NO discharge device with two gas outlets

Description

[0001] The present invention relates to a device or apparatus for supplying gaseous nitric oxide (NO) equipped with a backup system to ensure delivery of NO, in normal mode, in backup mode in case of failure or in manual ventilation mode, in particular in case of switching to manual ventilation by bag-valve-mask or manual insufflation (i.e. BVM), and an installation for administering NO to a patient comprising such a device or apparatus for supplying NO.

[0002] Inhaled nitric oxide or NOi is a gaseous drug commonly used to treat patients with acute pulmonary arterial hypertension, especially pulmonary vasoconstrictions in adults or children, including newborns (PPHN), as described for example by EP-A-560928 or EP-A-1516639.

[0003] A NOi therapy delivery system, commonly called an NO delivery system, typically includes one or more NO / N2 mixing cylinders supplying an NO delivery device that delivers the NO / N2 mixture at a controlled flow rate; a respiratory support device, also called a medical ventilator, to provide a breathing gas containing at least 21% vol. oxygen, such as an O2 / N2 mixture or air, to which NO (i.e., NO / N2) is added; circuit components, for example, one or more flexible hoses, to carry the gas flows between these different pieces of equipment and to the patient; and a breathing interface, such as a tracheal tube, to deliver the NO-containing gas mixture to the patient. A gas humidifier may also be included to humidify the gas mixture before administration to the patient. Such a system is schematically represented as follows: Fig. 1 .

[0004] Usually, the NO / N2 mixture delivered by the NO delivery device is injected into the breathing stream containing at least 21% vol. of oxygen (i.e. air or O2 / N2 mixture) from the medical ventilator before being administered by inhalation to the patient as a final breathing mixture (i.e. NO / N2 / O2 or NO / N2 / air mixture) generally containing a few tens of ppmv of NO (ppm by volume) and at least 21% vol. of oxygen O2, for example on the order of 1 to 80 ppmv of NO, the remainder being essentially nitrogen (N2).

[0005] Such a NO delivery system is used in hospitals to administer NOi therapy and thus treat patients who need to inhale NO to treat their pulmonary arterial hypertension. Examples of such NO delivery systems are given in documents WO-A-2012 / 094008, US-A-2015 / 320951, US-A-2015 / 273175, JP-A-H11192303, WO-A-02 / 40914, and US-A-2003 / 116159.

[0006] In the event of a failure or malfunction of the NO supply device or medical ventilator and / or in the event of the need to ventilate the patient with a manual ventilation bag, at the request of the nursing staff or following a slight failure of the device, the NO supply device must be able to continue to supply the NO / N2 mixture so that the patient's treatment is not abruptly interrupted, for obvious safety reasons, given that an abrupt interruption of NOi treatment could be fatal to fragile patients, especially newborns suffering from PPHN.

[0007] To ensure NO delivery, even in the event of a failure of manual ventilation or other means, it is known to equip the NO supply device with a secondary system or circuit, called a backup circuit, which is entirely pneumatic. This system is designed to deliver an adjustable O2 flow rate between 0 and 20 L / min and a fixed NO flow rate, for example, approximately 230 mL / min of NO / N2 mixture. These mixtures are blended in the NO supply device before being injected into a manual ventilation bag. Oxygen is typically supplied by an oxygen source, such as a pressurized oxygen cylinder, connected to the NO supply device. EP-A-3233171, for example, teaches the use of such a backup circuit.

[0008] Switching to "emergency mode" occurs after the user activates a selection method on the NO supply device, for example, an "emergency mode" selection button. Activating this button directs the gas flow to a secondary circuit, i.e., a backup and / or manual venting circuit for the NO supply device, such as the one illustrated in Fig. 2 .

[0009] However, such a purely pneumatic solution is not ideal because the NO concentration of the resulting gas mixture (i.e., NO / N₂ + O₂) varies depending on the oxygen flow rate set by the user, since the NO flow rate is fixed. Having an NO concentration that varies according to the chosen O₂ flow rate is not therapeutically desirable because it is essential to be able to deliver a specific dosage to the patient—that is, a fixed amount of NO corresponding to an effective concentration for treating their condition, or a reduced dosage if weaning the patient is necessary, particularly in manual ventilation mode using a manual resuscitator, i.e., a bag-valve-mask (BVM).

[0010] In view of this, one problem is to propose an improved NO supply device, which is capable of supplying a NO / N2 / O2 gas mixture to a patient, whether in normal operating mode but also in case of failure or malfunction, or during a switch to manual ventilation via BVM (e.g. at the request of the nursing staff or following a slight failure), preferably observing the desired dosage, i.e. a NO / N2 / O2 gas mixture whose composition is not solely dependent on the oxygen flow rate.

[0011] One solution of the invention relates to a device or apparatus for supplying NO (i.e., nitrogen monoxide) comprising: a main gas circuit comprising at least one main NO line fluidically connecting at least one NO inlet port to a main outlet port to deliver a NO / N2 mixture from said at least one NO inlet port to said main outlet port, and a backup circuit comprising a backup NO circuit and a backup O2 circuit, wherein: the backup NO circuit comprises a backup NO line supplied with a NO / N2 mixture from said at least one NO inlet port, and the backup O2 circuit comprises a main O2 line in fluidic communication with an O2 inlet port, the main O2 line fluidically connecting with the backup NO line to form a common line in fluidic communication with a secondary outlet, also called a backup outlet, supplying a NO / N2 / O2 mixture, in particular so as to be able to supply a manual ventilation bag (MVB) or similar.

[0012] In addition, the main NO line includes NO / N 2 flow control means driven by pilot means, and the main NO line is fluidly connected to the backup NO line, downstream of the NO / N 2 flow control means, via a first multi-way solenoid valve.

[0013] The NO supply device further includes a touch-sensitive digital information display configured to display at least one touch selection button. This at least one touch selection button on the display is configured to allow the user to set or select a desired NO concentration between 1 and 80 ppmv. The digital display is also configured to display the desired NO concentration.

