Patent Application
20240118160
This application claims the benefit of priority under 35 U.S.C. § 119 of German Application 10 2022 125 601.4, filed Oct. 5, 2022, the entire contents of which are incorporated herein by reference.
The present invention pertains to a device and a process which are capable of automatically detecting a leak, in particular an abrupt leak, during artificial ventilation of a patient. During artificial ventilation, a gas sample is branched off from a patient fluid guide unit and directed to a sensor arrangement, i.e. an arrangement which analyzes the gas sample. The leak can falsify (distort) measurements of the sensor arrangement.
It is an object of the invention to provide a monitoring process for monitoring a measurement system wherein the measurement system is capable of examining a gas sample from a ventilation arrangement for the artificial ventilation of a patient and the wherein the monitoring process is capable of automatically detecting a leakage relatively reliably. Furthermore, the invention is based on the object of providing a measurement system that is capable of examining a gas sample and automatically detecting a leak with relative reliability.
The object is attained by a monitoring process with monitoring process features according to the invention and by a measurement system with measurement system features according to the invention. Advantageous embodiments of the monitoring process according to the invention are, as far as useful, also advantageous embodiments of the measurement system according to the invention and vice versa.
The measurement system according to the invention is configured to be used during artificial ventilation of a patient. The patient is connected to a patient-side coupling unit or can be connected to a patient-side coupling unit at least temporarily. A breathing mask, tube, and catheter are examples of a patient-side coupling unit. At least temporarily during such artificial ventilation, a fluid connection is established between the patient-side coupling unit and a medical device. Preferably, the medical device is or comprises a ventilator that generates a gas mixture for artificial ventilation and delivers it through the fluid connection to the patient-side coupling unit. The medical device can also comprise a hand respiratory bag. The gas mixture contains oxygen and optionally at least one anesthetic. The fluid connection is established with the aid of a patient fluid guide unit.
The monitoring process according to the invention can be used to monitor such a measurement system. The monitoring process is performed while the fluid connection between the patient-side coupling unit and the medical device is established. The measurement system according to the invention is able to monitor itself for a leak.
The measurement system according to the invention comprises a sensor arrangement and a sensor fluid guide unit, the sensor fluid guide unit being at least temporarily in fluid connection with the patient fluid guide unit and with the sensor arrangement. The sensor arrangement comprises a thermal conductivity sensor and a signal processing unit.
The monitoring process according to the invention comprises the following automatically executed steps, and the measurement system according to the invention is configured to automatically perform the following steps:
A “fluid guide unit” is understood to be a component that guides (conducts, directs) a fluid along a trajectory, where this trajectory is predetermined by the geometry, configuration, and arrangement of the component. A corrugated hose, a smooth hose, and a tube are examples of a fluid guide unit. The fluid guide unit does not necessarily include a conveying unit (pump/blower).
In many cases, reliable artificial ventilation of the patient requires that the time course of the concentration of at least one component of the gas mixture flowing through the patient fluid guide unit be measured with sufficient accuracy. In particular, the concentration is the fraction in vol-%. For example, the actual concentration time course is to follow a predetermined required concentration time course. The medical device is controlled accordingly, for which control the actual concentration time course must be measured reliably. The sensor arrangement is configured to measure an indicator of the actual concentration of the component. It is possible that the sensor arrangement is capable of measuring an indicator for the respective actual concentration of at least two components of the gas sample in each case.
According to the invention, a gas sample is branched off from the patient fluid guide unit, guided to the sensor assembly, and examined by the sensor arrangement. The volume of the gas sample that is diverted and examined is generally small compared to the volume of the fluid that is in the patient fluid guide unit at any one time. Therefore, the monitoring process according to the invention and the measurement system according to the invention generally do not have a relevant influence on artificial ventilation of the patient. Preferably, the branched off gas sample is passed through the sensor arrangement and then fed back into the patient fluid guide unit.
A leak can falsify a measurement result of the sensor arrangement. Due to the negative pressure relative to the environment, ambient air can flow (penetrate) through this leak and reach the sensor arrangement, so that the sensor arrangement does not analyze the gas mixture from the patient fluid guide unit, but a generally unknown composition of this gas mixture and the ambient air. This can lead to an incorrect measurement result and therefore to incorrect artificial ventilation. In particular, a too low concentration of oxygen can be measured if the gas mixture has a higher oxygen concentration than the ambient air. It is therefore important to reliably and quickly detect an indication of a leak. If such an indication is detected, the measurement system can be checked more precisely automatically and/or manually, and the leak can then be eliminated—or it can be ruled out that a leak has actually occurred.
According to the invention, the thermal conductivity time course, i.e. the course of the thermal conductivity of the gas sample over time, is determined. For this determination, the thermal conductivity at a measuring position in the sensor arrangement or upstream from the sensor arrangement and downstream from a possible leak to be detected is used. The decision as to whether or not there is an indication of a leak is made as a function of the temporal change (derivative with respect to time) in the thermal conductivity.
