Medical device for artificial respiration of living being

Abstract

The invention relates to a method for carrying out an occlusion maneuver (100) and to a medical device for artificial respiration of a living being, having an operating function for carrying out an occlusion maneuver (100) in order to obtain a stationary pressure phase (Pplate.) (111) of the inspiration, the invention also relates to a computer program or to a computer program for carrying out the method. During and after the occlusion maneuver is carried out, it can be determined by means of a signal analysis (110) whether a stable and reliable inspiratory pressure stationary period (Pslab.) (111) can be obtained as a result of the occlusion maneuver (100).

Description

Technical Field

[0001] The present invention relates to a medical device suitable for artificially respirating a living being or patient, such as an anesthesia device, in particular in the form of a force-respiratory device, a home artificial respirator, a mobile emergency artificial respirator, or an artificial respirator for premature infants and / or newborns, small children, and children, the medical device having an operating function for performing an occlusion maneuver to achieve a pressure plateau during inspiration. Artificial respirators are often also referred to as respirators or ventilators. Background Art

[0002] During artificial respiration, certain artificial respiration parameters, such as the artificial respiration pressure (P_insp, PEEP), artificial respiration rate (RR), tidal volume (VT), I:E ratio, and minute ventilation (MV), are set and continuously monitored using sensors. These artificial respiration parameters identify not only the patient's condition but also the operating conditions and settings of the artificial respiration device. Furthermore, it is often of interest to obtain information about how the patient's condition has changed during treatment. To this end, special manipulations are often used, which can be partially performed manually by the user and, in this case, also partially supported by the artificial respiration device. These manipulations allow specific characteristics of the patient to be detected from time to time.

[0003] Here are three examples of manipulation:

[0004] RSVT maneuver (Respiratory Systolic Variability Test);

[0005] Occlusion control;

[0006] P0.1 control.

[0007] RSVT maneuvers are used to determine the characteristics of a patient's electrocardiographic system, particularly to obtain information about the patient's fluid budget. In routine clinical practice, volume therapy for ventilated patients can be individually organized and / or controlled based on the results of the RSVT maneuver. During the RSVT maneuver, the ventilator automatically increases the respiration pressure in stages. Simultaneously, a physiological patient monitor measures arterial blood pressure at these pressure levels, thereby determining the effect of the respiration pressure on blood pressure and, therefore, whether the patient would benefit from an additional dose of fluid.

[0008] The P0.1 manipulation is used to determine the patient's respiratory muscle function. This is achieved by blocking the airway for 0.12 seconds at the beginning of the inspiration phase after a complete exhalation during the patient's resting breathing, and determining the sealing pressure 0.1 seconds after the start of inspiration. The sealing pressure P0.1 is a reference value for the average inspiratory pressure (P_insp.) that must be applied per breath and therefore indicates both the load on the inspiratory muscles and the central respiratory drive. P0.1 also depends, in particular, on the pressure transfer from the inspiratory muscles to the mouth and the degree of artificial respiration. To obtain an evaluable database, multiple repetitions, for example five, may be necessary.

[0009] Unlike the P0.1 maneuver, the Occlusion maneuver is not performed at the beginning of inspiration, but rather at or near the end of the inspiratory phase. The Occlusion maneuver provides a snapshot of a situation where artificial respiration appears to have ceased. This snapshot allows the user to assess the course of the airway pressure curve over the duration of the Occlusion maneuver and, based on this course, estimate a measure of the patient's work of breathing or lung stretch. Summary of the Invention

[0010] The object of the present invention is to specify an operating function of a medical device, in particular a ventilator, for artificially respirating a living being, which allows a measure of the lung state of the living being to be acquired during inspiration.

[0011] This object and others are achieved by the medical device according to the invention for the artificial respiration of a living being, in particular an artificial respiration device.

[0012] The object of providing an operating function for a respirator is achieved by a medical device, in particular a respirator, according to the invention.

[0013] Advantageous embodiments of the present invention are derived from preferred exemplary embodiments and are explained in detail in the following description, partly with reference to the accompanying drawings. Features and details described in connection with the medical device or ventilator according to the invention naturally also apply in connection with the method, and vice versa, so that reference is always made to or can be made to one another regarding the disclosures relating to the various inventive aspects.

[0014] A medical device, in particular a respirator for artificially respiring a living being or a patient, is designed to carry out and configure artificial respiration.

[0015] Biological or patient is connected with artificial respiration apparatus by means of the pipeline system and patient connecting element, so-called Y-shaped thing in the form of artificial respiration hose mostly.On the Y-shaped thing, be connected with the endotracheal tube that is used to be connected with the patient's trachea system mostly.Y-shaped thing pneumatically contacts the artificial respiration hose of inspiration and provides gas quantity, and these gas quantities flow toward the patient from the artificial respiration apparatus and are used for the patient's inspiration by means of endotracheal tube.Y-shaped thing pneumatically contacts the artificial respiration hose of exhalation and will guide the gas quantity that continues to flow from the endotracheal tube with the exhalation from the patient to the artificial respiration apparatus.Therefore, the artificial respiration hose of inspiration and exhalation, together with the Y-shaped thing and endotracheal tube, constitute the pipeline system that is used to be connected with artificial respiration apparatus.

[0016] In a typical design, a medical device comprises a control unit, a gas delivery unit, and a breathing system, and oxygen and medical air are supplied to the medical device via a gas supply. The gas supply comprises components suitably designed for this purpose in order to provide a sufficient amount of a gas mixture for the medical device or artificial respiration device. The gas mixture advantageously consists of a variable mixture of air and oxygen, so that the patient can be artificially respired with an inhaled gas concentration exceeding 21% oxygen. The gas supply is usually implemented by means of a central gas supply (ZV). Alternatively, the gas delivery unit can also be designed appropriately as a blower drive, a compressor drive, or as a local compressed gas supply at the artificial respiration device, and can be supplied to the artificial respiration device by means of a flange.

[0017] During operation of the artificial respiration device, the control unit is configured to implement and control automated artificial respiration, i.e., for example, pressure-controlled or volume-controlled artificial respiration, by means of control and / or regulation. The control unit can further be configured to control and / or coordinate supportive artificial respiration patterns based on measured values ​​of the artificial respiration pressure, the inspiratory and / or expiratory flow rate, or the volume. Furthermore, the control unit is configured to control and / or manage alarm functionality of the artificial respiration device, including, in particular, threshold monitoring of the inspiratory and / or expiratory artificial respiration pressure, threshold monitoring of the gas concentration, and threshold monitoring of the expiratory flow rate.

[0018] The inspiratory branch of the respiratory system delivers a gas quantity provided by a gas supply to the inspiratory respiration hose by means of a gas delivery unit, for example in the embodiment as a radial blower, by means of a pneumatic interface, in order to deliver it to the patient as an inspiratory gas mixture.

[0019] The exhalation branch of the breathing system discharges the amount of exhalation gas exhaled by the patient and conducted away from the patient via the exhalation artificial respiration hose and flowing into the breathing system via the pneumatic interface to the surroundings in a controlled manner.

[0020] The connection of the breathing system to the artificial respiration hose is designed with a mostly passive nonreturn valve in order to predetermine the direction of the gas flow in the breathing system and in the line system.

[0021] To determine the current lung status of the patient and the relative contribution of the patient during artificial respiration, as described above and below, a so-called occlusion maneuver is used in everyday clinical practice. The pressure profile of the inspiratory airway or the airway pressure profile detected during the occlusion maneuver is then visually and manually evaluated by the user. In particular, the plateau pressure (P_Plat.) of the inspiratory airway during the occlusion phase is observed in order to derive a characteristic pressure, the so-called "driving pressure," from it. Currently, a measuring catheter in the esophagus is often used to detect the overall driving pressure.

[0022] The positive pressure observed in the ventilator during artificial respiration is added to the negative pressure measured using the measuring tube, resulting in an overall "propulsion pressure" when using this catheter method. When properly measured, the pressure in the esophagus roughly corresponds to the thoracic pressure and therefore reflects the patient's respiratory effort quite accurately. In a preferred method for determining this value without using an esophageal measuring tube, inspiration is artificially prolonged until the patient is neither inhaling nor exhaling, and the respiratory musculature is therefore ideally passive. This results in a pressure increase in the patient's lungs because the total volume—the amount of gas moved by the ventilator and the patient themselves given the limited extensibility of the patient's lungs, commonly referred to as compliance—leads to a higher total pressure in the lungs when the respiratory muscles are relaxed.

