Displaying maintenance reminder on apparatus for supplying medical nitric oxide
The NO delivery device addresses the issue of missed calibrations by incorporating a control system with daily maintenance reminders, ensuring reliable NO delivery and patient safety.
Patent Information
- Application Number
- JP2024103601
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-06-29
- Filing Date
- 2024-06-27
- Publication Date
- 2025-01-20
AI Technical Summary
Medical teams often fail to perform periodic calibration of NO delivery devices, which can lead to unexpected interruptions in treatment, posing serious risks to patients with acute pulmonary arterial hypertension.
A NO delivery device equipped with a microprocessor-based control system and a graphical display screen that prompts users to perform daily calibration checks through virtual selection keys, ensuring regular sensor calibration and maintenance reminders.
Ensures consistent and safe delivery of NO by minimizing the risk of calibration omission, thereby maintaining accurate NO dosage and reducing the likelihood of treatment interruptions.
Smart Images

Figure 2025009995000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an apparatus or device for delivering and monitoring a gas containing NO, particularly a NO / N2 gas mixture, commonly referred to as a nitric oxide (NO) delivery apparatus, for use in treating one or more individuals suffering from acute pulmonary arterial hypertension, and configured to display maintenance reminders, preferably daily. [Background technology]
[0002] Inhaled nitric oxide (NOi) is the standard of care for treating people, i.e., patients, suffering from acute pulmonary arterial hypertension. Indeed, when inhaled, NO increases oxygenation by dilating pulmonary blood vessels and improving gas exchange. These properties are used to treat various pathologies such as persistent pulmonary hypertension of the newborn (PPHN), acute respiratory distress syndrome (ARDS), mainly seen in adults, or pulmonary hypertension in cardiac surgery, seen in adults or children, as described in particular by EP-A-560928, EP-A-1516639, and US-A-10,201,564.
[0003] Usually, small amounts of gaseous NO (i.e., a few ppm by volume) diluted in nitrogen (N2) are injected and diluted in a gas stream containing oxygen, typically at least 20-21% by volume of oxygen (O2), such as an N2 / O2 mixture or air, or even pure oxygen, which is conveyed through a patient circuit of a gas supply facility, and the resulting final gas mixture containing NO and oxygen is then inhaled by the patient. The final concentration of NO corresponding to the dosage is determined by a physician or similar person. In general, the final concentration is of the order of 1-80 ppm by volume (ppmv), typically of the order of 10-20 ppm by volume (ppmv), in the final NO / N2 / O2 gas administered by inhalation to the patient in question, i.e., after injection of the NO / N2 mixture into the oxygen-containing gas stream conveyed by the patient circuit (i.e., greater than about 21% by volume), depending on the population to be treated, i.e., neonates, children, adolescents, or adults, and depending on the disease to be treated.
[0004] The administration of NOi therapy typically involves one or more NO / N2 cylinders (or NO generators), devices for delivering and monitoring NO, a medical ventilator, and a patient kit including a patient circuit and a breathing interface such as an endotracheal intubation tube, or other elements such as a gas humidifier or the like. Such equipment is described inter alia by US2022 / 106189, EP2581103, and EP0839546.
[0005] All of these pieces of equipment must be ready to begin NOi treatment as soon as it is prescribed by the doctor. Given that the time to treat a patient can be from a few hours to a few days, it is essential to check them regularly for proper functioning to ensure the smooth progress of the treatment and under this condition of optimal safety for the patient. Any unexpected interruption of the treatment exposes the patient to serious risks that may threaten his survival.
[0006] For this reason, verifying that the NO delivery device is functioning properly is particularly important, as it allows monitoring and controlling / regulating the amount of NO delivered to the patient during treatment with NOi. In particular, to ensure accurate measurements by the monitoring or analysis cells of the dose of NO administered to the patient and the absence (or near absence) of toxic NO2 and the percentage of oxygen, it is typically essential to periodically calibrate these cells, i.e., the NO, NO2, and O2 sensors used to measure the NO and NO2 content, and the inspired oxygen fraction FiO2 in the gas administered to the patient. Maintaining the accuracy of these measurements is a major safety aspect.
[0007] However, the medical teams (e.g., doctors, nurses, or other medical personnel) working in the hospital resuscitation and surgery units where the NOi is administered perform care and medical procedures every day, which may lead to the omission of certain monitoring tasks.