[0014] Depending on the embodiment considered, the NO supply device or apparatus of the invention may comprise one or more of the following features: The control means (i.e., control device) are supplied with electrical energy (i.e., electric current) by electrical power supply means. The main NO line is fluidly connected to the backup NO line via a first solenoid valve with at least 3 ports, preferably 3 or 5 ports, advantageously 3 ports. The first multi-port solenoid valve includes at least one inlet port fluidly connected to the main NO line downstream of the flow control means, and a first outlet port connected to the main NO line, in particular to the downstream portion of the main NO line including the main outlet orifice, and a second outlet port connected to the backup NO line upstream of the common line including the secondary outlet orifice.The first solenoid valve is controlled by the control means to direct the NO / N₂ mixture flow from the NO / N₂ flow control means (202) (i.e., flow control device): ▪ either into a downstream portion of the emergency NO line in fluidic communication with the common line in fluidic communication with the secondary outlet, ▪ or into a downstream portion of the main NO line in fluidic communication with the main outlet port. The emergency NO line includes a pneumatic valve for controlling the flow of the NO / N₂ mixture in the emergency NO line. The emergency NO line includes a second solenoid valve controlled by the control means. The second solenoid valve of the emergency NO circuit is normally open.The main O2 line includes a first control valve operated by a user-actuable actuation means to control the flow of oxygen in said main O2 line. The actuation means (i.e., actuating device) is configured to provide an activation signal to the pilot means in response to actuation of said actuation means by the user. The main O2 line includes a second pneumatic control valve arranged downstream of the first control valve. The pilot means are configured to control the NO / N2 flow control means so as to regulate the flow rate of the NO / N2 mixture in the main gas circuit.The control means are configured to operate the first solenoid valve in response to the activation signal received after the user activates the actuation device, for example, in the event of a minor fault that does not result in a complete power outage and / or a shutdown of the control means, or in particular when the user wishes to perform manual ventilation via a BVM (Bag Valve Mask). The control means are configured to operate the second solenoid valve of the emergency NO (Normally Open) circuit to interrupt all NO / N2 mixture circulation through said second solenoid valve. The first multi-way solenoid valve is arranged on the main NO line downstream of the NO / N2 flow control means and is in fluid communication with the emergency NO line downstream of the pneumatic valve and the second solenoid valve.The main O2 line further includes oxygen flow measurement means arranged downstream of the first control valve and configured to provide at least one oxygen flow measurement to the pilot means. The main O2 line further includes O2 flow control means (i.e., flow control device) arranged downstream of the oxygen flow measurement means. It includes NO content control means configured to allow a user to select a desired NO content and supply said desired NO content to the pilot means. The pilot means are configured to calculate a NO / N2 mixing flow rate to be supplied corresponding to the desired NO content and to control the NO / N2 flow control means to supply said calculated NO / N2 mixing flow rate.The control means are configured to calculate the required NO / N₂ mixture flow rate based on the desired NO content, the oxygen flow rate measured by the oxygen flow measurement means, and the NO content in the NO / N₂ mixture supplied via the main NO line. The digital touchscreen display is a touch panel display. The NO content adjustment means include at least one touch selection button displayed on the display, preferably multiple touch selection buttons. The NO content in the NO / N₂ mixture supplied via the main NO line is between 100 and 1000 ppmv.The control means are further configured to ensure normal operation of the device in the absence of user actuation of the actuation means by controlling the NO / N₂ flow control means to route the NO / N₂ mixture through the main gas circuit between at least one NO inlet port and the main outlet port. The main NO line is fluidly connected to two parallel NO inlet ports. The control means are configured to receive, when supplied with electrical energy (i.e., electric current), the activation signal delivered after user actuation of the actuation means. The backup NO line and the main O₂ line are fluidly connected to each other at a junction point located downstream of the O₂ flow control means of the main O₂ line and downstream of the second solenoid valve of the backup NO line.The O2 flow control means include a flow sensor or a differential pressure sensor. The main O2 line is configured to cooperate pneumatically with the pneumatic valve via a section of conduit fluidically connecting the main O2 line downstream of the second control valve to said pneumatic valve. The first control valve is of the on / off type. The first control valve is configured to control the circulation of oxygen flow in the main O2 line. The first control valve is operated by a user-operable actuation means, such as that used by a healthcare worker, when they wish to start or stop the backup circuit. The actuation means includes a user-operable rotary selector or similar device. The NO content adjustment means include at least one touch-operated selection button displayed on the display screen, i.e.One or more touch-sensitive selection buttons, configured to allow a user to set or select a desired NO concentration, preferably using touch-sensitive selection buttons displayed on the screen. In other words, the selection or setting of the desired NO concentration is done by the user pressing the touch-sensitive selection button(s) displayed on the screen. The control means are configured to control the display(s) on the screen. The control means include at least one (micro)processor, for example, a microcontroller. The control means include at least one electronic board containing said at least one microprocessor. The control means include at least one (micro)processor implementing at least one algorithm, for example, for data processing, calculation, or other purposes.The control means are further configured, in response to the activation signal, to act on the second solenoid valve to interrupt any flow of NO / N₂ mixture in the emergency NO line. The first solenoid valve is arranged on the main NO line downstream of the NO / N₂ flow control means and on the emergency NO line of the emergency NO circuit downstream of the pneumatic valve. The first multi-way solenoid valve cooperates with the emergency NO line via a connecting conduit linking the emergency NO line to one of the ports of the first solenoid valve. The first solenoid valve is arranged on the downstream portion of the main NO line conduit, between the NO / N₂ flow control means and the main outlet port. The first solenoid valve is controlled by the control means to allow or stop any flow of NO / N₂ mixture from the NO / N₂ flow control means.The junction site is located downstream of the first solenoid valve. The backup NO line includes a calibrated orifice device arranged downstream of the pneumatic valve. A first pressure regulator is arranged on the backup NO line upstream of the pneumatic valve. A second pressure regulator is arranged on the main O2 line between the second pneumatic control valve and the oxygen flow measurement means. An NO flow indicator device is arranged on the backup NO line upstream of the junction site of the main O2 line and the backup NO line. An O2 flow indicator device is arranged on the main O2 line, downstream of the O2 flow control device or means. The O2 flow indicator device includes a ball rotameter. The O2 flow control means include a calibrated orifice rotary disc or similar device.The O2 flow control means are configured to adjust the O2 flow rate between 5 and 20 L / min. It includes a flow selection means that cooperates with the O2 flow control means to select a desired O2 flow rate. The flow selection means is user-operable. The flow selection means includes a rotary knob or similar device. In another embodiment, the flow selection means includes a button or similar device displayed on a screen for selecting the O2 flow rate. It includes data storage means, for example, computer memory or similar device memory. It includes a rigid housing in which all or part of the elements of the NO supply device are arranged.The main O2 line is configured to cooperate pneumatically with the pneumatic valve to allow the passage of the NO / N2 mixture into the backup NO line, after actuation of the actuation means by the user, i.e., in response to a user actuation of the actuation means. The control means are further configured to ensure normal operation of the device in the absence of actuation of the actuation means by the user, by controlling the NO / N2 flow control means to route the NO / N2 mixture through the main gas circuit between at least one NO inlet port and the main outlet port. The tactile selection keys allow the user to choose from several available NO concentrations, i.e., to set or select a desired NO concentration, for example, from several predefined NO concentrations.Alternatively, the tactile selection keys include "+" and "-" keys allowing a given NO value to be incremented or decremented in steps, for example, by 1 ppmv, or other increments (e.g., by 2, 3, ..., or 5 ppmv). The desired NO content, chosen or selected by the user by pressing at least one tactile selection key, is provided to the control means, preferably by digital action. The display screen is color or black and white. The means for supplying electrical power, i.e., for providing electrical current, include means for connecting to the mains (110 / 220V), for example, an electrical cable with a plug or similar, and / or an electrical battery, preferably rechargeable. The display screen is mounted on the housing. The secondary output, i.e.An emergency outlet, such as a port or outlet, is configured to be fluidically connected to a manual air-supply device, such as a manual ventilation bag or BVM, notably via a flexible fluid connection conduit, i.e., flexible tubing or similar. The main NO line includes at least one upstream duct section, preferably two upstream duct sections arranged in parallel. The emergency NO circuit is supplied with NO / N2 by said at least one upstream duct section of the main NO line, preferably both upstream duct sections arranged in parallel. The emergency NO circuit is fluidly connected to said at least one upstream duct section, preferably both upstream duct sections arranged in parallel, via at least one NO inlet pipe section, preferably two parallel NO inlet pipe sections fluidly connected to the two upstream duct sections.The backup NO circuit is fluidly connected to the main NO line, upstream of the NO / N 2 flow control means, in particular to the aforementioned upstream conduit sections of the main NO line, so as to be supplied with NO / N 2. The one or two sections of NO inlet pipe are supplied with NO / N 2 by the one or two NO inlet ports.

