Remote tracking system of nitric oxide supply apparatus

0001The invention relates to a system for remote monitoring of at least one NO supply apparatus, preferably several apparatuses, used to treat patients with a gas containing NO, in particular a NO/N gas mixture.₂, that is, a gas based on NO.

0002Nitric oxide is used to treat people, i.e. patients, suffering from acute pulmonary arterial hypertension. When inhaled by the patient, NO, called "iNO," "iNO," or "inhaled NO," dilates the pulmonary vessels and increases oxygenation by improving gas exchange. These properties are used to treat various medical conditions, such as Pulmonary Arterial Hypertension of the Newborn or PPHN (for<i>Persistent Pulmonary Hypertension of the Newborn</i>), Acute Respiratory Distress Syndrome or ARDS observed mainly in adults or pulmonary hypertension (PH) in cardiac surgery in adults or children, as described in particular by<patcit id="pcit0001" dnum="EP560928A"><text>EP-A-560928</text></patcit>, <patcit id="pcit0002" dnum="EP1516639A"><text>EP-A-1516639</text></patcit> And<patcit id="pcit0003" dnum="US10201564A"><text>US-A-10,201,564</text></patcit>.

0003A gas supply installation used for implementing NOi treatment usually comprises one or more NO/N cylinders₂ containing a NO/N gas mixture₂ of given composition, a NO supply device supplied with NO/N mixture₂ and a medical ventilator providing a flow of gas containing oxygen (i.e. >20% vol. approximately), such as air, which NO supply device and medical ventilator supply a patient circuit fluidically connected to a respiratory interface (i.e., tracheal intubation tube, mask or other), which circuit includes a flow sensor and is used to convey the gas flow. It may include other elements, such as a gas humidifier or other.

0004The NO supply device and the medical ventilator are fluidically connected to the patient circuit to supply the NO/N gas mixture.₂ and the flow of oxygen-containing gas, respectively.

0005The NO/N gas mixture₂ feeding the NO supply device contains a small amount of gaseous NO (eg &lt;1000 ppm vol.) diluted in nitrogen (N₂). It is then injected by the NO supply device into the gas stream containing oxygen, typically about at least 20% vol. oxygen (O₂), such as a mixture N₂/O₂ or air, or even pure oxygen, from the medical ventilator so as to form a final NO/N gas mixture₂/O₂. The NO/N gas mixture₂ therefore undergoes dilution in the gas stream containing oxygen and the resulting final gas mixture therefore contains NO, nitrogen and oxygen, and even unavoidable impurities.

0006The final gas mixture NO/N₂/O₂ is carried by the patient circuit and is then administered by inhalation to the patient by means of the respiratory interface, such as a tracheal intubation tube, a respiratory mask or the like, providing the gaseous NO to the respiratory tract and/or lungs of the patient to be treated.

0007The final NO concentration in the final gas mixture (i.e. NO/N₂/O₂) administered to the patient corresponds to a dosage determined by a physician or similar. Generally, it is between 1 and 80 ppm by vol. (ppmv), typically in the order of 10 to 30 ppmv, depending on the population being treated, i.e. newborns, children, adolescents or adults, and/or the disease to be treated.

0008The NO supply device is therefore used to regulate the quantity of NO/N mixture₂ injected into the oxygen-based gas flow from the ventilator and to monitor the treatment, including the quantities of NO supplied, the NO setpoints set, the alarm thresholds set (eg NO, NO₂...), possible alarm triggers or other settings or events that occurred during the treatment of the patient(s). In other words, the NO supply device ensures the supply of NO and monitoring of this supply, and triggers audible and visual alarms if related problems are detected.

0009When an NO supply device is used in a hospital environment, there are numerous alarms triggered with different criticalities, all of which require action from the healthcare staff. Therefore, each alarm triggered must be noted by the healthcare staff, who must understand its origin and, if necessary, implement one or more appropriate corrective measures.

0010To do this, currently, healthcare staff must record in writing, for example in a register, notebook or similar, the list of all alarms that have been triggered as well as other related information, such as the device(s) concerned, the patient(s) concerned, the date and time of the triggers, etc. in order to be able to visualize after the fact which alarms were triggered over the period of time considered and, above all, to understand the reasons for these alarms being triggered so that appropriate corrective measures can be taken.

0011While alarms are essential for patient safety, they also generate stress for healthcare staff and are time-consuming, particularly due to the records that need to be made in the register.

0012Furthermore, these written records made by healthcare staff are sources of errors and omissions leading to errors of interpretation, or even to the implementation of inappropriate corrective actions which could impact the effectiveness of future treatments, and therefore patient safety.

0013This is even more true when several NO supply devices are used within the same hospital establishment.

0014Moreover,<patcit id="pcit0004" dnum="US2021268221A"><text>US2021268221</text></patcit> which teaches a device for generating NO from a reactive gas (eg N₂ and O₂), using electrodes arranged in one or more plasma chambers. A controller is used to regulate the amount of NO produced. A replaceable fan cartridge is used to house sensors that monitor flows and may include memory for storing various information, such as configuration information, batch or serial numbers, patient or alarm logs, history, etc. It includes a monitor displaying patient curves and alarms that can be remotely connected to a visualization system.

0015In addition, the user manual for the inhalation NO delivery device called INOmax DS_IR Plus, 2014-07, allows triggered alarms to be recorded in the device's memory. The alarm history can be viewed on the device itself.

0016These devices do not allow remote monitoring of alarms, particularly when several NO devices need to be monitored simultaneously, such as a fleet of devices used within the same hospital establishment.

