Displaying a pre-set dose of NO on a medical gas supply device

Abstract

Title of the Invention: Display of a Pre-set NO Dose on a Medical Gas Supply Device. The invention relates to a device (1) for supplying a gas containing NO, comprising at least one internal passage (6) with valve means (7) for conveying a flow of gas containing NO; a graphic display (4); and microprocessor-controlled control means (8) (9) cooperating at least with the valve means (7) to control the gas supply. Storage means (70) are provided for storing a pre-set non-zero dose of NO (NOmem). The control means (8) command a default display (at 71) on the graphic display (4), the pre-set NO dose (NOmem) having been stored. Abstract Figure: Figure 3

Description

Title of the invention: Display of a pre-set dose of NO on a medical gas supply device

[0001] The invention relates to an apparatus or device for supplying and monitoring a medical gas containing nitric oxide (NO), in particular a NO / N2 gas mixture, commonly called a NO supply apparatus, used to treat one or more persons suffering from acute pulmonary arterial hypertension, configured to display a memorized dose of NO called "default", when the apparatus is started.

[0002] Inhaled nitric oxide (NOi) is a standard treatment for treating people, i.e. patients, suffering from acute pulmonary arterial hypertension. When 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 Newborn Pulmonary Hypertension), 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] The implementation of a NOi treatment usually includes one or more NO / N2 mixture bottles (or a NO generator), a NO supply and monitoring device, a medical ventilator and a patient kit including a patient circuit and a respiratory interface, such as a tracheal intubation probe..., or even other elements, such as a gas humidifier or other.

[0004] Usually, a small quantity of gaseous NO (i.e. a few ppm vol.), diluted in nitrogen (N2) is injected and diluted in a gaseous flow containing oxygen, typically at least approximately 20% vol. of oxygen (O2), such as an N2 / O2 mixture or air, or even pure oxygen, which is conveyed by the patient circuit of a gas supply installation, and the final gaseous mixture obtained containing NO and oxygen is then inhaled by the patient.

[0005] The final NO concentration or dose, which corresponds to a dosage, is determined by the doctor or the like, or set by a medical protocol validated by the medical team. In general, it is between 1 and 80 ppm by volume (ppmv), typically of the order of 10 to 20 ppmv, depending on the population treated, i.e. newborns, children, adolescents or adults, and the disease to be treated, in the final NO / N2 / O2 gas mixture administered by inhalation to the patient in question, i.e. after injection of the NO / N2 mixture into the flow of gas containing oxygen (i.e. approximately >20% vol.) carried by the patient circuit.

[0006] The desired NO concentration or dose is generally set, adjusted or selected by the healthcare personnel, such as a doctor, nurse or the like, at the beginning of the treatment procedure of a patient and in the urgency of implementing the treatment, that is to say after starting the NO supply apparatus.

[0007] To do this, the NO supply device displays a so-called "starting" dose or concentration of zero, i.e. an NO concentration of 0 ppm, and the healthcare staff increments the dose in stages or directly enters / selects a desired "starting" dose, for example 10, 15 or 20 ppm, which will then be used by the NO supply device to provide a suitable NO flow rate, i.e. a NO / N2 gas mixture flow rate, making it possible to obtain this set "starting" dose in the final gas mixture administered by inhalation to the patient to be treated.

[0008] However, in practice, errors in NO dosage sometimes occur due to errors in setting or fixing the dose because the nursing staff must act urgently when starting NO treatment, and may therefore make a mistake when entering or selecting the dose of NO to be administered initially.

[0009] However, it is understood that a dose error can cause a risk for the patient who does not receive the desired dosage, that is to say an appropriate concentration or dose, in particular a risk of overdose if the content entered is too high or, in the opposite case, an under-dosage which can then lead to an absence of therapeutic effect due to an insufficient and ineffective dose.

[0010] A problem is therefore to be able to increase the safety of NO treatment by avoiding errors in setting the NO dose which may occur at the start of treatment, i.e. errors linked to the “starting” NO dose.

[0011] One solution of the invention relates to an apparatus or device for supplying a gas containing NO which can be used to treat a patient, such as a NO / N2 gas mixture, comprising: - at least one internal passage for conveying a gas flow containing NO, - valve means arranged on said at least one internal passage, - a graphic display, and - microprocessor control means cooperating at least with the valve means to control the supply of gas, in particular the gas flow rate in at least part of said internal passage.

[0012] Furthermore, the apparatus or device of the invention comprises:

[0013] - storage means for storing a dose (i.e. a concentration) non- zero prefixed NO (NOmém), - the control means are configured to command a display on the graphic display of the prefixed NO dose (NOmém) having been memorized, - and the graphic display is configured to operate a default display of said pre-fixed NO dose (NOmém) having been memorized.

