DEVICE AND SYSTEM FOR RESPIRATORY THERAPY

Description

[0001] The invention relates to a respiratory therapy for patients with disturbed or weak cough, in whom coughing up secretions in the respiratory tract - e.g. based on a lack of muscular strength - is difficult or not possible (insufficient cough).

[0002] Respiratory secretions have thixotropic properties, meaning that shear stress caused by passing gas in the airway does not initially cause liquefaction or movement of the secretion below a certain level. Only when a threshold shear stress is exceeded does the viscosity of the secretion change, setting it in motion. Achieving this level of shear stress from the passing (expiratory) gas requires a certain flow (peak flow, peak cough flow) during coughing. This, in turn, is subject to certain conditions and requires a minimum amount of muscular strength without mechanical assistance.

[0003] The process of a sufficient cough can be divided into three phases. The first phase involves insufflation and filling of the lungs as deeply as possible (with the glottis open), followed by closure of the glottis, immediately followed by compression and pressure buildup with the glottis closed, and finally, the cough with the glottis reopened, which aims to generate the greatest possible peak flow (peak cough flow, PCF).

[0004] Respiratory therapy may be necessary for patients with cough insufficiency or a lack of muscular strength to support the removal of secretions from the airways. Such therapy may include mechanical (pneumatic) insufflation / exsufflation using a respiratory therapy device. During the exsufflation phase, the respiratory therapy device provides the energy needed to generate the airflow during the cough, or at least supports the natural cough.

[0005] For a sufficient – ​​mechanically assisted – cough, in addition to the necessary energy being applied by the respiratory therapy device, good synchronization of the various phases described above between the respiratory therapy device and the patient is essential. For example, if the patient were to close the glottis too late before coughing, after the therapy device had already switched to the exsufflation phase, expiratory flow would be generated without coughing (without the required peak flow), and the cough would then be ineffective. On the other hand, if the patient were to close the glottis too early – i.e., before the insufflation phase is complete – the lungs might still be insufficiently filled, and the subsequent cough would again be suboptimal and possibly insufficient.Furthermore, if the mechanical support provided by the device and the muscle pressure generated by the patient do not coincide in time, the individual's optimal cough and peak cough flow will not be achieved. For these reasons, synchronization between the patient and the respiratory therapy device is crucial for adequate mechanical cough therapy.

[0006] Insufflation and exsufflation times can be set using adjustable time specifications, whereby the setting physician is responsible for selecting suitable times and setting them on the respiratory therapy device.

[0007] Alternatively, the insufflation time can also be determined automatically based on respiratory measurements. This method reacts to patient-related changes such as the degree of (increasing) lung filling and / or the patency of the upper airways based on the measured values ​​and detector signals. Limit states that can be measured and are relevant according to the invention can include, for example, a lung that is at least largely filled or a glottis that is largely or completely closed (at the end of the insufflation phase).

[0008] To optimize this synchronization, state-of-the-art optical or acoustic signals can be used to alert the patient to a change between these phases. These device-generated signals can be based on times stored on the device or can be set by the user via a user interface.

[0009] In a clinical setting, a physician can further enhance the mechanically assisted cough by manually compressing the patient's stomach area during exsufflation. This compression must be applied at the correct moment, synchronized with the patient's exhalation or cough.

[0010] EP 2 651 477 B1 discloses a respiratory therapy device which indicates to the physician the correct moment for supporting compression via an audio signal or a visual or light signal.

[0011] EP 3 212 264 B1 discloses a device for respiratory therapy of a patient with a cough. The device provides the patient with a warning in the form of a pressure increase to indicate impending coughing maneuvers.

[0012] US 2014 / 0007877 A1 discloses a device for respiratory therapy of a patient during childbirth. The device provides the patient with instructions to perform various respiratory tasks.

[0013] US 2019 / 0151581 A1 discloses a device for respiratory therapy of a patient with a cough. The device generates an oscillation in the respiratory gas to loosen secretions in the lungs and thus facilitate coughing.

[0014] US 2013 / 0269699 A1 discloses a device for respiratory therapy of a patient with a respiratory gas source for specifying different respiratory gas parameters, with at least one control unit and with a signal unit for outputting at least one signal, wherein the signal is a time signal which serves to signal changing respiratory gas parameters and is sensorially perceptible for the patient.

[0015] The disadvantages are that the environment can be disturbed by acoustic signals or that the perception of acoustic signals can be made more difficult by a noisy environment.

[0016] With regard to the perception of optical signals from the environment, light incident on the therapy device (direct sunlight) can interfere with the perception of these provided optical signals. A significant disadvantage, however, is that a physician or assistant is required.

[0017] Furthermore, according to the state of the art, the patient must use his acoustic or optical senses, while his concentration and focus is preferably directed on the intensive mechanical coughing maneuver - i.e., inwardly.

[0018] Another aspect in typical application scenarios is that the use of medical devices is often accompanied by acoustic stimuli that are perceived as disturbing, for example, the inherent noise of the devices or even – sometimes unnecessary – alarms. Accordingly, the object of the present invention is to provide a device for respiratory therapy that overcomes these deficiencies.

[0019] A significant advantage of the present invention is that the patient receives the signaling of changing respiratory gas parameters via the airway and thus very directly and clearly, and is thus able to achieve optimal synchronization of his own cough with the respiratory therapy device.

[0020] A further advantage of the present invention is that the signals according to the invention do not affect other senses such as the eye or ear of the patient, while the patient's entire attention is focused on the process of filling the lungs and preparing for the cough.

[0021] A particular advantage of the present invention is that the signals according to the invention can be perceived by the respiratory system.

[0022] According to the invention, the respiratory apparatus comprises at least the lungs, the upper and lower respiratory tract and also areas of the face that may come into contact with respiratory gas.

[0023] A further advantage of the present invention is that the signals according to the invention are particularly suitable for visually and / or hearing-impaired persons who cannot perceive acoustic or optical stimuli or who can only perceive them to a limited extent.

[0024] This object is achieved according to the invention by providing a device for respiratory therapy according to claim 1.

[0025] The invention relates to a device for respiratory therapy of a patient, comprising a respiratory gas source for specifying different respiratory gas parameters, at least one control unit, and a signal unit for outputting at least one signal. The signal serves to signal changing respiratory gas parameters and is sensorially perceptible to the patient.

