and second coil units being arranged such that the sum of the electromagnetic fields generated by the first and second coil units respectively is approximately zero, e.g., arranged on or substantially on axis and including windings wound in opposite directions; and a control unit configured to initiate stimulation in accordance with a predefined security policy including conditions for activating or preventing stimulation.

Description

Technical Field

[0001] The present invention relates to a stimulation device for stimulating nerves in a human or animal body using an electromagnetic field, thereby activating target cells in the human or animal body. The present invention also relates to respective methods for stimulating nerves in a human or animal body to activate target cells.

Background Art

[0002] In medicine, it is known that using stimulation by an electromagnetic field to activate target cells of a patient is multi-purpose and beneficial. To achieve such activation of cells in a patient's body, it is known to directly stimulate the cells or indirectly activate the cells through stimulation of specific parts of the nervous system. For example, target cells that are muscle cells can be activated by directly providing an electrical pulse to the muscle cells or to the nerves associated with the muscle cells.

[0003] In a hospital's critical care unit, it may be desirable to activate the diaphragm of a patient who is being mechanically ventilated to prevent the disadvantages of diaphragm disuse. It has been shown that disuse atrophy of diaphragm muscle fibers already occurs within the first 18 - 69 hours of mechanical ventilation, and the cross-sectional area of the muscle fibers decreases by more than 50% during this time. Therefore, it is aimed to repeatedly activate the diaphragm while the patient is given artificial or mechanical ventilation such that the function of the diaphragm can be maintained, or to activate the diaphragm during at least the weaning period to support an effective recovery of independent respiratory function.

[0004] U.S. Patent Application Publication No. 2016 / 0310730 (A1) describes a device for reducing diaphragmatic disuse in ventilation induction in patients receiving ventilation support from a ventilator. The device includes first and second types of electrode arrays and comprises a plurality of electrodes configured to stimulate the patient's phrenic nerve. At least one controller identifies the type of electrode array and generates a stimulation signal for stimulating the patient's phrenic nerve based on the identification of the electrode type.

[0005] DE 10 2007 013531 A1 describes a magnet coil configuration having at least two juxtaposed and primarily mirror-symmetric coil areas. The at least two coil areas are formed in a dispersed manner to create a dispersed field so that the electric field with the highest intensity is located near the ends of the magnet coil configuration.

[0006] However, when two target nerves inside the body, such as two phrenic nerves, are to be stimulated, the two coils are not only to be located close to each other but also to be operated simultaneously. The coil winding systems in today's stimulators used for electromagnetic stimulation have significant limitations.

[0007] Furthermore, the electromagnetic field generated by the coil winding system can adversely affect the functionality of other nearby medical devices. In the worst-case scenario, these medical devices may cease to function properly, which must be prevented at all costs.

[0008] Therefore, there is a need for non-invasive stimulation devices and respiratory support devices that avoid or minimize the effects generated by electrical or electromagnetic stimulation from other nearby medical devices. Further needs may include efficient stimulation of two nerves, overcoming spatial constraints, avoiding side effects on cells near the nerves, easy application in the body, and convenient and virtually painless application for the patient. [Overview of the project]

[0009] According to the present invention, this need is solved by a stimulating device as defined by the features of independent claim 1 and by a method as defined by the features of independent claim 33. Preferred embodiments are subject to the dependent claims.

[0010] In one embodiment, the present invention is a stimulation device for stimulating a first nerve and a second nerve in the body of a human or animal to activate a target cell in the body of a human or animal. The stimulation device includes a first coil unit, a second coil unit which is usually different from and detachable from the first coil unit, and a safety device.

[0011] A first coil unit is configured to be placed on the body of a human or animal to stimulate a first nerve by applying a first electric or electromagnetic field. A second coil unit is configured to be placed on the body of a human or animal to stimulate a second nerve by applying a second electric or electromagnetic field. Thereafter, the first coil unit can generate a first field independent of the second coil unit that generates the second field. By providing two independent fields, the first nerve and the second nerve can be stimulated individually by the first and second fields, respectively. In other words, the first and second fields are independent of and / or distinct from each other. Depending on the circumstances in a particular application, the first and second fields may further interact with each other, but are independent and distinct from each other. For example, when a stimulating device is operated such that a region is generated in which both the first and second fields are present, at least a portion of the first and second fields may overlap. Nevertheless, even in such a situation, the first and second fields are still independent and distinct from each other.

[0012] Efficient coordinated stimulation of first and second nerves can be achieved by having first and second coil units configured to generate first and second fields. For example, to promote respiration, the first coil unit may be positioned in the patient's neck to stimulate the patient's first phrenic nerve, and the second coil unit may be positioned to stimulate the patient's second phrenic nerve.

[0013] Furthermore, the safety device is configured to ensure compliance with the security policy during the stimulation of the first and second nerves using the first and second coil units. In this context, the term “configured” may refer to any appropriate physical, logical, or functional configuration of the safety device. For example, the safety device may have a processing unit adapted or programmed to perform an assessment of a given situation and draw conclusions regarding the assurance of compliance. In addition or by alternative means, the safety device may include means such as sensors for collecting data related to a given situation.

[0014] A stimulation device is proposed for stimulating first and second nerves in a human or animal body to activate target cells in the human or animal body, comprising, in a variant, a first coil unit configured to be placed in the human or animal body to stimulate a first nerve by applying a first electric or electromagnetic field, and a second coil unit configured to be placed in the human or animal body to stimulate a second nerve by applying a second electric or electromagnetic field, and configured to cancel the magnetic or electromagnetic field in a region offset from the first and second nerves when the first and second fields are applied.

[0015] In this specification, the term “place” and its derivatives usually relate to the location and orientation of an element or component. When an element or component is placed in such a way that it can do something, it is advantageously positioned and oriented to achieve its respective function. For example, first and second coil units placed to stimulate the phrenic nerve may relate to first and second coil units positioned and oriented such that the phrenic nerve is within the electric or electromagnetic field generated by each coil unit.

[0016] In this specification, the term “security policy” relates to at least one, advantageously more, constraints or conditions to be achieved. Specifically, constraints or conditions may be predefined. Constraints or conditions may depend on the specific application of the device. For example, when a stimulating device is used in a coronary care unit (CCU) or in other medical rooms such as an operating room, as described below, the constraints predefined in the security policy may be to minimize or eliminate interference by the stimulating device with other equipment placed in the same room.

[0017] The term "compliance" and its derivatives, as used in relation to security policies, may refer to meeting or fulfilling predefined constraints or conditions in a security policy.

[0018] The coil unit may consist of at least two coils or at least one conical, curved, or bulging coil, or at least one cylindrical or non-flat coil, or at least one small coil, i.e., a coil small enough to generate a sharp electromagnetic field, such as a coil having a diameter of 3 cm or less, or including such a coil. 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 creator.