[0023] According to formula 1, the driving pressure is obtained as the quotient of tidal volume and compliance:

[0024] ΔP=VT / C Formula 1

[0025] From the physical aspects of artificial respiration of living beings, it should be noted that modern artificial respiration devices are able to detect the properties of the tube system or artificial respiration hose system, such as resistance and compliance, as well as possible leaks during the device self-test and then take them into account during further artificial respiration operation.

[0026] The basic idea of ​​the present invention is to determine or establish an inspiratory plateau pressure (P_Plat.) from the pressure curve detected by means of the occlusion actuation.

[0027] In order to measure and measure this variable or "propulsion pressure" during the occlusion maneuver, a control unit is arranged, provided, and suitably configured in a medical device for artificially respiring a living being, in particular a respirator. The control unit is designed to carry out automated artificial respiration by controlling and temporally coordinating inspiration (inspiratory phase) and expiration (expiratory phase) with the aid of flow rates (Flow), volumes (Vt, MV), pressure levels, such as inspiratory pressure (P_insp.) and positive end-expiratory pressure (PEEP), and to control correspondingly suitably configured actuators via signal and data lines.

[0028] The actuators in the artificial respiration apparatus which are controlled and actuated by the control unit are, in particular, a gas delivery unit, such as a radial blower or a piston pump, and controllable metering valves, such as an exhalation valve.

[0029] Furthermore, the control unit is configured to acquire data from a sensor system comprising at least one pressure sensor and at least one flow sensor and incorporate this data into the coordination and control of automated artificial respiration. The control unit is also configured to control the occlusion maneuver and, near the end of the inspiratory phase or beyond the end of the inspiratory phase, actuate the actuator such that the patient is neither allowed to inhale further nor to exhale for the duration of the occlusion maneuver. During the duration of the occlusion maneuver, the patient is only able to exchange gas with the volume of the tubing system comprising the inspiratory and expiratory artificial respiration hoses. This means that the patient can not only inhale additional gas from the lungs into the volume of the tubing system, which may result in an increase in pressure in the tubing system, but also inhale a certain amount of gas from the volume of the tubing system into the lungs, which may result in a decrease in pressure in the tubing system.

[0030] In order to implement the basic concept explained above in a medical device designed for artificial respiration of a living being or a patient, the control unit is suitably designed and configured and the functionality according to the invention is correspondingly expanded for carrying out the occlusion actuation.

[0031] The control unit determines the inspiratory plateau pressure (P_Plat.) from the detected pressure curve by means of the occlusion actuation. The control unit can derive the propulsion pressure from the detected inspiratory plateau pressure (P_Plat.) as a measure for the total work of breathing or ventilation.

[0032] The medical device according to the invention, in particular a respirator, is designed for artificial respiration of a living being or a patient and comprises a control unit, a respiration system, a line system, and a sensor system.

[0033] The inhalation and exhalation artificial respiration hoses, together with the Y-shaped object and the endotracheal tube, form a pipeline system for connecting the artificial respiration device to the living being or the patient.

[0034] The breathing system is pneumatically connected to the line system via an interface. The breathing system has means for delivering a controlled amount of an inhaled breathing gas mixture to the living being. The inhalation branch of the breathing system provides a controlled amount of breathing gas mixture, for example, via a gas delivery unit in the form of a radial blower, and supplies this via a pneumatic interface to an artificial respiration hose for inhalation of the patient.

[0035] The breathing system also includes means for controlling the further flow of the exhaled volume of the breathing gas mixture. By means of a pneumatic interface, the volume of gas exhaled by the patient into the exhaled artificial respiration hose is discharged in a controlled manner, for example, by means of an exhalation valve, through the exhaled branch of the breathing system or the tubing system. The breathing system is thus designed to guide and control the volume of inhaled and exhaled gas within the medical device and to provide it to the patient or patient via the tubing system. To this end, the breathing system includes means for conveying and guiding the volume of the breathing gas mixture and for controlling the inhaled volume of the breathing gas mixture, as well as means for controlling the further flow of the exhaled volume of the breathing gas mixture. The means for conveying can be configured as a gas conveying and metering unit, for example, as a gas conveying unit combined with a controllable proportional valve serving as an inhalation valve. The means for further conveying can be configured as an actively controllable exhalation valve.

[0036] A non-return valve, which is generally passive, can be provided at the connection to the artificial respiration tube in order to predetermine the flow direction of the gas quantity in the breathing system and in the line system.

[0037] The medical device according to the invention provides a coordinated operating function with an occlusion maneuver in order to carry out a maneuver in the form of an occlusion maneuver that allows the detection of a pressure plateau (P_plat.) during inspiration.

[0038] The line system is designed to supply a quantity of breathing gas to the living being and to convey a quantity of breathing gas onward from the living being.

[0039] The breathing system is pneumatically connected to the pipe system by means of at least one interface or by means of two interfaces. The pipe system is configured, for example, as a double hose system having an artificial breathing hose for inspiration and an artificial breathing hose for expiration. In particular, in the design of emergency artificial respiration devices, a single hose system is often used, in which an amount of inhaled gas can be provided to the patient via an inhalation hose, and expiration can be performed via an exhalation valve controlled by a control unit and arranged near the patient's oral region. The breathing system can be configured as an artificial respiration device or a breathing system of an artificial respiration system in an intensive care unit (ICU) of a hospital, by which an amount of inhaled gas can be provided to the patient via an inspiration branch of the breathing system, and an amount of expiration gas can flow directly to the patient or by means of a structure that returns to the artificial respiration device via a pipe system and out to the surrounding environment via an expiration branch of the breathing system. The breathing system can also be configured as a circulatory system of an anesthesia device or an anesthesia system for performing inhalation anesthesia, through which a quantity of inhaled gas can be provided to the patient by means of a line system, and a quantity of expired gas can flow back to the anesthesia device or the anesthesia system via the line system and can circulate in a circulatory system having a component for absorbing carbon dioxide and can be provided again as new inhaled gas.

[0040] The sensor system comprises at least one pressure sensor, which is arranged on the breathing system or the line system in such a way that the inspiratory pressure level or the temporal curve of the inspiratory pressure level is continuously detected and provided to the control unit as an inspiratory pressure measurement value. The at least one pressure sensor can be designed, for example, as an inspiratory pressure sensor, which can be arranged on the inspiratory branch of the breathing system. The at least one pressure sensor can be designed, for example, as an expiratory pressure sensor, which can be arranged on the expiratory branch of the breathing system. The at least one pressure sensor can be designed, for example, as a patient-proximal pressure sensor or patient pressure sensor, which can be arranged on a patient connecting element (Y-shaped structure) or on an inspiratory and expiratory artificial respiration hose.

[0041] In particular, in a preferred embodiment, the sensor device can have at least one flow sensor, which is arranged on the breathing system or on the line system in such a way as to continuously detect at least one measured value of the flow and provide it to the control unit.

[0042] The at least one flow sensor can be designed, for example, as an inspiratory flow sensor, which can be arranged on the inspiratory branch of the breathing system. The at least one flow sensor can be designed, for example, as an expiratory flow sensor, which can be arranged on the expiratory branch of the breathing system. The at least one flow sensor can be designed, for example, as a patient-proximal flow sensor or patient flow sensor, which can be arranged on a patient connecting element (Y-piece) or on an inspiratory and expiratory artificial respiration hose.

