DE102018001887A1 - System for supporting blood gas exchange by means of ventilation and extracorporeal blood gas exchange and system operating according to the method - Google Patents

Abstract

The invention relates to a system (10) and a method for supporting blood gas exchange by means of ventilation and extracorporeal blood gas exchange, wherein the system (10) comprises at least one ventilator (14) and an oxygenator (16) for extracorporeal blood gas exchange, wherein for the operation of the ventilator ( 14), at least one first and one second data set (26, 28) with ventilation parameters is selectable, the first data set (26) for operating the ventilator (14) without the oxygenator (16) and the second data set (28) for operating the ventilator (14) is determined together with the oxygenator (16) and wherein, upon an appropriate selection of an operator, an operation of the ventilator (14) with the ventilation parameters of the second data set (28) can be activated.

Description

The invention relates to a system for supporting blood gas exchange by means of ventilation and extracorporeal blood gas exchange. The system includes a respiratory device in the form of a respirator, an anesthetic machine or the like for mechanical ventilation of a patient's lungs, and a so-called ECMO (Extracorporeal Life Support = ECLS) for extracorporeal blood gas exchange, namely a pumpless ECMO Device (pECLA). Within the system, the respiratory apparatus referred to below briefly but without renouncing any further generality as ventilator, and the pECLA referred to below briefly but also without omission of further universal validity as an oxygenator, are designed and furnished for this purpose, on the one hand, a machine respiratory support by the ventilator and, on the other hand, automatically perform an extracorporeal blood gas exchange through the oxygenator in a coordinated fashion. By means of the respirator is carried out in basically known manner, a gas exchange of oxygen and carbon dioxide in the lungs of the patient. By means of the oxygenator, an extracorporeal supply of oxygen and removal of carbon dioxide also takes place in a way which is generally known per se. The invention further relates to a method for operating such a system, that is to say a method for automatic coordination of the respiratory assistance by the respirator and of the extracorporeal blood gas exchange by the oxygenator. Finally, the invention also relates to a computer program with an implementation of the method.

From the DE 10 2014 107 980 A1 is a system of the type outlined above with an ECLS device for extracorporeal blood gas exchange and a respiratory device known. It is contemplated that the ECLS device will provide a level of extracorporeal blood gas exchange, and that the ventilator automatically adjusts to a level of machine respiratory assistance based on the level set by the ECLS device, for example, by correlating with a level of extracorporeal blood gas exchange the extracorporeal support in oxygenating the blood establishes a positive end-expiratory pressure (PEEP) upon delivery of the respiratory gas.

An object of the present invention is to facilitate the combined as well as simultaneous use of a ventilator and an oxygenator in the ventilation of a patient.

According to the invention, this object is achieved by means of a system having the features of claim 1 and by means of a method having the features of the parallel independent method claim. Such a system comprises at least one medical device in the form of a ventilator, referred to below as a ventilator. The system further includes a pumpless ECMO device (pECLA), hereinafter referred to as an oxygenator. By means of the respirator is carried out in a basically known manner a mechanical ventilation of a lung of the patient. By means of the oxygenator an extracorporeal blood gas exchange also takes place in a manner which is basically known per se. The blood gas exchange by means of the oxygenator supports the blood gas exchange by means of the ventilator. For operating the ventilator, at least a first and a second data set with ventilation parameters can be selected. The first record is for operation of the ventilator without the oxygenator. The second set of data is for operating the ventilator together with the oxygenator (combination operation or short combination operation). In an appropriate selection of an operator, usually a physician, in the system, an operation of the ventilator with the ventilation parameters of the second data set can be activated.

An advantage of the invention is that the second set of data includes predetermined or predefinable ventilation parameters which, when used in the operation of the ventilator, enable a combination operation of the ventilator, together with the oxygenator, favorable for the patient.

In a method of operating such a system or system according to any of the embodiments described below, the first set of data for operating the ventilator without the oxygenator (no combination mode) and the second set of data for operating the ventilator together with the oxygenator (combi mode) are selected. In this case, an operation of the ventilator with the ventilation parameters of the second data set is activated in response to a corresponding selection of an operator, for example in the form of an actuation of an input device or an element of a graphical user interface. Without such a selection, therefore, the ventilator is activated and operated with the ventilation parameters of the first data set. If the operator, such as the physician, desires a combined operation of the ventilator and oxygenator, only the aforementioned selection is necessary as a selection, which may be made when the operator is aware of the availability and functionality of the patient connected to the patient's bloodstream Oxygenators convinced to activate the combined operation with the ventilation parameters of the ventilator adapted for the combined operation.

In a specific embodiment, it may be provided that the aforementioned selection is not possible or, in the case of a successful selection, switching over to the second data record does not take place if it is automatically detected that no oxygenator is connected. Such automatic detection is possible, for example, by means of a communicative connection of all the medical devices belonging to the system, that is to say at least one communicative connection of the ventilator and the oxygenator. If a communicable connection to a medical device that can be automatically identified as an oxygenator is not possible in a created network, this is evaluated as a lack of the oxygenator in the system and then either the aforementioned selection is not possible or at any rate it is ensured that no switching to the one for the Combined operation provided second record is done.

