VENTILATION SYSTEM COMPRISING AT LEAST ONE VENTILATOR AND AT LEAST ONE DIAGNOSIS DEVICE AND METHOD OF OPERATING

Abstract

Ventilation system (having a ventilator and having a diagnostic device, wherein the ventilator comprises a ventilation unit for generating a respiratory gas flow for ventilation and a detection unit (for detecting a ventilation signal characteristic for the respiratory gas flow over time. The diagnostic device comprises a sensor unit for detecting a diagnostic signal over time. The synchronization unit is operationally connected to the detection unit and the sensor unit and is suitable and configured for studying a time curve of the ventilation signal and a time curve of the diagnostic signal respectively for a signal change caused by the same event and bringing the curve of the ventilation signal and the curve of the diagnostic signal into chronological correspondence so that the event occurs simultaneously in both signal curves.

Claims

1.-22. (canceled)

23. A ventilation system, wherein the ventilation system comprises at least one ventilator and at least one diagnostic device, the ventilator comprising at least one ventilation unit for generating a respiratory gas flow for a ventilation and at least one detection unit for detecting at least one ventilation signal characteristic for the respiratory gas flow over time and the diagnostic device comprising at least one sensor unit for detecting at least one diagnostic signal over time, and wherein at least one synchronization unit is operationally connected to the detection unit and the sensor unit, the synchronization unit being suitable and configured for studying at least one time curve of the ventilation signal and at least one time curve of the diagnostic signal respectively for at least one signal change caused by the same event and bringing the curve of the ventilation signal and the curve of the diagnostic signal into chronological correspondence so that the event occurs simultaneously in both signal curves.

24. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for recognizing at least one unique point in time in the time curve of the ventilation signal and in the time curve of the diagnostic signal by way of the signal changes which are caused by the same event and synchronizing the signal curves to this point in time.

25. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for ascertaining a measure of a similarity of the signal changes in the time curve of the ventilation signal and in the time curve of the diagnostic signal and determining in dependence on the similarity whether or not the signal changes are based on the same event.

26. The ventilation system of claim 25, wherein a measure of the similarity includes a duration and/or an intensity and/or a symmetry property.

27. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for studying the time curve of the ventilation signal and the time curve of the diagnostic signal respectively for a plurality of signal changes which are each based in pairs on the same event and bringing the time curve of the ventilation signal and the time curve of the diagnostic signal into chronological correspondence at least partially also in consideration of the further signal changes.

28. The ventilation system of claim 27, wherein a search is made in defined time ranges for paired signal changes.

29. The ventilation system of claim 28, wherein the time ranges comprise a therapy start and a therapy end and at least one chronological therapy range lying in between.

30. The ventilation system of claim 28, wherein the time ranges comprise at least 1 minute and at most 60 minutes.

31. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for recognizing at least one signal change which is based on an event which is taken from event types comprising acute or chronic dyspnea (respiration interruption, coughing), movement of the patient, slipped respiratory interface, leak.

32. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for recognizing signal changes which are caused by at least two different event types.

33. The ventilation system of claim 23, wherein the ventilation signal comprises a measure of a flow of the respiratory gas and/or a measure of a pressure of the respiratory gas and/or a measure of a leak rate.

34. The ventilation system of claim 23, wherein the diagnostic signal is taken from diagnostic signal types which comprise blood gas sensor signals, ECG signals, EMG signals, induction plethysmography signals, blood pressure sensor signals, (structure-borne sound) microphone signals, body position sensor signals, acceleration sensor signals, temperature sensor signals, pressure and/or flow sensor signals, video signals, thermal imaging signals, radar signals, ultrasonic signals.

35. The ventilation system of claim 23, wherein at least two ventilation signal types characteristic for the respiratory gas flow are detectable using the detection unit and/or wherein at least two diagnostic signal types are detectable using the sensor unit, and wherein an association of at least one ventilation signal type with at least one diagnostic signal type is stored in the synchronization unit and the synchronization unit is suitable and configured for synchronizing a signal curve of a ventilation signal type with a signal curve of an associated diagnostic signal type according to the association.

36. The ventilation system of claim 23, wherein the event is at least one user input on the ventilator and/or on the diagnostic device, at least one synchronization signal is generated by the user input and added to the ventilation signal and/or the diagnostic signal, and the synchronization unit is suitable and configured for recognizing the synchronization signal as a signal change and using it for the synchronization.