[0043] The control unit is configured to perform artificial respiration of the living being using means for controlled delivery and onward routing of a respiratory gas mixture to the breathing system and the line system, and to control at least one of predetermined parameters, such as the duration of the inspiratory phase (Ti), the duration of the expiratory phase (Te), the inspiratory pressure (P_insp.), the tidal volume (Vt), and the artificial respiration rate (RR). The control unit can be configured to use, depending on the situation, not only an expiratory pressure sensor and / or an inspiratory pressure sensor and / or a patient pressure sensor to determine the inspiratory pressure (P_insp.) in order to perform artificial respiration and / or coordinate the occlusion maneuver. The control unit can also be configured to use not only an expiratory flow sensor and / or an inspiratory flow sensor and / or a patient flow sensor for flow measurement in order to perform artificial respiration and / or coordinate the occlusion maneuver. Furthermore, the control unit is configured to perform, control, and coordinate artificial respiration of the living being using the sensor system, the breathing system, the line system, means for controlled metering of the inspiratory respiratory gas quantity, and the exhalation valve. The control unit is designed to receive data or signals from the sensor system, pre-process them by means of signal processing (A / D conversion) and / or signal amplification (OP-Amp's) and / or signal filtering, process them by means of a computer, and evaluate them using the processed data.

[0044] The computing unit can be designed, for example, as a processor unit (μP, μC) with an associated data memory (RAM, ROM). Thus, the computing unit and thus the control unit can be configured and programmed, for example, with the aid of program code to determine the current operating state of the medical device or the conditions of artificial respiration, inspiration, and expiration in interaction and / or coordination with the patient from the data or signals of the sensor system.

[0045] According to the invention, the control unit is designed to carry out a closure maneuver including sealing of the respiratory system during and / or immediately following an inhalation phase (Ti) by means of a device for controlled metering of inhaled and exhaled quantities of a respiratory gas mixture at the living being for a predetermined duration of the closure phase. During the predetermined duration of the closure phase, no inhaled quantity of the respiratory gas mixture can reach the living being from the medical device, and no exhaled quantity of the respiratory gas mixture can escape from the living being, for example into the surrounding environment.

[0046] The occlusion maneuver can and should be described in conjunction with the "Inspiration Hold" maneuver, or "inspiratory breath hold," or "inspiration hold maneuver." This concept already indicates that the inhalation phase can be maintained beyond a typical duration, i.e., prolonged. In such an inspiration hold maneuver, the exhalation valve is actuated by the control unit immediately after the completed inhalation phase so that it remains closed for a period of 1 to 40 seconds. The inspiration hold maneuver can be used to detect the inhalation pressure prevailing in the lungs of the living being.

[0047] Within the meaning of the present invention, the concept of the occlusion maneuver and the definition of the occlusion phase are to be understood more broadly than the previously described description of the inspiration hold maneuver. The occlusion phase does not necessarily refer solely to the duration near the end of the inspiration phase or after the end of the inspiration phase. Instead, the respiratory system can begin to be closed after half or two-thirds of the artificial respiration settings for the inspiration phase T_insp activated on the ventilator. Artificial respiration settings, such as the respiratory rate (RR) and the expiratory to inspiratory ratio (I:E-Ratio), also influence the duration of the inspiration phase T_insp, so that the duration of the inspiration phase can also be indirectly derived from other settings. Therefore, the occlusion phase can also end during the duration of the inspiration phase or not extend beyond the end of the inspiration phase. The predetermined duration of the respiratory system occlusion, i.e., the duration of the occlusion, and thus the duration of the occlusion phase, can be selected within the range of 1 to 5 seconds, preferably 2.0 seconds.

[0048] According to the present invention, the control unit is further configured to determine the inspiratory pressure plateau (P_plat.) based on the inspiratory pressure measurement values ​​acquired during the occlusion maneuver by means of signal analysis. The signal analysis is preferably performed within a defined time period after the start of the occlusion maneuver, also referred to as a time window, for example, within a time window having a duration of 0.2 to 0.8 seconds, preferably 0.4 seconds. For the actual implementation of the signal processing in the medical device by means of the control unit, it can be advantageous if the pressure measurement values ​​are smoothed and / or interference components are removed by means of suitable data preprocessing, such as averaging, median formation, and / or suitable signal filtering, using a low-pass filter. For this purpose, the control unit itself can include suitable components, but components for signal preprocessing can also be provided in the medical device, which can perform the aforementioned tasks and supplement the monitoring unit.

[0049] In a further preferred embodiment, the control unit can be configured to include the elasticity of the components of the line system in determining the pressure plateau (P_plat.) during inspiration. The line system usually consists of elastic breathing hoses, which are elastic and can therefore partially, through elastic deformation, dampen or compensate for pressure increases occurring in the breathing system, the line system, and the lungs of the patient during artificial respiration and / or during occlusion maneuvers. Therefore, the magnitude of the pressure change during an occlusion maneuver is only partially determined by the inspiratory effort and / or relaxation of the respiratory muscles, while the characteristics of the line system, more precisely as a component of the physical conditions, also influence the extent of such pressure changes.

[0050] It is common in current respiration systems to perform so-called compliance compensation during respiration, as the volume delivered to the breathing hose system is not always the same as the actual volume received by the patient. The difference between these two volumes is primarily due to the compliance of the breathing system and hose system. Typically, during a device self-test in anesthesia or respiration system, performed immediately after commissioning, along with compliance and resistance tests, or as part of a leak test, the control unit determines the properties of the hose or line system, in particular its elasticity or compliance. During the leak test, it is determined whether and to what extent a leak exists in the line system or connection relative to the patient. During the compliance test, it is determined whether and to what extent the line system can change volume in response to changes in respiration pressure. This measure of change is a characteristic of the line system or respiration hose system and is referred to as hose compliance. During the resistance test, it is determined to what extent a pressure drop occurs in the line system in response to a change in flow rate (Flow = dV / dt). This measure of pressure drop is a characteristic of the line system or respiration hose system and is referred to as hose resistance. The hose resistance and hose flexibility depend on the diameter, length, and material of the line system or hose system. Therefore, by means of a device self-test together with a leak test, a compliance test, and a resistance test, the corresponding configuration of the artificial respiration device, the line system, and the patient interface designed as a patient connection element (Y-shaped structure) and provided on the patient for use can be calibrated with respect to leakage, resistance, and compliance. During subsequent artificial respiration operation, when metering the gas quantity, the control unit can accordingly compensate for the hose resistance and hose flexibility so that the patient actually receives the set gas quantity during artificial respiration. In this preferred embodiment, the control unit can use the previously determined and thus known compliance of the hose system as the elasticity of the line system and include it in the determination of the pressure plateau (P_plat.) for inspiration, in the sense of formula 1.

[0051] In a preferred embodiment, the sensor system can include a further pressure sensor that can be arranged on the breathing system or on the line system in order to continuously detect the pressure level of the exhalation or the temporal profile of the exhalation pressure level and provide it to the control unit as an exhalation pressure measurement value. Like the at least one pressure sensor, the further pressure sensor can be designed, for example, as an exhalation pressure sensor that can be arranged on the exhalation branch of the breathing system.

[0052] The other pressure sensor can also be designed, for example, as an inspiratory pressure sensor, which can be arranged on the inspiratory branch of the breathing system. The other pressure sensor can be designed, for example, as a patient-closed pressure sensor or patient pressure sensor, which can be arranged on a patient connection element (Y-bar) on the inspiratory and expiratory artificial respiration hoses. The control unit can be designed to use, depending on the situation, not only the expiratory pressure sensor and / or the inspiratory pressure sensor and / or the patient pressure sensor to determine the expiratory pressure (P_exsp.), in particular the end-expiratory pressure (PEEP), in order to perform artificial respiration and / or coordinate the occlusion maneuver.

[0053] In this preferred embodiment, the control unit can also be designed to determine the pressure plateau (P_plat.) of the inspiration and the end-expiratory pressure (PEEP).

[0054] -Measurement of total work of breathing (P_driv.)

[0055] and / or

[0056] - A measure of the contribution of spontaneous respiration to the total work of breathing of an organism (P_spon.)

[0057] and / or

[0058] - a measure of the contribution of medical equipment or artificial respiration to the total work of breathing (P_vent.)

[0059] and / or

[0060] - A measure of the static extensibility of the lung of an organism (C_stat.).

