Stimulator and method for activating a patient

Abstract

The stimulation apparatus (1) comprises an induction device (2) having a field generator (21) configured to generate a spatial field having a target shape, and a control unit (3) in communication with the induction device (2) and configured to control the induction device (2) to generate the spatial field. The field generator (21) of the induction device (2) is configured to be placed on a human or animal patient (5) so that the target tissue can be stimulated by the spatial field generated by the coil design to activate the patient. The control unit (3) is configured to operate the induction device (2) so that the field generator (21) generates a series of continuous trains of multiple pulses of the electromagnetic field, the trains being intermittent.

Description

Technical Field

[0001] The present invention relates to a stimulation arrangement as described in the preamble of independent claim 1, and more particularly to a process for manufacturing such a stimulation arrangement, a method for activating a patient, and a computer program for controlling the activation of a patient.

Background Art

[0002] In medicine, it is known that for various therapeutic treatments, it is beneficial to activate a patient, i.e., to activate the patient's muscles or similar structures. Therefore, in many cases, it is intended to activate the patient by stimulating the target tissue with an electromagnetic field. For example, in the application to the treatment of the knee after surgical intervention, it is known to activate the muscles around the knee by direct muscle stimulation with an electromagnetic field. For such activation, certain stimulation devices are known that can be placed on the patient to generate an electromagnetic field.

[0003] In another exemplary field, especially in the intensive care unit of a hospital, it may be desirable to activate the diaphragm of a patient on a ventilator in order to prevent disorders caused by not using the diaphragm. For example, it has been shown that within the first 18 to 69 hours of mechanical ventilation, disuse atrophy of the diaphragm muscle fibers already occurs, at which time the cross-sectional area of the muscle fibers shrinks by more than 50%. Therefore, the goal is to repeatedly activate the diaphragm so that its function can be maintained while the patient is being given artificial or mechanical respiration, or to activate the diaphragm to support an effective recovery of the self-sufficient respiratory function, at least during the weaning period.

[0004] As mentioned above, to achieve such activation of tissues in a patient's body, it is known that the tissue can be activated either directly by stimulating it or indirectly by stimulating specific parts of the nervous system. For example, if the tissue is muscle tissue, it can be activated by supplying electrical pulses directly to the tissue or to the nerves associated with the tissue. More specifically, it is known that the diaphragm can be activated by stimulating the phrenic nerve in the patient's neck, for example.

[0005] While such activation in patients is known, it often causes discomfort. For example, unexpected electromagnetic stimulation can induce sudden seizures or other reactions in the patient's body, potentially interfering with the therapeutic effect. Furthermore, electromagnetic stimulation often generates noise, which can be undesirable for the patient's comfort.

[0006] Therefore, there is a need for a device, system, or procedure that enables relatively convenient and efficient activation of a patient, more specifically, effective activation of the diaphragm in a patient's ventilation procedure, through stimulation by an electromagnetic field. [Overview of the project]

[0007] According to the present invention, this need is solved by a stimulator defined by the features of independent claim 1, a manufacturing process for the stimulator defined by the features of independent claim 19, a method for activating a human or animal patient defined by the features of independent claim 20, and a computer program defined by the features of independent claim 40. Preferred embodiments are the subject of the dependent claims.

[0008] In one embodiment, the present invention is a stimulator comprising an induction device and a control unit. The induction device has a field generator configured to generate a spatial field having a target shape. The control unit communicates with the induction device and is configured to control the induction device to generate the spatial field. The field generator of the induction device is configured to be placed on a human or animal patient so that target tissue can be stimulated by the spatial field generated by the field generator in order to activate the patient. The control unit is further configured to operate the induction device so that the field generator generates a series of continuous pulses of a spatial field, the pulses being intermittent.

[0009] In the context of this invention, patient activation relates to the activation of any specific tissue in the patient's body, such as muscle tissue. Thereafter, the tissue can be activated directly by stimulating the tissue itself. In such a configuration, the activated tissue and the target tissue are identical. Alternatively, or in addition to this, the tissue can be activated indirectly, for example, through a part of the patient's nervous system. A stimulator may be particularly advantageous for indirectly activating the patient's diaphragm by stimulating the patient's phrenic nerve as the target tissue.

[0010] In the context of the embodiments of the present invention described below, the term “spatial field” refers to any field that enables stimulation of a patient’s target tissue. This may, in more detail, include electric fields, magnetic fields, or electromagnetic fields. Such fields make it possible to directly stimulate muscle structures or to indirectly stimulate muscle structures through the nervous system or other muscle structures.

[0011] The target shape of a spatial field can be realized, for example, by a locally inhibited spatial field having a peak. The spatial field can be adapted to activate a target region (e.g., the phrenic nerve to be activated), which is a nerve or tissue region to be activated using the spatial field, and the activation of the target region can be realized, for example, by a peak (focal region) in the spatial field. The target shape can generally be any shape of the components of the spatial field or time-dependent field that allows for the effective stimulation of one or more target nerves, while minimizing other undesirable side-stimulatory effects on surrounding, above, or immediately nearby tissues or nerves. A peak shape is such an example, as it maximizes the effect in the focal region while minimizing the effects outside of this region.

[0012] The term "pulse" in this invention relates to supplying a relatively short spatial field. Thus, a single pulse is related to the generation of a spatial field over a relatively short period of time, with a relatively long interruption between two subsequent pulses. Generally, a single pulse is supplied at a frequency of less than 10 Hz, such as 5 Hz or less, or the single pulse is ignited by a user or technician. A single pulse can have a time width of about 10 microseconds (μs) to about 300 μs. Such pulses can activate nerve and muscle structures and are identifiable by a patient or sensor. In detail, such a single pulse can result in a single spasm of a muscle or muscle structure.

[0013] In contrast, when the spatial field is generated as a series rather than a single pulse, it is generated sequentially or as a series of pulses that follow each other relatively quickly. Such pulses can be supplied in a frequency range of about 15 Hz to about 30 Hz. Each of the multiple pulses in the series preferably contains a relatively short, essentially identical pulse duration as mentioned. More specifically, the pulse duration is preferably in the range of about 160 microseconds to about 220 microseconds.