[0026] The device indicates that the signal is transmitted pneumatically - i.e. via the airway (device, hose system; patient interface) - to the patient's airway.

[0027] In some embodiments, the device is characterized in that the signal includes a modulation of the predetermined breathing gas in terms of pressure and / or flow and / or volume.

[0028] In some embodiments, the device is characterized in that the signal is preferably sensorily perceptible to the patient via his mechanoreceptors.

[0029] In some embodiments, the device is characterized in that the signal unit is arranged and designed to generate such signals that are perceptible to the patient via his mechanoreceptors.

[0030] In some embodiments, the device is characterized in that the signal unit is configured and designed to generate signals that are perceptible to the patient via his mechanoreceptors and acoustically.

[0031] In some embodiments, the device characterizes that the signal is not visually perceptible and is not a light signal.

[0032] The device is characterized in that the signal unit is designed to generate pneumatic signals and has, for example, a valve and / or a blower.

[0033] In some embodiments, the device is characterized in that the breathing gas source is a blower, which also serves as a signaling unit.

[0034] In some embodiments, the device indicates that the signal is generated by the breathing gas source.

[0035] In some embodiments, the device features that the signal unit is controlled by the control unit.

[0036] In some embodiments, the device features that the changing breathing gas parameter is the breathing gas pressure provided by the device.

[0037] The device is characterized in that the respiratory gas parameter is changed when switching from insufflation to the cough phase (expiration and / or exsufflation).

[0038] In some embodiments, the device is characterized in that the changing respiratory gas parameter is a positive respiratory gas pressure, which is reduced (expiration) or switched to negative pressure (exsufflation) following the insufflation phase for the coughing phase.

[0039] The device is characterized in that the device performs an insufflation with superimposed oscillation, wherein the signal is an oscillation which is modified before switching to the cough phase (exsufflation and / or expiration).

[0040] In some embodiments, the device features that the signal consists in the oscillation being switched off before switching to the cough phase.

[0041] In some embodiments, the device is characterized in that the signal consists in amplifying an existing oscillation.

[0042] In some embodiments, the device is characterized in that the signal comprises a modulation of pressure and / or flow (pneumatic signal).

[0043] The device is characterized in that the signal is a modulated oscillation / oscillation with a fixed or changing frequency and / or amplitude.

[0044] In some embodiments, the device is characterized in that the oscillation has a frequency between one and 40 Hz.

[0045] In some embodiments, the device is characterized in that the oscillation preferably has a frequency between 2 and 30 Hz.

[0046] In some embodiments, the device is characterized in that the oscillation again preferably has a frequency between 3 and 15 Hz

[0047] In some embodiments, the device is characterized in that the amplitude of the oscillation (peak to peak) is 0.2 to 50 hPa.

[0048] In some embodiments, the device is characterized in that the amplitude of the oscillation (peak to peak) is preferably 0.5 to 30 hPa.

[0049] In some embodiments, the device is characterized in that the amplitude of the oscillation (peak to peak) is again preferably between 1 and 20 hPa.

[0050] In some embodiments, the device features that the frequency and / or amplitude change in an increasing manner or change in a decreasing manner.

[0051] In some embodiments, the device features that the frequency and / or amplitude changes dynamically.

[0052] In some embodiments, the device features that the signal is a short positive or negative pressure and / or flow pulse on the air column.

[0053] In some embodiments, the device is characterized in that the device briefly increases a breathing gas pressure starting from a certain pressure towards the end of the insufflation phase and then lowers it back to the previous level (plateau).

[0054] In some embodiments, the device is characterized in that the pressure is raised at least once to the then highest pressure towards the end of the insufflation phase.

[0055] In some embodiments, the device features that the pressure drops briefly and then rises back to the previous level (plateau).

[0056] In some embodiments, the device features that the pressure drops slightly again towards the end of the insufflation phase.

[0057] In some embodiments, the device is characterized in that a (temporary) pressure adjustment is in the range of 0.2 to 8 hPa.

[0058] In some embodiments, the device is characterized in that a (temporary) pressure adjustment is in the range of 0.5 to 5 hPa.

[0059] In some embodiments, the device characterizes that the signal changes between the onset of the signal and the moment of switching.

[0060] In some embodiments, the device is characterized in that the device further comprises a generator for generating a detector signal and a sensor for detecting a change in the detector signal, wherein the detector signal is suitable for detecting changes in the patency of the airways (closure of the glottis) and / or an at least advanced or complete filling of the lungs and the sensor detects this change in the detector signal.

[0061] In some embodiments, the device is characterized in that an automatic switch to the coughing phase occurs when, based on the detector signal, a change in the patency of the airways (closure of the glottis) or at least advanced or complete filling of the lungs is detected.

[0062] In some embodiments, the device is characterized in that the detector signal is an oscillatory excitation and / or response and that a change in airway impedance is determined via a change in the detector signal.

[0063] In some embodiments, the device is characterized in that in the event of a sudden change (increase) in the airway impedance, a closure of the glottis is concluded by measurement.

[0064] In some embodiments, the device is characterized in that the automatic switching is based on an oscillatory pressure, flow and / or volume signal.

[0065] In some embodiments, the device is characterized in that the switching also takes place before the expiration of a stored or set time period if the glottic closure is determined by measurement by a detector signal.

[0066] In some embodiments, the device is characterized in that the preset time period then becomes a maximum duration, which can also be shortened based on a detector signal.

[0067] In some embodiments, the device is characterized in that based on the oscillatory pressure signal, a distinction can be made between open and closed glottis.

[0068] In some embodiments, the device is characterized in that the degree of filling of the lung can be inferred based on the oscillatory pressure signal. In some embodiments, the device is characterized in that the oscillation takes place during insufflation, wherein the oscillation is simultaneously used as the basis for the detector signal and a switchover occurs when, based on the detector signal, it can be inferred that the glottis is closed and / or that the lung is at least largely completely filled before the set insufflation time has elapsed.

[0069] In some embodiments, the device is characterized in that the oscillation is added as a basis for the detector signal for the glottic closure during the course of the insufflation, wherein the insufflation is terminated by a detected glottic closure or upon expiration of the set maximum insufflation time.

