CA3016247A1 - Method and device for ventilating a patient - Google Patents
Method and device for ventilating a patient Download PDFInfo
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- CA3016247A1 CA3016247A1 CA3016247A CA3016247A CA3016247A1 CA 3016247 A1 CA3016247 A1 CA 3016247A1 CA 3016247 A CA3016247 A CA 3016247A CA 3016247 A CA3016247 A CA 3016247A CA 3016247 A1 CA3016247 A1 CA 3016247A1
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- 238000000034 method Methods 0.000 title claims abstract description 114
- 238000009423 ventilation Methods 0.000 claims abstract description 204
- 239000012530 fluid Substances 0.000 claims abstract description 158
- 210000004072 lung Anatomy 0.000 claims abstract description 38
- 238000007599 discharging Methods 0.000 claims abstract description 14
- 238000005259 measurement Methods 0.000 claims description 7
- 230000001105 regulatory effect Effects 0.000 claims description 3
- 230000001276 controlling effect Effects 0.000 claims description 2
- 238000010586 diagram Methods 0.000 description 13
- 239000007789 gas Substances 0.000 description 13
- 230000029058 respiratory gaseous exchange Effects 0.000 description 6
- 210000000056 organ Anatomy 0.000 description 4
- 230000001419 dependent effect Effects 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 238000009530 blood pressure measurement Methods 0.000 description 2
- 210000000038 chest Anatomy 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 230000002269 spontaneous effect Effects 0.000 description 2
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 210000004177 elastic tissue Anatomy 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000009760 functional impairment Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000005399 mechanical ventilation Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
- A61M16/022—Control means therefor
- A61M16/024—Control means therefor including calculation means, e.g. using a processor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0051—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes with alarm devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/04—Tracheal tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3355—Controlling downstream pump pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2230/00—Measuring parameters of the user
- A61M2230/40—Respiratory characteristics
- A61M2230/46—Resistance or compliance of the lungs
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Pulmonology (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- External Artificial Organs (AREA)
- Ventilation (AREA)
Abstract
The invention relates to a ventilation device for ventilating a patient, comprising at least a fluid supply unit or, additionally, a fluid discharge unit which can be used to guide a fluid into at least one airway, that is part of a lung or in a lung, of a patient or for discharging the fluid from said airway; and to a control device which, during the ventilation of at least one airway of the patient, can be used to guide a fluid into the at least one airway and/or discharge the fluid from at least one airway by operating the ventilation device, for determining or also for estimating a path of at least one region of a compliance curve of the at least airway by guiding and/or discharging the fluid from the at least one airway and by determining at least one value of the compliance. The invention also relates to a method for operating a ventilation device.
Description
VI
CA Application Blakes Ref: 15785/00001
CA Application Blakes Ref: 15785/00001
2
3 The subject matter of the present invention relates to a ventilation device and to a method for
4 ventilating a patient. The device comprises at least a fluid supply unit or, additionally, a fluid discharge unit which can be used to supply a fluid (respiratory gas) into at least one airway, that is to 6 say into a lung part or into the lung, of a patient or for discharging the fluid from this airway.
8 When a patient is being ventilated, a mask or a tube is normally used via which a gas or gas mixture, 9 in particular oxygen and air, is supplied at low pressure to the airway sealed off from the outside.
Alternatively, however, a gas or gas mixture of this kind can also be injected in pulses at a high 11 pressure and a high flow rate through a thin, unblocked catheter into the airway lying open to the 12 outside (jet ventilation). This method is nowadays used particularly in diagnostic and therapeutic 13 interventions in the region of the upper airway (endotracheal or transtracheal jet ventilation). This 14 method can also be applied in emergency situations outside the hospital environment or in inpatient situations within hospitals.
17 In transtracheal jet ventilation, a patient can be supplied with oxygen or a fluid by way of a catheter 18 that has been introduced directly into the trachea through the skin or by way of a cannula thus 19 placed. These methods (transtracheal/endotracheal) are constituent parts of the currently valid algorithms for managing difficult airways and, in particular, the situation in which a patient cannot be 21 ventilated or cannot be intubated by conventional means (what is called a "cannot ventilate, cannot 22 i ntu bate" situation).
24 Moreover, WO 2008/113752 Al and WO 2015/004229 Al each disclose gas flow reversing devices with which ventilation (inhalation and exhalation) can also take place exclusively via a catheter.
27 Artificial or mechanical ventilation takes place either in a controlled manner or in the form of assisted 28 spontaneous ventilation. In the former case, the respirator has complete control over the breathing 29 pattern, whereas in the latter case the at least partially spontaneously breathing patient has considerable influence over the breathing pattern. However, a common aspect of all forms of 31 ventilation is that the respirator almost exclusively influences the inhalation phase. From the 32 perspective of the respirator, the exhalation can take place passively, i.e. the energy stored in the 33 elastic tissue elements of lung and thorax drives the exhalation.
Various methods of ventilation are known. Usually, volume-controlled ventilation is performed, in 36 which all the ventilation parameters are predefined. The target parameter and control parameter is 23454228.1 = CA Application Blakes Ref: 15785/00001 1 the tidal volume VT. The resulting airway pressures are dependent on the volumes that are set and 2 on the conditions of the patient's pulmonary system. Adjustment parameters are therefore 3 volumetric flow, ventilation frequency and PEEP (positive end-expiratory pressure). The positive 4 end-expiratory pressure denotes a positive pressure which is generated artificially in the lungs during ventilation and which is present after completion of the exhalation.
7 In pressure-controlled ventilation, an initially high volumetric flow is reduced only after a high 8 inhalation pressure level that has been set is reached. The target parameter and control variable is 9 therefore the pressure. An adjustment of the volumetric flow is therefore not possible here.
11 In contrast to the spontaneous ventilation of a patient, the fluid in artificial ventilation is supplied 12 counter to the elasticity of the airway. As a result of the increased pressure in the thorax, PEEP
13 reduces the return flow of the venous blood to the heart, as a result of which the cardiac output can 14 drop. Conversely, congestion occurs in the superior and inferior vena cave, with corresponding pressure increases in the upstream organs. Depending on the level of the PEEP, this can lead to 16 damage and functional impairment of the brain, liver, kidneys and other organs.
18 Proceeding from this, the object of the present invention is to propose an improved ventilation 19 method. In particular, the ventilation is intended to take place in a manner that is tailored to the individual as far as possible, i.e. the characteristics of the patient to be ventilated are to be taken 21 fully into consideration. Moreover, the ventilation should be as gentle as possible, and damage to the 22 airways and other organs must be prevented in every case. Moreover, a ventilation device is to be 23 proposed which allows such ventilation to be carried out.
This object is achieved by ventilation devices having the features of claims 1 and 9 and also by 26 methods having the features of claims 13 and 22. Advantageous developments and embodiments of 27 the ventilation devices and of the methods are the subject matter of the respective dependent 28 claims. It will be noted that the features specified individually in the dependent claims can be 29 combined with one another in any desired technologically meaningful way and define further embodiments of the invention. Furthermore, the features specified in the claims are rendered more 31 precisely and explained in more detail in the description, with further preferred embodiments of the 32 invention being presented.
34 The invention relates to a (first) ventilation device for ventilating a patient, at least comprising a fluid supply unit or, additionally, a fluid discharge unit, which is suitable for supplying a fluid into at least 36 one airway, that is to say into a lung part or into the lung, of a patient or for discharging the fluid from 23454228.1 CA Application Blakes Ref: 15785/00001 1 this airway. Moreover, the ventilation device comprises a control device which, during a ventilation of 2 the at least one airway of the patient, that is to say during the supply of a fluid into the at least one 3 airway and/or the discharge of the fluid from the at least one airway by operation of the ventilation 4 device, is suitable for determining or in addition estimating a profile of at least one subregion of a compliance curve of the at least one airway. The determination or the additional estimation of a 6 profile of at least one subregion of a compliance curve takes place by supplying and/or discharging 7 the fluid from the at least one airway and by determining at least one value of the compliance.
9 The following applies for the compliance:
C = V / delta p [milliliter/millibar].
12 The compliance indicates how much fluid, that is to say a volume V
[milliliter], is introduced into the 13 at least one airway or is removed from the airway, such that a pressure in the airway changes by a 14 pressure difference delta p [millibar]. The control device, taking into account the determined or additionally estimated profile of the at least one subregion of the compliance curve, determines a 16 position of a pressure interval with the pressures P1 and P2 and sets these pressures on the 17 ventilation device such that at least one ventilation process, that is to say an inhalation and/or an 18 exhalation, takes place between these pressures P1 and P2 and an absolute value of the 19 compliance of this ventilation process is as high as possible.
21 The absolute value indicates the value of the compliance independently of its sign.
23 The underlying concept of the invention is to perform ventilation of the patient with the lowest 24 possible energy input. A low energy input into the airways of the patient also signifies the least possible damage to the airways and other organs of the patient. This minimizing of the energy input 26 is achieved through the determination of the lowest possible pressure at which a required tidal 27 volume VT can be supplied to the patient. These pressures P1 and P2 of the pressure interval are 28 determined on the basis of the respectively existing compliance of the ventilated patient.
In particular, the profile of the compliance curve is thus determined or additionally estimated (e.g. on 31 the basis of empirical values) during at least one ventilation process (inhalation and/or exhalation). In 32 particular, it is specifically the subregion of the compliance curve at which a defined volume V (or VT) 33 can be supplied in the smallest possible pressure interval that is determined.
In particular, in order to determine the profile of the compliance curve, a volume of fluid, preferably a 36 small volume of at most 100 ml, particularly preferably of at most 50 ml, is supplied to the at least 23454228.1 CA Application Blakes Ref: 15785/00001 1 one airway via the fluid supply unit. During and/or preferably after the supply of this volume, the 2 pressure change delta p in the at least one airway is measured and a value for the compliance is 3 determined. At least the profile of the subregion of the compliance curve is then estimated, either 4 taking into consideration empirical values or, if appropriate, taking into consideration values that have already been determined for the compliance of this patient.