Advantageous embodiments of the invention are the subject of the dependent claims. This used backlinks point to the further development of the subject matter of the main claim by the features of the respective subclaim and are not to be understood as a waiver of the achievement of an independent, objective protection for the feature combinations of the related subclaims. Furthermore, in view of an interpretation of the claims and the description in a more detailed specification of a feature in a subordinate claim, it is to be understood that such a restriction in the respective preceding claims and a more general embodiment of the subject system or method does not exist. Each reference in the description to aspects of subordinate claims is therefore to be read even without special reference expressly as a description of optional features. Finally, it should be pointed out that the system proposed here can also be developed according to the dependent method claims and vice versa, for example by the system comprising means which are intended and / or arranged for carrying out one or more method steps or by the method comprising steps are executable by means of the system. In that regard, features and details described in connection with the proposed system for assisting the exchange of blood gas by means of ventilation and extracorporeal blood gas exchange and possible embodiments apply, of course, also in connection with and with regard to a method executed during operation of the system and vice versa, so that with respect to the disclosure of the individual aspects of the invention is always reciprocally referred to or can be.

In one embodiment of the system, the first and second data sets are loaded into a memory of a medical device included in the system, for example, a memory of the ventilator or a memory of a medical device acting as a parent device in the system. By means of a medical device, for example the respirator or the higher-level device, included in the system, a computer program functioning as a control program can be executed and is executed during operation of the system. Under the control of the computer program, an operation of the ventilator with the ventilation parameters of the first or second data set can be activated and, under the control of the computer program, the combination operation in the form of an operation of the ventilator with the ventilation parameters of the second data set can be activated with a corresponding selection of the operator.

In a particular embodiment of the system or a method for operating the system, at least one ventilation parameter which is effective together with the oxygenator during operation of the ventilator, ie a ventilation parameter effective during combination operation, can be adapted automatically and as a function of a measured value or automatically and in dependence on adapted to a measured value. Such automatic adaptability makes it possible, for example in the course of recovery of the patient, to automatically shift the center of gravity of the ventilation to the respiration by means of the ventilator, so that the oxygenator can be removed after a sufficient shift in the center of gravity. Such automatic adjustment relieves the operator of the need to identify and manually enter customized ventilation parameters.

As a measured value, due to which such an automatic adjustment of at least one effective in combination operation ventilation parameter, is particularly a blood pressure measurement, especially a by means of a sensor system of a medical device automatically and regularly recorded blood pressure reading, because the blood pressure reading is a good physiological characteristic and - as explained in more detail below in the special part of the description - a characteristic value for the effects of the combined operation of the ventilator and the oxygenator. In addition, a blood pressure reading is easily available. As a sensor, for example, the sensor technology of a system encompassed and functioning as a patient monitor medical device into consideration. Such a patient monitor is regularly used in intensive care Treatment of a patient used and therefore it can be assumed that this anyway as part of the otherwise at least the ventilator and the oxygenator comprehensive system is available. As a sensor, alternatively or additionally, a sensor of the oxygenator into consideration, by means of which the blood pressure can be measured directly due to the connection of the oxygenator to the blood circulation of the patient.

In yet another embodiment of the system or method of operating the system, the or each ventilation parameter that is adaptable to a measured value is cyclically variable by a predetermined or specifiable increment or by a predetermined or predeterminable percentage or cyclically by a predetermined or specifiable increment changed by a predetermined or predefinable percentage. Such an automatic and cyclic adjustment causes a systematic shift of focus of the patient's ventilation towards ventilation by means of the ventilator, ie a systematic "phasing out" of the respiration by means of the oxygenator, so that the oxygenator can finally be deactivated.

The method mentioned at the beginning and optional embodiments of the method as well as the method steps included therein are carried out automatically, ie without any special intervention of the user of the system. The automatic execution of the method steps takes place in a basically known manner under the control of a control unit of the respective medical device. This comprises a processing unit in the form of or in the manner of a microprocessor and a memory. A control program executable by the processing unit is loaded or loadable into the memory, which is executed by the processing unit during operation of the system.

Thus, the above-mentioned object is also achieved by means of a control unit, which operates according to the method as described here and below and in addition comprises means for carrying out the method. The invention is preferably implemented in software. The invention is thus on the one hand also a computer program with program code instructions executable by a computer and on the other hand a storage medium with such a computer program, thus a computer program product with program code means. Finally, the invention is also a control unit of a medical device or a medical device in whose or its memory is loaded or loadable as a means for carrying out the method and its embodiments, such a computer program, or a system with such a medical device.