[0061] The measure for the total work of breathing (P_driv.) can be derived from the relationship between the pressure plateau of inspiration (P_plat.) and the positive end-expiratory pressure (PEEP) according to the following formula 2:

[0062] P_driv.=P_plat.–PEEP Formula 2

[0063] The determination of the measure (P_spon.) for the contribution of the spontaneous respiration of the living being to the total work of breathing can be made from the relationship between the pressure level (P_plat.) and the inspiratory pressure (P_insp.) according to the following formula 3:

[0064] P_spon.=P_plat.–P_insp. Formula 3

[0065] The determination of the measure (P_vent.) as a measure of the contribution of the medical device or ventilator to the total work of breathing can be carried out from the relationship between the inspiratory pressure (P_insp.) and the positive end-expiratory pressure (PEEP) according to the following formula 4:

[0066] P_vent.=P_insp.–PEEP Formula 4

[0067] In this case, in equations 3 and 4, the pressure value effectively present in the patient, which is detected by measurement technology at the time before the occlusion maneuver, is used as the inspiratory pressure (P_insp.).

[0068] The static extensibility (static compliance) (C_stat.) of the lung of a living being can be determined using knowledge of the volume produced during the inspiration phase according to the following formula 5:

[0069] C_stat.=V_insp. / P_driv. Formula 5

[0070] In this case, the inspiratory volume (V_insp.) is the volume delivered to the patient during the inspiratory phase and also detected by measurement technology. To detect the volume (V_insp.), the control unit can use at least one flow sensor, which is arranged on the inspiratory or expiratory branch of the breathing system or as a flow sensor close to the patient or patient flow sensor on the patient connection element (Y-bar) of the tube system.

[0071] In another preferred embodiment, the control unit can be designed to determine the inspiratory pressure plateau (P_plat.) by applying statistical methods, in particular using a plurality of segmented linear, nonlinear, or polynomial regressions of the signal curve of the inspiratory pressure measurement values ​​during the occlusion phase. The regression is preferably performed after a certain waiting time of 0.25 to 0.75 seconds during the duration of the occlusion phase.

[0072] In a further preferred embodiment, the control unit can be designed to determine the pressure plateau (P_plat.) of the inspiration by using an analysis method, in particular by continuously determining the slope of the signal curve of the pressure measurement value for inspiration during the occlusion phase. To this end, the control unit can determine the pressure plateau (P_plat.) of the inspiration with the start of the occlusion of the respiratory system by differentiating the signal curve of the pressure measurement value for inspiration (first derivative of pressure P'(t)=dP / dt; second derivative of pressure P'(t)=d 2 P / dt 2 ; The third derivative of pressure P"'(t) = d 3 P / dt3 )) analyzes the signal curve in order to determine features in the signal curve, in particular the slope, the sign of the slope, zero point, maximum, minimum, inflection point or saddle point in the signal curve, and thereby identify phases of essentially constant pressure plateaus of the inhalation relative to phases with pressure increases or decreases and / or phases with signal fluctuations. If the third derivative fluctuates around the zero point ([f'=0] & [f'=0] & [f'≠0] -> saddle point) for the values ​​of the main quantity for longer time intervals, then, for example, constant plateaus can be identified by evaluating the third derivative. In contrast, phases with signal fluctuations have a transition between maximum and minimum values ​​in the signal curve over short time intervals ([f'=0] & [f'≠0]).

[0073] In a further preferred embodiment, the control unit can be designed to include mathematical methods, in particular methods for pattern comparison or trend analysis of the inspiratory pressure measurement values ​​using comparative data, for determining the inspiratory pressure plateau (P_plat.). For this purpose, the control unit can be assigned a data memory in which typical signal curves of the inspiratory pressure measurement values ​​during the occlusion maneuver are stored. Using the pattern comparison method, the control unit can determine the degree of similarity between different phases in the signal curve of the current inspiratory pressure measurement value and the stored patterns. Before using such a pattern comparison, it can be advantageous to normalize the inspiratory pressure measurement value so that a comparison with the standardized typical signal curve from the data memory can be performed.

[0074] The mathematical methods of this preferred embodiment also include, in an expanded sense, methods in which different properties of neural networks are used (single-layer and multi-layer feedforward networks, networks with feedback (recurrent networks)) or so-called deep learning methods, which can be taught or trained in different ways and methods (supervised learning or unsupervised learning, random learning) to obtain the pressure plateau (P_plat.) of inspiration.

[0075] In a further preferred embodiment, the control unit can be designed to check at least one criterion during the occlusion phase when detecting the pressure plateau (P_plat.) of inspiration.

[0076] in

[0077] - Maximum duration of the rise time of the inspiratory pressure measurement value (t_rise_max)

[0078] and / or

[0079] - Minimum duration of the plateau of the inspiratory pressure measurement (t_plat_min)

[0080] and / or

[0081] The stability of the plateau of the inspiratory pressure measurement value (P_stabil.) can be included in at least one criterion. To check at least one criterion, the signal curve of the inspiratory pressure measurement value is evaluated by the control unit by means of signal analysis during the occlusion phase.

[0082] At least one criterion for the maximum duration of the rise time of the inspiratory pressure measured value (t_rise_max) measures how long the rise to a stable inspiratory pressure plateau (P_plat.) lasts after the respiratory system is sealed. The control unit can analyze the pressure signal by means of a regression analysis of the pressure signal or by differentiation (first derivative of pressure P'(t) = ΔP / Δt) upon the start of the respiratory system sealing to determine whether a predetermined maximum duration of the rise time of the inspiratory pressure measured value is not exceeded. This can be achieved, for example, by the control unit evaluating, by means of a threshold comparison, when the differentiated pressure signal P'(t) approaches zero, indicating the end of the pressure rise and the transition to the pressure plateau.

[0083] Alternatively, the control unit can assess, for example, by means of a continuously repeated linear regression analysis according to the formula P(t)-y(t)=a*t+b over a predetermined number of inspiratory pressure measurement values ​​or over a predetermined duration of inspiratory pressure measurement values, when the coefficient a in the term y(t)=a*t+b approaches zero, which indicates the end of the pressure rise, together with a flattening of the slope a and the transition to a pressure plateau. For practical implementation, a duration of less than 0.75 seconds to 1.25 seconds has proven advantageous as the predetermined maximum rise time (t_rise_max).

[0084] At least one criterion, a minimum duration (t_plat_min) of the plateau of the inspiratory pressure measured value, determines whether the pressure rise has ended after the respiratory system or the patient's airways have been closed and a constant inspiratory pressure plateau (P_plat.) has occurred. The control unit can analyze the pressure signal by means of a regression analysis of the pressure signal or by means of differentiation (first derivative of pressure P'(t) = ΔP / Δt) as the respiratory system or the patient's airways begin to be closed to determine whether a pressure plateau exists. This can be achieved, for example, by the control unit determining that the differentiated pressure signal P'(t) remains approximately constant or constantly at zero for a predetermined duration, indicating that a constant pressure plateau has occurred. Alternatively, the control unit can assess, for example, by means of a continuously repeated linear regression analysis according to the formula P(t)-y(t)=a*t+b over a predetermined number of inspiratory pressure measurement values ​​or over a predetermined duration of inspiratory pressure measurement values, when and for what duration the coefficient a in the term y(t)=a*t+b approaches zero, which indicates a nearly zero slope (a=0). If this slope also remains nearly constant over a predetermined time, this indicates that the pressure level remains constant. For practical implementation, a time interval in the range of 1.0 to 2.0 seconds has proven to be advantageous as the predetermined minimum duration (t_plat_min.).

[0085] At least one criterion for the stability (P_stabil.) of the inspiratory pressure measured value during the plateau period can be implemented by the control unit by, for example, determining the standard deviation or variance of the measured values ​​of the inspiratory pressure (P_insp.) or the airway pressure (P_aw) during the duration of the pressure plateau period and comparing it with a predetermined threshold value for the maximum permissible fluctuation of the inspiratory pressure measured value (P_insp.) during the duration of the pressure plateau period. For practical implementation, a pressure fluctuation of the measured value of the inspiratory pressure (P_insp.) in the range of 0.4 mbar per second to 0.8 mbar per second has proven to be advantageous as the predetermined threshold value (P_stabil.).