Alternatively, further (small) 6 volumes are supplied and the respective pressure change delta p determined. From these values for 7 the compliance, the profile of at least the subregion of the compliance curve can be determined 8 and/or estimated (with increasing precision). Moreover, the profile of the compliance curve and the 9 preferred position of a pressure interval, provided for the subsequent ventilation of the patient, with the pressures P1 and P2 can be determined or estimated on the basis of decreasing or increasing 11 absolute values of the compliance values.
13 In particular, at least one of the following variables - PEEP, respiration rate, volumetric flow - can be 14 preset, such that the required tidal volume VT can be supplied, on condition of the lowest possible energy input. Preferably, each of these variables can also be further adapted, after determination 16 and evaluation of the ventilation process, such that a predetermined tidal volume VT is supplied 17 under the parameters that are then set.
19 A fluid supply unit, and optionally also a fluid discharge unit, comprises at least one source of compressed gas or a device with which a fluid (e.g. a gas or a gas mixture suitable for ensuring the 21 ventilation of a patient) can be introduced into and removed from the at least one airway of the 22 patient. Preferably, a source of compressed gas is exclusively present, or the exhalation also takes 23 place via a gas flow reversing device as mentioned above, wherein the fluid is introduced into the 24 airway via a lumen and is discharged again via the same lumen.
26 The control device is suitable for determining or additionally for estimating a profile of at least one 27 subregion of a compliance curve. The determination of the compliance curve takes place during a 28 ventilation by the supply and/or discharge of the fluid from the at least one airway and by 29 determination of at least one value of the compliance. The profile of the compliance curve of a patient can in particular be estimated taking into consideration the at least one value of the 31 compliance.
33 In particular, the control device falls back on the measured values of at least one pressure sensor 34 and monitors the volumetric flows that are supplied via the fluid supply unit and that are discharged via the fluid discharge unit.
23454228.1 CA Application Blakes Ref: 15785/00001 1 In particular, the pressure present in the respective airway is monitored and/or measured and 2 computationally estimated or determined. A pressure sensor is thus preferably arranged in the 3 airway, such that a continuous pressure measurement can in particular also take place in the airway 4 even during the ventilation.
6 Such an arrangement of a pressure sensor is particularly advantageous in the determination of the 7 profile of the compliance curve, since in this case the (respectively) changing pressure delta p can 8 be determined during the continuous or staged supply of a volume or of partial volumes of the fluid.
According to a preferred embodiment, the control device, at least during an inhalation or an 11 exhalation of a ventilation process, determines a plurality of values for the compliance and from 12 these determines, for at least one subsequent ventilation process, the position of the pressure 13 interval with the pressures P1 and P2, for which an absolute value of the compliance is as high as 14 possible. In particular, the control device determines the values for the compliance continuously or at predefinable time intervals. At least 5 values of the compliance, particularly preferably at least 10 16 values of the compliance, are preferably determined for each ventilation process.
18 In particular, the number of compliance values to be determined for each ventilation process is 19 adjustable. Preferably, a different number of values is determined for an inhalation than is determined for an exhalation.
22 In particular, values for the compliance are determined by the control device across a plurality of 23 ventilation processes continuously (that is to say not only during one ventilation process but during 24 each ventilation process), such that the position of the pressure interval with the pressures P1 and P2 can optionally be determined anew for each subsequent ventilation process or for a plurality of 26 successive ventilation processes.
28 In particular, the control unit, as a function of the determined position of the pressure interval, of the 29 pressure interval itself and of the determined compliance, determines at least for the subsequent ventilation process at least one of the following parameters:
31 - a tidal volume VT [milliliter], 32 - a pressure P1 and a pressure P2 [millibar], 33 - a ventilation frequency F [I/second].
8 When a patient is being ventilated, a mask or a tube is normally used via which a gas or gas mixture, 9 in particular oxygen and air, is supplied at low pressure to the airway sealed off from the outside.
Alternatively, however, a gas or gas mixture of this kind can also be injected in pulses at a high 11 pressure and a high flow rate through a thin, unblocked catheter into the airway lying open to the 12 outside (jet ventilation). This method is nowadays used particularly in diagnostic and therapeutic 13 interventions in the region of the upper airway (endotracheal or transtracheal jet ventilation). This 14 method can also be applied in emergency situations outside the hospital environment or in inpatient situations within hospitals.
17 In transtracheal jet ventilation, a patient can be supplied with oxygen or a fluid by way of a catheter 18 that has been introduced directly into the trachea through the skin or by way of a cannula thus 19 placed. These methods (transtracheal/endotracheal) are constituent parts of the currently valid algorithms for managing difficult airways and, in particular, the situation in which a patient cannot be 21 ventilated or cannot be intubated by conventional means (what is called a "cannot ventilate, cannot 22 i ntu bate" situation).
24 Moreover, WO 2008/113752 Al and WO 2015/004229 Al each disclose gas flow reversing devices with which ventilation (inhalation and exhalation) can also take place exclusively via a catheter.
27 Artificial or mechanical ventilation takes place either in a controlled manner or in the form of assisted 28 spontaneous ventilation. In the former case, the respirator has complete control over the breathing 29 pattern, whereas in the latter case the at least partially spontaneously breathing patient has considerable influence over the breathing pattern. However, a common aspect of all forms of 31 ventilation is that the respirator almost exclusively influences the inhalation phase. From the 32 perspective of the respirator, the exhalation can take place passively, i.e. the energy stored in the 33 elastic tissue elements of lung and thorax drives the exhalation.
Various methods of ventilation are known. Usually, volume-controlled ventilation is performed, in 36 which all the ventilation parameters are predefined. The target parameter and control parameter is 23454228.1 = CA Application Blakes Ref: 15785/00001 1 the tidal volume VT. The resulting airway pressures are dependent on the volumes that are set and 2 on the conditions of the patient's pulmonary system. Adjustment parameters are therefore 3 volumetric flow, ventilation frequency and PEEP (positive end-expiratory pressure). The positive 4 end-expiratory pressure denotes a positive pressure which is generated artificially in the lungs during ventilation and which is present after completion of the exhalation.
7 In pressure-controlled ventilation, an initially high volumetric flow is reduced only after a high 8 inhalation pressure level that has been set is reached. The target parameter and control variable is 9 therefore the pressure. An adjustment of the volumetric flow is therefore not possible here.
11 In contrast to the spontaneous ventilation of a patient, the fluid in artificial ventilation is supplied 12 counter to the elasticity of the airway. As a result of the increased pressure in the thorax, PEEP
13 reduces the return flow of the venous blood to the heart, as a result of which the cardiac output can 14 drop. Conversely, congestion occurs in the superior and inferior vena cave, with corresponding pressure increases in the upstream organs. Depending on the level of the PEEP, this can lead to 16 damage and functional impairment of the brain, liver, kidneys and other organs.
18 Proceeding from this, the object of the present invention is to propose an improved ventilation 19 method. In particular, the ventilation is intended to take place in a manner that is tailored to the individual as far as possible, i.e. the characteristics of the patient to be ventilated are to be taken 21 fully into consideration. Moreover, the ventilation should be as gentle as possible, and damage to the 22 airways and other organs must be prevented in every case. Moreover, a ventilation device is to be 23 proposed which allows such ventilation to be carried out.
This object is achieved by ventilation devices having the features of claims 1 and 9 and also by 26 methods having the features of claims 13 and 22. Advantageous developments and embodiments of 27 the ventilation devices and of the methods are the subject matter of the respective dependent 28 claims. It will be noted that the features specified individually in the dependent claims can be 29 combined with one another in any desired technologically meaningful way and define further embodiments of the invention. Furthermore, the features specified in the claims are rendered more 31 precisely and explained in more detail in the description, with further preferred embodiments of the 32 invention being presented.
34 The invention relates to a (first) ventilation device for ventilating a patient, at least comprising a fluid supply unit or, additionally, a fluid discharge unit, which is suitable for supplying a fluid into at least 36 one airway, that is to say into a lung part or into the lung, of a patient or for discharging the fluid from 23454228.1 CA Application Blakes Ref: 15785/00001 1 this airway. Moreover, the ventilation device comprises a control device which, during a ventilation of 2 the at least one airway of the patient, that is to say during the supply of a fluid into the at least one 3 airway and/or the discharge of the fluid from the at least one airway by operation of the ventilation 4 device, is suitable for determining or in addition estimating a profile of at least one subregion of a compliance curve of the at least one airway. The determination or the additional estimation of a 6 profile of at least one subregion of a compliance curve takes place by supplying and/or discharging 7 the fluid from the at least one airway and by determining at least one value of the compliance.
9 The following applies for the compliance:
C = V / delta p [milliliter/millibar].
12 The compliance indicates how much fluid, that is to say a volume V
[milliliter], is introduced into the 13 at least one airway or is removed from the airway, such that a pressure in the airway changes by a 14 pressure difference delta p [millibar]. The control device, taking into account the determined or additionally estimated profile of the at least one subregion of the compliance curve, determines a 16 position of a pressure interval with the pressures P1 and P2 and sets these pressures on the 17 ventilation device such that at least one ventilation process, that is to say an inhalation and/or an 18 exhalation, takes place between these pressures P1 and P2 and an absolute value of the 19 compliance of this ventilation process is as high as possible.
21 The absolute value indicates the value of the compliance independently of its sign.
23 The underlying concept of the invention is to perform ventilation of the patient with the lowest 24 possible energy input. A low energy input into the airways of the patient also signifies the least possible damage to the airways and other organs of the patient. This minimizing of the energy input 26 is achieved through the determination of the lowest possible pressure at which a required tidal 27 volume VT can be supplied to the patient. These pressures P1 and P2 of the pressure interval are 28 determined on the basis of the respectively existing compliance of the ventilated patient.
In particular, the profile of the compliance curve is thus determined or additionally estimated (e.g. on 31 the basis of empirical values) during at least one ventilation process (inhalation and/or exhalation). In 32 particular, it is specifically the subregion of the compliance curve at which a defined volume V (or VT) 33 can be supplied in the smallest possible pressure interval that is determined.