[0014] In detail, the column can activate nerves or muscles to induce tetany spasms or activations. Advantageously, the column is supplied by increasing the intensity (field intensity) and / or frequency until the target intensity and frequency are achieved (ramp protocol), as described below. Thus, sudden spasms or discomfort can be reduced. All these parameters are summarized under the terms “temporal characteristics” or “temporal parameters” of the spatial field. These temporal parameters can be manually adjusted via an input interface or automatically controlled by an adjustment mechanism or control unit.

[0015] Parameters such as the voltage or current waveform applied to generate the spatial field can affect the temporal characteristics of the spatial field, including the shape, amplitude, width, and polarity of the pulses, as well as the repetition frequency, duration, and interval of pulse bursts or columns, and the total number of pulses. In particular, the interval between stimulation sessions and the total number of sessions affect the intensity of the field, determining whether a target region or target tissue can be activated, and the intensity or "dose" at which activation is possible.

[0016] In the context of this invention, the term “row” refers to a series of pulses that are encompassed. More specifically, one single row of rows generally contains a group of pulses. Thereafter, each row contains preferably the same number or at least a similar number of pulses. In other words, the groups of pulses contained in each single row may consist of the same number of pulses. Furthermore, each row preferably contains essentially the same row duration. More specifically, the row duration is preferably in the range of about 0.5 seconds to about 1.5 seconds. Such pulse rows make it possible to stimulate target tissue so that the patient is efficiently activated.

[0017] In a preferred embodiment, the field generator of the induction device comprises electrodes, and the spatial field generated by the field generator is an electric field.

[0018] In an alternative preferred embodiment, the field generator of the induction device includes a coil design, and the spatial field generated by the field generator is an electromagnetic field. As used herein, the term “coil design” may include, or may include, at least two coils, at least one conical or curved or bulging coil, at least one cylindrical or non-flat coil, or at least one small coil for generating a sharp electromagnetic field, i.e., a sufficiently small coil such as a coil with a diameter of 3 cm or less. The target shape of the electromagnetic field described herein may include a peak formed by the spatial electromagnetic field. The electromagnetic field generator may also be referred to as an electromagnetic field generator.

[0019] The coil design of the electromagnetic field generator allows for shaping or individually adjusting the electromagnetic field according to the intended application of the ventilation device. In detail, the target shape can be generated to be relatively sharp. This makes it possible to selectively stimulate the nervous system or a specific part thereof. In detail, it is possible to selectively stimulate a nerve, such as the phrenic nerve, to reduce or prevent stimulation of other tissues or nerves in the vicinity, surrounding, or above the target nerve. To stimulate both phrenic nerves in the neck, coil designs may be provided that feature a dual coil, parabolic coil, or small circular coil to generate a focal electric field region.

[0020] The terms “placed in” or “held in” used in relation to field generators of induction devices may refer to field generators that are in physical contact with or near the patient’s body. This allows the position and orientation of the field generator or its components to be appropriately predefined or identified in order to stimulate target tissue. The field generator may be formed to conform to its position in order to be configured to be placed in the appropriate location. Furthermore, the field generator may be equipped with an appropriate mounting structure to secure it in that position.

[0021] A control unit that communicates with any other components may be coupled to those components by wire or wireless means. Thus, control signals may be transmitted to the other components for operation or control. In addition, or instead, the control unit may receive signals such as sensor signals. For example, such sensor signals may represent perceived dimensions or physical properties, for example, for further evaluation.

[0022] A control unit can be any computing entity suitable for performing the included tasks, ultimately for other purposes such as controlling induction devices and data evaluation. A control unit may be, or comprise, a laptop computer, desktop computer, server computer, tablet, smartphone, etc. The term "control unit" includes both single devices and combinations of such devices. A control unit may be a distributed system, such as a cloud solution, performing various tasks at various locations.

[0023] Generally, a control unit or computer includes a processor or central processing unit (CPU), a permanent data storage device having a recording medium such as a hard disk or flash memory, random access memory (RAM), read-only memory (ROM), communication adapters such as a universal serial bus (USB) adapter, local area network (LAN) adapter, wireless LAN (WLAN) adapter, or Bluetooth adapter, and a physical user interface such as a keyboard, mouse, touchscreen, screen, microphone, or speaker. A control unit or computer can be embodied using a variety of components.

[0024] A control unit may be embodied partially or entirely as a separate component or as a component integrated into another device or component. For example, a control unit or a part thereof may be embodied in a ventilator and / or induction device used to ventilate a patient.

[0025] The operation of the induction device may particularly include stimulating target tissue such as the phrenic nerve or both phrenic nerves of the patient by inducing the induction device to apply a spatial field. Thus, the control unit can activate the patient's diaphragm by operating the induction device.

[0026] By operating so that the induction device generates a series of continuous intermittent trains, the stimulation can be skillfully adapted and adjusted according to the needs and requirements given in a particular therapy. For example, such a configuration makes it possible to integrate the stimulation of diaphragm activation in conventional ventilation applications. Thus, ventilation can be favorably assisted by the stimulation device, and the disadvantages of purely theoretical mechanical ventilation can be reduced. Therefore, the stimulation device according to the present invention enables relatively convenient and efficient activation of the patient.

[0027] Preferably, each of the plurality of pulses of the train includes a first pulse having a first intensity and a maximum pulse having a maximum intensity higher than the first intensity. The first pulse is, in this context, the first pulse of each respective train. The maximum pulse may be the last pulse of each respective train or any pulse after the first pulse of the train. Further, there may be a plurality of pulses having a maximum intensity within one single train.

[0028] The term "intensity" used in relation to one of the one of the pulses relates to the field intensity of the spatial field generated in each respective pulse. The field intensity generally means the magnitude of the vector field that can be measured in volts per meter for an electric field and in amperes per meter for a magnetic field. Providing an electromagnetic field as the spatial field results in both an electric field strength and a magnetic field strength. However, in an electromagnetic field, one of the electric field strength or the magnetic field strength may be ignored.

