FR2905275A1 - Respiration parameter e.g. respiratory flow increase, capturing method for e.g. bi-level respirator assistance device, involves measuring respiratory gas flow, respiratory gas pressure, oxygen saturation or their combination as state value - Google Patents

Abstract

The method involves measuring respiratory gas flow, respiratory gas pressure, oxygen saturation or combination of the flow, pressure and saturation as a state value of a cardio-vascular system. A captured respiration parameter is compared with a reference value, and an adjustment signal is generated for a respirator assistance device (1) and/or a signal system with respect to the comparison.

Description

Method and device for biniveau respiratory assistance

  The invention relates to a method for capturing at least one breathing parameter, which is characteristic for the state of a patient's breathing, a method of measuring the evolution over time. at least one state value of the patient that changes several times as a function of respiration.  The invention furthermore relates to a respiratory assistance device which has at least one sensor for capturing at least one breathing parameter according to the measurement technique, and which is provided with a control controlled by a control unit, for a breathing pressure.  Central sleep apnea or, respectively, a special form of this disruption of respiration, Cheyne-Stokes respiration, represents a disturbance of the regulation of respiration, the cause of which often lies in a severe heart disease. .  In patients who have suffered an attack of apoplexy, however, one also observes the manifestation of a Cheyne-Stokes respiration.  It is characterized by a continual alternation of an increase and a reduction of the depth of respiration and the occurrence of repetitive stopping of breathing.  With regard to Cheyne-Stockes respiration, this is a serious disturbance of the respiratory center.  Breathing takes a sort of undulatory course in which, after a long period of respiratory arrest, a short breath first takes place, which then changes into very deep breaths, which become longer and longer.  The cause lies in the respiratory center, which reacts only to a strong change in the blood content of CO2.  Breathing is therefore triggered when the content of 002 has exceeded a certain level and then ceases when the content required in 002 is reached.  The breathing pattern of a CS breath is characterized by the alternation of periods of apnea and hyperpnea.  In general, they have a duration of 1 minute.  At a second phase of apnea or hyperpnea from 10 to 20 seconds, follows a breath of increasing depth and frequency.  The cycle is then repeated.  Despite periods of apnea, significant hypoxia occurs only rarely.  The other effects correspond to those of obstructive sleep apnea with all its harmful effects on health, especially on existing cardiac conditions.  The object of the invention is to provide a method and a device which automatically regulates the necessary respiratory gas pressure and provides a variable assist pressure for the stabilization of respiration, at least two pressure stages which can set and the volume of breathing gas used increasing in the phases of apnea or hyperpnea.  Another object of the invention is to provide a device that allows a high compliance of the patients and a practical evaluation of the data, the dis-positive being as small as possible and portable.  The invention can be implemented, for example, in the following medical devices: respiratory assistance devices CPAP, APAP, bi-level (also known as "Bilevel"), titration, domestic, emergency, clinical.  In general, respiratory assistance devices are currently often constructed in such a way that extremely complex and efficient devices are available which have a large number of functions as well as functional elements for the therapy of different diseases.  In most applications, most of these features and functional elements are not needed.  In general, the patient, or any other user, thus has at his / her disposal a device which presents a performance which is not necessary and is of a high price, difficult to handle, of a limited portability due to too much weight, and consumes a lot of power.  The construction according to the invention provides a respiratory assistance device which assumes the functions which are necessary for effective ventilation in the event of central disturbances of respiration, so that it is particularly possible to ventilate it. adapt other functional modules, such as a humidifier, a pulse oximeter, an oxygen line, a carbon dioxide line or a capnometer.  Preferably, the respiratory assistance device has at least one display system which may, for example, be designed as a display screen and / or a touch-sensitive surface.  In a preferred embodiment, provision is made for the respiratory assistance device to be able to exchange data.  In this way, it is possible to transmit data from the patient's control system, and conversely to display on the screen and to transmit setting parameters to the apparatus.  Here, it is preferably provided that the respiratory assistance device is capable of exchanging data wirelessly and / or wired.  Thus, all necessary information is transmitted, such as, for example, patient data and individual settings.  Also included are, for example, an identification code of the respiratory assistance device concerned, an individual patient code or treatment history.  Current measurement values are stored in the respiratory assistance device.  The data transmission takes place via USB, fire-wire, LAN interfaces or, preferably, wirelessly via internet, bluetooth, radio, SMS, mobile communication system (GSM), EDGE (Enhanced Data 25 Rates for GSM Evolution), WCDMA (Wide Band Multiple Division Access Code), or optically, ZigBee, WLAN or infrared.  In this way, data exchange can also take place even when the module and the respiratory assistance device are within a radius of up to 100 meters.  Alternatively, the possibility of establishing a communication with a mobile phone can be provided so that the data can be transmitted at greater distances.  