37. The ventilation system of claim 23, wherein data are transferable between the ventilator and the diagnostic device (2), the event is a dispatch and/or an arrival of a data packet to be transferred and the synchronization unit is suitable and configured for synchronizing the signal curves under an assumption that the dispatch and the arrival of the data packet take place simultaneously or with a defined time offset taken into consideration in the synchronization.

38. The ventilation system of claim 37, wherein the synchronization unit is suitable and configured for taking a transfer quality of the data packet into consideration for the synchronization.

39. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for deliberately manipulating the respiratory gas flow by means of the ventilation unit, so that at least one recognizable signal change respectively occurs in the time curve of the ventilation signal and in the time curve of the diagnostic signal, which are based on a simultaneous event caused by the manipulation of the respiratory gas flow.

40. The ventilation system of claim 39, wherein the manipulation comprises at least one deliberate pressure change and/or flow change of the respiratory gas flow.

41. The ventilation system of claim 23, wherein the synchronization unit is suitable and configured for plotting synchronized curves of the ventilation signal and the diagnostic signal on a common time axis.

42. The ventilation system of claim 23, wherein the synchronization unit is integrated in the ventilator and/or the sensor unit of the diagnostic device is at least partially arrangeable on a body of a patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0062] In the figures:

[0063] FIG. 1 shows a solely schematic illustration of a ventilation system according to the invention;

[0064] FIG. 2 shows a very schematic diagram having therapy phases and diagnostic phases;

[0065] FIG. 3 shows a solely schematic plot of ventilation signals and therapy signals over time;

[0066] FIG. 4 shows a solely schematic plot of the ventilation signals and therapy signals from FIG. 3 after a synchronization carried out by the ventilation system; and

[0067] FIG. 5 shows an enlarged detail of the plot from FIG. 4.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0068] The particulars shown herein are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show details of the present invention in more detail than is necessary for the fundamental understanding of the present invention, the description in combination with the drawings making apparent to those of skill in the art how the several forms of the present invention may be embodied in practice.

[0069] FIG. 1 shows a ventilation system 10 according to the invention having a ventilator 1 and a diagnostic device 2 coupled to the ventilator 1. The ventilation system 10 is operated according to the method according to the invention. The ventilator 1 has a ventilation unit 11, which generates a respiratory gas flow by means of a fan unit or a pressurized gas source and supplies it to the patient 100 for ventilation via a respiratory interface 41. The respiratory interface 41 is, for example, a breathing mask, which is connected via a hose unit to the ventilation unit 11.

[0070] Alternatively to the breathing mask, other patient interfaces can also be used, for example, a tracheostoma (or other invasive interface) or high-flow interface. The ventilation unit 11 can also be integrated in the mask. Optionally, a humidifier can be provided between ventilator 1 and patient 100 and/or a unit for introducing oxygen or aerosols and medications.

[0071] The ventilator 1 can be designed as noninvasive or invasive. These are also understood, for example, as devices 1 for sleep therapy (CPAP, autoCPAP, bilevel, ASV therapy) or nasal high-flow therapy. The device 1 also contains a user interface and terminals for power and connection to the patient 100 here.

[0072] The ventilator 1 comprises a detection unit 21 having sensor means for detecting at least one ventilation signal 3 presented with reference to FIG. 3 over time. Preferably, ventilation signals 3 of two or more ventilation signal types 3 are detected. The ventilation signals 3 are characteristic for the respiratory gas flow and relate, for example, to at least one pressure signal and one flow signal. For example, the therapy pressure and the respiratory flow and a leak rate are continuously monitored in this way. Moreover, the ventilator 1 has a controller or a control unit here for processing the signals and controlling the ventilation unit 11.

[0073] The ventilation signal curves are registered here in a storage unit 51 arranged inside the ventilator 1. For example, a working memory, a permanent memory, and/or a portable storage medium are provided. The ventilation signals 3 are temporarily stored and provided with a time stamp according to an internal clock.

[0074] For this purpose, at least one internal clock (RTC) is provided. This internal clock can preferably be provided independently or partially independently of the time displayed on the user interface—so that the user or patient can set the time of day as he or she wishes, and the internal measurement behavior of the ventilator 1 and the entire system 10 is not dependent thereon.

[0075] The ventilator 1 is equipped here with a communication unit 61 for transferring the recorded signals 3. For example, the communication unit 61 comprises wired connections (serial, network, HL7, PDMS, I2C, USB, Firewire, etc.), mobile storage media (storage card, USB stick, etc.), wireless short-range communication (Bluetooth, infrared), wireless long-range communication (GSM, LPWA, 3G, 4G, 5G, directional radio, Sigfox, Lora). Additionally or alternatively, further processing of the data can at least partially take place in the ventilator 1 itself.

