Device for ventilation and method for controlling a ventilator

Abstract

A ventilation device comprising a respiratory gas source connectable to a patient interface and a control unit designed to specify at least two different ventilation modes, and in which the control unit is designed to automatically detect, select, and apply the various ventilation modes for at least some respiratory disturbances according to a current patient-specific need, characterized in that the device is equipped with an identification number that allows for unique identification in a network or when connected to a PC in order to assign stored information from a database, and in that the device is equipped with a telemetry unit for outpatient use and / or at the patient's home.wherein the control unit has an analyzer for detecting at least one artifact and wherein the analyzer is coupled to the control unit in such a way that, upon detection of the artifact, an erroneous pressure change specified by the adaptation unit is avoided, wherein the detection of an artifact is exploited by the fact that specific artifacts lead to typical influences on the measured respiratory parameter and wherein the corresponding typical temporal profiles of the respiratory parameter, which are assigned to a specific artifact, enable an automatic evaluation of the signal profile with regard to the respective profiles and thus a control-technical identification of the respective artifact and wherein corresponding specific artifacts recognizable in the signal profile are mouth expiration, mouth breathing, leakage, swallowing, speaking or coughing and upon automatic detection of such events,The pressure control is modified in such a way that those measurement parameters which are evaluated by the control unit for a pressure increase or a pressure decrease in a normal state and which can no longer be reliably evaluated when the respective artifact occurs are not taken into account by the control unit for the duration of the artifact's occurrence.

Description

[0001] The invention relates to a ventilation device comprising a respiratory gas source connectable to a patient interface and a control unit designed to specify at least two different ventilation modes, and in which the control unit is designed to automatically detect, select and apply the different ventilation modes in at least some respiratory disorders according to a current patient-specific need.

[0002] The invention further relates to a device for ventilation which has a respiratory gas source connectable to a patient interface and a control unit which is designed to specify at least two different modes of ventilation, in which a sensor for detecting at least one parameter is connected to the control unit and in which the control unit is equipped with an event detection system.

[0003] For obstructive sleep apnea syndrome, determining the individual pressure for CPAP therapy (continuous positive airway pressure) is necessary. CPAP therapy is typically set during a titration night in a sleep lab. Various methods are used to determine the optimal constant pressure for the patient, ensuring the upper airways remain open. Currently, therapy initiation is quite conservative, taking place almost exclusively in a hospital setting and not at home. The optimal therapeutic CPAP can be determined through manual or automated titration during polysomnography or respiratory polygraphy.

[0004] The usual titration method for finding the optimal CPAP pressure consists of a gradual increase of the CPAP pressure during a nightly polysomnography until obstructive apneas, hypopneas and snoring no longer occur.

[0005] Alternatively, a CPAP device with automatic pressure regulation (auto-CPAP device) can be used in the clinic and / or at the patient's home for one or more nights. A pressure percentile can then be determined based on the data recorded by the device and set for long-term therapy, even though these devices are actually designed to deliver the minimum ventilation pressure currently required by the patient.

[0006] Currently, nasal CPAP therapy (nCPAP) with constant pressure and an individually adjustable increase rate at the beginning of sleep is the method of choice for moderate to severe sleep apnea syndrome. If a particularly high pressure is required, it is often poorly tolerated by patients. In these cases, the APAP or BiLevel method is frequently used. With the latter, a higher pressure is applied during inspiration and a lower pressure during expiration. This reduces the overall pressure load. This makes it possible to transition some patients to a positive pressure therapy.

[0007] Many patients with obstructive sleep apnea have a highly fluctuating pressure requirement; in these cases, "auto-CPAP devices," also called "smart CPAP devices," can be helpful. They detect at any given time whether an obstruction is developing and intervene in a timely manner, i.e., by increasing the pressure, to prevent airway closure.

[0008] Pressure oscillations integrated into the measurement procedure enable a differentiation between so-called open and closed apneas.

[0009] The automatic CPAP pressure is varied depending on signs of respiratory obstruction. The pressure is reduced to a minimum of 3 cmH2O.

[0010] Another application of positive pressure ventilation is non-invasive ventilation. In this case, the ventilator supports the failing respiratory system. Technical innovations such as more compact ventilators and, above all, leak-reducing nasal masks, which in many cases replace tracheostomy, have led to improvements in therapeutic options in recent years.

[0011] Indications for home ventilation include, among others, ventilation disorders in neuromuscular diseases (e.g., central sleep apnea syndrome, primary alveolar hypoventilation syndrome, obesity hypoventilation syndrome, CPAP-refractory obstructive sleep apnea syndrome, poliomyelitis and post-polio syndrome, spinal muscular atrophies, high cervical lesions, Guillain-Barré polyradiculitis, myopathies) as well as restrictive ventilation syndromes in diseases of the skeleton, pleura and lungs (e.g., kyphoscoliosis, status post extensive lung resection, extensive scarring of the pleura and lungs, status post thoracoplasty).

[0012] When titrating the optimal therapy pressure for treating obstructive sleep apnea syndrome, researchers typically look for signal parameters that allow for early detection of obstruction. For example, a plateau in the inspiratory flow signal can be observed as a sensitive indicator of mild obstruction. Increasing the CPAP pressure counteracts the increased resistance in the upper airways and leads to a normalization of the flow pattern.

[0013] A reliable but very invasive method for determining the level of obstruction is the combined measurement of esophageal pressure and airflow.

[0014] A convenient alternative is the measurement of respiratory impedance.

[0015] Automatic CPAP titrations are based on respiratory parameters that characterize the severity of upper airway obstruction.

[0016] The stepwise adjustment of CPAP pressure or ventilation parameters during nocturnal polysomnography (PSG) to optimize patient settings is not entirely free of subjective factors. For standardization, reproducibility, and traceability of the automated procedure, it would be a significant advantage if sufficiently accurate ventilation settings could be achieved using predefined algorithms.

[0017] Another advantage is that the computer-adjusted pressure is only applied during obstruction or hypoventilation, and the nCPAP pressure is significantly reduced during waking hours or periods of non-obstructive breathing. This could improve acceptance of the method and potentially also sleep quality, even during the titration phase.

[0018] Various measurements, such as oxygen saturation and airflow, can be considered for automated titration. For example, increased resistance in the upper airways can lead to a flattening of the inspiratory airflow / time curve. Therefore, increased resistance in the extrathoracic airways can be detected from the pattern of inspiratory airflow or other physiological or device signals even before the onset of significant hypopneas.

[0019] A ventilator with a device for automatically determining a critical air pressure is already known from US patent 65 30 372 B1.

[0020] US 6000396A describes a ventilator with an electronic ventilation system. The device can be operated in different modes.

[0021] US 20 020 884 65 A1 describes a ventilator in which it is possible to determine a maximum flow.

[0022] US patent 20 020 185 130 A1 discloses a ventilator with a device for automatically detecting critical health conditions of the patient.

[0023] DE 101 18 475 A1 describes a ventilator with a self-regulating pressure control.

[0024] From EP 11 36 00 94 A2, a ventilator with two differently adjustable pressure levels is known. The ventilation pressure is controlled depending on a measured ventilation parameter using pattern recognition.

[0025] From US patent 2003 / 0176774 A1, it is known to equip a device with an identification number, wherein the identification number supports unique identification within a network. Furthermore, the use of a telemetry unit in connection with mobile deployment is described.

[0026] The object of the present invention is to construct a device of the type mentioned in the introduction in such a way that automatic titration is supported.

[0027] This problem is solved according to the invention by equipping the device with an identification number that allows for unique identification in a network or when connected to a PC in order to assign stored information from a database, and by equipping the device with a telemetry unit for outpatient use.

[0028] This allows the settings to be adjusted regardless of location, e.g., at the patient's home. Furthermore, the device can be used for remote adjustment, therapy monitoring, and autotitration via a data processing program. This program automatically detects the connected device upon establishing communication and allows all titration parameters to be set.