[0070] In some embodiments, the device is characterized in that the pneumatic signal is generated for a fixed and / or adjustable period of time

[0071] In some embodiments, the device is characterized in that the pneumatic signal is generated from a fixed and / or adjustable time before switching to the coughing phase.

[0072] In some embodiments, the device is characterized in that the time duration of the generation of the signal is between 0.1 seconds and 2 seconds.

[0073] In some embodiments, the device is characterized in that the time duration of the generation of the signal is between 0.5 seconds and 1.5 seconds.

[0074] In some embodiments, the device is characterized in that the time duration of the generation of the signal is between 0.8 seconds and 1.2 seconds.

[0075] In some embodiments, the device is characterized in that the time before switching from insufflation to exsufflation and / or expiration at which the generation of the signal begins is between 0.1 seconds and 2 seconds.

[0076] In some embodiments, the device is characterized in that the time before switching from insufflation to exsufflation and / or expiration at which the generation of the signal begins is between 0.5 seconds and 1.5 seconds.

[0077] In some embodiments, the device is characterized in that the time before switching from insufflation to exsufflation and / or expiration at which the generation of the signal begins is between 0.8 seconds and 1.2 seconds.

[0078] In some embodiments, the device is characterized in that the pneumatic signal is generated over an adjustable time before switching to exsufflation.

[0079] In some embodiments, the device features that the pneumatic signal is generated based on pressure and flow values.

[0080] In some embodiments, the device features that pressure and / or flow are measured during a maneuver.

[0081] In some embodiments, the device is characterized in that the pneumatic signal is generated on the basis of the detector signal during the insufflation phase.

[0082] In some embodiments, the device features that when the flow is close to 0 l / min (i.e., the patient's lungs are fully filled), the pneumatic signal is generated.

[0083] In some embodiments, the device is characterized in that the signal is generated by a valve integrated into the device.

[0084] In some embodiments, the device is characterized in that the signal is generated by an actuator integrated into the device, which operates according to the displacement principle.

[0085] In some embodiments, the device is characterized in that the actuator operating according to the displacement principle is a piston.

[0086] In some embodiments, the device is characterized in that an oscillation is generated by means of an oscillatory pressure / flow pump.

[0087] In some embodiments, the device is characterized in that the oscillation and / or the pressure jump is generated by means of a valve integrated into the device.

[0088] In some embodiments, the device is characterized in that the flow and / or pressure reduction of the oscillation is generated by variable leakages.

[0089] In some embodiments, the device is characterized in that the flow and / or pressure reduction of the oscillation is generated by reciprocally connecting the airways to the pressure and suction sides of at least one flow source.

[0090] In some embodiments, the device features that the flow or pressure source is a blower.

[0091] In some embodiments, the device is characterized in that the oscillation and / or the pressure jump is generated by volume displacement(s).

[0092] In some embodiments, the device is characterized in that the signal is generated by varying and / or adjusting the speed of the at least one fan integrated into the device.

[0093] In some embodiments, the device is characterized in that toward the end of the insufflation phase, the device temporarily maintains the pressure at one level during a plateau period, and the signaling unit initiates the output of a signal before switching to a lower pressure so that the patient can close the glottis before the pressure is released and the coughing stroke begins.

[0094] The invention also relates to a system for respiratory therapy of a patient comprising the inventive device, wherein the system further comprises a patient interface and a breathing gas hose. It should be noted that the features listed individually in the claims and the description can be combined with one another in any technically reasonable manner and demonstrate further embodiments of the invention. The description further characterizes and specifies the invention, particularly in conjunction with the figures.

[0095] It should also be noted that a conjunction "and / or" used herein between two features and linking them together is always to be interpreted in such a way that in a first embodiment of the subject matter according to the invention only the first feature can be present, in a second embodiment only the second feature can be present and in a third embodiment both the first and the second feature can be present.

[0096] The device for respiratory therapy of a patient comprises at least one respiratory gas source for specifying different respiratory gas parameters, at least one control unit, and at least one signal unit for outputting at least one signal. The signal is sensory perceptible to the patient and serves to signal changing respiratory gas parameters. In the context of the invention, changing respiratory gas parameters are, in particular, changes in the respiratory gas parameters caused by the device. In some embodiments, the signal is transmitted at least pneumatically, i.e., via the airway, to the patient's airway. For example, the airway comprises at least the device, a hose system coupled to the device, and a patient interface coupled to the hose system. In some embodiments, the signal consists of a modulation of the pressure and / or flow to the patient.

[0097] In some embodiments, the signal serves to signal changing respiratory gas parameters in the form of the impending switch from mechanical insufflation to expiration and / or exsufflation during cough therapy and / or cough assistance. Expiration and / or exsufflation represent a cough phase. The signal therefore signals a switch to the cough phase. In some embodiments, during cough therapy, insufflation is followed by a sudden switch-off of the positive insufflation pressure, which forces expiration and possibly also causes the patient to cough. Thus, a switch is made from insufflation to exsufflation and / or expiration. In some embodiments, insufflation is followed by exsufflation, which creates a greater pressure difference to the insufflation and thus also creates greater energy for the cough response.In some embodiments, the signal indicates to the patient that he or she can or should manually switch to expiration and / or exsufflation.

[0098] In some embodiments, the signal is independent of whether the cough phase begins with a switch to expiration or exsufflation following insufflation. In some embodiments, a switch to the cough phase refers in particular to a switch to expiration and / or exsufflation.

[0099] In some embodiments, it may be provided that the insufflation is performed with a superimposed oscillation, wherein the signal consists in changing and / or deactivating the oscillation before switching from insufflation to expiration and / or exsufflation. Changing the oscillation can be achieved, for example, by amplifying or attenuating the oscillation. For example, the amplitude and / or frequency of the oscillation is increased or decreased.

[0100] If insufflation is performed without superimposed oscillation, the signal is intended to consist of a specific modulation before switching to the cough phase with exsufflation or expiration.

[0101] In some embodiments, the signal consists of a modulation of pressure and / or flow, for example, as a pneumatic signal. It can be provided, for example, that the signal is an oscillation and / or oscillation of the pressure and / or flow. The oscillation / oscillation has, for example, a frequency between 1 Hz and 40 Hz, preferably 2 Hz and 30 Hz, more preferably between 3 Hz and 15 Hz. The peak-to-peak amplitude of the oscillation / oscillation is, for example, 0.2 hPa to 50 hPa, for example, 0.5 hPa to 30 hPa. In some embodiments, the amplitude is 1 hPa to 20 hPa.