[0014] Depending on the embodiment considered, the apparatus of the invention may comprise one or more of the following characteristics: - the memorized pre-set NO dose (NOmém) is the only NO dose displayed when the device is started (i.e. when it is switched on), i.e. it is displayed on the display screen automatically and without any possible alternative, i.e. before any start of iNO treatment. - the pre-set NO dose (NOmem) corresponds to the desired NO concentration in the gas mixture to be administered to the patient, i.e. the dosage to be observed in the context of a treatment with the supply of inhaled NO to said patient. Typically, the administered gas mixture, also called the final mixture, contains NO, nitrogen (N2) and oxygen (O2), or even other compounds, such as water vapor and / or unwanted impurities such as NO2. - the control means are configured to control a default display of the pre-set NO dose (NOmém) stored as soon as the device is put into service, i.e. as soon as it is started up, for example as soon as a button or an on / off key of the device is pressed (i.e. the "on / off" key in English) and possibly after a latency period necessary for the initialization of the device or the like, in particular after a start-up self-test aimed at ensuring that the main elements of the device are functional, for example the processor(s), the operating system, etc. - the control means are configured to command a default display of the stored pre-set NO dose (NOmém), after commissioning the device, i.e. upon start-up, and before any actual start of patient treatment with administration of gas containing NO. - the control means are configured to command a default display of the stored pre-set NO dose (NOmém), after commissioning the device, i.e. upon start-up, and before any injection of gas containing NO into the inspiratory branch of the patient circuit. - the control means are configured to control an automatic and default display of the pre-set NO dose (NOmém) stored as soon as the device and the graphic display are started. - the control means are configured to control a display of the pre-set NO dose (NOmém) in a dedicated space on the screen, typically a display window. - the prefixed NO dose (NOmém) is between 1 and 40 ppmv, preferably between 5 and 20 ppmv, typically 5, 10, 15 or 20 ppmv. the storage means are configured to store a pre-fixed NO dose (NOmem) of between 1 and 40 ppmv, preferably between 5 and 20 ppmv, typically 5, 10, 15 or 20 ppmv. it further comprises a treatment start (validation) key, i.e. a selection key, operable (i.e. selectable) by the user, the actuation or selection of which generates a supply of a flow (i.e. flow rate) of gas containing NO making it possible to obtain the stored pre-fixed dose of NO (NOmém). said at least one internal passage for conveying the gas flow comprises one or more gas conduits, passages, pipes or the like, the (at least one) internal passage is configured to convey the gas flow containing NO between (at least) one gas inlet and (at least) one gas outlet providing the gas containing NO, i.e. a NO / N2 mixture. the valve means comprises one or more valves, in particular one or more solenoid valves or one or more on-off valves. the graphic display is touch-sensitive. The touchscreen graphic display is part of a GUI or graphical user interface. The graphic display includes a color or black and white screen. the control means include one or more microprocessors. the microprocessor(s) are arranged on an electronic card. the control means cooperate with the valve means to control the supply of gas, in particular the flow rate of gas containing NO, as a function of the dose of NO to be supplied, i.e. the pre-set dose of NO (NOmém). the control means cooperate with the valve means to authorize a supply of gas, in particular a flow of gas containing NO, at the start of treatment of the patient. conversely, the control means cooperate with the valve means to prevent or prohibit a supply of gas, in particular of a flow of gas containing NO, before the start of a treatment of the patient, in particular before the user presses a treatment start button. the graphic display is configured to display information, in particular the dose of NO to be supplied, i.e. the pre-set dose of NO (NOmém) - the control means are configured to control the display on the graphic display of the dose of NO expressed in ppmv. the graphic display is configured to additionally display a start treatment button. The start treatment key is a virtual key displayed on the graphic display. the touchscreen graphic display. the graphic display is configured to detect the contact of a user's finger, in particular their index finger, pressing on the surface of the graphic display, in particular on the touch screen of the graphic display. the control means are further configured to control a display on the graphic display of at least one confirmation key or window, i.e. a virtual key, in response to actuation by the user of the start of processing key (i.e. the validation key). the control means are configured to control the valve means to provide a given flow rate of gas containing NO making it possible to obtain the stored pre-fixed dose of NO (NOmém), in response to actuation by the user of at least the treatment start key, in particular at least the virtual (validation) treatment start key displayed on the graphic display. the control means are configured to control the valve means to supply a given flow rate of gas containing NO making it possible to obtain the memorized pre-set dose of NO (NOmém), in response to successive actuations by the user of the