Process for operating a ventilator and ventilator operating according to the process
11679216 · 2023-06-20
Assignee
Inventors
Cpc classification
A61B5/091
HUMAN NECESSITIES
A61M16/0003
HUMAN NECESSITIES
A61M16/0009
HUMAN NECESSITIES
G16H20/40
PHYSICS
A61M2016/0036
HUMAN NECESSITIES
A61M16/20
HUMAN NECESSITIES
A61M2230/005
HUMAN NECESSITIES
A61M16/024
HUMAN NECESSITIES
A61M2230/005
HUMAN NECESSITIES
International classification
A61M16/00
HUMAN NECESSITIES
A61B5/091
HUMAN NECESSITIES
Abstract
A process for operating a ventilator (12) and a ventilator (12) operating according to the process are provided. A pressure target value (p.sub.z) is determined during a phase of exhalation (48) as a function of a compliance (C) determined in relation to the lungs (14) of a patient being ventilated by means of the ventilator (12).
Claims
1. A process for operating a ventilator, the process comprising the steps of: ventilating a patient with the ventilator; determining a compliance in relation to the lungs of a patient being ventilated with the ventilator via a control unit based on input from a sensor system; and determining a pressure target value during a phase of exhalation as a function of the determined compliance via the control unit.
2. A process in accordance with claim 1, wherein the compliance is determined based on measured values recorded during operation of the ventilator by means of a sensor system arranged at a spaced location from the ventilator and close to the patient.
3. A process in accordance with claim 1, wherein the pressure target value is increased or reduced stepwise during a phase of exhalation when the determined compliance is outside a predefined or predefinable range of compliance values.
4. A process in accordance with claim 1, wherein the pressure target value is reduced at least at times to below an ambient pressure prevailing in an area of the ventilator.
5. A process according to claim 1, wherein a control program comprising program code executes, by means of the control unit of the ventilator, the steps of determining a compliance and determining a pressure target value.
6. A ventilator comprising: a ventilator module comprising a breathing gas delivery unit, an inhalation branch connection and an exhalation branch connection; a sensor system; and a control unit configured to: determine a compliance in relation to the lungs of a patient being ventilated with the ventilator based on input from the sensor system; and determine a pressure target value during a phase of exhalation as a function of the determined compliance.
7. A ventilator in accordance with claim 6, further comprising a patient module, which can be placed close to the patient, the patient module being signal connected to the ventilator module for the purpose of signal transmission and fluid connected to the ventilator module for admitting inhalation gas to detect an inhalation pressure, the patient module comprising sensors and being configured to determine measured values for determining the compliance of the lungs of the patient being ventilated by means of the ventilator.
8. A ventilator in accordance with claim 6, further comprising an exhalation valve, which is arranged close to the patient and can be actuated to obtain the pressure target value during a phase of exhalation.
9. A ventilator in accordance with claim 6, wherein: the ventilator module further comprises a vacuum port and a vacuum port valve associated with the vacuum port; and the vacuum port valve can be actuated to obtain the pressure target value during a phase of exhalation.
10. A ventilator in accordance with claim 6, wherein the control unit control unit comprises a processing unit and a memory, and wherein a control program is loaded into the memory to determine the compliance and to determine the pressure target value.
11. A patient module of a ventilator comprising a ventilator comprising a breathing gas delivery unit, an inhalation branch connection and an exhalation branch connection, a sensor system; and a control unit configured to determine a compliance in relation to the lungs of a patient being ventilated with the ventilator based on input from the sensor system and to determine a pressure target value during a phase of exhalation as a function of the determined compliance, the patient module comprising: signal connections to the ventilator module for the purpose of signal transmission; fluid connections to the ventilator module for admitting inhalation gas to detect an inhalation pressure; and sensors configured to determine measured values for determining a compliance of lungs of the patient being ventilated by means of the ventilator, the determined compliance being provided as output for determining the pressure target value during the phase of exhalation.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) In the drawings:
(2)
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DESCRIPTION OF PREFERRED EMBODIMENTS
(10) Referring to the drawings, in a highly simplified form, the view in
(11) The view in
(12) The view in
(13) The view in
(14) The first pressure curve 40 is the curve showing a pressure (p.sub.v) measured at the ventilator 12 over time. The first pressure curve 40 is obtained on the basis of a control or regulation of the ventilator 12, which control or regulation is known per se. The first pressure curve 40 fluctuates, as intended, between a respective predefined or predefinable PEEP (positive end-expiratory pressure) and a set point (p.sub.s) for the pressure during the phase of inhalation 46.