[0008] The challenge is therefore to enable medical teams using NOi in patients in need of NOi to minimize the risk of failing to perform some or all of the essential checks that the NO delivery device, i.e., the device delivering the NO-containing gas stream, is functioning properly, in particular, namely, the periodic calibration of the monitoring cells of the NO, NO2, and O2 sensors. Summary of the Invention
[0009] The solution of the invention therefore relates to a device for supplying (i.e. delivering) an NO-containing gas, also called an NO supply device or NO delivery device, which comprises: an internal gas circuit, for example an internal gas circuit for conveying a flow of NOx-containing gas, comprising valve means; a microprocessor-based control means, i.e. a controller or similar, - a tactile graphical display screen controlled by the control means; a gas analysis line and a measuring cell, each of which is provided with at least one sensor electrically connected to a control means; Equipped with.
[0010] Moreover, the control means is configured to control the momentary display of at least a first virtual selection key on the graphical display screen at a given time frequency, and activation of the first virtual selection key by a user causes the control means to initiate a calibration procedure of one or more sensors of the gas analysis line.
[0011] Depending on the embodiment under consideration, the device of the invention may comprise one or more of the following features: The internal gas circuit comprises one or more gas passages. The gas analysis line is also called the "calibration line," "monitoring line," or "sampling line." The device of the present invention is configured to monitor and deliver NO gas, i.e., NO-containing gas, such as a NO / N2 mixture. The sensor calibration procedure begins after the user activates the first virtual selection key. a first virtual selection key cooperates with the control means for supplying said control means with at least one control signal corresponding to a selection made by the user, said control signal corresponding to the initiation of a calibration procedure of the sensor; the control means are further adapted to control the display, on the graphical display screen, of at least one item of information related to one or more safety checks to be performed, in particular of a calibration procedure of the sensor. The device comprises storage means such as a computer memory, in particular a flash memory or similar. One or more safety check procedures are stored in the storage means, in particular a calibration procedure for the sensor. the storage means are adapted to store the procedure(s) of the safety check, in particular the procedure for calibrating the sensors; The safety check procedure includes a calibration procedure of one or more sensors in the gas analysis line. the control means are adapted to control the display of at least a first virtual selection key with a time frequency of 1 to 4 times per day, more preferably 1 or 2 times per day. -The control measures are carried out at least once a day, At a fixed time, for example, every day at 8:00 a.m. Or when the device is switched on, i.e. when the device is started, Or after a predefined period of time from the beginning of administration by the device, for example 24 hours after the start of treatment, Or after a predefined period of time since the last calibration was performed, for example 24 hours after the last calibration was performed , configured to control the display of at least a first virtual selection key. the control means are additionally adapted to control the display of a second virtual selection key, i.e. a second tactile key, simultaneously with or subsequent to the first virtual selection key. the second virtual selection key is configured to cancel or reject the sensor calibration procedure in response to a user activation of the second virtual selection key; a second virtual selection key cooperates with the control means for supplying the control means with at least one control signal corresponding to a selection made by a corresponding user for cancelling or rejecting the sensor calibration procedure, i.e. for putting the sensor calibration procedure on hold. the control means is configured to control the simultaneous display of at least one item of information and first and optionally second virtual selection keys; the control means are configured to control the display, within the pop-up, of at least one item of information and of a first virtual selection key and optionally a second virtual selection key. the control means are further configured to control the display on the graphical display screen of a third virtual selection key, activation of the third virtual selection key by the user causing an interruption of the calibration procedure that has begun, i.e. that has begun after the user pressed the first virtual selection key. the control means are further configured to control the display on the graphical display screen of a bar graph, hourglass or similar time graph representing the time elapsed since the start of the sensor calibration procedure and / or the time remaining before the end, i.e. the end, of the sensor calibration procedure. the control means are further configured to control the display, on the graphical display screen, of a time graph representing the time elapsed since the start of the sensor calibration procedure and / or the time remaining before the end of the sensor calibration procedure, in particular a time graph representing a bar graph or an hourglass, in particular a time graph representing a bar graph or an hourglass. the control means is further configured to cause the simultaneous display on the graphical display screen of a third virtual selection key and a time graph, i.e. the display of a third virtual selection key and a time graph, i.e. an hourglass, a bar graph or the like, is caused simultaneously. The device comprises an internal gas analyzer comprising a gas analysis line and at least one sensor, ie one or more sensors, preferably a NO sensor and a NO2 sensor, and preferably an O2 sensor. The internal gas circuit allows a flow of NO-containing gas to be conveyed between (at least) a gas inlet and (at least) a gas outlet supplying the NO-containing gas, i.e., a NO / N2 mixture. The internal circuit is a part of the gas circuit arranged in the NO supply device. At least one sensor comprises one or more electrochemical cells. - At least one sensor comprises an NO sensor configured to measure the