MEDICAL DEVICE AND PROCESS FOR ALARM ORGANIZATION

Abstract

A medical device is provided with an alarm organization. A process for alarm organization of a medical device is also provided. Based on pressure measured values (99) and flow measured values (97) and with a comparison criterion it is determined whether an elevation of an airway pressure (105) of an anesthesia device or of a ventilator is caused by a coughing event. A visual and/or acoustic output (117, 121) of a warning or alarm (42) is adapted, indicating the elevated airway pressure P.sub.AW.sub._.sub.High (105).

Claims

1. A process for alarm organization of a medical device, the process comprising the steps of: providing sensor signals of measuring sites of the medical device, wherein the sensor signals indicate pneumatic/fluidic physical states of a breathing gas in a connection system from and to the patient, which connection system is connected and coupled in a gas-routing manner to the medical device and to a patient and has a gas-routing configuration for the transport of gases; determining values of an airway pressure and of a flow rate that are present in the gas-routing connection system as well as values flow directions corresponding to the gas-routing connection system; comparing determined values of the airway pressure, the flow rate and determined flow directions to a comparison criterion whereby exceeding the comparison criterion indicates an elevated airway pressure; setting an alarm criterion indicating the elevated airway pressure based on the comparison, in a case of exceeding the comparison criterion; determining whether the medical device is in an operating state, in which a smaller quantity of breathing gas is being fed from the medical device to the patient than flows from the patient, based on a comparison of whether another comparison criterion is exceeded indicating a flow rate and a flow direction by the determined value of the flow rate and by the determined flow direction; resetting the alarm criterion indicating the elevated airway pressure: with an exceeding of the further comparison criterion, indicating the flow rate and the flow direction; and with the medical device in the operating state, in which a smaller quantity of breathing gas is being fed to the patient than flows from the patient; and adapting a visual and/or acoustic output of a warning or of an alarm indicating the elevated airway pressure based on the alarm criterion.

2. A process in accordance with claim 1, wherein the acoustic output of the warning or alarm is suppressed or muted as the adaptation of the output of the warning or alarm in case the alarm criterion indicating the elevated airway pressure is reset.

3. A process in accordance with claim 1, wherein the visual output of the warning or alarm is suppressed as the adaptation of the output of the warning or alarm in case the alarm criterion indicating the elevated airway pressure is reset.

4. A process in accordance with claim 1, wherein the visual and/or acoustic output of the warning or alarm is outputted with a time delay as the adaptation of the output of the warning or alarm based on the alarm criterion.

5. A process in accordance with claim 1, wherein both the visual and the acoustic output of the warning or alarm is suppressed as the adaptation of the output of the warning or alarm based on the alarm criterion.

6. A process in accordance with claim 1, wherein no visual and/or acoustic output of the warning or alarm is outputted as the adaptation of the output of the warning or alarm based on the alarm criterion, when the alarm criterion is obsolete and/or a valid resetting criterion for the alarm indicating the elevated airway pressure.

7. A process in accordance with claim 1, wherein before the setting the alarm criterion or before the resetting the alarm criterion, indicating the elevated airway pressure, carrying out a check of whether a configuration of the medical device or adaptations of settings for control of the ventilation at the medical device are currently or essentially simultaneously taking place and in case a configuration of the medical device is taking place or adaptations of settings for control of the ventilation at the medical device are taking place, no setting of the alarm criterion or no resetting of the alarm criterion is carried out.

8. A process in accordance with claim 1, wherein a detection of a breathing phase and the determination of whether the medical device is in an operating state, in which a smaller quantity of breathing gas is being fed from the medical device to the patient than flows from the patient, includes: considering a state of an exhalation valve and/or considering a control signal for such an exhalation valve and/or considering information from the procedure of the ventilation.