Overall, the innovation proposed here also includes the use of a system as described here and below, ie at least one system which comprises at least one medical device in the form of a respirator and a medical device in the form of an oxygenator for extracorporeal blood gas exchange as system components to support an exchange of Blood gas (blood gas exchange) of a patient by means of ventilation by means of the ventilator by the extracorporeal blood gas exchange by means of the oxygenator, wherein at least a first and a second set of ventilation parameters is selected for operation of the ventilator and is selected during operation of the system, wherein the first data set for the operation of the System and the respirator included therefrom without the oxygenator and the second set of data for operation of the system and the ventilator together with the oxygenator and wherein upon an appropriate selection of an operator an operation is made ieb the ventilator included in the system with the ventilation parameters of the second data set is activated or is activated.

An embodiment of the invention will be explained in more detail with reference to the drawing. Corresponding objects or elements are provided in all figures with the same reference numerals.

The embodiment is not to be understood as limiting the invention. Rather, modifications and modifications are possible within the scope of the present description, in particular those variants and combinations, for example, by combination or modification of individual features described in the general or specific description part as well as in the claims and / or the drawings for the skilled person with regard to the solution of the task can be removed and lead by combinable features to a new object.

• 1 ein System zur Beatmung eines Patienten, welches zumindest ein als Beatmungsgerät fungierendes Medizingerät umfasst,
• 2 einen von dem Beatmungsgerät umfassten Speicher, in den ein als Steuerungsprogramm des Beatmungsgeräts fungierendes Computerprogramm sowie ein erster und ein zweiter Datensatz mit Beatmungsparametern geladen sind,
• 3 eine in Form eines Flussdiagramms veranschaulichte Teilfunktionalität des Computerprogramms, nämlich eine Auswahl der Beatmungsparameter des ersten oder zweiten Datensatzes zum Betrieb des Beatmungsgeräts in Abhängigkeit von einer Benutzeraktion bewirkende Teilfunktionalität, und
• 4 eine ebenfalls in Form eines Flussdiagramms veranschaulichte weitere Teilfunktionalität des Computerprogramms, nämlich eine automatische Anpassung der beim Betrieb des Beatmungsgeräts wirksamen Beatmungsparameter in Abhängigkeit von einem Messwert bewirkende Teilfunktionalität.

Show it:

• 1 a system for ventilating a patient, which comprises at least one medical device acting as a respirator,
• 2 a memory comprised by the ventilator, in which a computer program functioning as a control program of the ventilator as well as a first and a second data set with ventilation parameters are loaded,
• 3 a partial functionality of the computer program illustrated in the form of a flow chart, namely a selection of the ventilation parameters of the first or second Record for operating the ventilator in response to a user action causing partial functionality, and
• 4 a likewise illustrated in the form of a flow chart further sub-functionality of the computer program, namely an automatic adaptation of the effective during operation of the ventilator ventilation parameters in response to a measured value causing partial functionality.

The representation in 1 shows - schematically simplistic - a system 10 for ventilation of a patient 12 , The system 10 includes at least two for ventilating the patient 12 certain medical devices 14 . 16 namely a first medical device 14 in the form of a respiratory device for mechanical ventilation of a lung of the patient 12 and a second medical device 16 in the form of a so-called pumpless ECMO device (pECLA). At least one removal of carbon dioxide (CO ₂ ) from the blood of the patient and an enrichment of the blood with oxygen (O ₂ ), ie an extracorporeal gas exchange, take place by means of the pumpless ECMO device. According to the simplification explained above, the ventilation device (first medical device 14 ) and the pECLA (second medical device 16 ) in the following briefly - but without waiving any further generality - as a ventilator 14 or oxygenator 16 designated. Optionally, the system includes 10 In addition, at least one other medical device 18 So, for example, a medical device 18 in the form of a so-called patient monitor 18 or similar. The at least one other medical device 18 includes, for example, a sensor 19 to record a blood pressure reading.

The ventilator 14 is in a manner known per se to the lungs of the patient 12 connected. The oxygenator 16 is in a manner also known per se to the bloodstream of the patient 12 connected. The circulatory system includes a pulmonary circulation, through which oxygen from the lungs into the blood and CO ₂ from the blood reaches the lungs.

In respiratory arrest - caused by the lack of movement of the lungs through the respiratory muscles and respiratory muscles - no fresh and oxygen-rich breathing air enters the lungs (no ventilation). In a cardiac arrest blood flow stops (no perfusion).

For a promising cardiopulmonary resuscitation (CPR) by external ventilation and cardiac pressure massage (CPR measures) are knowledge of the mutual effects of pressure conditions in the bloodstream, especially in the heart muscle, and in the pulmonary circulation, especially the pressure conditions in the Lungs and respiratory pressures, very essential.

A description of the relationship between resuscitation measures and ventilation pressures and their functional and temporal relationships are given in the DE 10 2012 024 672 A1 described. There it is shown that also from the perspective of ventilation as a therapy for lung recovery "bad implementation" of ventilation for a promising cardiopulmonary resuscitation can be helpful supportive. The inspiratory and expiratory respiratory pressures (P _insp , P _exsp ), in particular the end-expiratory pressure level (PEEP), are controlled in such a way that the lungs are filled with respiratory gas in such a way that the lungs occupy space in the chest such that the heart responds to the effects of the lungs Heart pressure massage can not escape.