[0102] Alternatively or additionally, the signal is a short positive or negative pressure and / or flow pulse on the air column, for example in the pressure plateau phase, where the pulse is to be understood relative to the plateau pressure and / or flow. For example, the pressure increases briefly for signaling purposes and then falls back to the previous level, e.g. the plateau pressure. In some embodiments, it can be provided that switching to exsufflation and / or expiration occurs immediately after the pressure has fallen to the plateau pressure. Alternatively, it can be provided that after the pressure has fallen to the plateau pressure, the plateau pressure is maintained for a short time before switching occurs. In some embodiments, it is alternatively or additionally provided that for signaling purposes, the pressure rises towards the end of the plateau phase to a pressure that is then at its highest during insufflation, and that switching then occurs at the highest pressure.It can be provided that the switchover occurs immediately after the highest pressure is reached. Alternatively, it can be provided that the highest pressure is maintained for a certain period of time before the switchover occurs.

[0103] In some embodiments, the signal consists of the pressure briefly dropping during the plateau phase and then rising back to the plateau level before the switchover occurs. It can be provided that the switchover occurs immediately after the return to the plateau level, or that the plateau level is maintained for a while before the switchover occurs. In some embodiments, it can be provided that the pressure is lowered for signaling purposes before the switchover, and the switchover occurs without a return rise.

[0104] The level of (temporary) pressure adjustment - increase or decrease - is 0.2 hPa to 8 hPa, preferably 0.5 hPa to 5 hPa.

[0105] In some embodiments, the signal may also change between the onset of the signal and the switching. For example, the pressure adjustment may increase during the signal, i.e., increase and / or decrease.

[0106] In some embodiments, the device is configured to automatically switch to the cough phase, i.e., expiration and / or exsufflation. The automatic switching can be based, for example, on an oscillatory pressure, flow, and / or volume signal. For example, it can be provided that an oscillation of the flow and / or volume is generated as a stimulus by the device, and the reaction of the airways to this oscillation, for example, in the form of a pressure signal, is measured as a response. In some embodiments, it can be provided that, in addition to the response, any phase shift between the stimulus and the response is also recorded and / or evaluated.

[0107] In some embodiments, it can be provided that the signal is maintained over a period of time until an automatic switchover is triggered based on the response and / or another detector signal. In some embodiments, the response of the airways can also be used to differentiate between a filled lung with an open and a closed glottis. For example, a change in airway impedance can be measured from the response. The state of the glottis (e.g. open / closed, possibly also partially closed) can then be determined from the airway impedance. If, for example, there is a sudden increase in airway impedance, it can be concluded that the glottis is closed. If the glottis closure is determined, for example by measurement, it can be provided that switching from insufflation to expiration or exsufflation takes place.In some embodiments, a time is stored and / or set for which insufflation should or should at least occur. If a glottic closure is detected, switching can also occur before the set or stored time has elapsed. The set or stored time can therefore also be a maximum insufflation time, for example.

[0108] In some embodiments, the device comprises a device (generator) for generating a detector signal and one or more sensors for detecting changes in the detector signal. The detector signal is suitable, for example, for detecting the patency and / or changes in the patency of the patient's airways. Reduced patency of the airways can, for example, indicate a closure of the glottis. In some embodiments, a closure of the glottis is taken as an indication that the patient has inhaled deeply enough and a switch from insufflation to exsufflation or expiration can occur. Alternatively or additionally, the detector signal can be suitable for detecting the filling level and / or changes in the filling level of the patient's lungs.

[0109] In some embodiments, the detector signal is a flow, volume, and / or pressure signal. In some embodiments, the detector signal is generated by an oscillation of the pressure and / or flow. For example, the device for generating the detector signal may be an oscillation valve.

[0110] In some embodiments, a superimposed oscillation may occur throughout the entire insufflation. This oscillation can be used to determine a response from the patient's airways via stimulation, for example in the form of an oscillatory pressure signal, for example, to detect glottic closure. For example, a switchover occurs if a (possibly premature) closure of the glottis occurs.

[0111] In some embodiments, the oscillation is added as a signal to signal the switching. For example, it can be provided that a time is set or stored for which insufflation is to take place before switching, wherein the signal signals, for example, the expiration of this time and the impending switching. If the signaling is via an oscillation, for example of the pressure, this oscillation can be used to determine an oscillatory pressure signal. Since automatic switching occurs when a closure of the glottis is detected, the stored or set time thus becomes a maximum time. In some embodiments, a minimum time can also be set or stored for which at least the period over which insufflation is to take place.

[0112] In some embodiments, alternatively or additionally, it is provided that the pneumatic signal is generated for a specified period of time before switching to exsufflation or expiration. The patient can prepare for the switchover according to the signal. In some embodiments, the specified period of time is between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds. In some embodiments, the specified period of time before switching is preferably between 0.8 and 1.2 seconds. In some embodiments, the time is additionally or alternatively adjustable between 0 seconds and 2 seconds.

[0113] In some embodiments, it may be provided that the intensity of the signal gradually decreases after a number of therapies. For example, it may be provided to accustom the patient to the switching time in this way, so that the patient is increasingly less dependent on the signal and can more easily recognize or anticipate the impending switch. Such an attenuation of the signal is particularly useful, for example, in conjunction with a fixed and / or adjustable signal generation time before the switch and a fixed insufflation time. In some embodiments, it may also be provided that the synchronicity between the patient and the device or therapy is evaluated, and if there is an increasing deviation after the signal has been attenuated, the signal is amplified again.

[0114] Additionally or alternatively, in some embodiments it is provided that the signal is generated based on pressure and / or flow values. For example, the pressure and / or flow are measured during insufflation. At certain pressures and / or flows it can then be provided that the signal is generated to signal a switch from insufflation to expiration or exsufflation. For example, it can be provided that during ventilation the pressure and / or flow is evaluated to determine whether the patient has inhaled deeply enough or whether insufflation is largely complete so that the switchover occurs or can occur promptly. For example, it can be provided that the signal is generated or output when the flow approaches 0 l / min, i.e. when the patient's lungs are fully filled.In some embodiments, it is provided that the device is configured to predict, based on the flow and / or pressure values, when the insufflation will be completed and a switchover will occur, so that the signal is generated for a fixed and / or adjustable period of time starting at a fixed and / or adjustable time before the switchover.

