Remote monitoring system for a nitric oxide supply device

Abstract

Title of the invention Remote monitoring system for a nitric oxide supply apparatus The invention relates to a system (S) for remote monitoring of a NO supply apparatus (1) used for treating patients with a gas containing NO, comprising means for storing operating data of the apparatus (1) collected during use of the apparatus (1) during successive patient treatments over a given period of time (Dt). The operating data comprise alarm triggers of different types occurring during the period of time considered. A remote server (200) processes the stored operating data and extracts therefrom information relating to the patient treatments that have been carried out and to the operating events that occurred during said patient treatments. A graphic display (300) displays various information relating to the triggered alarms. Abstract figure: Figure 1

Description

Title of the invention: Remote monitoring system for a nitric oxide supply device

[0001] The invention relates to a system for remote monitoring of at least one NO supply apparatus used to treat patients with a gas containing NO, in particular a NO / N2 gas mixture, i.e. an NO-based gas.

[0002] Nitric oxide is used to treat people, i.e. patients, suffering from acute pulmonary arterial hypertension. When inhaled by the patient, NO, called "NOi", "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 Persistent Pulmonary Hypertension of the Newborn or PPHN (for Persistent Pulmonary Hypertension of the Newborn), 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 EP-A-560928, EP-A-1516639 and US-A-10,201,564.

[0003] A gas supply installation used for implementing NOi treatment usually comprises one or more NO / N2 cylinders containing a NO / N2 gas mixture of given composition, a NO supply device supplied with NO / N2 mixture and a medical ventilator supplying a gas flow 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 comprises a flow sensor and is used to convey the gas flow. It may comprise other elements, such as a gas humidifier or other.

[0004] The NO supply apparatus and the medical ventilator are fluidically connected to the patient circuit to supply it with the NO / N2 gas mixture and the flow of gas containing oxygen, respectively.

[0005] The NO / N2 gas mixture supplying the NO supply apparatus contains a small quantity of gaseous NO (eg <1000 ppm vol.) diluted in nitrogen (N2). It is then injected by the NO supply apparatus into the gas flow containing oxygen, typically at least about 20% vol. of oxygen (O2), such as an N2 / O2 mixture or air, or even pure oxygen, coming from the medical ventilator so as to form a final NO / N2 / O2 gas mixture. The NO / N2 gas mixture therefore undergoes dilution in the gas flow containing oxygen and the resulting final gas mixture therefore contains NO, nitrogen and oxygen, or even impurities in- avoidable.

[0006] The final NO / N2 / O2 gas mixture is conveyed 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.

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

[0008] The NO supply device is therefore used to regulate the quantity of NO / N2 mixture injected into the oxygen-based gas flow coming from the ventilator and to ensure monitoring of the treatment, in particular the quantities of NO supplied, the set NO setpoint values, the set alarm thresholds (e.g. NO, NO2, etc.), any alarm triggering or other settings or events occurring during the treatment of the patient(s). In other words, the NO supply device makes it possible to ensure a supply of NO and a monitoring, i.e. monitoring, of this supply, and to trigger audible and visual alarms, in the event of detection of related problems.

[0009] When an NO supply device is used in a hospital environment, numerous alarms are triggered with different criticalities, all of which require action from the healthcare staff. Thus, 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.

[0010] To do this, currently, the healthcare staff must record in writing, for example in a register, notebook or similar, the list of all the 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 triggering, etc., in order to be able to view after the fact which alarms have been triggered over the period of time considered and, above all, to understand the reasons for these alarm triggerings so as to be able to take appropriate corrective measures.

[0011] While alarms are essential for patient safety, they also generate stress for the nursing staff and are time-consuming, particularly due to the entries to be made in the register.

[0012] Furthermore, these written records made by the 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 the safety of patients.

[0013] A problem is therefore to be able to avoid all or part of these problems, by particularly those related to the need to keep an alarm log, particularly in order to improve the effectiveness of iNO treatments and patient safety.