It is possible to make the decision about the presence of a leak additionally depending on the measured time course of the concentration of a component in the branched off gas sample and/or the measured pressure course of the gas sample. According to the invention, the thermal conductivity time course is used in addition to or instead of a time course of the concentration of a component of the gas sample and/or the pressure of the gas sample. This feature has the following advantage: As a rule, a gas mixture with different components is guided through the patient fluid guide unit. Some of these components, in particular oxygen and carbon dioxide, also occur in the ambient air and therefore also in the environment of the patient fluid guide unit and in the environment of the measurement system. It is possible that the concentration of a component of the gas mixture in the patient fluid guide unit differs only slightly from the concentration of that component in the environment. For example, lung-protective artificial ventilation is sometimes used in which the concentration of oxygen in the supplied gas mixture is only relatively slightly above the concentration of oxygen in the air. Therefore, a leak changes the concentration of oxygen in the sensor fluid guide unit and in the sensor arrangement relatively little compared to a condition without a leak. In this case, the concentration of oxygen in the gas sample alone is not a sufficiently reliable indicator to detect a leak. In many cases, a relatively small leak also does not have a strong effect on the pressure in the patient fluid guide unit. In this case, the pressure alone is also not a reliable indicator. If detection of a leak were to rely solely on measuring the concentration of at least one gas sample component that is also present in the ambient air and/or on the pressure, there is a greater risk than with the monitoring process and with the measurement system of the invention that a leak would not be detected.
Another advantage of the invention is the following: If the detection of a leak would depend exclusively on the respective time course of the concentration of at least one component of the gas sample, the reliability of the detection may strongly depend on which components of the gas sample are chosen for monitoring. In this case, either such a monitoring process can only be used for certain situations. Or it may be necessary to measure in advance which components are present in the gas mixture in the patient fluid guide unit and whether their respective concentrations differ greatly from the concentration in the ambient air. The invention saves such a necessity and such a restriction.
In general, the pressure in the measurement system depends much more on the time-varying pressure prevailing in the patient fluid-carrying unit than on the pressure change due to a leak. One reason: In general ventilation strokes are performed. Therefore, in many cases, the pressure is also not a suitable indicator for reliably detecting a leak.
The gas mixture that is guided through the patient fluid guide unit generally also contains components that do not occur at all or only at a significantly lower or even higher concentration in the ambient air. In particular, nitrogen usually occurs in the ambient air at a substantially higher concentration than in the gas mixture in the patient fluid guide unit. In contrast, usually neither an anesthetic nor nitrous oxide usually occurs with a relevant concentration in the environment. The commonly used anesthetics as well as nitrous oxide have a significantly lower thermal conductivity than air. Therefore, a leak usually significantly affects the thermal conductivity of the gas sample in the sensor assembly. A temporal change in thermal conductivity is therefore usually a reliable indicator that a leak has occurred.
Even when there is no leak, the thermal conductivity of the gas mixture in the patient fluid guide unit, and thus in the branched off gas sample, usually varies over time. This is particularly true when the medical device used is a ventilator that performs a sequence of ventilation strokes, delivering a quantity of the gas mixture to the patient-side coupling unit in each ventilation stroke. Typically, the thermal conductivity oscillates as a function of these ventilation strokes. Therefore, according to the invention, a temporal change (variation) of the thermal conductivity is used rather than just an instantaneous conductivity value. This feature further increases the reliability that a leak is actually detected and reduces the risk of false alarms. In particular the reliability is increased that an oscillation of the thermal conductivity due to a leak is distinguished from an oscillation due to ventilation strokes, especially if a smoothing procedure is applied on the thermal conductivity time course. A special case of the thermal conductivity course or a sliding average is that the thermal conductivity ideally remains constant as long as no leak has occurred. The temporal change is then zero.
The thermal conductivity of the gas mixture in the patient fluid guide unit may also be altered (changed) by other events. Often, at least some of these events are deliberately induced, for example, because the medical device greatly increases or also decreases the concentration of a component of the gas mixture in the patient fluid guide unit in response to a user specification or a specification or command from a higher-level controller. For example, the concentration of oxygen is intentionally increased abruptly. Such an event can be detected or captured, for example by detecting a corresponding message from a control unit of the medical device, and taken into account when deciding whether or not there is an indication of a leak.
Both in known processes and devices for leak detection and in the monitoring process and measurement system according to the invention, a false alarm can be generated—more precisely, an indication of a leak is detected, although in reality no leak has occurred. On the one hand, it is usually important to reliably detect every leak, even if false alarms are then triggered. On the other hand, in many cases it is possible to verify whether or not a leak has actually occurred by carrying out a more detailed inspection after the indication of a leak has been detected.
As a rule, a leak to be detected causes a volume flow to occur through the leak, namely a volume flow from the environment to the sensor arrangement due to the negative pressure. In a preferred embodiment, a first indicator of a relative leak volume flow is repeatedly determined. As usual, a “volume flow” is understood to be the volume per unit time of a fluid flowing through a fluid guide unit or even through a leak. The relative leak volume flow according to the embodiment of the invention is the proportion (share) of the volume flow through the leak to the total volume flow to the sensor arrangement. The volume flow to the sensor arrangement is the sum of
As a rule, the greater the relative leak volume flow is, the greater is the first indicator. In many cases, the total volume flow to the sensor arrangement and thus this sum remain constant over time, especially if the gas sample is branched off using a pump or other fluid conveying unit with a constant flow rate. However, a leak will change the relative leak volume flow.
According to a preferred embodiment, the first indicator of relative leak volume flow is determined as a function of the thermal conductivity time course measured by the sensor arrangement. In addition, the thermal conductivity of the environment (in general of ambient air) is specified and used. The thermal conductivity of ambient air is usually known and is specified. It is also possible to measure the thermal conductivity of the environment by the following process: For a short measurement period, a fluid connection is established between the sensor fluid guide unit and the environment, thus deliberately creating a leak. In one embodiment, the fluid connection between the sensor fluid guide unit and the patient fluid guide unit is interrupted at the same time. As a result, only ambient air is drawn to the sensor arrangement during the measurement period. During the measurement period, the thermal conductivity sensor of the sensor arrangement measures the thermal conductivity of the environment, e.g. ambient air, and not that of the gas mixture in the patient fluid guide unit.