[0115] To generate the signal, it can be provided, for example, that the signal, for example in the form of a pressure adjustment and / or oscillation, is generated by means of a valve integrated into the device. A flow and / or pressure reduction, for example to generate an oscillation, can be generated, for example, by variable leaks. In some embodiments, an oscillation and / or flow or pressure adjustment can be achieved by a reciprocal connection of the respiratory gas path to the patient with the pressure and suction sides of the pressure or flow source. For example, it can be provided that the pressure or flow source is a blower.

[0116] In some embodiments, the signal is generated in the form of an oscillation and / or pressure adjustment via volume shifts. For example, the signal can be generated by varying and / or adjusting the speed of a fan, for example, the pressure or flow source. Alternatively, the volume shifts can also be generated using a displacement principle, such as a piston. In some embodiments, an oscillation is generated via an oscillatory pressure and / or flow pump.

[0117] In some embodiments, the pneumatic signal is accompanied by an acoustic signal. In some embodiments, the acoustic signal is generated by the generation of the pneumatic signal. In some embodiments, the pneumatic signal may be supported by an additionally generated acoustic signal. Alternatively or additionally, the acoustic signal generated by the generation of the pneumatic signal may be additionally amplified.

[0118] In the Figures 1 to 9 The invention is described in more detail using exemplary embodiments.

[0119] In Figure 1An exemplary embodiment of a device 100 for respiratory therapy of a patient 109 is schematically shown. The device 100 comprises, for example, a flow or pressure source in the form of a blower 101, driven, for example, by a controllable motor unit 102. Pneumatically connected to the blower 101 are, for example, at least one valve 107 and a signal unit 106 for generating a signal 204 for signaling changing respiratory gas parameters. The signal unit 106 is, for example, also simultaneously an oscillation valve 110 for generating an oscillation of the pressure and / or flow. A pneumatic connection to the patient 109 is established via a hose system and patient interface (not shown) via the device outlet 108. Pressure and / or flow values, for example, are recorded via sensors 105.

[0120] The control unit 103 at least controls the motor unit 102 for driving the fan 101 as well as the valve 107 and the signal unit 106.

[0121] An exemplary respiratory therapy comprises insufflation 201 of patient 109, wherein the overpressure of insufflation 201 is stopped suddenly or immediately (<500 ms) by switching 202. This is followed by a (forced) expiration or exsufflation 203 of patient 109, also referred to as a coughing phase in the context of the invention. The exemplary device 100 is configured such that insufflation 201 and exsufflation 203 are possible with the blower 101. During exsufflation 203, a negative pressure (relative to the ambient pressure) is generated. A switchover 202 from insufflation 201 to exsufflation 203 is possible, for example, by valve 107. By switching valve 107, the suction side of the blower 101 is switched from ambient air to the respiratory gas path. During insufflation 201, the blower 101 sucks in the ambient air and conveys it as breathing gas towards the patient 109.After switching, the suction side of the blower 101 is connected to the respiratory gas path; the blower thus draws in air from the patient's side 109 and delivers air toward the ambient air. This creates a negative pressure on the patient's side during exsufflation 203. In some embodiments, the device 100 may be configured, additionally or alternatively, such that during the exemplary respiratory therapy, insufflation 201 is not followed by exsufflation 203, but rather the provision of positive pressure ends abruptly after insufflation 201, thus forcing expiration and, ideally, coughing from the patient 109.

[0122] In some embodiments, it may be possible to switch from insufflation 201 to expiration 203a without switching the valve 107. For example, the speed of the fan 101 is suddenly reduced to create a pressure drop.

[0123] According to the invention, the change in respiratory gas parameters by switching 202 from insufflation 201 to expiration 203a and / or exsufflation 203 is signaled or announced by a signal 204. This is preferably a pneumatic signal 204, which is generated in the exemplary device 100 via the signal unit 106. For example, the signal unit is an oscillation valve, which generates an oscillation of the insufflation pressure and / or flow, wherein the oscillation serves at least as signal 204. In some embodiments, the insufflation 201 is superimposed, apart from the signal 204, with an oscillation generated by the oscillation valve 110. A signal 204 can be generated, for example, by stopping the oscillation or by modulating the oscillation, for example by changing the amplitude and / or frequency.

[0124] To generate the signal 204, the signal unit 106 is controlled accordingly by the control unit 103 and controlled with corresponding control signals in order to implement, for example, specifications regarding the start, end, amplitude and / or frequency of the signal 204 in the form of an oscillation.

[0125] If the signal 204 consists of an oscillation, the oscillation has a frequency between 1 Hz and 40 Hz, preferably between 2 Hz and 30 Hz. In some embodiments, the frequency of the oscillation is preferably between 3 Hz and 15 Hz. The amplitude of the oscillation, which serves as signal 204, is, for example, 0.2 hPa to 50 hPa, preferably 0.5 hPa to 30 hPa. In some embodiments, the amplitude of the oscillation of the signal 204 is 1 hPa to 20 hPa. The amplitude denotes the distance between the two peaks.

[0126] Various respiratory gas parameters can be detected via the flow and / or pressure sensors 105. For example, it can be provided that the oscillation during insufflation - both as signal 204 and apart from signal 204 - is used to determine whether and / or when a switchover 202 should occur. In this case, it can be provided that a minimum and / or maximum time for insufflation is set and / or specified. Once the minimum insufflation time is reached, the signal can be generated, for example. The switchover can then occur after a set or specified period of time, for which the signal 204 is generated. Alternatively or additionally, it can be provided that the switchover occurs when it is determined via the oscillation that a switchover should occur.In some embodiments, the adjustable or fixed duration for signal 204 becomes a maximum duration, meaning that switching occurs at the latest after the signal time has elapsed. In some embodiments, alternatively or additionally, a maximum insufflation time is provided, after which switching 202 occurs independently of the oscillation measurements. For example, the maximum insufflation time can correspond to a minimum insufflation time plus a signal time. In some embodiments, particularly if no minimum insufflation time is provided, it can be provided that signal 204 is generated according to the duration of signal 204 before the maximum insufflation time has elapsed.