(15) The second pressure curve 42 results from the first pressure curve 40 and is the curve showing an alveolar pressure (p.sub.m) measured as close to the patient as possible over time. For distinction, the first pressure curve 40 is called the device-side pressure curve 40 and the second pressure curve 42 is called the alveolar pressure curve or lung-side pressure curve 42. The area between the alveolar pressure curve 42 and the device-side pressure curve 40 is proportional to a product of the flow resistance R (flow resistance of the ventilation tube 18 and the tube 16) by the respective volume flow dV/dt: Δp=R*dV/dt.
(16) The view in
(17) An adapted alveolar pressure curve 52 as well as an adapted volume flow curve 54 result from the adapted device-side pressure curve 50. The alveolar pressure curve 52 remains above the PEEP during the entire exhalation 48 despite the device-side vacuum 56 at the beginning of the phase of exhalation 48.
(18) As can be seen, the adapted alveolar pressure curve 52 essentially corresponds to the device-side pressure curve 40 according to
(19) It is consequently possible to compensate the flow resistance R by calculation by increasing (or excessively increasing) the pressure generated or made available by means of the ventilator 12 on the device side in the manner shown in
(20) The peculiarity of the solution being proposed here is that the alveolar pressure curve 52 corresponds or essentially corresponds to the values predefined on the device side not only during the phase of inhalation 46, but this was also achieved for the phase of exhalation 48. The ventilator 12 is controlled or regulated during ventilator operation in a manner that guarantees the described adapted device-side pressure curve 50. Instead of the set point p.sub.s, a pressure target value p.sub.z (p.sub.z=p.sub.s+R*dV/dt) formed with the set point p.sub.s is used for this during a phase of inhalation 46, and a pressure target value p.sub.z (p.sub.z=PEEP−R*dV/dt) is used instead of the PEEP during a phase of exhalation 48. This corresponds basically to a variable change in the set point p.sub.s during a phase of inhalation 46 as well as to a variable change in PEEP during a phase of exhalation 48, since the term R*dV/dt is time-dependent based on the volume flow flowing in. Depending on the value resulting for the term R*dV/dt, the pressure target value p.sub.z (p.sub.z=PEEP−R*dV/dt) may also become negative for the phase of exhalation 48, so that a pressure target value p.sub.z below the ambient pressure (p.sub.z<atm) will be obtained. To generate a device-side pressure with a negative pressure target value p.sub.z, the ventilator 12 has a vacuum port 28 (
(21) Depending on the pressure target value p.sub.z determined during the exhalation, the ventilator 12 makes available a vacuum relative to the alveolar pressure as needed and at least temporarily by means of a control or regulation. This may be brought about by means of an exhalation valve opening to the ambient pressure, as this is described in DE 10 2016 012 824.0 (corresponding to U.S. 2018110957 (A1), which is incorporated by reference in its entirety), which will be mentioned below with additional details. As an alternative or in addition, this may be brought about by means of a control or regulation of the vacuum port 28. The ventilator 12 optionally makes available a vacuum in relation to the ambient pressure (vacuum range 56) by means of the vacuum port 28. In any case, an increased pressure difference (between the device-side pressure and the alveolar pressure) may be used for the exhalation 48 as a drive for the volume flow from the patient's lungs 14. It should be noted that the range of the expiratory reserve volume V5 is not reached or at least it is not reached in an uncontrolled manner. The inspiratory capacity V6 of the patient's lungs 14 is otherwise undershot, so that the risk of collapse of individual regions of the lungs does, in principle, increase. To eliminate this risk, the so-called compliance of the lungs 14, i.e., the elasticity of the lungs, is determined and monitored during the phase of exhalation.