[0029] The intensity of the intermediate pulse between the first pulse and the maximum pulse preferably increases from the first pulse to the maximum pulse. Such a configuration of the columns makes it possible to improve convenience for the patient. Specifically, since each column initially has a lower intensity, by starting relatively gently, the patient can be accustomed. Such a gentle start can be equivalent to the natural movement of the tissue to be activated. Thus, sudden spasms and discomfort can be prevented, and the efficacy of activation can be improved.

[0030] In addition or alternatively, each of the plurality of pulses in a column preferably includes a last pulse having a last intensity lower than the maximum intensity. The first intensity and the last intensity may be the same. Thereby, the intensity of the intermediate pulse between the maximum pulse and the last pulse preferably decreases from the maximum pulse to the last pulse. By decreasing the intensity of each column towards the end of the column, tissues such as the patient's diaphragm, for example, can be activated more naturally, and the comfort can be further improved.

[0031] As described above, the pulse time width of each single pulse among the plurality of pulses can generally be substantially the same for all pulses. Preferably, the pulse time width includes an increasing portion with an increasing intensity and / or a decreasing portion with a decreasing intensity. When the spatial field is an electromagnetic field, a relatively large electromagnetic force can be applied between the windings of the coil of the electromagnetic field generator throughout the pulse, and since that force has an impact comparable to that of a shock using a rod on the coil, noise can occur. Such noise can cause discomfort to the patient and the surroundings. However, by supplying a single pulse with an increasing portion and / or a decreasing portion, the final intensity can be increasingly established and decreased. Thus, the noise induced by a single pulse can be essentially reduced. Thereby, the comfort during the activation of the patient can be improved.

[0032] The increasing and decreasing portions of a single pulse can be established by supplying multiple subpulses with varying intensity. Such subpulses may be particularly high-frequency subpulses. More specifically, the increasing portion of a single pulse can be established by multiple subpulses with increasing intensity. Similarly, the decreasing portion of a single pulse can be established by multiple subpulses with decreasing intensity.

[0033] To achieve a sufficient degree of noise reduction, the increasing portion and the particularly decreasing portion together preferably cover at least 60 percent or at least 80 percent of the pulse duration. In detail, the intensity of each single pulse can exhibit a clock-like shape.

[0034] Preferably, each column contains a cumulative intensity calculated by aggregating the intensities of the pulses within the column, and the cumulative intensities of the columns are different. There may also be columns with the same cumulative intensity. However, generally, at least two, or advantageously more, of the columns have different cumulative intensities.

[0035] Thereafter, the column preferably includes a first column having a first cumulative intensity and a maximum column having a maximum cumulative intensity higher than the first cumulative intensity. More specifically, the column may have multiple increasing columns in which the cumulative intensity increases from a first cumulative intensity to a maximum cumulative intensity. By progressively increasing the cumulative intensity from a first cumulative intensity to a maximum cumulative intensity, advantageously from one column to subsequent columns, a relatively high cumulative intensity can be supplied to the patient without causing discomfort. Rather, the patient can become accustomed to the maximum cumulative intensity. This makes it possible to provide efficient activation encompassing relatively high intensities without basic discomfort or adverse reactions such as sudden spasms.

[0036] Preferably, each column contains the same number of pulses. In addition, or instead, each column preferably has essentially the same duration as the column. For this purpose, the duration of each column is preferably in the range of about 0.5 seconds to about 1.5 seconds. Such a configuration can provide a stable stimulus and may reduce patient discomfort or startle that could lead to adverse reactions such as sudden seizures.

[0037] Preferably, the sequence includes approximately 10 to 20 sequences per minute. Such frequencies of sequences have been proven to deliver efficient stimulation to the target tissue and thus comfortably provide efficient activation to the patient.

[0038] Furthermore, the multiple pulses in the column preferably include frequencies in the range of approximately 15 Hz to approximately 25 Hz. By supplying pulses at such frequencies, efficient stimulation can be achieved. The combination of this pulse frequency and the column frequency described above may be particularly beneficial.

[0039] In another embodiment, the present invention is a process for manufacturing a stimulator. The manufacturing process includes (i) providing an induction device having a field generator configured to generate a spatial field having a target shape; (ii) configuring the induction device to be placed on a human or animal patient, such that a target tissue can be stimulated by the spatial field generated by the coil design to activate the patient; (iii) providing a control unit adapted to communicate with the induction device; (iv) configuring the control unit to control the induction device to generate a spatial field; and (v) configuring the control unit to operate the induction device such that the field generator generates a series of continuous sequences of pulses of a spatial field, wherein the sequences are intermittent.

[0040] The manufacturing process according to the present invention makes it possible to provide the stimulator according to the present invention as described above. In this way, the effects and benefits described above in relation to the stimulator can be efficiently realized. Furthermore, the effects and benefits described above in relation to the desirable features of the stimulator can be realized by the following additional steps and features of the manufacturing process.

[0041] A preferred step in configuring the control unit is to cause the induction device to cause the field generator to generate a plurality of pulses in each of a sequence, each having a first pulse with a first intensity and a maximum pulse with a maximum intensity higher than the first intensity. Thereafter, the intensity of intermediate pulses between the first pulse and the maximum pulse may increase from the first pulse to the maximum pulse. Furthermore, each of the plurality of pulses in the sequence may include a final pulse with a final intensity lower than the maximum intensity, and the intensity of intermediate pulses between the maximum pulse and the final pulse may decrease from the maximum pulse to the final pulse.

[0042] A preferred step in configuring the control unit is for the induction device to operate so that a field generator generates each column, the cumulative intensity of each column being calculated by aggregating the pulse intensities of that column and being different for each. Thus, a column may include a first column having a first cumulative intensity and a maximum column having a maximum cumulative intensity higher than the first cumulative intensity.

[0043] A preferred step in configuring the control unit is for the induction device to operate in such a way that it causes the field generator to produce each row having the same number of pulses.