treatment start key then of the confirmation key, typically virtual treatment start and confirmation keys / zones, i.e. the control means control the valve means to deliver gas only after selection (e.g. pressing) by the user of the treatment start (i.e. validation) key and then confirmation (e.g. pressing) of the confirmation key or zone so as to confirm the dose of NO and / or the start of treatment. the control means are configured to control a display of the confirmation key within a display window displayed on the display screen. conversely, the control means are configured to control the valve means so as not to provide a flow of gas containing NO, in response to actuation by the user of at least one treatment cancellation key or zone, in particular a virtual key or zone displayed on the graphic display, i.e. a key or zone making it possible to refuse, cancel or the like any treatment of the patient. the screen is configured to display a first key or confirmation zone whose selection by use (eg by digital press) allows to confirm the proposed starting dose and start the treatment, for example a key or area called "OK", "GO", "Start" or similar, the screen is configured to display a second confirmation key or area whose selection by use (eg by digital press) makes it possible to cancel or stop any start of treatment with supply of NO, for example a key or area called "Stop", "Abort", "Stop" or similar. according to one embodiment, the screen is configured to display the second confirmation key or area in response to a user pressing the first confirmation key or area. according to one embodiment, the screen is configured to display the two confirmation keys successively, that is to say one after the other. according to one embodiment, the screen is configured to display the two confirmation keys simultaneously, for example juxtaposed, according to one embodiment, the screen is configured to display a confirmation window comprising the two separate confirmation keys or zones, for example a confirmation window divided into two separate zones, ie juxtaposed. according to one embodiment, the screen is configured to display the confirmation window superimposed on the starting NO dose display window and the start of treatment validation key, partially or completely masking them. the graphic display is further configured to display simultaneously with the confirmation window, a sentence or similar reminding the user what he must confirm or deny, for example: Start of treatment at the dose of 10 ppm? or other useful information. The confirmation window includes touch-sensitive confirmation keys or areas, i.e. virtual ones which are displayed on the touch screen panel. the control means act in response to any digital pressure from a user on one and / or other of the keys or virtual zones displayed on the touchscreen display. the user's actuation(s) or selection(s) of the treatment start key and / or the confirmation key(s) or zone(s) are made by digital pressure from the user, for example by pressing the index finger. the control means are configured to control a simultaneous display, on the touchscreen graphic display, of the pre-set NO dose (NOmém) and the treatment start key, i.e. the virtual key allowing to start / commence a patient treatment. the touchscreen graphic display is configured to display the preset NO dose (NOmem) and the treatment start key juxtaposedly, i.e. next to each other. the control means are configured to control the valve means to deliver a given gas flow rate corresponding to the pre-set NO dose (NOmém) of between 5 and 40 ppmv, preferably between 5 and 20 ppmv. 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 electronic card. it includes means of electrical supply, such as an electrical connection to the sector (110 / 220V). It includes a rigid case, that is to say an external protective casing. the rigid housing comprises said at least one internal passage, said valve means, the graphic display and the control means. the device is configured to operate monitoring and supply of gaseous NO, i.e. gas containing NO, such as a NO / N2 mixture. the treatment start key, typically a virtual selection key, cooperates with the control means to provide them with at least one control signal to operate a supply of a flow rate of gas containing NO corresponding to the desired stored pre-fixed dose of NO (NOmém) in the final gas mixture. the control means are configured to control the valve means in response to said control signal. it comprises dose adjustment means, in particular configuration means, making it possible to adjust or modify the NO dose displayed by default, for example making it possible to increase or decrease the memorized pre-fixed NO dose (NOmém) displayed on the display screen. It includes configuration means allowing you to adjust or select and memorize the desired dose of NO (NOmém). Configuration means include a configuration menu accessible via the display screen. the dose adjustment means comprise one or more adjustment keys, for example “+” and “-” keys allowing the displayed dose to be increased or decreased by 1 ppm (or more). the adjustment key(s) are virtual keys displayed on the display screen, i.e. touch screen. - the adjustment key(s) are virtual keys configured to cause an increase or decrease in the displayed dose in response to the user pressing one or other of these keys. - the dose adjustment means cooperate with the control means. - the control means modifies the displayed NO dose value in response to user activation of the dose adjustment means, in particular in response to a digital press on one or other of these keys.