[0019] The first and second fields can specifically be target shapes. Target shapes can be achieved by locally inhibiting each field, or by having, for example, a peak in the target electric or electromagnetic field. This can be achieved, for example, by a peak within each field (focal area), and can be configured to activate in the target area, which is a nerve or cellular area (e.g., the phrenic nerve) that is to be activated in each field. Target shapes can generally be any shape of each field or time-dependent field component that allows for effective stimulation of one or more target nerves while minimizing other undesirable co-stimulatory effects on surrounding, superior, or immediate cells or nerves. A peak shape is one example, as it maximizes the effect within the focal area and minimizes the effect outside of this area.

[0020] In an advantageous embodiment, the stimulating device is configured to activate the diaphragm of a human or animal. Thus, the two nerves, one in a human and one in an animal, may specifically be the phrenic nerve, and the coil unit may be designed to be positioned in the neck of the human or animal to stimulate the phrenic nerve located in the neck.

[0021] By having a safety device, the stimulation device of the present invention can ensure that the security policy is complied with. Specifically, it can be achieved that the security policy is satisfied while the stimulation device is in operation. In this way, the security during operation of the stimulation device can be increased or ensured. This makes it possible for the stimulation device to be specifically suitable for medical applications such as diaphragmatic activation by stimulating the phrenic nerve in an equally sensitive location such as the neck. The stimulation device according to the present invention can also automatically take action if compliance cannot be ensured. For example, if the security policy is not complied with, the stimulation device can block the stimulation or provide a signal such as a visual and / or acoustic signal.

[0022] Advantageously, the stimulating device is configured to generate first and second fields in pulses, or more specifically, in a single pulse, a matrix of pulses, or a combination thereof. Thereafter, the term “single pulse” may relate to the generation of a first or second field that is equally short in duration and has equally long interruptions between two subsequent pulses. Typically, a single pulse is provided at a frequency of less than 10 hertz (Hz), for example, 5 Hz or less, or a single pulse is initiated by the user or practitioner. A single pulse can have a temporal width of about 10 microseconds (μs) to about 300 μs. Such pulses can activate nerve and muscle structures and are identifiable by the patient or by a sensor. Specifically, such a single pulse may cause a single spasm of a muscle or muscle structure. The term “matrix of pulses” may relate to the sequential generation of a first or second field, or the generation of a series of pulses of a first or second field that are equally rapid and follow each other. Such pulses may be provided in a frequency range of about 15 Hz to about 30 Hz. Specifically, the matrix can achieve the activation of nerves or muscles so that tetanus or activation is induced. Advantageously, the matrix is ​​provided by increasing the intensity (field strength) and / or frequency (ramp protocol) until the target intensity and frequency are achieved. In this way, sudden convulsions or unpleasant symptoms can be reduced. All of these parameters are summarized under the terms “temporal characteristics” or “temporal parameters” of the first and second fields. These temporal parameters can be manually adjusted via the input contact surface or automatically controlled by an adjustment mechanism or control unit.

[0023] The parameters of the voltage or current waveforms applied to generate the first and / or second fields may affect the temporal characteristics of each field, including pulse shape, amplitude, width, polarity, and repetition frequency, the duration of the burst or pulse matrix and the intervals between them, the total number of pulses, the intervals between stimulation sessions, and the total number of sessions, the total number of sessions in particular affecting the field strength and determining whether a target area or target cell can be activated, or at what intensity or “dosage” it can be activated.

[0024] The temporal characteristics and spatial distribution of the first and / or second field can be adjusted in such a way that a desired activation of the muscle structure (activation feedback) is achieved. Thus, the activation feedback (signal) may refer to a signal that exhibits appropriate characteristics of muscle structure activation, such as a signal reaching or exceeding a target value (threshold), a signal exhibiting a particular curve pattern or shape, a signal executing a particular algorithm known to represent appropriate target muscle structure activation at a desired intensity, or any combination thereof. Specifically, the activation feedback (signal) may include feedback regarding a desired muscle activation intensity that is to be achieved before the adjustment mechanism ceases to fluctuate. Appropriate activation feedback signal characteristics can be defined by the user via an input contact surface or detected by an algorithm.

[0025] The parameters of the voltage or current waveform applied to the coil by the generator affect the temporal characteristics of the first and / or second field, including pulse shape, amplitude, width, polarity, and repetition frequency, the duration of the burst or pulse matrix and the intervals between them, the total number of pulses, and the intervals between stimulation sessions. The total number of sessions, in particular, affects the field intensity, determining whether a target area or target cell can be activated, or at what intensity or "dosage" it can be activated.

[0026] Preferably, the security policy includes canceling an electric field or an electromagnetic field in an area displaced from the first and second nerves when the first and second coil units are applying the first and second fields. The term "displaced from the first and second nerves" relates to any field or portion of a field that is not necessary for the stimulation of the first and second nerves. It can specifically include the far fields generated by the first and second coil units.

[0027] Thus, canceling the field can include essentially reducing or eliminating the field. More specifically, canceling the field can include reducing the field such that interference with other devices or apparatuses can be eliminated. Also, the complete field that is not necessary for stimulation can be canceled, or only that portion thereof that can cause interference can be canceled.

[0028] By implementing such a security policy, the stimulation device may be suitable for use or application near other devices or components that may be susceptible to interference by an electric field or an electromagnetic field. Thus, the stimulation device may be particularly suitable for medical applications, such as in a coronary care unit.

[0029] Preferably, the safety device comprises a support or bracket structure that positions the first and second coil units substantially axially, where the first coil unit comprises a first winding and the second coil unit comprises a second winding, and in an axial view, in the axial view of the first or second winding, the stimulation current flows in opposite directions through the first and second windings. In other words, the direction of the stimulation current is opposite to the second direction when viewed from a distinct point in space. Specifically, the stimulation current flows clockwise in the first winding and counterclockwise in the second winding, or vice versa. In this context, the term "axial view" relates to the view or perspective along the axis along which the first and second coil units are arranged using the bracket structure. Such an arrangement enables the first and second fields to be efficiently canceled so that the side effects of the generation of the first and second fields can be reduced or limited.

[0030] The different directions of the current flow are achieved by the first winding being wound in a first direction and the second winding being wound in a second direction, where the first direction is opposite to the second direction. In other words, the first direction may be clockwise and the second direction counterclockwise, or vice versa.

[0031] The first and second coil units are preferably adjustable with respect to the support structure such that the angle between the axis of the first coil unit and the axis of the second coil unit is 30° or less, or 20° or less, or 10° or less.

[0032] The axis of the coil unit can specifically be the axis around which each winding is wound. Thus, the axis can be the central axis of the first and second coil units.