9. A medical device with an alarm organization, the medical device comprising: a connection system configured for a transport of breathing gases, the connection system comprising a connection component, an expiratory path configured to carry away an expiratory quantity of breathing gas from the patient, an inspiratory path configured to bring an inspiratory quantity of breathing gas of the medical device to the patient, a patient connection path configured to bring the inspiratory quantity of breathing gas from the medical device to the patient and for carrying the expiratory quantity of breathing gas away from the patient, wherein the expiratory path and the inspiratory path are connected to one another and to the patient connection path by the connection component; a pressure measuring unit comprising at least one pressure sensor, which is arranged in or at the medical device or the connection system and is configured to detect a pressure measured value of a pressure that is present in the connection system, and wherein the pressure measuring unit is configured to provide the at least one pressure measured value as an airway pressure; a flow measuring unit comprising at least one flow sensor arranged in or at the connection system or in or at the medical device and configured to detect at least one flow rate measured value of a quantity of breathing gas and a flow direction of the breathing gas corresponding to the flow rate measured value, which quantity of breathing gas flows from the patient in the connection system or flows from the medical device towards the patient, and wherein the flow measuring unit is configured to provide at least one flow rate measured value and the corresponding flow direction value; an alarm unit; and a control unit receiving the pressure measured value and the flow rate measured value and the corresponding flow direction value, the control unit being configured to: compare the detected pressure measured value with a predefined pressure threshold value and assess, based on the comparison, whether the detected pressure measured value indicates an elevated airway pressure and for activating an alarm criterion that indicates the elevated airway pressure; compare the at least one detected flow rate measured value with a predefined flow rate threshold value and to assess, based on the comparison, whether the at least one flow rate measured value exceeds a predefined flow rate threshold value; assess whether the at least one flow rate measured value and the corresponding flow direction indicate an operating state with a patient flow rate and with a flow direction corresponding to the patient flow rate, in which a smaller quantity of breathing gas is being fed to the patient from the medical device than is flowing from the patient; deactivate the alarm criterion indicating the elevated airway pressure, for a predefined time, when the at least one detected flow rate measured value exceeds the predefined flow rate threshold value and the pressure measured value exceeds the predefined pressure threshold value; and the operating state is indicated in which the quantity of breathing gas flowing towards the patient is smaller than the quantity of breathing gas flowing from the patient; and activate and deactivate the alarm unit for an output of an alerting of a visual and/or an acoustic warning or alarm indicating the elevated airway pressure based on the alarm criterion.

10. A medical device in accordance with claim 9, wherein the airway pressure is determined by the control unit based on a detection with the pressure measuring unit including the pressure sensor arranged at the patient connection path or at the connection component of the connection system and/or by means of a pressure sensor arranged at the inspiratory path of the connection system and/or by means of a pressure sensor being arranged at the expiratory path of the connection system.

11. A medical device in accordance with claim 9, wherein the airway pressure is determined by the control unit based on a detection with the pressure measuring unit including the pressure sensor arranged in or at the patient connection path or at the connection component of the connection system.

12. A medical device in accordance with claim 9, wherein the patient flow rate is detected and determined by the control unit with the flow measuring unit providing a difference of the flow sensor arranged in or at the expiratory path of the connection system and a flow sensor arranged in or at the inspiratory path of the connection system.

13. A medical device in accordance with claim 9, wherein the patient flow rate is detected and determined by the control unit with the flow measuring unit including the flow sensor arranged in or at the patient connection path of the connection system.

14. A medical device in accordance with claim 10, wherein the pressure sensor is configured as a sensor according to measurement principles of a piston manometer or of a pressure scale, of a compression liquid manometer, of a spring manometer, of a piezoelectric measuring component or of a strain measuring component.

15. A medical device in accordance with claim 12, wherein the flow sensor is configured as according to measurement principles of a differential pressure measurement, as a sensor according to a measurement principle of an ultrasonic flow measurement, as a sensor according to a thermoelectric measurement principle, as a sensor according to a resistive measurement principle or as a sensor according to a resistive or thermoelectric measurement principle combined with an analysis of a heat transport.