[0086] Such a criterion can be used, for example, by means of a series of segmented linear regressions or the use of linear regressions within a predetermined regression period for the measured values ​​of the inspiratory pressure (P_insp.) and can be used as a characteristic variable to characterize the course of the measured values ​​of the inspiratory pressure (P_insp.) during the duration of the occlusion phase. The measured values ​​of the inspiratory pressure (P_insp.) used as the regression period for the linear regression preferably correspond to a time interval of 0.2 to 0.6 seconds, preferably 0.4 seconds. The execution of the linear regression over the duration of the occlusion phase generates a plurality of straight line segments that can be compared, analyzed, and interpreted individually or with one another in order to thereby assess the course and shape of the inspiratory pressure (P_insp.) and determine whether and at what point in time a stable inspiratory pressure plateau (P_plat.) has been established after activation of the occlusion by sealing the respiratory system, and at which pressure level the detected inspiratory pressure plateau (P_plat.) is present.

[0087] As different possibilities for designing the checking of the above-mentioned criteria, a design with the acquisition of suitable characteristic variables can be implemented by the control unit. For this purpose, the following examples can be mentioned as options:

[0088] i. characteristic parameter k1 (slope index), which indicates the slope of the corresponding straight line segment obtained by means of linear regression;

[0089] ii. characteristic variable k2 (regression value index regression value index), which respectively indicates the difference between the measured value of the inspiratory pressure (P_insp.) used for linear regression and the value approximately calculated by means of linear regression on the straight line segment;

[0090] iii. Characteristic parameter k3 (mean value index), which indicates the mean value of numerical values ​​approximately calculated by means of linear regression.

[0091] The characteristic variables k1 , k2 , k3 (if advantageous) can also be normalized, denormalized and / or weighted for further analysis and simplification.

[0092] Furthermore, the characteristic variables k1 , k2 , k3 can also be combined in a weighted or unweighted manner, from which a total characteristic variable KG can then be formed. This total characteristic variable KG directly and / or indirectly indicates the plateau pressure (P_plat.) of the inhalation.

[0093] In a further preferred embodiment, the control unit can be designed to include a reliability indicator when determining the inspiratory pressure plateau (P_plat.) during the occlusion phase. Such a reliability indicator can be determined continuously during the occlusion maneuver. The reliability indicator can preferably be determined based on the measurement of the inspiratory pressure (P_insp.) with a time delay of, for example, 0.5 to 2 seconds following the start of the occlusion maneuver. To form the reliability indicator, the standard deviation of the measured values ​​of the inspiratory pressure (P_insp.) can be determined within a predetermined time period of, for example, 1 to 2 seconds, and this process can be repeated continuously after each regression cycle, i.e., for example, every 50 ms. For evaluation, the reliability indicator can be compared with a threshold value in order to evaluate the determination of the inspiratory pressure plateau (P_plat.).

[0094] If the reliability indicator determined is below a predetermined threshold value, for example 0.6 mbar, the measurement is considered successful and the signal analysis is continued until the predetermined duration of the occlusion phase has expired.

[0095] According to a particularly preferred embodiment, the plateau pressure acquisition can be terminated directly and immediately if the reliability indicator falls below another predetermined threshold value, since continuous acquisition of the inspiratory pressure plateau (P_plat.) already yields very good results with respect to the temporal profile of the occlusion phase. If the acquired standard deviation of the measured values ​​of the inspiratory pressure (P_insp.) or the airway pressure (P_aw) falls significantly below another predetermined threshold value, such as 0.3 mbar, before the end of the second half of the occlusion maneuver, the occlusion maneuver can be terminated prematurely, since the acquired inspiratory pressure plateau (P_plat.) already has a very high reliability. This means that the acquisition of the inspiratory pressure plateau (P_plat.) was successful.

[0096] This results in another preferred embodiment for evaluating threshold value violations by comparison and thus terminating the occlusion maneuver prematurely. If, for example, during the second half of the occlusion maneuver, the determined standard deviation of the measured values ​​of the inspiratory pressure (P_insp.) or the airway pressure (P_aw) significantly and continuously exceeds a predetermined threshold value and / or another specific threshold value, such as 0.9 mbar, the occlusion maneuver can also be terminated prematurely, since it is no longer possible to determine a reliable value for the inspiratory pressure plateau (P_plat.) during the current occlusion maneuver. This means that the determination of the inspiratory pressure plateau (P_plat.) was unsuccessful.

[0097] The early termination of the occlusion maneuver offers a significant comfort advantage to the patient, since the airway is closed only for as long as is actually necessary to achieve a stable inspiratory pressure plateau (P_plat.).

[0098] In a further preferred embodiment, an input element can be arranged on the medical device, which is designed and configured to provide a signal to the control unit in order to cause the control unit to initiate activation or initiation of a closure maneuver. Upon user actuation of the input element, activation of the closure maneuver and sealing of the respiratory system can be initiated within a predetermined time interval or a maximum time interval. In an alternative embodiment, upon user actuation of the input element, activation of the closure maneuver can occur and sealing of the respiratory system can occur for the duration of the actuation of the input element. This allows the user not only to select and activate an automated process for a closure maneuver with a predetermined duration but also to individually extend the duration of the closure phase beyond a predetermined duration, for example based on their own observation of a graphical representation of the flow and / or pressure profiles on the ventilator.

[0099] According to another aspect, a method for detecting a pressure plateau during inspiration is provided. In the method, an occlusion maneuver is used to implement and enable the detection of the pressure plateau during inspiration.

[0100] A method for determining the pressure plateau (P_plat.) of inspiration can be designed by a sequence of steps comprising the following steps:

[0101] - providing a data set which indicates the signal progression of the inspiratory pressure measurement value, wherein the inspiratory pressure measurement value corresponds to the duration of the occlusion phase,

[0102] A signal analysis of the inspiratory pressure measurement values ​​is performed in order to determine the inspiratory pressure plateau (P_plat.).

[0103] A data set indicating the signal progression of inspiratory pressure measurement values ​​can be provided to a data network via a medical device designed for artificial respiration of a living being, and a signal analysis of the inspiratory pressure measurement values ​​can be performed in the data network, for example, by means of a suitably programmed computing unit (server) in order to determine an inspiratory pressure plateau (P_plat.).

[0104] A method having an operating function for operating a medical device designed for artificially respiring a living being with the detection of a pressure plateau (P_plat.) for inspiration can be designed by a sequence of steps having the following steps:

[0105] - activating means for controlled metering of the inhaled and expiratory quantities of the respiratory gas mixture in order to coordinate the artificial respiration with a cyclic process having inhalation and exhalation phases,

[0106] - activating a component of the medical device in order to cause closure of the respiratory system during the inspiratory phase or at the end of the inspiratory phase for a predetermined duration of the occlusion phase;

[0107] - providing or detecting a signal trend of a pressure measurement value, the pressure measurement value being indicative of the pressure level of inspiration;

[0108] A signal analysis of the inspiratory pressure measurement values ​​is performed in order to determine the inspiratory pressure plateau (P_plat.).

[0109] This sequence of steps can be coordinated, for example, by a control unit of the medical device. A data set indicating the signal profile of the inspiratory pressure measurement values ​​can be provided to a data network by a medical device designed for artificial respiration of a living being, and a signal analysis of the inspiratory pressure measurement values ​​can be performed in the data network, for example, by means of a suitably programmed control unit or a computing unit, in order to determine the inspiratory pressure plateau (P_plat.).

[0110] The aspects described and explained within the scope of the description of the medical device according to the invention with regard to the definitions, functions and scope with regard to the operating function, the inspiratory phase, the occlusion phase and the occlusion maneuver naturally also apply here to the method.

[0111] In a preferred embodiment of the method, a data set is provided in a further step, which data set indicates the signal curve of the pressure measurement value of expiration and / or the end-expiratory pressure (PEEP) or the detection of the signal curve of the pressure measurement value of expiration. In this preferred embodiment, in a subsequent step, a signal analysis can be performed based on the pressure plateau (P_plat.) of inspiration and the end-expiratory pressure (PEEP) in order to determine

[0112] -Measurement of total work of breathing (P_driv.)

[0113] - and / or a measure for the contribution of the organism's spontaneous respiration to the total work of respiration (P_spon.)

[0114] - and / or a measure for the contribution of a medical device or artificial respiration device to the total work of breathing (P_vent.)

[0115] - and / or a measure of the static extensibility of the lung of an organism (C_stat.).