[0033] As the distance from the source increases, the strength of the electric and magnetic fields decreases. Typically, the far field relates to electric and / or magnetic fields at a distance to the coil that is greater than approximately 10 times the dimensions of the coil. In comparison, the near field relates to the electromagnetic field closer to the coil. In this invention, the far field represents the electromagnetic field that may negatively interfere with the arrangement of other medical devices around the stimulating device, while the near field relates to the electromagnetic field that is effectively used for nerve stimulation. Therefore, the electromagnetic field in the far field should be kept as small as possible to avoid affecting other medical devices during stimulation. In this invention, the near field can be at a distance of 0.1 cm, 0.5 cm, or 4 cm or less from the coil, while the far field can be at a distance of 30 cm or 45 cm from the coil.

[0034] By fixing or setting the possible orientations of the first and second coil units relative to each other, it is possible to eliminate potentially interfering fields. More specifically, the electric or electromagnetic fields generated by the first and second coil units, respectively, can be offset from the first and second fields and compensate for each other. The total electric or electromagnetic field, i.e., the sum or aggregate of the first and second electric or electromagnetic fields, can be reduced or minimized, thereby avoiding interference with surrounding devices.

[0035] Preferably, the first and second coil units are arranged such that the sum of the first and second fields generated by the first and second coil units is approximately zero at the central axis point between the first and second coil units, or at a distance greater than 30 cm or 45 cm from the first or second coil unit, i.e., in the so-called far-field. This is specifically advantageous for reducing or avoiding the influence of electric or electromagnetic fields from other medical devices around the stimulating device. The sum of the first and second fields may still be effective at a distance of 0.1 to 4 cm, i.e., the near-field. In other words, each of the first and second fields is still effective for stimulation. This is specifically advantageous for reducing or avoiding the influence of electromagnetic fields from other medical devices around the stimulating device.

[0036] Advantageously, the distance between the first and second coil units is defined for compensation or cancellation. The distance may vary when using the stimulation device for different patients. Preferably, the first and second coil units are placed close to the two nerves, and the distance between them depends on the patient's body. The total electric or electromagnetic field may also depend on the strength of the stimulation current and the physical attributes of the coil units. In an ideal case, the two fields can perfectly complement each other. In other words, the sum of the electric or electromagnetic fields generated by the first and second coil units may be approximately zero in the respects described above.

[0037] Preferably, the safety device comprises a control unit, which may be or comprise any suitable computer or computing device suitable for controlling the stimulation device. Specifically, the control unit may be implemented by a specific or general-purpose computing device. Alternatively, the control unit may be implemented in a computing device or structure included in another device, such as a ventilation device or similar.

[0038] The computer or computing device implementing the control unit may include a processor, volatile and / or permanent memory, data storage, communication contacts, user contacts, or similar components. These are typically programmable or configurable.

[0039] The control unit may be configured to initiate stimulation according to a security policy which may include constraints or conditions for activating or deactivating the stimulation. If at least one of the conditions or constraints defined in the security policy is not met, the stimulation may be deactivated or not activated at all. In other words, the control unit can prevent the stimulation from being activated when security requirements are not met. Thus, the first and second fields are not generated by the coil unit, and thereby adverse effects on other medical devices placed near the stimulation device can be avoided.

[0040] The control unit of the safety device is preferably configured to detect violations of the security policy and to prevent the activation of the first and second coil units when a violation is detected. A violation may be given when any constraint or condition of the security policy is not met.

[0041] For example, if a security policy defines that the first and second coil units must be in specific relative positions, the safety device may be configured to verify the current relative positions of the first and second coil units, so that the control unit prevents the activation of the first and second coil units if the current relative positions do not conform to the specific relative positions. The specific relative positions may also include a range of relative positions in which the first and second coil units must be positioned.

[0042] The control unit is preferably configured to activate the first and second coil units when the security policy is met. Such embodiments enable efficient operation of the stimulation device only when it complies with the security policy.

[0043] Preferably, the stimulation configuration is configured to activate the first and second coil units by supplying a stimulation current to the first and second coil units. Such activation of the first and second coil units enables the stimulation device to operate efficiently. Specifically, such activation can be precisely performed by a control unit.

[0044] Preferably, the safety device includes a sensor unit configured to determine the positions of the first and second coil units relative to each other. The position information determined by the sensor unit can be used for calculating the total electromagnetic field. In other words, the total electromagnetic field can be estimated using the position and orientation information without activating the stimulus. In this embodiment, the security policy can define one of the conditions that must be met for the activation of the stimulus, namely, the relative position and orientation must be within a certain range. The range may vary in the application of the stimulus device and the physical properties of the stimulus device. For example, for a particular stimulus device, the range of relative orientation may be ±15° or 90°±15°. In any case, the range can be predefined or calculated for a particular stimulus device in a particular application. The evaluation of the determined position may be implemented specifically in the control unit.

[0045] Therefore, the security policy preferably includes ensuring that relative positions are within a predetermined range. In this way, it can be ensured that coil units are activated only when they are properly positioned. For example, a sensor unit can determine whether the coil units are oriented at least somewhat axially relative to each other at a predetermined distance. In this way, it can be ensured that the field is canceled when not needed.

[0046] The sensor unit may include any sensor suitable for determining the positions of the first and second coil units. For example, the sensor unit may include a gyroscope. Such a gyroscope allows for the measurement of angular velocity in an equally fast manner. Thus, absolute angle measurement is not normally possible with a gyroscope, but angular changes can be efficiently detected, for example, using integration. Furthermore, gyroscopes are available at an equally low cost and in an equally small dimension.

[0047] Alternatively or in addition, the sensor unit may include an accelerometer. Such an accelerometer or three-axis accelerometer allows for equally accurate angle measurements and specifically absolute angle measurements, so that conclusions can be drawn regarding the position of the coil unit. Furthermore, accelerometers are available at equally low cost and in equally small dimensions.

[0048] Alternatively or in addition, the sensor unit may include a magnetometer. Such a magnetometer may enable the measurement of the three-dimensional orientation of the sensor with equal accuracy so that conclusions regarding the orientation of the intervention device can be drawn.

[0049] Alternatively or in addition, the sensor unit may include another inertial sensor and / or global positioning system.

[0050] The sensor unit may also associate two parts with one of the coil units. Furthermore, the sensor unit may include a camera, for example, a stereo camera for determining relative position by observation.

[0051] Preferably, the safety device includes a measuring unit configured to measure a first magnetic flux of a first coil unit and a second magnetic flux of a second coil unit. Measuring such fluxes makes it possible to implement certain security measures. For example, the fluxes may indicate the condition of the coil units. Thus, evaluating the fluxes makes it possible to identify damaged or improper coil units. Therefore, the measuring unit makes it possible to enhance the operational safety of the stimulating device.

[0052] Therefore, the security policy preferably includes preventing the sum of the first and second magnetic fluxes from exceeding a predetermined threshold, for example, a few millitesla. For example, the control unit may be configured to stop or block the activation of the coil unit when the sum of the first and second magnetic flux densities exceeds a predetermined threshold. In this way, an even greater level of safety can be achieved.