[0029] This can result in significant cost and time savings, as more patients can be monitored simultaneously with fewer staff. Furthermore, better results can be achieved in home settings due to the patient's familiar environment.

[0030] Furthermore, such a titration / therapy device can close the existing gap between diagnosis and therapy.

[0031] The drawings schematically illustrate exemplary embodiments of the invention. They show: Fig. 1. A user interface for entering and displaying device parameters, Fig. 2. Another control screen for event evaluation, Fig. 3 a representation of cumulative pressure profiles, Fig. 4 a technical diagram of the equipment, Fig. 5 a representation of a displayed print history, Fig. 6. A screen display of a results compilation. Fig. 7 signal waveforms for performing the titration, Fig. 8 a perspective view of a ventilator with breathing gas hose and breathing mask, Fig. 9. A pressure curve to illustrate a control characteristic of the ventilator. Fig. 10 a flowchart for carrying out device control and Fig. 11. A block diagram for the structured representation of the device control.

[0032] The process involves analysis by at least one sensor that records physiological and device-specific signals such as compliance, resistance, blood values ​​(O2, CO2, HB, CO, etc.), pressure, flow, MDS, temperature, motor power, and fan current and voltage, and transmits this data to an analyzer. Using a selection function, the analyzer compares the received signal information with information stored in memory (which can be deleted or modified). This information is based on an individual patient history and / or evaluated patient histories, which are linked and analyzed using fuzzy logic and / or neural networks. The analyzer performs a mode assignment, and based on this assignment, including parameter settings, a control unit is activated to control effectors (display, fan, etc.).

[0033] Alternatively [specifically for APAP titration and BiLevel titration], the analysis can also be performed by a person who independently assigns the mode.

[0034] In its preferred form, the concept allows the physician to select and configure an existing ventilation mode / type (automatic with fixed pressure profiles, CPAP, APAP, BiLevel, CPAP autotitration, BiLevel autotitration, etc.) during the diagnostic phase. Alternatively, an automatic option can be selected, in which the device independently initiates ventilation based on various parameters provided and measured by the patient.

[0035] In the relevant modes, after the titration phase, the device issues a therapy recommendation, which is either implemented immediately without further consultation with the physician or must first be confirmed by the physician / user. Furthermore, additional recommendations are issued regarding any necessary oxygen or aerosol therapy and / or the mask or human-machine interface to be used.

[0036] In a further particularly preferred embodiment, after the device is started, current parameters of the device, such as pressure, flow, MDS, temperature, as well as of the patient, such as compliance, resistance, blood values ​​(O2, CO2, HB, CO, etc.), are measured. This is done in Fig. Figure 10 illustrates this. In a further step, these values ​​are compared with the data from an individual patient history, with values ​​preset in the parameter software, and / or with ideal values ​​in an automatic mode, and an assessment of the patient's demand-based ventilation is calculated. This is shown in Fig. 11 clearly.

[0037] The device generates a recommendation for demand-based ventilation, suggesting the type of ventilation (e.g., CPAP, APAP, BiLevel) along with its associated ventilation parameters, as well as the type of additional, supportive functions of the device (e.g., oxygen delivery, patient data monitoring and storage, aerosol therapy, humidifier, full-face mask, etc.). The physician can then accept the therapy as suggested by the device or adjust and configure the ventilation parameters within the ranges within which the device is permitted to change the parameters independently.

[0038] During the initial setup of the device, the doctor can also grant it almost complete autonomy to change the parameters, so that after the therapy recommendation, the device automatically switches to the recommended mode and continues to ventilate the patient in this mode.

[0039] The device continuously monitors and adjusts its parameters until the patient receives the appropriate level of ventilation. This can be done either at a predefined or automatic interval, or by generating a new recommendation based on the severity of the respiratory distress.

[0040] If the patient is ventilated as needed, the cycle can begin again after a set or automatic interval.

[0041] The device and the procedure utilize a technology that incorporates continuous, automatic event detection derived from MDS (modulated pressure signal), flow, and pressure-related parameters, as well as ventilation pressure-related artifact detection, to control the applied ventilation pressure. However, this is not only for controlling ventilation pressure, but also for determining various parameters important for ventilation. The events and artifacts occurring during breathing are fed into an event-indexing rule set in the titration modes during ventilation application to determine the optimal and sufficient therapeutic pressures and other ventilation parameters for the patient.

[0042] APAP devices are equipped with pressurized gas sources that are connected to a patient's airways via a breathing tube and a face mask. The pressurized gas source is typically controlled by adjusting the pressure based on a measured respiratory parameter, such as flow or pressure.

[0043] As a further embodiment, particularly for outpatient titration and / or titration at the user's home, it is envisaged that a diagnostic device records a patient's physiological signals and submits them for evaluation. The evaluation is performed automatically according to definable criteria such as AHI.

[0044] Based on the results of the evaluation, the diagnostic device signals a recommendation, for example, a request to the patient to use a ventilator, such as a CPAP-APAP-Bilevel device.

[0045] The diagnostic device communicates with the ventilator in the sense of a titration. Both devices can influence each other. Ideally, the diagnostic device controls the ventilator.

[0046] By adjusting the ventilation parameters, an optimal setting of the ventilator for the patient is determined and / or maintained.

[0047] In a further embodiment of the invention, if a need for therapy is detected, the diagnostic device triggers an alarm to wake the patient so that he can put on the ventilator.

[0048] During the second part of the night, the diagnostic device continues to record signals and controls the ventilator, in the sense of a titration, in such a way that an optimal therapy for the patient is determined and / or maintained.

[0049] This makes it possible to diagnose and adjust therapy at the patient's home in just one night.

[0050] In a supplementary embodiment, the doctor receives a diagnostic and a therapy report from the same night.

[0051] A further major advantage of the present invention is the optional coupling of the therapy device with a diagnostic device or with the PC software of the diagnostic device for configuring the therapy device or for feeding signals, detected events, or internal states of the therapy device into the diagnostic device. This input is possible online or offline with a very fast data transmission time, so that the therapy device, coupled with a device for acquiring polysomnographic data, can perform diagnostics regarding sleep stages and position, hypoxia, cardiac disorders, hyper / hypocapnia, leg movements, respiratory effort, mouth and mask leaks, mouth expirations, signs of obstruction such as snoring, flow limitations, obstructive apneas and hypopneas, as well as hyper- and hypoventilation, centrally mediated respiratory disorders, and other conditions.

[0052] The device operates both standalone and in conjunction with computer programs for remote configuration, data visualization, and analysis. Event-driven pressure adjustment is performed depending on the selected device mode. However, event detection and storage are identical in all device modes.

[0053] It has the following modes: • CPAP autotitration mode (various rule sets are available) • Print profile mode (fixed and adjustable print profiles) • CPAP mode (for the control night or manual titration) • APAP mode • Bi-Level mode (optional) • APAP residual index mode • Autotitration Bi-Level mode (optional) • Automatic mode (device selects ventilation mode automatically or as a result of data supplied by the diagnostic device or the sensor and analyzer) (optional) Mode selection with effector control

[0054] In CPAP autotitration mode, pressure adjustments are performed based on events according to the selected rule set. The rule set defines the weighting of the events (for calculating the event index) as well as the parameters for pressure adjustment.

[0055] The preferred embodiment includes a fixed rule set (AT1) and a user-defined rule set (AT2). The user can activate the fixed or user-defined rule set in standby (offline) mode. The rule set parameters can be viewed and modified (user-defined rule set only) in standby (offline) mode using PC software (via the serial interface).

[0056] In a particularly preferred embodiment, the user can specify or set the following parameters for ventilation in the control system, which can also be configured via the interface: the period or different periods for the start and end of titration, minimum waiting times for pressure adjustment, and the following parameters: Starting pressure, control start, lower and upper pressure limits, pressure rise rate, rule for recommended titration pressure, split night option.