The transmitted data may be: calibration values, measurement ranges, extreme values, pressure values, flux values, respiration parameters, respiration history, signalization domains, pre-set alarms, especially when alarm areas, patient status data and / or respiratory assistance device are reached, as well as an identification of the device.  In addition, the possibility of wired or wireless data transmission to a PC can be provided.  The data transmission can also take place by means of a removable memory card which has for this purpose a storage capacity of at least 1 MB, preferably at least 2 MB.  In the region of the housing of the apparatus is provided an insertion slot for the card.  For protection purposes, the insertion slot is covered by means of a shutter.  In addition, it may be provided to provide both the basic apparatus and at least one module of a radio frequency identification (RFID) identification system so that when a module is brought closer to the radio frequency As a basic apparatus, the module data is compared with a list of identifications, and in the presence of a known identification, the respiratory assistance device immediately calls up and displays data from the module and / or patient data, by means of a technical program system.  In addition, it is possible to develop the data exchange systems so that, as part of remote maintenance, software updates can be installed.  Preferably, it is provided that parameters for estimating the quality of the therapy can be output on the screen.  Alternatively, the output of parameters for estimating the quality of the therapy by means of a memory card and / or by wireless and / or wired and / or optical data exchange is also contemplated.  Both momentary parameters and general characteristic parameters, such as, for example, the Respiratory Disturbance Index (RDI) of the last measurement, and / or therapy data may be output and data relating to the patient can be introduced.  The data memory is preferably used for receiving breathing signals and / or leaks and / or respiratory events and / or conditions of the apparatus and / or compliance data.  Preferably, it is provided that the respiratory assistance device has a housing for at least one module.  The housing can be made in the form of an insertion rack with an engagement mechanism which ensures a reliable maintenance of the module 20 in the housing and simultaneously allows it to remove without problem if necessary.  In a preferred development, it is provided that the respiratory assistance device and the at least one module have load contacts which are complementary to one another so that a module inserted into the housing is supplied with electrical energy via the charging contacts and that a connection is simultaneously established for the exchange of data.  In a preferred embodiment, the respiratory assistance device is provided with an alarm system.  The alarm system is designed so that when receiving access data 2905275 7 of at least one module, an optical, acoustic, mechanical, electrical or pneumatic signal is generated.  Preferably, the respiratory assistance device is designed to be portable so that the apparatus can also be used, for example, in motor vehicles or in a mobile manner by the patient.  In particular, it is preferably provided that the weight of the respiratory assistance device is less than 2.5 kg.  In doing so, it is preferably provided that the respiratory assistance device as well as the at least one module each have a system for power supply independent of the mains.  For this purpose, accumulators, solar cells or fuel cells are provided next to a power supply and a charging apparatus.  Preferably it is provided that the respiratory assistance device can be used for operation at electrical voltages in the range of 3 to 240 volts.  For this purpose, the respiratory assistance device has a universal power supply for different voltages and frequencies of the network.  Alternatively, an external power supply is also envisaged.  Preferably, the medical technical apparatus according to the invention further comprises a synchronization base for receiving at least one base station.  The synchronization base is made for wired and / or wireless data exchange with the basic apparatus and can have a large number of technical components such as, for example, a charging interface, a printer, patient card reader, a GSM module, external storage means, a pocket for accessories, a cardiac monitor, a more developed sensory system for emergency transport (IPB, CO2, temperature), as well as an interface to an external monitor.  Here, the synchronization base can be made for mounting in a rescue vehicle, such as an ambulance or a helicopter.  Alternately, the synchronization base can also be designed for use in buildings, for example in hospitals, and simultaneously present a wall support.  The cradle can also be placed next to the base unit.  According to the invention, it is provided that a pulsoximeter / pulsospectrometer is connected to the respiratory assistance device via an interface, which means that pulse-x-ray meter / pulsospectrometer measurement values are communicated to the device. Respiratory assistance and may be used as parameters for the control of the respiratory assistance device.  In a preferred embodiment, it is provided that the synchronization base and the basic apparatus have charging contacts designed in a complementary manner so that the basic apparatus is supplied with electrical power by the synchronization base.  An electrical connection is established because said basic apparatus is placed in a housing equipping the synchronization base, so that it is not necessary to make a connection by means of cables and plugs.  The respiratory assistance device is controlled by a control unit.  Preferably, the control unit has a servo motor with variable speed which drives a fan wheel.  The fan wheel is preferably mounted on the shaft of the electric motor.  In a preferred embodiment, the pressure of the respiratory gas is controlled by a sensory system that captures the pressure, and the flow of respiratory gas is controlled by a sensory system that captures the flow.  The sensing system capturing the pressure generates an electrical signal as a function of the pressure, which signal is transmitted to the control unit.  