[0044] A preferred step in configuring the control unit is for the induction device to cause the field generator to generate each column having essentially the same time width. For this purpose, the time width of the columns may be in the range of approximately 0.5 seconds to approximately 1.5 seconds.

[0045] A preferred step in configuring the control unit causes the induction device to operate in such a way that it causes the field generator to produce a column with approximately 10 to 20 columns per minute.

[0046] A preferred step in configuring the control unit is for the induction device to cause the field generator to generate each of a series of pulses having essentially the same pulse duration. For this purpose, the pulse duration may range from approximately 160 microseconds to approximately 220 microseconds. Furthermore, the pulse duration may include an increasing portion with increasing intensity and / or a decreasing portion with decreasing intensity, and together the increasing and decreasing portions preferably cover at least 60 percent of the pulse duration.

[0047] A preferred step in configuring the control unit is to cause the induction device to cause the field generator to generate a series of pulses having frequencies in the range of approximately 15 Hz to approximately 25 Hz.

[0048] In a preferred embodiment, the field generator of the provided induction device comprises electrodes, and the spatial field generated by the field generator is an electric field.

[0049] In another preferred embodiment, the field generator of the provided induction device includes a coil design, and the spatial field generated by the field generator is an electromagnetic field.

[0050] In yet another embodiment, the present invention relates to a method for activating a patient by stimulating target tissue of a human or animal patient. The activation method includes the steps of (a) obtaining an induction device having a field generator configured to generate a spatial field having a target shape, and a control unit communicating with the induction device and configured to control the induction device to generate the spatial field; (b) positioning the field generator of the induction device on the patient so that the spatial field generated by the coil design can stimulate the target tissue; and (c) operating the induction device to generate a series of consecutive sequences of multiple pulses of a spatial field by the field generator, wherein the sequences are intermittent.

[0051] The activation method according to the present invention makes it possible to efficiently realize the effects and benefits described above in relation to the stimulator. Thereafter, advantageously, such a stimulator is used to apply the activation method or at least some part of it.

[0052] Preferably, the target tissue is the patient's phrenic nerve, and the patient's activation is the activation of the patient's diaphragm. Thus, this method can be used for or to assist the patient's ventilation. In such applications, the present invention may be particularly beneficial.

[0053] More specifically, the activation method preferably includes the steps of connecting a conduit interface to the patient's respiratory system, delivering air to the patient's respiratory system through the conduit interface, controlling the delivery of air to the patient's respiratory system according to the breathing pattern, and activating the patient's diaphragm in coordination with the breathing pattern. Such an implementation of the activation method can provide efficient support for mechanical ventilation and prevent or reduce the risk of adverse events such as acute respiratory failure syndrome (ARDS) or ventilator-associated pneumonia (VAP) or ventilator-induced lung injury (VILI).

[0054] The following additional steps and features of the activation method may enable the effects and benefits described above in relation to the preferred features of the stimulator to be realized by the following additional steps and features of the activation method.

[0055] Preferably, each of the multiple pulses in a column generated by the field generator of the induction device includes a first pulse having a first intensity and a maximum pulse having a maximum intensity higher than the first intensity. Thereafter, the intensity of the intermediate pulses between the first pulse and the maximum pulse preferably increases from the first pulse to the maximum pulse. Furthermore, each of the multiple pulses in a column preferably includes a final pulse having a final intensity lower than the maximum intensity, and the intensity of the intermediate pulses between the maximum pulse and the final pulse preferably decreases from the maximum pulse to the final pulse.

[0056] Preferably, each column includes a cumulative intensity calculated by aggregating the intensities of the pulses in the column, and the cumulative intensities of the columns are different. Thereafter, each column preferably includes a first column having a first cumulative intensity and a maximum column having a maximum cumulative intensity higher than the first cumulative intensity.

[0057] Preferably, each row contains the same number of pulses.

[0058] Preferably, each column contains essentially the same time width. For this reason, the time width of the columns is preferably in the range of about 0.5 seconds to about 1.5 seconds.

[0059] Preferably, the columns include about 10 to about 20 columns per minute.

[0060] Preferably, each of the multiple pulses in a column contains essentially the same pulse duration. For this purpose, the pulse duration is preferably in the range of about 160 microseconds to about 220 microseconds. Furthermore, the pulse duration preferably includes an increasing portion with increasing intensity and / or a decreasing portion with decreasing intensity, and together the increasing and decreasing portions preferably cover at least 60 percent of the pulse duration.

[0061] Preferably, the multiple pulses in the column include frequencies in the range of about 15 Hz to about 25 Hz.

[0062] In a preferred embodiment, the field generator of the induction device used in this method comprises electrodes, and the spatial field generated by the field generator is an electric field.

[0063] In another preferred embodiment, the field generator of the inductive device used in this method includes a coil design, and the spatial field generated by the field generator is an electromagnetic field.

[0064] In yet another embodiment, the present invention is a computer program comprising instructions, which, when executed by a control unit, causes the control unit to operate a field generator of an induction device placed on a human or animal patient, and the patient's target tissue may be stimulated by a spatial field generated by the coil design of the field generator of the induction device, the field generator generating a series of continuous sequences of multiple pulses of the spatial field, the sequences being intermittent.

[0065] A computer program may be a computer program product that includes computer code means configured to control the computer's processor to perform the steps and / or features described above or below when executed in a control unit. Furthermore, a computer-readable medium may be provided that, when executed by a computer or control unit, causes the computer or control unit to perform the steps and / or features described above or below. The computer-readable medium may be a storage medium and may be a mobile or portable storage medium to enable convenient distribution. Alternatively, a data carrier signal for carrying the computer program previously described herein may be provided to enable transfer over the Internet or for other purposes. A computer program may also be referred to as software, or may be included in software.

[0066] The computer program according to the present invention makes it possible to efficiently realize the effects and benefits described above in relation to the stimulator. Thereafter, advantageously, at least some parts of the stimulator, such as the stimulator or its control unit, are incorporated to execute the computer program.