[0057] The starting pressure can be adjusted according to Fig. The following settings can be set: 1. Pressure between 3 and 80 hPa in 0.1 hPa increments, 2. Control start time between 0 and 600 minutes in 5-minute increments, 3. Lower pressure limit between 3 and 80 hPa in 0.1 hPa increments, 4. Upper pressure limit between 3 and 80 hPa in 0.1 hPa increments, 5. Pressure rise rate between 0.1 and 0.6 hPa / s in 0.1 hPa / s increments. The current event index [ / h] and the current pressure can be displayed via the software.

[0058] Furthermore, in a particularly preferred embodiment, the weighting factors and control criteria for pressure increase and decrease can be included in the control set. While all control sets can be saved in the software, only a user-defined control set and a default control set are stored in the therapy device. The default control set in the therapy device cannot be overwritten. Changes to the settings of the control set in the therapy device can only be made to the user-defined control set.

[0059] In autotitration mode, a split-night option is implemented in a particularly advantageous form. This means that the titration is stopped after a defined time, the recommended titration pressure is calculated, and then the therapy is carried out at this calculated pressure. A minimum titration time cannot be undercut, and the titration range can be increased in increments (e.g., a titration range of 60–600 minutes or no automatic titration termination).

[0060] In a preferred format, the resulting CPAP cycle is saved in the device's log and can be accessed by the physician. The device can be operated, for example, via a user interface consisting of buttons, rotary knobs, touchscreens, and / or other controls; only the preset pressure profiles and rules can be activated directly on the device, not edited. Editing the titration parameters, the pressure profile, or manually adjusting the pressure requires a connection to a PC and software via an interface.

[0061] In a particularly preferred form, the recommended titration pressure can be calculated as time-related pressure percentiles or as event-related pressure percentiles. In each case, a value for the percentile and a percentage value can be specified in defined increments from a base value (e.g., 10%) of the titration time. Alternatively, the pressure can be set or determined by outputting the final pressure or the median of the last percentage of the titration time in fixed or, optionally, variable increments (e.g., 5%).

[0062] The following information can be recorded for a printable “titration report” as well as for the screen display: the starting pressure, the start of regulation after X minutes, the lower pressure limit, the upper pressure limit, the rate of pressure increase, the titration pressure set after X minutes, the therapy duration and the recommended titration pressure (rule and value).

[0063] The pressure limits are set using an intelligent adjustment mechanism: If the starting pressure increases above the lower and / or upper pressure limit, the lower and / or upper pressure limit is automatically increased to the starting pressure. If the starting pressure decreases below the lower pressure limit, the lower pressure limit is automatically reduced to the starting pressure. If the lower pressure limit increases above the starting pressure and / or the upper pressure limit, the starting pressure and / or the upper pressure limit is automatically increased to the lower pressure limit. If the upper pressure limit decreases below the starting pressure and / or the lower pressure limit, the starting pressure and / or the lower pressure limit is automatically reduced to the upper pressure limit.

[0064] The settings for the control start time and the split-night time also incorporate an intelligent change: If the control start time is increased above the time for starting the titration pressure adjustment, the time for setting the titration pressure is automatically adjusted.

[0065] If the time for setting the titration pressure is reduced below the time for the start of the control process, the time for the start of the control process is automatically reduced to the selected amount.

[0066] If the nasal mask is removed during autotitration (e.g., the patient goes to the toilet), event analysis, index calculation, and pressure adjustment are paused, while data storage continues. A message is displayed (e.g., "PAUSE"). The blower is deactivated (or operated at minimum speed). If the interruption is less than a user-defined or fixed time limit, autotitration (event detection and pressure adjustment) resumes; if the interruption is longer, the device is switched off.

[0067] The index calculation is reinitialized after an interruption within a configurable or fixed time limit.

[0068] In print profile mode, print adjustments can be made according to the selected print profile. Events do not trigger print adjustments. Both fixed and user-defined profiles are stored. These stored profiles are used, for example, in... Fig. 5 and Fig. 6 clearly.

[0069] The user can activate one of the two fixed or the user-defined print profile in both standby (offline) and online modes. The print profiles can be viewed and modified (user-defined print profiles only) via the serial interface using PC software in both standby (offline) and online modes. If the profile duration is shorter than the therapy duration, the therapy continues with the last print from the last profile.

[0070] In this mode, the titration pressure calculation can also be selected. This allows for precise assessment of pressure insufficiency during therapy monitoring using patient-specific profiles based on the previous therapy pressure value.

[0071] In one embodiment, for better visualization and understanding of the current pressure, a moving marker (e.g. a dot, crosshair, etc.) is displayed on the screen of the PC software and / or on the display of the control element, which represents the current target pressure and position in the sequence on the pressure curve over the night.

[0072] In APAP mode, pressure is adjusted immediately based on individual therapy-relevant events. With the mask open and automatic adjustment activated, the device switches off after 5 seconds. APAP residual event index

[0073] Up to now, in every obstructive event, the pressure is increased, held constant for a while, and then slowly lowered again; this principle is virtually the same for all APAP devices.

[0074] The time at which the initial pressure (that which was at the beginning of the event) is reached again is called the "Event reaction cycle time" (ERCT); this is how long the event has an influence on the pressure.

[0075] As in Fig. As shown in step 9, if the next event occurs faster than the ERCT, the device reacts again, but this time with an even higher starting pressure. If the next event occurs faster than the ERCT of the second event, the pressure is increased even further, and so on. Thus, there is a net pressure increase.

[0076] If the next event occurs later than the ERCT, the pressure has already dropped below the initial pressure. While there is a subsequent rise in pressure as a response to the event, it will be at a lower level than at the first event. If the next event again occurs later than the ERCT, the device will be at an even lower pressure level, and so on. There is a net pressure drop.

[0077] If the next event occurs immediately after the ERCT (Emergency Response Time), the device will be back at its initial pressure. It therefore oscillates between two pressure levels, but the net pressure remains constant.

[0078] By carefully selecting the ERCT interval, a stable operating point can be established, meaning a time between two events at which the system remains stable. The reciprocal of the ERCT interval is the event index resulting at this stable point. Therefore, to achieve a long-term stable residual AHI of 5 during therapy, the ERCT interval must be set to 12 minutes.

[0079] Since the patient is not a completely stable, time-invariant system, a corresponding pressure control naturally does not result in exactly an AHI of 5, but it is a fairly robust starting point for setting the lowering waiting times and speed of an APAP device.

[0080] Thus, 4 parameters can be set: lowering waiting times and speed, as well as the pressure increase when an event occurs and the ERCT.

[0081] Most APAP devices reduce airflow far too early and therefore rely on the patient developing several minor obstructions to which the device can respond before developing another severe, AHI-relevant obstruction.

[0082] However, since there is no knowledge about whether the current patient develops 4 minor obstructions, 20 more severe ones, or none at all, most APAP devices result in a highly variable AHI.

[0083] In contrast, the above approach “guarantees” (as long as the patient is stable) an AHI <= 5, even without any minor obstructions.

[0084] In CPAP mode, no pressure adjustment is performed. The device constantly provides the set pressure. With the mask open and automatic activation, the device switches off after 5 seconds.

[0085] In a particularly preferred configuration, the device incorporates a selectable "soft start" mode, which, upon activation, gradually and automatically increases the pressures (primarily the CPAP pressure) to the desired level (CPAP mode) or pressure range (APAP mode) within a specific, adjustable timeframe. This option can be deactivated in auto-titration mode.

[0086] In Bi-Level mode, no pressure adjustment is performed. The device constantly provides the set inspiratory and expiratory pressures along with the associated ventilation parameters (e.g., rate of pressure change, assisted, controlled, assisted / controlled ventilation modes).