The sensory system capturing the stream likewise generates an electrical signal which is transmitted to the control unit.  The control unit determines the breathing phase of the patient from the electrical signals of the sensing system capturing the pressure and / or sensory system capturing the flow.  The control unit controls the electric motor according to the phases of suc- tion, and corresponding pressure and / or flow signals.  In addition, from the electrical signals of the sensory system capturing the pressure and / or sensory system capturing the flow, the control unit 20 determines the respiratory volume as a function of time of the respiratory gas delivered to the patient.  Preferably, the control unit is constructed so that the excitation of the electric motor according to the breathing phases takes place so that a lower respiratory gas pressure (EPAP) is obtained at the same time. expiratory phase of the patient and higher pressure (IPAP) during the inspiratory phase.  Through the control unit, it is possible to predetermine maximum and minimum pressures.  On the basis of the temporary analysis of the pressure and / or flow signals, an evaluation unit, connected to the control unit, alternately or additionally determines the volume of an inspiration and / or the volume as a function of time and / or respiratory rate and / or snoring and / or leakage and / or duration of inspiration and expiration and / or apnea and / or hypopnoea and / or / or flow limitations.  In doing so, the control unit can set at least one pressure value in a part of an inspiration (IPAP), at least one pressure value in a part of an expiration (EPAP) and at least one value of pres - 10 Sion at the end of an expiration (EEPAP).  The respective pressure values for IPAP, EPAP and EEPAP may differ depending on each respiratory support situation.  The respective pressure values for the IPAP, EPAP and EEPAP pressures can be as substantially the same.  For the determination of the appropriate pressure level for each respiratory assistance situation, at least the respiratory volume as a function of time is, for example, taken into consideration as a setting parameter.  For this purpose, at least one breathing parameter is entered by a sensor and the respiratory volume as a function of time is determined from it in the control unit.  Alternatively and / or additionally, the maximum respiratory flow or the respiratory volume is taken into consideration as a setting parameter.  In another embodiment, the respiratory volume as a function of time is corrected for dead space ventilation.  The control unit can be programmed in such a way that, during a normal-time breathing volume (= Idle-Mode) definable and / or automatically determined from the device, the pressure of the control unit can be adjusted. Respiratory rate is briefly reduced by 1 to 3 hPa (EEPAP), in addition to the EPA to facilitate expiration.  The IPAP is not or only slightly increased compared to the EEPAP.  5 In case of definable, higher and increasing (definite) breathing volume (hyperventilation), the expiry assistance is gradually suppressed to reduce hyperventilation.  For this purpose, a reduction of the EEPAP-EPAP difference up to 0 is gradually achieved; then we have: IPAP = EEPAP = EPAP.  In the case of definable, reduced or decreasing respiratory volume (hypoventilation), an increase in the difference between IPAP and EPAP first occurs by a reduction in the EPAP to mechanically assist the respiratory activity of the patient. patient.  In this way, an improvement in the ventilation of the patient is obtained.  When the pre-set EPAP lower pressure limit is reached, an increase in the IPAP is performed.  When the hypoventilation lasts more than 60 seconds (index: no Cheyne-Stokes breathing), there is a reduction of the respiratory assistance in that the EPAP pressure is increased again and that, if necessary, the pressure IPAP is also reduced again.  This prevents the respiratory and patient assistance system from switching to permanent controlled ventilation.  Here, hyperventilation or hypo-ventilation is not defined by going up or, respectively, exceeding a percentage set for normal breathing (e.g.  90%) and set according to this as a target value.  Instead, to increase comfort and performance, spontaneous variability of the patient's breathing is allowed over a wide range of percentages around normal breathing.  This includes one or more percentage domains of hypoventilation and, in addition to this, one or more percentage domains of hyperventilation.  Depending on the percentage range in which the current inspiration and the previous inspiration of the patient are set, and whether the difference between the two is positive or negative, the difference between the IPAP and EPAP pressures is increased. or reduced by a value defined by the control unit.  Here, the difference between the current inspiration and the previous inspiration is the decisive criterion according to which the direction of the difference between IPAP and EPAP is modified.  The absolute percentage of the current inspiration in comparison with the normal respiration only has the effect of amplifying or weakening the reaction of the pressure.  To the same extent, the information, according to which the pressure difference has already been increased or reduced before the last inspiration, serves as a decisive feature for an increase or a reduction of the pressure reaction since this makes it possible to judge if the change in respiratory volume as a function of time was caused by the change in mechanical ventilation or by the modification of the spontaneous breathing of the patient.  According to the invention, it is envisaged to dampen the cyclic changes in the spontaneous breathing of the patient by a counter-cyclic mechanical ventilation.  Here, it is observed that spontaneous breathing is controlled by the modification of the CO2 content of the blood.  In hypoventilation and central apnea phases, the CO2 content is too low.  The respiratory support of the apparatus should not be higher than necessary for the CO2 content to slowly normalize again and spontaneous breathing to resume.  