0017A problem is therefore to be able to avoid all or part of these problems, in particular those linked to the need to keep an alarm log for each NO supply device, in particular in order to improve the effectiveness of iNO treatments and patient safety. It is understood that this problem is all the more important as the number of NO supply devices is high, knowing that in some hospitals or similar, a fleet of several dozen devices can be used to treat patients.

0018In other words, it is essential to be able to ensure effective monitoring, i.e. over time, of one or more NO supply devices used to treat patients in a hospital environment, in particular of a fleet of NO supply devices used within the same hospital establishment, which devices are each likely to trigger alarms during their operation, i.e. when they are used to treat patients.

0019One solution of the invention relates to a system for remote monitoring, i.e. monitoring, of at least one NO supply device used to treat patients with a gas containing NO, in particular a NO/N gas mixture.₂, comprising storage means for storing operating data of the apparatus in question collected during the use of the apparatus in question during successive patient treatments having taken place during a given period of time (Dt), each NO supply apparatus being supplied with gas containing NO, typically a NO/N gas mixture₂, during said patient treatments, said operating data comprising alarm triggers of different types having occurred during said given period of time (Dt).

0020The said remote tracking system includes:<ul id="ul0001" list-style="dash" compact="compact"><li>at least one remote server configured to process the operating data stored by the storage means of the NO supply device and to extract therefrom information relating to the patient treatments having been carried out and to the operating events occurring during said patient treatments, and</li><li>a graphic display configured to display at least part of said information, the information displayed by the graphic display comprising, for at least one time interval (It) considered in the given time period (Dt):<ul id="ul0002" list-style="none" compact="compact"><li>▪ at least some of the most frequently triggered alarms, i.e. the most frequent,</li><li>▪ an occurrence or number of triggers of at least some of the most frequently triggered alarms,</li><li>▪ a proportion of triggering of at least some of the most frequently triggered alarms,</li><li>▪ an average resolution time for at least some of the most frequently triggered alarms,</li><li>▪ an average number of alarms triggered per treatment and/or</li><li>▪ an average resolution time for at least some of the most frequently triggered alarms.</li></ul></li></ul>

0021In addition, the remote monitoring system further comprises time interval duration selection means (It) configured to allow a user to choose a period start date and a period end date, or a period start date and a duration.