[0087] In Bi-Level Titration mode, pressure and other parameter adjustments are made based on a variety of respiratory events. Volume-controlled or pressure-controlled ventilation can be performed. With the mask open and the automatic function activated, the device switches off after 5 seconds.

[0088] In the titration modes, the user can specify or set the aforementioned weighting of events occurring during breathing and ventilation pressure-related artifacts that are relevant to the airway disorder and its therapy, as well as artifact sensitivities for ventilation.

[0089] Examples of such ventilation pressure-relevant artifacts include: Parameters derived from MDS, flow and pressure-related quantities, such as patient position changes, mouth and mask leaks, mouth expiration, speaking, coughing, throat clearing, and swallowing.

[0090] The following signals, among others, are used to detect events and artifacts: In a further particularly preferred embodiment, the (device) flow signal is determined from the (blower) speed and the current (mask) pressure; this calculation is performed at 100 Hz (10 ms).

[0091] The MDS is generated by bandpass filtering (IIR filter) of the raw MDS signal. In a further particularly preferred embodiment, frequencies between 19 and 21 Hz are passed through during the filtering process, while all other frequencies are suppressed.

[0092] Filtering is performed at 500 Hz (2 ms). The signal is then rectified, and the maximum oscillation is determined over a period of 50 ms. After 50 ms (25 values), the maximum is stored as a new MDS value and reinitialized.

[0093] The snoring signal is generated by bandpass filtering (IIR filter) of the raw MDS signal. In a further particularly preferred embodiment, frequencies between 65 and 190 Hz are passed through, while all other frequencies are suppressed.

[0094] The filtering is performed at 500Hz (2ms). The signal is then rectified.

[0095] The present invention is intended to ensure that optimal device control is guaranteed even when malfunctions occur.

[0096] This problem is solved according to the invention by the fact that the control system has an analyzer for detecting at least one artifact and that the analyzer is coupled to the control system in such a way that an erroneous pressure change specified by the adaptation device is avoided when the artifact is detected.

[0097] The device and method according to the invention exploit the fact that specific artifacts lead to typical influences on the measured respiratory parameter. The corresponding typical temporal profiles of the respiratory parameter, which are assigned to a specific artifact, enable an automatic evaluation of the signal profile with regard to the respective profiles and thus a control-technical identification of the respective artifact.

[0098] Corresponding specific artifacts, recognizable by the signal pattern, include mouth exhalation, mouth breathing, leakage, swallowing, speaking, or coughing. With automatic detection of such events, it is possible to modify the pressure control system so that those measurement parameters which, under normal conditions, are evaluated by the control system to determine pressure increases or decreases, and which can no longer be reliably evaluated when the respective artifact occurs, are disregarded by the control system for the duration of the artifact's occurrence.

[0099] A basic procedure for detecting and controlling artifacts can be implemented as follows: First, inspirational and expiratory phases are identified by evaluating a signal related to flow or pressure fluctuations. The amplitude or power of expiratory pressure fluctuations, either generated by the device or originating from the patient, is then measured. Device-generated pressure fluctuations can be created using a modulated pressure signal, such as an MDS or FOT signal. Patient-generated pressure fluctuations might include hissing sounds during mouth expiration or leakage.

[0100] After the measurement is performed, the measured amplitude or power is compared with a reference value derived from previous expiratory or inspiratory phases. If a significant change is detected, one or more types of artifacts are identified.

[0101] Optionally, it is possible to differentiate the artifacts based on the magnitude of the change, the number of consecutive breaths with change, or by evaluating whether the respective change occurs only in expiratory or also in inspiratory phases compared to the previous breath.

[0102] It is also optionally possible to further increase the analysis quality by evaluating the flow curve, for example if the expiratory half-wave is missing during mouth expiration.

[0103] The amplitude of the pressure oscillation measured during expiration is compared with the amplitude of the pressure oscillation measured during inspiratory breathing. This involves comparing the mean values ​​of the two breathing phases.

[0104] If the expiratory value is higher than the inspiratory value by at least a predetermined initial amount, a single expiratory artifact, such as swallowing, coughing, or speaking, will be detected.

[0105] If the expiratory values ​​are higher than the inspiratory values ​​by at least a predetermined second amount for a predetermined number of breaths, mouth breathing or mouth expiration is detected.

[0106] Depending on the evaluation result, the evaluation of the inspiratory flow volume is suppressed, thus suppressing hypobnea detection and also suppressing the evaluation of the inspiratory amplitude of the pressure oscillation in connection with oscilloresistometry, since a corresponding reaction is unreliable during mouth breathing or when an expiratory artifact occurs.

[0107] According to another embodiment, natural pressure fluctuations in a specific frequency band are measured by bandpass filtering the measured pressure signal to detect snoring or hissing sounds. An expiratory increase indicates the detection of mouth exhalations, while an inspiratory or expiratory increase indicates a leak. In each case, events are suppressed or threshold values ​​are shifted, for example, to detect snoring.

[0108] A typical procedure involves the control system being trained to perform APAP ventilation.

[0109] According to one embodiment, the analyzer is designed to evaluate a flow profile.

[0110] Furthermore, it has also been taken into account that the analyzer is designed to evaluate a pressure profile.

[0111] One variant of the procedure involves the analyzer being designed to evaluate inspiration phases.

[0112] Furthermore, it is also possible that the analyzer is designed to evaluate expiratory phases.

[0113] A simple evaluation principle is that the analyzer is designed to evaluate amplitude values.

[0114] Furthermore, it is also possible that the analyzer is trained to evaluate performance values.

[0115] According to another embodiment, the analyzer is provided to have a reference value comparator.

[0116] Frequency-dependent signal evaluation is supported by performing bandpass filtering of the measured pressure signal.

[0117] In particular, it is intended that a frequency band in bandpass filtering is defined in such a way that an amplitude of a volume oscillation generated by the device is measured.

[0118] An excitation signal adapted to the bandpass filtering can be provided by generating the volume vibration using a diaphragm pump.

[0119] According to another embodiment, it is possible that the volume oscillation is generated by a blower control.

[0120] A good compromise between simple technical feasibility and good evaluation of the excitation signal is to generate a volume vibration with a frequency of about 20 Hz.

[0121] According to a typical evaluation procedure, the evaluation is carried out in such a way that an expiratory increase in the pressure oscillation amplitude compared to a reference value is used to detect an expiratory narrowing of the airways.

[0122] One special variant of the disturbance detection involves conducting an evaluation in such a way that individual or cumulative expiratory constrictions are assessed as artifacts.

[0123] Analyzing the frequency of artifact occurrence allows for an assessment of the quality of the mask type used. This enables quality control in APAP, CPAP, and bilevel applications.

[0124] The events mentioned above can include: Parameters derived from MDS, flow and pressure-related variables such as obstructive / central apneas, obstructive / central hypopneas, snoring with and without airway obstruction, airflow flattening, mild and severe obstructions, respiratory resistance and compliance.

[0125] The event recording period for therapy monitoring is, for example, 42 days.