[0053] The stimulator is preferably configured to measure first and second magnetic fluxes by measuring the current flowing through first and second coil units. The current flowing through the first and second coil units can be used for measurement. This can be a specific measuring current that is sufficiently small so that the electromagnetic field it generates does not interfere with other medical devices or harm the patient, but is still sufficient for measuring and calculating the total electromagnetic field.

[0054] The stimulating device is preferably configured to measure first and second magnetic fluxes by using a first portion of a plurality of continuous waveforms of a stimulating current, where a safety device is configured to deactivate the stimulation when the sum of the first and second magnetic fluxes exceeds a predetermined threshold. Thereafter, the current for measurement may be an initial portion of the stimulating current that is short but still sufficient for measurement. The measurement may be performed during the startup process of the stimulating device, which should be short, for example, a few milliseconds to several hundred milliseconds. After the measurement results indicate that the total magnetic flux density exceeds the predetermined threshold, the stimulation may be stopped at the startup stage, i.e., the stimulation will not be activated.

[0055] Preferably, the safety device includes a monitoring unit configured to detect faults in the first coil unit and / or the second coil unit. Faults may be defective coil windings or shorts between turns or to ground. In addition, an incorrect value of inductance can be a fault. For example, very low inductance can lead to high current, thereby damaging the stimulation device and the patient. Depending on the application, the inductance should have a threshold below which it cannot be lowered; for example, the minimum inductance should not be below 10% of the specified or default valve.

[0056] Therefore, the security policy preferably includes the monitoring unit not detecting a failure in the first coil unit and / or the second coil unit. In this embodiment, the condition defined in the security policy may also be that the first and second coil units are operating normally.

[0057] Preferably, the stimulating device includes a connector configured to be electrically connected in series with first and second coil units. The electrical series connection of the first and second coil units can facilitate the simple activation and control of simultaneous stimulation of two nerves. In conventional methods, the two coils are controlled individually, thereby requiring the simultaneous activation of both coils, which can be difficult in the same use case. In comparison, by connecting the first and second coil units in series, stimulation of the two nerves is activated simultaneously, thereby eliminating the need for additional means to control the simultaneous activation of the stimulation.

[0058] Time-synchronized stimulation of both nerves is advantageous for enabling time-synchronized activation of both nerves and the resulting balanced contraction of both diaphragmatic hemispheres. Time-synchronized stimulation of both nerves is even more advantageous for minimizing the electromagnetic far-field, which is only possible when currents in both coils are induced precisely simultaneously in time and when the induced time-varying magnetic fields, at their peak values ​​at exactly the same time, are opposite each other in direction or nearly opposite within + / - 20°.

[0059] Preferably, the connector has an electrical conduction that directly connects the first and second coil units. The electrical conduction can be carried out by any conductive structure, such as a metal wire or the like. Such an electrical conduction allows for efficient connection of the first and second coil units in series.

[0060] Preferably, the first and second coil units can be placed individually on the body of a human or animal. The term “can be placed individually” refers to the placement of the coils individually on the body. Thus, the coil units are generally not placed in one single location on the body, but in two separate locations. However, while the coil units can be placed individually, they can also be fixed to each other. Alternatively, the coil units may be movable relative to each other, at least to some extent.

[0061] The stimulation device may include a holder structure for holding the coil units. Specifically, the holder structure may have a bracket, column, or similar element to which the coil units are fixedly or displaceably mounted. The holder may mechanically connect the first and second coil units to each other. Another direct mechanical connection between the first and second coil units may be prevented, which may prevent or limit the relative positioning of the first and second coil units. Thereafter, the first and second coil units may be placed individually on the body of a human or animal.

[0062] Preferably, the stimulation is configured such that each of the first and second coil units generates a biphasic impulse.

[0063] Furthermore, the stimulation device is preferably configured to generate time-varying currents in the first and second coil units simultaneously over time.

[0064] Preferably, the stimulation device comprises a stimulation device configured to induce an electric current in a coil unit.

[0065] Preferably, the stimulation device is configured such that the induced current in the first coil is the same as the induced current in the second coil. For example, this can be implemented by arranging the first and second coil units electrically in series.

[0066] Preferably, the stimulation device is configured to induce an impulse generated by a single current.

[0067] Preferably, the safety device comprises a first temperature sensing array and a second temperature sensing array, the first coil unit comprises the first temperature sensing array, and the second coil unit comprises the second temperature sensing array. Such temperature sensing arrays enable the determination of the temperatures of the first and second coil units. This may be related to security when operating the device.

[0068] The term “temperature-sensing configuration” relates to any structure and / or configuration that enables temperature sensing. A “temperature-sensing configuration” may be a multipart structure or a single element.

[0069] Therefore, preferably, the first temperature sensing configuration comprises a first temperature sensor and a second temperature sensor, and the second temperature sensing configuration comprises a first temperature sensor and a second temperature sensor. All temperature sensors are advantageously capable of operating at the same voltage. Furthermore, all temperature sensors are advantageously capable of having two outputs for transferring the sensed temperature to the other component. Providing two temperature sensors in each coil unit makes it possible to achieve a high level of security mechanism.

[0070] The security policy preferably includes ensuring that the current consumption of the first temperature sensor of the first temperature sensing unit, the current consumption of the second temperature sensor of the first temperature sensing unit, the current consumption of the first temperature sensor of the second temperature sensing unit, and the current consumption of the second temperature sensor of the second temperature sensing unit are within a predetermined threshold range for current consumption. Such a configuration allows for efficient security checks of the operation of the first and second coil units. Such predetermined threshold ranges for current consumption may be, for example, within 80% and 120% of the nominal values.

[0071] The security policy preferably includes ensuring that the temperature measured by the first and second temperature sensing systems is below a predetermined threshold temperature, for example, 41°C. Such a configuration makes it possible to prevent overheating of the coil unit, which could indicate improper operation of the device.

[0072] Preferably, the safety device includes a counter member configured to count the number of pulses induced by the first and second coil units. The counter member may include a splitter or a plug. The counter member can store or determine the number of pulses of the first and second fields provided to the patient. The counter member can be used to ensure that the patient is not continuously induced to inhale.

[0073] Therefore, the security policy preferably includes ensuring that the counted number of pulses per instance is less than a predetermined threshold number of pulses.

[0074] Preferably, a button is provided, configured to, when activated, operate a first coil unit to induce a pulse of a first field and a second coil unit to induce a pulse of a second field. The button is advantageously given two members or touch feelers, both of which must be pressed or touched in order to activate the button.