[0015] According to another aspect, the invention also relates to a therapeutic gas administration system containing NO, for a patient (P) comprising an NO supply device according to the invention, in particular as described above, supplied with a NO / N2 mixture by at least one pressurized gas container and with oxygen by a pressurized oxygen container, said NO supply device providing: either a NO / N2 mixture via the main outlet port (210), to a breathing gas circuit (3) connected to a medical ventilator (2), or a NO / N2 / O2 mixture via the secondary port (141), to a manual resuscitator or BVM.

[0016] Depending on the embodiment considered, the therapeutic gas administration system of the invention may include one or more of the following features: Said at least one pressurized gas container contains the NO / N₂ mixture. Said at least one pressurized gas container contains an NO / N₂ mixture containing 100 to 1000 ppmv of NO, the remainder being nitrogen. The pressurized oxygen container contains medical oxygen. The container(s) are gas cylinders. The gas container(s) contain an NO / N₂ mixture or medical oxygen at a pressure of at least 150 bar, or at least 180 bar. The breathing gas circuit includes an inspiratory branch and an expiratory branch. The inspiratory and expiratory branches are fluidically connected to each other via a junction piece, such as a Y-piece. The junction piece is fluidly connected to a breathing interface, such as a tracheal tube or a breathing mask. The inspiratory and expiratory branches include flexible tubing.A gas humidifier is installed on the breathing gas circuit, specifically on the inspiratory branch. The inspiratory branch includes a flow sensor electrically connected to the NO supply device, specifically to the control means. The flow sensor is installed on the inspiratory branch upstream of the NO injection site. The flow sensor is of the mass or differential pressure type. A gas sampling line fluidly connects the NO supply device to the breathing gas circuit, preferably near the junction piece, i.e., the Y-piece.The medical ventilator and the NO supply device are electrically powered by means of electrical power supply, i.e. at least one source of electrical current, in particular means of electrical connection to the mains (110 / 220V), for example an electrical cable fitted with an electrical plug or similar, and / or an electrical battery, preferably rechargeable. The secondary outlet, i.e. emergency outlet, of the NO supply device is fluidically connected to a manual insufflation bag, preferably via a connecting conduit, such as a flexible tube.

[0017] According to another (unclaimed) aspect, the present disclosure also relates to a method of treating a person, referred to as a patient, suffering from a pathology or medical condition causing acute pulmonary arterial hypertension, in particular pulmonary vasoconstrictions in adults, adolescents, or children, including newborns and infants, for example, to treat persistent pulmonary hypertension of the newborn (PPHN) in a newborn, infant, child, or the like, or pulmonary hypertension in a person undergoing cardiac surgery, wherein an inhalation administration is carried out to said patient in need, of a gas mixture containing oxygen (preferably >21% vol), nitrogen, and NO (preferably <100 ppmv), said gas mixture being supplied by a therapeutic gas delivery system according to the invention comprising a device or apparatus for supplying NO according to the invention,in particular as described above and / or below, which NO supply device is supplied with NO / N2 mixture by at least one pressurized gas container, preferably several pressurized gas containers 5, such as NO / N2 cylinders, and with oxygen by at least one pressurized oxygen container, such as an O2 cylinder, and which NO supply device can supply: either a NO / N2 mixture, via the main outlet port, to the breathing gas circuit connected to a medical ventilator of the therapeutic gas delivery system according to the invention, or a NO / N2 / O2 mixture via the secondary port, to a manual resuscitator, in particular a manual resuscitator bag or BVM.

[0018] The invention will now be better understood through the following detailed description, given by way of illustration but not limitation, with reference to the attached figures, among which: Fig. 1 represents an embodiment of a therapeutic gas administration system for a patient P incorporating a NO supply device, Fig. 2 diagram shows a method of implementing the backup circuit of a NO supply device according to the prior art, Fig. 3 illustrates a schematic embodiment of the internal architecture of a NO supply device according to the present invention, and Fig. 4 is a detailed diagram of the NO / N 2 flow control means of the device Fig. 3 .

[0019] Fig. 1 diagrams an embodiment of a therapeutic gas delivery installation 100, i.e. a gas mixture based on NO, to a patient P incorporating a NO supply device 1, such as that according to the present invention.

[0020] More specifically, it comprises two pressurized gas containers 5, arranged in parallel, each containing a gaseous mixture of NO and nitrogen (N2), i.e., a NO / N2 mixture, typically containing 250 to 1000 ppmv of NO and nitrogen (N2) for the remainder, conditioned at a pressure of up to 180 bar or more, for example, a NO / N2 mixture containing 450 ppmv or 800 ppmv of NO. Such gas containers 5 are commonly called NO cylinders 5.

[0021] The NO5 bottles supply the NO / N2 mixture to a NO1 supply device, such as that according to the invention, the internal architecture of which is illustrated on Fig. 3 et Fig. 4 They are fluidly connected to the gas supply device 1 by NO supply lines 50, i.e. gas pipelines, such as flexible hoses or the like. Each NO supply line 50 is connected to an NO inlet port 101 of the NO supply device 1 to supply a main gas circuit 200 internal to the housing 199 of the NO supply device 1 (cf. Fig. 3 ).

[0022] The NO 1 supply device also includes an oxygen inlet port 53 fluidically connected, via an oxygen supply line 51, such as a flexible hose or similar, to an oxygen source, for example a pressurized oxygen container 52, typically an O 2 cylinder or, alternatively, the hospital network, i.e. an oxygen supply pipeline arranged in the hospital building where patient P is being treated.

[0023] The NO5 and O2 52 cylinders are equipped with a gas dispensing valve 55, preferably incorporating gas pressure reduction means, i.e., an RDI or valve with integrated regulator, so as to be able to control the flow rate and / or pressure of the gas they deliver. The gas dispensing valve 55 is preferably protected against impacts by a protective cover.

[0024] Furthermore, installation 100 also includes a medical ventilator 2, that is to say a respiratory support device, providing a flow of respiratory gas containing at least 21% vol. of oxygen, such as air or an oxygen / nitrogen mixture (N2 / O2), to patient P.

[0025] The medical ventilator 2 is fluidically connected to patient P via a respiratory gas circuit 3 which here has two respiratory branches 30, 31 given that it includes an inspiratory branch 30, i.e. a gas supply line, used to bring the respiratory gas to patient P and an expiratory branch 31 used to recover the CO2-enriched gas exhaled by patient P.

[0026] The two respiratory branches 30, 31 are typically flexible tubes made of polymer or similar material. The two respiratory branches 30, 31 are, on the one hand, connected to the medical ventilator 2 and, on the other hand, connected to each other at a junction piece 32, typically a Y-piece, which is in fluidic communication with a respiratory interface 4 supplying the gas to the patient P, such as a tracheal tube or other.

[0027] Of course, the medical ventilator 2 and the NO supply device 1 are normally powered by an electrical source (or sources), particularly their components requiring electrical power to operate, especially the control means 900 of the NO supply device 1 and the control system of the medical ventilator 2, i.e., the microprocessor-based electronic board(s), or any other component, including the internal motorized turbine that supplies the airflow or analog, i.e., the breathing gas. The electrical source can be mains power (110 / 220V) and / or an electric battery, preferably rechargeable.

[0028] As can be seen, the NO supply device 1 allows the NO / N 2 mixture to be injected into the inspiratory limb 30, via an NO injection conduit 11 opening into the inspiratory limb 30 at an injection site 8, so as to produce a mixture of the NO / N 2 flow and the respiratory gas flow containing at least 21% O 2, i.e. air or oxygen / nitrogen mixture, delivered by the medical ventilator 2.