Frequently, the total volume flow to the sensor arrangement is also known, especially if a pump or other fluid conveying unit or conveying unit draws in (sucks) the gas sample and the volume flow generated by the fluid conveying unit is known or measured, especially constant over time.
The decision as to whether or not an indication of a leak has occurred is made as a function of a temporal change (derivative with respect to time) of this first indicator of the relative leak volume flow, which is based on thermal conductivity.
Using an indicator of the relative leak volume flow has the following advantage over other possible approaches to using thermal conductivity to detect an indication of a leak: If a leak has occurred, the relative leak volume flow increases. If the first indicator is set such that the larger the relative leak volume flow is, the larger is the first indicator, then a leak will cause the first indicator to increase, otherwise the first indicator will decrease. This effect applies regardless of whether the leak increases or decreases the thermal conductivity of the gas sample flowing to the sensor arrangement, compared to a condition without a leak. In other words, this effect applies regardless of whether the ambient air or other gas mixture in the vicinity of the sensing system has a larger or a smaller thermal conductivity than the branched off gas sample. Therefore, this embodiment eliminates the need to specify or measure whether a leak increases or decreases thermal conductivity.
The decision as to whether an indication of a leak has occurred is made as a function of at least a temporal change in that indicator of relative leak volume flow which depends on thermal conductivity.
Preferably, an indication of a leak is only detected if the first indicator deviates sufficiently strongly and for a sufficiently long time from a reference state. A lower time duration threshold and a lower change threshold are specified. An indication of a leak is detected if the following conditions are cumulatively fulfilled:
Preferably, the thermal conductivity sensor continuously measures the thermal conductivity of the gas sample, and the decision period is a floating period ending, for example, at the current time, preferably a period of fixed duration.
In one embodiment, the first indicator is an estimate of the relative leak volume flow, for which a predetermined calculation rule is applied. For example, the first indicator is established in advance using the following assumption: The thermal conductivity of the gas mixture reaching the sensor array is a weighted average of the thermal conductivity of the branched off gas sample and the thermal conductivity of the gas in the environment of the measurement system, usually ambient air. The weight factor by which the gas from the environment is included in the thermal conductivity of the gas mixture is the relative leak volume flow or depends on the relative leak volume flow. If there is no leak, then this weight factor is ideally zero. The thermal conductivity of the gas in the environment is specified or measured, e.g., as described earlier. According to the invention, the thermal conductivity of the gas mixture reaching the sensor arrangement is measured by the thermal conductivity sensor of the sensor arrangement. In one embodiment, the thermal conductivity of the branched off gas sample is measured at a time when it is determined that no leak has occurred, or measured in the medical device or patient fluid guide unit. Therefore, the relative leak volume flow is the only unknown in this context. The first indicator is the larger the greater the relative leak volume flow is, and is usually only an approximation for the actual relative leak volume flow.
According to the invention, the decision whether an indication of a leak has occurred is made depending on the measured thermal conductivity course of the gas sample reaching the sensor arrangement. Preferably, a first indicator of relative leak volume flow is used for this decision, the first indicator being based on thermal conductivity, for example according to the calculation procedure just mentioned. According to one embodiment, the temporal change (time variation) of the first indicator is used for the decision.
Preferably, the decision as to whether or not an indication of a leak has occurred is additionally made as a function of at least one further measurand. In a first alternative, the or at least one further measurand (measurement variable, measured variable) is the time course of the concentration of a component of the gas sample. This component is, for example, oxygen or carbon dioxide or nitrous oxide or an anesthetic (anesthetic agent). It is possible to use two different measurands, where each of the measurands is based on the time course of one component of the gas sample and each measurand relates to different components. It is also possible that the or at least one measurand is the time course of the summed concentrations of several components. In a second alternative, the further measurand is the time course of the pressure of the gas sample. These two alternatives can be combined with each other, so that the thermal conductivity and at least two further measured variables are used.
In one implementation, a second indicator of the relative leak volume flow is calculated depending on the concentration course and/or the pressure course. The decision whether an indication of a leak has occurred is made depending on a temporal change of the first indicator and a temporal change of the second indicator are used to decide.
In a first alternative, it is determined that an indication of a leak is present if both the thermal conductivity and the or at least one other measurand change, within a tolerance, at the same time and preferably lasting for at least one lower time duration threshold. With this alternative, there is less danger of triggering a false alarm. This alternative has the advantage that in some situations a changed thermal conductivity alone is not caused by a leak, but by a deliberately brought about event, for example by a deliberate change in the gas mixture provided by the medical device during artificial ventilation.
In a second alternative, it is determined that an indication of a leak exists if the thermal conductivity or the or at least one further measurand changes, but not necessarily both the thermal conductivity and the further measurand. This second alternative increases the certainty that every leak is actually detected.
A preferred embodiment of the measurement system according to the invention provides a measurement process and a sensor, which are capable of measuring both the thermal conductivity and the concentration of a component of the gas sample. The prerequisite is that the component is a paramagnetic gas and is present in the gas sample at a sufficiently large concentration. Oxygen is a paramagnetic gas that is in general contained in the gas mixture that is guided through the patient fluid guide unit to the patient-side coupling unit and the concentration of oxygen is to be measured in many cases anyway.
According to the embodiment, the following steps are performed, and the sensor arrangement is configured to perform the following steps:
Compared to an embodiment in which a first sensor is used for thermal conductivity and a second sensor is used for concentration, this embodiment saves space and components. This is because multiple elements of the sensor arrangement can be used to measure both the thermal conductivity of the gas sample and the concentration of the paramagnetic gas. If the gas sample contains at least two different paramagnetic gases, this embodiment usually measures the sum of the concentrations of both gases.