[0014] In 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, which are likely to trigger alarms during their operation.

[0015] A solution of the invention relates to a system for remote monitoring, i.e. monitoring, of at least one NO supply apparatus used to treat patients with a gas containing NO, in particular a NO / N2 gas mixture, said NO supply apparatus comprising storage means for storing operating data of the apparatus collected during the use of the apparatus during successive patient treatments having taken place during a given period of time (Dt), said operating data comprising triggerings of alarms of different types having occurred during said given period of time (Dt),

[0016] said system (S) comprising: - 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 that have been carried out and to the operating events that have occurred during said patient treatments, and - 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): • at least some of the most frequently triggered alarms, i.e. the most frequent, • an occurrence or number of triggers of at least some of the most frequently triggered alarms, • a proportion of triggering of at least some of the most frequently triggered alarms, • an average resolution time for at least some of the most frequently triggered alarms, • an average number of alarms triggered per treatment and / or • an average resolution time for at least some of the most frequently triggered alarms.

[0017] Depending on the embodiment considered, the remote tracking system of the invention may comprise one or more of the following characteristics: the graphic display is configured to display several different information chosen from the aforementioned information. 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. 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. The 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. the information displayed by the graphic display includes the occurrences or number of triggers of so-called “critical” alarms or critical alarms. the information displayed by the graphic display includes the frequency or proportion (%) of triggers of so-called “critical” alarms or critical alarms. The graphic display is of the color display type. the graphic display is further configured to display the time interval (It) considered, for example a start date and an end date. 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. 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. the graphic 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 currency. the graphic display is further configured to display the most frequently triggered alarms and / or critical alarms in one or more display windows displayed on the graphic display. it comprises means for selecting the duration of the time interval (It), preferably several weeks, more preferably several months, for example from 2 to 12 months, in particular from 3 to 8 months, for example a duration of 1 year. the NO supply apparatus is supplied with gas containing NO, in particular a NO / N2 gas mixture, from one or more NO cylinders containing a NO / N2 gas mixture. the NO supply apparatus comprises telecommunication means configured to transmit the operating data of the apparatus to said at least one remote server. the telecommunications means are configured to operate using a mobile network, in particular a 4G, 5G or similar type network, or other. the telecommunication means include transmission means, typically they include (at least) one transmitting antenna. the telecommunication means comprise transmission means configured to transmit data in encrypted and / or analog form, said at least one remote server comprises a “cloud” type server, for example the AWS (Amazon Web Service) “cloud”, said at least one remote server comprises reception means for receiving the operating data transmitted by the NO supply device. the types of alarms (i.e. the types of alarms identified) are chosen from: 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. an alarm for too low NO concentration, an alarm for too high NO concentration, an alarm for too low FiO2, an alarm for too high FiO2, a battery fault alarm, i.e. battery malfunction (e.g. empty, broken down, etc.), an alarm for faulty NO injection line, an alarm for faulty flow measurement line, i.e. flow sensor malfunction, an alarm for faulty gas flow from the fan (i.e. air or O2 / N2 mixture), for example absence of gas flow or, conversely, excessive flow, a patient connection fault alarm, for example patient disconnected or connected / connected but without NO flow administration, a water trap fault alarm, an analysis line fault alarm, i.e. malfunction of the analysis or sampling line and a gas source fault alarm (NO, O2), for example non-connection or detection of an empty gas cylinder (i.e. NO cylinder and / or O2 cylinder), typically an alarm for the total absence of a full NO cylinder connected to the NO supply device, i.e. an empty NO cylinder alarm. preferably, the alarm types further include: an alarm for activation of the manual ventilation system (i.e. via a manual ventilation bag (BAVU) connected to the NO supply device), an emergency administration mode activation alarm, 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 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). 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. the computer processing means are further configured to control the display of the information displayed by the graphic display. 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. - it is configured to remotely monitor multiple NO supply devices - the graphic display is configured to display at least part of the information relating to each of said NO supply devices. - it includes selection means configured to allow a user to choose or select the device about which he wishes to know the information, i.e. alarms, for example the means of selection include the keys of a computer, a touch screen, a mouse and / or the like. - 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 monitor several dozen NO supply devices simultaneously. - the 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.