(22)
(23) For the operation of the ventilator 12, this means that a vacuum can be applied on the device side during the phase of exhalation 48, especially at the beginning of the phase of exhalation 48, as long as the expansion of the patient's lungs 14 does not become too low. The expansion of the patient's lungs 14 may also become lower in this case—at least briefly—than in the relaxed state.
(24) Excessively minimal expansion of the patient's lungs 14 is ruled out whenever the product of the particular measured (sensor system 26) volume flow by the flow resistance R determined based on measurements (sensor system 26) is greater than the vacuum applied on the device side. A higher vacuum may be applied on the device side only if it is ensured by frequent measurements of the compliance C and of the corresponding volume that the expiratory reserve volume V5 is not reached.
(25) The measurement of the compliance C may be carried out, for example, according to the principle described in the older German patent application not published previously referenced (DE 10 2016 012 824.0) entitled “Process and Device for the Adaptive Regulation of a Positive End-expiratory Pressure (PEEP),” and corresponding U.S. 2018110957 (A1) whose contents shall be considered to have been fully included in the description being presented here, also for the purpose of including features from U.S. 2018110957 (A1) in claims for defining the invention underlying the description being presented here.
(26) According to DE 10 2016 012 824.0 and corresponding U.S. 2018110957 (A1), the pressure present on the device side (
(27) According to the principle being disclosed here, the determined compliance C is a certain factor for a controlled application of an adapted pressure target value p.sub.z (p.sub.z=PEEP−X; X=R.sub.exp*dV/dt) during the phase of exhalation 48. Provisions are made for this for the term X, which lowers the pressure target value p.sub.z possibly to below the PEEP and possibly even to below the ambient pressure, to depend on the particular determined compliance C of the patient's lungs: X=f(C).
(28) It is considered for this, for example, that the value of the term X is obtained according to the contents of a lookup table 70, as this is shown in a schematically simplified manner in the view shown in
(29) Accordingly, values for a “good” compliance C are filed, for example, in such a lookup table 70 (C.sub.g1, C.sub.g2, . . . , C.sub.gn), and the lookup table 70 shows the term R.sub.exp*dV/dt for each corresponding compliance value in case of a “good” compliance C. In case of a “poor” compliance, i.e., at compliance values outside the “good” range, for example, the last value used for X is reduced, and the “poorer” the compliance value is, i.e., the farther the compliance value is from the edge of the “good” range, the more greatly is it optionally reduced. This is shown in the view in
(30) TABLE-US-00001 X = R.sub.exp * dV/dt | C.sub.gl < C < C.sub.gn X = n [R.sub.exp * dV/dt] | C > C.sub.gn; n = 1 X = [R.sub.exp * dV/dt]/n | C < C.sub.gl; n = 1, 2, 3, 4 . . .
It was formulated above that a vacuum exceeding the product of the measured volume flow by the resistance R (exhalation resistance R.sub.exp) may only be applied on the device side if it is ensured by frequent measurement of the compliance C and of the corresponding volume that the expiratory reserve volume V5 is not reached. It is even possible theoretically to utilize a part of the expiratory reserve volume V5. This requires a continuous (slight) vacuum relative to the ambient pressure during the terminal phase of the exhalation 48.
(31) Finally, the view in
(32) An inhalation pressure p.sub.insp, which is especially constant and is predefined or can be predefined by the user, is made available by the ventilator 12 for the ventilation of the patient for the inhalation, and an exhalation pressure p.sub.exsp, which is especially constant and is likewise predefined or can be predefined by the user, is made available for the exhalation. The inhalation pressure p.sub.insp is above the ambient pressure (atm), and a volume flow into the patient's lungs 14 (“pushing”) results from the inhalation pressure p.sub.insp. A volume flow out of the patient's lungs 14 (“suction”) results from the exhalation pressure p.sub.exsp.