16. A medical device alarm organization process, the process comprising: providing a medical device with a connection system configured for a transport of breathing gases, the connection system comprising a connection component, an expiratory path configured to carry away an expiratory quantity of breathing gas from the patient, an inspiratory path configured to bring an inspiratory quantity of breathing gas of the medical device to the patient, a patient connection path configured to bring the inspiratory quantity of breathing gas from the medical device to the patient and for carrying the expiratory quantity of breathing gas away from the patient, wherein the expiratory path and the inspiratory path are connected to one another and to the patient connection path by the connection component; providing a pressure measuring unit comprising at least one pressure sensor, which is arranged in or at the medical device or the connection system and is configured to detect a pressure measured value of a pressure that is present in the connection system, and wherein the pressure measuring unit is configured to provide the at least one pressure measured value; providing a flow measuring unit comprising at least one flow sensor arranged in or at the connection system or in or at the medical device and configured to detect at least one flow rate measured value of a quantity of breathing gas and a flow direction of the breathing gas corresponding to the flow rate measured value, which quantity of breathing gas flows from the patient in the connection system or flows from the medical device towards the patient, and wherein the flow measuring unit is configured to provide at least one flow rate measured value and the corresponding flow direction value; providing an alarm unit; providing a control unit; receiving the pressure measured value and the flow rate measured value and the corresponding flow direction value at the control unit; and with the control unit comparing the detected pressure measured value with a predefined pressure threshold value and assess, based on the comparison, whether the detected pressure measured value indicates an elevated airway pressure and for activating an alarm criterion that indicates the elevated airway pressure; with the control unit comparing the at least one detected flow rate measured value with a predefined flow rate threshold value and to assess, based on the comparison, whether the at least one flow rate measured value exceeds a predefined flow rate threshold value; with the control unit assessing whether the at least one flow rate measured value and the corresponding flow direction indicate an operating state with a patient flow rate and with a flow direction corresponding to the patient flow rate, in which a smaller quantity of breathing gas is being fed to the patient from the medical device than is flowing from the patient; with the control unit deactivating the alarm criterion indicating the elevated airway pressure, for a predefined time, when the at least one detected flow rate measured value exceeds the predefined flow rate threshold value and the pressure measured value exceeds the predefined pressure threshold value; and the operating state is indicated in which the quantity of breathing gas flowing towards the patient is smaller than the quantity of breathing gas flowing from the patient; and with the control unit activating and deactivating the alarm unit for an output of an alerting of a visual and/or an acoustic warning or alarm indicating the elevated airway pressure based on the alarm criterion.

17. A process in accordance with claim 16, wherein the airway pressure is detected and determined by the control unit with the pressure measuring unit including the pressure sensor arranged at the patient connection path or at the connection component of the connection system and/or by means of the pressure sensor arranged at the inspiratory path of the connection system and/or by means of the pressure sensor being arranged at the expiratory path of the connection system.

18. A process in accordance with claim 16, wherein the airway pressure is detected and determined by the control unit with the pressure measuring unit including the pressure sensor arranged in or at the patient connection path or at the connection component of the connection system.

19. A process in accordance with claim 16, wherein the patient flow rate is detected and determined by the control unit with the flow measuring unit providing a difference of the flow sensor arranged in or at the expiratory path of the connection system and a flow sensor arranged in or at the inspiratory path of the connection system.

20. A process in accordance with claim 16, wherein the patient flow rate is detected and determined by the control unit with the flow measuring unit including the flow sensor arranged in or at the patient connection path of the connection system.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0109] In the drawings:

[0110] FIG. 1 is a schematic view of a medical device suitably configured for a ventilation; and

[0111] FIG. 2 is a flow chart view of a sequence of actions and steps of an alarm organization.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0112] Referring to the drawings FIG. 1 shows a schematic view of a medical device which is suitably configured for a ventilation, for example and preferably a ventilator with its essential components.