[0018] According to the embodiment considered, the 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: - 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. - it comprises microprocessor control means, namely a controller or the like, comprising one or more microprocessors. - the microprocessor control means cooperate (at least) with the valve means to control the gas flow in at least part of said internal passage or internal gas circuit. - 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. - the microprocessor(s) are arranged on an electronic card. - the storage means comprise a computer storage device, such as a computer memory, for example a flash memory. - the computer memory is arranged on the or an electronic card. - it includes means of electrical supply, such as an electrical connection to the sector (110 / 220V). - it includes a graphical user interface (GUI), preferably the GUI includes a display screen and / or selection keys, such as virtual keys displayed on the display screen, i.e. a touch screen.

[0019] Furthermore, the installation for administering gas to a patient, i.e. a gas containing NO, including the apparatus or device for supplying a gas containing NO comprises: - at least one source of gas containing gaseous NO, in particular a NO / N2 gas mixture, preferably one or more pressurized gas cylinders, - the 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 the NO / N2 gas mixture, - a medical ventilator for supplying an oxygen-containing gas, such as air or an O2 / N2 gas mixture, and - a supply line supplied by the gas supply device with gas containing NO, such as the NO / N2 gas mixture, and by the medical ventilator with gas containing oxygen, such as air or the O2 / N2 mixture.

[0020] Depending on the embodiment considered, said gas administration installation may comprise one or more of the following characteristics: - the 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 an N2 / O2 mixture. - the medical ventilator is a respiratory assistance device supplying gas at constant pressure or, alternatively, the medical ventilator is an HFO (High Frequency Oscillations) type ventilator delivering gas by high frequency oscillations. - the gas supply line is supplied with NO / N2 mixture by the gas supply device and with a breathing gas containing at least about 20% vol. of oxygen, preferably at least about 21% vol. of oxygen, preferably air or an N2 / O2 mixture, by the medical ventilator. - the gas supply line is supplied with NO / N2 mixture by the gas supply device and with a respiratory gas containing oxygen, preferably air or an N2 / O2 mixture, by the medical ventilator so as to form therein 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 NO2 species formed by oxidation of part of the NO. 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. 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. the gas source(s) contains a NO / N2 gas mixture containing less than 2,000 ppmv of NO, the remainder being nitrogen, preferably less than 1,000 ppmv of NO, the remainder being nitrogen. preferably, the therapeutic gas source(s) contains a NO / N2 mixture containing from 250 to 900 ppmv of NO, the remainder being nitrogen, for example of the order of 800 ppmv of NO, the remainder being nitrogen. 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, it further comprises a line for recovering the gases exhaled by the patient. 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. the supply line forms an inspiratory branch of the patient circuit. the exhaled gas recovery line forms an expiratory branch of the patient circuit. the NO supply apparatus further comprises a gas analysis line fluidly connected to the gas supply line, i.e. the inspiratory branch. 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. the flow sensor is connected to the control means of the NO supply device. The flow sensor measures the flow of gas containing oxygen (i.e. air or N2 / O2 mixture) delivered by the medical ventilator and circulating in the gas supply line, i.e. the inspiratory branch. The flow sensor returns gas flow values or signals. the control means are configured to control the valve means for deliver the gas flow containing NO (e.g. NO / N2 mixture) at a given flow rate making it possible to obtain a dose of NO in the gas supply line corresponding to the desired dose, i.e. the dosage set by the healthcare staff. - the gas supply line feeds a respiratory interface, for example a breathing mask, a tracheal intubation tube or the like. - 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. - 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 all or part of the gases 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. - the gas container(s) is / are equipped with a gas distribution tap with or without an integrated pressure regulator (RDI). - the gas distribution tap is made of a copper alloy, such as brass, and / or is equipped with a protective cover arranged around the gas distribution tap, for example made of a polymer material (i.e. plastic), metal or combinations thereof. - 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. - the fluid container has a generally cylindrical shape, in particular an ogive shape.