[0029] The NO 1 supply device includes a main outlet port 210 located at the outlet of its main gas circuit 200 through which the NO / N 2 flow exits the housing 199 of the NO 1 supply device and enters the NO injection line 11. The NO injection line 11 is fluidly connected to the main outlet port 210, for example via a connector or similar.

[0030] The resulting therapeutic gas mixture therefore contains oxygen (>21% vol.), nitrogen, and a variable and adjustable NO concentration, typically between 1 and 80 ppmv, due to the dilution of the propellant during the mixing of the gas streams. Of course, unavoidable impurities may be present in the gas, but these are undesirable, especially when the gas stream from fan 2 is atmospheric air rather than an O2 / N2 mixture.

[0031] Advantageously, a gas humidifier 6 is also provided, arranged here on the inspiratory branch 30 downstream of the injection site 8, to humidify the therapeutic gas flow, e.g., a NO / N₂ / O₂ mixture, by adding water vapor, before it is inhaled by patient P. This prevents or limits the drying of patient P's airways during their inhalation treatment. In another embodiment, the gas humidifier 6 could also be arranged upstream of the injection site 8. Depending on the case, the expiratory branch 31, which collects the CO₂-rich exhaled gases, may include one or more optional components, such as a CO₂ removal device, i.e., a CO₂ trap, such as a hot tank or similar, to remove the CO₂ present in the patient's exhaled gases, a filter, or similar.

[0032] As seen on Fig. 1 It is also provided on the inspiratory branch 30, upstream of the injection site 8, a flow sensor 7, for example of the mass or differential pressure type, connected to the NO supply device 1, in particular to the control means 900 of said NO supply device 1, via a breathing gas flow measurement line 71 used to measure the gas flow from the ventilator 2 within the inspiratory branch 30. Determining this ventilator flow (Qv) makes it possible in particular to regulate the passage of NO through the NO supply device 1, in particular to be able to choose the flow rate of NO / N2 mixture to be injected according to the desired NO content, the composition of the NO / N2 mixture from the cylinders and the gas flow rate (i.e. air or air / O2) from the ventilator 2.

[0033] In addition, a gas sampling line 33 can also be provided, fluidly connecting the NO supply device 1 to the breathing gas circuit 3, preferably near the Y-piece 32, for example about 10 to 20 cm upstream of the Y-piece 32, used to collect gas samples and to check their conformity with the desired gas mixture to be administered to patient P.

[0034] More specifically, the NO supply device 1 includes an internal main gas circuit 200 for conveying the NO / N 2 mixture entering through the gas inlet port(s) 101 to the NO injection conduit 11. This main gas circuit 200 includes NO / N 2 flow control means 202 (cf. Fig. 3 et Fig. 4 ), such as valves, calibrated orifices..., controlled by the control means 900 of the NO supply device 1, typically a microprocessor (or microprocessors) arranged on an electronic board, the operation of which is explained below. All these components are arranged in a housing 199, that is to say a rigid external casing.

[0035] In addition, the NO supply device 1 includes a backup circuit 110, called the "backup" circuit, designed to deliver an adjustable O2 flow rate and a fixed NO flow rate in order to ensure a supply of NO, even in the event of a failure or other, as detailed below.

[0036] So, Fig. 2 This diagram illustrates a possible implementation of the emergency circuit 110 or secondary circuit of a conventional NO supply device 1. It is important to first clarify that, on Fig. 2 The main gas circuit 200 of the NO supply device 1, which carries the NO / N2 mixture during normal operation of the device 1 (i.e., when not malfunctioning or similar), is not shown in order to avoid unnecessarily cluttering the diagram and complicating its understanding. Nevertheless, this main gas circuit 200, which is arranged in the housing 199, includes, as shown, the one illustrated on Fig. 3 ou Fig. 4 , a main line of NO 201, 203 comprising at least one upstream duct section 201, namely here two upstream duct sections 201 arranged in parallel, since 2 NO 5 cylinders are connected to the NO 1 supply device, as illustrated on Fig. 2 à Fig. 4 , and also at least a downstream portion 203.

[0037] As can be seen, the emergency circuit 110, 120, whose operation can be entirely pneumatic, which is also arranged in the box 199, includes an emergency NO circuit 110 and an emergency O2 circuit 120, each of which includes gas pipes, passages or conduits to carry the different gases or gas mixtures into the box 199.

[0038] The NO 110 emergency circuit is supplied in NO / N 2 by at least one section of NO 111-1, 111-2 inlet pipe, namely here two sections of NO 111-1, 111-2 inlet pipe arranged in parallel, themselves supplied by the two inlet ports of NO 101 to which the NO 5 cylinders are connected, via the supply line 50, as explained above.

[0039] The inlet pipe section(s) 111-1, 111-2, connect fluidly to the upstream conduit sections 201 (partially shown on Fig. 2 ) downstream of a filter 115 located immediately downstream of each NO 101 inlet port in the upstream duct portion(s) 201, as detailed in Fig. 3 .

[0040] A check valve 116 is arranged in each inlet pipe section 111-1, 111-2. These two inlet pipe sections 111-1, 111-2 join downstream of the check valves 116 to form a common emergency NO line 111, from a junction site 111-3.

[0041] Each upstream conduit section 201 further includes a pressure measurement means 118, such as a strain gauge pressure sensor ( silicon pressure sensor (in English) or similar, used to verify the existence of pressure in the upstream portion of the conduit 201, reflecting the presence of a connected cylinder, and thus also to verify the quantity of gas it contains in order to decide whether it needs to be changed (if the cylinder is almost empty) and to switch to the other gas cylinder. Said pressure measuring device 118 is located downstream of the filter 115.

[0042] Of course, according to another embodiment, the device 1 may comprise only one NO inlet port 101 and therefore only one portion of upstream conduit 201 and only one section of inlet pipe 111-1. In this case, only an oxygen supply line 51, such as a flexible hose or similar, may be fluidly connected to it, which is supplied with a NO / N 2 mixture by one or more NO 5 cylinders.

[0043] The emergency NO line 111 allows the NO / N 2 mixture under pressure to be conveyed, via the inlet pipe sections 111-1, 111-2, from the upstream conduit sections 201 supplied by the NO 5 cylinders delivering the NO / N 2 mixture at a pressure of around 3 to 6 bar relative at the outlet of the RDI 55.

[0044] It can also be seen that the emergency NO line 111 further includes a first pressure regulator 112, downstream of the junction site 111-3, to reduce or control the pressure of the NO / N2 mixture, for example to deliver a reduced pressure equal to approximately 3.2 bar relative, and a pneumatic valve 113 for controlling the circulation of the NO / N2 mixture. This pneumatic valve 113 is located downstream of the first pressure regulator 112, considering the direction of gas flow, given that the gaseous NO / N2 mixture flows from each gas inlet port 101 towards the pressure regulator 112.

[0045] The opening of the pneumatic valve 113, and therefore the passage of the NO / N2 flow, is controlled by the pressure of the oxygen flow brought by the main O2 line 121 via the second section of conduit 121-2, as explained below.

[0046] Downstream of the pneumatic valve 113, the emergency NO line 111 includes a calibrated orifice device 114 or similar for regulating the gas flow, i.e. of the NO / N2 mixture, and an NO flow indicator device 117 for checking that the NO / N2 mixture flow rate is equal to the expected fixed value, for example of the order of 230 mL / min.