0022Depending on the embodiment considered, the remote tracking system of the invention may comprise one or more of the following features:<ul id="ul0003" list-style="dash" compact="compact"><li>the graphic display is configured to display several different information chosen from the aforementioned information.</li><li>the information displayed by the graphic display includes the 3 to 20 most frequently triggered alarms, i.e. the most frequent, over the time interval (It) considered, preferably the 5 to 15 most frequently triggered alarms, for example the 10 most frequently triggered alarms.</li><li>the information displayed by the graphic display includes so-called “critical” alarms or critical alarms chosen from among the most frequently triggered alarms, i.e. the most frequent, over the time interval (It) considered, preferably the 3 to 7 critical alarms. Critical alarms correspond to the most frequently triggered alarms with the highest occurrences, i.e. the most numerous or having triggered most often over the time interval (It) considered.</li><li>the information displayed by the graphic display includes the occurrences or number of triggers of so-called “critical” alarms or critical alarms.</li><li>the information displayed by the graphic display includes the frequency or proportion (%) of triggers of so-called “critical” alarms or critical alarms.</li><li>The graphic display is of the color display type.</li><li>the graphic display is further configured to display the time interval (It) considered, for example a start date and an end date.</li><li>the graphic display is further configured to display, for the time interval (It) considered: a total number of treatments, a number of short treatments, preferably less than 6 hours, and/or a number of long treatments, preferably at least 6 hours.</li><li>the graphic display is further configured to display for the time interval (It) considered, 3 to 6 critical alarms corresponding to the 3 to 6 most frequently triggered alarms with the highest occurrences, for example 5 critical alarms.</li><li>the graphical display is further configured to display the most frequently triggered alarms and/or critical alarms according to their occurrence, for example a list starting with the alarm with the highest occurrence and ending with the one with the lowest occurrence.</li><li>the graphical display is further configured to display the most frequently triggered alarms and/or critical alarms in one or more display windows displayed on the graphical display.</li><li>the means for selecting the duration of the time interval (It) are configured to allow the selection of a time interval (It), i.e. a duration of several weeks, preferably several months, for example 2 to 12 months, in particular 3 to 8 months, for example a duration of 1 year.</li><li>the NO supply apparatus is supplied with gaseous NO from one or more NO containers containing said NO-based gas, typically the NO/N gas mixture₂.</li><li>the NO supply device is supplied with a NO/N gas mixture₂ from one or more NO containers, typically one or more NO cylinders, containing the NO/N gas mixture₂.</li><li>the NO supply apparatus comprises telecommunication means configured to transmit the operating data of the apparatus to said at least one remote server.</li><li>the telecommunications means are configured to operate using a mobile network, in particular a 4G, 5G or similar type network, or other.</li><li>the telecommunication means include transmission means, typically they include (at least) one transmitting antenna.</li><li>the telecommunication means comprise transmission means configured to transmit data in encrypted and/or analog form.</li><li>said at least one remote server comprises a “cloud” type server (“cloud”), for example the AWS (Amazon Web Service) “cloud”.</li><li>said at least one remote server comprises receiving means for receiving the operating data transmitted by the NO supply apparatus.</li><li>the alarm types (i.e. the identified alarm types) are chosen from:<ul id="ul0004" list-style="none" compact="compact"><li>▪ a “non-compliant” NO concentration alarm corresponding to an analyzed concentration value very different from the set concentration value, for example with a deviation of at least 30%, preferably at least 40%, more preferably at least 50% of the target dose.</li><li>▪ an alarm for too low NO concentration,</li><li>▪ an alarm for excessively high NO concentration,</li><li>▪ an FiO alarm₂ too low,</li><li>▪ an FiO alarm₂ too high,</li><li>▪ a battery fault alarm, i.e. battery malfunction (e.g. empty, broken, etc.),</li><li>▪ a NO injection line fault alarm,</li><li>▪ a flow measurement line fault alarm, i.e. a malfunction of the flow sensor,</li><li>▪ a gas flow fault alarm from the fan (i.e. air or O mixture₂/N₂), for example, absence of gas flow or, conversely, excessive flow,</li><li>▪ a patient connection fault alarm, for example patient disconnected or connected/plugged in but without NO flow administration,</li><li>▪ a water trap fault alarm,</li><li>▪ an analysis line fault alarm, i.e. malfunction of the analysis or sampling line and</li><li>▪ a gas source fault alarm (NO, O₂), for example non-connection or detection of empty gas cylinder (i.e. NO cylinder and/or O cylinder₂), typically a total absence alarm of full NO bottle connected to the NO supply device, i.e. empty NO bottle alarm.</li></ul></li><li>preferably, the alarm types further include:<ul id="ul0005" list-style="none" compact="compact"><li>▪ an alarm for activation of the manual ventilation system (i.e. via a manual ventilation balloon (BAVU) connected to the NO supply device),</li><li>▪ an emergency administration mode activation alarm,</li><li>▪ a battery operation alarm, i.e. when the power cord is unplugged or in the event of a mains power failure (i.e. 110V/220V), and/or</li><li>▪ an empty or almost empty battery alarm, for example having a battery life less than 10% of the maximum battery life (i.e. fully charged battery).</li></ul></li><li>it further comprises computer processing means configured to receive and process at least part of the processed information provided by said at least one remote server.</li><li>the computer processing means are further configured to control the display of the information displayed by the graphic display.</li><li>the computer processing means implement at least one algorithm configured to identify each processing, extract the events sought/monitored, and process these events to determine the related alarms.</li><li>the graphic display is configured to display at least part of the information relating to each of said NO supply devices.</li><li>it is configured to remotely monitor multiple NO supply devices.</li><li>it is configured to remotely monitor 2 to 50 NO supply devices used within a single hospital. Indeed, in larger hospitals, it may be necessary to simultaneously monitor a fleet of devices, typically several dozen NO supply devices.</li><li>it is configured to remotely monitor at least 5 NO supply devices used within the same hospital establishment, preferably at least 10 devices, more preferably at least 15 to 20 devices.</li><li>it comprises selection means configured to allow a user to choose or select the device for which he wishes to know the information, i.e. the alarms, i.e. a given device from a plurality of devices, i.e. a fleet of NO supply devices, used within a hospital establishment.</li><li>the selection means comprise one or more keys of a computer or other keyboard, a touch screen, a mouse and/or the like.</li><li>the or each NO supply apparatus is part of a gas administration installation further comprising a medical ventilator for supplying an oxygen-containing gas and a patient circuit supplied by the NO supply apparatus with NO-containing gas and by the medical ventilator with oxygen-containing gas.</li></ul>

0023According to the embodiment considered, the or each apparatus or device for supplying a gas containing NO forming part of the remote monitoring system of the invention, may comprise one or more of the following characteristics:<ul id="ul0006" list-style="dash" compact="compact"><li>it comprises at least one internal passage, typically a gas circuit comprising several gas passages, for example one or more gas conduits, passages, pipes or the like, for conveying the flow of gas containing NO and valve means arranged on said at least one internal passage, for example one or more valves, in particular one or more solenoid valves or one or more on/off valves.</li><li>it comprises microprocessor control means, namely a controller or the like, comprising one or more microprocessors.</li><li>the microprocessor control means cooperate (at least) with the valve means to control the gas flow in at least a part of said internal passage or internal gas circuit.</li><li>the control means are configured to control the telecommunication means, in particular to control the transmissions of operating data from the device to said at least one remote server.</li><li>the microprocessor(s) are arranged on an electronic card.</li><li>the storage means comprise a computer storage device, such as a computer memory, for example a flash memory.</li><li>computer memory is arranged on the or an electronic card.</li><li>it includes means of electrical supply, such as an electrical connection to the sector (110/220V).</li><li>it comprises a graphical user interface (GUI), preferably the GUI comprises a display screen and/or selection keys, such as virtual keys displayed on the display screen, ie a touch screen.</li></ul>

0024In addition, the or each installation for administering gas to a patient, i.e. a gas containing NO, including the or each apparatus or device for supplying a gas containing NO comprises:<ul id="ul0007" list-style="dash" compact="compact"><li>at least one gas source containing gaseous NO, in particular a NO/N gas mixture₂, preferably one or more gas containers, such as one or more pressurized gas cylinders,</li><li>a gas supply apparatus according to the invention, in particular as described above, supplied with gas containing NO by said at least one gas source, such as a NO/N gas mixture₂,</li><li>a medical ventilator for supplying an oxygen-containing gas, such as air or an O gas mixture₂/N₂, And</li><li>a supply line supplied by the gas supply device with gas containing NO, such as a NO/N gas mixture₂, and by the medical ventilator gas containing oxygen, such as air or the mixture O₂/N₂.</li></ul>