concentration (i.e. content or dosage) of NO. - At least one sensor comprises a NO2 sensor configured to measure the concentration (i.e., content or dosage) of NO2. - At least one sensor comprises an O2 sensor configured to measure the concentration (i.e., content or dosage) of O2. The one or more sensors are arranged to perform concentration measurements in the gas analysis line. The internal circuit comprises one or more ducts, passages, tubes, or the like. The gas analysis line comprises a duct, passage, tube or the like. The microprocessor-based control means comprises (at least) an electronic board. the control means comprise one or more microprocessors arranged on an electronic board; The tactile graphical display screen is part of a graphical user interface (GUI). - The graphical display screen shows a color display. The graphical display screen is configured to detect contact of a user's finger pressing on a surface of the graphical display screen. -The graphical display screen is equipped with a touch panel. The first and second virtual selection keys are tactile keys displayed on the graphical display screen. a first and a second virtual selection key cooperating with the control means; the control means are actuated in response to any depression of a user's finger on one and / or the other of the first and second selection keys; the control means comprises a time counter; The control means are integrated with or cooperate with a time counter. The time counter is integrated into the microprocessor. The indication is effected automatically at a given frequency, typically every 24 hours, i.e. at least once a day, and is controlled by control means cooperating with a time counter. The display comprises a selection means for modifying, setting or selecting the desired amount of NO, i.e. the NO content or concentration. The selection means comprises at least one key or one button, in particular a virtual key displayed on a graphical display screen. the valve means comprises at least one solenoid valve, preferably one or more proportional solenoid valves; - the valve means, in particular one or more solenoid valves, are controlled by the control means to control the flow of gas within the internal gas circuit.
[0012] The invention also relates to an installation for administering a gas, i.e. an NO-containing gas, to a patient, said installation comprising: at least one gas source containing gaseous NO, in particular a NO / N2 gas mixture; a gas supply device according to the invention, into which an NOx-containing gas is input by means of at least one gas source; - a medical ventilator for supplying a gas containing oxygen; an input line through which gas (i.e. a NO-containing gas, such as a NO / N2 mixture) is supplied by a gas supply device according to the invention and through which gas (i.e. a gas containing oxygen, for example air or an O2 / N2 mixture) is supplied by a medical ventilator; Equipped with.
[0013] According to the embodiments considered, the gas dosing installation of the invention may comprise one or more of the following features: - a medical ventilator, i.e. a ventilatory support device, in fluid communication with the input line for supplying the input line with a breathing gas containing at least about 21% by volume of oxygen, in particular air or a N2 / O2 mixture. A medical ventilator is a respiratory support device that delivers gas at a constant pressure, or alternatively, a medical ventilator is a high frequency oscillator ventilator that delivers gas by HFO (high frequency oscillation). The gas input line is supplied with a therapeutic gas, preferably a NO / N2 mixture, by a gas supply device and with a breathing gas containing at least about 21% by volume of oxygen, preferably air or a N2 / O2 mixture, by a medical ventilator. the gas source comprises a NO / N2 mixture containing less than 2000 ppm by volume NO, the remainder being nitrogen, preferably less than 1000 ppm by volume NO, the remainder being preferably nitrogen, the therapeutic gas source comprises a NO / N2 mixture containing 250-900 ppm by volume NO, the remainder being nitrogen, for example in the order of 800 ppm by volume NO, the remainder being nitrogen. the gas source further comprises a gas humidifier arranged on the gas input line, preferably downstream of the point at which a device for supplying therapeutic gas is fluidly connected to the gas input line for inputting therapeutic gas to said device. The gas source further comprises a line for collecting gas exhaled by the patient. The gas input line and the exhaled gas return line are connected at a connecting piece, preferably a Y-piece, to define or form all or part of a patient circuit. The input line forms the inspiratory branch of the patient circuit. - The exhaled gas collection line forms the expiratory branch of the patient circuit. The gas analysis line of the -NO supply is fluidly connected to the gas input line, i.e., the intake branch. The gas input line, ie the inspiratory branch, is equipped with a flow sensor located between the ventilator and the injection site of the NO-containing gas coming from the NO supply device. The flow sensor is connected to a control means of the NO delivery device. The flow sensor is delivered by the medical ventilator and measures the flow of oxygen-containing gas circulating in the gas input line, i.e., the inspiratory branch. The gas input line, i.e., the inspiratory branch, is fluidly connected to the outlet port of the medical ventilator to collect and carry gas delivered by the medical ventilator. - An exhaled gas collection line, i.e., the expiratory branch, is fluidly connected to the inlet port of the medical ventilator so as to carry all or a portion of the gas exhaled by the patient to the medical ventilator. At least one source of therapeutic gas comprises one or more gas containers, in particular one or more pressurized gas cylinders. - One or more gas containers are equipped with a gas dispensing valve with or without an integral pressure reducer (RDI). The gas distribution valve may be made from a copper alloy, such as brass, and / or may be equipped with a protective cowl disposed around the gas distribution valve, for example made from a polymeric material (i.e., plastic), a metal, or a combination thereof. The one or more fluid containers are pressurized gas cylinders containing a gas mixture, in particular NO / N2, at a pressure of at least 150-200 bar abs, or at least 250-300 bar abs when full. The fluid vessel has the general shape of a cylinder, in particular an ogive.