[0021] Generally speaking, within the framework of the invention: - “ppmv” means parts per million by volume, - “%vol.” means percentage by volume. - “NO” means nitrogen monoxide. - “NO2” means nitrogen dioxide. - “N2” means nitrogen. - “O2” means oxygen. - the terms “concentration”, “dose” and “content” are considered equivalent. - the terms “device” and “apparatus” are considered equivalent. - the terms “supply” and “delivery” are considered equivalent. - the terms “means of / to / for” are considered to be completely equivalent and substitutable by the terms “device of / to / for”, for example the terms "control means" may be replaced by "control device", the terms "valve means" may be replaced by "valve device", "memorization means" may be replaced by "memorization device"...

[0022] The 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:

[0023] [Fig-1] 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.

[0024] [Fig.2] shows a diagram of an embodiment of a gas administration installation comprising an NO supply apparatus that can be remotely monitored by a remote monitoring system according to the invention, such as that of [Fig.l].

[0025] [Fig.3] schematizes an example of the displays operated by a tracking system at distance according to the invention, such as that of [Fig.l].

[0026] [Fig.2] shows a diagram of an embodiment of a gas administration installation 100 comprising an apparatus for supplying NO 1, that is to say a gaseous mixture based on nitrogen monoxide, which can be monitored remotely by a remote monitoring system S according to the invention, such as that shown diagrammatically in [Fig.l], as explained below.

[0027] More precisely, the installation 100 here comprises two pressurized gas cylinders 10 each containing a NO / N2 gas mixture, namely here a NO / N2 gas mixture typically containing between 100 and 1500 ppmv of NO (N2 remainder), for example 450 or 800 ppmv of NO (N2 remainder), or any other suitable concentration, which supply the NO / N2 mixture to the device or apparatus 1 for supplying, i.e. delivering, NO, making it possible to monitor and control the supply of the NO / N2 gas mixture.

[0028] The 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 serving to convey the gas within the NO 1 supply apparatus, i.e. into the external casing or frame of the apparatus 1.

[0029] The 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 oxygen arranged in a hospital building.

[0030] The 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% by volume of oxygen, preferably at least approximately 21% by volume of oxygen, such as air or an oxygen / nitrogen mixture (N2 / O2).

[0031] The 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 / N2 mixture) coming from the medical ventilator 50 and the NO-based flow, i.e. the NO / N2 gas mixture, delivered by the NO 1 supply apparatus.

[0032] More precisely, the NO 1 supply apparatus delivers or injects the NO / N2 mixture, for example at 450 or 800 ppmv of NO, into the gas supply line 21, via an injection conduit or line 23, fluidically connecting the internal gas circuit (not visible in [Fig.2]) of the NO 1 supply apparatus to the gas supply line 21.

[0033] The flow of NO / N2 supplied 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 supplied 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 (e.g. argon, CO2, NO2, etc.), i.e. a final gas mixture NO / N2 / O2.

[0034] Preferably, 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.

[0035] The NO / N2 / O2 gas mixture 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 the final gas (i.e. NO / N2 / O2) to be delivered into the patient's lungs.

[0036] A 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 piece in

[0037] The 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 N2 / O 2 mixture, coming from the medical ventilator 50, while the expiratory branch 22 conveying 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 comprise one or more optional components, for example a CO2 elimination device 35, i.e. a CO2 trap, such as a hot tank or the like, making it possible to eliminate the CO2 present in the gases exhaled by the patient, a filter or the like.