However, the respiratory support must be at least so strong that the number of hyperventilations not related to sleep fragmentation, following hypoventilations, is significantly reduced.  For this reason, according to the invention, in case of hypoventilation or central apnea respectively, the difference between the IPAP and EPAP pressures is at first greatly increased, but the inspiration time is, however, reduced. optionally, by premature switching on EPAP, when a respiratory volume as a function of time is exceeded in a current inspiration.  In a preselected ST mode, after a too long pause of breath, whose limit value depends on the respiratory rate or is adjustable, a controlled ventilation, thus triggered by the apparatus and not by the patient, the difference between the TPAP and EPAP pressures which increases little by little when the respiratory volume as a function of time is too small.  In a preferred form of development, the control unit then predefines the inspiration and expiration times and thus the duration of the IPAP, EPAP and EEPAP pressures applied.  In doing so, at least one signal is taken into account, which represents the previous respiratory rate or the patient's respiratory volume.  In addition to this, the pressure is again reduced from the IPAP level by the control unit when a minimum respiratory volume is reached.  Via the control system there is additionally an automatic adaptation of the pressure EEPAP to avoid obstructive respiratory disturbances when ascertaining a resistance of the respiratory tracts.  Compared to other existing methods having only 2 pressure levels (IPAP and EPAP), due to the level of pressure avoiding end-of-exhalation obstructions, the effective possibility of respiratory assistance (IPAP-EPAP difference) however, it is maintained throughout the pressure range of the device (eg.  4 to 35 hPa), although elevated pressure is required at the end of expiration to avoid blockage.  This avoids a further increase in the maximum IPAP pressure which would otherwise be required.  This allows a reduction in the size and weight of the device, as well as the energy consumption of the pressure generating system.  The danger of side effects for the patient is also reduced.  With the EEPAP control, the minute breathing volume can also be influenced in addition to the IPAP-EPAP difference.  Higher CPAP or EEPAP pressure causes an increase in minute respiratory volume, which is triggered, for example, by the lung stretching receptors.  In a preferred embodiment of the invention, the EEPAP pressure, or mean pressure, is therefore reduced by the control system during hyperventilation, while it is increased during a hypopnea.  In addition, an analyzer determines the loss flow of the respiratory assistance device and transmits to the control unit a signal about the loss of the device.  In addition, the loss flow can be differentiated by the analyzer as a scanning flow and a leak flow.  The magnitude of the sweep flow is a function of the pressure and the flow / pressure characteristic line of the outlet system.  This may be different because different accessories (masks) can be used together with the device.  In a preferred embodiment, the control unit is able to automatically determine this characteristic line during service due to the signals.  In this way, it is possible to more accurately determine not only the leakage but also the actual respiratory volume, without the user having to indicate the type of mask or outlet valve.  In addition, the control unit is able to enter safe mode when a certain leak is exceeded.  In this mode, the signals are evaluated in another way and the reaction of the pressure is also changed.  This should serve to avoid improper behavior of the apparatus due to the leak situation.  In particular, it is envisaged to no longer take into account certain events and to limit the reaction of the pressure.  This should prevent, for example, a trigger.  An additional security mode is provided in the event that the apparatus detects a patient's respiratory activity that is not in synchronism with the IPAP, EPAP, EEPAP command.  In this case, the complexity of the pressure regulation can be, for example, reduced - and thus the increased robustness by reducing the number of pressure levels (EPAP-EEPAP) to 2.  The concentration of 002 in the blood has a considerable influence on the regulation of respiration.  This is strongly influenced by the concentration of 002 in the lungs and thus also in the breathing mask and the breathing tube.  When the air exhaled by the patient is not completely driven out of the mask and thereby also out of the lungs, the CO2 content then increases in the mask and, therefore, also in the lungs and in the lungs. the blood.  In a preferred embodiment of the invention, the EEPAP pressure or the average pressure is reduced so that the 002 content does not drop too much in the blood despite hyperventilation.  In this way, the following hypopneas and apneas are avoided.  In an evaluation system, the value 002 re-inspired is evaluated according to at least one parameter relating to the ventilation pressure, the respiratory flow, the respiratory volume, the leak and the type of mask.  In another embodiment, the apparatus first analyzes the patient's breathing pattern and, where appropriate, stores the values of the breathing pattern; it does not change its pressure values yet during a first phase.  By analyzing at least two inspirations, both the patient's normal breathing and cyclic variability of breathing can be detected.  As a result, the apparatus can not only react to changes in individual volumes due, for example, to a change in body position, awakening, speech, etc. , but also very specifically determine periodic breathing phases or Cheyne-Stokes.  This detection can be effected by envelope filtering applied to the breathing activity, storing the calculated values, and processing the signal.  At least one parameter is obtained which is related to the duration of the cycle of periodic respiration, another parameter which is related to the importance of the hypopnea / apnea, as well as to the phase of hyperventilation, as well as a third parameter that is related to the respiratory rate.  