[0113] These essential components also represent the basic components of the gas supply, gas dispensing and gas feeding to the patient and for an anesthesia device. The additional, other components that are needed for an anesthesia device, which are not shown in this FIG. 1 and shall also not be listed conclusively at this point, because they do not make any inventive contribution to the present invention for alarm organization in case of a medical device 1, are, for example, gas supply components for dispensing nitrous oxide and anesthetics, gas concentration measurement (anesthesia gas monitoring) for anesthetics and gases, removal of carbon dioxide, and anesthetic gas delivery (AGS). Nevertheless, configurations of the medical device as an anesthesia device, as well as other types of ventilators with different devices for generating and dispensing breathing gas shall also be covered by the view according to FIG. 1. As examples of different devices for generating and dispensing breathing gas, technical configurations with radial flow compressors, blowers, fan impellers, piston drive, valves or nozzles, for example, ejectors or supercritical nozzles, should be mentioned here.

[0114] The ventilator 1 has a control unit 27, which is preferably configured as an electronic controller, which is suitably configured and intended to control or regulate a gas mixing and dispensing unit 23 with a dispensing valve arrangement 25 arranged there. Furthermore, measuring sites 15, 17, 19, 21 within the ventilator 1 are shown in the ventilator 1. A measuring site of the inspiratory flow rate 15 and a measuring site for an inspiratory pressure 19 are arranged downstream of the gas mixing and dispensing unit 23. An inhalation branch 17 of a pneumatic connection system, via which the ventilator 1 supplies inspiratory breathing gases to the patient 3, is arranged following these measuring sites 15, 19. A measuring site of a patient flow rate 11 and a measuring site of a patient pressure 13, from which the patient 3 is connected to the ventilator 1 via a patient gas supply line 5, which is usually configured as an endotracheal tube, for the exchange of inhaled and exhaled air, are arranged as connection components at a so-called Y-piece 11 directly at the patient 3, outside 150 of the ventilator 1, but interacting with the ventilator 1.

[0115] As an alternative to the endotracheal tube, non-invasive components can also be used for the patient gas supply 5 as a patient connection path, such as masks, for example, nasal masks at the Y-piece. The exhaled air of the patient 3 is fed back by expiration to the ventilator 1 from the Y-piece at the patient 3 via an exhalation branch 9 of the pneumatic connection system. In the ventilator 1, the pressure in the exhalation branch 9 and hence also the pressure present in the lungs of the patient are set by the control unit 27 by means of an exhalation valve 26, which is often also called “PEEP” valve. In addition, the control of the ventilation with cyclical changing of inhalation phases and exhalation phases is brought about via the exhalation valve 26 in connection with the control unit 27 in connection with the gas mixing and dispensing unit 23 and the dispensing valve arrangement 25 arranged therein. A measuring site of the expiratory flow rate 17 and a measuring site for an expiratory pressure 21 are arranged downstream of the exhalation branch of the patient gas supply line 9 within or in the interior 160 of the ventilator 1. In alternative and special embodiments of ventilators 1, specially adapted to the application, such as emergency ventilators or ventilators for home, as well as anesthesia devices, which have, besides the components needed for anesthesia devices for an anesthesia, also components for ventilation, the distribution of measuring sites and components (sensors) may be embodied in reference to the components in the interior 160 and outside 150 differing from the embodiment which is shown in a simplified manner in this FIG. 1. Thus, the components 15, 17, 19, 21 may be arranged outside of 150 as well as within 160 the ventilator.

[0116] Such embodiments are also covered by the idea of the present invention, but are not shown for the sake of a simplified view and for the sake of clarity. The exhaled air of the patient 3 is discharged from these measuring sites 17, 21 into the surrounding area. The measuring sites 11, 13, 15, 17, 19, 21 and the flow sensors and pressure sensors—but not shown in detail in this FIG. 1 for the sake of clarity—arranged at these measuring sites are each connected to the control unit 27 via suitable signal and data lines 63, 67, 69, 83, 87, 89. In this FIG. 1, a flow measuring unit and a pressure measuring unit—not shown in this FIG. 1 for the sake of clarity—are configured as integrated into the control unit 27. The control unit 27 has, in addition to the flow measuring unit and the pressure measuring unit, suitably configured data processing and conversion units (signal boosting, signal filtering, A/D conversion), which are not shown in this schematic view according to FIG. 1. The control unit 27 has, furthermore, a processor unit 29 and a data storage unit 31, to configure and to execute the procedure of ventilation by and with the ventilator 1. Gases 33 that are needed for the ventilation, such as oxygen and air, are fed to the gas mixing and dispensing unit 23 by means of lines not shown in this FIG. 1 and are converted there into a gas mixture, which is suitable for a ventilation of the patient 3, through the dispensing valve arrangement 25.