In one embodiment, the step that an indication of a leak has been detected according to the invention triggers the step that an alarm is issued in at least one form that can be perceived by a human. In a preferred embodiment, however, a verification sequence is first triggered to verify whether or not a leak has actually occurred. The alarm is issued if the verification sequence provides the result with sufficient reliability that a leak has actually occurred. The verification sequence includes the following steps, which are performed automatically:
In the verification period, the sensor arrangement cannot measure the concentration of a component of the gas mixture flowing through the patient fluid guide unit. Thanks to the invention, the verification sequence only needs to be performed when an indication of a leak has been detected. Preferably, on the other hand, the verification sequence is performed while the indication of a leak has occurred, i.e., while the sensor arrangement is measuring the concentration of at least one component.
The invention further relates to a ventilation process and a ventilation arrangement which are capable of artificially ventilating a patient. The patient is connected to a patient-side coupling unit or can at least temporarily be connected to a patient-side coupling unit. The ventilation process comprises the step of delivering (conveying) a gas mixture from a medical device through a patient fluid guide unit to the patient-side coupling unit. The gas mixture comprises oxygen and optionally anesthetic (at least one anesthetic agent). The ventilation arrangement includes a medical device, a patient fluid guide unit, and the patient-side coupling unit, and is configured to convey a gas mixture from the medical device to the patient-side coupling unit.
The ventilation process is performed using a measurement system according to the invention, and the ventilation arrangement additionally comprises a measurement system according to the invention. A monitoring process according to the invention is used to decide whether an indication of a leak has occurred between the patient fluid guide unit and the sensor arrangement of the measurement system. The ventilation arrangement is capable of making such a decision automatically.
Advantageous embodiments of the verification process according to the invention are also advantageous embodiments of the ventilation process. Advantageous configurations of the measurement system according to the invention are also advantageous configurations of the ventilation arrangement.
In the following, the invention is described by means of an embodiment example. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which preferred embodiments of the invention are illustrated.
In the drawings:
Referring to the drawings,
In the ventilation circuit 40, a gas mixture Gg is supplied to the patient P, which comprises oxygen (O2), optionally carbon dioxide (CO2), in the embodiment example at least one anesthetic agent, optionally a carrier gas for the anesthetic agent, and optionally further components. The air exhaled by the patient P preferably re-enters the ventilation circuit 40 and therefore does not enter the environment.
The invention can also be used for artificial ventilation in which a gas mixture Gg comprising oxygen is supplied to the patient P, but this gas mixture Gg does not comprise an anesthetic. The air exhaled by the patient P is therefore allowed to escape into the environment. Therefore, preferably, no ventilation circuit is implemented, but only a patient-fluid connection from the ventilator 1 to the patient P.
It is possible that artificial ventilation with or without anesthetic and patient P's own respiratory activity overlap. Patient P's own respiratory activity is brought about by the patient's respiratory musculature, namely through the patient's spontaneous breathing and optionally through external stimulation of the respiratory musculature.
A patient-side coupling unit 21, shown only schematically, for example a mouthpiece or a breathing mask or a tube, connects the patient P to the ventilation circuit 40 or to the patient-fluid connection. The patient-side coupling unit 21 is connected to a Y-piece 22. The Y-piece 22 is connected to a breathing gas line 32 for inhalation (inspiration) and to a breathing gas line 33 for exhalation (expiration).
A pump 24a draws in (sucks in) breathing gas and generates a continuous flow of breathing air through the inhalation breathing gas line 32 toward the Y-piece 22 and the patient-side coupling unit 21, and thus toward the patient P. Preferably, this pump 24a operates as a compressor that generates positive pressure and rotates at a speed in excess of 10,000 rpm. A carbon dioxide absorber (CO2 absorber) 25a is capable of absorbing carbon dioxide (CO2) from the ventilation circuit 40. A check valve (non-return valve) 23a allows gas to flow in the inspiratory breathing gas line 32 toward the Y-piece 22 and blocks gas flow in the reverse direction.
A check valve 23b allows gas flow in the exhalation breathing gas line 33 to flow away from the Y-piece 22 and blocks gas flow in the opposite direction. A controllable positive end-expiratory pressure (PEEP) valve 24b, depending on its position, allows the airflow generated by pump 24a to pass or blocks it, thereby contributing to the generation of the individual ventilatory breaths and determining the amplitudes and frequencies of these ventilatory breaths. The PEEP valve 24b also ensures that a sufficiently large air pressure is maintained in the lungs of the patient P, even at the end of the exhalation or when the ventilation circuit 40 is opened or interrupted for a short time. This reduces the risk of the patient P's lungs collapsing due to insufficient pressure.
A pressure relief valve 29 is able to relieve an overpressure in the ventilation circuit 40 by releasing breathing gas, preferably into a reforwarding line for anesthetic gas or also into the environment. This overpressure valve 29 is preferably configured as an “adjustable pressure limiting valve” and reduces the risk that the lungs of the patient P are damaged by an excessively high pressure, in particular in the case of manual ventilation by means of a breathing bag 26. The pressure threshold at which this overpressure valve 29 opens can be set manually from the outside and/or automatically by means of a control of the overpressure valve 29.
An anesthetic vaporizer 31 is capable of injecting a fluid stream 28 comprising a vaporous mixture of a carrier gas and at least one anesthetic into the ventilation circuit 40. The carrier gas preferably comprises oxygen. In addition, a fluid stream 27 of fresh air or other fresh gas can be supplied to the ventilation circuit 40.