[0067] Hereinafter, advantageous embodiments of the computer program according to the present invention are described, which enable the realization of the effects and benefits described above in relation to a preferred embodiment of the stimulator.

[0068] Preferably, each of the multiple pulses in a column includes a first pulse having a first intensity and a maximum pulse having a maximum intensity higher than the first intensity. Thereafter, the intensity of the intermediate pulses between the first pulse and the maximum pulse preferably increases from the first pulse to the maximum pulse. Furthermore, each of the multiple pulses in a column preferably includes a final pulse having a final intensity lower than the maximum intensity, and the intensity of the intermediate pulses between the maximum pulse and the final pulse preferably decreases from the maximum pulse to the final pulse.

[0069] Preferably, each column includes a cumulative intensity calculated by aggregating the intensities of the pulses in the column, and the cumulative intensities of the columns are different. Thereafter, each column preferably includes a first column having a first cumulative intensity and a maximum column having a maximum cumulative intensity higher than the first cumulative intensity.

[0070] Preferably, each row contains the same number of pulses.

[0071] Preferably, each column contains essentially the same time width. For this reason, the time width of the columns is preferably in the range of about 0.5 seconds to about 1.5 seconds.

[0072] Preferably, the columns include about 10 to about 20 columns per minute.

[0073] Preferably, each of the multiple pulses in a column contains essentially the same pulse duration. For this purpose, the pulse duration is preferably in the range of about 160 microseconds to about 220 microseconds. Furthermore, the pulse duration preferably includes an increasing portion with increasing intensity and a decreasing portion with decreasing intensity, and together the increasing and decreasing portions preferably cover at least 60 percent of the pulse duration.

[0074] Preferably, the multiple pulses in the column include frequencies in the range of about 15 Hz to about 25 Hz.

[0075] In a preferred embodiment of the computer program, the field generator of the induction device comprises electrodes, and the spatial field generated by the field generator is an electric field.

[0076] In another preferred embodiment of the computer program, the field generator of the induction device includes a coil design, and the spatial field generated by the field generator is an electromagnetic field.

[0077] In this specification, a stimulator according to the present invention, a manufacturing process for such a stimulator according to the present invention, a method for activating a patient according to the present invention, and a computer program for controlling patient activation according to the present invention will be described in more detail below with reference to the accompanying drawings, as exemplary embodiments. [Brief explanation of the drawing]

[0078] [Figure 1] This is a schematic diagram of one embodiment of a stimulator according to the present invention, implemented in a ventilation arrangement. This stimulator is manufactured by a process according to the present invention, carries out one embodiment of the method according to the present invention, and executes a computer program according to the present invention. [Figure 2] This figure shows a first embodiment of the supply of an electromagnetic field array according to the present invention. [Figure 3] This figure shows a second embodiment of the supply of an electromagnetic field array according to the present invention. [Figure 4] This figure shows a single pulse representing a third embodiment of the supply of an electromagnetic field train. [Modes for carrying out the invention]

[0079] In the following description, certain terms are used for convenience but are not intended to limit the invention. Terms such as “right,” “left,” “up,” “down,” “below,” and “above” refer to directions in the figure. Technical terms include terms explicitly mentioned, as well as their derivatives and terms with similar meanings. Additionally, spatial relative terms such as “directly below,” “lower,” “downward,” “above,” “upward,” “proximal,” and “distal” may be used to describe the relationship of one element or feature shown in the figure to another element or feature. These spatial relative terms are intended to encompass different positions and orientations of the device when in use or in operation, in addition to the position and orientation shown in the figure. For example, if the device in the figure is inverted, an element described as “lower” or “directly below” another element or feature should then be “above” or “above” the other element or feature. Thus, the exemplary term “lower” can encompass both position and orientation, such as “up” and “down.” The device may be oriented differently (rotated by 90 degrees or other orientations), and the spatial relative descriptors used herein may be interpreted accordingly. Similarly, descriptions of motion along and around various axes include the position and orientation of various special devices.

[0080] To avoid repetition of 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 mean that it is missing from embodiments that incorporate that aspect. Rather, the aspect is omitted for clarity and to avoid redundant descriptions. In this context, the following applies to the remainder of this description: If the reference numerals contained in a figure are not described in the directly relevant part of the description in order to clarify the drawing, those reference numerals will be referred to in a preceding or following paragraph of the description. Furthermore, if, for clarity, not all features of a part in a drawing are given a reference numeral, they will be referenced in other drawings showing the same part. Similar numbers in two or more figures represent the same or similar elements.

[0081] Figure 1 shows one embodiment of the stimulator 1 according to the present invention as a ventilation device. The stimulator 1 includes a ventilation machine 6, an electromagnetic induction device 2 (hereinafter also called an EMI device) as an induction device, a control unit 3, and a sensor 4. The EMI device 2 comprises an electromagnetic field generator 21 as a field generator having two coils 211 as a coil design. The coils 211 are arranged in one common plane and configured to generate a spatial electromagnetic field 212 as a spatial field. When operating, the two coils 211 generate an electromagnetic field directed toward the neck 52 of the patient 5. The electromagnetic field has a central target shape with a focal region, where the electromagnetic field extends to the neck 52 to the greatest extent possible. Furthermore, the mounting device 22 of the EMI device 2 is fixed to the bed 51 on which the patient 5 is lying, and a cervical arc 221 is positioned on the neck 52 of the patient 5. The cervical arc 221 is equipped with a joint 222 as a rearrangement structure for the electromagnetic field adjustment mechanism of the EMI device 2. The joint 222 holds the coil 211 to the neck 52 of the patient 5.

[0082] The ventilation machine 6 comprises a ventilator 61 as an airflow generator through which a ventilation tube 63 extends, and a mouthpiece 62 as a conduit interface. The mouthpiece 62 is a tube that is passed through the patient's mouth and into the respiratory system.