For mandatory ventilation using a ventilator 14 in combination with an oxygenator 16 for extracorporeal blood gas exchange can be carried out in a similar way from the point of view of perfusion and ventilation in the lung "not optimal" ventilation, as part of the required - otherwise carried out by perfusion and ventilation in the lungs - life is performed in the extracorporeal circuit. The level of pressure (PEEP) increases intrathoracic pressure in the lungs and affects venous return to the heart, which corresponds to an increase in "internal flow resistance" in the bloodstream. In the pulmonary artery there is an increase in pressure.

If the heart has to supply the extracorporeal blood circulation against external flow resistance of the oxygenator and the necessary supplies (tubing, venous and arterial access) in addition to the body's own blood circulation with pumping power, then this may be in addition to the pressure settings on the ventilator 14 lead to additional changes in cardiac output (HZV) and therefore also in mean arterial blood pressure (MAP = ½ * (systolic value in mmHg + diastolic value in mmHg, normal value ~ 100 mmHG) to the volumes in the leads and the flow resistances mentioned This is evident from the inaugural dissertation by Anne Mareike Leuchtenberg entitled "Influence of positive end-expiratory pressure on hepatic blood flow: Doppler ultrasound examination" (Justus Liebig University Giessen) Investigations: "Ventilation with increased end-tidal pressure, with both intrinsic and extrinsic PEEP, increases intrathoracic pressure, resulting in a decrease in venous return and an increase in central venous pressure (CVED). At the same time there is an increase in pulmonary artery pressure and a decrease in cardiac output (CO). As a result of diminished CO, there is a fall in mean arterial blood pressure. "

Under certain circumstances, this may represent a burden on the heart that is not permissible for long-term therapy. This is sometimes associated with an increase in the heart rate, which may also be an additional burden on the heart in the long term.

So there are settings on the ventilator during a therapy in a special mode 14 possible and possibly also "allowed" and possibly also advantageous, which without a parallel "ventilation" by means of the oxygenator 16 usually lead to a rather unadapted and possibly inadequate ventilation of the lungs.

• - ein Minutenvolumen (MV),
• - eine Beatmungsfrequenz (RR),
• - ein Inspirations-/Exspirationszeitverhältnis (I:E-Ratio) und/oder
• - ein Tidalvolumen (VT).

Setting _variables which can be set in another way in such an operating mode (in addition to inspiratory pressure (P _insp ), expiratory pressures (P _exsp , PEEP)) are

• a minute volume (MV),
• a respiration rate (RR),
• an inspiratory / expiratory time ratio (I: E ratio) and / or
• a tidal volume (VT).

In addition to the pressure settings (P _insp , P _{ex p} , PEEP), these setting _values also affect the pressure conditions in the lungs. Thus, for example, a constellation of so-called "air trapping" may result, in which the lung can not empty itself to almost the functional residual capacity (FRC) over an extended period of time, namely due to settings for the ventilation frequency and the inspiratory / expiratory time ratio or the expiratory period or tidal volume, expiratory time, and ventilation rate settings. There then remains a residual amount of exhaled gas in the lung, which can lead to a (continuous) incremental increase in the end-expiratory pressure level (PEEP), a so-called "intrinsic PEEP". In many cases of conventional ventilation, an intrinsic PEEP, taking into account special patient situations, is accepted in favor of the life support and the therapeutic effect of ventilation, and in exceptional cases even provoked.

An intrinsic PEEP can thus result even with suitably selected pressure settings (P _insp , P _{ex p} , PEEP) and can lead to an increased load (pressure load) of the heart in the course of a therapy.

So it applies to a parallel "ventilation" by means of an oxygenator 16 To avoid excessive PEEP and intrinsic PEEP in order to avoid effects on cardiac output (CPM) and mean arterial blood pressure (MAP) to the heart as a "motor" for parallel "ventilation" using an oxygenator 16 (pECLA) should not be charged additionally.

Because the parallel "ventilation" by means of an oxygenator 16 Ensures a portion of the blood gas exchange, but this also gives a chance to adjust the pressure settings and the other ventilation settings.

Thus, for example, to avoid an intrinsic PEEP, the expiratory time compared to a usual expiratory period by a predetermined period of time (eg 5% to 15% of the usual expiratory period without oxygenator 16 ) to avoid pressure build-up.

This can also be combined with an increase in the ventilation rate (RR) by 10% to 20% or more (RR> 18 min ^-1 ), as a fundamentally unfavorable increased dead space ventilation due to the increase of the ventilation frequency by the parallel "ventilation" by means of the oxygenator 16 can be compensated

Furthermore, with a dose of, for example, 100% oxygen by means of the oxygenator 16 a reduction in oxygen concentration on the ventilator 14 possible. By such an adaptation it is ensured that the body by means of the oxygenator 16 (Bloodstream) and by means of the ventilator 14 (Respiratory gas) supplied (total) amount of oxygen remains below a threshold, which would correspond to an O ₂ concentration increase in the breathing gas above 50%. As is known, oxygen concentrations of 50% or more, depending on the duration of ventilation, can lead to lung damage.