In particular, in order to determine the profile of the compliance curve, a volume of fluid, preferably a 36 small volume of at most 100 ml, particularly preferably of at most 50 ml, is supplied to the at least 23454228.1 CA Application Blakes Ref: 15785/00001 1 one airway via the fluid supply unit. During and/or preferably after the supply of this volume, the 2 pressure change delta p in the at least one airway is measured and a value for the compliance is 3 determined. At least the profile of the subregion of the compliance curve is then estimated, either 4 taking into consideration empirical values or, if appropriate, taking into consideration values that have already been determined for the compliance of this patient.
Alternatively, further (small) 6 volumes are supplied and the respective pressure change delta p determined. From these values for 7 the compliance, the profile of at least the subregion of the compliance curve can be determined 8 and/or estimated (with increasing precision). Moreover, the profile of the compliance curve and the 9 preferred position of a pressure interval, provided for the subsequent ventilation of the patient, with the pressures P1 and P2 can be determined or estimated on the basis of decreasing or increasing 11 absolute values of the compliance values.
13 In particular, at least one of the following variables - PEEP, respiration rate, volumetric flow - can be 14 preset, such that the required tidal volume VT can be supplied, on condition of the lowest possible energy input. Preferably, each of these variables can also be further adapted, after determination 16 and evaluation of the ventilation process, such that a predetermined tidal volume VT is supplied 17 under the parameters that are then set.
19 A fluid supply unit, and optionally also a fluid discharge unit, comprises at least one source of compressed gas or a device with which a fluid (e.g. a gas or a gas mixture suitable for ensuring the 21 ventilation of a patient) can be introduced into and removed from the at least one airway of the 22 patient. Preferably, a source of compressed gas is exclusively present, or the exhalation also takes 23 place via a gas flow reversing device as mentioned above, wherein the fluid is introduced into the 24 airway via a lumen and is discharged again via the same lumen.
26 The control device is suitable for determining or additionally for estimating a profile of at least one 27 subregion of a compliance curve. The determination of the compliance curve takes place during a 28 ventilation by the supply and/or discharge of the fluid from the at least one airway and by 29 determination of at least one value of the compliance. The profile of the compliance curve of a patient can in particular be estimated taking into consideration the at least one value of the 31 compliance.
33 In particular, the control device falls back on the measured values of at least one pressure sensor 34 and monitors the volumetric flows that are supplied via the fluid supply unit and that are discharged via the fluid discharge unit.
23454228.1 CA Application Blakes Ref: 15785/00001 1 In particular, the pressure present in the respective airway is monitored and/or measured and 2 computationally estimated or determined. A pressure sensor is thus preferably arranged in the 3 airway, such that a continuous pressure measurement can in particular also take place in the airway 4 even during the ventilation.
6 Such an arrangement of a pressure sensor is particularly advantageous in the determination of the 7 profile of the compliance curve, since in this case the (respectively) changing pressure delta p can 8 be determined during the continuous or staged supply of a volume or of partial volumes of the fluid.
According to a preferred embodiment, the control device, at least during an inhalation or an 11 exhalation of a ventilation process, determines a plurality of values for the compliance and from 12 these determines, for at least one subsequent ventilation process, the position of the pressure 13 interval with the pressures P1 and P2, for which an absolute value of the compliance is as high as 14 possible. In particular, the control device determines the values for the compliance continuously or at predefinable time intervals. At least 5 values of the compliance, particularly preferably at least 10 16 values of the compliance, are preferably determined for each ventilation process.
18 In particular, the number of compliance values to be determined for each ventilation process is 19 adjustable. Preferably, a different number of values is determined for an inhalation than is determined for an exhalation.
22 In particular, values for the compliance are determined by the control device across a plurality of 23 ventilation processes continuously (that is to say not only during one ventilation process but during 24 each ventilation process), such that the position of the pressure interval with the pressures P1 and P2 can optionally be determined anew for each subsequent ventilation process or for a plurality of 26 successive ventilation processes.
28 In particular, the control unit, as a function of the determined position of the pressure interval, of the 29 pressure interval itself and of the determined compliance, determines at least for the subsequent ventilation process at least one of the following parameters:
31 - a tidal volume VT [milliliter], 32 - a pressure P1 and a pressure P2 [millibar], 33 - a ventilation frequency F [I/second].
5 23454228.1 CA Application Blakes Ref: 15785/00001 1 According to a preferred embodiment of the ventilation device, at least one pressure sensor can be 2 arranged inside the airways of the patient, and the pressure in the airway can be determined by a 3 measurement inside the at least one airway.
At least the pressure rise, that is to say delta p/delta t [millibar/second], during an inhalation can
At least the pressure rise, that is to say delta p/delta t [millibar/second], during an inhalation can
6 preferably be controlled and limited by the ventilation device.
7
8 According to a preferred embodiment of the ventilation device, at least the pressure drop, that is to
9 say delta p/delta t [millibar/second], during an exhalation can be controlled and limited by the ventilation device.
12 According to a preferred embodiment of the ventilation device, the pressure rise and the pressure 13 drop can be controlled and limited.
Preferably, the absolute value of the pressure rise or pressure drop can be limited to at most 40 16 mbar/s [millibar/second], in particular at most 30 mbar/s, preferably at most 20 mbar/s.
18 Moreover, a (first) method is proposed for operating a ventilation device, in particular the ventilation 19 device according to the invention. The ventilation device is provided for ventilating a patient. The method comprises at least the following steps:
21 a) supplying a fluid into at least one airway, that is to say a lung part or the lung, of the patient 22 and/or discharging the fluid from this airway by operation of the ventilation device;
23 b) determining or additionally estimating a profile of at least one subregion of a compliance 24 curve of the at least one airway by the supply and/or discharge of the fluid in step a) and determining at least one value of the compliance, wherein the following applies for the 26 compliance:
27 C = V / delta p [milliliter/millibar];
28 wherein the compliance indicates how much fluid, that is to say a volume V [milliliter], is 29 introduced into the at least one airway or is removed from the airway, such that a pressure in the airway changes by a pressure difference delta p [millibar];
31 c) determining a position of a pressure interval with the pressures P1 and P2 along the profile 32 of the at least one subregion of the compliance curve determined or additionally estimated in 33 step b), wherein an absolute value of the compliance is as high as possible for a ventilation 34 process performed in this pressure interval, that is to say an inhalation and/or an exhalation;
d) supplying and/or discharging the fluid within the pressure interval determined in step c), in at 36 least one ventilation process following on from step c).
23454228.1 !I
CA Application Blakes Ref: 15785/00001 2 The statements concerning the ventilation device apply equally to the method proposed here, and 3 vice versa.
A method is thus proposed for ventilating a patient with the lowest possible energy input. The 6 minimizing of the energy input is achieved through the determination of the lowest possible pressure 7 at which a required tidal volume VT can be supplied to the patient. These pressures P1 and P2 of the 8 pressure interval are determined on the basis of the respectively existing compliance of the 9 ventilated patient.
11 In particular, in step b), a plurality of values for the compliance are determined at least during an 12 inhalation or an exhalation of a ventilation process, such that in step c) it is possible to determine, for 13 at least one subsequent ventilation process, the position of the pressure interval with the pressures 14 P1 and P2 for which an absolute value of the compliance is as high as possible. In particular, the control device determines the values for the compliance continuously or at predefinable time 16 intervals. At least 5 values of the compliance, particularly preferably at least 10 values of the 17 compliance, are preferably determined for each ventilation process.
19 Steps b), c) and d) are preferably carried out continuously, such that the position of the pressure interval with the pressures P1 and P2 is optionally newly determined for each subsequent ventilation 21 process or for a plurality of successive ventilation processes.
23 According to a preferred embodiment, as a function of the position of the pressure interval 24 determined in step c), of the pressure interval itself and of the determined compliance, at least one of the following parameters is determined at least for the subsequent ventilation process:
26 - a tidal volume VT [milliliter], 27 - a pressure P1 and a pressure P2 [millibar], 28 - a ventilation frequency F [I/second].
According to a preferred embodiment, the pressure is determined by a measurement inside the 31 airways.
33 According to an advantageous embodiment, at least the pressure rise, that is to say delta p/delta t 34 [millibar/second], during an inhalation is controlled and limited.
23454228.1 CA Application Blakes Ref: 15785/00001 1 According to another advantageous embodiment, at least the pressure drop, that is to say delta 2 p/delta t [millibar/second], during an exhalation is controlled and limited.
4 The pressure rise and the pressure drop are preferably controlled and limited.
6 In particular, the absolute value of the pressure rise or pressure drop is limited to at most 40 mbar/s 7 [millibar/second], in particular at most 30 mbar/s, preferably at most 20 mbar/s.
9 In particular, the patient is ventilated using a catheter which has a cross section of at most 30 mm2 [square millimeters] for the passage of at least one fluid supplied during the inhalation.
12 In particular, with such a small cross section (with inhalation and exhalation exclusively via this 13 lumen), the pressure rise can be limited during the inhalation but also during the exhalation.
In particular, a resistance (e.g. a flow resistance or the like) can be provided in a fluid discharge unit 16 and limits and controls the pressure drop during the exhalation.
18 For ventilation device and method, it applies equally that a subregion of a compliance curve present 19 for the at least one airway of the patient to be ventilated is in particular initially determined and, if appropriate, additionally estimated. For this, the pressure rise during the delivery of a defined 21 volume V (e.g. 50 01 100 ml [milliliter]; optionally also VT) is measured.
23 Moreover, a PEEP level is in particular determined thereafter (that is to say the lower pressure of P1 24 and P2). To determine the PEEP level with which the patient is subsequently to be ventilated, several ventilation processes can initially also be carried out with in each case different PEEP levels.
27 Moreover, a tidal volume V-r anticipated for the patient in question is set. This tidal volume VT can be 28 further adapted during the ventilation, e.g. on the basis of monitoring the CO2 level. Alternatively or 29 additionally, the CO2 level can also be influenced by means of the frequency of the ventilation processes.
32 In particular, the pressure rise and/or the pressure drop is controlled and monitored during the 33 ventilation, such that the shear stress acting on the at least one airway is minimized.