[0047] In addition, the emergency oxygen circuit 120 includes a main O2 line 121 used to carry oxygen into the housing 199, which is supplied by the O2 inlet port 102 to which the O2 cylinder 52 is connected, via the supply line 51 which brings gaseous oxygen at a pressure typically between 3 and 6 bar.

[0048] The main O2 line 121 connects at a junction site 130 to the backup NO line 111, downstream of the NO flow indicator device 117, forming a common line 140, so as to operate a mixing of the adjustable flow oxygen, as explained below, and the NO / N2 flow which has a fixed flow rate of the order of 230 mL / min for example.

[0049] As can be seen on Fig. 2 The main O2 line 121 also includes a filter 106, arranged immediately downstream of the O2 inlet port 102, as well as a first control valve 122 and a second pneumatic control valve 123. It also includes a pressure measurement means 118, such as a strain gauge pressure sensor, as explained above.

[0050] The first control valve 122, typically of the on / off type, allows control of the circulation of the oxygen flow in the main O2 line 121. It is controlled by an actuation means 195, such as a rotary selector, a push button, a selection key or similar, which can be operated by the user, such as a healthcare worker, when they wish to start or stop the backup circuit 110, 120.

[0051] A first section of conduit 121-1 connects fluidly to the main O2 line 121 between the O2 inlet port 102, in particular downstream of the filter 106, and the first control valve 122. The first section of conduit 121-1 allows pneumatic control of the second pneumatic control valve 123.

[0052] As long as the first control valve 122 is closed, the gas pressure exerted in the portion of the main O2 line 121 located upstream of the first control valve 122 and therefore also in the first section of conduit 121-1 will act on the second pneumatic control valve 123 by keeping it closed, which will prevent any passage of oxygen through this second control valve 123.

[0053] When the user activates the actuation means 195, the first control valve 122 opens and allows the gas to pass towards the second control valve 123. Due to the pressure of the oxygen arriving at the second control valve 123, sufficient force will be exerted to open the control valve 123 due to the pressure supplied by the first section of conduit 121-1, which will then open the second control valve 123 and allow oxygen to pass into the downstream part of the oxygen circuit 120 which is located downstream of the second control valve 123.

[0054] The oxygen then continues its path in the main O2 line 121, passing through a second pressure regulator 124 to reduce or control the oxygen flow pressure, for example, to obtain a relative absolute pressure of 1.6 bar. The O2 flow rate can then be adjusted, for example, between 5 and 20 L / min, by O2 flow control means 125, such as a rotary disc with calibrated orifices or similar, arranged on the main O2 line 121 downstream of the second pressure regulator 124.

[0055] The selection of the desired O2 flow rate can be operated by the user via a flow rate selection means 196, such as a rotary knob or similar, carried by the housing 199 of the device (or according to another embodiment, a selection of an O2 flow rate via a button or similar displayed on a display screen 950), which flow rate selection means 196 cooperates with the O2 flow rate adjustment means 125.

[0056] The oxygen flow can then be checked via an O2 flow indicator device 126, such as a ball rotameter or similar, arranged downstream of the O2 flow control device or means 125. The resulting oxygen flow can then be mixed with the NO / N2 flow from the junction site 130 where the main O2 line 121 connects to the backup NO line 111, as already mentioned.

[0057] This emergency circuit 110, 120 being entirely pneumatic, in order to control the circulation of NO / N 2 within the emergency NO line 111, a second section of conduit 121-2 is provided, connecting fluidly to the main O 2 line 121 between the second control valve 123 and the second pressure regulator 124. This second section of conduit 121-2 controls the pneumatic valve 113 of the emergency NO circuit 110 thanks to the oxygen pressure it contains.

[0058] More specifically, as long as the second control valve 123 is closed, the oxygen flow pressure is not exerted in the second conduit section 121-2, so the pneumatic valve 113 of the NO circuit 110 also remains closed.

[0059] Conversely, when the second control valve 123 opens after the user has actuation the actuation means 195 and opened the first control valve 122, as explained above, the pressurized oxygen flow will be able to pass through the second control valve 123, then spread downstream of it, in particular in the second conduit section 121-2 to then pneumatically act on the pneumatic valve 113 of the NO circuit 110 and open it, thus releasing the passage of the NO / N2 mixture and its circulation in the downstream part of the emergency NO line 111 located downstream of the pneumatic valve 113.

[0060] The first control valve 122, the second control valve 123 and the pneumatic valve 113 are, for example, pneumatically piloted valves of the spring-loaded poppet type.

[0061] In other words, the activation of the actuation means 195 by the user leads to a quasi-synchronized and / or quasi-simultaneous release of the NO / N2 and O2 mixture flows within the emergency NO circuit 110 and the emergency oxygen circuit 120, thus leading to their mixing from and downstream of the junction site 130, i.e. in the common emergency line 140 which leads to an emergency outlet 141, i.e. a secondary outlet, for example carried by a connecting connector or similar, to which a manual gas blower, i.e. a manual ventilation bag or similar, can be connected.

[0062] It is understood that the operation of this backup or secondary gas circuit 110, 120 is entirely pneumatic since it only uses gas pipes and pneumatic valves to control gas flows.

[0063] However, as already explained, such a fully pneumatic circuit is not ideal because the concentration of NO in the gas mixture obtained (i.e. NO / N2 + O2) from the junction site 130 and therefore in the common backup line 140 located downstream, varies according to the oxygen flow rate set by the user since the NO flow rate is fixed while the oxygen flow rate is adjustable.

[0064] Thus, for a NO / N2 gas mixture with 800 ppmv of NO (rest nitrogen), the concentration of NO varies between 8 and 32 ppmv for an oxygen flow rate between 5 and 20 L / min, while for a NO / N2 mixture with 450 ppmv of NO, the concentration of NO varies between 4.5 and 18 ppmv for the same oxygen flow rate.

[0065] However, having a concentration of NO that varies according to the chosen O2 flow rate is not acceptable because it must be possible to deliver a given dosage to the patient, that is to say a fixed quantity of NO corresponding to an effective concentration to treat his pathology, in particular in the context of ventilation of the patient by a manual ventilation bag or BVM instead of normal ventilation by the medical ventilator 2.

[0066] It is therefore necessary to be able to make the concentration of NO of the NO / N 2 / O 2 gas mixture obtained independent of the oxygen flow rate, when the emergency mode is activated by the user and ventilation of the patient via a manual ventilation bag must be carried out.

[0067] To achieve this, the improved NO1 supply system is provided for as illustrated in Fig. 3 et Fig. 4 which schematically illustrate an embodiment of the internal architecture of a NO 1 supply device according to the present invention.

[0068] First, the NO 1 supply device of Fig. 3 includes the fully pneumatic components of the emergency gas circuit 110, 120 Fig. 2 , these bear the same references and are therefore not explained again below.

[0069] Next, as can be seen on Fig. 3 The NO supply device 1 of the invention also includes the internal main gas circuit 200 which, during normal operation of the device 1, supplies the NO / N2 mixture, via the NO injection conduit 11, to the inspiratory branch 30 of the ventilatory circuit 3 which is connected to and supplied by the medical ventilator 2 with respiratory gas, i.e. air or N2 / O2 mixture, as explained above in connection with the Fig. 1 .