[0015] The invention also relates to an installation for administering gas to a patient, i.e. a gas containing NO, comprising: - at least one source of gas containing gaseous NO, in particular a gaseous NO / N2 mixture, - 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 the NO / N2 gas mixture, - a medical ventilator to supply 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.

[0016] Depending on the embodiment considered, the gas administration installation of the invention may comprise one or more of the following features: - 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 approximately 20% vol. of oxygen, preferably at least approximately 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 the pre-fixed NO dose (NOmem). the final gas mixture to be administered to the patient contains at least 20% vol. of oxygen, NO in a proportion (approximately) equal to the pre-fixed dose of NO (NOmem) and nitrogen. the gas source contains a NO / N2 gas mixture containing less than 2000 ppmv of NO, the remainder being nitrogen, preferably less than 1000 ppmv of NO, the remainder being nitrogen, preferably, the therapeutic gas source 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 also includes a line for recovering 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 oxygen-containing gas 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 to 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 stored dose (NOmém), which given flow rate is determined from the gas flow rate (e.g. air) measured by the flow sensor and the NO concentration in the NO / N2 mixture. - 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 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. - 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 150 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.

[0017] The invention further relates to a method for therapeutic treatment of a human person, i.e. a patient, using an apparatus for supplying NO and / or a gas administration facility, i.e. a gas containing NO, comprising an apparatus for supplying NO, for supplying said person with a gas mixture containing NO at a given dosage, said person inhaling said gas mixture, in particular a final gas mixture based on NO comprising NO, at least 20% oxygen and nitrogen, preferably at least 21% oxygen.

[0018] In the context of this treatment method: - the person suffers from acute pulmonary arterial hypertension, in particular Neonatal Pulmonary Hypertension or PPHN, Acute Respiratory Distress Syndrome or ARDS or pulmonary hypertension (PH) during heart surgery. - the person is an adult, an adolescent, a child, a baby, a newborn or a premature baby. - the final gas mixture is administered by means of a respiratory interface, in particular a respiratory mask or a tracheal intubation tube. - the final gas mixture contains nitrogen, oxygen (>21% approximately) and NO in a proportion corresponding to the pre-fixed NO dose (NOmém). - the final gas mixture contains less than 80 ppmv of NO, typically between 5 and 40 ppmv. - the final gas mixture is administered over 1 to several hours to 1 or several days.

[0019] 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 "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" 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" ...

[0020] 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:

[0021] [Fig-1] represents an embodiment of a gas administration installation, i.e. a gas containing NO, comprising an NO supply apparatus according to the invention.

[0022] [Fig.2] shows schematically the operation of an NO supply device according to the invention.

[0023] [Fig.3] shows schematically an embodiment of the display of the starting dose of NO on the display screen of an NO supply device according to the invention, such as that of [Fig.2], particularly when used in an administration facility according to [Fig.l], before starting any supply of NO to the patient.

[0024] [Fig.4] shows a diagram of an embodiment of the configuration menu allowing setting the starting NO dose of an NO supply device according to the invention, such as that of [Fig.2] and [Fig.3].

[0025] One embodiment of a gas delivery facility 100 is illustrated in [Fig.l], namely for providing a therapeutic NO-based mixture for treating a patient in need thereof.

[0026] The installation 100 here comprises two pressurized gas cylinders as gas sources 10 each containing a NO / N2 gas mixture containing up to 1% vol of NO, typically between 100 and 1500 ppmv of NO (N2 remainder), namely here a NO / N2 gas mixture containing for example 450 or 800 ppmv of NO (N2 remainder), which supply with NO / N2 mixture, a device or apparatus for supplying, i.e. delivering, NO 1 making it possible to monitor / follow-up and control the supply of the NO / N2 gas mixture.

[0027] The gas cylinders 10 are fluidically connected to the NO 1 supply device, 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 gas regulators 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 delivery device, i.e. into the external casing or frame of the NO 1 delivery device.

[0028] The NO 1 supply device also comprises an oxygen inlet 3 fluidically connected, via an oxygen supply line 12, such as a flexible pipe or the like, to an oxygen source, for example a pressurized oxygen cylinder or a hospital network, i.e. an oxygen supply pipe arranged in a hospital establishment.

[0029] The gas administration installation 100 further comprises a medical ventilator 50, i.e. a respiratory assistance device, which provides a flow of respiratory gas containing oxygen, typically of the order of at least approximately 20% oxygen, preferably at least approximately 21% oxygen, such as air or an oxygen / nitrogen mixture (N2 / O2), or even pure oxygen in certain cases.

[0030] 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, also called inspiratory branch 21, of a patient circuit 20. The gas supply line 21 is used to convey the gas flow to the patient, which is formed by mixing the oxygen-based flow (i.e. air or NO / N2 mixture) coming from of the medical ventilator 50 and the flow containing the NO, i.e. the NO / N2 gas mixture, delivered by the NO 1 supply device.