[0117] An alarm unit 40 with an optical signal generation component 41 and an acoustic signal generation component 42 is connected to the control unit 27 to signal user alarm situations, which may occur during the operation of the ventilator 1, to the user. Furthermore, an output unit 44 for an output in text form or graphic form is arranged at the alarm unit 40 to output notices, alarms and messages to the user. In addition, an input unit 43, via which the user can both carry out settings, such as ventilation parameters, e.g., ventilation rate, tidal volume, ventilation pressures (Pinsp, PEEP) and alarm limits corresponding thereto, such as the maximum permissible airway pressure (P.sub.AW-high), volume limits (MV.sub.Low) at the ventilator 1 and can acknowledge signaled alarm situations, is also connected to the control unit 27.

[0118] FIG. 2 shows in a schematic view a sequence of actions and steps of an alarm organization, often also called alarm management or alarm handling. A sequence of actions and steps 91 is shown with a start 93, with an overall function of a ventilation operation 95, as well as other steps and functions in sequence and in conjunction with measured values of the flow 97 and the pressure 99 during the ventilation operation 95. In the regular ventilation operation 95, which is shown here schematically as a function block, pressure measured values 99 and flow measured values 97 are obtained, which are combined in a measured value analysis 101 and are then fed to a patient flow evaluation 103. The patient flow evaluation 103 is executed to assess whether a patient flow is flowing from the patient 3 (FIG. 1) to the ventilator 1 (FIG. 1) at the moment and currently. According to this FIG. 2, a situation with a pressure alarm event 105 arises from the regular and routine ventilation operation 95. This pressure alarm event 105 (P.sub.AW High) is a pressure alarm event, which occurs if the pressure measured values 99 exceed a predefined pressure threshold value 104 and hence the event 105 is considered to be valid. A setting (Set) 106 of a marker 107 for a pressure alarm is brought about due to the event 105.

[0119] The flow measured values 97 from the ventilation operation 95 and the pressure measured values 99 from the ventilation operation 95 are provided by the ventilator 1 (FIG. 1). Possible measuring sites or measuring points that are suitable to provide flow measured values and pressure measured values 97, 99, appear from FIG. 1 from the measuring points shown 11, 13, 15, 17, 19, 21 (FIG. 1), which are provided to the control unit 27 (FIG. 1) by signals and data lines 63, 67, 69, 83, 87, 89 (FIG. 1). This control unit 27 (FIG. 1) controls the ventilation operation 95 according to this FIG. 1, as well as the execution of the alarm organization, as it appears, furthermore, from this FIG. 2.

[0120] After detecting that a pressure alarm event 105 is present and after setting 106 the marker 107 for the pressure alarm, it is checked in a case differentiation 109 whether the pressure alarm is due to a patient flow in connection with a flow direction with a flow rate flowing from the patient, which exceeds a predefined flow threshold value 108.

[0121] An exceeding of the flow threshold value 108 by the patient flow indicates that a coughing event or cough attack has triggered the pressure alarm event 105 (P.sub.AW High).

[0122] As a result of this case differentiation 109, the further course of the sequence of steps and actions 91 branches either to a pressure alarm cause 111 which was caused by the patient flow, or to a pressure alarm cause 113 which was not caused by the patient flow. In case of the pressure alarm cause 111, the output of an acoustic pressure alarm 117 is suppressed; a visual alarm output 115 is suppressed as well. In addition, the marker 107 is reset in a resetting step 123. After the suppression of the pressure alarm cause 111, the further operation of the ventilator 1 (FIG. 1) is continued by means of a return to the start 93. In this connection, a branch back is made either directly via a path of a possibility of a manual input and operation 125 of the ventilator 1 (FIG. 1), which is optional and given at any time during the procedure 91, or indirectly to the start 93, in order to again continue the regular ventilation operation 95 from there.