[0076] The diagnostic device 2 is used here to supervise the respiratory therapy. For this purpose, the diagnostic device 2 is operationally connected if needed to the ventilator 1, so that parameters can be detected during the therapy which then permit an assessment of the therapy quality. For this purpose, the diagnostic device 2 comprises a sensor unit 12 here for detecting diagnostic signals 4 of various diagnostic signal types, which are registered in a storage unit 32 of the diagnostic device 2 over time. The diagnostic signals 4 are presented in more detail with reference to FIG. 3. The diagnostic signals 4 are temporarily stored and can be provided with a time stamp according to an internal clock.

[0077] For the connection to the patient 100, the diagnostic device 2 comprises multiple diagnostic interfaces 22, of which only one is shown here as an example. The diagnostic interfaces 22 are provided by sensors of the sensor unit 12. For example, the sensor unit 12 comprises electrodes, effort belts, EIT belts, sensors for measuring blood gases, structure-borne sound microphones, location sensors, acceleration sensors, pressure or flow sensors, temperature sensors, blood pressure sensors, ECG sensors, EMG sensors, optical sensors, electrical sensors, and chemical sensors. Additionally or alternatively to an effort belt, a belt designed for induction plethysmography can be provided. Moreover, a reception of images (video camera) or speech (microphone) can be provided. A user interface can also be provided for the input of values, e.g., filling out questionnaires on symptoms, quality-of-life, side effects, and problems.

[0078] The diagnostic device 2 can have a user interface for further inputs/outputs, terminals for power and connection to the patient 100, a battery, an accumulator, a controller or a control unit for processing the signals 4 and/or controlling the components of the diagnostic device 2, and/or at least one internal clock (RTC).

[0079] The diagnostic device 2 is equipped here with a communication unit 42 for transferring the recorded signals 4. The communication unit 42 is designed, for example, like the communication unit 61 of the ventilator 1. Additionally or alternatively, further processing of the data can at least partially take place in the diagnostic device 2 itself. The storage unit 32 of the diagnostic device 2 can also be designed like the storage unit 51 of the ventilator 1.

[0080] If needed, two or more diagnostic devices 2 can also be attached to the patient 100 and coupled to the ventilator 1.

[0081] To be able to evaluate the ventilation signals 3 and the diagnostic signals 4 for the therapy supervision, they generally have to be compared to one another. For this purpose, it is helpful and often also absolutely necessary to bring the signals 3, 4 into chronological correspondence (synchrony) or to synchronize them. After completed synchronization, then, for example, a physician and/or also an evaluation algorithm of the ventilation system 10 can recognize in the signal curves which special events have occurred in the breathing activity of the patient simultaneously with other occurrences, for example, with changes of the blood pressure or the heart rate or the like. In addition, a diagnosis can be made particularly reliably and the ventilation settings can be adapted better to the needs.

[0082] To execute the synchronization automatically, the ventilation system 10 comprises a synchronization unit 5, which is operationally connected to the ventilator 1 and the diagnostic device. In the example shown here, the synchronization unit 5 can exchange data for this purpose with the communication units 42, 61.

[0083] The synchronization unit 5 of the ventilation system 10 of FIG. 1 and its functionality are presented in more detail hereinafter with reference to FIGS. 2 to 5.

[0084] The synchronization unit 5 ascertains here, for example, at least once, ideally repeatedly, the time offset of the signals 3, 4 and corrects it so that these signals can subsequently be further processed or evaluated synchronously in time with an offset less than 1 second.

[0085] The synchronization unit 5 generates or receives a reference time signal (which can also be referred to as a data packet or time stamp) and transfers it in quasi-real-time according to the dashed lines in FIG. 1 at 11 and 12. The two devices 1, 2 use this reference signal to set their internal clock time (RTC). This is only possible if a permanent connection exists between the synchronization unit 5 and the devices 1, 2 in quasi-real-time. The event 6 is in such a case then the transfer of the data packet and the time of day connected thereto.

[0086] The synchronization unit 5 evaluates the time stamps of the individual devices 1, 2, ascertains the difference of the two, and corrects at least one of the time stamps in such a way that a time offset less than 1 second exists for the further processing of the signals 3, 4. For this purpose, a connection in quasi-real-time between the devices 1, 2 and the synchronization unit 5 is necessary at least once.