[0083] The control unit 3 has a user interface 31 for exchanging information with personnel who monitor or set up ventilation for patient 5. For example, the user interface 31 may be embodied as a touchscreen to enable information input and output. Furthermore, the control unit 3 is equipped with a device interface 32 configured to connect to the interface unit of the ventilation machine 6, the EMI device 2, and the sensor 4 by wire 33. In this way, the control unit 3 communicates with the ventilation machine 6, the EMI device 2, and the sensor 4.

[0084] More specifically, as will be described in more detail below, the control unit 3 is configured to receive ventilation data regarding patient 5's ventilation from the ventilation machine 6 and to control the EMI device 2 to generate a spatial electromagnetic field according to the evaluated ventilation data. Furthermore, the control unit 3 is configured to operate the junction 222 to automatically change the position of the focal region 213 of the spatial electromagnetic field 212 generated by the coil 211, thereby changing the field intensity of the spatial electromagnetic field 212. The purpose of changing the field intensity and position of the spatial electromagnetic field 212 is to adjust the spatial electromagnetic field 212 to selectively stimulate the phrenic nerve of patient 5. Stimulation of the phrenic nerve 53 activates the diaphragm of patient 5, thereby inducing airflow or respiration.

[0085] The ventilation machine 6 is configured to mechanically ventilate patient 5 by supplying air to the patient's respiratory system through a mouthpiece 62. More specifically, the ventilator 61 is configured to deliver air through the mouthpiece 62. The control unit 3 is configured to control the ventilator 61 to deliver air according to a breathing pattern defined in the control unit 3. In addition, the control unit 3 adjusts the activation of the diaphragm in coordination with the breathing pattern so that the activation of the diaphragm by the phrenic nerve 53 is coordinated with the ventilation of patient 5.

[0086] To enable the provision of various treatments during ventilation, the computer in the control unit 3 executes a computer program to define combinations of stimulation duration and repetition rate, and configures the EMI device 2 to operate according to the defined stimulation duration and determined repetition rate. Thereafter, the control unit 3 provides the operator with treatment options via the user interface 31. The operator selects the appropriate treatment and sets the included parameters.

[0087] To enable the prevention of diaphragmatic muscle weakness and / or the reduction of the risk of VIDD, a first operating mode is set in the control unit 3 by defining a stimulation duration ranging from approximately 3 minutes to approximately 20 minutes and a repetition rate ranging from approximately 1 time / day to approximately 3 times / day.

[0088] To reduce the risk of ARDS development, the control unit 3 sets a second operating mode by defining a repetition rate ranging from approximately 2 times per hour to approximately 1 time every 2 hours, and a stimulation duration ranging from approximately 0.5 minutes to approximately 3 minutes.

[0089] To alternatively reduce the risk of ARDS development, a third operating mode is set in control unit 3 by defining a stimulation period ranging from approximately 1 respiratory cycle to approximately 5 respiratory cycles and a repetition rate ranging from approximately every 1 minute to approximately every 30 minutes.

[0090] A fourth operating mode is set in the control unit 3 to induce a respiratory cycle or stimulate deep breathing. In this fourth operating mode, the control unit 3 evaluates the oxygen or carbon dioxide level of the patient's blood, as measured by the sensor 4, and compares it to a predetermined threshold. The control unit 3 then activates the EMI device 2 if the measured oxygen or carbon dioxide level exceeds the predetermined threshold. Specifically, the control unit 3 activates the EMI device 2 when the measured oxygen level is below the threshold, or when the measured carbon dioxide level is above the threshold.

[0091] Furthermore, by executing a computer program, the control unit 3 is configured to operate the EMI device 2 such that the electromagnetic field generator 21 generates a series of intermittent pulses of spatial electromagnetic fields.

[0092] As shown in Figure 2, in the first embodiment, the control unit 3 operates the EMI device 2 so that the electromagnetic field generator 21 generates a series of columns 7, each column 7 containing a group of four electromagnetic field pulses 8 having a pulse time width 84 of 160 microseconds (μs). Column 7 has a uniform column time width 74 of 0.5 seconds. Column 7 has a uniform interruption of 2 to 5 seconds.

[0093] Each single pulse 8 in column 7 has the same intensity I. More specifically, the first column 71 contains four first pulses 81 having a first intensity I1, the second column 72 contains four second pulses 82 having a second intensity I2, and the third largest column 73 contains four pulses 83 having a third largest intensity I3. Each of the columns 7 contains a cumulative intensity calculated by summing the intensities of its pulses 7. Thus, the first cumulative intensity of the first column 71 is calculated by summing the four first intensities I1 of its first pulses 81. Correspondingly, the second cumulative intensity of the second column 72 is calculated by summing the four second intensities I2 of its second pulses 82, and the maximum cumulative intensity of the largest column 73 is calculated by summing the four maximum intensities I3 of its maximum pulses 83. Therefore, the cumulative intensities of column 7 differ because the second cumulative intensity of the second column 72 is lower than the maximum cumulative intensity of the maximum column 73, and the first cumulative intensity of the first column 71 is lower than the second cumulative intensity of the second column 72.

[0094] By increasing the cumulative intensity stepwise from one column 7 to the next, patient 5 adapts to the maximum cumulative intensity. In this way, tolerance may be improved and a reverse reaction in patient 5 may be prevented.

[0095] As shown in Figure 3, in the second embodiment, the control unit 3 operates the EMI device 2 so that the electromagnetic field generator 21 generates a column 70, each column 701 containing a group of 20 electromagnetic field pulses. In detail, the column 70 includes a first pulse 801 having a first intensity, followed by a second pulse 802 having a second intensity higher than the first, followed by a third pulse 803 having a third intensity higher than the second, followed by 14 maximum pulses 804 having a maximum intensity higher than the third, followed by another third pulse 803, followed by another second pulse 802, followed by another first pulse 801. The time width of the column 701 is 1 second.

[0096] By gradually increasing the intensity within each individual column 701 from the first pulse 801, through the second pulse 802 and the third pulse 803, to the maximum pulse 804, patient 5 adapts to the maximum intensity. In this way, the receptivity of each column 701 can be improved, and adverse reactions such as sudden seizures in patient 5 can be prevented.