[0014] Generally, within the scope of the present invention: - "ppmv" stands for parts per million by volume. "Volume %" stands for volume percentage. "NO" means nitric oxide. -"NO2" means nitrogen dioxide. "N2" means nitrogen. - "O2" means oxygen. - "sensor" means a measurement device designed, suitable and / or configured to measure and provide one or more signals or measurements, for example, an NO sensor is a NO concentration measurement device for measuring and providing one or more nitric oxide concentration signals or measurements. - The terms "concentration", "dosage" and "content" should be considered equivalent. - the term "means of / to / for" is considered to be fully equivalent to and replaceable with the term "device of / to / for", e.g. the term "control means" can be replaced by "control device", the term "valve means" can be replaced by "valve device", "control means" can be replaced by "control device", etc.
[0015] The invention will now be better understood from the following detailed description, given by way of non-limiting example, with reference to the attached drawings, in which: [Brief description of the drawings]
[0016] [Figure 1] 1 shows an embodiment of an installation for administering a gas, i.e. an NO-containing gas, comprising an NO supply device according to the invention. [Diagram 2] 1 illustrates a schematic of the operation of an NO delivery device according to the present invention. [Diagram 3] 2A-2C are schematic diagrams illustrating an example of the display of information relating to a safety check to be performed and first and second virtual selection keys on a graphical display screen of an NO delivery device according to the present invention; [Figure 4] 13A-13C are schematic diagrams illustrating an example of the display of a third virtual selection key on a graphical display screen of an NO delivery device in accordance with the present invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] An embodiment of an installation 100 for administering gas is illustrated in Fig. 1. Here, the installation 100 comprises two pressurized gas cylinders or gas sources 10, each containing a NO / N2 gas mixture containing up to 1% by volume NO, typically 100-1500 ppmv NO (rest N2), i.e. here for example a NO / N2 gas mixture containing 450 or 800 ppmv NO (rest N2), which is fed into a device or apparatus 1 for supplying, i.e. delivering, NO, and which allows monitoring / tracking and controlling the supply of the NO / N2 gas mixture.
[0018] Gas cylinder 10 is fluidly connected to NO supply apparatus 1 via a gas input line 12, such as a flexible hose or conduit or the like, which may be equipped with devices for regulating and / or monitoring gas pressure, such as a gas regulator 13, a pressure gauge, etc. Gas input line 12 is connected to one or more gas inlets 2 of NO delivery device 1, which supplies an internal gas circuit, e.g., one or more gas passages internal to NO delivery apparatus 1, that serve to carry gas within NO delivery device 1, i.e., into the housing or shell of NO delivery device 1.
[0019] The NO delivery device 1 also comprises an oxygen inlet 3 that is fluidly connected via an oxygen input line 12, such as a flexible hose or the like, to a source of oxygen, e.g., a pressurized oxygen cylinder or a hospital network, i.e., oxygen supply lines located throughout the hospital premises.
[0020] The equipment 100 for administering gas further comprises a medical ventilator 50, i.e. a respiratory assistance device, which delivers a flow of breathing gas, such as air or an oxygen / nitrogen (N2 / O2) mixture, or even oxygen, typically containing at least about 21% of oxygen.
[0021] The medical ventilator 50 and the NO supply device 1 of the installation 100 for administering gases are in fluid communication with a gas input line or inspiratory branch 21 of the patient circuit 20. The gas input line or inspiratory branch 21 serves to deliver a gas flow to the patient, which gas flow is formed by mixing an oxygen-based flow (i.e. air or a NO / N2 mixture) from the medical ventilator 50 with an NO-containing flow delivered by the NO supply device 1, i.e. the NO / N2 gas mixture.
[0022] More precisely, the NO supply device 1 delivers or injects an NO / N2 mixture, e.g., at 450 or 800 ppmv NO, into the gas input line 21 via an inlet line or duct 23 connected to the NO outlet 5 of the device 1, and mixes (at 24.1) the NO / N2 stream with an oxygen-based gas stream (having at least about 21% O2), e.g., air or an oxygen / nitrogen mixture, delivered by the medical ventilator 50 and carried through the inspiratory branch 21 of the patient circuit 20, to obtain a final mixture, i.e., a NO / N2 / O2 gas mixture, essentially containing the desired dosage of NO, nitrogen (N2) and oxygen (O2), and possibly unavoidable impurities (e.g., argon, CO2, NO2, etc.).