[0127] Alternatively or additionally, sensors 105 can be used to determine whether the patient's 109 lungs are fully filled and whether a switchover 202 from insufflation 201 to expiration 203a or exsufflation 203 should occur. For example, a flow approaching 0 l / min may indicate a fully filled lung, so that control unit 103 controls signal unit 106 to generate signal 204 to signal changing respiratory gas parameters—here, the switchover from insufflation to exsufflation 203 or expiration 203a.

[0128] For example, inputs of data, information, and / or parameters are possible via the user interface 104. Among other things, parameters for the signal 204 can be entered. For example, the time before switching, duration, frequency, amplitude, and / or intensity of the signal 204 can be set. The time is, for example, a duration of the signal 204 and / or from when the signal 204 is generated before the switching 202 from insufflation 201 to exsufflation 203 or expiration. For example, it can be specified and / or adjustable that the signal is generated over a period of 0.1 to 2 seconds. The adjustable and / or fixed period is preferably 0.5 seconds to 1.5 seconds. In some embodiments, the adjustable and / or fixed period is preferably 0.8 seconds to 1.2 seconds.

[0129] In some embodiments, alternatively or additionally, the blower 101 or the motor unit 102 and / or the valve 107 can be designed as a signal unit 106. For example, it can be provided that the device 100 comprises several signal units 106, which can generate different types of signals 204. How the blower 101 and / or the valve 107 can be used as signal units 106 is described in more detail in the Figure 2 and 3 explained.

[0130] Another exemplary embodiment of the device 100 is shown in Figure 2 shown schematically. The exemplary device 100 has at least one breathing gas source in the form of a blower 101, which is driven by a motor unit 102 controllable by the control unit 103.

[0131] The device 100 further comprises a valve 107 which can switch between an insufflation 201 and an exsufflation 203, as also shown in the Figure 1 described embodiment. The gas flow is switched so that the suction side of the blower 101 is connected to an intake area for ambient air during insufflation 201. For exsufflation 203, the valve is switched so that the suction side of the blower 101 is connected to the respiratory gas path to or from the patient 109, thus generating a negative pressure for the patient 109.

[0132] The valve 107 is also configured as a signal unit 106 and can be controlled by the control unit 103 to generate a pneumatic signal 204 to signal changing respiratory gas parameters. In particular, the signal 204 can signal a switchover 202 from insufflation 201 to exsufflation 203 or expiration 203a.

[0133] The signal 204 can, for example, be an adjustment of the pressure and / or flow during insufflation 201. It can also be provided that an oscillation can be generated as signal 204 by targeted switching of the valve 107.

[0134] For example, an adjustment of the pressure and / or flow to generate the signal 204 can be achieved in this way. In this case, the pressure and / or flow is increased or decreased for a fixed and / or adjustable time before switching. A one-time, brief reduction in pressure can be achieved, for example, by briefly switching the valve 107, so that for a brief moment the suction side of the blower 101 is connected to the respiratory gas path from / to the patient 109, thus briefly reducing the pressure there. In some embodiments, a reduction in the speed of the blower 101 can be provided, for example for a longer period in which a lower pressure is to serve as signal 204. Likewise, an increase in the pressure as signal 204 can be achieved by increasing the speed of the blower 101.

[0135] The sensor unit 105 and the user interface 104 are exemplary as in the embodiments of the Figure 1 executed.

[0136] Figure 3 schematically shows an exemplary embodiment of the device 100 for respiratory therapy of a patient 109. The device 100 has a respiratory gas source in the form of a blower 101 driven by a motor unit 102, which is also designed as a signaling unit 106. The blower 101 is configured, for example, to provide the patient 109 with positive pressure during an insufflation 201. By suddenly switching to expiration 203a, for example by suddenly braking the blower 101, an expiration can be forced in the patient 109 and a cough can be triggered. Thus, the device switches from the insufflation 201 to the coughing phase. In order to signal, among other things, these changing respiratory gas parameters, a pneumatic signal can be generated by the signaling unit 106.

[0137] To generate signal 204, motor 102 is controlled by control unit 103 such that blower 101 can generate variations in the pressure provided during insufflation 201. For example, the generation of signal 204 begins a time before switching and then continues for a certain period of time.

[0138] For example, an oscillatory signal 204 can be generated by periodically decreasing and increasing the rotational speed. In some embodiments, the entire insufflation 201 can be superimposed with an oscillation. The signal 204 can then consist, for example, of the oscillation being modulated, i.e., changing its frequency and / or amplitude. It can also be provided that the signal 204 is generated by stopping the oscillation.

[0139] In some embodiments, signal 204 is provided as a change in pressure and / or flow. For example, to generate signal 204s, the speed of fan 101 is increased, which leads to an at least temporarily increasing pressure and / or flow and signals changing respiratory gas parameters, in particular the switching from insufflation 201 to expiration 203a, to the patient 109 via signal 204. In some embodiments, it can be provided that the increase in pressure and / or flow does not last for the entire period until switching, but only for a shorter period before switching. Alternatively or additionally, signal 204 can be provided as an at least temporary reduction in pressure. For example, the pressure is briefly reduced and then raised again to the plateau level of insufflation 201 before switching occurs.

[0140] The sensor unit 105 and the user interface 104 are exemplary as in the embodiments of the Figure 1 executed.

[0141] In the Figures 4 to 9 Various pressure curves of an insufflation 201 and exsufflation 203 or expiration 203a are shown schematically as examples. Figure 4a describes an example of a pressure curve for insufflation 201 and exsufflation 203 according to the state of the art, Figure 4b shows expiration 203a instead of exsufflation 203. In the Figures 5 to 9Various signals 204 are shown as examples before switching based on a pressure curve with insufflation 201 and exsufflation 203. The signals 204 can equally well be applied to embodiments in which no exsufflation 203 occurs after switching, but rather a switch to expiration 203a is provided. In the diagrams shown, the x-axis denotes the pressure p and the y-axis denotes time t. The zero line shown here refers to the ambient pressure. A pressure p of zero corresponds to the ambient pressure.