[0075] The aforementioned conditions for activating the stimulation device may be expanded and / or modified as necessary. For example, if there are no nearby medical devices affected by electromagnetic fields, the default threshold for total magnetic flux density may be increased, or this condition may be removed or disabled from the security policy. When the stimulation device is used in a different environment with medical devices affected by electromagnetic fields, this condition may be added or enabled again. Other conditions, such as the maximum, minimum, or duration of stimulation intensity, may also be added as necessary. For example, if the stimulation device is intended for use with patients whose physical composition should not be stressed with stimulation exceeding a certain intensity. In this case, the stimulation device will check the current configuration and compare it to the maximum intensity before activating the stimulation.

[0076] In another aspect, the present invention is a method for stimulating first and second nerves in the body of a human or animal to activate target cells in the body of a human or animal. The method comprises the steps of: stimulating a first nerve by placing a first coil unit on a first nerve in the body of a human or animal and applying a first electric or electromagnetic field; placing a second coil unit on a second nerve in the body of a human or animal by applying a second electric or electromagnetic field; and ensuring compliance with a security policy during the stimulation of the first and second nerves using the first and second coil units.

[0077] The method according to the present invention and preferred embodiments thereof described later enable the achievement of the effects and benefits described above in relation to the stimulating device according to the present invention and preferred embodiments thereof.

[0078] Preferably, the method includes the step of adjusting the positions of the first and second coil units.

[0079] Preferably, the method includes the step of adjusting the stimulation current supplied to the first and second coil units.

[0080] Preferably, the security policy includes canceling electric or electromagnetic fields in regions offset from the first and second nerves when the first and second coil units are applying the first and second fields.

[0081] Preferably, the method includes the step of arranging the first and second coil units substantially axially, so that the first coil unit comprises a first winding wound in a first direction and the second coil unit comprises a second winding wound in a second direction, the first direction being opposite to the second direction.

[0082] Therefore, the angle between the axis of the first coil unit and the axis of the second coil unit is preferably 10° or less, or 5° or less.

[0083] Preferably, the first and second coil units are arranged such that the sum of the first and second fields generated by the first and second coil units is approximately zero.

[0084] Preferably, the method includes the steps of detecting a security policy violation and preventing the activation of the first and second coil units when a violation is detected.

[0085] Preferably, the method includes the step of activating the first and second coil units when the security policy is met.

[0086] Preferably, the method includes the step of activating the first and second coils by supplying a stimulating current to the first and second coil units.

[0087] Preferably, the method includes the step of determining the positions of the first coil unit and the second coil unit relative to each other.

[0088] Therefore, the security policy preferably includes the condition that the relative position is within a predetermined range.

[0089] Preferably, the method includes the step of measuring a first magnetic flux of a first coil unit and a second magnetic flux of a second coil unit.

[0090] The security policy preferably includes preventing the sum of the first and second magnetic fluxes from exceeding a predetermined threshold.

[0091] The first and second magnetic fluxes are preferably measured by measuring the currents flowing through the first and second coil units.

[0092] The method preferably includes the steps of measuring first and second magnetic fluxes by using a first portion of a plurality of continuous waveforms of a stimulating current, and deactivating the stimulus when the sum of the first and second magnetic fluxes exceeds a predetermined threshold.

[0093] Preferably, the method includes the step of detecting a fault in the first coil unit and / or the second coil unit.

[0094] Therefore, the security policy preferably includes not detecting failures in the first coil unit and / or the second coil unit.

[0095] Preferably, the first and second coil units are connected in series.

[0096] Preferably, the method includes the step of placing the first and second coil units separately on the body of a human or animal.

[0097] Preferably, the method includes the step of sensing the temperature of a first coil unit and the temperature of a second coil unit.

[0098] Therefore, the security policy preferably includes the condition that the detected temperature is below a predetermined threshold temperature.

[0099] Preferably, the method includes the steps of providing a first temperature sensor and a second temperature sensor to a first coil unit, and providing a first temperature sensor and a second temperature sensor to a second coil unit.

[0100] Therefore, the security policy preferably includes ensuring that the current consumption of the first temperature sensor of the first temperature sensing system, the current consumption of the second temperature sensor of the first temperature sensing system, the current consumption of the first temperature sensor of the second temperature sensing system, and the current consumption of the second temperature sensor of the second temperature sensing system are within a predetermined threshold range for current consumption.

[0101] Preferably, the method includes the steps of counting the number of pulses induced by a first coil unit per cycle and counting the number of pulses induced by a second coil unit per cycle.

[0102] Therefore, the security policy preferably includes ensuring that the counted number of pulses per instance is less than a predetermined threshold number of pulses.

[0103] Preferably, the method includes the steps of manually operating a first coil unit to induce a pulse of a first field and manually operating a second coil unit to induce a pulse of a second field.

[0104] Preferably, the aforementioned stimulation device is used in this method.

[0105] In yet another embodiment, the present invention relates to a respiratory facilitator or ventilation machine for coordinating stimulation of two phrenic nerves in a patient to activate the patient's diaphragm. The respiratory facilitator comprises the stimulation device described above.

[0106] The stimulation device and method according to the present invention will be described in more detail below using exemplary embodiments and with reference to the accompanying drawings. [Brief explanation of the drawing]

[0107] [Figure 1] A schematic diagram of the stimulation device according to the present invention is shown. [Figure 2a] A schematic diagram of the electrical connectivity of the stimulation device according to the present invention is shown. [Figure 2b] A schematic diagram of the stimulation device according to the present invention, positioned in the patient's neck, is shown. [Figure 2c] Another schematic diagram of the electrical connectivity of the stimulation device according to the present invention is shown. [Figure 3a] A schematic top view is shown of first and second coil units placed in the patient's neck, in which the coil windings are arranged on the body surface with their cylindrical outer circumference. [Figure 3b] A schematic top view is shown of first and second coil units placed in the patient's neck, with the coil windings positioned on the body surface with their outermost windings facing the body surface. [Figure 4a]A schematic diagram of the arrangement of the first and second coil windings in the patient's neck is shown. [Figure 4b] A schematic diagram of the arrangement of the first and second coil windings in the patient's nerve is shown. [Figure 5] A schematic diagram is shown of the arrangement of the first and second coil units having a favorable direction of electromagnetic fields that is advantageous for canceling them out. [Figure 6] A schematic diagram of a respiratory support device equipped with a stimulation device according to the present invention is shown. [Figure 7] A schematic flowchart illustrating the operation of the stimulation device according to the present invention is shown. [Modes for carrying out the invention]

[0108] In the following description, certain terms are used for convenience and do not limit the invention. The terms “right,” “left,” “up,” “down,” “below,” and “upwards” refer to directions in the figures. Technical terms include those explicitly stated, as well as their derivatives and terms with similar meanings. Additionally, spatial terms, such as “below,” “down,” “low,” “up,” “upwards,” “proximal,” “terminal,” and similar terms, may be used to describe the relationship of one element or feature to another element or feature as shown in the figures. These spatial terms encompass different positions and orientations of the device in use or operation, in addition to the positions and orientations shown in the figures. For example, if the device in the figure is turned upside down, an element described as “below” or “below” another element or feature will then become “up” or “upwards” the other element or feature. Thus, the exemplary term “down” may encompass both up and down positions and orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial descriptors used herein will be interpreted accordingly. Similarly, descriptions of movement along and around various axes include various special device positions and orientations.