[0038] A 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.

[0039] The flow sensor 25 is used to measure the flow rate 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 / N2 / O2 gas mixture is produced. This makes it possible to more effectively regulate the delivery of the NO (i.e. N2 / O2) flow by the NO 1 supply device since the flow rate measurements made by the flow 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.

[0040] More 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, serving to convey the flow of NO-based gas, i.e. the NO / N2 mixture, coming from the NO / N2 mixture bottles 12, and / or the flow of oxygen coming from the oxygen source 11.

[0041] The 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 flow of NO-based gas. Valve means (not shown), i.e. one or more valve devices, 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 apparatus 1 to control the gas flow circulating therein towards the injection line 23 and the injection site 24.

[0042] The valve means of the NO 1 supply apparatus are themselves controlled by the control means, i.e. one (or more) control devices, also called (micro)controller, arranged in the housing of the NO 1 supply device.

[0043] The 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 NO content value 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.

[0044] The 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 conforms to 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 / N2 flow. These flow rate measurements are processed by the control means in order to ensure efficient delivery of NO as a function in particular of the flow rate of O2-based gas supplied by the medical ventilator 50.

[0045] Preferably, 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, e.g. reduce, the pressure of the NO-based gas coming from the gas cylinders 10.

[0046] Usually, 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 panel, 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 (e.g. flow rate, NO dosage, etc.), or any other information or data useful to the healthcare personnel. Preferably, the display is in color but it can also be in black and white.

[0047] The control means of the NO 1 supply apparatus 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 apparatus 1. More precisely, the control card preferably integrates the control unit and is configured to control and furthermore analyze and / or process the signals coming from the various components, such as the sensors...

[0048] The electrical power supply of the NO 1 supply apparatus, in particular the components requiring electrical current to operate, such as the control means, the graphic display 4, 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 plug type, and / or one (or more) electrical power supply batteries, preferably rechargeable, and / or a current transformer. The electrical 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.

[0049] Finally, 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. the Y-shaped piece, typically in the immediate vicinity of the junction piece 25, and also 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.

[0050] The 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 NO2, NO and O2 sensors, such as electrochemical cells or the like, which must be calibrated periodically, for example every week.

[0051] Indeed, it is appropriate to check that the composition of the final gas is consistent with that of the desired NO / N2 / O2 gas mixture to be administered to the patient, in particular to ensure that it does not contain an excessive quantity of toxic NO2 species, that its oxygen content is not hypoxic (i.e. <20% vol), and that its NO content corresponds to the desired dosage, i.e. the dose of NO to be administered to the patient which is usually chosen by the healthcare personnel, i.e. a doctor or the like.

[0052] The 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 (i.e. hypoxic) or different from the desired NO dosage.

[0053] Such 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, i.e. 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.

[0054] Within a hospital establishment, it regularly happens that several NO supply devices 1 are used within a given department and / or in different departments, such as in emergency, intensive care, cardiology, etc., i.e. a fleet of NO supply devices 1.

[0055] Each of these NO supply devices 1 makes it possible to ensure a supply of NO and a tracking, i.e. monitoring, 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.

[0056] In order to avoid the nursing staff having to record in writing all the triggering of alarms and related information, the invention proposes a remote monitoring system S making it possible to monitor one or more NO supply devices 1, in particular a fleet of devices 1 implemented in a hospital establishment, such as a hospital or the like, to treat patients with iNO.

[0057] Thus, [Fig.l] schematizes an embodiment of such a remote monitoring system according to the invention of one (or more) NO supply apparatus 1, in particular of the NO supply apparatus 1 forming part of the gas administration installation 100 of [Fig.2] detailed above.

[0058] Generally speaking, in the remote monitoring system S of [Fig.l], the NO 1 supply apparatus is provided with storage means, namely a computer memory or the like, configured to store operating data of the apparatus 1 collected during the use of the apparatus 1 during successive patient treatments having taken place over a given period of time Dt, for example several weeks or several months, typically over a period of 2 to 18 months, preferably a period of 6 to 12 months.