• Für einen solchen Patienten 12 (Alter 35 bis 45 Jahre, 78 bis 82 kg, Größe ca. 1,85 m) ergeben sich für eine druckkontrollierte Beatmung (MV= RR * Vt, keine assistierte Spontanatmungs-Unterstützung mittels P_ASB, Vt = ca. 0,5 Liter (mit Vt = ca. 4-10 ml/kg) am Beatmungsgerät 14 die folgenden üblichen Einstellungen als Startwerte:
  1. 1. I:E = 1,0 : 2,0,
  2. 2. P_insp = 12 hPa (Normbereich 8 bis 16 hPa),
  3. 3. PEEP = 7 hPa (Normbereich 5 bis 8 hPa),
  4. 4. RR = 12 Atemzüge je Minute (Normbereich 12-15 min^-1),
  5. 5. Sauerstoffkonzentration 21% - 40%.

In the following, what has been said above is exemplified by an accidental, but otherwise medically unproblematic, male, adult patient 12 explains:

• For such a patient 12 (Older 35 to 45 Years, 78 to 82 kg, size approx. 1.85 m) result in pressure-controlled ventilation (MV = RR * Vt, no assisted spontaneous breathing support using P _ASB , Vt = approx. 0.5 liters (with Vt = approx 4-10 ml / kg) on the ventilator 14 the following usual settings as starting values:
  1. 1. I: E = 1.0: 2.0,
  2. 2. P _insp = 12 hPa (standard range 8 to 16 hPa),
  3. 3. PEEP = 7 hPa (standard range 5 to 8 hPa),
  4. 4. RR = 12 breaths per minute (normal range 12-15 min ^-1 ),
  5. 5. Oxygen concentration 21% - 40%.

• - dass das Atmen für den Patienten 12 schmerzhaft ist und infolge dessen seine Spontanatmung eher flach ausfallen würde und
• - dass bedingt durch den Unfall im Innern des Thorax der Platz für Herz und Lunge eingeschränkt ist, zum Beispiel aufgrund von Schwellungen und/oder Blutergüssen.

This (in itself) unproblematic patient 12 exemplifies a combination therapy using a ventilator 14 and an oxygenator 16 treated, for example, because he has contracted a rib fracture in the accident. This accident brings with it the following concomitants:

• - that breathing for the patient 12 is painful and as a result his spontaneous breathing would be rather flat and
• - that due to the accident inside the thorax the space for the heart and lungs is limited, for example due to swelling and / or bruising.

During ventilation, it should therefore be taken into account that pressure build-up due to ventilation by the ventilator 14 Cause or increase pain.

The representation in 2 shows the ventilator 14 according to 1 without the oxygenator 16 , The ventilator 14 comprises in principle known per se, a processing unit 20 in the form of or in the nature of a microprocessor and a memory 22 into a computer program 24 is loadable and in the operation of the ventilator 14 a computer program 24 What the functionality of the ventilator 14 determined, loaded. Others, from the ventilator 14 in units also known per se units, such as a fan, are not shown.

1. 1. ein Inspirations-/Exspirationszeitverhältnis (I:E-Ratio),
2. 2. einen inspiratorischen Druck P_insp,
3. 3. einen endexspiratorischer Druck PEEP,
4. 4. eine Beatmungsfrequenz RR,
5. 5. und eine Sauerstoffkonzentration.

In the store 22 are next to the computer program 24 at least a first record 26 and a second record 28 loaded. Each record, so at least the first and the second record 26 . 28 , includes ventilation parameters, for example predetermined or predeterminable values for

1. 1. an inspiratory / expiratory time ratio (I: E ratio),
2. 2. an inspiratory pressure P _insp ,
3. 3. an end-expiratory pressure PEEP,
4. 4. a respiratory rate RR,
5. 5. and an oxygen concentration.

1. 1. I:E = 1,0 : 2,0,
2. 2. P_insp = 12 hPa,
3. 3. PEEP = 7 hPa,
4. 4. RR = 12 min^-1,
5. 5. Sauerstoffkonzentration 21% - 40%.

The first record 26 includes, for example, the above values, namely

1. 1. I: E = 1.0: 2.0,
2. 2. P _insp = 12 hPa,
3. 3. PEEP = 7 hPa,
4. 4. RR = 12 min ^-1 ,
5. 5. Oxygen concentration 21% - 40%.

The first record 26 and its values are (at least as starting values) under the control of the computer program 24 during operation of the ventilator 14 used when ventilating the patient 12 only by means of the ventilator 14 takes place, so without one with the ventilator 14 combined oxygenator 16 ,

The second record 28 and its values are (at least as starting values) under the control of the computer program 24 during operation of the ventilator 14 used when ventilating the patient 12 by means of the ventilator 14 and by means of the ventilator 14 combined oxygenators 16 he follows.