[0109] To avoid repetition in the figures and descriptions of various aspects and exemplary embodiments, please understand that many features are common to many aspects and embodiments. The omission of an aspect from the description or figures does not imply that the aspect is missing from the embodiments that incorporate that aspect. Rather, aspects may be omitted for clarity and to avoid redundant descriptions. In this regard, the following applies to the remainder of this description: For clarity in the drawings, if a drawing contains reference numerals not described in the directly relevant part of the description, it will be referred to the preceding or following part of the description. Furthermore, for clarity, if not all features of a part are given reference numerals in a drawing, it will be referred to another drawing showing the same part. Similar numbers in multiple figures represent the same or similar elements.

[0110] Figure 1 shows an exemplary embodiment of a stimulation device 1 for synergistically stimulating the phrenic nerve in the neck of a human patient, thereby activating the patient's diaphragm as a target cell. The stimulation device 1 comprises a connector having a first coil unit 10, a second coil unit 20, and a metal wire 15 as an electrical conductor. The wire 15 directly connects the first and second coil units 10, 20 so that they are electrically connected in series.

[0111] As shown in Figure 2a, the first coil unit 10 comprises a first coil winding 11 for generating a first electromagnetic field for stimulating a first phrenic nerve of the phrenic nerve. The second coil unit 20 comprises a second coil winding 21 for generating a second electromagnetic field for stimulating a second phrenic nerve of the phrenic nerve. The first and second coil units 10, 20 each have a housing in which the first and second coil windings 11, 21 are arranged, i.e., enclosed. To increase the enhancement of the electromagnetic field, each of the first and second coil units 10, 20 may also be provided with a plurality of coil windings 11, 21.

[0112] As shown in Figure 1, so that the stimulation device 1 can be used on bodies of different sizes or shapes, the first coil unit 10 and the second coil unit 20 can be positioned individually on the body or neck. Specifically, for this purpose, the stimulation device 1 has a bracket structure 30 as a support structure or holder that mechanically connects the first coil unit 10 and the second coil unit 20. As shown in Figure 1, the first coil unit 10 and the second coil unit 20 are mechanically connected to each other only via the bracket structure 30. More specifically, the bracket structure 30 comprises two arms connected to one of their longitudinal ends via a connecting member. The angle between the arms is adjustable in the connecting member. At the longitudinal ends opposite the connecting member, the first and second coil units 10 and 20 are swivelably mounted on the arms of the bracket structure 30. This facilitates the individual positioning of the coil units 10 and 20 on the human body, particularly in the human neck.

[0113] Figure 2a schematically shows the electrical circuit of the stimulation device 1, where the first and second coil windings 11 and 21 are connected in series via a connector wire 15. The series connection further includes a power supply 51 of a control unit 50 which is connected in series to the coil windings 11 and 21 via an additional connector wire 40. As previously mentioned, the first and second coil windings 11 and 21 are directly connected via a wire 15, which is also part of the series connection. The wire 15 is located within a bracket 30.

[0114] Figure 2c schematically shows an alternative electrical circuit for the stimulation device 1, in which the first and second coil windings 11 and 21 are connected in series via a splitter 70. Specifically, the first coil winding 11 is connected to the splitter using a first electrical cable 41 having forward electrical conductivity 411 and rear electrical conductivity 412. Similarly, the second coil winding 21 is connected to the splitter 70 using a second electrical cable 42 having forward electrical conductivity 421 and rear electrical conductivity 422.

[0115] Figure 2b schematically shows a stimulating device 1 positioned on the phrenic nerve. Specifically, the first coil unit 10 generates a first electromagnetic field B1 for stimulating the first phrenic nerve, and the second coil unit 20 generates a second electromagnetic field B2 for stimulating the second phrenic nerve. As shown in the figure, the first and second coil units 10 and 20 are connected in series via a wire 15. The first and second coil units are positioned substantially axially with respect to each other, taking into account the axes of the first coil winding 11 and the second coil winding 21. Furthermore, the stimulating current flows through the coil windings in opposite directions (not shown). Thus, the electromagnetic field B1 generated by the first coil unit 10 has an opposite direction to the electromagnetic field B2 generated by the second coil unit. In an ideal case, the electromagnetic fields B1 and B2 can cancel each other out at a distance of 30 cm or 45 cm or more, thereby avoiding interference with other medical devices. At the same time, electromagnetic fields B1 and B2 are still effective for stimulation, i.e., in the patient's nerves close to coil units 10 and 20, for example, 0.1 cm, 0.5 cm, or 4 cm or less.

[0116] Furthermore, the first coil unit 10 comprises a first double temperature sensor 13 of the first temperature sensing configuration and a first pressing member 14 of the button. The second coil unit 20 comprises a second double temperature sensor 23 of the second temperature sensing configuration and a second pressing member 24 of the button. The security policy of the stimulating device includes the current consumption of the first temperature sensor 13 and the second temperature sensor 23. Furthermore, the security policy includes that the temperature measured by the first temperature sensor 13 and the second temperature sensor 23 is below a predetermined threshold temperature. Simultaneously, pressing the first and second pressing members 14, 24 activates the button so that the first and second coil units 10, 20 provide pulses.

[0117] Figure 3a shows an exemplary arrangement of the coil unit, where the first and second coil windings 11, 21 are placed on the skin on both sides of the patient's neck near the patient's phrenic nerves 61, 62. In other words, each of the coil windings 11, 21 is placed between the anterior edge of the right sternocleidomastoid muscle 61 and the larynx 63. The optimal position may vary depending on the changing physiological functions of different patients and the different treatments provided for them. In this example, the first and second coil windings 11, 21 are placed on the cervical surface with their cylindrical outer circumferences, i.e., the axes of the coil windings are parallel to the neck. In other words, the coil windings 11, 21 are substantially aligned axially. When the coil windings 11 and 21 are also wound axially in opposite directions, the electromagnetic fields generated by the first and second coil windings 11 and 21 can compensate for each other; that is, the sum of the first and second electromagnetic fields decreases, i.e., the value of the combined electromagnetic field is smaller than that of the first or second electromagnetic field. In an ideal case, i.e., when the first and second coil windings 11 and 21 are axially symmetric and have a certain distance between them, the first and second electromagnetic fields completely compensate for each other, i.e., the sum of the first and second electromagnetic fields is zero. This is, for example, an anti-Helmholtz coil.