From these at least three parameters obtained is derived the adaptation of the pressure during the following cycle of periodic breathing.  During the realization of this adaptation of the pressure, at least the three mentioned parameters as well as the applied pressure are detected.  On this basis, the pressure adaptation is modified for the following inspirations or for the next cycle, with the aim of continuing to stabilize the breathing.  In a preferred embodiment, one of the following states is identified due to at least one of the pressure or respiratory flow signals, respiratory volume as a function of time, respiratory rate or snoring.  In doing so, the modification in time, the regularity of the modification over time as well as the dispersion of the signals are analyzed in particular: State of respiratory irregularities not susceptible of therapy.  These may be phases of movement or other phases with a great variability of spontaneous breathing, without harmful influence for the patient.  In particular, these may be phases that indicate that the patient would no longer tolerate a more intense therapy in the sense of increasing at least one level of pressure, respectively that this would disrupt his sleep.  Steady state of spontaneous breathing: In this state, the patient breathes sufficiently stably so that the therapy can be modified in the sense of a reduction in the intensity of the therapy.  2905275 18 State of Respiratory Irregularity Requiring Therapy: In this state, the patient needs more intense therapy so that the stability of breathing can be increased.  These states may be related to stages of classic sleep, awakening, NREM sleep and REM sleep, as well as to arousals.  This is however not necessarily the case.  The device according to the invention reacts appropriately to the detected state by ceasing the therapy, or by increasing, respectively reducing the intensity thereof, or the intensity of the therapy remains unchanged.  In each case, the goal is to stabilize the patient's breathing, however only as long as this is possible and the patient tolerates it.  In a particularly preferred embodiment, it is memorized in the apparatus at what intensity of the therapy certain states have manifested, in order to learn in the long run what therapeutic intensity is optimal for the patient.  The control unit preferably has a microprocessor which receives from a pulse oximeter a Sp02 or Sa02 signal as an additional input signal.  The control unit then sends a signal to the valve for oxygen supply when the measurement values Sa02 leave a definable domain.  The control unit also sends control signals to the electric motor when the measured values Sa02 leave a definable domain.  According to the invention, it is possible to connect to the respiratory assistance device or to integrate in the apparatus a pulsoximeter which operates at least at 2 wavelengths and can measure the following parameters: Sp0 2, SaO 2, SaCO, cHb.  In one embodiment of the invention, the control unit monitors not only the magnitude of the SaO2 signal but also the speed of the signal change.  The pulse rate and heartbeat amplitude, as well as the heartbeat baseline are also controlled.  Pulse rate and heartbeat rate and heartbeat baseline control are performed for the detection of arousals so that definable limit values can be predetermined for the signals which are in relation to pulse rate, heart rate or heartbeat baseline.  When these limit values are exceeded, the control unit generates control signals for the electric motor for adjusting the pressure.  In this way, the pressure can be adjusted to the optimum sleep quality, since an increase in pressure occurs only when necessary.  In doing so, the limit values can be absolute limit values or limit values for percentage changes in signals within a certain time range.  For reliable detection of apnea and / or hypopnea, oxygen saturation is measured and taken into consideration in addition to the measured respiratory gas, pressure and flow parameters.  This avoids the reaction to unimportant events.  For the detection and therapy of hypoventilation (adiposity), the respiratory volume per minute is currently considered.  Since respiratory volume per minute varies greatly depending on sleep phase, temperature, digestion and body position, it is not sufficiently capable of serving as a single parameter for detection. and the therapy of hypoventilation (adiposity).  In accordance with the invention, it is therefore contemplated to also take into account the desaturation of SpO2 / SaO2 for the detection and therapy of hypoventilation (adiposity).  During this period, the nominal respiratory volume per minute is not considered to be constant, When a desaturation below a certain limit value of Sp02 / Sa02 (88%, for example) occurs during At a certain time (eg 5 minutes), the control unit generates control signals at the address of the electric motor for the adaptation of the pressure in the sense of a stronger breathing assistance by the apparatus according to the invention.  An aspect of the invention also resides in the evaluation of the pulse oximetry signal for the confirmation of respiratory disturbances, such as hypopneas or flow limitation that can be detected by a pressure and / or flux signal analysis.  For the determination of the state of the cardiovascular system, the pulse rate and the heartbeat are preferably evaluated.  In this way, according to the invention, it is possible to measure not only the success of the respiratory (secondary) disturbance therapy in case of Cheyne-Stokes respiration but also the progress, respectively the improvements of the heart disease proper.  With regard to data entry, at least two of the following events can be captured in less than one minute: Increased respiratory flow, decreased respiratory flow, flattened respiratory flow, stopped breathing flow, increased resistance , leakage modification, aspiration, exhalation, breath-holding time, increase in respiratory volume, decrease in respiratory volume, increase in fresh respiratory gas pressure, decrease in fresh respiratory gas pressure , increasing the volume of fresh breathing gas in circuit as well as reducing the volume of fresh breathing gas in circuit.  