1. 1. I:E = 1,0 : 2,5,
2. 2. P_insp = 8 hPa,
3. 3. PEEP = 5 hPa,
4. 4. RR = 15 Atemzüge je Minute und
5. 5. Sauerstoffkonzentration 21% - 40%.

The second record 28 includes, for example, the following values:

1. 1. I: E = 1.0: 2.5,
2. 2. P _insp = 8 hPa,
3. 3. PEEP = 5 hPa,
4. 4. RR = 15 breaths per minute and
5. 5. Oxygen concentration 21% - 40%.

The second record 28 does not have to include a value for each parameter. If a value is missing, it can be provided that then the corresponding value from the first record 26 is used. So if the second record 28 for example, does not include a value for the oxygen concentration, which is in the first record 26 specified oxygen concentration used.

In the second record 28 Instead of absolute values, relationships, ratios, differences or difference values to the first data set can be used 26 be deposited.

To select the coordinated operation of the ventilator 14 and oxygenator 16 So to select a ventilation of the patient 12 by means of the ventilator 14 and at the same time by means of the oxygenator 16 (Combined operation), is an input device 30 for operation by an operator, so for example a doctor provided. At the input device 30 It may - as shown schematically simplified - to a button or the like act. Just as much as an input device 30 an element of a graphical user interface into consideration.

Actuation or activation of the input device 30 causes a use of the second record 28 instead of the first record 26 during operation of the ventilator 14 , By actuating or activating the input device 30 On the one hand, the respective operator shows a connected oxygenator 16 on the other hand shows the desire of a combined operation of ventilator 14 and oxygenator 16 that is, the desire for coordinated ventilation of the patient 12 by means of the ventilator 14 and by means of the oxygenator 16 , using the adapted for such a combined operation ventilation parameters in the second record 28 ,

The representation in 3 shows this procedure schematically simplified in the form of a flow chart. The flowchart represents part of the functionality of the computer program 24 represents the functionality of the ventilator 14 certainly.

As shown in 3 is determined by a case distinction 32 checked if the input device 30 is pressed or activated. If so, it becomes a program section 34 branches, in which the second record 28 and the values included for the operation of the ventilator 14 can be selected (corresponding to the program section 34 also as a combination operation selection program section 34 be designated). Then the ventilator becomes 14 hereafter operated with ventilation parameters, based on the coordinated operation of respirator 14 and oxygenator 16 are turned off. If, however, in the context of case distinction 32 that results in the input device 30 is not activated or activated, becomes a program section 36 branches, in which the first record 26 and the values included for the operation of the ventilator 14 to be selected. Then the ventilator becomes 14 hereafter operated with ventilation parameters that respond to a single operation of the ventilator 14 are turned off. The program section 36 can according as normal operation selection program section 36 be designated.

The basis of the representation in 3 The steps described are used when operating the ventilator 14 automatically executed. By means of a cyclic or comparable embodiment, it is ensured that an actuation or activation of the input device 30 also at different times in the operation of the ventilator 14 is recognized.

On the continuation of the computer program 24 immediately after the program sections 34 . 36 it does not matter. It is essential, however, that due to the selection presented at a later date and under the control of the computer program 24 a program section 38
(Ventilation program section 38 ) is executed with computer program instructions that cause the ventilation of the patient 12 by means of the ventilator 14 with the in one of the program sections 34 . 36 selected ventilation parameters.

With the above (exemplary) values of the second record 28 results in a lowering of the pressure level in the thoracic space. The lungs of the patient 12 can "relax" in the expiration. An intrinsic PEEP is avoided and essentially fast and shallow ventilation avoids pain.

Once accident consequences (swelling, bruising) or the like have healed in part, a new adjustment of the settings makes sense, for example, a gradual withdrawal in the form of activation of the ventilation parameters of the second data set 28 instead of the ventilation parameters of the first record 26 caused adjustments. Such a withdrawal initially by activation of the second record 28 The adaptation can be done automatically.

The representation in 4 shows an optional functionality of the ventilator 14 and thus a section of one of the respirator 14 during operation executed computer program 24 which includes this optional functionality. In the 4 functionality shown, for example, belongs to the program section 38 whose computer program instructions ventilate the patient 12 effect with the ventilation parameters. Anyway, when starting the in 4 provided functionality provided that usable ventilation parameters are present, in particular in the form of the first or second data set 26 . 28 ,

$${\text{P}}_{\text{insp}}:={\text{P}}_{\text{insp}}-\Delta {\text{P}}_{\text{insp}},$$