0025Depending on the embodiment considered, the or each gas administration installation may comprise one or more of the following characteristics:<ul id="ul0008" list-style="dash" compact="compact"><li>the (each) medical ventilator, i.e. a ventilatory assistance device, is in fluid communication with the supply line to supply said supply line with a respiratory gas containing at least about 20% vol. of oxygen, preferably at least about 21% vol. of oxygen, in particular air or a mixture N₂/O₂.</li><li>the (each) medical ventilator is a respiratory assistance device providing gas at constant pressure or, alternatively, the medical ventilator is an HFO type ventilator (<i>High Frequency Oscillations</i>) delivering the gas by high-frequency oscillations.</li><li>the gas supply line is supplied with NO/N mixture₂ by the (each) gas supply device and into a breathing gas containing at least about 20% vol. oxygen, preferably at least about 21% vol. oxygen, preferably air or a mixture N₂/O₂, by the medical ventilator.</li><li>the gas supply line is supplied with NO/N mixture₂ by the gas supply device and into a breathing gas containing oxygen, preferably air or an N mixture₂/O₂, by the medical ventilator so as to form a final gas mixture to be administered to the patient containing NO, nitrogen and oxygen, or even other compounds such as water vapor and/or impurities, such as argon or NO species₂ formed by oxidation of part of the NO.</li><li>the final gas mixture to be administered to the patient contains nitrogen, oxygen and NO in a proportion corresponding to a pre-fixed dose of NO, i.e. a dosage.</li><li>the final gas mixture to be administered to the patient contains at least 20% vol. oxygen, 150 to 1000 ppmv NO and nitrogen, and possibly unavoidable impurities and/or water vapor.</li><li>the gas source(s) contains a NO/N gas mixture₂ containing less than 2,000 ppmv of NO, the remainder being nitrogen, preferably less than 1,000 ppmv of NO, the remainder being nitrogen.</li><li>preferably, the source(s) of therapeutic gas contains a NO/N mixture₂ containing 250 to 900 ppmv of NO, the remainder being nitrogen, for example in the order of 800 ppmv of NO, the remainder being nitrogen.</li><li>it further comprises a gas humidifier arranged on the gas supply line, preferably downstream of the site where the therapeutic gas supply device is fluidically connected to said gas supply line so as to supply it with therapeutic gas.</li><li>It also includes a line for recovering gases exhaled by the patient.</li><li>the gas supply line and the exhaled gas recovery line are connected to a connecting piece, preferably a Y-piece, and define or form all or part of a patient circuit.</li><li>the supply line forms an inspiratory branch of the patient circuit.</li><li>the exhaled gas recovery line forms an expiratory branch of the patient circuit.</li><li>the NO supply apparatus further comprises a gas analysis line fluidly connected to the gas supply line, i.e. the inspiratory branch.</li><li>the gas supply line, i.e. the inspiratory branch, comprises a flow sensor arranged between the ventilator and the injection site of the gas containing the NO coming from the NO supply device.</li><li>the flow sensor is connected to the control means of the NO supply device.</li><li>The flow sensor measures the flow of gas containing oxygen (i.e. air or N mixture₂/O₂) delivered by the medical ventilator and circulating in the gas supply line, i.e. the inspiratory branch.</li><li>The flow sensor returns gas flow values or signals.</li><li>the control means are configured to control the valve means to deliver the gas flow containing NO (eg NO/N mixture₂) at a given flow rate allowing a dose of NO to be obtained in the gas supply line corresponding to the desired dose, i.e. the dosage set by the nursing staff.</li><li>the gas supply line feeds a respiratory interface, for example a breathing mask, a tracheal intubation tube or the like.</li><li>the gas supply line, i.e. the inspiratory branch, is fluidically connected to an outlet port of the medical ventilator so as to recover and convey the gas delivered by the medical ventilator.</li><li>the exhaled gas recovery line, i.e. the expiratory branch, is fluidically connected to an inlet port of the medical ventilator so as to convey to the medical ventilator all or part of the gases exhaled by the patient.</li><li>at least one source of therapeutic gas comprises one or more gas containers, in particular one or more pressurized gas cylinders.</li><li>the gas container(s) is/are equipped with a gas distribution tap with or without an integrated regulator (RDI).</li><li>the gas distribution valve is made of a copper alloy, such as brass, and/or is equipped with a protective cover arranged around the gas distribution valve, for example made of a polymer material (i.e. plastic), metal or combinations thereof.</li><li>the fluid container(s) is (are) a pressurized gas cylinder containing, when full, a gas mixture, in particular NO/N₂, at a pressure of at least 135 to 200 bar abs, or even at least 250 to 300 bar abs.</li><li>the fluid container has a generally cylindrical shape, particularly an ogive shape.</li></ul>

0026Generally speaking, within the framework of the invention:<ul id="ul0009" list-style="dash" compact="compact"><li>“ppmv” means parts per million by volume,</li><li>“%vol.” means percentage by volume.</li><li>"NO" stands for nitric oxide.</li><li>"NO₂ » refers to nitrogen dioxide.</li><li>"N₂ » refers to nitrogen.</li><li>"O₂ » refers to oxygen.</li><li>the terms “concentration”, “dose” and “content” are considered equivalent.</li><li>the terms “device” and “apparatus” are considered equivalent.</li><li>the terms “supply” and “delivery” are considered equivalent.</li><li>the terms "means of/to/for" are considered to be fully equivalent and substitutable by the terms "device of/to/for", for example the terms "control means" can be replaced by "control device", the terms "valve means" can be replaced by "valve device", the "memorization means" can be replaced by "memorization device" ...</li></ul>

