FR3133316A1 - NO delivery device with emergency circuit - Google Patents

Abstract

Title of the invention NO delivery device with emergency circuit The invention relates to an NO delivery device (1) comprising: control means (900); a main gas circuit (200) with NO/N2 flow control means (202) controlled by the control means (900) and comprising a main outlet orifice (210); a backup circuit (110, 120) including a backup NO circuit (110) and a backup O2 circuit (120) which are fluidly connected to each other to form a common backup line (140 ) comprising an emergency outlet (141) which can be used in the event of failure of the NO supply device (1) to supply a manual insufflation balloon. The invention also relates to an installation (100) for administering therapeutic gas containing NO to a patient (P) comprising a respiratory gas circuit (3) connected to a medical ventilator (2) and supplied by said ventilation device. supply of NO (1). Abstract figure: Fig. 3

Description

NO delivery device with emergency circuit

The present invention relates to a device or apparatus for supplying gaseous nitrogen monoxide (NO) making it possible to ensure delivery of NO, in normal mode, in emergency mode in the event of a breakdown or in manual ventilation mode, and an installation for administration of NO to a patient comprising such an NO delivery device.

Inhaled nitric oxide or NOi is a gaseous medication commonly used to treat patients with acute pulmonary hypertension, particularly pulmonary vasoconstrictions in adults or children, including neonates (PPHN), as described for example by EP-A-560928 or EP-A-1516639.

An installation for implementing a NOi treatment, commonly called an NO administration installation, conventionally comprises one or more bottles of NO/N ₂ mixture supplying an NO supply device which delivers the NO/N ₂ mixture to controlled flow, a respiratory assistance device, also called a medical ventilator, to provide a respiratory gas containing at least 21% vol. oxygen, such as an O ₂ /N ₂ mixture or air, to which NO (ie NO / N ₂ ) is added, circuit elements, for example one or more flexible conduits, to convey the gas flows between these different pieces of equipment and up to the patient, and a respiratory interface, such as a tracheal tube, to supply the gas mixture containing NO to the patient. A gas humidifier can also be provided to humidify the gas mixture before its administration to the patient. Such an installation is schematized in .

Usually, the NO/N ₂ mixture delivered by the NO delivery device is injected into the respiratory stream containing at least 21% vol. of oxygen (ie air or O ₂ /N ₂ mixture) coming from the medical ventilator before being administered by inhalation to the patient in the form of a final respiratory mixture (ie NO/N ₂ /O ₂ or NO/N ₂ mixture /air) generally containing a few tens ppmv of NO (ppm by volume) and at least 21% vol. of oxygen O ₂ , for example of the order of 1 to 80 ppmv of NO, the remainder being essentially nitrogen (N ₂ ).

Such an NO administration installation is used in a hospital environment to administer NOi treatment and thus treat patients needing to inhale NO to treat their pulmonary arterial hypertension. Examples of such NO administration installations are given by 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.

In the event of a breakdown or failure of the NO supply device or the medical ventilator and/or in the event of a 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 device supply of NO must be able to supply the NO/N ₂ mixture so that the patient's treatment is not abruptly interrupted, for obvious safety reasons given that a sudden interruption of treatment with NOi could be fatal to patients fragile, particularly newborns suffering from PPHN.

It is known to equip the NO supply device with a secondary system or circuit, called an emergency circuit which can also be used in the event of manual ventilation by BAVU, entirely pneumatic, designed to deliver an O ₂ flow rate adjustable between 0 and 20 L/min and a fixed flow rate of NO, for example of the order of 230 mL/min of NO/N ₂ mixture, which are mixed with each other in the NO supply device before be 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. Thus, we can cite EP-A-3233171 which teaches the use of such an emergency circuit.

Activation by the user of a dedicated selection means of the NO supply device, for example a selection button, will direct the gas flows in this emergency and/or manual ventilation circuit of the NO supply device. NO, such as the one illustrated in .

However, such a purely pneumatic solution is not ideal because the NO concentration of the gas mixture obtained (ie NO/N ₂ + O ₂ ) varies depending on the oxygen flow rate set by the user since the NO flow rate is fixed. However, having a concentration of NO which varies according to the flow rate of O ₂ chosen, is not desirable from a therapeutic point of view because we must be able to deliver to the patient a given dosage, that is to say a fixed quantity of NO corresponding to an effective concentration to treat the pathology or a reduced dosage if the patient needs to be weaned, in particular in manual ventilation mode via a manual insufflator, that is to say a manual ventilation bag or BAVU.