wobei ΔPEEP und ΔP_insp die jeweils verwendeten Inkremente sind, bei denen es sich um vorgegebene oder vorgebbare Absolutwerte, aber alternativ auch um vorgegebene oder vorgebbare Prozentwerte handeln kann, so dass im letzteren Fall der jeweilige Beatmungsparameter zum Beispiel schrittweise um einen vorgegebenen oder vorgebbaren Prozentsatz reduziert wird, zum Beispiel jeweils um 5%. Die beispielhaft beschriebene Anpassung der Beatmungsparameter ist damit ein Beispiel für die Funktionalität des Programmabschnitts 42, in welchem die jeweils bisher gültigen Beatmungsparameter angepasst werden und sich aufgrund der Anpassung neue, aktuelle Beatmungsparameter ergeben.At the in 4 shown optional functionality of the ventilator 14 An automatic adjustment of at least one during operation of the ventilator 14 effective ventilation parameter depending on one in the system 10 or on the patient 12 recorded measured value, for example, a blood pressure reading. In the case of a blood pressure reading - the following applies mutatis mutandis - for other measured values - this is done by means of a case distinction 40 checked whether a currently determined blood pressure reading (pA) is less than a predetermined or predeterminable blood pressure _setpoint (pA _setpoint ): pA <pA _setpoint ? When this condition is met, it becomes a program section 42 branches, in which at least one of the previous ventilation parameters is adjusted (corresponding to the program section 42 also referred to as a ventilation parameter adjustment program section). On the other hand, if this condition is not met, the program section becomes 42 , in which at least one of the previous ventilation parameters is adjusted, skipped. Following, ie after the adaptation of at least one respiration parameter or after skipping such an adaptation, the program section, for example, becomes 38 whose computer program instructions cause the ventilation of the patient 12 by means of the ventilator 14 with the respectively valid (ie the adapted or the previous) ventilation parameters. Subsequently, for the purpose of a cyclical execution of the in 4 shown functionality, for example by means of a case distinction 44 be checked whether a criterion for the termination of ventilation (termination criterion) is present. If this is not the case, the beginning of the in 4 branched shown functionality. In the resulting cyclic or at least regular execution always takes place when the blood pressure reading in the case distinction 40 The tested condition satisfies a renewed adaptation (ie overall and over several cycles an incremental adaptation) of at least one ventilation parameter. The adaptation of the ventilation parameters in the form of an adaptation of at least one ventilation parameter or in the form of a simultaneous adaptation of several ventilation parameters takes place, for example, by reducing (or also increasing) a ventilation parameter (or several ventilation parameters) by a predetermined or predefinable increment. As an example of such an adaptation of ventilation parameters, the following adaptation may be mentioned: $$\text{PEEP}:=\text{PEEP}-\Delta \text{PEEP}.$$

$${\text{P}}_{\text{insp}}:={\text{P}}_{\text{insp}}-\Delta {\text{P}}_{\text{insp}}.$$

where ΔPEEP and ΔP _{insp are} the increments respectively used, which may be predetermined or predefinable absolute values, but alternatively also predetermined or predefinable percent values, so that in the latter case the respective ventilation parameter is reduced stepwise by a predetermined or specifiable percentage, for example is, for example, by 5% each. The adaptation of the ventilation parameters described by way of example is thus an example of the functionality of the program section 42 in which the currently valid respiration parameters are adjusted and, as a result of the adaptation, new, current ventilation parameters result.

The adaptation of at least one ventilation parameter described above is a shortened representation. It is preferably checked before an adaptation whether the adaptation leads to an exceeding or falling below a (predetermined or predefinable) limit value for the ventilation parameter. This monitoring ensures that the adaptation can not lead a ventilation parameter into an inadmissible range.

The blood pressure measured value pA and thus the decisive influencing factor for the automatic adaptation of at least one ventilation parameter is, for example, by means of a patient monitor 18 ( 1 ) acting medical device 18 and one of them included sensors 19 for example, as mean value MAP = ½ * (systolic value in mmHG + diastolic value in mmHG). Alternatively, the blood pressure reading pA, for example, by means of a (not shown) of the sensor to the bloodstream of the patient 12 connected oxygenators 16 added.

The described optional adaptation of at least one ventilation parameter as a function of a measured value, in particular a blood pressure measured value, is optionally by means of an operating action on the ventilator 14 or at one in the system 10 can be activated as a higher-level device. The activation is usually done by a doctor, at least by medically trained personnel. The activation causes a "phasing out" of the ventilation by means of the oxygenator 16 , By adapting the at least one respiration parameter, the center of gravity of the respiration gradually shifts to the respirator 14 such that after some time of adaptation of the at least one ventilation parameter the coordinated operation of the respirator 14 and oxygenator 16 can be stopped and the oxygenator 16 Will get removed.

Optionally, it is provided that the described optional adaptation of at least one respiration parameter as a function of a measured value, in particular a blood pressure measured value, takes place only at predefined or predefinable times or in predetermined or predefinable time intervals, so that the phase out of the respiration by means of the oxygenator 16 over a longer period, in particular a can be influenced by specifying the times and / or the time intervals, takes place.