[0142] Figure 4ashows a schematic of an exemplary pressure curve for an insufflation 201 followed by an exsufflation 203 according to the prior art. At the beginning of insufflation 201, the pressure p increases until a plateau level is reached. This plateau is maintained for a time until insufflation 201 is completed and switching 202 to exsufflation 203 occurs. By switching 202 to exsufflation 203, the pressure drops rapidly and forces the patient to exhale and / or cough. During exsufflation 203, a negative pressure (relative to the ambient pressure) is provided to the patient or a negative pressure is applied towards the patient's airways 109, whereby exhalation or coughing is more strongly forced.

[0143] Figure 4bschematically shows an exemplary pressure curve for an insufflation 201 during which a switchover 202 to expiration 203a occurs. In contrast to exsufflation 203, no negative pressure relative to the ambient pressure is provided here; rather, the positive pressure provided during insufflation 201 is sharply and suddenly reduced and, in some embodiments, approaches ambient pressure. Due to the sharp reduction in pressure, the patient is forced into an expiration 203a, possibly accompanied by a cough.

[0144] An exemplary embodiment of the signal 204 is shown in Figure 5shown schematically. The signal 204 is shown by way of example in an embodiment with insufflation 201 and exsufflation 203, but can equally be applied to embodiments in which the insufflation 201 is followed by expiration 203a without a negative pressure being provided. After an increase, the pressure during the insufflation 201 reaches a plateau level at which the pressure for the insufflation 201 is kept essentially constant and the patient 109 is ventilated with a positive pressure. At an adjustable or fixed time before the switchover 202, the signal 204 signals to the patient 109 changing respiratory gas parameters, here by way of example the switchover 202 from insufflation 201 to exsufflation 203. Changing respiratory gas parameters are at least the pressure and / or the flow, which change due to the switchover 202. The signal 204 is generated, for example, for an adjustable or fixed period of time.This time period can be, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds. In some embodiments, the duration of signal 204 is preferably between 0.8 seconds and 1.2 seconds. The time before switching, at which the generation of signal 204 begins, is, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds, more preferably between 0.8 seconds and 1.2 seconds.

[0145] In the Figure 5In the embodiment shown, the signal 204 consists of a pressure oscillation 205. The oscillation 205 can be generated, for example, by periodically increasing and decreasing the speed of a fan 101 and / or by switching an oscillation valve 110. In some embodiments, a valve 107, which switches the suction side of the fan 101, can also generate a pressure oscillation 205 and thus a pneumatic signal 204.

[0146] The amplitude of the oscillation 205 is between 0.2 hPa and 50 hPa, preferably between 0.5 hPa and 30 hPa. In some embodiments, the amplitude is preferably between 1 hPa and 20 hPa. The amplitude refers to the distance between the peaks.

[0147] The frequency of the oscillation 205 is between 1 Hz and 40 Hz, preferably between 2 Hz and 30 Hz. In some embodiments, the frequency of the oscillation 205 is preferably between 3 Hz and 15 Hz.

[0148] In some embodiments, it can be provided that the frequency and / or amplitude of the oscillation 205 change in an increasing and / or decreasing manner during the generation of the signal. Alternatively or additionally, it can also be provided that the frequency and / or amplitude change dynamically. In some embodiments, it can be provided that the amplitude and / or frequency initially increases and then decreases again. For example, the amplitude and / or frequency itself can oscillate, i.e., periodically increase and decrease. In some embodiments, it can be provided that the frequency and / or amplitude of the oscillation 205 increases towards the time of switching 202 and reaches its maximum immediately before switching 202.

[0149] For example, it may be provided that the time before switching 202, the duration of the signal 204, the frequency and / or amplitude of the oscillation 205 are adjustable via the user interface 104. Additionally or alternatively, it may be provided that the time before switching 202, the duration of the signal 204, the frequency and / or amplitude of the oscillation 205 are fixed and / or can be selected from fixed values.

[0150] In some embodiments, it may be provided that the oscillation 205 used as signal 204 is also used for measuring purposes, for example to use respiratory gas signals to draw conclusions about various respiratory parameters, e.g. the filling state of the lungs of the patient 109 and / or secretion deposits.

[0151] A further exemplary embodiment of the signal 204 for signaling changing respiratory parameters, in particular the switching 202 from insufflation 201 to exsufflation 203 or expiration 203a (not shown here), is shown in Figure 6 shown schematically.

[0152] For example, insufflation 201 is superimposed with an oscillation 207. In this case, signal 204 consists of a switching off 206 of oscillation 207. At a specified and / or adjustable time before switching 202 from insufflation 201 to exsufflation 203, oscillation 207 is switched off to signal to patient 109 that switching 202 from insufflation 201 to exsufflation 203 will occur after a certain period of time.

[0153] The duration can be, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds. In some embodiments, the duration of signal 204 is preferably between 0.8 seconds and 1.2 seconds. The time before switching, at which the generation of signal 204 begins, is, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds, more preferably between 0.8 seconds and 1.2 seconds. In some embodiments, the duration corresponds to the time before switching.

[0154] In some embodiments, it may be provided that the insufflation 201 takes place for a fixed and / or adjustable time. Alternatively or additionally, it may be provided that the time of the insufflation 201 is dynamically adjusted, for example, based on values ​​recorded by the sensors 105. For example, a filling level of the lungs of the patient 109 can be determined. Once a certain filling level is reached, it may be provided that the switchover 202 is signaled. In some embodiments, the oscillation 207 can be used to determine various respiratory parameters of the patient 109, which are then evaluated, for example, to determine whether a switchover 202 should take place.

[0155] In some embodiments, an oscillation 207 during insufflation 201 may also include a modulation 208 of the oscillation to signal changing respiratory gas parameters, such as switching 202 from insufflation 201 to exsufflation 203. Such an embodiment is illustrated by way of example in Figure 7 At a time before switching 202, a pneumatic signal 204 is generated for the patient 109 via a modulation 208 of the oscillation, which signals the upcoming changes in respiratory gas parameters. For example, the amplitude and / or frequency of the oscillation is increased or decreased.

[0156] The amplitude of the modulated oscillation 208 is between 0.2 hPa and 50 hPa, preferably between 0.5 hPa and 30 hPa. In some embodiments, the amplitude is preferably between 1 hPa and 20 hPa. The amplitude refers to the distance between the peaks.