In any case, however, the ventilation device and/or the method ensures that an absolute value of the 36 compliance during a ventilation process is as high as possible, or in particular in other words that 23454228.1 CA Application Blakes Ref: 15785/00001 1 (1) the ventilation takes place in a pressure interval in which the supplied volume of the fluid is 2 maximal, or 3 (2) the supply or discharge of a predetermined volume V or of a tidal volume VT of the fluid takes 4 place within a pressure interval that is as small as possible.
6 The invention relates to a further (second) method for ventilating a patient and/or for operating a 7 ventilation device, in particular the ventilation device according to the invention. The ventilation 8 device is provided for ventilating a patient.
The second method is also directed to the ventilation of a patient, wherein the lowest possible 11 energy input into the airways of the patient is to be achieved.
According to the second method, the 12 fluid supplied during the inhalation of the patient's lung or discharged during the exhalation from the 13 patient's lung by the ventilation device is controlled actively and continuously (that is to say at each 14 point in time) during the ventilation of the patient. The active control comprises a continuous pressure change of the supplied and discharged fluid by the ventilation device. The continuously 16 changed pressure is in particular the pressure inside the airways and thus inside the lung. This 17 pressure can be determined by a sensor via a measurement at the end of a ventilation device, e.g. a 18 catheter, that reaches into the airway.
The continuous pressure change leads in particular to a continuous control of the fluid supply rate 21 and fluid discharge rate [milliliter/second] through the ventilation device to the lung or from the lung 22 during the ventilation processes. In particular, the fluid volume present in the lung is thus 23 continuously changed. During the change of the fluid volume located in the lung, the fluid supply rate 24 and/or the fluid discharge rate through the ventilation device to the lung or from the lung are preferably not changed and thus remain substantially constant. The fluid supply rate does not 26 necessarily have to correspond to the fluid discharge rate, although it can also be of the same 27 magnitude. Moreover, the fluid supply rate can be varied from one inhalation process to the following 28 inhalation process. The same applies, in particular independently thereof, to the fluid discharge rate 29 during successive exhalation processes.
31 In particular, states are avoided in which there is no change of the pressure and in particular no 32 change of the fluid volume present in the lung within a time interval.
Preferably, such time intervals in 33 which there is no change of the pressure and/or in particular no change of the fluid volume present 34 in the lung are at most 0.5 s [seconds], in particular at most 0.2 s, preferably at most 0.1 s in length and in particular concern (exclusively) the time of reversal of the flow of fluid (that is to say the 36 transition from fluid supply to fluid discharge, and vice versa).
23454228.1 CA Application Blakes Ref: 15785/00001 2 The pressure is in particular measured in the patient himself, particularly advantageously in the 3 region of the outflow from the ventilation device, that is to say from a lumen (tube/catheter) 4 transporting the fluid, into the airway of the patient. Alternatively and/or additionally, the pressure is measured in the ventilation device.
7 In particular, the pressure in the ventilation device does not correspond to the pressure in the airway 8 of the patient. In particular, a continuous change of the pressure in the airways can also be set by an 9 at least intermittently constant pressure in the ventilation device.
11 A change of the pressure in the airways can in particular also still be measured when a fluid supply 12 rate or fluid discharge rate is zero. This change results in particular from the properties of the 13 airways themselves. However, the (second) method is geared toward the connection between fluid 14 supply rate and fluid discharge rate (not equal to zero) and pressure change. A fluid supply rate and fluid discharge rate of zero should as far as possible be avoided (at most for time intervals of up to 16 0.5 s [seconds], in particular at most 0.2 s or 0.1 s, and then also only at the time of reversal of the 17 flow of fluid; if appropriate, longer time intervals of up to 2.0 s are possible, e.g. in order to carry out 18 a pressure measurement, wherein such an extended time interval is provided only at distances of at 19 least 30 s, in particular at least 2 minutes, preferably at least 5 minutes). For this purpose, the fluid supply rate and fluid discharge rate is in particular predefined (exclusively) by the ventilation device, 21 wherein the pressure in the airways is monitored.
23 In particular, a sinusoidal or sawtooth-shaped breathing pattern (pressure [millibar] over time 24 [second]) is thus set, wherein a rise of the curve (pressure over time) is constantly not equal to zero, and it has a rise equal to zero in particular only at the time of reversal of the flow of fluid for a time 26 interval of at most 0.5 s [seconds], in particular at most 0.2 s, preferably at most 0.1 s, particularly 27 preferably never.
29 In the context of the second method, a breathing pattern is predefined for the patient preferably at all times during the ventilation by the ventilation device, i.e. the fluid supply rate (inhalation flow) and 31 fluid discharge rate (exhalation flow) are controlled and determined (alone) by the ventilation device 32 (and not by the patient).
34 In particular, the fluid supply and, if appropriate, additionally the fluid discharge take place exclusively via the ventilation device or via at least one lumen inserted into the airways of the 36 patient.
23454228.1 CA Application Blakes Ref: 15785/00001 2 The continuous pressure change ensures that the fluid supply and fluid discharge do not take place 3 too quickly or too slowly, and it is thus possible to prevent or at least minimize damage to the 4 airways and in particular to the lung tissue.
6 Moreover, the fluid supply and fluid discharge can take place, e.g.
taking into consideration a 7 compliance of the airways (see statements concerning the first method and the ventilation device, 8 which can be transferred equally to the second method) at advantageous pressure intervals (that is 9 to say between a first, higher pressure and a second, lower pressure) and at a predefinable ventilation frequency.
12 In particular, in the second method, a ventilation pause (i.e. no flow of fluid to or from the airway) of 13 more than 0.5 s [seconds], in particular of more than 0.2 s, preferably of more than 0.1 s, is avoided, 14 particularly preferably never. In the known ventilation methods, such ventilation pauses are provided in order to maintain a predefined ventilation rhythm (frequency and/or ratio of inhalation and 16 exhalation) or in order to limit the fluid volume to be supplied (at a predefined pressure). Moreover, 17 in the known ventilation methods, ventilation pauses also occur (randomly) on account of the 18 characteristics of the lung (e.g. compliance) or are influenced by these. However, ventilation pauses 19 have the consequence that a fluid supply or fluid discharge has to be intensified or carried out more quickly at other times (with a greater flow of fluid and higher energy input into the airways or the lung 21 of the patient).
23 This problem is solved by the second method in that ventilation pauses are (largely) avoided and the 24 fluid supply or fluid discharge can then be carried out at other times with a reduced flow of fluid and thus lower energy input into the airways or the lung of the patient.
27 Besides the (second) method, a (second) ventilation device is also claimed, in particular the (first) 28 ventilation device according to the invention. The ventilation device is used to ventilate a patient and 29 comprises at least a fluid supply unit or, additionally, a fluid discharge unit which is suitable for supplying a fluid into at least one airway, that is to say into a lung part or into the lung, of a patient or 31 for discharging the fluid from this airway. The ventilation device moreover comprises a control device 32 which, during ventilation of the at least one airway of the patient, that is to say during the supply of a 33 fluid into the at least one airway and/or the discharge of the fluid from the at least one airway, is 34 suitable for regulating the ventilation, that is to say in particular for controlling a profile of at least one of the following variables: pressure in the airway of the patient (e.g. by measurement in the 36 ventilation device and if appropriate by assessment of the pressure in the airway; or by 23454228.1 CA Application Blakes Ref: 15785/00001 1 measurement in the airway of the patient), supply rate of the fluid, discharge rate of the fluid, volume 2 in the airway, etc.
4 The control device regulates at least one ventilation process such that a pressure in the at least one airway is continuously changed at least during an entire inhalation or at least during an entire 6 exhalation, by continuous control of a fluid supply rate or of a fluid discharge rate during the 7 ventilation process.
9 In particular, the control device regulates at least one ventilation process such that there is a substantially constant fluid supply rate [milliliter/second] at least during an entire inhalation or there is 11 a substantially constant fluid discharge rate [milliliter/second] at least during an entire exhalation.
13 Preferably, the control device regulates at least one ventilation process, which comprises at least 14 one inhalation and one exhalation, such that a pressure in the at least one airway is changed continuously during the ventilation process.
17 In particular, a continuous change of the pressure entails that the pressure remains constant for at 18 most 0.5 s [seconds], in particular at most 0.2 s, preferably 0.1 s, particularly preferably never. In 19 particular, the pressure is constant only when a switch is made between a fluid supply rate and a fluid discharge rate.
22 The statements concerning the first ventilation device, the second ventilation device, the control 23 device, the first method and the second method can be transferred in each case to the other 24 subjects of the present invention.
26 It is expressly noted that the control device may also be claimed independently of the ventilation 27 device. The control device serves in particular to regulate the ventilation processes. It establishes 28 which variables are used to control the ventilation process and which parameters 29 (maximum/minimum pressure, maximum/minimum fluid supply rate and fluid discharge rate, etc.) are thereby monitored.
32 The invention and the technical field will be explained in more detail below on the basis of the 33 figures. It should be noted that the figures show a particularly preferred embodiment variant of the 34 invention, to which the invention is however not restricted. Here, identical components in the figures are denoted by the same reference signs. In the figures, in each case schematically:
23454228.1 fl CA Application Blakes Ref: 15785/00001 1 Fig. 1 shows a ventilation device and a patient;
3 Fig. 2 shows a profile of a compliance curve;
Fig. 3 shows ventilation processes in a pressure/time diagram;
7 Fig. 4 shows ventilation processes in a volume/time diagram;
9 Fig. 5 shows ventilation processes in a fluid supply rate and fluid discharge rate/time diagram;
11 Fig. 6 shows ventilation processes in a further pressure/time diagram;
and 13 Fig. 7 shows ventilation processes in a further volume/time diagram.
Fig. 1 shows a ventilation device 1 and a patient with at least one airway 5 or a lung. The ventilation 16 device 1 comprises a fluid supply unit 2 and a fluid discharge unit 3 which are suitable for supplying 17 a fluid 4 into an airway 5, that is to say into a lung part or into the lung, of a patient and for 18 discharging the fluid 4 from this airway 5. The ventilation device 1 further comprises a control device 19 6 which, during a ventilation of the at least one airway 5 of the patient, that is to say the supply of a fluid 4 into the at least one airway 5 and/or the discharge of the fluid 4 from the at least one airway 5 21 by operation of the ventilation device 1, is suitable for determining or additionally for estimating a 22 profile 7 of at least one subregion 8 of a compliance curve 9 of the at least one airway 5 by the 23 supply and/or discharge of the fluid 4 from the at least one airway 5 and by determination of at least 24 one value 10 of the compliance 11. Here, the ventilation device 1 is connected to the airway 5 of the patient via a catheter 27 with a lumen cross section 28 through which the fluid 4 can flow. The 26 ventilation thus takes place, for example, via a single lumen, in particular using a gas flow reversal 27 device.