The drawings show exemplary embodiments of the invention.  They show: FIG. 1: a perspective view of a breathing assistance device with a connected breathing tube and a sequence valve arranged above the respiratory assistance device for supplying oxygen and / or of carbon dioxide.  FIG. 2 is an enlarged view of the details II of FIG. 1, FIG. 3: an arrangement similar to FIG.  1, showing in addition a display system, FIG. 4: a modification of FIG. 3 with a separate sequence valve of the respiratory assistance device, FIG. 5: a sketch of principle showing a possibility of adaptation of the valve of FIG. FIG. 6: a modification of the embodiment according to FIG. 5, with the additional implementation of a safety valve and a safety valve. additional pipe, integrated, for the supply of oxygen and / or carbon dioxide, Figure 7: an embodiment with a sequence valve, integrated into a humidifier, for the supply of oxygen and / or FIG. 8: another embodiment of a sequence valve integrated in a breathing gas humidifier, FIG. 9: a basic sketch showing a possibility of adaptation FIG. a perspective view of a respiratory assistance device (1) which is provided with a hose connector (2), a display (3) and actuating elements (4).  At the hose connection (2) there is connected a breathing hose (5) through which a pressure measurement line (6) extends.  In the region of a housing of the apparatus, a breathing gas pump is installed in an interior space of the apparatus.  A breathing pipe is connected by a coupling device.  Along the connecting pipe, an additional hose for measuring the pressure can be extended, which can be connected to the housing of the apparatus.  To enable data transmission, the housing of the apparatus is equipped with an interface (11).  In the region of the housing of the apparatus, a noise damping device is installed in the suction zone and in the pressure zone.  The noise damping device surrounds, at least in sections, the breathing gas pump and is coated, at least in sections, with a sound-insulating material for obtaining sound radiation located in a range below 29 dbA, preferably less than 26 dbA.  In the region of an extension of the breathing tube opposite the housing of the apparatus, there is an expiratory member (not shown).  An exhalation valve can also be used.  As a patient interface, a breathing mask can be attached which can be attached to a patient's head by means of a hood.  In the region of its extension directed towards the breathing tube, the breathing mask has a coupling element.  On the outside of the breathing pipe (5) there is a pipe (7) which is connected to a sequence valve (8).  By means of the line, oxygen (02) and / or carbon dioxide (CO2) doses can be added to the breathing gas.  The sequence valve (8) is connected to a source of CO2 and / or O2, not shown, via a supply line (9).  The sequence valve (8) is connected to a control connection (11) of the respiratory assistance device (1) via a control line (10).  The control connection (11) is connected to a control unit of the respiratory assistance device (1) which is not shown in FIG.  In the exemplary embodiment shown in FIG. 1, the sequence valve (8) is installed on the outside of the respiratory assistance device (1), and in the embodiment shown, the installation is performed above the respiratory assistance device (1).  In use of the sequence valve (8), a patient connected to a respiratory assistance device (1) can typically be provided with up to 20 liters / minute of oxygen.  Alternatively or additionally, the respiratory gas can be enriched with 2% to 5% CO2.  The metered dose can take place in the CPAP, bi-level or domestic respiratory support setting.  In addition to this, other applications are also possible in the context of respiratory therapy or in emergency situations.  Typical process pressure is in the range of 1 to 80 mbar.  Typically in a range of 2 to 35 mbar.  The

  supply line (9) can be connected to an oxygen concentrator, a CO2 cylinder with a pressure reducer, an oxygen cylinder with a pressure reducer, a liquid oxygen supply system or a central gas supply system. The sequence valve (8) typically operates under ambient conditions with an air pressure of 500 to 2060 hPa. Permissible moisture content of the air is up to 100%. For power supply of the sequence valve (8) and the respiratory assistance device, electrical voltages in the range of 3 to 240 V may be used. For this purpose, the respiratory assistance device has a universal, integrated power supply suitable for different mains voltages and frequencies. Alternatively, it is also contemplated to use an external power supply. Advantageously, the sequence valve (8) is provided with a suppression device. A control of the sequence valve (8) can also be performed from the respiratory assistance device (1) by means of different interfaces. The interfaces may be wired, made as an infrared interface or as a bluetooth interface. The connection between the sequence valve (8) and the respiratory assistance device (1) can be in particular electrical, pneumatic, optical, mechanical or made by combining the aforementioned variants. The sequence valve may also operate automatically when a cyclic interrogation system relating to the correct or disturbed state of operation of the respiratory assistance device is arranged in the region of the sequence valve. For reliable operation of the apparatus, it is advantageous for the respiratory assistance device to continuously, cyclically, check, at short intervals, the operating state of the sequence valve (8). ). For performing the switching of a supply of oxygen, the sequence valve (8) is provided with a magnetic valve which is disposed within a modular housing (12) of the sequence valve. (8). In particular, it is advantageous for a subsequent assembly of the sequence valve (8) to use, for the control of said sequence valve (8), a control connection (11) which already equips the respiratory assistance device. (1). Via this already existing interface is the communication between the sequence valve (8) and the control unit of the respiratory assistance device (1).