[0157] The frequency of the modulated oscillation 208 is between 1 Hz and 40 Hz, preferably between 2 Hz and 30 Hz. In some embodiments, the frequency of the oscillation 205 is preferably between 3 Hz and 15 Hz.

[0158] The duration of signal 204 can be, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds. In some embodiments, the duration of signal 204 is preferably between 0.8 seconds and 1.2 seconds. The time before switching, at which the generation of signal 204 begins, is, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds, more preferably between 0.8 seconds and 1.2 seconds. In some embodiments, the duration corresponds to the time before switching.

[0159] In some embodiments, the signal 204 consists of a temporary increase 209 of the pressure, as in Figure 8shown by way of example. In this case, at a time before switching 202, the plateau pressure of insufflation 201 is further raised in order to then provide a maximum pressure. This raised pressure 209 remains, for example, for a period of time. The switching from insufflation 201 to exsufflation 203 then occurs from the raised pressure 209 of signal 204 without returning to the plateau level. In some embodiments, it can be provided alternatively or additionally that the raised pressure 209 is not maintained until switching 202, but rather first drops back to plateau level and only after a further period of time does the switching 202 to exsufflation 203 occur. Alternatively or additionally, it can be provided that the pressure increases continuously until switching and reaches the maximum immediately before switching 202.

[0160] The duration of signal 204 can be, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds. In some embodiments, the duration of signal 204 is preferably between 0.8 seconds and 1.2 seconds. The time before switching, at which the generation of signal 204 begins, is, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds, more preferably between 0.8 seconds and 1.2 seconds. In some embodiments, the duration corresponds to the time before switching.

[0161] To generate signal 204, the pressure can be temporarily increased, for example, within a range of 0.2 hPa to 8 hPa. Preferably, the pressure is temporarily increased within a range of 0.5 hPa to 5 hPa. The pressure increase 209 can be generated, for example, via an increased speed of fan 101.

[0162] In some embodiments, the signal 204 consists of a temporary lowering 210 of the pressure, as in Figure 9 shown by way of example. In this case, at a time before switching 202, the plateau pressure of insufflation 201 is at least temporarily reduced. This reduced pressure 210 remains, for example, for a period of time. The switching from insufflation 201 to exsufflation 203 then occurs from the reduced pressure 210 of signal 204 without returning to the plateau level. In some embodiments, it can be provided alternatively or additionally that the reduced pressure 210 is not maintained until switching 202, but is first raised again to plateau level and only after a further period of time does the switching 202 to exsufflation 203 occur. Alternatively or additionally, it can be provided that the pressure decreases continuously until switching and from there, switching directly to exsufflation 203.

[0163] The duration of signal 204 can be, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds. In some embodiments, the duration of signal 204 is preferably between 0.8 seconds and 1.2 seconds. The time before switching, at which the generation of signal 204 begins, is, for example, between 0.1 seconds and 2 seconds, preferably between 0.5 seconds and 1.5 seconds, more preferably between 0.8 seconds and 1.2 seconds. In some embodiments, the duration corresponds to the time before switching.

[0164] To generate signal 204, the pressure can be temporarily reduced, for example, within a range of 0.2 hPa to 8 hPa. Preferably, the pressure is temporarily reduced within a range of 0.5 hPa to 5 hPa. The pressure reduction 210 can be achieved, for example, by reducing the speed of the fan 101.

Claims

1. An apparatus (100) for respiratory therapy of a patient with a respiratory gas source (101) for specifying different respiratory gas parameters, with at least one control unit (103) and with a signal unit (106) for outputting at least one signal, wherein the signal serves to signal changing respiratory gas parameters and is perceptible to the patient through the senses, wherein the signal is a modulated vibration / oscillation with a fixed or variable frequency and / or amplitude, characterized in that the signal unit is designed to generate at least one pneumatic signal and wherein the apparatus is configured to change the respiratory gas parameter when switching from insufflation to the cough phase and wherein the apparatus is configured to perform insufflation with a superimposed oscillation, wherein the signal is a modulated oscillation that is changed before the switch to the cough phase.

2. The apparatus (100) according to at least one of the preceding claims, wherein the signal unit (106) is controlled by the control unit (103).

3. The apparatus (100) according to at least one of the preceding claims, wherein the variable respiratory gas parameter is the respiratory gas pressure provided by the apparatus.

4. The apparatus (100) according to claim 1, wherein the variable respiratory gas parameter is a positive respiratory gas pressure which is reduced or is switched to negative pressure for the cough phase at the conclusion of the insufflation phase.

5. The apparatus (100) according to at least one of the preceding claims 1 or 4, wherein the apparatus is configured to perform insufflation without oscillation, wherein the signal is a specific modulation of the respiratory gas with regard to pressure and / or flow and / or volume.

6. The apparatus (100) according to claim 1, wherein the vibration has a frequency between one and 40 Hz, preferably a frequency between 2 and 30 Hz, and that the amplitude of the vibration is 0.2 to 50 hPa, preferably 0.5 to 30 hPa.

7. The apparatus (100) according to at least one of the preceding claims, wherein the apparatus also has a generator for generating a detector signal and a sensor (105) for determining a change in the detector signal, wherein the apparatus is configured to detect, using the detector signal, changes in the patency of the airways and / or an at least advanced or complete filling of the lung and the sensor determines this change in the detector signal.

8. The apparatus according to claim 1, wherein an automatic switch to the cough phase occurs when, based on the detector signal, a change in the patency of the airways or an at least advanced or complete filling of the lung is determined.

9. The apparatus (100) according to at least one of the preceding claims 1 or 8, wherein the automatic switch is based on an oscillatory pressure, flow, and / or volume signal.

10. The apparatus (100) according to at least one of the preceding claims 1, 8, or 9, wherein the switch also takes places before a saved or set time duration has elapsed when glottal closure is ascertained by measurement by means of a detector signal.

11. The apparatus (100) according to at least one of the preceding claims 1, 4, or 5, wherein the oscillation takes place during insufflation, wherein the oscillation is used simultaneously as the basis for the detector signal and a switch occurs when, based on the detector signal, a closure of the glottis and / or an at least largely completely filled lung can be inferred before the set insufflation time has elapsed.

12. A system for respiratory therapy of a patient comprising an apparatus (100) according to at least one of the preceding claims, wherein the system also comprises a patient interface and a respiratory gas hose.