[0031] More precisely, the NO 1 supply device delivers or injects a given, i.e. controlled, flow rate of NO / N2 gas mixture, for example at 450 or 800 ppmv of NO, into the gas supply line 21, via a conduit or injection line 23 connected to an NO outlet 5 of the device 1, so as to mix (at 24) the NO / N2 flow with the flow of oxygen-based gas (with at least approximately 20 to 21% of O2), e.g. air or an oxygen / nitrogen mixture, delivered by the medical ventilator 50 and conveyed by the inspiratory branch 21 of the patient circuit 20 so as to obtain a final mixture essentially containing NO at the desired dosage, nitrogen (N2) and oxygen (O2), and possibly unavoidable impurities (e.g. argon, CO2, NO2, ....), that is to say a gaseous mixture NO / N2 / O2.

[0032] The inspiratory branch 21 further comprises a gas humidifier 30 arranged downstream of the site 24 where the injection of NO into the inspiratory branch 21 takes place. It makes it possible to humidify the gas flow, e.g. the NO / N2 / O2 gas mixture, before it is inhaled by the patient to be treated, by means of a respiratory interface 40, such as a tracheal intubation probe, a respiratory mask or the like.

[0033] A line for recovering the gases exhaled by the patient is also provided, forming the expiratory branch 22 of the patient circuit 20. The gas supply line or inspiratory branch 21 and the recovery line or expiratory branch 22 of the exhaled gases are connected to a connecting piece 25, preferably a Y-shaped piece.

[0034] 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 / O2 mixture (containing approximately >20 to 21% O2) delivered by 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.

[0035] The expiratory branch 22 of the expired gases may comprise one or more optional components, such as for example a CO2 elimination device 35, i.e. a CO2 trap, such as a hot tank or other, making it possible to eliminate the CO2 present in the gases expired by the patient or a filter or other.

[0036] A flow sensor 25, for example of the hot wire or pressure differential 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 device, via a flow measurement line 26. This arrangement is used to measure the flow rate of oxygen-based gas delivered by the fan 50, e.g. air or an N2 / O2 mixture, circulating in the branch inspiratory 21, upstream of the connection site 24 of the conduit or injection line 23 where the NO / N2 / O2 gas mixture is made. The measurements made by the flow sensor 25 are supplied to the control means of the NO 1 delivery device 1 where they are processed and used to control the flow rate of NO-based gas delivered, e.g. the NO / N2 mixture.

[0037] Indeed, knowing the flow rate of oxygen-based gas makes it possible to more effectively regulate the delivery of the NO flow (i.e. N2 / O2) by the NO 1 delivery device thanks to the flow rate measurements carried out by the flow sensor 25 which are returned, via the flow rate measurement line 26, to the control means of the NO 1 delivery device.

[0038] Regulating the flow rate of NO (i.e. N2 / O2) makes it possible to provide an adequate proportion or quantity of NO making it possible to obtain, after mixing with the flow of oxygen-based gas coming from the ventilator 50, the desired NO dosage in the final mixture administered to the patient, for example the stored NO concentration (NOmém) displayed by default when the device 1 is put into service as explained below.

[0039] More precisely, as shown diagrammatically in [Fig. 2], the NO 1 supply apparatus comprises, in a conventional manner, a rigid casing, for example made of polymer, crossed by one (or more) internal gas passages 6, such as a gas conduit or the like, to convey the flow of NO / N2 supplied by the gas supply line(s) 12 which is supplied by the NO / N2 mixture bottles 10.

[0040] The internal gas passage 6 fluidly connects the gas inlet (or inlets) 2 of the NO 1 supply apparatus to the injection line 23, via an NO 5 outlet of the apparatus 1, so as to convey the NO-based gas flow between them. Valve means 7, i.e. one (or more) valve devices, for example one or more solenoid valves arranged in parallel, preferably one or more proportional (solenoid) valves, are arranged on the internal gas passage 6 to control the gas flow circulating therein towards the gas outlet 5 supplying the injection line 23.

[0041] The valve means 7 are controlled by control means 8, i.e. one (or more) control devices, also called controller or control electronics, arranged in the housing of the NO 1 supply apparatus, typically an electronic card comprising one (or more) microprocessor(s) 9, preferably one (or more) microcontroller(s), implementing one or more algorithms. They may comprise other elements, such as one (or more) computer memory, such as a flash memory (not shown).

[0042] The control means 8 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 all or part of the valve(s), to obtain a determined gas flow rate which is calculated by the control means 8 from a desired NO dose value and as a function of the oxygen-based gas flow rate (i.e. air or N2 / O2) coming from the ventilator 50 and measured by the flow sensor 25 which is arranged on the inspiratory branch 21 and is connected to the NO supply device 1, by the flow measurement line 26, as already explained.