[0097] As shown in Figure 4, in the third embodiment, the control unit 3 operates the EMI device 2 so that the electromagnetic field generator 21 generates a single pulse 800 containing high-frequency subpulses. Each pulse 800 contains a group of five electromagnetic field subpulses. More specifically, each pulse includes a first subpulse 811 having a first intensity, followed by a second subpulse 812 having a second intensity higher than the first, followed by a third subpulse 813 having a third intensity higher than the second, followed by a maximum subpulse 814 having the highest intensity higher than the third, followed by another third subpulse 813, followed by another second subpulse 812, followed by another first subpulse 801. The subpulses generate a bell-shaped pulse intensity 810. The pulse duration 840 of each pulse is 160 μs. At the start of pulse 800, the first subpulse 811, the second subpulse 812, and the highest subpulse 813 form the increasing portion of pulse 800. At the end of pulse 800, the third sub-subpulse 813, the second subpulse 812, and the first subpulse 822 form the decreasing portion of pulse 800.

[0098] By increasing the intensity within each single pulse 800 in an increasing portion, from the first subpulse 811, through the second subpulse 812 and the third subpulse 813, to the highest subpulse 814, the patient 5 adapts to the intensity of each single pulse. In this way, the receptivity of each pulse 800 can be improved so that higher pulse intensities can be supplied. Furthermore, by additionally decreasing the intensity within each single pulse 800 in a decreasing portion, from the highest subpulse 814, through the third subpulse 813 and the second subpulse 812, to the first subpulse 811, the generation of noise can be substantially reduced. In this way, the receptivity of the stimulation therapy can be further improved.

[0099] This description and the accompanying drawings illustrating aspects and embodiments of the present invention should not be construed as limiting the claims defining the protected invention. In other words, although the present invention is illustrated and described in detail in the drawings and the preceding description, such illustrations and descriptions should be considered as examples and illustrative, and not limiting. Various mechanical, structural, structural, electrical, and operational modifications can be made without departing from the spirit and scope of this description and the claims. In some cases, well-known circuits, structures, and techniques are not shown in detail so as not to obscure the present invention. Therefore, it will be understood by those skilled in the art that modifications and alterations can be made within the scope and spirit of the following claims. More specifically, the present invention further covers embodiments having any combination of features from the various embodiments described above and below. For example, the present invention can be, Embodiments combining pulse supply within a single column range, as shown in Figure 3, with adaptation of the cumulative intensity of the column, as shown in Figure 2, and / or Embodiments combining pulse supply having a clock-shaped pulse intensity or a pulse intensity of a similar shape as shown in Figure 4 with pulse supply within a single column range as shown in Figure 3 and / or adaptation of the cumulative intensity of a column as shown in Figure 2. It can be operated in that environment.

[0100] All further features individually shown in the figures are also included in this disclosure, even if they are not described in the above or below descriptions. Furthermore, a single alternative form of an embodiment described in the figures and descriptions, and a single alternative form of its features, may be waived 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 containing such features.

[0101] Furthermore, the word “equipped with” in the claims does not exclude other elements or steps, and the indefinite articles “one (a)” or “one (an)” do not exclude plurals. One unit or step may satisfy the function of several features detailed in the claims. The mere fact that certain means are enumerated in different dependent claims does not indicate that combinations of these means cannot be used effectively. Terms such as “basically,” “about,” and “approximately” in relation to attributes or values ​​also precisely define the attribute or value, respectively. The term “about” in the context of a given number or range refers to a value or range of, for example, within 20%, within 10%, within 5%, or within 2% of a given value or range. Components described as “combined” or “connected” may be directly coupled electrically or mechanically, or indirectly coupled through one or more intermediate components. No reference numeral in the claims should be construed as limiting the range.

[0102] Computer programs can be stored / distributed on suitable media such as optical or solid-state media supplied together with or as part of other hardware, but they can also be distributed in other forms, such as via the Internet or other wired or wireless communication systems. More specifically, for example, a computer program may be a computer program product stored on a computer-readable medium, and a computer program product may have computer executable program code adapted to be executed to carry out a particular method, such as the method according to the present invention. Furthermore, a computer program may also be a product or signal of data structures for embodying a particular method, such as the method according to the present invention.

Claims

1. An induction device (2) having a field generator (21) including a coil design configured to generate a spatial electromagnetic field having a target shape, A control unit (3) is configured to communicate with the induction device (2) and to control the induction device (2) to generate the spatial electromagnetic field, A stimulator (1) comprising, In the stimulator (1), the field generator (21) of the induction device (2) is configured to be positioned in the neck of a human or animal patient (5) so that the phrenic nerve can be stimulated by the spatial electromagnetic field generated by the field generator (21) in order to activate the diaphragm of the patient (5), The control unit (3) is configured to operate the induction device (2) so that the field generator (21) generates a series of consecutive rows (7, 70) of multiple pulses (8, 80, 800) of the spatial electromagnetic field, wherein each row in the series of consecutive rows (7, 70) contains the multiple pulses, and adjacent rows are separated by a temporal interruption. A stimulator (1) wherein each of the rows (7, 70) includes a cumulative intensity calculated by summing the intensities of its pulses (81, 82, 83, 80, 800), and the cumulative intensities of the rows (7, 70) are different.

2. The stimulator (1) according to claim 1, wherein each of the plurality of pulses (8, 80, 800) in the row (7, 70) includes a first pulse (801) having a first intensity and a maximum pulse (804) having a maximum intensity higher than the first intensity.

3. The stimulator (1) according to claim 2, wherein the intensity of the intermediate pulses (802, 803) between the first pulse (801) and the maximum pulse (804) increases from the first pulse (801) to the maximum pulse (804).

4. The stimulator (1) according to claim 2 or 3, wherein each of the plurality of pulses (8, 80, 800) in the row (7, 70) includes a final pulse (801) having a final intensity lower than the maximum intensity.

5. The stimulator (1) according to claim 4, wherein the intensity of the intermediate pulses (803, 802) between the maximum pulse (804) and the last pulse (801) decreases from the maximum pulse (804) to the last pulse (801).