[0023] The inspiratory branch 21 further comprises a gas humidifier 30 arranged downstream of the site 24 where NO is injected into the inspiratory branch 21. The gas humidifier 30 makes it possible to humidify a gas flow, for example a NO / N2 / O2 gas mixture, before it is inhaled by a patient to be treated by means of a respiratory interface 40, such as a tracheal intubation tube, a respiratory mask or the like.
[0024] Also provided is a line for collecting gases exhaled by the patient, forming the expiratory branch 22 of the patient circuit 20. The gas input line or inhalation branch 21 and the exhaled gas collection line or expiratory branch 22 are connected at a connection piece 25, preferably a Y-piece.
[0025] The inspiratory branch 21 is fluidly connected upstream to an outlet port 51 of the medical ventilator 50, such as a connector, coupling, or the like, to collect and carry the oxygen-based gas delivered by the medical ventilator 50, typically air or a N2 / O2 mixture (containing about 21% O2), while the expiratory branch 22, which carries exhaled gases, is fluidly connected to an inlet port 52 of the medical ventilator 50, such as a connector, coupling, or the like, to return all or a portion of the flow of gases exhaled by the patient to the medical ventilator 50.
[0026] The expiratory branch 22 for exhaled gases may comprise one or more optional components used to remove CO2 present in the patient's exhaled gases, for example a CO2 removal device 35, i.e. a CO2 trap such as a high temperature container or the like, or a filter or the like.
[0027] A flow sensor 25, for example of the hot wire or differential pressure type, is arranged on the gas input line or inhalation branch 21 between the ventilator 50 and the humidifier 30 and is connected to the NO delivery device 1 via a flow measurement line 26. This arrangement serves to measure the flow rate of gas, such as air or an N2 / O2 mixture, delivered by the ventilator 50 and circulating in the inhalation branch 21 upstream of the site 24 where the inlet conduit or line 23 is connected and where the NO / N2 / O2 gas mixture is formed. This allows for a more efficient regulation of the delivery of the NO flow (i.e. N2 / O2) by the NO delivery device 1, since the flow measurement performed by the flow sensor 25 is returned via the flow measurement line 26 to the control means of the NO delivery device 1.
[0028] 2, the NO supply device 1 comprises a rigid housing, made in a conventional manner, for example from a polymer, through which passes an internal gas circuit 6, such as a gas conduit or the like, for carrying a NO / N2 stream input through one or more gas input lines 12, which are fed by a NO / N2 mixture cylinder 31. The internal gas circuit 6 fluidly connects a gas inlet (or inlets) 21 of the NO supply device 1 to an input line 23 via a NO outlet 5 of the device 1, for carrying an NO-based gas stream therebetween. The internal gas circuit 6 is disposed in the housing.
[0029] A flow control means, typically a valve means 7, i.e. one or more valve devices, for example a solenoid valve or multiple solenoid valves arranged in parallel, preferably one or more proportional (solenoid) valves, is arranged in the internal gas circuit 6, typically on the internal gas passage, to control the gas flow(s) circulating in the internal gas circuit 6 in the direction of the injection line 23, i.e. the flow rate.
[0030] To do this, the valve means 7 are controlled by control means 8, i.e. one or more control devices or controllers, typically one or more microprocessors 9 implementing one or more algorithms, typically one or more microcontrollers, also arranged in the housing of the NO delivery device 1, an electronic board. The control means 8 may comprise other elements such as storage means (not shown), for example one or more computer memories such as flash memories. The control means 8 makes it possible in particular to adjust or control the gas flow rate by controlling the valve means, typically opening or closing one or more of said valves, in order to obtain a gas flow rate determined and / or calculated by the control means 8 depending on the flow rate of gas, i.e. air, delivered by the ventilator 50 from a value set / fixed by the user and measured by a flow sensor 25 arranged on the inspiratory branch 21 and connected to the NO delivery device 1 by a flow measurement line 26.
[0031] The internal gas circuit 6, in particular the internal gas passages, of the NO supply device 1 may also comprise one or more flow meters (not shown) and / or pressure regulators, such as pressure reducers (not shown), arranged upstream and / or downstream of the valve means 7, to determine the flow rate of the NO-based gas circulating through the NO supply device 1. The flow meters may be of differential pressure type, hot wire type, or of some other type. The flow meters again cooperate with the control means 8 to provide the control means with measurements of the NO / N2 flow rates, which are processed by the control means 8 to ensure efficient delivery of NO, in particular as a function of the flow rate of the O2-based gas supplied by the medical ventilator 50.