The ventilation circuit 40 is kept running by the pump 24a and optionally by a breathing bag 26, which can be manually operated.
The pump 24a, the optional anesthetic vaporizer 31, the carbon dioxide absorber 25a, the check valves 23a and 23b as well as the valves 24b and 29 and the optional breathing bag 26 belong to a ventilator 1 shown only schematically, which can be configured as an anesthetic device. It is also possible that the ventilation circuit 40 is kept running solely with the aid of the breathing bag 26, for example on board a vehicle or in another location where no stationary power supply is available or where power supply has failed.
A signal-processing ventilation control unit (controller) 35, shown only schematically, receives measured values from a pressure sensor 58, which measures the air pressure Pamb (ambient pressure) in the environment of the ventilation circuit 40, and a signal from an optional temperature sensor 39, which measures the ambient temperature. In addition, the ventilation control unit 35 receives measured values from a pressure sensor 36 that measures the current pressure in the ventilation circuit 40, for example the ventilation pressure (pressure in airway, Paw) applied to the patient P, in one embodiment as a differential pressure relative to the ambient pressure Pamb. The ventilation control unit 35 controls the pump 24a, the anesthetic vaporizer 31, and other components of the ventilation circuit 40 in order to implement a desired artificial ventilation and optionally anesthetization of the patient P.
It is often desired that the gas mixture Gg, which is supplied to the patient P, fulfills a certain property. In particular, the concentration of a component of the gas mixture Gg should lie within a predetermined range. For example, the proportion of pure oxygen is to be in a predetermined range, for example between 40 vol-% and 50 vol-% or even between 25 vol-% and 30 vol-%. Or the proportion of anesthetic should be in a predetermined range. It is possible that this predetermined range is variable over time. In addition, the actual pressure of the gas mixture Gg should often follow a predetermined pressure time course (course over time).
In particular, for the control of the ventilator 1, it is necessary to measure the actual current concentration of carbon dioxide (CO2) and/or oxygen (O2) and/or nitrous oxide (N2O) and/or pressure Paw and optionally of injected anesthetic, namely the concentrations and pressure Paw at a measuring position close to the patient-side coupling unit 21 and thus close to the mouth and/or nose of the patient P.
For this purpose, a sample containing breathing gas (hereinafter: a gas sample Gp) is diverted (branched off) from the ventilation circuit 40 via a gas sample fluid guide unit (sensor fluid guide unit) in the form of a sampling tube (sampling hose) 52, analyzed and fed back into the ventilation circuit 40 via a discharge tube (discharge hose) 56. The sampling tube 52 begins at a branch point 34 between the patient-side coupling unit 21 and the Y-piece 22. At the branch point 34 there is optionally a valve, not shown, which in the closed position disconnects the sampling tube 52 from the ventilation circuit 40 and which can be controlled by the ventilation control unit 35. When the valve is fully open or omitted, the sampling tube 52 is in unrestricted fluid connection with the ventilation circuit 40. The discharge tube 56 leads to a confluence point 37 upstream from the carbon dioxide absorber 25a.
The sampling hose 52 conducts the gas sample Gp to a sensor arrangement 50. This sensor arrangement 50 is spatially remote from the patient-side coupling unit 21 and also belongs, for example, to the schematically shown ventilator 1. In
A sensor 54 is capable of generating signals that correlate with the respective concentration of CO2, N2O and anesthetic in the exhausted gas sample Gp. Preferably, this sensor 54 comprises an infrared sensing head that exploits the dipole moment of molecules in the gas sample Gp and quantitatively evaluates the absorption of infrared active gases to determine the respective concentration. Preferably, the sensor 54 comprises a radiation source that emits electromagnetic radiation and a detector that measures an indicator of the intensity of impinging electromagnetic radiation and generates a corresponding signal. The radiation penetrates the gas sample Gp, and a gas to be detected absorbs a portion of the radiation.
A sensor 53 is capable of generating a signal that correlates with, among other things, the concentration of O2 or other parametric component(s) of the gas sample Gp. The sensor 53 is described in more detail below.
In one embodiment, the sampling tube 52 temporarily contains breathing air delivered to the patient P and temporarily breathing air exhaled by the patient P. In one embodiment, the rule of thumb is used that the proportion of oxygen in exhaled air is 5 vol % lower than the proportion of oxygen in the inhaled air.
It is possible that the sensor arrangement 50 comprises further concentration sensors, in particular to provide redundancy. In addition, the sensor arrangement 50 comprises a pressure sensor 57 that measures the pressure Pcell of the gas sample Gp at the inlet of the sensor arrangement 50. This pressure Pcell is time varying because the pressure in the ventilation circuit 40 varies and because the sampling tube 52 is in fluid connection with the ventilation circuit 40 when there is no valve at the branch point 34 or as long as the optional valve at the branch point 34 is open. When the valve is omitted or open, the pressure in the ventilation circuit 40 propagates to the sensor arrangement 50 at approximately the speed of sound.
The sensor arrangement 50, a signal processing unit 30 described below, the pump 55, a water trap 51 described below, the sampling tube 52 and the discharge tube 56 belong to a measurement system 100, which is schematically indicated in
Referring to
Two pole shoes (pole pieces) 6, 7 and two field coils 4, 5 generate a magnetic field. An air gap 3 occurs between the two pole shoes 6, 7 which gap 3 acts as a measuring chamber 2. This measuring chamber 2 is delimited by the two pole pieces 6, 7 and a wall 9. An inlet 10 and an outlet 11 are inserted into the wall 9. The gas sample Gp flows from the inlet 10 through the measuring chamber 2 to the outlet 11.