[0116] The data set indicates the signal trend of the pressure measurement value of the expiration, which can be provided by the medical device by means of measurement technology detection. The data set indicates the signal trend of the pressure measurement value of the expiration, which can also be provided by the medical device to a data network. The signal analysis based on the pressure plateau (P_plat.) and the expiratory pressure (PEEP) of the inspiration can be performed by the control unit of the medical device and / or in the data network by means of a computing unit that is appropriately configured by programming.

[0117] - a measure for the total work of breathing (P_driv.),

[0118] - A measure of the contribution of spontaneous respiration to the total work of breathing of an organism (P_spon.)

[0119] - a measure of the contribution of the medical device or artificial respiration device to the total work of breathing (P_vent.),

[0120] The determination of the measure (C_stat.) for the static extensibility of the lungs of a living being can be carried out, for example and / or preferably, as described for the corresponding embodiments of the medical device according to the invention, in particular the artificial respiration device according to the invention, by specifying corresponding relationships and / or formulas.

[0121] In a preferred embodiment of the method, the signal analysis for determining the pressure plateau (P_plat.) of the inspiratory air can be performed using

[0122] - Statistical methods in the form of multiple piecewise regressions, such as linear, nonlinear or polynomial regressions

[0123] or

[0124] - an analysis method comprising the step of continuously acquiring the slope trend via the signal trend of the inspiratory pressure measurement value

[0125] or

[0126] Mathematical method for pattern comparison of inspiratory pressure measurements using comparison data. The signal analysis for detecting the inspiratory pressure plateau (P_plat.) can be performed, for example and / or preferably, as described for the corresponding embodiment of the medical device according to the invention.

[0127] In a preferred embodiment of the method, at least one criterion can be checked when detecting the pressure plateau (P_plat.) of the inspiration.

[0128] in

[0129] - Maximum duration of the rise time of the inspiratory pressure measurement value (t_rise_max.)

[0130] and / or

[0131] - Minimum duration of the plateau of the inspiratory pressure measurement (t_plat_min.)

[0132] and / or

[0133] The stability of the inspiratory pressure measurement value (P_stabil.) can be included in at least one criterion. When determining the inspiratory pressure plateau (P_plat.), the criteria (t_rise_max.), (t_plat_min.), and (P_stabil.) can be designed and included, for example and / or preferably, as described with respect to the corresponding embodiment of the medical device according to the present invention.

[0134] In a preferred embodiment of the method, a plausibility indicator can be checked when determining the pressure plateau (P_plat.) of the inhalation. The plausibility indicator can preferably be included when determining the pressure plateau (P_plat.) of the inhalation in a manner similar to that described for the corresponding embodiments of the medical device according to the invention.

[0135] In a preferred embodiment of the method, the properties of the line system, in particular the elasticity of its components, can also be included in the determination of the pressure plateau (P_plat.) of the inspiration. The properties of the line system can be included in the determination of the pressure plateau (P_plat.) of the inspiration, for example and / or preferably as described with respect to the corresponding embodiments of the medical device according to the invention.

[0136] Another embodiment is formed by a computer program or computer program product having a program code for obtaining an inspiratory pressure plateau. The computer program or computer program product is suitably constructed to implement the method and is thus configured to obtain an inspiratory pressure level (P_plat.). The program code is preferably executable on a computer, a processor, or a programmable hardware component. The steps, operations, or processes of the various methods described above can be executed by a programmed computer or processor. Examples can also cover machine-readable, processor-readable, or computer-readable program storage devices, such as digital data storage media, and can encode machine-executable, processor-executable, or computer-executable programs of instructions. The instructions execute some or all of the steps of the above-mentioned method or cause the execution of the steps. The program storage device can, for example, include or be a digital memory, a magnetic memory, such as a disk and tape, a hard drive, or an optically readable digital data storage medium. Other examples can also cover computers, processors or control units programmed to perform the steps of the above-described method or (field) programmable logic arrays ((F)PLAs = (field) programmable logic arrays) or (field) programmable gate arrays ((F)PGA = (field) programmable gate arrays) programmed to perform the steps of the above-described method. It goes without saying that the disclosure of multiple steps, processes, operations or functions disclosed in the description or in the embodiments should not be interpreted as being in a specific order, unless this is explicitly or implicitly stated in other ways, for example for technical reasons. In addition, in some examples, a single step, function, process or operation can include and / or be split into multiple sub-steps, sub-functions, sub-processes or sub-operations. Such sub-steps can be included and be part of the disclosure of this single step, if these sub-steps are not explicitly excluded.

[0137] In summary, it can be seen that the present invention allows reliable detection of the inspiratory pressure plateau (P_plat.), based on which the “propulsion pressure” (P_driv.) serving as a measure for the total work of breathing is determined and made available to the user. BRIEF DESCRIPTION OF THE DRAWINGS

[0138] Exemplary embodiments of the present invention are described in detail below with the aid of the accompanying drawings, without limiting the generality of the inventive concept.

[0139] Figure 1 shows a schematic diagram of an artificial respiration apparatus;

[0140] Figure 2 shows a schematic flow of occlusion manipulation;

[0141] Figure 3 Shown in accordance with Figure 2 Details of the schematic process;

[0142] Figure 4 Aspects of the evaluation of the pressure signal trend are shown. DETAILED DESCRIPTION

[0143] Figure 1 The schematic diagram shows an artificial respiration device 1 having a gas supply device 9 and a breathing system 8. A sensor system 3 having an inspiratory flow sensor 31, an inspiratory pressure sensor 32, an expiratory flow sensor 33, and an expiratory pressure sensor 34 is shown on the breathing system 8.

[0144] In the breathing system 8 , an actuator 4 with an inspiratory metering element 41 and an expiratory valve 42 , for example in the form of a gas delivery unit (Blower) combined with a proportional valve, and passive nonreturn valves 51 , 52 are shown in each of the inspiratory branch 81 and the expiratory branch 82 .

[0145] The line system 6 connects the breathing system 8 with the inspiratory breathing hose 61 and the expiratory breathing hose 62 to the patient 50 via a pneumatic interface 92 with the aid of a patient connecting element (Y-shaped structure) 7, in order to supply a quantity of breathing gas to the patient 50 and to conduct the exhaled gas from the patient 50 onward to the surrounding environment 5.

[0146] The gas supply device 9 provides medical air (Air) and oxygen (O 2 ) to the breathing system 8 in the artificial respiration device 1 at a further pneumatic connection 91 .

[0147] A control unit 20 having a computing unit (μC), a driver stage, a signal processing device such as an amplifier (OP-Amps), a filter circuit, an A / D converter and an associated data memory 21 for performing artificial respiration and for performing an occlusion maneuver 100 ( Figure 2 ) and control actuators 4, 41, and 42.

[0148] To perform artificial respiration and to perform occlusion maneuver 100 ( Figure 2 ), the measured values ​​acquired and provided by the sensor devices 3, 31, 32, 33, 34 of the control unit 20 are used via the signal line 85. The input element 23 and the operating and display element (UI, GUI) 23 are connected as a human-machine interface via the data line 83. With the help of the operating and display element 23, the user can start the execution or process 100 of the blocking operation ( Figure 2) or to make settings for performing artificial respiration on the artificial respiration device 1. In addition, the operating and display element 23 serves to provide and / or display measured values ​​or measurement curves of the sensor device 3, events, alarm situations, and an acoustic signal output and an optional data interface can also be arranged in the operating and display element 23.

[0149] Figure 2 A schematic flow chart 100 for performing artificial respiration in a situation involving occlusion is shown. Figure 1 and 2 middle, Figure 1 and Figure 2 The same elements are denoted by the same reference numerals. For example, the control of this process 100 can be performed by following Figure 1 After the start 101 of artificial respiration, measured values ​​of the inspiratory pressure level (P_insp.) 104 are continuously acquired in a program 102 .

[0150] Towards the end of the inhalation phase, for example, when the user activates the operating and display element 23 ( Figure 1 ) is started by interaction 103, with actuators 4, 41, 42 ( Figure 1 ) is activated 106 to start 105 the occlusion maneuver in order to cause the respiratory system 8, 81, 82 ( Figure 1 ) piping system 6, 61, 62 ( Figure 1 ) of the patient. Therefore, during the duration of the occlusion, the patient 50 ( Figure 1 ) only the pipe systems 6, 61, 62 ( Figure 1 ) volume for gas exchange.