29 Fig. 2 shows a profile 7 of a compliance curve 9 in a pressure/volume diagram. The pressure 13 is plotted on the horizontal axis, the volume 12 on the vertical axis. The profile 7 of the compliance 31 curve 9 is to be determined individually for each patient. Moreover, the profile 7 may also change 32 during a ventilation.
34 At least one value 10 of the compliance 11 is initially determined in the context of the method and by the ventilation device 1, wherein the following applies for the compliance 11:
C = volume V 12 / delta 36 p 14 in milliliter/millibar. In the subregion 8 of the compliance curve 9 illustrated here, the absolute 23454228.1 CA Application Blakes Ref: 15785/00001 1 value of the compliance 11 is maximal. By determination or estimation of the profile 7 of the 2 compliance curve 9, it is now possible to determine the position 15 of a pressure interval 16 with the 3 pressures 17, 18 in which a tidal volume VT 22 of the fluid 4 can be supplied to the at least one 4 airway 5. These pressures 17, 18 are set on the ventilation device 1, such that at least one ventilation process 19, that is to say an inhalation 20 and/or an exhalation 21, takes place in each 6 case with a tidal volume VT 22 between these pressures P117 and P2 18.
8 Fig. 3 shows ventilation processes 19 in a pressure/time diagram. The time 29 is plotted on the 9 horizontal axis, the pressure 13 on the vertical axis. The ventilation takes place in a pressure interval 16 between the pressures P1 17 and P2 18. The pressure rise 25, that is to say delta p/delta t, 11 during the inhalation 20 is monitored and controlled. Moreover, the pressure drop 26, that is to say 12 delta p /delta t, during the exhalation 21 is monitored and controlled.
14 Fig. 4 shows ventilation processes 19 in a volume/time diagram. The time 29 is plotted on the horizontal axis, the volume 12 on the vertical axis. The volume supplied to the airway 5 in the 16 pressure interval 16 is designated as the tidal volume VT 22. The profile of the curve in the 17 volume/time diagram follows the profile of the pressure (see Fig. 3).
19 Fig. 5 shows ventilation processes 19 in a fluid supply rate and fluid discharge rate/time diagram.
The time 29 is plotted on the horizontal axis, the fluid supply rate 30 (top, i.e. positive value) and fluid 21 discharge rate 31 (bottom, i.e. negative value) on the vertical axis.
The fluid supply rate 30 and the 22 fluid discharge rate 31 are each constant and never zero. The fluid supply rate 30 and fluid 23 discharge rate 31 can be set manually by the user on the ventilation device 1 or can be automatically 24 regulated by the control logic unit of the ventilation device 1 or of the control device 6, wherein the pressure 13 is monitored. Alternatively, the pressure 13 (in the airway 5), as shown in Fig. 3, can be 26 set e.g. by the user and monitored e.g. by the control logic unit, such that, at the ventilation 27 frequency F 23 and/or the intended duration or time ratio of inhalation 20 and exhalation 21, the 28 desired fluid supply rate 30 and fluid discharge rate 31 result from the set pressure 13.
In particular, the fluid supply rate 30 and fluid discharge rate 31 can be set via gas flow reversing 31 elements already known from WO 2008/113752 Al and WO 2015/004229 Al as ventilation devices 32 1 which can be operated mechanically or manually.
34 Fig. 6 shows ventilation processes 19 in a further pressure/time diagram. The time 29 is plotted on the horizontal axis, the pressure 13 on the vertical axis. The ventilation takes place in a pressure 36 interval 16 with the position 15 between the pressures P117 and P2 18.
The pressure rise 25, that is 23454228.1 CA Application Blakes Ref: 15785/00001 1 to say delta p/delta t during the inhalation 20 is monitored and controlled. Moreover, the pressure 2 drop 26, that is to say delta p/delta t, during the exhalation 21 is monitored and controlled. It will be 3 seen here that the rise of the pressure profile is constant both during the inhalation 20 and also 4 during the exhalation 21.
6 Fig. 7 shows ventilation processes 19 in a further volume/time diagram.
The time 29 is plotted on the 7 horizontal axis, the volume 12 on the vertical axis. The volume supplied to the airway 5 in the 8 pressure interval 16 is designated as tidal volume VT 22. The profile of the curve in the volume/time 9 diagram follows the profile of the pressure (see Fig. 6). It will also be seen here that the rise of the volume profile is constant both during the inhalation 20 and also during the exhalation 21.
12 It will be seen from the ventilation processes 19 in Figures 3 to 7 that there are no ventilation 13 pauses. The alternation between inhalation and exhalation takes place in each case without a 14 pause.
23454228.1 CA Application Blakes Ref: 15785/00001 2 List of reference signs 1 ventilation device 2 fluid supply unit 3 fluid discharge unit 4 fluid airway 6 control device 7 profile 8 subregion 9 compliance curve value 11 compliance C
12 volume V
13 pressure 14 pressure difference delta p position 16 pressure interval 17 pressure P1 18 pressure P2 19 ventilation process inhalation 21 exhalation 22 tidal volume VT
23 ventilation frequency F
24 pressure sensor pressure rise 26 pressure drop 27 catheter 28 cross section 29 time fluid supply rate 31 fluid discharge rate 23454228.1
12 According to a preferred embodiment of the ventilation device, the pressure rise and the pressure 13 drop can be controlled and limited.
Preferably, the absolute value of the pressure rise or pressure drop can be limited to at most 40 16 mbar/s [millibar/second], in particular at most 30 mbar/s, preferably at most 20 mbar/s.
18 Moreover, a (first) method is proposed for operating a ventilation device, in particular the ventilation 19 device according to the invention. The ventilation device is provided for ventilating a patient. The method comprises at least the following steps:
21 a) supplying a fluid into at least one airway, that is to say a lung part or the lung, of the patient 22 and/or discharging the fluid from this airway by operation of the ventilation device;
23 b) determining or additionally estimating a profile of at least one subregion of a compliance 24 curve of the at least one airway by the supply and/or discharge of the fluid in step a) and determining at least one value of the compliance, wherein the following applies for the 26 compliance:
27 C = V / delta p [milliliter/millibar];
28 wherein the compliance indicates how much fluid, that is to say a volume V [milliliter], is 29 introduced into the at least one airway or is removed from the airway, such that a pressure in the airway changes by a pressure difference delta p [millibar];
31 c) determining a position of a pressure interval with the pressures P1 and P2 along the profile 32 of the at least one subregion of the compliance curve determined or additionally estimated in 33 step b), wherein an absolute value of the compliance is as high as possible for a ventilation 34 process performed in this pressure interval, that is to say an inhalation and/or an exhalation;
d) supplying and/or discharging the fluid within the pressure interval determined in step c), in at 36 least one ventilation process following on from step c).
23454228.1 !I
CA Application Blakes Ref: 15785/00001 2 The statements concerning the ventilation device apply equally to the method proposed here, and 3 vice versa.
A method is thus proposed for ventilating a patient with the lowest possible energy input. The 6 minimizing of the energy input is achieved through the determination of the lowest possible pressure 7 at which a required tidal volume VT can be supplied to the patient. These pressures P1 and P2 of the 8 pressure interval are determined on the basis of the respectively existing compliance of the 9 ventilated patient.
11 In particular, in step b), a plurality of values for the compliance are determined at least during an 12 inhalation or an exhalation of a ventilation process, such that in step c) it is possible to determine, for 13 at least one subsequent ventilation process, the position of the pressure interval with the pressures 14 P1 and P2 for which an absolute value of the compliance is as high as possible. In particular, the control device determines the values for the compliance continuously or at predefinable time 16 intervals. At least 5 values of the compliance, particularly preferably at least 10 values of the 17 compliance, are preferably determined for each ventilation process.
19 Steps b), c) and d) are preferably carried out continuously, such that the position of the pressure interval with the pressures P1 and P2 is optionally newly determined for each subsequent ventilation 21 process or for a plurality of successive ventilation processes.
23 According to a preferred embodiment, as a function of the position of the pressure interval 24 determined in step c), of the pressure interval itself and of the determined compliance, at least one of the following parameters is determined at least for the subsequent ventilation process:
26 - a tidal volume VT [milliliter], 27 - a pressure P1 and a pressure P2 [millibar], 28 - a ventilation frequency F [I/second].
According to a preferred embodiment, the pressure is determined by a measurement inside the 31 airways.
33 According to an advantageous embodiment, at least the pressure rise, that is to say delta p/delta t 34 [millibar/second], during an inhalation is controlled and limited.
23454228.1 CA Application Blakes Ref: 15785/00001 1 According to another advantageous embodiment, at least the pressure drop, that is to say delta 2 p/delta t [millibar/second], during an exhalation is controlled and limited.
4 The pressure rise and the pressure drop are preferably controlled and limited.
6 In particular, the absolute value of the pressure rise or pressure drop is limited to at most 40 mbar/s 7 [millibar/second], in particular at most 30 mbar/s, preferably at most 20 mbar/s.
9 In particular, the patient is ventilated using a catheter which has a cross section of at most 30 mm2 [square millimeters] for the passage of at least one fluid supplied during the inhalation.
12 In particular, with such a small cross section (with inhalation and exhalation exclusively via this 13 lumen), the pressure rise can be limited during the inhalation but also during the exhalation.
In particular, a resistance (e.g. a flow resistance or the like) can be provided in a fluid discharge unit 16 and limits and controls the pressure drop during the exhalation.
18 For ventilation device and method, it applies equally that a subregion of a compliance curve present 19 for the at least one airway of the patient to be ventilated is in particular initially determined and, if appropriate, additionally estimated. For this, the pressure rise during the delivery of a defined 21 volume V (e.g. 50 01 100 ml [milliliter]; optionally also VT) is measured.