[0126] In a further particularly preferred embodiment, all or only individually integrated events are detected as follows: Obstructive apnea: Severely reduced airflow for at least 7 seconds (and 2 breaths) with an increase in MDS. (The MDS threshold increases with pressure; above 12.5 hPa (adjustable value) all apneas are considered central; above 7 hPa (adjustable value) the MDS increase must not occur only at the end of the apnea.) Obstructive hypopnea: Reduced flow volume (2 consecutive inspirations, max. 60% (value adjustable) with OE1 or OE2 (In sections with many central events: only with OE2) Obstructive snoring: Cumulative snoring (3 (number adjustable) consecutive inspirations) with OE1, OE2 or with flattening. The snoring signal exceeds the defined threshold for a defined minimum duration (0.3 s (adjustable value)) during inspiration. Snoring is recorded in the titration data (as an event) and in the weekly compliance data (as a trend, period with / without snoring). Grade 2 obstructive event: Significant cumulative (3 (number adjustable) breaths) inspiratory MDS increase Obstructive flattening: Cumulative and pronounced flattening (at least 3 out of 6 inspirations (number adjustable)), at least one inspirational MDS increase Primary snoring: Cumulative snoring (3 (number adjustable) consecutive inspirations) without an inspiratory MDS increase. The snoring signal exceeds the defined threshold for a defined minimum duration (0.3 s (number adjustable)) during inspiration. Snoring is recorded in the titration data (as an event) and in the weekly compliance data (as a trend, epoch with / without snoring). Flattening: Cumulative flattening (3 out of 6 (number adjustable) inspirations) Grade 1 obstructive event: Slightly pronounced cumulative (2 breaths (number adjustable)) inspiratory MDS increase Central apnea: Significantly reduced flow volume for at least 10 seconds without an increase in MDS. Central hypopnea: Reduced flow volume (min. 2 consecutive inspirations and min. 10 s (number and minimum duration adjustable)) without MDS increase Artifact: Time and disturbance criteria, e.g., regarding the flow and / or MDS signal, are no longer being detected. Indexing continues unchanged. Mask open: The target pressure cannot be reached. No further events are being detected. The target pressure and index are frozen. Mouth and mask leakage: Loss flow exceeding 0.33 l / s (= 20 l / min). No further events are detected. The pressure is kept constant or reduced according to the index criteria as long as it remains above 10 hPa (adjustable value). Mouth exhalation: Significant expiratory MDS increases (minimum 3 times (number adjustable)). Obstructive events and hypopneas are no longer detected. The index calculation is frozen. MDS artifact

[0127] Expiratory MDS increase. Obstructive events and hypopneas are no longer detected. Index calculation continues unchanged.

[0128] Other applications include respiratory events relevant to ventilation parameters, such as arousals and hyperventilation (inspiratory volume increased).

[0129] To better identify and adjust the devices individually to the patient, the user can further define the following in the titration mode rules: Event index limits, which are composed of the above-mentioned respiratory events and their evaluation and lead to pressure adaptation if exceeded or fallen below within the above-defined period, absolute pressure increases of the device or pressure drops when the previously defined event index limits are reached.

[0130] The following weighting factors are defined for event evaluation: Obstructive Apnea Weighting Factor: Severely reduced flow volume for at least 7 seconds with an increase in MDS: Setting range: 0 - 1, in 0.1 increments

[0131] Weighting factor for obstructive hypopnea: Reduced flow volume with inspiratory MDS increase: Setting range: 0 - 1, in 0.1 increments

[0132] Weighting factor for grade 1 obstructive event: Significant cumulative MDS increase (outside of the above events): Setting range: 0 - 1, in 0.1 increments

[0133] Weighting factor for grade 2 obstructive event: Slight cumulative MDS increase (outside of the above events): Setting range: 0 - 1, in 0.1 increments

[0134] Snoring weighting factor: Cumulative inspiratory snoring with / without MDS increase or flattening: Setting range: 0 - 1, in 0.1 increments

[0135] Weighting factor for flattening: Cumulative flattening with / without MDS increase: Setting range: 0 - 1, in 0.1 increments

[0136] Weighting factor Central apnea / hypopnea: Setting range: -1 to 1, in 0.1 increments,

[0137] Pressure adjustment based on events is performed according to the selected rule set. The event index is calculated from the events that occurred during the waiting period for pressure increases or decreases. Pressure is increased if the event index exceeds one of two defined pressure increase thresholds and the waiting period before a further pressure increase has elapsed. Pressure is decreased if the event index falls below the defined pressure decrease threshold and the waiting period before a further pressure decrease has elapsed. After a pressure increase or decrease, the event index, the counters for the period used to calculate the index, and the waiting periods before a further pressure increase / decrease are reset to 0.

[0138] The pressure increase settings can vary, but are preferably chosen as follows: • Event index 1: 0 ... 30 [ / h], Resolution: 0.1 [ / h] • Event index 2: 0 ... 30 [ / h], Resolution: 0.1 [ / h] • Pressure increase: 0 ... 10 [hPa], resolution 0.1 [hPa] • Pressure increase2: 0 ... 10 [hPa], resolution 0.1 [hPa] • Waiting time (=period for index calculation): 1 ... 120 [min], Resolution: 1 [min]

[0139] In order to quickly meet the initially high demand for increased pressure, two criteria for the pressure increase are defined, but the waiting time for both criteria must be identical. Fig. Figure 2 shows a corresponding screen display.

[0140] The pressure reduction settings can vary, but are preferably chosen as follows: • Event index: 0 ... 30 [ / h], Resolution: 0.1 [ / h] • Pressure reduction: 0 ... 10 [hPa], resolution 0.1 [hPa] • Waiting time (=period for index calculation): 1 ... 120 [min], Resolution: 1 [min],

[0141] Split-Night option: This means the titration can be stopped after a defined period. If the Split-Night option is activated, the titration will end after the specified duration. The recommended titration pressure will be calculated and set. The instrument will then operate at this pressure until the user switches it off.

[0142] Setting ranges: No interruption of the titration 120 ... 600 [min], resolution: 5 [min], (Default: no split-night)

[0143] During periods of artifacts (e.g., with the mask open), event detection is suspended and the index is frozen. The index calculation is reinitialized after an artifact-laden period of 5 minutes or more (configurable). Titration pressure calculation

[0144] The recommended titration pressure (in CPAP titration mode) can be determined according to the following procedure if a titration duration of at least 2 hours (adjustable) has been observed (including the start time of regulation), whereby time-, event- and pressure-related values ​​for a CPAP titration pressure are derived from the applied pressures according to the rules defined above. Pressure percentiles

[0145] The pressure profile over the specified titration period is analyzed. The pressure values ​​are divided into 0.5 hPa classes, and the percentage (frequency) of occurrence (of each pressure class) during the analysis period is determined. The classes are then cumulatively calculated, and the titration pressure is determined according to the specified percentile (the lowest pressure value at which the percentage first exceeds the specified percentile). The pressure profiles are shown in Fig. 3 shown.

[0146] The pressure values ​​can be classified in a preferred form into the following (36) classes: • Class 0: p < 3 hPa. • Class 1: 3 <= p < 3.5 hPa • Class 2: 3.5 <= p < 4 hPa • Class 34: 19.5 <= p < 20 hPa • Class 35: p <= 20 hPa

[0147] The analysis period is specified as a % of the titration time (last n% of the titration time); value range: 10 ... 100%, resolution: 5%, (default: 90%).

[0148] The percentile is given in percent; value range: 50 ... 100%, resolution: 5%, (default: 95%). Event percentiles

[0149] The pressure profile over the specified analysis period is evaluated. In a preferred embodiment, the pressure values ​​during obstructive events (obstruction, obstructive apnea, obstructive hypopnea, snoring, flattening) are classified into 0.5 mbar increments, the percentages are determined, and the titration pressure is calculated from the cumulative values ​​(the lowest pressure value at which the percentage first exceeds the specified percentile). The settings are identical to the pressure percentile. Final pressure

[0150] When setting the final pressure, the current (target) pressure at the time of reaching the "split-night time" is preferably used as the titration pressure or stored as the recommended titration pressure. median

[0151] In a preferred embodiment, the pressure profile of the specified analysis period is evaluated and the "mean value" (median) is returned as the titration pressure.

[0152] The analysis period is specified as a % of the titration time (last n% of the titration time). Value range: 10 ... 100%, resolution: 5%, (default: 90%)

[0153] Error detection for titration pressure calculation: The function for calculating the titration pressure returns the determined titration pressure in the range 40 ... 200 (4 ... 20 mbar). Values ​​outside this range are reserved as error codes.

[0154] In a further particularly preferred embodiment of the invention, a further selection function can perform the subsequent mode selection after the titration phase.