[0070] The main gas circuit 200 includes at least one upstream conduit section 201, namely here two upstream conduit sections 201 to which the inlet pipe sections 111-1, 111-2 are fluidly connected at a connection point 205 located between the filter 115 and the non-return valve 116 of each inlet pipe section 111-1, 111-2, as shown on Fig. 3 . Of course, if only a section of inlet pipe 111-1 is planned, according to the embodiment considered, as explained above, then only a portion of upstream conduit 201 is required.

[0071] The upstream conduit section(s) 201 carry the NO / N₂ mixture from the inlet pipe sections 111-1, 111-2 to NO / N₂ flow control means 202, which control the flow rate of the NO / N₂ mixture that is then supplied to the injection conduit 11. An embodiment of the NO / N₂ flow control means 202 is detailed in Fig. 4 .

[0072] After passing through the NO / N 2 202 flow control means, the gas flow is conveyed by a portion of downstream conduit 203 of the main NO 201, 203 line which brings it and supplies it to the injection conduit 11, via the main outlet port 210 which is located at the outlet end of the portion of downstream conduit 203 of the main gas circuit 200.

[0073] A first multi-way solenoid valve 204, here with three ports, is arranged on the downstream section 203 of the main NO line 201, 203, between the NO / N2 flow control means 202 and the main outlet 210. That is, it is connected by two of its three ports to the downstream section 203 of the main line so as to control the gas flow in the downstream section 203 of the main line. It is also connected, via its third port, to the emergency NO line 111, downstream of the pneumatic valve 113, which is itself located downstream of the first pressure regulator 112, considering the direction of gas flow, i.e., NO / N2 mixture, in the emergency NO line 111. The first solenoid valve 204 cooperates here with the emergency NO line 111 via a connecting conduit linking the emergency NO line. 111 to the third way of the first solenoid valve 204.

[0074] Furthermore, as can be seen on Fig. 3 The emergency NO line 111 includes a second 2-way solenoid valve 150 which is normally in the open position, i.e., it allows gas to flow within the emergency NO line 111, and the calibrated orifice device 114 or similar for regulating the gas flow, i.e., the NO / N2 mixture, which on Fig. 2 is arranged near the NO flow indicator device 117. The second solenoid valve 150 is therefore located between the pneumatic valve 113 and the first 3-way solenoid valve 204.

[0075] The second solenoid valve 150 is normally in the open position but can be controlled by the control means 900, in particular in the event of activation of the emergency mode in the event of a slight failure, as explained below, or in the event of need to ventilate a patient using the manual insufflator to perform alveolar recruitment maneuvers for example.

[0076] According to another embodiment (not shown schematically), the first 3-way solenoid valve 204 and the second 2-way solenoid valve 150 can be replaced by a single 5-way solenoid valve which would be installed in place of the first 3-way solenoid valve 204 (the second 150 solenoid valve would then be removed).

[0077] Furthermore, the NO 1 supply device of the invention finally includes oxygen flow measurement means 160 arranged on the main O 2 line 121 between the second pressure regulator 124 and the O 2 flow control device or means 125.

[0078] These oxygen flow measurement means 160 may include a flow sensor or a differential pressure sensor whose pressure taps 161, 162 are connected upstream and downstream of a flow restriction 163, such as a venturi system, a calibrated orifice or other, in order to measure a pressure differential (ΔP), i.e. a pressure drop, allowing an oxygen flow rate (Q O2) to be deduced.

[0079] Fig. 4 represents a detailed embodiment of the NO / N 2 202 flow control means used to control the NO / N 2 mixture flow within the main gas circuit 200 arranged in the housing 199 of the NO 1 supply device.

[0080] As can be seen, the two upstream conduit sections 201 of the main gas circuit 200 join to form a common section 201-1 carrying the NO / N2 mixture. Each upstream conduit section 201 includes a first control valve 700 arranged upstream of the junction site of the two upstream conduit sections 201, which serves to allow or stop the flow of the NO / N2 mixture brought by either of the upstream conduit sections 201.

[0081] The common section 201-1 then divides into two secondary sections 201-2 arranged in parallel with each other, each of which includes a pressure regulating device 701 and a pressure sensor 702.

[0082] The two secondary sections 201-2 are in turn divided into several sub-sections 201-3 which are also arranged in parallel with each other, namely here two sub-sections 201-3. Each sub-section 201-3 includes a second control valve 703. Sub-sections 201-3 also include additional flow control means 704, for example a calibrated orifice or similar, allowing the flow to be adjusted to a desired flow value.

[0083] Of course, the NO / N flow control means 2 202 may include additional sub-sections 201-3, each equipped with a control valve 703 and additional flow control means 704, typically a calibrated orifice, to allow for a wider range of NO flow rates, if necessary. Preferably, the control valve(s) 703 is an on / off (ON) type valve. The gas flow rate through it is fixed and depends on the pressure of the pressure regulator 701, i.e., a pressure reducing valve, and the cross-sectional area of ​​the calibrated orifice.

[0084] In fact, the control means 900 of the NO supply device 1, such as an electronic card carrying one or more microprocessors implementing one or more algorithms, control the first control valves 700 and the second control valves 703 in order to direct the gases into the appropriate sections to obtain the desired NO dosage.

[0085] The desired NO content is selected by the user via NO content selection means (not shown schematically) arranged on the device, for example one or more keys, sliders, selection buttons, including a rotary knob, or similar, which allow the selection or setting of a desired NO content.

[0086] Advantageously, the NO1 supply device of the invention is equipped with a 950 information display screen, typically a digital screen, preferably a touch screen, in color or black and white, configured to display the desired NO content value and / or other information, such as the NO content in the NO5 bottles or the NO or O2 flow rate values, and for example also the NO2 concentration, the flow rate delivered by the fan...

[0087] In one embodiment, the information display screen 950 is a digital touchscreen, and the means for selecting the NO content are touch-activated selection buttons displayed on the digital touchscreen display screen 950. The selection or setting of the desired NO concentration is therefore achieved by the user pressing one or more touch-activated selection buttons displayed on the display screen 950.

[0088] Once the NO content has been selected, the control means 900 of the NO supply device 1 calculate the flow rate of NO / N 2 mixture to be supplied, in particular as a function of other parameters, such as the NO content of the NO / N 2 mixture coming from the cylinders 5, and also the flow rate of breathing gas (typically air or air / O 2) supplied by the fan 2, and then determine which control valves 700, 703 should be opened or closed in order to direct the gases into the sections suitable for obtaining the fixed NO dosage.

[0089] The sub-sections 201-3 then join upstream of the first 3-way solenoid valve 204 into a single line which forms the downstream conduit portion 203 of the main gas circuit 200. It may include a pressure sensor 705 or similar, upstream of the first solenoid valve 204, in order to be able to correct the flow rate which depends on the pressure variation (ΔP) of the gas when it passes through the additional flow control means 704, typically one or more calibrated orifices.

[0090] Furthermore, it can also be seen that the NO 1 supply device of the invention further comprises a purge line 800 communicating with the outside via a purge orifice 802 arranged in the housing 199. The purge line 800 branches into two purge sections 801 which connect to the two upstream conduit sections 201 in order to perform a gas purge of these two upstream conduit sections 201. Each purge section 801 includes a purge valve 803 controlled by the control means 900 so as to be able to eliminate all NO 2 species which may form in the residual gas present in the pipes by oxidation of the NO molecules by oxygen, when the device 1 is not in operation, i.e. not in use.