[0087] A signal 3, 4, for example, the therapy pressure, is recorded by both devices 1, 2. On the basis of a similarity analysis of the signal 3, 4, the synchronization unit 5 recognizes the time offset and corrects the time stamp of at least one of the two devices 1, 2 in such a way that the time offset is reduced to less than one second. The similarity analysis can be carried out, for example, by a correlation, a matching pursuit comparison, an equalization of the switching on and switching off times, or a minimization of the error sum or sum of the error squares.

[0088] An item of information, for example, the breathing activity, is recorded differently in both devices 1, 2, for example, by a flow sensor in the ventilator 1 and by an effort sensor in the diagnostic device 2. On the basis of a similarity analysis of the signal 3, 4, the synchronization unit 5 recognizes the time offset and corrects the time stamp of at least one of the two devices 1, 2 in such a way that the time offset is reduced to less than one second. The similarity analysis can be carried out, for example, by a correlation, a matching pursuit comparison, an equalization of the switching on and switching off times, or a minimization of the error sum or sum of the error squares. The phasing of the different respiration signals due to the different sensors used is recognized and corrected here. For example, the beginning of the inhalation corresponds to a local minimum in the effort signal and a zero crossing in the respiratory flow signal.

[0089] Both devices 1, 2 receive a time signal from a time generator, for example, via radio, at least once, preferably at regular intervals, and adjust their internal RTC clock accordingly.

[0090] The devices 1, 2 are connected to one another here in such a way that one of the two sends a time marker to the other device 1, 2 or the synchronization unit 5 at characteristic points in time, for example, upon beginning measurement, on the basis of which the time stamps can be compared and corrected.

[0091] The time offset often changes over time due to the different speeds of the internal clocks (RTC) of device 1 and 2. This is ideally also equalized. For this purpose, the difference between both time stamps is repeatedly carried out according to one of the mentioned methods and the rate differences are ascertained again to equalize them subsequently. Different numbers of sample values of the signals 3, 4 of the devices 1, 2 thus result. This is equalized, for example, by keeping a sample value or interpolation of sample values in such a way that the signals run synchronously in time following the synchronization unit 5 and again have equal numbers of sampling steps.

[0092] The synchronization unit 5 is equipped here with a regulating unit 15. This changes the operating state of the ventilator 1 based on the sum of the time-synchronous signals of both devices 1, 2. For example, on the basis of manual control or by an automatic controller which recognizes, for example, asynchrony on the basis of the effort signals of device 2 and the pressure signal of device 1 and changes the settings of the ventilation unit 11 based thereon, for example, the trigger sensitivity or the cycling sensitivity or the inspiration time or the expiration time, with the goal of improving the synchrony between ventilator 1 and patient 100. Alternatively, expirational or inspirational flow limitation can be recognized on the basis of effort signals or EMG signals or EIT signals in combination with the respiratory flow signal of the ventilator 1 and reduced by a change of at least one pressure level or at least one slope of the transition between inspirational and expirational pressure.

[0093] A display unit 25 displays the time-synchronous signals 3, 4 from ventilator 1 and diagnostic device 2.

[0094] A storage unit 35 stores the time-synchronous signals 3, 4 from ventilator 1 and diagnostic device 2. The storage unit 35 optionally sends the signals 3, 4 to a remote station, for example, a server or PC or a mobile terminal.

[0095] The synchronization unit 5 and in particular its components 15, 25, 35 can be integrated as modules individually or jointly in one of the two devices 1 or 2 or in a PC or server or mobile terminal or in an evaluation unit specially produced for this purpose.

[0096] An exemplary course of therapy having a therapy supervision is shown in FIG. 2. Therapy phases 102 (dashed lines) and sections without therapy (no dashed lines) are plotted over the time 101 on the axis A. The ventilator 1 typically remains on the patient 100 over a longer time period, at least several days, and therapy sessions take place repeatedly. In addition to the signal data, statistical data are also stored, e.g., usage duration per day or medians of respiratory frequency, leak, tidal volume, minute volume per day, or the number of events such as apnea or asynchrony per day or per hour.