[0032] Typically, the NO delivery device 1 also comprises a graphical display screen 4, preferably a touch screen, i.e. a graphical user interface (GUI) with a touch panel, which serves to display various information items or data, icons, curves, warnings, etc., as well as virtual selection keys and / or panes or windows, in particular for choosing, making selections, or for inputting information such as desired values (e.g. flow rate, dose of NO, etc.), or any other information or data useful to the medical practitioner. The display is preferably in color, but can also be in black and white.
[0033] The control means 8 of the NO delivery device 1 comprise, for example, an electronic control card and a microprocessor-based control unit 9, typically a microcontroller or similar. The control means 8 make it possible to regulate or control all the electromechanical elements of the device 1. More precisely, the control card preferably integrates the control unit and is configured to control and to analyze the signals coming from the various components such as sensors, etc.
[0034] Power for the NO delivery device 1, in particular for the components that require an electric current to operate, such as the control means, the graphical display screen 4, etc., is conventionally provided by a current source and / or electrical supply means (not shown), e.g. a connection to the mains current (110 / 220 V), such as an electric cord and a connecting socket, and / or one or more batteries, preferably rechargeable batteries, and / or a current transformer. The power supply to the medical ventilator 50 is ensured in a similar manner, in particular by a connection to the mains current or by an internal battery.
[0035] Finally, the installation 100 also comprises a gas collection line 60 fluidly connecting the inlet branch 21 to the NO supply 1. The gas collection line 60 is fluidly connected (at 61) to the gas input line 21 between the humidifier 30 and the junction piece 25, i.e., the Y-piece, typically in the immediate vicinity of the junction piece 25, and also to an inlet port 62 of the NO delivery device 1, e.g., a port 62 supported by a connector, coupling, or the like, for connecting the gas collection line 60, e.g., a flexible hose or the like, to a gas analysis line 111 equipped with a sensor 112 of an internal gas analyzer 110, as will be described in more detail below.
[0036] The gas collection line 60 allows a gas sample to be taken from the inspiratory branch 21 of the patient circuit 20 and carried to the NO delivery device 1 where the gas sample is analysed in an internal gas analyser 110, i.e. in a gas analysis line 111 equipped with one or more sensors 112, typically measuring means such as, for example, one or more electrochemical cells, electrically connected to the control means 8 to verify the consistency of the analysed gas sample.
[0037] It should be verified in particular that the composition of the final gas matches the composition of the desired NO / N2 / O2 gas mixture to be administered to the patient, in order to ensure that the final gas does not contain excessive amounts of toxic NO2 species, that the oxygen content of the final gas is not hypoxic, that the final gas does not have an excessively high NO2 content, and that the NO content of the final gas corresponds to the desired dosage, i.e. the dosage of NO to be administered by inhalation, which is usually selected by a medical professional, i.e. a physician or similar person.
[0038] In other words, the gas sampling line 60 makes it possible to monitor the composition of the final gas mixture, i.e., the NO / N2 / O2 gas mixture, to ensure that the content of NO and O2 species complies with the desired contents and that the content of toxic NO2 species does not exceed a few ppmv.
[0039] This consistency check is conventionally performed by dedicated measurement means, typically the NO2, NO and O2 sensors 112, e.g. electrochemical cells or the like, which themselves must be calibrated periodically, e.g. weekly, by initiating a predefined calibration procedure stored in a storage means of the device 1, such as a flash memory or the like.
[0040] The control means 8 of the device 1 is also configured to collect and process, i.e. analyze, the signals coming from the various sensors 112 of the gas analyzer 110 arranged in the device 1 and to operate in response to these signals, in particular to calibrate the sensors.
[0041] According to the present invention, this is to minimize the risk that a medical professional, such as a doctor, nurse, or other, i.e., one or more care teams, will fail to initiate all or some of the checks essential for the proper functioning of the NO supply device 1, in particular the periodic calibration of the sensors 112, i.e., the monitoring cells of the gas analysis line 111, typically the NO and NO2 sensors 112.
[0042] To do this, the control means 8, electrically connected to the one or more sensors 112 of the gas analysis line 111, i.e. the one or more NO and NO2 sensors, is configured to control the display on the graphical display screen 4 at a given time frequency, for example once a day, i.e. every 24 hours, of at least one item of information related to one or more safety checks to be performed, typically a reminder of a calibration to be performed, and a first virtual selection key 81, i.e. a first tactile key, wherein activation of the first virtual selection key 81 by a user, i.e. nursing staff, causes the control means 8 to initiate a procedure of a safety check selected from those displayed by the graphical display screen 4, i.e. a stored procedure, particularly preferably a calibration procedure to be performed daily, i.e. at least once a day.