[0043] The internal gas passage 6 of the NO 1 supply apparatus may also comprise one or more flow meters (not shown) and / or a pressure regulator, such as a pressure reducer, (not shown) arranged upstream and / or downstream of the valve means 7, to determine the flow rate of NO-based gas circulating in the NO 1 supply apparatus. The flow meter may be of the pressure differential, hot wire or other type. It cooperates with the control means to provide them, again, with flow rate measurements of the NO / N2 flow, which measurements are processed by the control means 8 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.

[0044] 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.

[0045] The control means 8 of the NO supply apparatus 1 conventionally comprise an electronic control card and a microprocessor control unit 9, typically a microcontroller or the like. The control means 8 make it possible 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 further analyze the signals coming from the various components, such as the sensors...

[0046] The electrical power supply of the NO 1 supply apparatus, 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 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.

[0047] 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, 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 gas sampling line 60 to be connected, such as a flexible pipe or the like, to a gas analysis line 111 provided with sensors 112 of an internal gas analyzer 110.The gas samples taken from the inspiratory branch 21 are conveyed to the NO 1 supply device where they are analyzed in the internal gas analyzer 110, typically one or more NO2, NO and O2 sensors 112, such as electrochemical cells for example, electrically connected to the control means 8, in order to verify the conformity of the analyzed gas samples.

[0048] Indeed, it is appropriate to check, for obvious safety reasons, 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, that it does not contain too high a NO2 content and that its NO content corresponds to the desired dosage, i.e. the dose of NO to be administered by inhalation which is usually chosen by the healthcare personnel, i.e. a doctor or similar.

[0049] As already explained, the starting dose of NO is usually chosen, i.e. set or selected, by the medical personnel at the level of the NO supply device used, after starting the NO supply device. Thus, when a NO supply device is put into operation, i.e. “turned on” or put into service, the display 4 displays a content or dose of NO equal to 0 ppm and the healthcare personnel must then set the dose of NO called “start” or “starting” which is that desired at the start of treatment.

[0050] In other words, when it is started up, a NO 1 supply device according to the prior art displays a so-called "starting" dose of zero (i.e. 0 ppm), i.e. a concentration of NO equal to 0 ppm, and the healthcare personnel sets a desired "starting" dose, for example 5, 10, 15 or 20 ppm, by intervening for example at the user interface of the device to enter the dose or select it from a menu displaying different choices of possible doses, or the like.

[0051] It is therefore understood that errors in NO dosage can sometimes occur resulting from errors in setting or selection of the starting dose. Indeed, the nursing staff must often act urgently when starting treatment with NO. in a patient, for example a hypoxic newborn, and may therefore make a mistake when entering or selecting the dose of NO to be administered initially.

[0052] However, it is easy to understand that any dose error, i.e. an over- or under-dose, can have serious consequences for the patient, especially since people needing iNO treatment are often fragile and / or in a serious medical condition, such as, for example, newborns with severe hypoxemia.

[0053] According to the invention, the NO 1 supply device 1 has been modified to reduce the risk of the patient receiving an unsuitable concentration or dose, and therefore to increase the safety of NO treatment by avoiding errors in setting the NO dose that may occur at the start of treatment, i.e. errors related to setting the “starting” NO dose, i.e. just before starting the administration of NO to the patient, i.e. the start of treatment of the patient.

[0054] To do this, according to the invention, the NO 1 supply device 1 is provided with storage means 70 configured to store a non-zero dose of pre-fixed NO (NOmém), that is to say a dose provided and decided in advance, typically a dose between 1 and 40 ppm, for example a dose of 10, 15, 20 ppm or other, which will be the so-called starting dose.

[0055] Furthermore, the control means 8 including the microprocessor 9, which cooperate with the storage means 70, are configured to control a display (at 71) on the graphic display 4 of the pre-set dose of NO (NOmém) stored as the starting dose. The storage means 70, for example a flash memory or the like, may be arranged on the electronic card carrying the microprocessor 9 and connected to it.

[0056] In other words, the control means 8, typically the microprocessor 9, control or command the graphic display 4 to produce a default display of the stored pre-set NO dose (NOmém), upon starting the device 1, i.e. upon its commissioning, within a dedicated space of the screen 4, typically a display window 71 or the like. For example, the graphic display 4 can display (at 71) a starting dose value of “10 ppm”, as illustrated in [Fig.3].