[0097] Diagnostic phases 103 (dashed lines) carried out using the diagnostic device 2 and sections without diagnostic device 2 (no dashed lines) are plotted over the time 101 on the axis B. The diagnostic device 2 usually only remains for a shorter time for the therapy supervision with the patient 100. Often only for one day/one night or a few days and nights. Therefore, data on fewer therapy days are often in the memory 32 than in the ventilator 1. The starting and end times of the diagnostic measurements are typically not synchronous with the starting and end times of the therapy measurements. This can additionally be amplified by differently set internal clocks (RTC). Therefore, two time scales are also shown here. The data from the ventilators 1 are typically interrupted more often, for example, by trips to the toilet, than those of the diagnostic device 2, so that multiple measurement sections (or signal curves 3) of the one device 1 have to be connected to one measurement section (or signal curve 4) of the other device 2.

[0098] The synchronization unit 5 is capable here of processing, storing, and displaying the entirety of the stored information and using it as the basis for optimization of the ventilation settings. That is to say, for days lying further back, only statistical data and sometimes also signal data from the ventilator 1 are often provided, for the days of the therapy supervision, in addition also data from the diagnostic device 2. Signals 3, 4 are accordingly additionally processed and displayed for these days.

[0099] In FIG. 3, exemplary ventilation signals 3 and diagnostic signals 4 are plotted over the time 101, which were detected during a therapy supervision. The signals 3, 4 are in the original state here, thus not time-synchronous. The diagnostic signals 4 comprise three diagnostic signal types here: therapy pressure (a), effort belt thorax (b), effort belt abdomen (c). The ventilation signals 3 comprise two ventilation signal types here: therapy pressure (d), respiratory flow (e). It can be seen well from the two therapy pressure signals (a, d) that the recordings are shifted in relation to one another with respect to the time 101.

[0100] FIG. 4 shows the ventilation signals 3 and diagnostic signals 4 of FIG. 3 after they have been synchronized by the synchronization unit 5. For better clarity, FIG. 5 shows a detailed enlargement of FIG. 4.

[0101] The ventilation signals 3 were shifted on the time axis here to run synchronously with the diagnostic signals 4. The correct chronological association can be seen particularly well particularly on the pressure curves (a, d). For the synchronization, however, the signal of the thorax effort belt (b) of the diagnostic device 2 and the respiratory flow signal (e) of the ventilator 1 were used here. In FIG. 5, the high level of time synchrony after the correction having a remaining offset less than 1 second can be seen well.

[0102] For the synchronization shown here, the synchronization unit 5 has identified signal changes 13, 14, which were caused by the same event 6, in the time curve of the ventilation signal 3 and in the time curve of the diagnostic signal 4. Such signal changes 13, 14 are marked by way of example in FIG. 5 for the signal types b and e. In both signals, a significantly linear curve having a slope of approximately zero occurred due to the same event 6 (for example, dyspnea or a leak due to a mask leak). Beginning and end of the event 6 are to be identified clearly by the brief changes of the slope.

[0103] Starting from these signal changes 13, 14, the synchronization unit 5 has also brought the remaining curves of ventilation signals 3 and diagnostic signals 4 into chronological correspondence. A comparison of other signal changes 13, 14 in the curve and, for example, the maxima and minima shows that these are also in very accurate correspondence. The synchronization is plausible over the entire curve.

[0104] For the synchronization, the synchronization unit 5 can also deliberately search for signal changes 13, 14 which originate from events other than the above-described events 6. For example, the ventilation signals 3 and/or diagnostic signals 4 can be assigned signal changes 13, 14 during their recording, which are triggered by a user input on the devices 1, 2. A synchronization signal can thus be added to each of the signal curves from both devices 1, 2 by the user input, which marks a unique point in time. For example, signal changes (for example time stamps) can also be deliberately generated by the dispatch and/or arrival of the transferred data packets with the signals 3, 4, which the synchronization unit 5 then searches out for synchronization and uses as reference points. Such signal changes 13, 14 are not shown here and can be embedded, for example, in a file of the signal curve.

LIST OF REFERENCE SIGNS

[0105] 1 ventilator [0106] 2 diagnostic device [0107] 3 ventilation signal [0108] 4 diagnostic signal [0109] 5 synchronization unit [0110] 6 event [0111] 10 ventilation system [0112] 11 ventilation unit [0113] 12 sensor unit [0114] 13 signal change [0115] 14 signal change [0116] 15 regulation unit [0117] 21 detection unit [0118] 22 diagnostic interface [0119] 25 display unit [0120] 32 storage unit [0121] 35 storage unit [0122] 41 respiration interface [0123] 42 communication unit [0124] 51 storage unit [0125] 61 communication unit [0126] 100 patient [0127] 101 time [0128] 102 therapy phase [0129] 103 diagnostic phase