[0155] In one embodiment, the selection function can be based on the frequency of events occurring per hour (e.g. the AHI) and / or the variability of the pressure values ​​set during the diagnostic phase when events are triggered, and select a definition of the initial parameters.

[0156] Furthermore, if this option is selected, the therapy recommendation can be directly incorporated into the patient's demand-based ventilation without prior user intervention. (Automatic mode) Pressure adjustment in profile mode

[0157] Print adjustment is performed according to a selected print profile. Events do not trigger print adjustment. • The print profile defines the print sequence in profile mode. In a preferred embodiment, three print profiles can be stored, with each print profile consisting of a maximum of 50 segments. Each segment can contain the time since device startup and the print value. These can be modified within their respective bandwidths. • Profile ID: 1 ... 3 (1, 2: fixed profiles, 3: user-defined profile) • Timer current position in print profile • Number of segments used: 1 ... 50 • Segment duration (segment 1 ... 50): 0 ... 255 minutes, resolution: 1 minute • Starting pressure (segment 1 ... 50): 2 ... 18 hPa, resolution: 0.1 hPa • Final pressure (segment 1 ... 50): 2 ... 18 hPa, resolution: 0.1 hPa

[0158] As an example, the therapy recommendation mentioned above can include the type, the parameters within each form of therapy, as well as a recommendation for human-machine interface and aerosol therapy.

[0159] In this context, the CPAP pressure and the slope of the soft start can be recommended by the device in a particularly preferred form for CPAP therapy.

[0160] In a particularly preferred form for APAP therapy, the baseline pressure (average pressure) of the last therapy night or the pressure fluctuation range (upper / lower pressure limit) can be recommended by the device.

[0161] In this context, the device can recommend the inspiratory and expiratory pressure levels, and thus also the pressure differential, as well as the inspiratory and expiratory times, in a particularly advantageous manner for BiLevel therapy. A safety check for a minimum minute ventilation (PMV) can be performed, and the parameters can be adjusted accordingly to ensure sufficient ventilation for the patient.

[0162] After completing the analysis phase, the device provides a statement regarding the suitability of the mask to be used for the patient, determined from events (primarily leaks) that occurred at various pressures. At least the following types are available for selection: nasal pillow, nasal mask, full-face mask, whole-head mask, and endotracheal tube.

[0163] In another embodiment, it is envisaged that, based on at least two different parameters selected from the group: Flow (thermistor, stagnation pressure, flow aperture, from therapy device), flow contour, effort (e.g. from thorax and abdominal excursion sensors), airway resistance (MDS or esophageal probe), plethysmogram, oxygen saturation, CO2, ECG, EEG, EMG (chin and up to 2 leg EMGs), EOG, actimeter, microphone, video, body position, light, the device should be able to assign / recommend a ventilation mode (CPAP, APAP, Bi-Level, other ventilation modes).

[0164] In one embodiment, it is intended to carry out the measurement of modulated pressure and flow values ​​via various sensors, such as piezo, thermo or optical, acoustic, resistive, capacitive, inductive.

[0165] Since the pressure during the expiratory phase (EPAP) keeps the airways open, in a particularly preferred embodiment the resistance is measured via MDS and it is recorded whether the lungs are open.

[0166] In a particularly preferred embodiment of the invention, MDS is used to detect respiratory activity and respiratory phase, e.g., by widening the upper airways, etc.

[0167] In a particularly preferred embodiment of the invention, the bi-level difference, i.e., the upper and lower pressure, is determined from the MDS and the compliance. (Mode Bi-Level Titration)

[0168] In a particularly preferred embodiment of the invention, it is intended to use the MDS to stimulate receptors in order to provoke a reflex arc through the sensitivity of the pharynx, which results in a reflex muscular splinting of the airways.

[0169] In a further embodiment of the invention, it is intended to derive the work of breathing from the MDS and to assess respiratory effort by determining the impedance. By determining the respiratory drive or respiratory effort, these can be used as key parameters for controlling the therapy device.

[0170] In a preferred embodiment of the invention, if the therapy is insufficient, the device sends a message to the doctor, e.g. via Bluetooth, and stores this message in the device.

[0171] Based on the physician's diagnosis, the device can be preset and, via the humidifier / nebulizer, allows for the continuous administration of medication, known as aerosol therapy, which aims at the direct deposition of medication at the target organ, i.e., in the lower respiratory tract. A preferred embodiment of the invention is limited to bronchial diseases. The advantage of inhaling a medication instead of administering it as a tablet or via injection is that the substance quickly reaches the site of action and has fewer undesirable side effects in other organs.

[0172] The following types of aerosol generation are currently available: compressed air or ultrasonic nebulizers, propellant-operated metered-dose inhalers, and dry powder inhalers. The humidifier can be used in all device modes. It is activated or deactivated by pressing the humidifier button or via the serial interface. The humidification level can be set by the user via the keypad or serial interface. The humidifier is automatically deactivated as soon as the water supply is exhausted or the humidifier is disconnected from the device. The humidifier can be operated at least six different humidification levels and displays a warning message when empty.

[0173] External appearance characteristics and designs of the connections, technical framework conditions: The invention is extremely flexible externally due to its modular composition of sensors from sensor groups that are connected to each other via plug connections, cables or wirelessly, as well as to a storage and a visualization unit, which can be a PC or a PDA; the configurability of the measurement acquisition electronics for different sensors (e.g. different gain factors, filters, ...) is retained.

[0174] A particular advantage of the invention is that the configuration of the diagnostic system can be carried out from the PC or PDA via cable (directly or via network) or wirelessly; operation is possible on the device itself with a user interface.

[0175] In a preferred embodiment of the invention, the data can be stored in the device for subsequent evaluation, e.g. on a PC.

[0176] In another version, the therapy device is equipped with a memory that can be easily removed (e.g. Compact Flash card) or read remotely (via mobile network, Internet, telephone line, ...).

[0177] Power can be supplied via battery or rechargeable battery. A self-test is performed at least after switching on, and the battery charge level is checked repeatedly.

[0178] Furthermore, free channels are available for the analog input of additional signals with or without amplification.

[0179] In a special embodiment, the quality of individual signals, e.g. by measuring the impedance of electrodes, is also displayed on the device via LEDs or a display.

[0180] In another embodiment, it is envisaged to combine a disposable EEG electrode and an associated amplifier circuit with an A / D converter and an algorithm that recognizes sleep stages (possibly using neural networks and fuzzy logic, cybernetics) in order to be able to react to the individual sleep stages with targeted parameter settings.

[0181] In addition, the therapy device can be equipped with storage for patient data (e.g. weight, gender, diagnosis).

[0182] In a particularly preferred embodiment, the therapy device can be equipped with an identification number with which it can uniquely identify itself in a network or when connected to a PC in order to assign stored information (about maintenance, patient, etc.) from a database to it.

[0183] In a further particularly preferred embodiment, the device can be equipped with a telemetry unit for outpatient use, so that the diagnosis can be made before a service provider returns to the patient and can thus initiate therapy immediately. Furthermore, the device can independently communicate with the service center, e.g., for maintenance, in case of a malfunction, or to change the configuration. Archiving multiple sets of rules

[0184] When the software reads therapy parameters from the therapy device, the user is prompted to save the rule set if it does not match any of the software-stored rule sets and the therapy device is in titration mode. Changes to the rule set can be saved software-based. The rule sets are stored, for example, in an XML file in the directory, so that the saved rule sets can be transferred to the device, retrieved, and printed as a parameter list.

[0185] Signal output is possible in both analog and digital formats (e.g., for polysomnography).

[0186] The device's control system has access to the individual device units (blower, oscillation generator, humidifier, ...) and can change their parameters as needed.

[0187] Data storage includes the storage of device, calibration and titration / therapy data, as well as all other data necessary for function and for deriving diagnostic values.