[0151] Then, in a program 108 , measured values ​​of the inspiratory pressure level (P_insp.) 107 are recorded continuously.

[0152] At the same time, in program 108, the continuously acquired measured values ​​of the inspiratory pressure level (P_insp.) 107 are analyzed 110 in order to determine the inspiratory pressure plateau (P_plat.). As a result of this analysis 110, a measure 111 is output or provided, which indicates the inspiratory pressure plateau (P_plat.). In addition, the analysis 110 is used to determine an optional reliability indicator 113, which can indicate the reliability of the determined inspiratory plateau pressure (P_plat.) 111. With the control of the actuators 4, 41, 42 ( Figure 1 ) is deactivated 109 and the occlusion is ended 112. Artificial respiration of the patient 50 can then be continued as before ( Figure 1 ). In some aspects, with the help of Figure 3 The implementation of analysis 110 will be explained in detail.

[0153] Figure 3 Shown in accordance with Figure 2 The schematic process 100 is detailed with respect to the analysis 110 for obtaining the pressure plateau (P_plat.) 111 of the inspiration. Figure 1 、 2 and 3, Figure 1 、 2 and Figure 3 Identical elements are denoted by the same reference numerals. Preferably, after the start of occlusion 108, an optional waiting time 1100 of, for example, 0.3 to 0.5 seconds is activated. Subsequently, using a linear regression of many segments of the signal curve of the pressure measurement value (P_insp.) 107 for inspiration, as a subfunction of the analysis 110 ( Figure 2 ) for signal analysis 1101( Figure 2 ), the suction pressure measurement value is continuously stored as data in the element 1102 for data storage.

[0154] Suitable characteristic variables k1, k2, k3 1107, 1108, 1109 are obtained by using a segmented linear regression, which is continuously applied to the data volume of the measured value of the inspiratory pressure (P_insp.) 107 during the duration of the occlusion phase of approximately 2 seconds, and the characteristic variables characterize the trend of the measured value of the inspiratory pressure (P_insp.) 107.

[0155] The linear regression performed over the duration of the occlusion phase results in a plurality of straight line segments which can be compared, analyzed, and interpreted individually or with one another in order to evaluate the course and shape of the inspiratory pressure (P_insp.) 107 and to determine at least one characteristic variable k1, k2, k3 1107, 1108, 1109 based on the data in the element 1102 for data storage, namely whether and during activation of the occlusion 106 ( Figure 2 ) at which time after the acquisition a stable inspiratory pressure plateau (P_plat.) 111 has been established and at which pressure level the acquired inspiratory pressure plateau (P_plat.) 111 is located.

[0156] Several possible solutions for obtaining suitable characteristic parameters k1, k2, k3 1107, 1108, 1109 when performing linear regression are listed as follows:

[0157] - Characteristic variable k11107, which indicates the slope of the acquired straight line segment;

[0158] Characteristic variable k2 1108, which indicates the difference between the value approximately calculated by means of regression and the measured value of the inspiratory pressure (P_insp.) 107;

[0159] - Characteristic variable k31109, which indicates the average value of the approximately calculated value.

[0160] The characteristic variables k1, k2, k3 1107, 1108, 1109 (if appropriate) can also be normalized, denormalized, and / or weighted for further analysis and simplification. Furthermore, the characteristic values ​​k1, k2, k3 1107, 1108, 1109 can also be combined in a weighted or unweighted manner in a total characteristic variable KG 1110. This total characteristic variable KG 1110 directly and / or indirectly indicates the plateau pressure (P_plat.) 111 of the inhalation determined from the characteristic variables k1, k2, k3 1107, 1108, 1109.

[0161] After the characteristic variables k1, k2, k3 1107, 1108, 1109, KG 1110 have been determined, preferably by including them in a linear regression process, an optional reliability indicator 113 can be determined 1103 based on the measured values ​​of the inspiratory pressure (P_insp.) or the time curve of the measured values ​​of the inspiratory pressure (P_insp.), which can indicate the reliability of the determined inspiratory plateau pressure (P_plat.) 111. For this purpose, the standard deviation for the inspiratory pressure (P_insp.) 107 can be formed, the time curve can be calculated with the start 105 ( Figure 2 ) In each regression cycle, by comparison with a threshold value or a comparison value, it is evaluated whether and / or to what extent the acquired plateau pressure (P_plat.) 111 of the inspiration is reliable and / or reliable and thus whether and / or to what extent it is suitable for output to the user. Figure 2 ) to form the standard deviation for the inspiratory pressure (P_insp.) 107 in this way, as can also be illustrated in the figure Figure 4 As shown by way of example in FIG. 1 , the visual evaluation of the graph or curve profile of the inspiratory pressure (P_insp.) 107 is simulated in an automated manner and thus objectified and advantageously made independent of the subjective impression of the user.

[0162] In order to Figure 4Examples of visual evaluation of the graph or curve profile of the inspiratory pressure (P_insp.) are provided for illustration in the accompanying drawings. Following the acquisition 1103 of the reliability indicator 113, a comparison 1104 is used to check whether, on the one hand, the maximum occlusion duration 1105 has been reached, and, on the other hand, to what extent the reliability indicator 113 indicates that the acquired inspiratory plateau pressure (P_plat.) 111 can be evaluated as reliable. If the duration or the maximum occlusion duration 1105 has not yet been reached, the acquisition of measured values ​​for the inspiratory pressure (P_insp.) 107 continues.

[0163] If the maximum occlusion duration 1105 is reached and the reliability indicator 113 indicates that the acquired plateau pressure (P_plat.) 111 of inspiration can be assessed as reliable, the occlusion is concluded 112 ( Figure 2 ) and the output of the suction pressure plateau (P_plat.) 111 is used to perform result output 1106. In the result output 1106, an optional output of an optional reliability index 113 can also be provided.

[0164] Optionally, you can Figure 3 The process check 1106 of the embodiment provides that the occlusion is terminated prematurely if, for example, the pressure plateau (P_plat.) 111 of the inspiration is obtained with very high reliability 113 before the end of the maximum occlusion duration 1105. Then, a return is made from this procedure 110 to the process 100 ( Figure 2 ) in the transition.

[0165] Figure 4 Shown in accordance with Figure 1 、 2 and 3. Acquisition of the inspiratory pressure plateau. Figure 1 、 2 , 3 and 4, Figure 1 、 2 , 3 and Figure 4 The same elements in the drawings are denoted by the same reference numerals. Figure 4 A possible approach for deriving specific features F1 4111 , F2 4112 , F3 4113 from the signal curve of the inspiratory pressure (P_insp.) 107 is visualized, which can be used, for example, to analyze the detected inspiratory pressure plateau (P_plat.) 111 ( Figure 3 )’s quality is evaluated.

[0166] For this purpose, the inspiratory pressure (P_insp.) 107 ( Figure 2 、 Figure 3) . In this case, for the three features F1 4111 , F2 4112 , F3 4113 , a scenario 4121 with an ideal signal profile is shown in the left part of the diagram 4120 , and a corresponding scenario 4122 with an unideal signal profile of the inspiratory pressure (P_insp.) 107 is shown in the right part of the diagram 4120 .

[0167] Here are some brief explanations about features F14111, F24112, and F34113:

[0168] Feature F14111 is used to start the occlusion 105 ( Figure 2 ) is then evaluated based on the maximum rise time (t_rise_max) of the inspiratory pressure measurement value (P_insp.) 107.

[0169] Feature F24112 is used to start the occlusion 105 ( Figure 2 ) is then evaluated based on the minimum duration (t_plat_min) of the plateau of the inspiratory pressure measurement value (P_insp.) 107 .

[0170] Feature F34113 is used to start the occlusion 105 ( Figure 2 ) is then evaluated based on the stability (P_stabil.) of the plateau of the inspiratory pressure measurement value (P_insp.) 107.