[0118] Figure 3b shows another exemplary arrangement of the coil units 10, 20 of the stimulator 1, where the first and second coil windings 11, 21 are oriented toward nerves 61, 62 and placed on the skin on both sides of the patient's neck. In contrast to the embodiment shown in Figure 3a, the coil windings 11, 21 are positioned with their outermost windings on the surface of the neck. In this example, the axes 11, 21 of the coil windings are more or less perpendicular to the skin of the body and substantially parallel to each other.

[0119] Figure 4a shows an exemplary arrangement of the first coil winding 11 and the second coil winding 12 in the patient's neck 62. For clarity, the first coil unit 10 and the second coil unit 20 are not fully shown. In this embodiment, the stimulating current flows in opposite directions in the first and second coil windings. This can be achieved, for example, by winding the first and second coil windings in opposite directions, as indicated by the two arrows in the drawing. The coil windings 11 and 21 are connected to a control unit 50. The current can be supplied by the control unit 50 to the coil windings to generate an electromagnetic field, thereby stimulating nerves in the patient's neck.

[0120] Figure 4b shows an exemplary arrangement of the first coil winding 11 and the second coil winding 12 in a patient's nerve 62. For simplicity, the first coil unit 10 and the second coil unit 20 are not shown. In this embodiment, the stimulating current flows in opposite directions in the first and second coil windings. This can be achieved, for example, by winding the first and second coil windings in opposite directions, as indicated by the two arrows.

[0121] Figure 5 shows an exemplary arrangement of coil units 10 and 20 of the stimulator 1, where the first and second coil units are arranged substantially axially with respect to each other, taking into account the axes of the first coil winding 11 and the second coil winding 21. Furthermore, the stimulatory current flows in opposite directions through the coil windings (not shown). Thus, the electromagnetic field B1 generated by the first coil unit 10 has an opposite direction to the electromagnetic field B2 generated by the second coil unit. In an ideal case, the electromagnetic fields B1 and B2 can cancel each other out at a distance of 30 cm or 45 cm or more, thereby avoiding interference with other medical devices. At the same time, the electromagnetic fields B1 and B2 are still effective for stimulation close to the coil units 10 and 20, for example, 0.1 cm, 0.5 cm, or 4 cm or less, i.e., in the patient's nerves.

[0122] Figure 6 shows a respiratory facilitator including a stimulation device according to the present invention. First and second coil units 10, 20 are placed near the patient's two phrenic nerves. When stimulation is initiated, a control unit 50 supplies an electric current to the coil units, thereby generating an electromagnetic field that stimulates the phrenic nerves. As a result, the patient's diaphragm is activated. The movement of the diaphragm 58 creates compression in the patient's thoracic cavity, which facilitates the flow of air from the breathing tube 55. The control unit 50 can monitor the movement of the diaphragm 58 and adjust the intensity of the stimulation as needed.

[0123] Figure 7 shows an example of a method according to the present invention for operating the aforementioned stimulation device 1. When the power is turned on, the stimulation device 1 is initialized. During the initialization process, the current device parameters and status must be checked by the security policy.

[0124] For example, in order to verify the arrangement of the first and second coil units 10 and 20 against the conditions in the security policy, the relative positions and orientations of the first and second coil units 10 and 20 are measured. If the results are within the range defined in the security policy, stimulation may be initiated.

[0125] Alternatively or in addition, the total magnetic flux of the first and second coil units 10 and 20 is measured. If this value does not exceed a predetermined threshold, the stimulation may be activated. This security measure prevents stimulation from affecting other medical devices located nearby.

[0126] Similarly, coil windings 11 and 21 can also be verified before activation, which can be done by measuring some of the following parameters of the coil windings: inductance, resistance, impedance, and leakage current to the ground wire. Impedance is voltage divided by current. Inductance is the imaginary part of resistance, and resistance is the real part of impedance. The onset of other electrical components can also be verified prior to the activation of the stimulus. This security measure for the stimulation device can be seen as an automated self-check.

[0127] After the control unit 50 confirms that the current setup of the stimulation device complies with the security policy, i.e., that all conditions defined in the policy are met, stimulation may be activated. If one or more specific conditions are not met, stimulation will not be initiated. Instead, the operator may be prompted to adjust the arrangement of the coil units 10, 20, the stimulation current, or any other configuration. After adjustment, the stimulation device may be reinitialized, i.e., the adjusted setup will be verified again against the security policy.

[0128] In addition, each of the first and second coil units 10 and 20 can generate a biphase current. Furthermore, the time-varying currents of the first and second coil units are synchronized in a timely manner. A current can be induced by one stimulator unit, where the induced current in the first coil is the same as the induced current in the second coil, and the induced impulse is generated by a single current.

[0129] This specification and accompanying drawings describing aspects and embodiments of the present invention should not be taken as limiting claims—claims defining a protected invention. In other words, although the present invention is illustrated and described in detail in the drawings and the foregoing description, such illustrations and descriptions should be considered as examples or illustrative, not limiting. Various mechanical, compositional, structural, electrical, and operational modifications can be made without departing from the spirit and scope of this specification and these claims. In some cases, well-known circuits, structures, and techniques are not shown in detail so as not to obscure the present invention. It will be understood that changes and modifications can be made by those skilled in the art within the scope and spirit of the following claims. Specifically, the present invention encompasses further embodiments having any combination of features of the different embodiments described above and below.

[0130] This disclosure also encompasses all further features shown individually in the figures, which may not be described above or below. Furthermore, any single substitute for the embodiments and features described in the figures and specification may be disregarded from the subject matter of the invention or the disclosed subject matter. This disclosure includes subject matter consisting of features defined in the claims or exemplary embodiments, as well as subject matter possessing such features.

[0131] Furthermore, in this claim, the word “including” does not exclude other elements or steps, and the indefinite article “a” or “an” (one, one) does not exclude the plural. A single unit or step may perform the functions of some of the features described in this claim. The mere fact that certain means are enumerated in different dependent claims does not indicate that combinations of these means cannot be used advantageously. The terms “essentially,” “about,” “approximately,” and similar terms relating to attributes or values ​​specifically define strictly those attributes or strictly those values, respectively. The term “about” relating to a given number or range refers, for example, to a value or range within 20%, 10%, 5%, or 2% of a given value or range. Components described as connected or linked may be directly connected electrically or mechanically, or they may be indirectly connected through one or more intermediate components. None of the reference symbols in this claim should be construed as limiting the range.

[0132] A computer program for operating the control unit 50 may be stored / distributed on a suitable medium, such as an optical storage medium or a solid-state medium supplied together with or as part of other hardware, but may also be distributed in other forms, such as via the Internet or other wired or wireless telecommunication systems. Specifically, for example, a computer program may be a computer program product stored on a computer-readable medium, and the computer program product may have computer executable program code made to be executed to implement a particular method, such as the method according to the present invention. Furthermore, a computer program may also be a data structure product or a signal for carrying out a particular method, such as the method according to the present invention.