[0188] In a further particularly preferred embodiment, communication with external devices via a serial interface is possible, also for operating the device with remote settings / PC and data export to the PC.

[0189] As one example, the hardware environment can consist of various functional groups that are in Fig. 4 are shown.

[0190] A multi-line display is provided for the information shown. It is addressed via the microcontroller's I2C interface and additionally contains symbols for, e.g., filter change, service, humidifier, humidifier alarm, ventilation parameters and mode, soft start, pressure increase, pressure decrease and clock, as well as the names and units of the displayed values.

[0191] Error messages can be displayed on the device screen.

[0192] In another preferred embodiment, the MDS raw signal can be sampled at 500Hz and then smoothed by (a moving) averaging over at least 3 values.

[0193] In another preferred embodiment, the pressure signal can be sampled at 100 Hz and then smoothed by averaging over at least 100 values. (New value after 1 s)

[0194] In another preferred embodiment, the humidifier voltage can be sampled at 50 Hz and then smoothed by averaging over at least 5 values. (New value after 0.1 s)

[0195] In another preferred embodiment, the (device) temperature can be sampled at 10Hz and then smoothed by averaging over 10 values ​​(new value after 1s).

[0196] In another preferred embodiment, the fan speed can be detected via a signal generated in the power board. A timer unit (capture function) of the microcontroller measures the transit time of the pulses and converts it into a speed value.

[0197] In another preferred embodiment, the rotational speed of the oscillation generator (pump) can be determined by evaluating the microphone signal. A timer unit of the microcontroller captures the microphone pulses (2 per revolution) over a period of 500 ms and calculates the current rotational speed of the oscillation generator (pump) from this data.

[0198] In another preferred embodiment, a 4-channel digital-to-analog converter (DAC) with a resolution of 10 bits can be used for analog signal output. Two channels of the DAC are used for internal purposes (setpoint fan speed). The other two channels are used to output signals to external devices (e.g., a polysomnograph). The output signal can be configured via the serial interface using the device's software (modification of the corresponding EEPROM cell). The settings are stored in the EEPROM. Device- and patient-specific signals can be selected for output on the device, such as: MDS, pressure, flow, and loss flow.

[0199] In a preferred embodiment, the MDS and flow signals can be output in the default setting.

[0200] In another preferred embodiment, humidifier output is controlled via PWM (pulse width modulation). The PWM signal is generated in the microcontroller (with a capture / compare unit) and transmitted to the power board (via a port pin).

[0201] In another preferred embodiment, the blower is enabled or disabled via a port pin.

[0202] In another preferred embodiment, the speed of the oscillation generator (pump) is controlled via a PWM signal. The PWM signal is generated in the microcontroller (with a capture / compare unit) and output (via a port pin).

[0203] In another preferred embodiment, the external real-time clock is addressed via the microcontroller's I2C interface. Setting the date and time (via the serial interface or keyboard) is only possible in standby (offline) mode.

[0204] In a further preferred embodiment, the device's data memory can store at least the lower pressure limit, upper pressure limit, pressure rise rate, soft start pressure, and soft start time in APAP mode, and the CPAP, soft start pressure, and soft start time in CPAP mode.

[0205] The recording time for the data from the previous night is ≥ 8 hours. Additionally, the calibration data of the pressure sensor is saved.

[0206] In another preferred embodiment, annual compliance is recorded over a period of 366 days. The application time (device switched on, pressure > threshold) per day is stored in 0.1-hour increments. A day is defined as 24 hours, with the day changing at 12:00 noon.

[0207] In a preferred embodiment, humidifier compliance is recorded over a period of 366 days. The operating time (with humidifier) ​​per day is stored in 0.1-hour increments. A day is defined as 24 hours, with the day changing at 12:00 noon.

[0208] In a preferred embodiment, the titration data are recorded over a period of up to 10 hours. A maximum of 10 recordings (therapy starts) are stored. If more than 10 recordings are made or the maximum recording time is exceeded, the oldest entries or data are overwritten. Recordings with a duration of less than 5 minutes are overwritten the next time the device is started.

[0209] In another preferred embodiment, weekly compliance is recorded over a period of 30 days. Up to 30 therapy starts are recorded per day. A day is defined as 24 hours, with the day changing at 12:00 noon. Only days on which a titration / therapy was performed are stored. After 30 entries, the oldest entry is overwritten. The following data is recorded for each entry: Cross-system interfaces in a particularly preferred embodiment • For communication with external devices (PC, remote control, test computer) • Bluetooth • Infrared • Memory card • Data export

[0210] Data export to the PC. The PC (running the software) acts as the master and requests the data from the device. The device sends the requested data, with a checksum being sent at the end of the transmission.

[0211] The transmission time for titration and weekly compliance cannot exceed 1 minute (total).

[0212] Device parameters can be queried / modified via the serial interface (RS485) using a test computer during testing.

[0213] In another CPAP autotitration protocol, the pressure is increased more quickly when arousals occur. During therapy checks, the lower pressure limit is set below the patient's current pressure to test the necessity of the higher pressure level. This can also be achieved using a pre-configured pressure profile.

[0214] In another embodiment, the pressure regulation also takes place depending on the current or already completed sleep stage.

[0215] In particular, the titration only begins once the patient has fallen asleep and / or a pressure reduction occurs during the patient's waking periods at night.

[0216] Other preferred embodiments include the following functions, either individually or in combination: 1. Autotitration CPAP or Bi-level starts automatically once a certain number of respiratory disturbances (e.g. 30 apneas) and / or resulting arousals and / or oxygen desaturations and / or other pathological changes caused by sleep-related breathing disorders have occurred. 2. Positive pressure ventilation is initiated at a higher pressure if the patient has difficulty falling asleep (the patient feels they are not getting enough air). Common conditions associated with this problem include nasal congestion, severe obesity, and prior chronic CPAP treatment. If several attempts to slowly increase the pressure to a level sufficient to keep the airways open are not tolerated, the system automatically switches to bi-level autotitration. 3. If persistent arterial oxygen desaturation (SaO2 < 88%) occurs despite adequate airflow during CPAP, an attempt is first made to increase the CPAP by 1-2 cmH2O. If high CPAP levels are already being used, bilevel ventilation is attempted. If these attempts are unsuccessful, additional oxygen is added to the system in 1-LPM increments until SaO2 > 90%. 4. If the patient has difficulty tolerating nasal ventilation due to nasal constriction, a humidifier is automatically activated. If the difficulties persist, a notification is sent to the physician to administer a vasoconstrictor (vasoconstricting agent). Otherwise, a recommendation for titration using a full-face mask is issued. 5. If patients do not tolerate a level of CPAP or Bilevel pressure sufficient to stabilize the airway, a warning will be issued, or the head of the bed will be raised by 30° via an interface, or a recommendation will be given to position the patient on their side. 6. If significant mouth leakage occurs, the humidifier is activated and the use of a chin strap is recommended. If this is unsuccessful, the system switches to bilevel ventilation or APAP to reduce the mean effective pressure. If this is also unsuccessful, the use of a full-face mask is recommended. 7. Bi-level titration is set as follows: IPAP = EPAP are increased until obstructive apnea is no longer present. Then, IPAP is increased until hypopnea / snoring / oxygen desaturation is resolved. If events occur despite maximally tolerated IPAP, EPAP is increased in 1 cmH2O increments until these events cease and adequate ventilation is maintained.

[0217] Oxygen titration: 1. If the patient uses oxygen to maintain adequate arterial oxygen saturation during the day, supplemental oxygen will be introduced at the usual flow rate at the start of the diagnostic study unless otherwise set by the user. 2. If arterial oxygen desaturation persists in the absence of apneas, hypopneas, or severe snoring, oxygen titration will be initiated—but only after a usable diagnostic period to document the need for oxygen administration. If severe snoring occurs along with oxygen desaturation, CPAP treatment will be attempted before oxygen is initiated. 3. When oxygen is added to a ventilation treatment or when oxygen titration is performed due to oxygen desaturation unrelated to apnea / hypopnea, oxygen is titrated upwards in 1-LPM increments until arterial oxygen saturation is > 92% (> 90% if more than 3 LPM is requested). There is a maximum value (e.g., 5 LPM) that can be automatically set by the device without physician consultation; higher values ​​can be set manually.