[0059] The recorded operating data include in particular the triggering of alarms of different types having been triggered during the period of time considered Dt 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.

[0060] In addition, the system S also comprises one (or more) remote server 200, i.e. a computer server, for example a Cloud type server or other, configured to process the operating data stored by the NO 1 supply device and 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 that have led to the various alarm triggers.

[0061] In order to be able to transmit the operating data of the device 1, the NO supply device 1 comprises communication means configured to transmit to the remote computer server 200 which comprises, for its part, reception means to receive the operating data transmitted by the NO supply device 1.

[0062] More 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.

[0063] The computer processing means 250 comprise one or more (micro)processors implementing algorithms.

[0064] In other words, the remote server 200 cooperates with a graphic display 300, for example that of a computer 301, as illustrated in [Fig.l] and [Fig.3], 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.

[0065] Preferably, 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.

[0066] In particular, according to the invention, the information displayed by the graphic display 300 preferably comprises: - 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, - a trigger occurrence 304 (ie number) of at least part of the most frequently triggered alarms 302, for example the number of critical alarms 305 triggered, - the proportion (%) 303 of at least some of the most frequently triggered alarms, for example that of critical alarms 305. - 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. - an average number of alarms triggered per treatment 308, - an average time (or average duration) for resolving 306 each of the most frequently triggered alarms 302 and / or - an average time (or average duration) for resolving 309 of the most frequently triggered alarms 302.

[0067] Preferably, the graphic display 300 is configured to display several of the information from this list, in particular the triggered alarms.

[0068] Advantageously, the different types of alarms that can be displayed are for example:

[0069] - an alarm for (too) low NO concentration, eg lower than the desired dose,

[0070] - an alarm for (too) high NO concentration, eg higher than the desired dose,

[0071] - a so-called “non-compliant” NO concentration alarm, i.e. very far away of 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). This difference can be prefixed and / or stored.

[0072] - a (too) low FiO2 alarm, eg lower than the desired FiO2,

[0073] - a (too) high FiO2 alarm, eg higher than the desired FiO2,

[0074] - a battery malfunction alarm (empty, broken down, etc.),

[0075] - a NO injection line fault alarm,

[0076] - a flow measurement line fault alarm, i.e. a malfunction operation of the flow sensor,

[0077] - a gas flow fault alarm from the fan, for example a flow insufficient or interrupted, or too high,

[0078] - a connected patient alarm without NO-based flow administration,

[0079] - an alarm for a patient not connected, i.e. not receiving a flow based on NO,

[0080] - a malfunctioning water trap alarm, for example disconnected or saturated humidity,

[0081] - a malfunctioning analysis line alarm, i.e. of the sampling line, and

[0082] - an alarm for detecting an empty gas bottle (NO, O2), i.e. one whose gas was consumed.

[0083] Of course, other types of alarms can also be taken into account and displayed on the graphic display 300.

[0084] Preferably, 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, i.e. having had a duration greater than the given maximum duration, for example more than 6 hours.

[0085] [Fig.3] gives an example of displays operated on the graphic display 300 of a system according to the invention S, such as that of [Fig.l].

[0086] It can be seen 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: - the hospital concerned 301, for example the name and address of the hospital, - the 5 so-called critical alarms 302 (called “Top 5 Alarms”) among the 10 most frequently triggered alarms 305, - the proportion (%) 303 of each of these so-called critical alarms 302. - the number or occurrences 304 of each of these so-called critical alarms 302, - the list of the 10 most frequently triggered alarms and their duration of response average solution 306, - the number of long treatments 307, for example at least 6 hours, - the average number of alarms triggered per treatment 308, and - the average duration or average resolution time 309 of the 5 critical alarms 305.