(33) Either an exhalation valve (not shown here; see DE 10 2016 012 824.0 and FIG. 1 in that document) is provided at the patient module 10 for this suctioning operation, or the ventilator 12 comprises the vacuum port 28 on the exhalation branch 22 or in a continuation of the exhalation branch 22. Such an exhalation valve opens to the ambient pressure (atm) and thus ensures the pressure difference necessary for the exhalation between the alveolar pressure, which is high following the preceding inhalation, and the ambient pressure. In case of a vacuum port 28, the exhalation valve is located in the exhalation branch 22, especially within the patient module 10 in the exhalation branch 22. To obtain the desired pressure target value p.sub.z, the exhalation valve is actuated with a control signal intended for influencing the position of the exhalation valve.
(34) The exhalation valve is actuated on the basis of at least one signal 82 from the sensor system 26. The at least one signal 82 may be a measured value (for example, a measured value for the volume flow) recorded by means of the patient module 10 or a plurality of measured values. The processing of the signal 82 may take place in the patient module 10 or in the ventilator 12. For processing in the ventilator 12, the signal 82 is transmitted to the ventilator and to a control unit 84 located there in a wired or wireless manner in a manner known, in principle, per se. The control unit 84 assumes the processing of the at least one signal 82 and determines, for example, the compliance C, the exhalation resistance R.sub.exp, the pressure target value p.sub.z as well as a control signal for the exhalation valve. The control unit 84 comprises a processing unit in the form of a microprocessor, or one or more processors or the like as well as a memory, into which a computer program executable by means of the processing unit and which acts as a control program 86 is loaded. A control signal determined by a control unit 84 in the ventilator 12 for the exhalation valve and/or the pressure target value is transmitted by the control unit 84 to the patient module 10 and it is active there for the actuation of the exhalation valve. As an alternative, the processing of the at least one signal 82 may also be carried out by means of the patient module 10 itself. The patient module 10 now comprises a control unit 84, as it is shown in the view shown in
(35) The patient module 10 may be configured, in principle, in the manner as described in US 20130167843 (which is incorporated by reference in its entirety).
(36) The control program 86 comprises an implementation of the steps explained above for determining the pressure target value p.sub.z in software, and the execution of the control program 86 during the operation of the ventilator 12 accordingly brings about the compliance-dependent determination of the pressure target value p.sub.z and further the automatic, compliance-dependent setting of the pressure target value p.sub.z.
(37) Individual aspects of the description being submitted here, which are in the foreground, can be summarized as follows: Proposed is a process for operating a ventilator 12 and a ventilator 12 operating according to the process, in which a pressure target value p.sub.z is determined during a phase of exhalation 48 as a function of a compliance C determined in relation to the lungs 14 of a patient being ventilated by means of the ventilator 12.
(38) While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.
APPENDIX
List of Reference Designations
(39) 10 Patient module 12 Ventilator 14 Lungs, patient's lungs 16 Tube, endotracheal tube 18 Ventilation tube 20 Inhalation branch 22 Exhalation branch 24 Y-piece 26 Sensor system 28 Vacuum port 30 Volume curve, device-side pressure curve 40 First pressure curve, device-side pressure curve 42 Second pressure curve, alveolar pressure curve 44 Volume flow curve 46 Phase of inhalation 48 Phase of exhalation 50 Adapted device-side pressure curve 52 Adapted alveolar pressure curve 54 Adapted volume flow curve 56 Vacuum range 70 Lookup table 80 Vacuum port valve 82 Signal 84 Control unit 86 Control program 88 Control signal V1 Total capacity of the lungs V2 Vital capacity of the lungs V3 Tidal volume V4 Inspiratory reserve volume of the lungs V5 Expiratory reserve volume of the lungs V6 Inspiratory capacity of the lungs