[0043] FIG. 3 shows an example of the display of information 80 concerning safety checks to be performed, namely here checking the water trap and the pressure of the gas in the cylinder of the device 1, in particular the pressure of the NO / N2 gas mixture, as well as calibrating the sensors of the gas analysis line, and the display of a first virtual selection key 81 (calibration key) on the graphical display screen 4 of the NO supply device 1, which serves to start the calibration procedure, and preferably also a second virtual selection key 82 (cancel key), which serves to delay or cancel the start, i.e. the beginning, of the calibration procedure.
[0044] Preferably, these indications are shown in pop-up windows 84 that appear on the graphical display screen 4 .
[0045] One or more items of information 80 relating to the safety checks to be performed, in particular the calibration of the sensors, as well as the first and second virtual selection keys 81, 82 are automatically displayed on the graphical display screen at a given time frequency, typically at least once a day, i.e. at least every 24 hours. This is done by control means 8 integrated with or cooperating with a time counter, for example a time counter integrated in the microprocessor 9.
[0046] Information 80 relating to the security checks to be performed is preferably stored in a storage means of the device 1, such as a flash memory or any other type of computer memory.
[0047] When the user sees one or more items of information 80 relating to a safety check to be performed, in particular the calibration of a sensor, and first and optionally second virtual selection keys 81, 82 appearing on the graphical display screen 4, in particular in a pop-up window, the user may: - delaying or preventing / rejecting the start of the calibration procedure by pressing a second virtual selection key 82 that is configured to prevent, i.e. not start, the calibration procedure; or starting the calibration procedure by pressing the first virtual selection key 81. You can decide to do one of the following:
[0048] Thus, when the first virtual selection key 81 is pressed, a first signal (i.e. a calibration start signal) is sent to the control means 8 which, in response to this pressing / selection by the user, commands the display of one or more items of information 80 related to safety checks to be performed, e.g. sensor calibration, and the interruption of the display of the first and second virtual selection keys 81, 82, and the control means 8 also starts a calibration procedure of the sensor of the gas analysis line of the device 1.
[0049] In this case, the safety checks to be performed, e.g. sensor calibration, as well as one or more items of information 80 relating to the first and optionally second keys, will only be re-displayed, in particular in a new pop-up window, at the end of a given time frequency, e.g. 1 to 4 times a day.
[0050] However, according to the embodiment illustrated in Fig. 4, once a calibration procedure of the sensor has been started, the device 1 can be configured to display, after pressing the first virtual selection key 81, on the graphical display screen 4 a third virtual selection key 83 (stop key) which can also be actuated by the user by pressing, the actuation of which generates a calibration procedure cancel signal which is transmitted to the control means 8 which then, in response to this cancel signal, commands that the started calibration procedure is stopped. This thus allows the user to stop the calibration procedure, for example, if the user has made a mistake by unintentionally starting such a procedure or, moreover, if the procedure has to be interrupted due to an urgent need of the device 1.
[0051] In other words, the control means can also be configured to control the display of a third virtual selection key 83 on the graphical display screen 4, the actuation of the third virtual selection key 83 by the user causing an interruption of the calibration procedure that has begun, i.e. that began after the user pressed the first virtual selection key.
[0052] Advantageously, a time graph 85, such as a bar graph, hourglass or the like, is also displayed, indicating the time that has elapsed since the start of the calibration procedure and / or the time remaining before the end, i.e. the end, of the calibration procedure. This helps the user to decide whether or not to interrupt the calibration procedure by pressing the third virtual selection key 83.
[0053] Conversely, if the user presses the second virtual selection key 82, a second signal (i.e. a signal for non-starting calibration or delayed calibration) is sent to the control means 8 which, in response to this pressing / selection by the user, commands the display of information 80 relating to the safety check to be performed, e.g. the calibration of the sensor, and the interruption of the display of the first and second virtual selection keys 81, 82, but does not start the calibration.
[0054] In this case, one or more items of information 80 relating to a safety check to be performed, e.g. sensor calibration, as well as the first and preferably second virtual selection keys 81, 82 will then disappear from the display screen 4 and re-appear there only after a given period of time, e.g. after one or two hours, or after another period of time, or only at a given frequency of time, i.e. for example after 24 hours.
[0055] The display on the display screen 4 may be in color or black and white, depending on what is selected by the user from the menu of the device 1.