[0091] In normal operation, i.e., when the user has not actuated the actuation means 195, the NO / N₂ mixture travels through the main gas circuit 200 of the NO₂ supply device 1 of the invention, via the NO / N₂ flow control means 202, from one of the gas inlet ports 101 to the main outlet port 210, which supplies the NO / N₂ mixture to the NO injection conduit 11 so that it can then be injected at the desired NO concentration into the inspiratory limb 30 of the ventilation circuit 3 connected to the medical ventilator 2, as explained above in connection with Fig. 1 And Fig. 4 .

[0092] In this case, the second 2-way solenoid valve 150 is in the "normally open" position, meaning that it does not interrupt the passage of gas in the emergency NO line 111, and the first 3-way solenoid valve 204 is in the "normal operation" position allowing the passage of gas flow in the downstream portion of conduit 203 to the main outlet port 210.

[0093] The first solenoid valve 204 is controlled by the pilot means 900 to allow or stop any passage of NO / N 2 mixture coming from the NO 202 flow control (i.e. adjustment) means.

[0094] In the event of a serious or severe failure of the NO supply device 1 of the invention leading to a loss of electrical energy and / or a shutdown of the control means 900 of the device 1, or even of the medical ventilator 2, in particular of a software or other control program or algorithm implemented by one or more microprocessors of said control means, the second 2-way solenoid valve 150 remains in the "normally open" position and the first 3-way solenoid valve 204 remains in the "normal operating" position so as to allow gas flow in the downstream portion of the conduit 203 up to the main outlet 210. This allows, after actuation by the user of the actuation means 195, a switch to a fully pneumatic backup mode, as explained in connection with Fig. 2 . This results in the delivery by the emergency NO line 111, downstream of the NO flow indicator device 117, of a flow of NO / N 2 at a fixed flow rate of the order of 230 mL / min for example which mixes (in 130) with the flow of oxygen at adjustable flow rate coming from the main O 2 line 121.

[0095] The resulting emergency gas mixture of NO / N₂ / O₂ can then be conveyed via the common line 140 to the secondary or emergency outlet 141, which supplies this emergency gas mixture to a manual ventilation bag, also known as a bag-valve-mask (BVM). Subsequently, the patient is ventilated via the manual ventilation bag to ensure a supply of NO to the patient despite the severe or similar failure.

[0096] On the other hand, if the failure of the NO supply device 1 of the invention is a slight failure not leading to a total loss of electrical energy and / or to a cessation of operation of the control means 900 of the device 1 and / or if the healthcare staff decides to operate a ventilation of the patient via a manual ventilation bag while wishing to respect the NO dosage, then the NO supply device 1 of the invention and more particularly the control means 900 and the display screen 950 remain supplied with electrical energy by the electrical energy supply means, therefore the control means 900 remain able to function.

[0097] In this case, the user wishing to switch device 1 to emergency or BVM ventilation mode, to ensure gas supply to the patient via a manual ventilation bag or BVM, will activate, as before, the actuation means 195. This will then open the first control valve 122, allowing the flow of oxygen in the main O2 line 121 to the second control valve 123, which will also open and allow oxygen to flow into the downstream part of the oxygen circuit 120, located downstream of the second control valve 123, as explained above in connection with Fig. 2 .

[0098] The oxygen flow measurement means 160 which are arranged on the main O2 line 121 downstream of the second pressure regulator 124 will then be able to measure the oxygen flow (Q O2) and transmit this O2 flow measurement (i.e. signal or value) to the control means 900 in order to allow the calculation of the NO / N2 flow to be supplied as explained below.

[0099] The oxygen flow can then continue its path to the junction site 130 where the O2 / NO / N2 mixing takes place, via the O2 flow control means 125 and the O2 flow indicator device 126, such as a ball rotameter or similar, as already explained.

[0100] However, in this case, the actuation means 195 is electrically connected to the control means 900 and configured to provide them with actuation information, namely an activation signal corresponding to the position of the actuation means 195, i.e., in emergency mode (i.e., emergency activated) or in normal mode (i.e., emergency not activated). This activation signal is electrically supplied to the control means 900 of the NO supply device 1 of the invention, which receive and process it to determine whether the actuation means 195 has been actuated by the user to trigger the emergency or BAV ventilation mode, in order to ventilate the patient via a manual ventilation bag connected to the secondary outlet, i.e., the emergency outlet 141, of the NO supply device 1 of the invention, for example, via a flexible tube.

[0101] If this is the case, the control means 900 of the NO 1 supply device of the invention, which remain supplied with electrical energy (i.e., electric current), feedback, in response to this signal, on the NO / N 2 flow control means 202 to supply the NO / N 2 mixture at the desired flow rate and on the first 3-way solenoid valve 204 to allow the passage of the NO / N 2 flow from the downstream portion of the conduit 203 of the main gas circuit 200 to the downstream part of the emergency NO line 111 located downstream of the first solenoid valve 204 and conveying the NO / N 2 flow via the NO flow indicator device 117, to the mixing site 130 where the main O 2 line 121 and the emergency NO line 111 meet, as already explained.

[0102] Thus, since the NO / N₂ mixture is prepared within the NO / N₂ flow control means 202, it is possible to set the most suitable NO flow rate. This NO / N₂ mixture flow rate to be supplied by the NO / N₂ flow control means 202 can be calculated by the control means 900 of the NO supply device 1 of the invention based on the desired final NO content, the composition of the NO / N₂ mixture in the cylinders 5, and the oxygen flow rate measured by the oxygen flow measurement means 160, which are arranged on the main O₂ line 121 downstream of the second pressure regulator 124.

[0103] The desired final NO content is therefore, in this case, chosen by the user via the NO content adjustment means arranged on the device, preferably one or more digitally operated numeric keys displayed on the 950 digital display screen which also remains electrically powered.

[0104] Being able to use a NO / N₂ mixture prepared within the NO / N₂ flow control means 202, in the event of activation of the emergency circuit and in the absence of a complete failure of device 1, i.e. in the event of a minor failure, and / or the desire to ventilate the patient via a manual ventilation bag, has the advantage of guaranteeing greater accuracy in the NO concentration of the emergency mixture supplied to the patient, given that the final NO content can be adjusted by the user via the NO content adjustment means (i.e.choice or selection) and that the control means 900 use this set NO content value, the concentration of NO in the NO / N 2 mixture supplied by the NO 5 cylinders and the measured O 2 flow value to determine the NO / N 2 flow to be supplied and act accordingly on the NO / N 2 flow control means 202, in particular the first control valves 700 and the second control valves 703, to supply the appropriate NO / N 2 flow by controlling the passage of gas in particular in the secondary sections 201-2, the pressure regulating device 701, the two secondary sections 201-2 and the sub-sections 201-3 including the additional flow control means 704, for example calibrated orifices or the like, allowing the flow to be adjusted to a desired flow value.

[0105] In other words, thanks to the incorporation of the oxygen flow measurement means 160 on the main O2 line 121, downstream of the second pressure regulator 124, which measure the oxygen flow (Q O2) and transmit this O2 flow measurement to the control means, the latter can calculate a NO / N2 flow setpoint to be supplied by the NO / N2 flow control means 202 taking into account not only the NO setpoint set by the user but also the concentration of NO in the NO / N2 mixture coming from the NO5 cylinders.

[0106] This leads to the possibility of obtaining from mixing site 130, a final mixture with a precise NO content since the NO / N2 mixing flow rate is no longer fixed (e.g. equal to 230 mL / min) but is adjustable according to other influencing parameters.