A thermocouple 8 is attached to two support wires 15, 16 at two junctions 12 and 14, the two support wires 15, 16 passing through the lower pole shoe 7 and being in thermal contact with the lower pole shoe 7. The thermocouple 8 comprises two wires 17, 18 connected together at a junction 13. A voltage source 20 applies an AC voltage to the two support wires 15, 16 and thus to the thermocouple 8. The flowing current heats the thermocouple 8 to a working temperature which is greater than the temperature of the gas sample Gp in the measuring chamber 2. A voltage U is measured at a measuring resistor 19. This voltage U contains an alternating current component and a direct current component.
The actual working temperature of the thermocouple 8 is measured at the junction 13. This temperature depends on the one hand on the voltage U which occurs between the support wires 15, 16 and on the other hand on the thermal conductivity of the gas sample Gp in the measuring chamber 2. A closed-loop control is carried out with the control gain (control objective) that the working temperature of the thermocouple 8 takes a constant value. The controlled (manipulated) variable is the time-varying voltage U which the voltage source 20 applies to the support wires 15, 16. Because the temperature of the thermocouple 8 remains the same, an electrical detection variable of the thermocouple 8 correlates with the thermal conductivity of the gas sample Gp in measurement chamber 2. It is possible that the applied electrical voltage U is itself the detection variable.
Another implementation to measure the detection variable is as follows: The time-varying electric power supplied to the thermocouple 8 is measured as the detection variable. The two support wires 15 and 16 are electrically connected to each other by the electrical measuring resistor 19. The electrical voltage U applied to this measuring resistor 19 is measured. An indicator of the magnitude of the electric current (amperage) flowing through the thermocouple 8 is also measured. As is well known, the electrical power depends on the voltage and the current strength.
A voltage source 43 is connected to the field coil 5 via a power amplifier 42, and the field coil 4 is connected to electrical ground. The voltage source 43 outputs an oscillating, in particular sinusoidal, electrical voltage. This voltage generates an oscillating, in particular sinusoidally varying magnetic field in the measurement chamber 2. The thermocouple 8, which is heated to a constant temperature, emits an amount of heat per unit time to the gas sample Gp in the measurement chamber 2. This amount of heat emitted per unit time correlates with the measured electrical power supplied to thermocouple 8. Because the field strength of the magnetic field in the measuring chamber 2 oscillates periodically, the quantity of heat supplied per unit time also oscillates—provided that a paramagnetic gas is present as part of the gas sample Gp in the measuring chamber 2. The time course of the thermal conductivity contains a magnetically modulated thermal conductivity, which is a component that oscillates with the strength of the applied magnetic field. By appropriate filtering, two signals can be derived, namely an indicator of the magnetically modulated thermal conductivity and an indicator of the total thermal conductivity of the gas sample Gp.
An electromagnet 62 with an electric coil 63 generates a time-varying magnetic field in the air gap 3, cf.
The heating element 66 heats the measuring element 65 to a working temperature greater than the temperature of a gas sample Gp in the measuring chamber 2. The heated measuring element 65 measures the temperature at the measuring point 68. In the implementation shown, the measuring element 65 measures a thermoelectric voltage and exploits the Seebeck effect. The thermal conductivity of the gas sample Gp at the measuring point 68 changes synchronously with the time-varying magnetic field generated by the electromagnet 62, provided that the gas sample Gp at the measuring point 68 contains a paramagnetic gas with a sufficiently large concentration. A higher thermal conductivity results in a better dissipation of thermal energy. This in turn causes a lower temperature, which in turn causes a lower thermoelectric voltage.
The heating element 66 is connected to the DC voltage source 72 via the amplifier 70 and the voltage divider 71. The output signal of the heat conduction measuring element 65 is fed through the low-pass filter 73 as well as the high-pass filter 74. An oscillating, in particular sinusoidal, i.e., periodically fluctuating signal 75 is present at the output of the high-pass filter 74. The oscillation of the signal 75 is determined by the oscillation of the applied magnetic field. The signal 75 correlates with the magnetically modulated thermal conductivity and thus with the proportion of paramagnetic gas, for example with the proportion of oxygen, in the gas sample Gp. At the output of the low-pass filter 73, a signal 76 is present which does not fluctuate (vary) periodically, or at least does not fluctuate as a function of the oscillation of the magnetic field, and correlates with the total thermal conductivity of the gas sample Gp.
The amount of heat per unit time comprises a superposition of a temporally constant portion and a periodically fluctuating portion. The periodically fluctuating portion correlates with the thermal conductivity and thus with the concentration of oxygen in the measuring chamber 2. The constant portion, i.e. the portion that does not oscillate with the strength of the magnetic field, correlates with the thermal conductivity of the entire gas sample Gp in the measuring chamber 2. The thermal conductivity of the oxygen and the respective thermal conductivity of each other component of the gas sample Gp contribute to this thermal conductivity of the gas sample Gp. Both components are measured. The sensor 53 thus supplies two signals:
Optionally, a measured value for the concentration of a component and/or for the thermal conductivity are displayed on a display device 44, cf.
The pressure sensor 57 of the sensor arrangement 50 measures the total (entire) absolute pressure Pcell,abs of the gas sample Gp. The quotient of a partial pressure and the total absolute pressure Pcell,abs provides an indicator of the concentration of a component of the extracted gas sample Gp. In addition, the pressure sensor 57 provides an indicator of the pressure of the gas sample Gp.