Figure 3 shows a view similar to Figure 1, further exposing a display system (16) in the region of the sequence valve (8). The display system (16) has state indications (17, 18). The display system (16) can be optically, acoustically or both optically and acoustically constructed. The state indications (17, 18) signal the operation of the sequence valve (8). When the respiratory assistance device (1) is disconnected or not operating properly, the sequence valve (8) closes and the display system (16) turns off. After the correct operating state of the respiratory assistance device (1) has been restored, the sequence valve (8) opens again. Alternatively, in place of a display system (16), also permanently visible symbols which are, for example, printed may be used. The sequence valve (8) is connected to the suction pipe (5) on the one hand and to the respiratory assistance device (1) on the other hand. The state indications (17, 18) may relate to the operating state, the oxygen flow rate, and the oxygen concentration. According to FIG. 4, the sequence valve (8) is removably arranged on the housing of the apparatus. To prevent oxygen reflux in the respiratory assistance device (1), adapting it (20) according to FIG. 5 is connected to a nonreturn valve (22). In a simplified embodiment, the active control valve (22) may consist of a shutter which, when spring loaded, is pulled into a basic position and opens automatically when the breathing gas flows from the respiratory assistance device (1) towards the patient, and closes upon expiration by the patient. Preferably, such an application is performed using a two-pipe system, respectively an expiration valve close to the patient. This facilitates the necessary re-inspiration in case of CPAP and bi-level ventilation. FIG. 6 shows a more developed construction with respect to the embodiment shown in FIG. 5. In the region of the reduction valve (21) is installed an additional safety valve (23) which opens when a pressure oxygen supply is greater than a limit value. In addition to this, from the reduction valve (21) to the breathing pipe (5) extends an injection line (24) for oxygen or CO2. A flow opening of the injection line (24) is directed towards a main flow within the breathing pipe (5). Figure 7 shows an integration of the sequence valve (8) into a humidifier (25) for the breathing gas. The humidifier (25) can be arranged between the breathing tube (5) and the respiratory assistance device (1) and is mounted on the hose connector (2) of the respiratory assistance device (1). Of a typical material, the humidifier (25) has a heating element (26) which can be connected to the respiratory assistance device (1) via an electrical connector (27). The humidifier (25) typically has a water reservoir (28) and a lid (29). In the region of the cover (29) is arranged a filling orifice (30) with a closure (31). The humidifier (25) can be snapped onto the respiratory assistance device, said humidifier (25), in the mounted state, being adapted to the respiratory assistance device substantially by interlocking. Alternatively, the humidifier (25) may be fully or partially integrated in the respiratory assistance device. Communication with the respiratory assistance device (1) can be effected by means of a connector existing between the humidifier (25) and the respiratory assistance device (1). The display system (16) can be positioned in the region of a surface of the humidifier (25).

Figure 8 shows a cross-section of the humidifier (25). The humidifier (25) is connected via a connecting adapter (32) to the respiratory assistance device (1) which is not shown in FIG. 8. Through the humidifier (25) extends a pressure measuring line (33) which can be connected to the pressure measuring pipe (6). In the region of a breathing gas supply system (34), the humidifier (25) may be equipped with a non-return valve (22). Here too, the control valve (22) prevents reflux of oxygen to the respiratory assistance device (1). The switching point of the sequence valve (8), to which it opens and closes the oxygen line (7) and / or the line 002, can be adjusted and adapted individually to the patient's needs and to each situation. respiratory assistance. The quantity is dosed according to the set EPAP pressure.