23 Moreover, a PEEP level is in particular determined thereafter (that is to say the lower pressure of P1 24 and P2). To determine the PEEP level with which the patient is subsequently to be ventilated, several ventilation processes can initially also be carried out with in each case different PEEP levels.
27 Moreover, a tidal volume V-r anticipated for the patient in question is set. This tidal volume VT can be 28 further adapted during the ventilation, e.g. on the basis of monitoring the CO2 level. Alternatively or 29 additionally, the CO2 level can also be influenced by means of the frequency of the ventilation processes.
32 In particular, the pressure rise and/or the pressure drop is controlled and monitored during the 33 ventilation, such that the shear stress acting on the at least one airway is minimized.
In any case, however, the ventilation device and/or the method ensures that an absolute value of the 36 compliance during a ventilation process is as high as possible, or in particular in other words that 23454228.1 CA Application Blakes Ref: 15785/00001 1 (1) the ventilation takes place in a pressure interval in which the supplied volume of the fluid is 2 maximal, or 3 (2) the supply or discharge of a predetermined volume V or of a tidal volume VT of the fluid takes 4 place within a pressure interval that is as small as possible.
6 The invention relates to a further (second) method for ventilating a patient and/or for operating a 7 ventilation device, in particular the ventilation device according to the invention. The ventilation 8 device is provided for ventilating a patient.
The second method is also directed to the ventilation of a patient, wherein the lowest possible 11 energy input into the airways of the patient is to be achieved.
According to the second method, the 12 fluid supplied during the inhalation of the patient's lung or discharged during the exhalation from the 13 patient's lung by the ventilation device is controlled actively and continuously (that is to say at each 14 point in time) during the ventilation of the patient. The active control comprises a continuous pressure change of the supplied and discharged fluid by the ventilation device. The continuously 16 changed pressure is in particular the pressure inside the airways and thus inside the lung. This 17 pressure can be determined by a sensor via a measurement at the end of a ventilation device, e.g. a 18 catheter, that reaches into the airway.
The continuous pressure change leads in particular to a continuous control of the fluid supply rate 21 and fluid discharge rate [milliliter/second] through the ventilation device to the lung or from the lung 22 during the ventilation processes. In particular, the fluid volume present in the lung is thus 23 continuously changed. During the change of the fluid volume located in the lung, the fluid supply rate 24 and/or the fluid discharge rate through the ventilation device to the lung or from the lung are preferably not changed and thus remain substantially constant. The fluid supply rate does not 26 necessarily have to correspond to the fluid discharge rate, although it can also be of the same 27 magnitude. Moreover, the fluid supply rate can be varied from one inhalation process to the following 28 inhalation process. The same applies, in particular independently thereof, to the fluid discharge rate 29 during successive exhalation processes.
31 In particular, states are avoided in which there is no change of the pressure and in particular no 32 change of the fluid volume present in the lung within a time interval.
Preferably, such time intervals in 33 which there is no change of the pressure and/or in particular no change of the fluid volume present 34 in the lung are at most 0.5 s [seconds], in particular at most 0.2 s, preferably at most 0.1 s in length and in particular concern (exclusively) the time of reversal of the flow of fluid (that is to say the 36 transition from fluid supply to fluid discharge, and vice versa).
23454228.1 CA Application Blakes Ref: 15785/00001 2 The pressure is in particular measured in the patient himself, particularly advantageously in the 3 region of the outflow from the ventilation device, that is to say from a lumen (tube/catheter) 4 transporting the fluid, into the airway of the patient. Alternatively and/or additionally, the pressure is measured in the ventilation device.
7 In particular, the pressure in the ventilation device does not correspond to the pressure in the airway 8 of the patient. In particular, a continuous change of the pressure in the airways can also be set by an 9 at least intermittently constant pressure in the ventilation device.
11 A change of the pressure in the airways can in particular also still be measured when a fluid supply 12 rate or fluid discharge rate is zero. This change results in particular from the properties of the 13 airways themselves. However, the (second) method is geared toward the connection between fluid 14 supply rate and fluid discharge rate (not equal to zero) and pressure change. A fluid supply rate and fluid discharge rate of zero should as far as possible be avoided (at most for time intervals of up to 16 0.5 s [seconds], in particular at most 0.2 s or 0.1 s, and then also only at the time of reversal of the 17 flow of fluid; if appropriate, longer time intervals of up to 2.0 s are possible, e.g. in order to carry out 18 a pressure measurement, wherein such an extended time interval is provided only at distances of at 19 least 30 s, in particular at least 2 minutes, preferably at least 5 minutes). For this purpose, the fluid supply rate and fluid discharge rate is in particular predefined (exclusively) by the ventilation device, 21 wherein the pressure in the airways is monitored.
23 In particular, a sinusoidal or sawtooth-shaped breathing pattern (pressure [millibar] over time 24 [second]) is thus set, wherein a rise of the curve (pressure over time) is constantly not equal to zero, and it has a rise equal to zero in particular only at the time of reversal of the flow of fluid for a time 26 interval of at most 0.5 s [seconds], in particular at most 0.2 s, preferably at most 0.1 s, particularly 27 preferably never.
29 In the context of the second method, a breathing pattern is predefined for the patient preferably at all times during the ventilation by the ventilation device, i.e. the fluid supply rate (inhalation flow) and 31 fluid discharge rate (exhalation flow) are controlled and determined (alone) by the ventilation device 32 (and not by the patient).
34 In particular, the fluid supply and, if appropriate, additionally the fluid discharge take place exclusively via the ventilation device or via at least one lumen inserted into the airways of the 36 patient.
23454228.1 CA Application Blakes Ref: 15785/00001 2 The continuous pressure change ensures that the fluid supply and fluid discharge do not take place 3 too quickly or too slowly, and it is thus possible to prevent or at least minimize damage to the 4 airways and in particular to the lung tissue.
6 Moreover, the fluid supply and fluid discharge can take place, e.g.
taking into consideration a 7 compliance of the airways (see statements concerning the first method and the ventilation device, 8 which can be transferred equally to the second method) at advantageous pressure intervals (that is 9 to say between a first, higher pressure and a second, lower pressure) and at a predefinable ventilation frequency.
12 In particular, in the second method, a ventilation pause (i.e. no flow of fluid to or from the airway) of 13 more than 0.5 s [seconds], in particular of more than 0.2 s, preferably of more than 0.1 s, is avoided, 14 particularly preferably never. In the known ventilation methods, such ventilation pauses are provided in order to maintain a predefined ventilation rhythm (frequency and/or ratio of inhalation and 16 exhalation) or in order to limit the fluid volume to be supplied (at a predefined pressure). Moreover, 17 in the known ventilation methods, ventilation pauses also occur (randomly) on account of the 18 characteristics of the lung (e.g. compliance) or are influenced by these. However, ventilation pauses 19 have the consequence that a fluid supply or fluid discharge has to be intensified or carried out more quickly at other times (with a greater flow of fluid and higher energy input into the airways or the lung 21 of the patient).
23 This problem is solved by the second method in that ventilation pauses are (largely) avoided and the 24 fluid supply or fluid discharge can then be carried out at other times with a reduced flow of fluid and thus lower energy input into the airways or the lung of the patient.
27 Besides the (second) method, a (second) ventilation device is also claimed, in particular the (first) 28 ventilation device according to the invention. The ventilation device is used to ventilate a patient and 29 comprises at least a fluid supply unit or, additionally, a fluid discharge unit which is suitable for supplying a fluid into at least one airway, that is to say into a lung part or into the lung, of a patient or 31 for discharging the fluid from this airway. The ventilation device moreover comprises a control device 32 which, during ventilation of the at least one airway of the patient, that is to say during the supply of a 33 fluid into the at least one airway and/or the discharge of the fluid from the at least one airway, is 34 suitable for regulating the ventilation, that is to say in particular for controlling a profile of at least one of the following variables: pressure in the airway of the patient (e.g. by measurement in the 36 ventilation device and if appropriate by assessment of the pressure in the airway; or by 23454228.1 CA Application Blakes Ref: 15785/00001 1 measurement in the airway of the patient), supply rate of the fluid, discharge rate of the fluid, volume 2 in the airway, etc.
4 The control device regulates at least one ventilation process such that a pressure in the at least one airway is continuously changed at least during an entire inhalation or at least during an entire 6 exhalation, by continuous control of a fluid supply rate or of a fluid discharge rate during the 7 ventilation process.
9 In particular, the control device regulates at least one ventilation process such that there is a substantially constant fluid supply rate [milliliter/second] at least during an entire inhalation or there is 11 a substantially constant fluid discharge rate [milliliter/second] at least during an entire exhalation.
13 Preferably, the control device regulates at least one ventilation process, which comprises at least 14 one inhalation and one exhalation, such that a pressure in the at least one airway is changed continuously during the ventilation process.
17 In particular, a continuous change of the pressure entails that the pressure remains constant for at 18 most 0.5 s [seconds], in particular at most 0.2 s, preferably 0.1 s, particularly preferably never. In 19 particular, the pressure is constant only when a switch is made between a fluid supply rate and a fluid discharge rate.
22 The statements concerning the first ventilation device, the second ventilation device, the control 23 device, the first method and the second method can be transferred in each case to the other 24 subjects of the present invention.
26 It is expressly noted that the control device may also be claimed independently of the ventilation 27 device. The control device serves in particular to regulate the ventilation processes. It establishes 28 which variables are used to control the ventilation process and which parameters 29 (maximum/minimum pressure, maximum/minimum fluid supply rate and fluid discharge rate, etc.) are thereby monitored.
32 The invention and the technical field will be explained in more detail below on the basis of the 33 figures. It should be noted that the figures show a particularly preferred embodiment variant of the 34 invention, to which the invention is however not restricted. Here, identical components in the figures are denoted by the same reference signs. In the figures, in each case schematically:
23454228.1 fl CA Application Blakes Ref: 15785/00001 1 Fig. 1 shows a ventilation device and a patient;
3 Fig. 2 shows a profile of a compliance curve;
Fig. 3 shows ventilation processes in a pressure/time diagram;
7 Fig. 4 shows ventilation processes in a volume/time diagram;
9 Fig. 5 shows ventilation processes in a fluid supply rate and fluid discharge rate/time diagram;
11 Fig. 6 shows ventilation processes in a further pressure/time diagram;
and 13 Fig. 7 shows ventilation processes in a further volume/time diagram.