[0107] However, in this case, it is essential to prevent the oxygen flow passing through the second control valve 123, which acts on the pneumatic valve 113, from causing an excessive supply of NO via the emergency NO line 111 through the second 2-way solenoid valve 150. To this end, when they receive the activation signal from the actuation means 195, which corresponds to a switch to emergency mode, the control means 900 of the NO supply device 1 of the invention are also configured to act on the second 2-way solenoid valve 150, which is normally in the open position, to close it and thus prevent the NO / N2 mixture from circulating within the emergency NO line 111 and supplying the downstream part of the emergency NO line 111 located downstream of the first solenoid valve 204.

[0108] The NO / N2 / O2 mixture thus obtained is then, as before, conveyed by the common line 140 which leads to an emergency exit 141, i.e. secondary exit, to provide the emergency gas mixture made up of NO / N2 / O2 and to be able to bring it, via a flexible conduit or similar, to a manual ventilation bag to perform manual ventilation of the patient with the NO / N2 / O2 gas mixture having the desired dosage

[0109] Conversely, in the event of a serious failure of device 1 with a power supply failure, no activation signal is generated by the actuation means 195 and / or is not used / processed by the control means 900 and / or the display screen cannot function; therefore, if the emergency mode is activated via the actuation means 195, device 1 reverts to fully pneumatic emergency mode, as explained in connection with Fig. 2 .

[0110] The NO 1 supply device according to the invention presents a higher level of safety by allowing more precise adjustment of the NO content in case of failure or slight breakdown, without loss of power supply, or when the user wants to switch to manual ventilation of the patient by BVM.

[0111] In general, the NO1 supply device according to the invention is particularly suitable for use within a therapeutic gas administration system 100 containing NO (< 100 ppmv), O2 (>21% vol), and nitrogen for a patient P, such as system 100 of Fig. 1, implemented to treat one or more patients suffering from a pathology or medical condition causing acute pulmonary arterial hypertension, in particular pulmonary vasoconstrictions in adults or children, including newborns, for example to treat PPHN in a newborn, or pulmonary hypertension in a person undergoing cardiac surgery.

[0112] In other words, according to another (unclaimed) aspect, the present disclosure therefore also relates to a method of treating a person, referred to as a patient, suffering from a pathology or medical condition causing acute pulmonary arterial hypertension, in particular pulmonary vasoconstrictions in adults or children, including newborns, for example to treat persistent pulmonary hypertension of the newborn (PPHN) in a newborn, baby or similar, or pulmonary hypertension in a person undergoing cardiac surgery, wherein an inhalation administration is carried out to said patient in need, of a gas mixture containing oxygen (preferably >21% vol), nitrogen and NO (preferably < 100 ppmv), said gas mixture being supplied by a therapeutic gas delivery installation 100 according to the invention comprising a NO supply device 1 according to the invention,which NO1 supply device is supplied with NO / N2 mixture by at least one pressurized gas container 5, preferably several pressurized gas containers 5, such as NO / N2 cylinders, and with oxygen by at least one pressurized oxygen container 52, such as an O2 cylinder, and which NO1 supply device is capable of and designed to supply: either a NO / N2 mixture via the main outlet port 210, to the breathing gas circuit 3 connected to a medical ventilator 2 of the therapeutic gas delivery system 100, or a NO / N2 / O2 mixture via the secondary port 141, to a manual resuscitator, in particular a manual resuscitator bag or BVM.

[0113] In general, within the framework of the present invention, all the terms "means of" or "means of" are considered to be totally equivalent and substitutable by the term "device of", for example the term "control means" can be replaced by "control device", the term "measuring means" can be replaced by "measuring device".....

Claims

1. A NO supply device (1) comprising: - a main gas circuit (200) comprising at least one NO main line (201, 203) fluidically connecting at least one NO inlet port (101) to a main outlet port (210) for conveying an NO / N2 from said at least one NO inlet port (101) to said main outlet port (210), and - a backup circuit (110, 120) comprising a backup NO circuit (110) and a backup O2 circuit (120), wherein: . the backup NO circuit (110) comprises a backup NO line (111) supplied with NO / O2 mixture from said at least one NO inlet port (101), and . the backup O2 circuit (120) comprises a main O2 line (121) in fluid communication with an O2 inlet port (102), the main O2 line (121) being fluidly connected (130) to the backup NO line (111) to form a common line (140) in fluidic communication with a secondary outlet (141) supplying an NO / N2 / O2 mixture, wherein: - the main NO line (201, 203) comprises NO / N2 flow control means (202) controlled by control means (900), characterized in that: - the main NO line (201, 203) is fluidly connected to the backup NO line (111) downstream of the NO / N2 flow control means, via a first multi-way solenoid valve (204), and - it further comprises a touch-controlled digital information display screen (950) configured to display at least one touch selection key, - said at least one touch-sensitive selection key displayed on the display screen (950) is configured to allow the user to set or select a desired NO content between 1 and 80 ppmv, and - said digital display (950) is configured to further display the desired NO content.

2. Device according to claim 1, characterized in that the touch selection keys allow the user to choose from among several proposed NO contents.

3. Device according to claim 1, characterized in that the touch selection keys include "+" and "-" keys for incrementing or decrementing a given NO value in steps.

4. Device according to claim 3, characterized in that the touch selection keys allow the given NO value to be increased or decreased by 1 ppmv at a time.

5. Device according to one of claims 1 to 4, characterized in that said desired NO content, which is chosen or selected by the user by pressing said at least one touch selection key, is supplied to the control means (900) of the NO supply device (1).

6. Device according to claim 1, characterized in that the display screen is a color display.

7. Device according to claim 1, characterized in that the display screen is configured to additionally display the NO content in the NO cylinders (5), the NO or O2 flow rates, the NO2 concentration, and / or the flow rate delivered by a ventilator.

8. Device according to claim 1, characterized in that the first solenoid valve (204) is at least a 3-way valve, preferably a 3-way valve.

9. Device according to claims 1 and 5, characterized in that the first multi-way solenoid valve (204) is controlled by the control means (900) so as to direct the flow of NO / N2 mixture from the NO / N2 flow control means (202): - either into a downstream portion of the backup NO line (111) in fluid communication with the common line (140) in fluid communication with the secondary outlet (141), - or into a downstream portion (203) of the main NO line (201, 203) in fluid communication with the main outlet port (210).

10. Device according to claims 1 and 5, characterized in that: - it comprises NO content adjustment means configured to allow a user to select a desired NO content and provide said desired NO content to the control means (900), the NO content adjustment means comprising said at least one touch selection key displayed on the display screen (950) and - the control means (900) are configured to calculate a NO / N2 mixture flow rate to be supplied corresponding to the desired NO content and to control the NO / N2 flow rate control means (202) to supply said calculated NO / N2 mixture flow rate.

11. Device according to claim 1, characterized in that the secondary outlet (141) is configured to be fluidically connected to a manual insufflator, in particular a manual ventilation bag (BAVU), preferably via a flexible fluid connection conduit.

12. Device according to claim 5, characterized in that the control means (900) comprise at least one microprocessor.

13. Installation (100) for administering therapeutic gas containing NO to a patient (P), comprising an NO supply device (1) according to one of the preceding claims, supplied with a mixture of NO / N2 by at least one pressurized gas container (5) and with oxygen by a pressurized oxygen container (52), said NO supply device (1) supplying: - either an NO / N2 mixture via the main outlet port (210) to a respiratory gas circuit (3) connected to a medical ventilator (2), - or an NO / N2 / O2 mixture via the secondary outlet (141) to a manual insufflator or BAVU.