0027The invention will now be better understood thanks to the following detailed description, given for illustrative but non-limiting purposes, with reference to the appended figures among which:<ul id="ul0010" list-style="none" compact="compact"><li><figref idref="f0001">Fig. 1</figref> schematizes an embodiment of a remote monitoring system according to the invention of an NO supply apparatus, in particular an NO supply apparatus forming part of a gas administration installation.</li><li><figref idref="f0001">Fig. 2</figref> schematizes an embodiment of a gas administration installation comprising an NO supply apparatus which can be remotely monitored by a remote monitoring system according to the invention, such as that of<figref idref="f0001">Fig. 1</figref>.</li><li><figref idref="f0002">Fig. 3</figref> schematizes an example of the displays operated by a remote monitoring system according to the invention, such as that of<figref idref="f0001">Fig. 1</figref>.</li></ul>

0028<figref idref="f0001">Fig. 2</figref> schematizes an embodiment of a gas administration installation 100 comprising an apparatus for supplying NO 1, that is to say a gas mixture based on nitrogen monoxide, which can be monitored remotely by a remote monitoring system S according to the invention, such as that schematized in<figref idref="f0001">Fig. 1</figref>, as explained below.

0029More specifically, the installation 100 here comprises two pressurized gas cylinders 10 each containing a NO/N gas mixture₂, namely here a gaseous mixture NO/N₂ typically containing between 100 and 1500 ppmv of NO (N remainder₂), for example 450 or 800 ppmv of NO (remainder N₂), or any other suitable concentration, which supply NO/N mixture₂, the device or apparatus 1 for supplying, i.e. delivering, NO making it possible to monitor and control the supply of the NO/N gas mixture₂.

0030The gas cylinders 10 are fluidically connected to the NO supply apparatus 1, via gas supply lines 12, such as flexible pipes or conduits or the like, which may be equipped with gas pressure regulating and/or monitoring devices, such as a gas regulator 13, pressure gauges, etc. The gas supply lines 12 are connected to one or more gas inlets 2 of the NO 1 delivery device which supply an internal gas passage used to convey the gas within the NO 1 supply apparatus, i.e. into the external housing or casing of the apparatus 1.

0031The NO 1 supply apparatus also comprises an oxygen inlet 3 fluidically connected, via an oxygen supply line 11, such as a flexible hose or the like, to an oxygen source (not shown), for example a pressurized oxygen cylinder or a hospital network, i.e. an oxygen supply pipe arranged in a hospital building.

0032The gas administration installation 100 further comprises a medical ventilator 50, i.e. a respiratory assistance device, which provides a flow of oxygen-based respiratory gas, i.e. containing at least approximately 20% vol. of oxygen, preferably at least approximately 21% vol. of oxygen, such as air or an oxygen/nitrogen mixture (N₂/O₂).

0033The medical ventilator 50 and the NO 1 supply apparatus of the gas administration installation 100 are in fluid communication with a gas supply line or inspiratory branch 21 of a patient circuit 20. The gas supply line or inspiratory branch 21 serves to convey the gas flow to the patient (not shown), in particular the final gas mixture to be administered to the patient which is formed by mixing the oxygen-based flow (e.g. air or NO/N mixture₂) from the medical ventilator 50 and the NO-based flow, i.e. the NO/N gas mixture₂, delivered by the NO 1 supply device.

0034More specifically, the NO 1 supply device delivers or injects the NO/N mixture₂, for example at 450 or 800 ppmv of NO, in the gas supply line 21, via a conduit or injection line 23, fluidically connecting the internal gas circuit (not visible on<figref idref="f0001">Fig. 2</figref>) from the NO 1 supply device to the gas supply line 21.

0035The NO/N flow₂ brought by the injection line 23 mixes, at an injection site 24, with the flow of oxygen-based gas (> 20% O₂) delivered by the medical ventilator 50 and brought by the upstream portion of the inspiratory branch 21 of the patient circuit 20 so as to obtain the final mixture to be administered to the patient, which essentially contains NO at the desired dosage, nitrogen (N₂) and oxygen (O₂), and possibly unavoidable impurities (eg argon, CO₂, NO₂, ....), i.e. a final gas mixture NO/N₂/O₂.

0036Preferably, the inspiratory branch 21 further comprises a gas humidifier 30 arranged downstream of the injection site 24 where the injection of NO into the inspiratory branch 21 takes place. It makes it possible to humidify the final gas flow before its administration to the patient.

0037The NO/N gas mixture₂/O₂ is then administered by inhalation to the patient to be treated by means of a respiratory interface 40, such as a tracheal intubation tube, a respiratory mask or the like, allowing delivery of the final gas (i.e. NO/N₂/O₂) in the patient's lungs.

0038A line for recovering gases exhaled by the patient forms an expiratory branch 22 of the patient circuit 20. It is fluidically connected to the gas supply line or inspiratory branch 21 via a connecting piece 25, such as a Y-shaped piece.