Fig. 1 shows a ventilation device 1 and a patient with at least one airway 5 or a lung. The ventilation 16 device 1 comprises a fluid supply unit 2 and a fluid discharge unit 3 which are suitable for supplying 17 a fluid 4 into an airway 5, that is to say into a lung part or into the lung, of a patient and for 18 discharging the fluid 4 from this airway 5. The ventilation device 1 further comprises a control device 19 6 which, during a ventilation of the at least one airway 5 of the patient, that is to say the supply of a fluid 4 into the at least one airway 5 and/or the discharge of the fluid 4 from the at least one airway 5 21 by operation of the ventilation device 1, is suitable for determining or additionally for estimating a 22 profile 7 of at least one subregion 8 of a compliance curve 9 of the at least one airway 5 by the 23 supply and/or discharge of the fluid 4 from the at least one airway 5 and by determination of at least 24 one value 10 of the compliance 11. Here, the ventilation device 1 is connected to the airway 5 of the patient via a catheter 27 with a lumen cross section 28 through which the fluid 4 can flow. The 26 ventilation thus takes place, for example, via a single lumen, in particular using a gas flow reversal 27 device.
29 Fig. 2 shows a profile 7 of a compliance curve 9 in a pressure/volume diagram. The pressure 13 is plotted on the horizontal axis, the volume 12 on the vertical axis. The profile 7 of the compliance 31 curve 9 is to be determined individually for each patient. Moreover, the profile 7 may also change 32 during a ventilation.
34 At least one value 10 of the compliance 11 is initially determined in the context of the method and by the ventilation device 1, wherein the following applies for the compliance 11:
C = volume V 12 / delta 36 p 14 in milliliter/millibar. In the subregion 8 of the compliance curve 9 illustrated here, the absolute 23454228.1 CA Application Blakes Ref: 15785/00001 1 value of the compliance 11 is maximal. By determination or estimation of the profile 7 of the 2 compliance curve 9, it is now possible to determine the position 15 of a pressure interval 16 with the 3 pressures 17, 18 in which a tidal volume VT 22 of the fluid 4 can be supplied to the at least one 4 airway 5. These pressures 17, 18 are set on the ventilation device 1, such that at least one ventilation process 19, that is to say an inhalation 20 and/or an exhalation 21, takes place in each 6 case with a tidal volume VT 22 between these pressures P117 and P2 18.
8 Fig. 3 shows ventilation processes 19 in a pressure/time diagram. The time 29 is plotted on the 9 horizontal axis, the pressure 13 on the vertical axis. The ventilation takes place in a pressure interval 16 between the pressures P1 17 and P2 18. The pressure rise 25, that is to say delta p/delta t, 11 during the inhalation 20 is monitored and controlled. Moreover, the pressure drop 26, that is to say 12 delta p /delta t, during the exhalation 21 is monitored and controlled.
14 Fig. 4 shows ventilation processes 19 in a volume/time diagram. The time 29 is plotted on the horizontal axis, the volume 12 on the vertical axis. The volume supplied to the airway 5 in the 16 pressure interval 16 is designated as the tidal volume VT 22. The profile of the curve in the 17 volume/time diagram follows the profile of the pressure (see Fig. 3).
19 Fig. 5 shows ventilation processes 19 in a fluid supply rate and fluid discharge rate/time diagram.
The time 29 is plotted on the horizontal axis, the fluid supply rate 30 (top, i.e. positive value) and fluid 21 discharge rate 31 (bottom, i.e. negative value) on the vertical axis.
The fluid supply rate 30 and the 22 fluid discharge rate 31 are each constant and never zero. The fluid supply rate 30 and fluid 23 discharge rate 31 can be set manually by the user on the ventilation device 1 or can be automatically 24 regulated by the control logic unit of the ventilation device 1 or of the control device 6, wherein the pressure 13 is monitored. Alternatively, the pressure 13 (in the airway 5), as shown in Fig. 3, can be 26 set e.g. by the user and monitored e.g. by the control logic unit, such that, at the ventilation 27 frequency F 23 and/or the intended duration or time ratio of inhalation 20 and exhalation 21, the 28 desired fluid supply rate 30 and fluid discharge rate 31 result from the set pressure 13.
In particular, the fluid supply rate 30 and fluid discharge rate 31 can be set via gas flow reversing 31 elements already known from WO 2008/113752 Al and WO 2015/004229 Al as ventilation devices 32 1 which can be operated mechanically or manually.
34 Fig. 6 shows ventilation processes 19 in a further pressure/time diagram. The time 29 is plotted on the horizontal axis, the pressure 13 on the vertical axis. The ventilation takes place in a pressure 36 interval 16 with the position 15 between the pressures P117 and P2 18.
The pressure rise 25, that is 23454228.1 CA Application Blakes Ref: 15785/00001 1 to say delta p/delta t during the inhalation 20 is monitored and controlled. Moreover, the pressure 2 drop 26, that is to say delta p/delta t, during the exhalation 21 is monitored and controlled. It will be 3 seen here that the rise of the pressure profile is constant both during the inhalation 20 and also 4 during the exhalation 21.
6 Fig. 7 shows ventilation processes 19 in a further volume/time diagram.
The time 29 is plotted on the 7 horizontal axis, the volume 12 on the vertical axis. The volume supplied to the airway 5 in the 8 pressure interval 16 is designated as tidal volume VT 22. The profile of the curve in the volume/time 9 diagram follows the profile of the pressure (see Fig. 6). It will also be seen here that the rise of the volume profile is constant both during the inhalation 20 and also during the exhalation 21.
12 It will be seen from the ventilation processes 19 in Figures 3 to 7 that there are no ventilation 13 pauses. The alternation between inhalation and exhalation takes place in each case without a 14 pause.
23454228.1 CA Application Blakes Ref: 15785/00001 2 List of reference signs 1 ventilation device 2 fluid supply unit 3 fluid discharge unit 4 fluid airway 6 control device 7 profile 8 subregion 9 compliance curve value 11 compliance C
12 volume V
13 pressure 14 pressure difference delta p position 16 pressure interval 17 pressure P1 18 pressure P2 19 ventilation process inhalation 21 exhalation 22 tidal volume VT
23 ventilation frequency F
24 pressure sensor pressure rise 26 pressure drop 27 catheter 28 cross section 29 time fluid supply rate 31 fluid discharge rate 23454228.1
Claims (24)
1. Ventilation device (1) for ventilating a patient, at least comprising a fluid supply unit (2) or, additionally, a fluid discharge unit (3), which is suitable for supplying a fluid (4) into at least one airway (5), that is to say into a lung part or into the lung, of a patient or for discharging the fluid (4) from this airway (5); and a control device (6) which, during a ventilation of the at least one airway (5), that is to say during the supply of the fluid (4) into the at least one airway (5) and/or the discharge of the fluid (4) from the at least one airway (5) by operation of the ventilation device (1), is suitable for determining or in addition for estimating a profile (7) of at least one subregion (8) of a compliance curve (9) of the at least one airway (5) by the supply and/or discharge of the fluid (4) from the at least one airway (5) and by determination of at least one value (10) of the compliance (11); wherein the following applies for the compliance C (11):
C = V / delta p [milliliter/millibar];
wherein the compliance (11) indicates how much fluid (4), that is to say a volume V (12) [milliliter], is introduced into the at least one airway (5) or is removed from the airway (5), such that a pressure (13) in the airway (5) changes by a pressure difference delta p (14) [millibar]; wherein the control device (6), taking into account the determined or additionally estimated profile (7) of the at least one subregion (8) of the compliance curve (9), determines a position (15) of a pressure interval (16) with the pressures P1 (17) and P2 (18) and sets the ventilation device (1) such that at least one ventilation process (19), that is to say an inhalation (20) and/or an exhalation (21), takes place between these pressures P1 (17) and P2 (18) and an absolute value of the compliance (11) of this ventilation process (19) is as high as possible.
C = V / delta p [milliliter/millibar];
wherein the compliance (11) indicates how much fluid (4), that is to say a volume V (12) [milliliter], is introduced into the at least one airway (5) or is removed from the airway (5), such that a pressure (13) in the airway (5) changes by a pressure difference delta p (14) [millibar]; wherein the control device (6), taking into account the determined or additionally estimated profile (7) of the at least one subregion (8) of the compliance curve (9), determines a position (15) of a pressure interval (16) with the pressures P1 (17) and P2 (18) and sets the ventilation device (1) such that at least one ventilation process (19), that is to say an inhalation (20) and/or an exhalation (21), takes place between these pressures P1 (17) and P2 (18) and an absolute value of the compliance (11) of this ventilation process (19) is as high as possible.
2. Ventilation device (1) as claimed in claim 1, wherein the control device (6), at least during an inhalation (20) or an exhalation (21) of a ventilation process (19), determines a plurality of values (10) for the compliance (11) and from these determines, for at least one subsequent ventilation process (19), the position (15) of the pressure interval (16) with the pressures P1 (17) and P2 (18), for which an absolute value of the compliance (11) is as high as possible.
3. Ventilation device (1) as claimed in one of the preceding claims, wherein the control device (6) continuously determines values (10) for the compliance (11), such that the position (15) of the pressure interval (16) with the pressures P1 (17) and P2 (18) can be newly determined optionally for each subsequent ventilation process (19) or for a plurality of successive ventilation processes (19).
4. Ventilation device (1) as claimed in one of the preceding claims, wherein the control device (6), as a function of the determined position (15) of the pressure interval (16), of the pressure interval (16) itself and of the determined compliance (11), determines at least for the subsequent ventilation process (19) at least one of the following parameters:
- a tidal volume V T (22) [milliliter], - a pressure P1 (17) and a pressure P2 (18) [millibar], - a ventilation frequency F (23) [I/second].