Claims

1. A stimulator (1) for stimulating a first nerve (62) and a second nerve (62) in the body of a human or animal in order to activate a target cell in the body of the human or animal, A first coil unit (10) configured to be placed on the body of a human or animal in order to stimulate the first nerve (62) by applying a first electric field or electromagnetic field, A second coil unit (20) configured to be placed on the body of a human or animal in order to stimulate the second nerve (62) by applying a second electric or electromagnetic field, A safety device configured to ensure compliance with the security policy during stimulation of the first nerve (62) using the first coil unit (10) and the second nerve (62) using the second coil unit (20), and A stimulator (1) comprising a safety device, the safety device comprising a measuring unit configured to measure the first magnetic flux of the first coil unit (10) and the second magnetic flux of the second coil unit (20).

2. The stimulator (1) according to claim 1, wherein the security policy includes canceling the electric or electromagnetic fields in a region offset from the first and second nerves (62) when the first coil unit (10) and the second coil unit (20) are applying the first and second electric or electromagnetic fields.

3. The stimulation device (1) according to claim 1 or 2, wherein the safety device comprises a support structure (30) that substantially positions the first coil unit (10) and the second coil unit (20) in the axial direction, the first coil unit (10) comprises a first winding (11), the second coil unit (20) comprises a second winding (21), and in an axial view, a stimulation current flows in opposite directions through the first winding (11) and the second winding (21).

4. In an axial view, the first winding (11) is wound in a first direction, the second winding (21) is wound in a second direction, the first direction is opposite to the second direction, and / or The stimulator (1) according to claim 3, wherein the first coil unit (10) and the second coil unit (20) are adjustable with respect to the support structure (30) such that the angle between the axis of the first coil unit (10) and the axis of the second coil unit (20) is 30° or less, or 20° or less, or 10° or less.

5. The stimulator (1) according to any one of claims 1 to 4, wherein the first coil unit (10) and the second coil unit (20) are arranged such that the sum of the first electric field or electromagnetic field and the second electric field or electromagnetic field generated by the first coil unit (10) and the second coil unit (20) is approximately zero at a distance greater than 30 cm or 45 cm.

6. The stimulation device (1) according to any one of claims 1 to 5, wherein the safety device comprises a control unit.

7. The control unit of the safety device is configured to detect a violation of the security policy and to prevent the activation of the first coil unit (10) and the second coil unit (20) when such violation is detected, and / or The stimulator (1) according to claim 6, wherein the control unit is configured to activate the first coil unit (10) and the second coil unit (20) when the security policy is satisfied.

8. A stimulator (1) according to any one of claims 1 to 7, configured to activate the first coil unit (10) and the second coil unit (20) by supplying a stimulating current to the first coil unit (10) and the second coil unit (20).

9. The safety device includes a sensor unit configured to determine the relative positions of the first coil unit (10) and the second coil unit (20), or The stimulator (1) according to any one of claims 1 to 8, wherein the safety device comprises a sensor unit configured to determine the relative positions of the first coil unit (10) and the second coil unit (20), and the security policy includes that the relative positions are within a predetermined range.

10. The security policy includes preventing the sum of the first magnetic flux and the second magnetic flux from exceeding a predetermined threshold, and / or The stimulating device (1) is configured to measure the first and second magnetic fluxes by measuring the current flowing through the first coil unit (10) and the second coil unit (20), and / or The stimulator (1) according to any one of claims 1 to 9, wherein the stimulator (1) is configured to measure the first and second magnetic fluxes by using a first portion of a plurality of continuous waveforms of a stimulator current, and the safety device is configured to deactivate the stimulator when the sum of the first and second magnetic fluxes exceeds a predetermined threshold.

11. The safety device includes a monitoring unit configured to detect a failure in the first coil unit (10) and / or the second coil unit (20), or The stimulator (1) according to any one of claims 1 to 10, wherein the safety device comprises a monitoring unit configured to detect a failure in the first coil unit (10) and / or the second coil unit (20), and the security policy includes the monitoring unit not detecting the failure in the first coil unit (10) and / or the second coil unit (20).

12. A connector configured to be electrically connected in series with the first coil unit (10) and the second coil unit (20), and / or The stimulator (1) according to any one of claims 1 to 11, further comprising a button configured to operate the first coil unit to induce a pulse of the first electric field or electromagnetic field when activated, and to operate the second coil unit to induce a pulse of the second electric field or electromagnetic field.

13. The stimulator (1) according to any one of claims 1 to 12, wherein the first coil unit (10) and the second coil unit (20) can be individually placed on the body of a human or animal.

14. A stimulator (1) according to any one of claims 1 to 13, wherein the first coil unit (10) and the second coil unit (20) are configured to each generate a biphasic impulse.

15. It is configured to generate time-varying currents in the first coil unit (10) and the second coil unit (20) simultaneously in time, and / or The device comprises a stimulator unit configured to induce current in the first coil unit (10) and the second coil unit (20), and / or The second coil unit (20) is configured such that the induced current in the first coil unit (10) is the same, and / or A stimulator (1) according to any one of claims 1 to 14, configured to induce an impulse generated by a single current.

16. The stimulation device (1) according to any one of claims 1 to 15, wherein the safety device comprises a first temperature sensing assembly and a second temperature sensing assembly, the first coil unit (10) comprises the first temperature sensing assembly, and the second coil unit (20) comprises the second temperature sensing assembly.

17. The first temperature sensing system comprises a first temperature sensor and a second temperature sensor, and the second temperature sensing system comprises a first temperature sensor and a second temperature sensor, or The stimulator (1) according to claim 16, wherein the first temperature sensing configuration comprises a first temperature sensor and a second temperature sensor, the second temperature sensing configuration comprises a first temperature sensor and a second temperature sensor, and the security policy includes that the current consumption of the first temperature sensor of the first temperature sensing configuration, the current consumption of the second temperature sensor of the first temperature sensing configuration, the current consumption of the first temperature sensor of the second temperature sensing configuration, and the current consumption of the second temperature sensor of the second temperature sensing configuration are within a predetermined threshold range of current consumption.

18. The stimulator (1) according to claim 16 or 17, wherein the security policy includes that the temperature measured by the first temperature sensing array and the second temperature sensing array is below a predetermined threshold temperature.

19. The safety device includes a counter member configured to count the number of pulses induced by the first coil unit (10) and the second coil unit (20), or The stimulator (1) according to any one of claims 1 to 18, wherein the safety device comprises a counter member configured to count the number of pulses induced by the first coil unit (10) and the second coil unit (20), and the security policy includes that the counted number of pulses per instance is less than a predetermined threshold number of pulses.

20. A stimulator (1) according to any one of claims 1 to 19, comprising a button configured to operate the first coil unit to induce a pulse of the first electric field or electromagnetic field when activated, and to operate the second coil unit to induce a pulse of the second electric field or electromagnetic field.

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