[0171] Reference Signs List

[0172] 1 Medical equipment, artificial respiration equipment

[0173] 3 Sensing device

[0174] 4 Actuators

[0175] 5 Surrounding environment

[0176] 6 Pipeline system, artificial respiration hose system

[0177] 7 Patient connection member, Y-shaped object

[0178] 8 Respiratory system

[0179] 9 Gas supply units for oxygen and medical air

[0180] 20 Control Unit

[0181] 21 Data Storage

[0182] 23 Input elements, operating and display elements, UI, GUI

[0183] 31 Inspiratory flow sensor

[0184] 32 Inspiratory pressure sensor

[0185] 33 Exhalation flow sensor

[0186] 34 Exhalation pressure sensor

[0187] 41 Inhalation metering element

[0188] 42 Exhalation valve

[0189] 50 patients, organisms

[0190] 51, 52 Passive check valve

[0191] 61 Artificial respiration hose for inspiration

[0192] 62 Exhalation artificial respiration hose

[0193] 81 Inspiratory branch

[0194] 82 Expiratory branch

[0195] 83 data cable

[0196] 84 control lines, control signals

[0197] 85 Signal lines, signals, measured values

[0198] 91, 92 pneumatic interface

[0199] 100 Process and Implementation of Block Control

[0200] 101 Beginning of Blocking Maneuvers

[0201] 102, 108 Continuous measurement value acquisition

[0202] 103 User Interaction

[0203] 104, 107 Measured value of suction pressure P_insp.

[0204] 105 Initiation and start of occlusion operation

[0205] 106 Activation and control of actuators and valves

[0206] 109 Deactivation and control of actuators and valves

[0207] 110 Obtaining the inspiratory pressure plateau period P_plat. 111 Obtaining the inspiratory pressure plateau period P_plat.

[0208] 112 Stopping and ending the blocking operation

[0209] 113 Reliability Index

[0210] 1100 Waiting time, delay

[0211] 1101 Signal Analysis, Regression, and Characteristic Parameter Acquisition 1102 Elements for Data Storage (Fields, Arrays, Vectors) 1103 Acquisition of Reliability Indicators

[0212] 1104 Comparative Implementation

[0213] 1105 Maximum occlusion duration

[0214] 1106 Result Output

[0215] 1107-1111 Characteristic parameters k1, k2, k3, KG

[0216] 4111-4113 Features F1, F2, F3

[0217] 4120 Scene Diagram

[0218] Scenes 4121 and 4122

Claims

1. A medical device (1) for artificially respiring a living being (50), having an operating function for performing an occlusion maneuver (100) in order to obtain an inspiratory pressure plateau (P_plat.) (111), the medical device comprising a control unit (20), a breathing system (8), a sensor device (3) and a line system (6); a) wherein the breathing system (8) is pneumatically connected to the tube system (6) by means of an interface (92); b) wherein the breathing system (8) comprises means (41) for conveying and supplying an inhaled amount of a breathing gas mixture to the living being (50) in a controlled manner; c) wherein the breathing system (8) comprises means (42) for controlled further conduction of the exhaled volume of the breathing gas mixture; d) wherein the line system (6) is designed to supply a quantity of the breathing gas mixture to the living being (50) and to convey a quantity of the breathing gas mixture from the living being (50); e) wherein the sensor device (3) comprises at least one pressure sensor (32) which is arranged on the breathing system (8) or on the line system (6) in such a way as to continuously detect the inspiratory pressure level or the temporal profile of the inspiratory pressure level and to provide it to the control unit (20) as an inspiratory pressure measurement value (P_insp) (104, 107); f) wherein the control unit (20) is designed to perform artificial respiration of a living being (50) using the device (4) for controlled delivery and onward guidance of the amount of the respiratory gas mixture, the breathing system (8) and the line system (6) and to control at least one of the predetermined parameters: - Duration of the inspiratory phase (Ti); - Duration of the exhalation phase (Te); - Inspiratory pressure (P_insp.) (104, 107); - Tidal volume (Vt); -Respiratory rate (RR); g) wherein the control unit (20) is designed to carry out an occlusion maneuver (100) by sealing (106) the respiratory system (8) during and / or immediately after the inspiratory phase (Ti) using the device (4) for controlled metering of the inspiratory and expiratory quantities of the respiratory gas mixture on the living being (50) for a predetermined duration (1105) of the occlusion phase, wherein during the predetermined duration (1105) of the occlusion phase, no amount of the inhaled respiratory gas mixture can flow from the medical device (1) to the living being (50) and no amount of the exhaled respiratory gas mixture can leave the living being (50); h) The control unit (20) is designed to determine the inspiratory pressure plateau (P_plat.) (111) by means of signal analysis based on inspiratory pressure measurement values ​​(P_insp.) (104, 107) acquired during the occlusion maneuver.

2. The medical device (1) according to claim 1, The control unit (20) is designed to include the elasticity of components of the line system (6) in the determination of the pressure plateau (P_plat.) (111) for inspiration.

3. The medical device (1) according to claim 1 or claim 2, The sensor device (3) is designed with at least one pressure sensor (32) or with the aid of another pressure sensor (34) arranged on the breathing system (8) or on the line system (6) to continuously detect the expiratory pressure level or the time curve of the expiratory pressure level and to provide it to the control unit (20) as an expiratory pressure measurement value; wherein the control unit (20) is configured to obtain a positive end-expiratory pressure (PEEP) based on a pressure measurement value of exhalation; And wherein the control unit (20) is configured to obtain based on the pressure plateau (P_plat.) (111) of inspiration and the end-expiratory pressure (PEEP) a. Measure of total work of breathing (P_driv.) and / or b. A measure of the contribution of spontaneous respiration to the total work of respiration for an organism (50) (P_spon.) and / or c. Measure of the contribution of medical equipment (1) or artificial respiration equipment to the total work of breathing (P_vent.) and / or d. Measure of the static extensibility (C_stat.) of the lung of an organism (50).

4. The medical device (1) according to claim 1 or 2, The control unit (20) is designed to determine the inspiratory pressure plateau (P_plat.) (111) by means of the signal curve of the inspiratory pressure measurement value during the occlusion phase. - applying or implementing statistical methods using a number of piecewise linear, nonlinear or polynomial regressions, or - using or implementing an analysis method using the signal curve of the pressure measurement value (P_insp) (104, 107) by inspiration to continuously determine the slope curve, or A mathematical method is employed or implemented to compare patterns or perform trend analysis on the inspiratory pressure measurements (P_insp) (104, 107) using comparative data.

5. The medical device (1) according to claim 1 or 2, wherein the control unit (20) is designed to check at least one criterion (1110) when detecting an inspiratory pressure plateau (P_plat.) (111) during the occlusion phase, in - the maximum duration (t_rise_max.) of the rise time of the inspiratory pressure measurement value (P_insp) (104, 107) and / or - Minimum duration (t_plat_min.) of the plateau of the inspiratory pressure measurement value (P_insp) (104, 107) and / or The stability (P_stabil.) of the plateau of the inspiratory pressure measurement value (P_insp) (104, 107) is also included in the at least one criterion (1110).

6. The medical device (1) according to claim 1 or 2, The control unit (20) is designed to include a reliability indicator (113) when detecting the pressure plateau (P_plat.) (111) of inspiration during the occlusion phase.

7. The medical device (1) according to claim 1 or 2, The control unit (20) is designed to terminate the blocking maneuver (113) based on a check of a reliability indicator (113).

8. The medical device (1) according to claim 1 or 2, The sensor device (3) comprises at least one flow sensor (31, 33) which is arranged on the breathing system (8) or on the line system (6, 61, 62) in such a way as to continuously acquire at least one measured value of the flow and to provide it to a control unit (20). The at least one flow sensor (31, 33) is designed as an inspiratory flow sensor (31), an expiratory flow sensor (33) or a patient-close flow sensor (7, 50).

9. The medical device (1) according to claim 1 or 2, An input element (23) is arranged on the medical device (1), which is designed and configured to provide a signal to a control unit (20) in order to cause the control unit (20) to initiate activation or start (105, 106) of a blocking maneuver. In this case, the breathing system (8) is closed (106) by actuating the input element (23) by the user within a predetermined time interval (1105) or a maximum time interval or for the duration of the actuation of the input element (23).

10. The medical device (1) according to claim 2, wherein the medical device is an artificial respiration device.

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