- a tidal volume V T (22) [milliliter], - a pressure P1 (17) and a pressure P2 (18) [millibar], - a ventilation frequency F (23) [I/second].
5. Ventilation device (1) as claimed in one of the preceding claims, wherein a pressure sensor (24) can be arranged inside the at least one airway (5), and the pressure (13) can be determined by a measurement inside the at least one airway (5).
6. Ventilation device (1) as claimed in one of the preceding claims, wherein at least one pressure rise (25), that is to say delta p/delta t [millibar/ second], during an inhalation (20) can be controlled and limited by the ventilation device (1).
7. Ventilation device (1) as claimed in one of the preceding claims, wherein at least one pressure drop (26), that is to say delta p/delta t [millibar/ second], during an exhalation (21) can be controlled and limited by the ventilation device (1).
8. Ventilation device (1) as claimed in claim 6 or 7, wherein the absolute value of the pressure rise (25) or pressure drop (26) can be limited to at most 40 mbar/s [millibar/second].
9. Ventilation device (1) for ventilating a patient, at least comprising a fluid supply unit (2) or, additionally, a fluid discharge unit (3), which is suitable for supplying a fluid (4) into at least one airway (5), that is to say into a lung part or into the lung, of a patient or for discharging the fluid (4) from this airway (5); and a control device (6) which, during a ventilation of the at least one airway (5), that is to say during the supply of the fluid (4) into the at least one airway (5) and/or the discharge of the fluid (4) from the at least one airway (5) by operation of the ventilation device (1), is suitable for regulating the ventilation;
wherein the control device (6) regulates at least one ventilation process (19) such that a pressure (13) in the at least one airway (5) is continuously changed at least during an entire inhalation (20) or at least during an entire exhalation (21), by continuous control of a fluid supply rate (30) or of a fluid discharge rate (31) during the ventilation process (19).
wherein the control device (6) regulates at least one ventilation process (19) such that a pressure (13) in the at least one airway (5) is continuously changed at least during an entire inhalation (20) or at least during an entire exhalation (21), by continuous control of a fluid supply rate (30) or of a fluid discharge rate (31) during the ventilation process (19).
10. Ventilation device (1) as claimed in claim 9, wherein the control device (6) regulates at least one ventilation process (19) such that there is a substantially constant fluid supply rate (30) [milliliter/second] at least during an entire inhalation (20) or there is a substantially constant fluid discharge rate (31) [milliliter/second] at least during an entire exhalation (21).
11. Ventilation device (1) as claimed in either of claims 9 and 10, wherein the control device (6) regulates at least one ventilation process (19), which comprises at least one inhalation (20) and one exhalation (21), such that a pressure (13) in the at least one airway (5) is changed continuously during the ventilation process (19).
12. Ventilation device (1) as claimed in claim 11, wherein a continuous change of the pressure (13) entails that the pressure (13) remains constant for at most 0.5 s [seconds].
13. Method for operating a ventilation device (1), which is provided for ventilating a patient, said method comprising at least the following steps:
a) supplying a fluid (4) into at least one airway (5), that is to say a lung part or the lung, of the patient and/or discharging the fluid (4) from this airway (5) by operation of the ventilation device (1);
b) determining or additionally estimating a profile (7) of at least one subregion (8) of a compliance curve (9) of the at least one airway (5) by the supply and/or discharge of the fluid (4) in step a) and determination of at least one value (10) of the compliance (11), wherein the following applies for the compliance (11):
C = V / delta p [milliliter/millibar];
wherein the compliance (11) indicates how much fluid (4), that is to say a volume V (12) [milliliter], is introduced into the at least one airway (5) or is removed from the airway (5), such that a pressure (13) in the airway (5) changes by a pressure difference delta p (14) [millibar];
c) determining a position (15) of a pressure interval (16) with the pressures P1 (17) and P2 (18) along the profile (7) of the at least one subregion (8) of the compliance curve (9) determined or additionally estimated in step b), wherein an absolute value of the compliance (11) is as high as possible for a ventilation process (19) performed in this pressure interval (16), i.e. an inhalation (20) and/or an exhalation (21);
d) supplying and/or discharging the fluid (4) within the pressure interval (16) determined in step c), in at least one ventilation process (19) following on from step c).
a) supplying a fluid (4) into at least one airway (5), that is to say a lung part or the lung, of the patient and/or discharging the fluid (4) from this airway (5) by operation of the ventilation device (1);
b) determining or additionally estimating a profile (7) of at least one subregion (8) of a compliance curve (9) of the at least one airway (5) by the supply and/or discharge of the fluid (4) in step a) and determination of at least one value (10) of the compliance (11), wherein the following applies for the compliance (11):
C = V / delta p [milliliter/millibar];
wherein the compliance (11) indicates how much fluid (4), that is to say a volume V (12) [milliliter], is introduced into the at least one airway (5) or is removed from the airway (5), such that a pressure (13) in the airway (5) changes by a pressure difference delta p (14) [millibar];
c) determining a position (15) of a pressure interval (16) with the pressures P1 (17) and P2 (18) along the profile (7) of the at least one subregion (8) of the compliance curve (9) determined or additionally estimated in step b), wherein an absolute value of the compliance (11) is as high as possible for a ventilation process (19) performed in this pressure interval (16), i.e. an inhalation (20) and/or an exhalation (21);
d) supplying and/or discharging the fluid (4) within the pressure interval (16) determined in step c), in at least one ventilation process (19) following on from step c).
14. Method as claimed in claim 13, wherein in step b) a plurality of values (10) for the compliance (11) are determined at least during an inhalation (20) or an exhalation (21) of a ventilation process (19), such that in step c) it is possible to determine, for at least one subsequent ventilation process (19), the position (15) of the pressure interval (16) with the pressures P1 (17) and P2 (18) for which an absolute value of the compliance (11) is as high as possible.
15. Method as claimed in either of claims 13 and 14, wherein the steps b), c) and d) are carried out continuously, such that the position (15) of the pressure interval (16) with the pressures P1 (17) and P2 (18) is newly determined optionally for each subsequent ventilation process (19) or for a plurality of successive ventilation processes (19).
16. Method as claimed in one of claims 13 through 15, wherein, as a function of the position (15) of the pressure interval (16) determined in step c), of the pressure interval (16) itself and of the determined compliance (11), at least one of the following parameters is determined at least for the subsequent ventilation process (19):
- a tidal volume V T (22) [milliliter], - a pressure P1 (17) and a pressure P2 (18) [millibar], - a ventilation frequency F (23) [l/second].
- a tidal volume V T (22) [milliliter], - a pressure P1 (17) and a pressure P2 (18) [millibar], - a ventilation frequency F (23) [l/second].
17. Method as claimed in one of claims 13 through 16, wherein the pressure (13) is determined by a measurement inside the at least one airway (5).
18. Method as claimed in one of claims 13 through 17, wherein at least one pressure rise (25), that is to say delta p/delta t [millibar/second], during an inhalation (20) is controlled and limited.
19. Method as claimed in one of claims 13 through 18, wherein at least one pressure drop (26), that is to say delta p/delta t [millibar/second], during an exhalation (21) is controlled and limited.
20. Method as claimed in either of claims 18 and 19, wherein the absolute value of the pressure rise (25) or pressure drop (26) is limited to at most 40 mbar/s [millibar/second].
21. Method as claimed in one of claims 13 through 20, wherein the patient is ventilated using a catheter (27) which has a cross section (28) of at most 30 mm2 [square millimeters] for the passage of at least one fluid (4) supplied during the inhalation (20).
22. Method for operating a ventilation device (1), which is provided for ventilating a patient, said method comprising at least the following steps:
a) supplying a fluid (4) into at least one airway (5), that is to say a lung part or the lung, of the patient and/or discharging the fluid (4) from this airway (5) by operation of the ventilation device (1);
b) continuously changing a pressure (13) in the at least one airway (5) by continuously controlling a fluid supply rate (30) and a fluid discharge rate (31) during the ventilation processes (19).
a) supplying a fluid (4) into at least one airway (5), that is to say a lung part or the lung, of the patient and/or discharging the fluid (4) from this airway (5) by operation of the ventilation device (1);
b) continuously changing a pressure (13) in the at least one airway (5) by continuously controlling a fluid supply rate (30) and a fluid discharge rate (31) during the ventilation processes (19).
23. Method as claimed in claim 22, wherein the continuous change of the pressure (13) entails that the pressure (13) remains constant for at most 0.5 s [seconds].
24. Method as claimed in either of claims 22 and 23, wherein there is a substantially constant fluid supply rate (30) [milliliter/second] at least during an entire inhalation (20) or there is a substantially constant fluid discharge rate (31) [milliliter/second] at least during an entire exhalation (21).
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| DE102016103678 | 2016-03-01 | ||
| DE102016109528.1A DE102016109528A1 (en) | 2016-03-01 | 2016-05-24 | Method and device for ventilating a patient |
| DE102016109528.1 | 2016-05-24 | ||
| PCT/EP2017/052001 WO2017148639A1 (en) | 2016-03-01 | 2017-01-31 | Method and device for ventilating a patient |
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| CA3016247A1 true CA3016247A1 (en) | 2017-09-08 |
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| US (1) | US20190022342A1 (en) |
| EP (1) | EP3423136B1 (en) |
| JP (1) | JP2019506976A (en) |
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| BR (1) | BR112018067480A2 (en) |
| CA (1) | CA3016247A1 (en) |
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| ES (1) | ES2895408T3 (en) |
| RU (1) | RU2745966C2 (en) |
| WO (1) | WO2017148639A1 (en) |
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| CN109011066A (en) * | 2018-08-29 | 2018-12-18 | 宋兴荣 | A kind of ventilator schema control system |
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| DE102016012824A1 (en) * | 2016-10-25 | 2018-04-26 | Drägerwerk AG & Co. KGaA | Method and apparatus for adaptively controlling positive end-expiratory pressure (PEEP) |
| DE102017101645A1 (en) | 2017-01-27 | 2018-08-02 | Ventinova Technologies B.V. | Apparatus and methods for ventilating a patient |
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| CN109011066B (en) * | 2018-08-29 | 2019-07-02 | 宋兴荣 | A kind of ventilator schema control system |
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