6. The stimulator (1) according to any one of claims 1 to 5, wherein the rows (7, 70) include a first row (81) having a first cumulative intensity and a maximum row (83) having a maximum cumulative intensity higher than the first cumulative intensity.

7. Each of the aforementioned rows (7, 70) contains the same number of pulses (8, 80, 800), and / or The aforementioned column (7, 70) includes a column (7, 70) with a rate of 10 to 20 per minute, and / or The stimulator (1) according to any one of claims 1 to 6, wherein the plurality of pulses (8, 80, 800) in the row (7, 70) include frequencies in the range of 15 Hz to 25 Hz.

8. The stimulator (1) according to any one of claims 1 to 7, wherein each of the aforementioned columns (7, 70) includes essentially the same time width (74, 704) of the column.

9. The stimulator (1) according to claim 8, wherein the time interval (74, 704) of the aforementioned column is in the range of 0.5 seconds to 1.5 seconds.

10. Each of the plurality of pulses (8, 80, 800) in the row (7, 70) contains essentially the same pulse time width (84, 840), or The stimulator (1) according to any one of claims 1 to 9, wherein each of the plurality of pulses (8, 80, 800) in the row (7, 70) includes essentially the same pulse time width (84, 840), and the pulse time width (84, 840) is in the range of 160 microseconds to 220 microseconds.

11. The pulse time width (84, 840) includes an increasing portion accompanied by an increase in intensity and / or a decreasing portion accompanied by a decrease in intensity, or The stimulator (1) according to claim 10, wherein the pulse time width (84, 840) includes an increasing portion with increasing intensity and / or a decreasing portion with decreasing intensity, and the increasing portion and the decreasing portion together cover at least 60 percent of the pulse time width (84, 840).

12. To provide an induction device (2) having a field generator (21) including a coil design configured to generate a spatial electromagnetic field having a target shape, The induction device (2) is configured to be positioned in the neck of a human or animal patient (5) so that the phrenic nerve can be stimulated by the spatial electromagnetic field generated by the field generator (21) in order to activate the diaphragm of the patient (5), To provide a control unit (3) adapted to communicate with the aforementioned induction device, The control unit (3) is configured to control the induction device (2) to generate the spatial electromagnetic field, The control unit (3) is configured to operate the induction device (2) so that the field generator (21) generates a series of consecutive sequences (7, 70) of multiple pulses (8, 80, 800) of the spatial electromagnetic field, wherein each sequence in the series of consecutive sequences (7, 70) contains the multiple pulses, and adjacent sequences are separated by a temporal interruption, and the control unit (3) is configured accordingly. The control unit (3) is configured to operate the induction device (2) such that the field generator (21) generates each of the rows (7, 70), wherein each of the rows (7, 70) has a cumulative intensity calculated by aggregating the intensity of its pulses, and the control unit (3) is configured such that the cumulative intensity of the rows (7, 70) is different. A process for manufacturing stimulators, including [specific details omitted].

13. A computer program including instructions, which, when executed by a control unit, causes the control unit (3) to operate the field generator (21) of an induction device (2) positioned in the neck of a human or animal patient (5) so that the phrenic nerve of the patient (5) can be stimulated by a spatial electromagnetic field generated by the field generator (21) of the induction device, including a coil design, in order to activate the diaphragm of the patient (5), thereby causing the field generator (21) to generate a series of consecutive columns (7, 70) of a plurality of pulses (8, 80, 800) of the spatial electromagnetic field, wherein each column in the series of consecutive columns (7, 70) includes the plurality of pulses, adjacent columns are separated by a temporal interruption, and each column (7, 70) includes a cumulative intensity calculated by aggregating the intensity of its pulses, wherein the cumulative intensity of the columns (7, 70) is different.

14. The computer program according to claim 13, wherein each of the plurality of pulses (8, 80, 800) in the row (7, 70) includes a first pulse having a first intensity and a maximum pulse having a maximum intensity higher than the first intensity.

15. The computer program according to claim 14, wherein the intensity of the intermediate pulse between the first pulse and the maximum pulse increases from the first pulse to the maximum pulse.

16. The computer program according to claim 14 or 15, wherein each of the plurality of pulses (8, 80, 800) in the row (7, 70) includes a last pulse having a last intensity lower than the maximum intensity.

17. The computer program according to claim 16, wherein the intensity of the intermediate pulse between the maximum pulse and the last pulse decreases from the maximum pulse to the last pulse.

18. The computer program according to any one of claims 13 to 17, wherein each of the columns (7, 70) includes a first column having a first cumulative intensity and a maximum column having a maximum cumulative intensity higher than the first cumulative intensity.

19. Each of the aforementioned rows (7, 70) contains the same number of pulses, and / or The aforementioned column (7, 70) includes a column (7, 70) with a rate of 10 to 20 per minute, and / or The computer program according to any one of claims 13 to 18, wherein the plurality of pulses (8, 80, 800) in the row (7, 70) include frequencies in the range of 15 Hz to 25 Hz.

20. Each of the aforementioned columns (7, 70) contains essentially the same time range, or The computer program according to any one of claims 13 to 19, wherein each of the aforementioned columns (7, 70) includes essentially the same time width, and the time width of the aforementioned columns is in the range of 0.5 seconds to 1.5 seconds.

21. Each of the plurality of pulses (8, 80, 800) in the row (7, 70) contains essentially the same pulse duration, or The computer program according to any one of claims 13 to 20, wherein each of the plurality of pulses (8, 80, 800) in the row (7, 70) includes essentially the same pulse time width, and the pulse time width is in the range of 160 microseconds to 220 microseconds.

22. The pulse duration includes an increasing portion accompanied by an increase in intensity and / or a decreasing portion accompanied by a decrease in intensity, and / or The computer program according to claim 21, wherein the pulse time width includes an increasing portion accompanied by an increase in intensity and / or a decreasing portion accompanied by a decrease in intensity, wherein the increasing portion and the decreasing portion together cover at least 60 percent of the pulse time width.

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