[0056] The NO supply device 1 of the present invention can be used in a gas administration facility 100, e.g., that of FIG. 1, to administer nitric oxide (NOi), i.e., the resulting final NO / O2 / N2 mixture, via a mask or tracheal intubation tube, to one or more persons, i.e., patients, who require the final NO / O2 / N2 mixture to treat a lung disease, typically one or more patients suffering from acute pulmonary arterial hypertension, in particular to increase oxygenation of the pulmonary blood vessels by dilating the patient's pulmonary blood vessels and / or improving pulmonary gas exchange, in particular to treat pulmonary arterial hypertension of the newborn (PPHN), acute respiratory distress syndrome (ARDS), mainly seen in adults, or pulmonary hypertension (PH) in cardiac surgery, seen in adults or children.
Claims
1. An apparatus (1) for supplying a NOx-containing gas, comprising: - an internal gas circuit (6) for conveying a flow of NO-containing gas, comprising valve means (7); - control means (8) having a microprocessor (9); - a tactile graphical display screen (4) controlled by said control means (8); a gas analysis line (111) equipped with at least one sensor (112) electrically connected to said control means (8); wherein the control means (8) is configured to control, at a given time frequency, the momentary display on the tactile graphical display screen (4) of at least a first virtual selection key (81), wherein activation of the first virtual selection key (81) by a user causes the control means (8) to initiate a calibration procedure of one or more of the sensors (112) of the gas analysis line (111).
2. 2. The device according to claim 1, characterized in that said first virtual selection key (81) cooperates with said control means (8) to supply said control means (8) with at least one control signal corresponding to a selection made by said user, said selection corresponding to the initiation of a calibration procedure of said sensor.
3. 2. The device according to claim 1, characterized in that the control means (8) are further adapted to control the display on the tactile graphical display screen (4) of at least one item of information (80) related to one or more safety checks to be performed, in particular a calibration procedure for the sensor.
4. 4. The device according to claim 3, characterized in that the control means (8) are adapted to control the display of at least one item of information (80) and / or the first virtual selection key (81) with a time frequency of at least once a day.
5. 2. The device of claim 1, wherein the control means (8) is further configured to control the display of a second virtual selection key (82) simultaneously with or subsequent to the first virtual selection key (81), the second virtual selection key (82) being configured to cancel or reject a calibration procedure of the sensor in response to a user actuation of the second virtual selection key (82).
6. 6. Apparatus according to claim 5 when dependent on claim 3, characterised in that the control means (8) is adapted to control the simultaneous display of at least one item of information (80) and of the first virtual selection key (81) and optionally a second virtual selection key (82).
7. 2. The device according to claim 1, characterized in that the control means (8) controls the valve means (7) to control the flow of gas in the internal gas circuit (6) so as to allow or stop any circulation of gas in the internal gas circuit (6).
8. The apparatus of claim 1 , wherein at least one of the sensors (112) comprises one or more electrochemical cells.
9. 7. The device according to claim 6, characterized in that said control means (8) are configured to control the simultaneous display of at least one item of said information (80) and of said first virtual selection key (81) and optionally a second virtual selection key (82) in a pop-up window (84).
10. 5. Apparatus according to claim 4, characterized in that the control means (8) are arranged to control the display of at least one item of information (80) and / or the first virtual selection key (81) with a time frequency of 1 to 4 times per day, preferably 1 or 2 times per day.
11. 4. Apparatus according to claim 3, characterized in that it comprises storage means arranged to store one or more of said safety check procedures, in particular a calibration procedure for said sensor.
12. 6. The device according to claim 1 or 5, characterized in that the control means (8) is further configured to control the display on the tactile graphical display screen (4) of a third virtual selection key (83), the activation of which by the user causes an interruption of the started calibration procedure.
13. 2. The device according to claim 1, characterized in that the control means (8) are further adapted to control the display on the tactile graphical display screen (4) of a time graph (85), in particular a time graph representing a bar graph or an hourglass, representing the time elapsed since the start of the sensor calibration procedure and / or the time remaining before the end of the sensor calibration procedure.
14. 14. Apparatus according to claim 13 when dependent on claim 12, characterized in that the control means (8) are further adapted to control the simultaneous display of the third virtual selection key (83) and of the time graph (85) on the tactile graphical display screen (4).
15. An apparatus (100) for administering gas to a patient, comprising: - gaseous NO, especially NO / N 2 At least one gas source (10) containing a gas mixture; - a device (1) according to any one of claims 1 to 14, in which an NO-containing gas is input by at least one said gas source (10); - a medical ventilator (50) for supplying an oxygen-containing gas; a gas input line (21) through which gas is supplied by said device (1) and by said medical ventilator (50); Equipped with, facilities.
Citation Information
Cited By
Oxygen generator
KR102908347B1