[0087] As can be 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 dose of NO is very far from the set dose, that is to say that 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 care staff how to better use the special filters called "for nebulization / aerosol therapy", while the least frequent is that linked to a malfunction of the sampling line (called "blocked").

[0088] In the embodiment presented in [Fig.3], 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 juxtaposed here, preferably large display windows 311 in order to facilitate reading.

[0089] Generally 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 of people, i.e. patients, by inhaled NO (iNO), in particular those suffering from acute pulmonary arterial hypertension, such as Pulmonary Arterial Hypertension of the Newborn (PPHN), Acute Respiratory Distress Syndrome (ARDS) or pulmonary hypertension (PH) in cardiac surgery.

Claims

Claims

1. System (S) for remote monitoring of at least one NO supply apparatus (1) used to treat patients with a gas containing NO, said NO supply apparatus (1) comprising storage means for storing operating data of the apparatus (1) collected during use of the apparatus (1) during successive patient treatments having taken place during a given period of time (Dt), said operating data comprising triggerings of alarms of different types having occurred during said given period of time (Dt), said system (S) comprising: - at least one remote server (200) configured to process the operating data stored by the storage means of the NO supply apparatus (1) 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 - a graphic display (300) configured to display at least part of said information, the information displayed by the graphic display (300) comprising, for at least one time interval (It) considered of the given time period (Dt): at least some of the most frequently triggered alarms (302, 305), an occurrence or trigger number (304) of at least some of the most frequently triggered alarms, a trigger proportion (303) of at least a portion of the most frequently triggered alarms, an average resolution time (306) of at least some of the most frequently triggered alarms, an average number (308) of alarms triggered per treatment and / or an average resolution time (309) of at least some of the most frequently triggered alarms.

2. System according to claim 1, characterized in that the information displayed by the graphic display (300) includes the 3 to 15 alarms most frequently triggered over the time interval (It) considered.

3. System according to claim 1, characterized in that the graphic display (300) is further configured to further display: - the time interval (It) considered (310), and / or - for the time interval (It) considered: • a total number of treatments, a number of short treatments and / or a number of long treatments (307), and / or • critical alarms (305) chosen from among the most frequently triggered alarms (302), preferably from 3 to 7 critical alarms (305).

4. System according to one of claims 1 to 3, characterized in that it comprises means for selecting the duration of the time interval (It), preferably several weeks, more preferably several months, for example 2 to 12 months, in particular 3 to 8 months.

5. System according to claim 1, characterized in that: - the NO supply apparatus (1) comprises communication means configured to transmit the operating data of the apparatus (1) to said at least one remote server (200), and - said at least one remote server (200) comprises reception means for receiving the operating data transmitted by the NO supply apparatus (1).

6. System according to claim 1, characterized in that the types of alarms are chosen from: - a “non-compliant” NO concentration alarm, - a too low NO concentration alarm, - a too high NO concentration alarm, - a too low FiO2 alarm, - a too high FiO2 alarm, - a battery fault alarm, - a NO injection line fault alarm, - a flow measurement line fault alarm, - a gas flow fault alarm from the ventilator, - a patient connection fault alarm, - a water trap fault alarm, - an analysis line fault alarm and - a gas source fault alarm (NO, O2).

7. System according to claim 1, characterized in that it further comprises computer processing means (250) configured to receive and process at least part of the information provided by said at least one remote server (200), and control the display of the information displayed by the graphic display (300).

8. System according to claim 7, characterized in that the computer processing means (250) implement at least one algorithm.

9. System according to claim 1, characterized in that it is configured to remotely monitor several NO supply devices (1), preferably from 2 to 50 NO supply devices (1).

10. System according to claim 1, characterized in that the NO supply apparatus (1) is part of a gas administration installation (100) further comprising a medical ventilator (50) for supplying an oxygen-containing gas and a patient circuit (20) supplied by the NO supply apparatus (1) with NO-containing gas and by the medical ventilator (50) with oxygen-containing gas.

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