[0057] The stored starting dose can be set once and for all by the healthcare staff, for example by a member of the healthcare team designated by the Hospital Service and preferably in the presence of a person certified by the manufacturer of the device, via a menu and / or one or more configuration keys 85 of the device 1 for example, as shown diagrammatically in [Fig. 5], and then recorded by the storage means 70, for example a flash memory or the like. This dose may possibly be modified subsequently, via the configuration menu and / or the configuration key(s) 85, if the healthcare staff so wishes and the new starting dose will then be stored in the same way.

[0058] Furthermore, the apparatus 1 comprises a treatment start button 72, actuable by the user, the actuation of which generates a supply of the flow of gas containing NO, i.e. a control NO flow rate, to obtain the stored pre-fixed dose of NO (NOmém) in the final mixture administered by inhalation to the patient.

[0059] Advantageously, the graphic display 4 has a touch screen, typically a color touch screen (called a touch pad in English), and the start of processing key 72, i.e. processing validation key, is a virtual key displayed on the graphic display 4, i.e. a touch key displayed on the touch screen, as illustrated in [Fig.3].

[0060] When a healthcare worker presses with his finger, his index finger for example, on the treatment start validation key 72, this press will be recognized by the touch screen and a corresponding signal will be transmitted to the control means 8, typically to the microprocessor 9, which will then control the valve means in particular to start an iNO treatment with sending a flow of NO into the inspiratory branch 21 of the patient circuit 20, where it mixes (at 24) with the flow of gas containing oxygen coming from the ventilator 50, such as air or an O2 / N2 mixture, and thus obtain the desired final gas mixture containing the desired NO dosage, namely the memorized pre-fixed NO dose (NOmem) of 10 ppm here at the start of the treatment.

[0061] Of course, this dose can be modified subsequently depending on the patient's response to his iNO treatment, i.e. increased or decreased by the healthcare staff. This can be done at any time, before the start of treatment and, subsequently, throughout the duration of treatment...

[0062] In the example of [Fig.3], we see how screen 4 may appear after it has been started by the nursing staff but before any administration of NO. The stored pre-fixed dose of NO (NOmém), namely 10 ppm here, is displayed by default in the display window 71 and the treatment start validation key 72 is also displayed, right next to the display window 71.

[0063] It can be seen in [Fig. 3] that, despite the display of the starting dose of 10 ppm, the administration of NO has not yet started, that is to say that the device 1 is not yet injecting a flow of NO, typically a NO / N2 mixture at controlled flow rate, into the inspiratory branch 21 of the patient circuit 20, given that the graphic display 4 also displays zero NO and NO2 contents (i.e. 0 ppm) in dedicated windows 80, 81. On the other hand, it can be seen that the ventilator 50 is already delivering the flow of gas containing oxygen (>20% vol), since a dedicated window 82 displays an oxygen (O2) content of 23% here. These concentrations of NO, O2 and NO2 are determined by the internal gas analyzer 110, namely the gas analysis line 111 provided with NO2, NO and O2 sensors 112, such as electrochemical cells, electrically connected strictly to the piloting means 8, as explained above.

[0064] The fact that the treatment has not yet started is also confirmed by an additional display of information relating to the treatment (i.e. in progress or not) intended for the nursing staff, in a dedicated space 83 of the screen 4, namely here the following information: STAND-BY (waiting) - Patient Not Treated, or similar information.

[0065] Of course, the information relating to the treatment changes as soon as the patient staff presses the treatment start key 72, i.e. it is updated. The screen 4 can then display new information of the type: TREATMENT IN PROGRESS - Patient Treated, or similar.

[0066] The proper progress of the treatment can then be checked by the nursing staff by consulting in particular the dedicated windows 80, 81, 82 which then display non-zero NO and O2 values. The NO2 content must be as low as possible, preferably (quasi-)zero, i.e. approximately 0 ppm, because the NO2 species (which result from oxidation of a small part of the NO by oxygen) are toxic and must be minimized / avoided.

[0067] According to an advantageous embodiment, the control means 8 are further configured to control a display on the graphic display 4 of one (or more) confirmation key or window 73, that is to say one (or more) other virtual or similar key, in response to an actuation by the user of the start of processing key 72, as illustrated in [Fig.4].

[0068] This (or these) confirmation key or window 73 allows the nursing staff to confirm or cancel the start of treatment of the patient with start at the memorized pre-fixed NO dose (NOmém), for example 10 ppm in the example of [Fig.3].