According to a preferred embodiment, the gas supply can also take place during inspiration. To do this, information is communicated to the sequence valve (8) by the command of the respiratory assistance dis-positive, respectively the sequence valve is activated during the expiration phase. It is particularly advantageous that the oxygen supply pipe (7) is longer than the pressure measuring pipe (5). In this way, it is avoided that the flow of oxygen out of the oxygen supply pipe (7) systematically distorts the measurement pressure signal. This would be critical because the measurement signal in question is taken into account for the control of the respiratory assistance device (1). In Figure 9, the points ABCD refer to point A = start of reduction: peak of inspiration certainly exceeded 29 2905275 point B = end of reduction: sidewall of the pressure drop as a function of respiratory rate, maximum slope determined by the idling of the ventilator, 5 point C = beginning of the increase: peak of expiration certainly exceeded point D = end of the increase: side of the rise of the pressure according to the respiratory rate.

FIG. 9 shows that the control unit adjusts the pressure of the breathing gas so that a lower circuit breathing gas pressure (EPAP) is available during the exhalation and pressure phase. higher (PPI) during the patient's inhalation phase. Through the control unit, maximum and minimum pressures can be predetermined. An evaluation unit, connected to the control unit, determines, on the basis of the analysis of the pressure and / or the flow as a function of time, alternately or additionally the volume of the inspiration and / or the respiratory volume as a function of time and / or the frequency of breathing and / or snoring and / or leakage and / or duration of inspiration and expiration and / or apnea and / or hypopnoea and / or or flow limitation. The control unit may be programmed so that, at a patient's definable normal breathing time (= Idle-Mode), the breathing gas pressure is briefly reduced from 1 to 3 hPa (EEPAP). in addition to the EPAP to facilitate expiration. In the event of a definable elevated respiratory volume (hyperventilation), the expiratory assistance is gradually removed. For this purpose, the difference between EEPAP and EPAP is reduced step by step until 0; then we have: IPAP = EEPAP. In case of reduced respiratory volume as a function of reduced definable time (hypoventilation), there is an increase in the difference between the IPAP and EPAP pressures by reduction of the IPAP. In this way, an improvement in the ventilation of the patient is obtained. When the lower limit of the preset EPAP pressure is reached, an increase in the IPAP occurs. When hypoventilation lasts more than 60 seconds (index: no Cheyne-Stokes breathing), there is a reduction in respiratory assistance by a further increase in EPAP pressure and, if appropriate, by a further reduction of IPAP pressure. In the preselectable mode T, in the case of a too long stopping time of the breathing, whose limit value is a function of the frequency of the respiration and can be adjusted, ventilation with difference increasing between IPAP and EPAP pressures. Through the control unit, in addition, when ascertaining a raised respiratory resistance, an automatic adjustment of the pressure is made to avoid obstructive respiratory disturbances. When assessing the respiratory volume as a function of time, normal breathing is recognized when the respiratory volume as a function of time differs by more than or equal to 10% in a comparison between the current inspiration. and the previous inspiration. Hypoventilation is recognized when the carbon dioxide content of exhaled air is decreasing. Inadequate respiratory assistance from the respiratory assistance device is recognized when the carbon dioxide content of the exhaled air increases. 32

Claims (5)

claims   A method for entering at least one breathing parameter which is characteristic for a patient's breathing state, a measure of the time course of at least one patient's state value, being modified several times depending on the respiration, being carried out, characterized in that, as a state value, the flow of respiratory gas, the respiratory gas pressure or the oxygen saturation, or any combination thereof, is measured settings.   2. Method according to claim 1, characterized in that a state value of the cardiovascular system is evaluated.   3. Method according to one of the preceding claims, characterized in that at least one respiratory parameter entered is compared with a reference value 20 and that, as a function of the comparison, a control signal is generated for a control system. respiratory assistance and / or signaling system.   4. Respiratory assistance device which has at least one sensor for capturing at least one parameter relating to respiration, according to the measurement technique, and which is provided with a control, servocontrolled to a control unit. control, for the control of a respiratory pressure, characterized in that the control unit 30 comprises means for determining the respiratory volume of the patient as a function of time, from at least one of the parameters relating to the pressure and / or flow and that the respiratory volume as a function of time at least 2905275 serves as a control parameter for the respiratory gas pressure of the respiratory assistance device.   5. Device according to claim 4, characterized in that a measuring device is provided which is equipped with sensors for measuring the evolution over time of at least one state value of the cardiovascular system of the device. probative that varies repeatedly depending on the breathing.