Individual aspects of the description submitted here can be briefly summarized as follows: It becomes a system 10 specified, which as system components at least one as a respirator 14 acting medical device 14 and one as an oxygenator 16 acting medical device 16 includes and the combined operation of respirator 14 and oxygenator 16 facilitated. To operate the ventilator 14 is at least a first and a second record 26 . 28 selectable, which each include ventilation parameters. The first record 26 is for operating the ventilator 14 without the oxygenator 16 certainly. The second record 28 is for operating the ventilator 14 together with the oxygenator 16 certainly. An appropriate selection of an operator is an operation of the ventilator 14 with the ventilation parameters of the second data set 28 activatable and the ventilation of the patient 12 by means of the ventilator 14 takes place with the ventilation parameters of the second data record 28 ,

LIST OF REFERENCE NUMBERS

10

System (to support blood gas exchange via ventilation and extracorporeal blood gas exchange)

12

patient

14

Medical device, ventilator

16

Medical device, oxygenator

18

Medical device, patient monitor

19

sensors

20

processing unit

22

Storage

24

computer program

26

first record

28

second record

30

input device

32

Case distinction

34

Program section (of computer program), combination operation selection program section

36

Program section (of computer program), normal operation selection program section

38

Program section (of the computer program), respiratory program section

40

Case distinction

42

Program section (of the computer program), ventilation parameter adjustment program section

44

Case distinction

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 102014107980 A1 [0002]
• DE 102012024672 A1 [0023]

Claims (13)

A system (10) for supporting an exchange of blood gas of a patient (12) on the one hand by means of ventilation by means of a ventilator (14) and on the other hand by means of extracorporeal blood gas exchange by means of an oxygenator (16), the system (10) comprising as system components at least one medical device in the form of a ventilator (14) and a medical device in the form of an oxygenator (16) for extracorporeal blood gas exchange, wherein for the operation of the ventilator (14) at least a first and a second data set (26, 28) with ventilation parameters is selectable, wherein the first data set (26) for operating the ventilator (14) without the oxygenator (16) and the second data set (28) for operating the ventilator (14) together with the oxygenator (16) is determined, and wherein a corresponding selection of a Operator operation of the ventilator (14) with the ventilation parameters of the second data set (28) can be activated. System (10) after Claim 1 wherein the first and second data sets (26, 28) are loaded into a memory (22) of a medical device (14, 16) encompassed by the system (10), a medical device (14, 16) included in the system (10). 16), a computer program (24) can be executed and is executed during operation of the system (10) and wherein, under the control of the computer program (24), operation of the ventilator (14) with the ventilation parameters of the first or second data set (26, 28) can be activated , System (10) after Claim 2 wherein the memory (22) is a memory (22) of the ventilator (14), the computer program (24) being loaded into the memory (22) of the ventilator (14) and wherein the computer program (24) is powered by the ventilator ( 14) processing unit (20) during operation of the ventilator (14) is executable. System (10) according to one of the preceding claims, wherein at least one during operation of the ventilator (14) together with the oxygenator (16) effective ventilation parameters automatically and in response to a measured value is adjustable. System (10) after Claim 4 wherein the measured value is a recordable blood pressure measured value by means of a sensor system (19) of a medical device (14, 16, 18) included in the system (10). System (10) after Claim 5 wherein the blood pressure measured value can be recorded by means of a sensor system (19) of a medical device (18) included in the system (10) and functioning as a patient monitor (18). System (10) after Claim 4 . 5 or 6 in which the or each ventilation parameter which can be adapted as a function of a measured value can be changed cyclically by a predetermined or predefinable increment or by a predetermined or predefinable percentage. Method for operating a system (10) according to one of the preceding claims, wherein the first data set (26) for operating the ventilator (14) without the oxygenator (16) and the second data set (28) for operating the ventilator (14) together with the oxygenator (16) is selected, and wherein an operation of the ventilator (14) with the ventilation parameters of the second data set (28) is activated on a corresponding selection of an operator. Method according to Claim 8 , wherein at least one during the operation of the ventilator (14) together with the oxygenator (16) effective ventilation parameters automatically and in response to a measured value, in particular a blood pressure measured value is adjusted. Method according to Claim 9 in which the or each ventilation parameter which can be adapted as a function of a measured value is changed cyclically by a predetermined or predefinable increment or by a predetermined or predefinable percentage. Control program in the form of a computer program (24) containing program code means for carrying out all steps of any one of Claims 8 to 10 when the control program is executed by means of a processing unit (20) of a medical device (14, 16, 18). System (10) according to one of Claims 1 to 7 with a medical device (14, 16, 18) with means (20, 22, 24) for carrying out a method according to one of Claims 8 to 10 , Use of a system (10) which comprises as system components at least one medical device in the form of a respirator (14) and a medical device in the form of an oxygenator (16) for extracorporeal blood gas exchange, to support an exchange of blood gas of a patient (12) by means of ventilation by means of the Ventilator (14) by the extracorporeal blood gas exchange by means of the oxygenator (16), wherein for operation of the ventilator (14) at least a first and a second data set (26, 28) with ventilation parameters is selectable, the first data set (26) for operating the ventilator (14) without the oxygenator (16) and the second data set ( 28) for the operation of the ventilator (14) together with the oxygenator (16) is determined and wherein on an appropriate selection of an operator operation of the ventilator (14) with the ventilation parameters of the second data set (28) can be activated.

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