[0069] To do this, depending on the embodiment, it is possible to provide either two separate confirmation keys 73, i.e. juxtaposed, or, as illustrated in [Fig.4], a confirmation window 73 divided into two separate juxtaposed zones 73.1, 73.2: - one of which 73.1 (i.e. first zone) allows the starting dose to be confirmed proposed, ie 10 ppm here, and start the treatment, for example a key or zone 73.1 called "OK", "GO" or "Start" or any similar term; and - the other 3.2 (ie second zone) of which allows to cancel or stop any start of treatment with supply of NO, for example a key or zone 73.2 called "Stop", "Abort" or "Stop" or any similar term.

[0070] Confirmation or cancellation (i.e. non-confirmation) is preferably done by pressing a finger (e.g. the index finger) by a healthcare worker on one or other of these distinct zones or keys 73.1, 73.2.

[0071] As illustrated in [Fig.4], it can be provided that the screen or graphic display 4 displays, in the foreground, a confirmation window 73 which is superimposed on the display window 71 of the starting NO dose and the start of treatment validation key 72, by partially or completely hiding them. The second plane of screen 4 can then be grayed out.

[0072] In addition, the graphic display 4 can also be configured to simultaneously display a sentence or other (at 73) reminding the user what he must confirm or deny, namely here: Start of treatment at the dose of 10 ppm? or other information.

[0073] Thanks to the invention, no dose error is possible when starting the device 1 because the stored dose of NO is proposed, that is to say is displayed by default (at 71) on the graphic display 4, as soon as the device 1 is started, therefore before any supply of NO to the inspiratory branch 21 of the patient circuit 20, therefore to the patient. The supply of NO then only begins after validation of this proposed NO by the nursing staff, or even only after confirmation of the treatment via the confirmation key(s) or window 73.

Claims

Claims

1. Apparatus (1) for supplying a gas containing NO comprising: - at least one internal passage (6) for conveying a flow of gas containing NO, - valve means (7) arranged on said at least one internal passage, - a graphic display (4), and - control means (8) with a microprocessor (9) cooperating at least with the valve means (7) to control the supply of gas, characterized in that: - it further comprises storage means (70) for storing a non-zero dose of pre-fixed NO (NOmém), - the control means (8) are configured to control a display on the graphic display (4) of the dose of pre-fixed NO (NOmém) having been stored, and - the graphic display (4) is configured to operate a default display (at 71) of the dose of pre-fixed NO (NOmém ) having been stored.

2. Apparatus according to claim 1, characterized in that it further comprises a treatment start button (72), actuable by the user, the actuation of which causes a supply of the flow of gas containing NO to obtain the stored pre-fixed dose of NO (NO

3. mem / * Apparatus according to claims 1 and 2, characterized in that the graphic display (4) has a touch screen and the processing start key (72) is a virtual key displayed on the graphic display (4).

4. Apparatus according to one of claims 2 or 3, characterized in that the control means (8) are further configured to control a display on the graphic display (4) of at least one confirmation key or window (73) in response to actuation by the user of the treatment start key (72).

5. Apparatus according to one of claims 2 or 3, characterized in that the control means (8) are configured to control the means to valve (7) for providing a given flow rate of gas containing NO making it possible to obtain the memorized pre-fixed dose of NO (NOmém), in response to an actuation by the user of at least the treatment start key (72), in particular of at least the virtual treatment start key (72) displayed on the graphic display (4).

6. Apparatus according to claims 2 and 4, characterized in that the control means (8) are configured to control the valve means (7) to provide a given flow rate of gas containing NO making it possible to obtain the stored pre-fixed dose of NO (NOmém), in response to successive actuations by the user of the treatment start key (72) then of the confirmation key or window (73).

7. Apparatus according to claim 6, characterized in that the actuation(s) by the user of the treatment start key (72) and / or of the confirmation key or window (73) are carried out by digital pressure from the user.

8. Apparatus according to claim 1, characterized in that the storage means (70) are configured to store a pre-fixed dose of NO (NOmém) of between 1 and 40 ppmv, preferably between 5 and 20 ppmv.

9. Apparatus according to claim 1, characterized in that the control means (8) are configured to control a display of the pre-set NO dose (NOmém) having been stored, upon commissioning of the apparatus (1).

10. Installation for administering gas (100) to a patient, i.e. a gas containing NO, comprising: - at least one gas source (10) containing gaseous NO, in particular a NO / N2 gas mixture, - a gas supply apparatus (1) according to one of the preceding claims, supplied with gas containing NO by said at least one gas source (10), such as the NO / N2 gas mixture, - a medical ventilator (50) for supplying a gas containing oxygen, such as air or an O2 / N2 gas mixture, and - a supply line (20, 21) supplied by the gas supply apparatus (1) with gas containing NO, such as the NO / N2 gas mixture, and by the medical ventilator (50) with gas containing oxygen, such as air or the O2 / N2 mixture.

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