0039The inspiratory branch 21 is connected, upstream, fluidically to an outlet port 51 of the medical ventilator 50, such as a connector, fitting or the like, so as to recover and convey the oxygen-based gas, typically air or N mixture₂/O₂, coming from the medical ventilator 50, while the expiratory branch 22 carrying the exhaled gases is fluidically connected to an inlet port 52 of the medical ventilator 50, such as a connector, fitting or the like, so as to return to the medical ventilator 50 all or part of the flow of gases exhaled by the patient. The expiratory branch 22 may include one or more optional components, for example a CO removal device₂ 35, ie a CO trap₂, such as a hot tank or other, allowing CO to be eliminated₂ present in the gases exhaled by the patient, a filter or other.

0040A flow sensor 25, for example of the hot wire, pressure differential or mass type, is arranged on the gas supply line 21, between the fan 50 and the humidifier 30, and is connected to the NO 1 delivery apparatus, via one or more flow measurement lines 26.

0041The flow sensor 25 is used to measure the flow of gas delivered by the ventilator 50 circulating in the inspiratory branch 21, upstream of the injection site 24 where the injection line 23 is connected and the NO/N gas mixture is created.₂/O₂. This allows for more efficient regulation of the delivery of the NO flow (i.e. N₂/O₂) by the NO 1 supply device since the flow rate measurements made by the flow rate sensor 25 are returned, via the flow rate measurement line 26, to control means (not shown) embedded in the NO 1 supply device. Typically, the control means comprise an electronic card comprising one (or more) microprocessor(s), typically one (or more) (micro)controller(s), implementing one or more algorithms.

0042More specifically, the NO 1 supply apparatus comprises a rigid housing, for example made of polymer, comprising an internal gas circuit (not visible), such as a gas conduit(s) or the like, used to convey the flow of NO-based gas, i.e. the NO/N mixture₂, from NO/N mix bottles₂ 12, and/or the flow of oxygen from the oxygen source 11.

0043The internal gas circuit of the NO 1 supply apparatus fluidly connects the gas inlet(s) 21 of the apparatus 1 to the injection line 23 in order to convey the NO-based gas flow. Valve means (not shown), i.e. one (or more) valve device(s), for example a plurality of solenoid valves arranged in parallel, preferably one or more proportional (solenoid) valves, are arranged on the internal gas circuit of the device 1 to control the gas flow which circulates therein towards the injection line 23 and the injection site 24.

0044The valve means of the NO 1 supply device are themselves controlled by the control means, i.e. one (or more) control devices, also called (micro)controllers, arranged in the housing of the NO 1 supply device.

0045The control means make it possible in particular to adjust or control the flow rate of NO-based gas by controlling the valve means, typically to open or close this or these valves, to obtain a determined flow rate of NO-based gas, which has been calculated by the control means from a value of NO content set and/or fixed by the user, typically a desired dosage, and as a function of the gas flow rate, e.g. air or N₂/O₂, delivered by the ventilator 50, which is measured by the flow sensor 25 arranged on the inspiratory branch 21 and connected to the NO 1 supply device, in particular to the control means, by the flow measurement line 26.

0046The internal gas circuit of the NO 1 supply apparatus may also comprise one or more flow meters arranged upstream and/or downstream of the valve means, to determine the flow rate of NO-based gas circulating in the NO 1 supply apparatus, in particular to ensure that it complies with the desired flow rate. The flow meter may be of the pressure differential, hot wire or other type. It cooperates with the control means to provide them with flow rate measurements of the NO/N flow₂These flow measurements are processed by the control means in order to ensure efficient delivery of NO depending in particular on the flow of O-based gas.₂ provided by the medical ventilator 50.

0047Preferably, the internal gas circuit of the NO 1 supply apparatus may also comprise a pressure regulator, such as a gas pressure reducer or the like, in order to adjust, eg reduce, the pressure of the NO-based gas coming from the gas cylinders 10.

0048Usually, the NO 1 supply device also comprises a graphical user interface or GUI comprising a graphical display 4, preferably a touch screen, i.e. a touch screen, used to display various information or data, icons, curves, alarms, etc., as well as virtual selection keys and/or blocks or windows, used in particular to make choices, selections or to enter information, such as desired values (eg flow rate, NO dosage, etc.), or any other information or data useful to the healthcare staff. Preferably, the display is in color but it can also be in black and white.

0049The control means of the NO 1 supply device comprise at least one electronic control card and at least one microprocessor control unit, typically a microcontroller or the like. The control means also make it possible to carry out calculations and/or to control or command all the electromechanical elements of the device 1. More specifically, the control board preferably integrates the control unit and is configured to control and otherwise analyze and/or process the signals coming from the various components, such as sensors...

0050The electrical power supply of the NO 1 supply device, in particular of the components requiring electrical current to operate, such as the control means, the graphic display 4, etc., is conventionally provided by a source of electrical current and/or electrical power supply means (not shown), for example a connection to the mains current (110/220V) of the electrical cord and connection socket type, and/or one (or more) electrical power supply batteries, preferably rechargeable, and/or a current transformer. The power supply of the medical ventilator 50 is provided in a similar manner, in particular by a connection to the mains current or an internal battery.

0051Finally, the installation 100 also comprises a gas sampling line 60 which fluidly connects the inspiratory branch 21 to the NO 1 supply device. It is fluidly connected (at 61) to the gas supply line 21, downstream of the injection site 24, namely here between the humidifier 30 and the junction piece 25, i.e. Y-piece, typically in the immediate vicinity of the junction piece 25, and furthermore to an inlet port 62 of the NO 1 supply device, for example a port 62 carried by a connector, fitting or the like, allowing the connection of the gas sampling line 60, such as a flexible pipe or the like.