[0218] Central apnea: 1. If obstructive or mixed apnea transitions to Cheyne-Stokes central apnea during CPAP titration, further increasing CPAP titration can be attempted. If no pressure level eliminates the central apnea, the pressure level is increased until it eliminates the obstructive component or reaches 10-12 cmH2O, whichever is higher. 2. Short central apneas during REM sleep phases that do not result in oxygen desaturation or arousal are not treated by further increasing the CPAP by the device. 3. If frequent central apneas (non-Cheyne-Stokes type) and subsequent arousals are detected by the device during CPAP titration, a higher CPAP level will be applied after prior confirmation of snoring / flattening. If this is unsuccessful, a slightly lower CPAP level will be attempted (possible arousals in addition to increased pressure / leakage).

[0219] Other preferred embodiments include the following functions, either individually or in combination: The titration begins according to Fig. 1 with a predefined starting pressure pini (1). Upper (4) and lower pressure limits (3) are predefined. A pressure rise rate (5) is also predefined. In addition, the time after which the control starts and ends is adjustable by the user (2).

[0220] Fig. Figure 6 shows a display of various settings that can be configured in profile mode. This input screen allows the user to configure the pressure sequence, including individual pressure sequences, their duration, start time, and applied pressure. This enables the user to individually configure pressure profiles for each patient and save them as a profile.

[0221] According to Fig. Depending on the weighted event indices (6) over a total period t (7), different pressures (8) are applied to the patient during time ti (9). The pressure increase rate (5) and minimum values ​​for time ti (9) are adjustable. During ti, the applied pressure remains constant; the current event index is reset after each required pressure adjustment and continuously recalculated during ti. If an event index limit (10) is reached, a pressure adjustment (11) is performed.

[0222] Fig.Figure 8 shows the basic structure of a ventilation device. A breathing gas pump is arranged inside a device housing (21) with a control panel (22) and display (23). A connecting hose (25) is attached via a coupling (24). An additional pressure measuring hose (26) can run along the connecting hose (25) and can be connected to the device housing (21) via a pressure inlet port (27). The device housing (21) has an interface (28) to enable data transmission.

[0223] An exhalation element (29) is arranged in the area of ​​an extension of the connecting hose (25) facing away from the device housing (21). An exhalation valve can also be used.

[0224] Furthermore, the figure shows a ventilation mask (30) designed as a nasal mask. It can be secured to the patient's head using a head covering (31). The ventilation mask (30) has a coupling element (32) in the area where it connects to the tubing (25).

Claims

[1] A ventilation device comprising a respiratory gas source connectable to a patient interface and a control unit designed to specify at least two different ventilation modes and in which the control unit is designed to automatically detect, select and apply the different ventilation modes in at least some respiratory disorders according to a current patient-specific need, characterized bythat the device is equipped with an identification number that allows for unique identification in a network or when connected to a PC in order to assign stored information from a database, and that the device is equipped with a telemetry unit for outpatient use and / or at the patient's home, wherein the control unit has an analyzer for detecting at least one artifact, and wherein the analyzer is coupled to the control unit in such a way that an erroneous pressure change specified by the adaptation unit is avoided when the artifact is detected, wherein the detection of an artifact is exploited by the fact that specific artifacts lead to typical influences on the measured respiratory parameter, and wherein the corresponding typical temporal profiles of the respiratory parameter that are assigned to a specific artifact,an automatic evaluation of the signal profile with regard to the respective profiles and thus a control-technical identification of the respective artifact, whereby corresponding specific artifacts recognizable in the signal profile are mouth expiration, mouth breathing, leakage, swallowing, speaking or coughing, and upon automatic detection of such events, the pressure control is modified in such a way that those measurement parameters which are evaluated by the control unit in a normal state for a pressure increase or a pressure decrease and which can no longer be reliably evaluated when the respective artifact occurs, are not taken into account by the control unit for the duration of the occurrence of the artifact. [2] Device according to claim 1, characterized by that the control unit is connected to at least one sensor for detecting a parameter. [3] Device according to claim 1 or 2, characterized by that the sensor is designed to detect a physiological parameter. [4] Device according to claim 1 or 2, characterized by that the sensor is designed to detect a device-specific parameter. [5] Device according to any one of claims 1 to 4, characterized by that the control unit has an analyzer for signal evaluation. [6] Device according to any one of claims 1 to 5, characterized by that a set of rules is used to perform a pressure adjustment. [7] Device according to claim 6, characterized by that the set of rules is firmly established. [8] Device according to claim 6, characterized by that the rule set is user-defined. [9] Device according to any one of claims 1 to 8, characterized by that the control unit includes an adaptation device for changing the ventilation mode. [10] Device according to any one of claims 1 to 9, characterized by that the analyzer is designed to suppress a mode change during artifact detection. [11] Device according to any one of claims 1 to 10, characterized by that the analyzer is designed to detect inspirational and expiratory phases. [12] Device according to any one of claims 1 to 11, characterized by that the analyzer is designed to evaluate at least one parameter related to the flow. [13] Device according to any one of claims 1 to 12, characterized by that the analyzer is designed to evaluate at least one parameter related to pressure. [14] Device according to any one of claims 1 to 13, characterized by that the analyzer has bandpass filtering. [15] Device according to any one of claims 1 to 14, characterized bythat the analyzer has a comparator that takes into account an individual patient history. [16] Device according to any one of claims 1 to 14, characterized by that the analyzer has a comparison device that takes into account preset parameter values. [17] Device according to any one of claims 1 to 14, characterized by that the analyzer has a comparison device that takes ideal values ​​into account. [18] Device according to any one of claims 1 to 17, characterized by that the control device is designed to adapt the mode with a fixed time interval. [19] Device according to any one of claims 1 to 17, characterized by that the control device for mode adjustment is designed with an adaptive time interval. [20] A ventilation device comprising a respiratory gas source connectable to a patient interface and a control unit designed to specify at least two different ventilation modes, wherein a sensor for detecting at least one parameter is connected to the control unit and the control unit is equipped with event detection, characterized bythat the control unit has an analyzer for assigning a weight to different classes of events, that the analyzer generates an event index within a predefinable evaluation interval depending on the frequency of events per time period, and that the control unit specifies a pressure change depending on threshold exceedances, whereby different threshold levels are assigned to different pressure changes of the ventilation pressure to be implemented, and that the device is equipped with an identification number with which a unique identification is carried out in a network or when connected to a PC in order to assign stored information from a database, and that the device is equipped with a telemetry unit for outpatient use and / or at the patient's home.wherein the control unit has an analyzer for detecting at least one artifact and wherein the analyzer is coupled to the control unit in such a way that, upon detection of the artifact, an erroneous pressure change specified by the adaptation unit is avoided, wherein the detection of an artifact is exploited by the fact that specific artifacts lead to typical influences on the measured respiratory parameter and wherein the corresponding typical temporal profiles of the respiratory parameter, which are assigned to a specific artifact, enable an automatic evaluation of the signal profile with regard to the respective profiles and thus a control-technical identification of the respective artifact and wherein corresponding specific artifacts recognizable in the signal profile are mouth expiration, mouth breathing, leakage, swallowing, speaking or coughing and upon automatic detection of such events,The pressure control is modified in such a way that those measurement parameters which are evaluated by the control unit for a pressure increase or a pressure decrease in a normal state and which can no longer be reliably evaluated when the respective artifact occurs, are not taken into account by the control unit for the duration of the artifact's occurrence.

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