Preferably, the pressure sensor 57 of the sensor arrangement 50 measures an absolute pressure Pcell,abs. In the following, the internal pressure in the sensor arrangement 50 relative to the ambient pressure P am b is used as the pressure Pcell, i.e. Pcell=Pcell,abs−Pamb. The relative pressure Pcell can therefore also assume negative values, namely in the case of a negative pressure in the sensor arrangement 50 relative to the ambient pressure Pamb. Preferably, the relative pressure is measured several times during a breathing process, and a value calculated by suitable averaging over these measured values obtained during a breathing process is used as the pressure Pcell.
A signal processing unit 30 (control unit) shown schematically in
The gas sample Gp, which is preferably continuously sucked in by the pump 55, flows through a schematically shown water trap 51, which is arranged upstream of the sensors 53 and 54. This water trap 51 is configured with at least one gas-permeable membrane, this membrane preferably being made of a chemically inert material, e.g. polytetrafluoroethylene (PTFE). This water trap 51 can be constructed, for example, as described in DE 10 2007 046 533 B3 (corresponding U.S. Pat. No. 8,291,903 (B2) is incorporated by reference) or in DE 10 2009 024 040 A1 (corresponding U.S. Pat. No. 8,221,530 (B2) is incorporated by reference). In this way, the aspirated gas sample Gp is freed from condensate, particles, suspended matter, and germs. Liquid, in particular condensed-out water vapor, is retained by the membrane and flows into a tank of the water trap 51.
It is possible that a leak occurs on the path from the branch point 34 of the sampling hose 52 to the sensors 54 and 53, for example because the sampling hose 52 is not properly connected to the patient-side coupling unit 21, the Y-piece 22 or the water trap 51, or because material fatigue or contact or other mechanical influence from outside has led to a leak. This leak can occur abruptly, for example due to a mechanical influence or because artificial ventilation is started although two parts are mistakenly not connected fluid-tightly, or gradually, for example due to material fatigue.
Such a leak L can falsify the measurement results of sensors 53 and 54 and of optional further sensors. This is because a negative pressure occurs in the sampling tube 52 relative to the ambient pressure Pamb and also relative to the pressure Paw in the ventilation circuit 40, at least during exhalation. This negative pressure results from the fact that the pump 55 of the measurement system 100 continuously extracts a gas sample Gp, and is, for example, 100 hPa. Ambient air can therefore be drawn through this leak L into the sampling tube 52 or into the sensor arrangement 50 because of the negative pressure relative to the environment. The negative pressure depends on the current and time-varying pressure in the breathing circuit 40. Because the negative pressure in the extraction hose 52 varies relative to the ambient pressure Pamb, the amount of ambient air sucked in generally also varies over time in the event of a leak L.
The ambient air drawn in can, for example, simulate (feign) a higher or even a lower oxygen concentration in the ventilation circuit 40 than the actual oxygen concentration and therefore lead to an incorrect measurement. This false measurement could lead to an error in the artificial ventilation of the patient P. Therefore, a leak L must be detected as soon as possible, and a corresponding alarm must be issued in order to be able to locate and eliminate the leak L quickly. On the other hand, it is desired to generate as few false alarms as possible, ideally no false alarms are generated.
The following is an example of how such a leak L is detected. The term “volume flow” is used to describe the volume per unit of time that flows through a fluid guide unit. The following symbols are used:
Because the pump 55 of the sensor arrangement 50 draws (sucks) in the gas sample Gp, the leak L causes air to be drawn in from the environment in addition to the gas sample Gp from the ventilation circuit 40 and to reach the sensor arrangement 50. Therefore, a superposition of two volume flows reaches the sensor arrangement 50, namely
So the following applies:
Vol′(50)=Vol′(40)+Vol′(env) (1)
The term “relative leak volume flow” Vol′(rel) refers to the proportion of the volume flow Vol′(env) through the leak L in the total volume flow Vol′(50) to the sensor arrangement 50, i.e.
Vol′(rel)=Vol′(env)/Vol′(50). (2)
If no leak L has occurred, then Vol′(50)=Vol′(40) and Vol′(rel)=0. A rapidly occurring leak L leads to a rapid increase in the relative leak volume flow Vol′(rel).
Two different indicators of relative leak volume flow Vol′(rel) are described below. Both indicators are measured continuously to check whether a leak has occurred. Both indicators are each based on one measurand (measured variable). Ideally, the two indicators coincide, but in practice they differ from each other. The embodiment that at least two indicators are measured increases the reliability that each leak L is detected, and no false alarm is generated. The embodiment that at least two indicators are used for the relative leak volume flow Vol′(rel) has the following further advantage: When a leak occurs, the relative leak volume flow Vol′(rel) increases, regardless of whether the measurand itself increases or decreases due to the leak L.
In the embodiment, the one indicator is based on oxygen concentration and is denoted con(rel). In general, the volume flow of a component of a gas mixture through a fluid guide assembly is the product of the total volume flow through the fluid guide assembly and the proportion of the component in the gas mixture measured as vol %. The volume flow of oxygen into the sensor arrangement 50 results from a volumetric flow of oxygen from the ventilation circuit 40 and then, if a leak L has occurred, a volume flow of oxygen from the ambient environment through the leak L. Therefore, the volume of oxygen supplied per unit time is:
Vol′(50)*con(50)=Vol′(40)*con(40)+Vol′(env)*con(env)=[1−Vor(rel)]*Vol′(50)*con(40)+Vol′(rel)_Vol′*con(env). (3)
By a transformation it follows that for the relative leak volume flow Vol′(rel) holds:
Vol′(rel)=Vol′(env)/Vol′(40)=[con(40)−con(50)]/[con(40)−con(env)]. (4)
This equation is only ideally valid. The right-hand side is used as the first indicator of the relative leak volume flow Vol′(rel), i.e.
con(rel)=[con(40)−con(50)]/[con(40)−con(env)]. (5)
The oxygen concentration con(env) in air is known and predetermined. The sensor 53 continuously measures the concentration con(50) of oxygen in the sensor arrangement 50.