0052The gas sampling line 60 makes it possible to take gas samples from the inspiratory branch 21 of the patient circuit 20 and convey them to the NO 1 supply device where they are analyzed in an internal gas analyzer (not shown), that is to say within a calibration line comprising at least one sensor electrically connected to the control means, in order to verify their conformity. Typically, a calibration line is provided comprising NO sensors₂, NO and O₂, such as electrochemical cells or the like, which must be calibrated periodically, for example every week.

0053In fact, it is necessary to check that the composition of the final gas is consistent with that of the NO/N gas mixture₂/O₂ desired to be administered to the patient, in particular to ensure that it does not contain excessive amounts of NO species₂ toxic, that its oxygen content is not hypoxic (i.e. &lt;20%vol), and that its NO content corresponds to the desired dosage, i.e. dose of NO to be administered to the patient which is usually chosen by the healthcare staff, i.e. doctor or similar.

0054The control means of the device 1 are configured to recover and process, i.e. analyze, the signals coming from the different sensors of the gas analyzer and to act in response to these signals, in particular to trigger an alarm in the event of detection of a non-compliant concentration, for example excessive in NO₂, insufficient in O₂ (ie hypoxic) or different from the desired NO dosage.

0055Such a gas administration installation 100 can be used to administer by inhalation nitric oxide (NOi), i.e. the final mixture obtained NO/O₂/N₂, to people, ie patients suffering from acute pulmonary arterial hypertension, in particular to operate a dilation of their pulmonary vessels and an increase in their oxygenation by improving pulmonary gas exchange, in particular to treat Pulmonary Arterial Hypertension of the Newborn or PPHN, Acute Respiratory Distress Syndrome or ARDS observed mainly in adults, or pulmonary hypertension (PH) in cardiac surgery in adults or children.

0056Within a hospital establishment, i.e. hospital or similar, it regularly happens that several NO supply devices are used within a given department and/or in different departments, such as in emergency, intensive care, cardiology, etc., i.e. a park or fleet of NO supply devices. It is common to find at least 5 to 10 devices within a single hospital, or even more, for example, up to 50 devices in larger facilities. These devices can be used (at least some of them) simultaneously or alternately.

0057However, each of these NO supply devices 1 makes it possible to ensure a supply of NO and monitoring, i.e., of this supply over time, in particular during successive patient treatments, and to trigger audible and visual alarms, in the event of detection of problems occurring during these successive patient treatments.

0058In order to avoid the nursing staff having to record in writing all the alarm triggers and related information for each of the devices, the invention proposes a remote monitoring system S making it possible to monitor one or more NO supply devices 1, in particular one of the devices 1 used in a hospital establishment, such as a hospital or the like, to treat patients with iNO. When in use, each device is supplied with NO as explained above.

0059So,<figref idref="f0001">Fig. 1</figref> schematizes an embodiment of such a remote monitoring system according to the invention of one or more NO supply apparatus(es) 1, in particular of the NO supply apparatus 1 forming part of the gas administration installation 100 of<figref idref="f0001">Fig. 2</figref> detailed above.

0060Generally speaking, in the remote tracking system S<figref idref="f0001">Fig. 1</figref>, each NO 1 supply device is equipped with storage means, namely a computer memory or the like, configured to store operating data of each device 1 considered collected during its use or operation, i.e. during the treatments of successive patients having taken place over a given period of time Dt, including over long periods, for example several weeks or several months, typically over a period of 2 to 18 months, preferably a period of 6 to 12 months.

0061The recorded operating data include in particular the triggering of alarms of different types having been triggered during the period of time considered Dt by each device 1 but also all the information linked to these triggerings, namely the date and time of each alarm triggering, the reference of the device 1 concerned, an identification of the treatment, the hospital site concerned or others.

0062In addition, the system S also comprises one or more remote servers 200, i.e. a computer server, for example a Cloud or other type server, configured to process the operating data stored by each NO 1 supply device and to extract processed information therefrom relating to the patient treatments that have been carried out and to the operating events that have occurred during said patient treatments, in particular those which led to the various alarms being triggered.

0063In order to be able to transmit the operating data of each device 1, each NO supply device 1 comprises communication means configured to transmit to the remote computer server 200 which, for its part, comprises reception means to receive the operating data transmitted by the NO supply device 1.

0064More specifically, the system 1 also comprises computer processing means 250, which can be integrated into the server 200, which are configured to receive and process the information provided to them by the remote server 200 and to then control the display of the information displayed by a graphic display 300.

0065The computer processing means 250 comprise one or more (micro)processors implementing algorithms.

0066In other words, the remote server 200 cooperates with a graphic display 300, for example that of a computer 301, as illustrated in<figref idref="f0001">Fig. 1</figref> And<figref idref="f0002">Fig. 3</figref>, of a digital tablet or the like, used to display all or part of the information processed by the remote server 200, in particular by the computer processing means 250, for example the information collected and stored corresponding to a determined time interval (It), for example 1 to 3 months (or another duration) of the given time period (Dt), for example a period Dt of 12 months.

0067Preferably, the system S comprises selection means for selecting the duration of the time interval (It), for example a duration of several weeks or several months, for example from 2 to 12 months, in particular from 3 to 8 months. This can be done by choosing a period start date and a period end date, or a period start date and a duration, for example 3 months.

0068In addition, selection means are also provided allowing a user to select a particular device for which he wishes to know the information, i.e. alarms or other, from within the pool of monitored devices. The selection means comprise, for example, one or more keys or the like.