[0123] This possibility of a manual input and operation 125 of the ventilator 1 (FIG. 1) given at any time is shown here in this FIG. 2, as an example and in a simplified manner, in the procedure 91 as a component in the branching back to the beginning 93. In a real conversion, the possibility of a manual input and operation 125 is possible by configuring the procedure control almost at any time during the operation of the ventilator 1 (FIG. 1).

[0124] In case of a pressure alarm cause 113, i.e., in case the pressure alarm cause 113 was not caused by the patient flow, but, for example, was caused directly by effects of the ventilation control or by an operation or changes of settings of the ventilation controller, an acoustic alarm 121, 42 as well as a visual alarm output 119, 41 (FIG. 1) are outputted. Following the generation of the alarms 113, a branch back is made to the beginning 93 of the sequence of steps and actions 91 via a manual input of an operation of the ventilator 1 (FIG. 1), in which the user acknowledges the alarms, i.e., cancels the marker 107 with a resetting 123.

[0125] As an alternative, the resetting 123 of the marker 107 may also be carried out due to the reason for the alarm, i.e., the pressure measured value 99 having again dropped below the threshold value and/or other possible criteria (time criteria, alarm limit settings, configuration of alarm prioritizations) in the procedure 91 being given for the resetting 123. This alternative is not shown in this FIG. 2 for the sake of clarity of the procedure 91. Furthermore, the ventilation operation 95 with the overall function for the operation of the ventilator (FIG. 1) with the continual procedure of the sequence of steps and actions 91, including the alarm organization of the alarm for the elevated airway pressure (P.sub.AW High) 105, is then continued at the beginning 93.

[0126] 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 Numbers

[0127] 1 Medical device arrangement, ventilator [0128] 3 Patient [0129] 5 Patient gas supply line (pneumatic connection system) [0130] 7 Inhalation branch (pneumatic connection system) [0131] 9 Exhalation branch (pneumatic connection system) [0132] 11 Measuring site for patient flow rate, Y-piece, connection component [0133] 13 Measuring site for patient pressure, airway pressure [0134] 15 Measuring site for inspiratory flow rate [0135] 17 Measuring site for expiratory flow rate [0136] 19 Inspiratory pressure, measuring site [0137] 21 Expiratory pressure, measuring site [0138] 23 Gas mixing and dispensing unit [0139] 25 Dispensing valve arrangement [0140] 26 Exhalation valve [0141] 27 Control unit, electronic controller [0142] 29 Processor unit [0143] 31 Data storage unit [0144] 40 Alarm unit, alarm output [0145] 41 Optical signal generation component [0146] 42 Acoustic signal generation component [0147] 43 Input unit [0148] 63, 67, 69 Signal/data lines of the pressure measuring sites [0149] 83, 87, 89 Signal/data lines of the flow measuring sites [0150] 91 Sequence of steps and actions [0151] 93 Beginning, start [0152] 95 Ventilation operation, overall function [0153] 97 Flow measured values from the ventilation operation [0154] 99 Pressure measured values from the ventilation operation [0155] 101 Analysis of measured values [0156] 103 Patient flow evaluation [0157] 104 Pressure threshold value [0158] 105 Pressure alarm event (P.sub.AW High) [0159] 106 Setting of the marker for pressure alarm event (Set) [0160] 107 Marker for pressure alarm [0161] 108 Flow threshold value [0162] 109 Case differentiation for cause of pressure alarm [0163] 111 Cause of pressure alarm due to patient flow [0164] 113 Cause of pressure alarm, e.g., due to ventilation control or operation [0165] 115 Alarm with output suppression, visual [0166] 117 Alarm with output suppression, acoustic [0167] 119 Alarm with alarm output, visual (display screen/indicator light) [0168] 121 Alarm with alarm output, acoustic (loudspeaker, alarm sound) [0169] 123 Resetting of the marker for pressure alarm event (Reset) [0170] 125 Operation of the ventilator, manual input [0171] 150 Components arranged outside of the device [0172] 160 Components arranged inside of the device