In one embodiment, an oxygen sensor (not shown) measures the actual oxygen concentration con(40) in the ventilation circuit 40. Often, a desired oxygen concentration in the ventilation circuit 40 is predetermined. Depending on the predetermined desired oxygen concentration, oxygen is injected into the ventilation circuit 40. Optionally, an oxygen sensor (not shown) in the ventilator 1 measures the actual oxygen concentration con(40) in the injected gas mixture Gg. The predetermined or measured oxygen concentration is used as the oxygen concentration con(40). It is also possible that it is assumed that no leak L occurred at the beginning of artificial ventilation. Then con(50)=con(40) and Vol′(rel)=0. If a leak L suddenly occurs, the relative leak volume flow Vol′(rel) increases rapidly.
According to the implementation just described, the sensor 53 described above with reference to
According to the invention, the detection of a leak is not, or at least not only, based on the change in oxygen concentration. This is because a rapid change in the relative leak volume flow Vol′(rel) can also have a cause other than a leak, for example a deliberate change during artificial ventilation, in particular an occlusion during which the supply of respiratory air to patient P is interrupted for a very short time in order to measure one of patient P's vital parameters. Therefore, in the embodiment example, additionally a further time-varying property of the gas sample Gp is monitored. According to the invention, this further property is the relative thermal conductivity, and a rapid change in the measured relative thermal conductivity of the gas sample Gp is detected. It is also possible to base the monitoring of whether a leak has occurred solely on the thermal conductivity.
The following designations are used below:
If no leak L has occurred, WLF(50)=WLF(40) and WLF′(rel)=0 holds.
In one embodiment, it is assumed that the thermal conductivity WLF(50) of the gas sample Gp reaching the sensor arrangement 50 is a weighted average of the thermal conductivity WLF(40) of the gas sample Gp exhausted from the ventilation circuit 40 and the thermal conductivity WLF(env) of the ambient air. The weight factor for the thermal conductivity WLF(env) of the ambient air is the relative leak volume flow Vol′(rel), and the weight factor for the thermal conductivity of the gas mixture Gg in the ventilation circuit 40 is therefore 1−Vol′(rel).
WLF(50)=Vol′(rel)*WLF(env)+[1−Vol′(rel)]*WLF(40). (6)
The indicator WLF(rel) for the relative leak volume flow Vol′(rel), which is based on the thermal conductivity, is ideally equal to Vol′(rel) and is calculated according to the following calculation rule, which is obtained by solving formula (6) for Vol′(rel):
WLF(rel)=[WLF(40)−WLF(50)]/[WLF(40)−WLF(env)]. (7)
The thermal conductivity WLF(env) of dry ambient air is known, it is λ=0.02603 W/mK at 1 bar and 15 degrees C. The sensor 53 described with reference to
On the y-axis of
As a rule, a leak L causes the thermal conductivity of the gas sample Gp reaching the sensor arrangement 50 to increase. One reason is that ambient air generally has a higher thermal conductivity than those components other than oxygen contained in the breathing circuit 40. In individual cases, however, the leak may result in a lower thermal conductivity. The invention eliminates the need to make appropriate case discrimination and the required measurement.
In the example of
As can be seen in
The example of
Ideally, the or each indicator of relative volume flow Vol′(rel) is equal to the actual relative leak volume flow. Ideally, then, at any time t
con(rel)(t)=con(rel,CO2)(t)=WLF(rel)(t)=Vol′(rel)(t).
As a rule, however, the indicator or each indicator differs from the actual relative leak volumetric flow Vol′(rel), in particular due to measurement errors and because the respective measurand propagates only at a limited speed. Therefore, in the embodiment example, the monitoring procedure described below is used to decide with greater certainty whether a leak L has actually occurred or not.
A minimum time period ΔT is specified. It is checked whether, in a decision period T(dec) which is at least as long as the minimum time period ΔT, the indicators con(rel), con(rel, CO2), WLF(rel) used for the relative leak volume flow Vol′(rel) cumulatively fulfill the following criteria:
According to the invention, at least one indicator of relative leak volume flow Vol′(rel) is determined and analyzed. Preferably, several indicators are compared with each other. This procedure detects an indication of a leak. This indication actually comes from a leak with a relatively high reliability. However, false alarms are possible, especially because an event other than a leak L significantly changes the relative leak volume flow Vol′(rel). It is therefore possible that an indication of a leak is detected, but in reality no leak has occurred.
In one embodiment, when an indication of a leak is detected as just described, an alarm is issued. A user can then check the fluid connections.
Preferably, however, a verification sequence is first performed and triggered automatically. If this verification sequence shows that a leak L has actually occurred, a corresponding alarm is output. However, this verification sequence causes the sensor arrangement 50 to be temporarily unable to supply any signals. Therefore, the verification sequence is preferably only carried out when an indication of a leak L is detected.
The verification sequence includes the following steps:
If the two measured pressures differ by more than one tolerance, a leak L is detected and a corresponding alarm is generated. Otherwise, a leak can be excluded.
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.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2022 125 601.4 | Oct 2022 | DE | national |