0069In particular, according to the invention, the information displayed by the graphic display 300 preferably comprises:<ul id="ul0011" list-style="dash" compact="compact"><li>the most frequently triggered alarms 302, i.e. a list of frequent alarms, typically 3 to 15 frequent alarms, for example the 10 most frequently triggered alarms, and preferably the 5 most critical alarms 305 or the most frequently triggered, called critical alarms (or top alarms), among these most frequently triggered alarms 302,</li><li>a trigger occurrence 304 (ie number) of at least a portion of the most frequently triggered alarms 302, for example the number of critical alarms 305 triggered,</li><li>the proportion (%) 303 of at least some of the most frequently triggered alarms, for example that of critical alarms 305.</li><li>an average resolution time 309 of the most frequently triggered alarms 302, i.e. the time elapsing between an alarm being triggered and the acknowledgment of this alarm by the user, for example by pressing an acknowledgment button, by resolving the problem or otherwise.</li><li>an average number of alarms triggered per treatment 308,</li><li>an average resolution time (or average duration) 306 of each of the most frequently triggered alarms 302 and/or</li><li>an average time (or average duration) to resolve 309 of the most frequently triggered alarms 302.</li></ul>

0070Preferably, the graphic display 300 is configured to display several of the information in this list, in particular the triggered alarms.

0071Advantageously, the different types of alarms that can be displayed are for example:<ul id="ul0012" list-style="dash" compact="compact"><li>an alarm for (too) low NO concentration, e.g. lower than the desired dose,</li><li>an alarm of (too) high NO concentration, eg higher than the desired dose,</li><li>a so-called "non-compliant" NO concentration alarm, i.e. very far from the desired dose, for example when the concentration difference is at least 30%, preferably at least 40%, more preferably at least 50% of the expected value). This difference can be pre-set and/or stored.</li><li>an FiO alarm₂ (too) low, eg below FiO₂ desired,</li><li>an FiO alarm₂ (too) high, eg higher than FiO₂ desired,</li><li>a battery malfunction alarm (empty, broken, etc.),</li><li>a NO injection line fault alarm,</li><li>a flow measurement line fault alarm, i.e. a malfunction of the flow sensor,</li><li>a gas flow fault alarm from the fan, for example insufficient or interrupted flow, or too high,</li><li>a connected patient alarm without NO-based flow administration,</li><li>an alarm for a patient not connected, i.e. not receiving NO-based flow,</li><li>a malfunctioning water trap alarm, for example unplugged or saturated with moisture,</li><li>a malfunctioning analysis line alarm, i.e. the sampling line, and</li><li>a gas bottle detection alarm (NO, O₂) empty, that is to say whose gas has been consumed.</li></ul>

0072Of course, other types of alarms can also be taken into account and displayed on the graphic display 300.

0073Preferably, the graphic display 300 is further configured to display, for the time interval (It) considered 310, a total number of treatments, i.e. patients having been treated with iNO and/or, among these, the number of short treatments (TC), i.e. treatments having had a duration less than or equal to a given maximum duration, for example a maximum duration of 6 hours (or another given duration), and/or the number of long treatments (TL) 307, that is to say having had a duration greater than the maximum duration given, for example more than 6 hours.

0074<figref idref="f0002">Fig. 3</figref> gives an example of displays operated on the graphic display 300 of a system according to the invention S, such as that of<figref idref="f0001">Fig. 1</figref>.

0075We see that the following are displayed, for a period of time considered which can be set by the user, typically by selecting a start date and an end date for the period 310, for example here between January 1 and December 31, 2023:<ul id="ul0013" list-style="dash" compact="compact"><li>the hospital concerned 301, for example the name and address of the hospital,</li><li>the 5 so-called critical alarms 302 (called “Top 5 Alarms”) among the 10 most frequently triggered alarms 305,</li><li>the proportion (%) 303 of each of these so-called critical alarms 302.</li><li>the number or occurrences 304 of each of these so-called critical alarms 302,</li><li>the list of the 10 most frequently triggered alarms and their average resolution time 306,</li><li>the number of long treatments 307, for example at least 6 hours,</li><li>the average number of alarms triggered per treatment 308, and</li><li>the average duration or average resolution time 309 of the 5 critical alarms 305.</li></ul>

0076As seen here, among the 5 so-called critical alarms 305, the most frequent alarm is that relating to a so-called "non-compliant" NO concentration meaning that the measured NO dose is very far from the set dose, i.e. the difference is for example at least 50%. This occurs when the care team disconnects the analysis line during treatment; for example during nebulization/aerosol therapy treatments. Recording this alarm and its recurrence makes it possible to detect this malfunction in the use of the equipment and to correct it by indicating to the nursing staff how to better use the special filters called "for nebulization/aerosol therapy", while the less frequent one is that linked to a malfunction of the sampling line (called "blocked").

0077In the embodiment presented in<figref idref="f0002">Fig. 3</figref>, the list of the most frequently triggered alarms 305 and that of the 5 so-called critical alarms 305 are displayed in different display windows 311, namely here juxtaposed, preferably large display windows 311 in order to facilitate reading.

0078Generally speaking, the system S of the invention makes it possible to remotely monitor several NO 1 supply devices used within a hospital establishment and the graphic display 300 makes it possible to display information relating to each of the NO 1 supply devices monitored remotely and used to implement treatments for people, i.e. patients, by inhaled NO (iNO), particularly those suffering from acute pulmonary hypertension, such as Pulmonary Hypertension of the Newborn (PPHN), Acute Respiratory Distress Syndrome (ARDS) or pulmonary hypertension (PH) in cardiac surgery.