In view of this, a problem is to propose an improved NO supply device, which is capable of supplying a NO/N ₂ /O ₂ gas mixture to a patient whether in normal operating mode but also in the event of a breakdown. or failure, or even manual ventilation (eg at the request of the nursing staff or following a slight failure), preferably by observing the desired dosage, that is to say a NO/N ₂ /O ₂ gas mixture including the composition is not only dependent on the oxygen flow.

One solution of the invention concerns a device for supplying NO (i.e. nitrogen monoxide) comprising:

• means of control,
• a main gas circuit comprising at least one main NO line fluidly connecting at least one NO inlet port to a main outlet orifice for conveying a NO/N ₂ mixture from said at least one NO inlet port to said orifice main output, said main NO line comprising NO/N ₂ flow control means controlled by the control means,
• an emergency circuit, ie a secondary circuit, comprising an emergency NO circuit and an emergency O ₂ circuit, in which:

1. the emergency NO circuit comprises an emergency NO line in fluid communication with the main NO line, the emergency NO line comprising a pneumatic valve making it possible to control the circulation of the NO/N ₂ mixture in the NO line of emergency and a second solenoid valve controlled by the control means, and
2. the emergency O ₂ circuit comprises a main O ₂ line in fluid communication with an O ₂ inlet port, said main O ₂ line comprising:

. a first control valve controlled by actuation means operable by a user to control the circulation of the oxygen flow in said main O ₂ line, said actuation means being further configured to provide an activation signal to the control means in response to an actuation of said actuation means by the user,

. a second pneumatic control valve arranged downstream of the first control valve,

. oxygen flow measurement means arranged downstream of the first control valve and configured to provide at least one oxygen flow measurement to the control means,

. and means for adjusting the O ₂ flow rate arranged downstream of the means for measuring the oxygen flow rate,

and in which:

• the main O ₂ line is configured to cooperate pneumatically with the pneumatic valve to authorize the passage of the NO/N ₂ mixture into the emergency NO line in response to actuation by the user of the actuation means, and
• the emergency NO line of the emergency NO circuit and the main O ₂ line of the emergency O ₂ circuit are fluidly connected to each other to form a common emergency line in fluid communication with a emergency exit, also called secondary exit.

Depending on the embodiment considered, the NO supply device of the invention may comprise one or more of the following characteristics:

• the second solenoid valve is normally in the open position.
• the emergency or secondary outlet, i.e. a port or orifice, is configured to be fluidly connected to a manual insufflator, such as a manual ventilation bag or BAVU, in particular via a flexible fluid connection conduit, i.e. flexible pipe or the like.
• the main gas circuit comprises a main NO line fluidly connected to two NO inlet ports arranged in parallel.
• the emergency NO line of the emergency NO circuit and the main O ₂ line of the emergency O ₂ circuit are fluidly connected to each other at a junction site located downstream of the adjustment means of O ₂ flow rate of the main O ₂ line and downstream of the second solenoid valve of the emergency NO line.
• the O ₂ flow control means include a flow sensor or a differential pressure sensor.
• the main O ₂ line is configured to cooperate pneumatically with the pneumatic valve via a section of conduit fluidly connecting the main O ₂ line downstream of the second control valve, to said pneumatic valve.
• the first control valve is of the all or nothing type.
• the first control valve is configured to control the circulation of oxygen flow in the main O ₂ line.
• the first control valve is controlled by an actuation means operable by the user, such as a nursing staff, when he wishes to start or stop the emergency circuit.
• the actuation means is a rotary selector operable by the user.
• it comprises NO content adjustment means configured to allow a user to choose a desired NO content and supply said desired NO content to the control means.
• it further comprises an information display screen, preferably a touch-controlled digital screen.
• the means for adjusting the NO content comprise at least one touch-actuated selection key displayed on the display screen, i.e. one or more touch-sensitive selection keys, and configured to allow a user to set or select a NO content NO desired. In other words, the selection or setting of the desired NO concentration is therefore done by digital support from the user on the touch-activated selection key(s) displayed on the display screen.
• the control means are configured to control the display(s) on the display screen.
• the control means comprise at least one (micro)processor, for example a microcontroller.
• the control means comprise at least one electronic card comprising said at least one microprocessor.
• the control means comprise at least one microprocessor implementing at least one algorithm, for example data processing, calculation or other.
• the control means are configured to, in response to receipt of the activation signal resulting from actuation by the user of the actuation means, calculate a NO/N ₂ mixture flow rate to be supplied corresponding to the NO content desired and control the NO/N ₂ flow control means to provide said calculated NO/N ₂ mixture flow.
• the control means are configured to calculate the NO/N ₂ mixture flow rate to be supplied from the desired NO content, the oxygen flow rate measured by the oxygen flow measurement means and a NO content in the NO/N ₂ mixture conveyed by the main NO line.
• the control means are further configured, in response to receipt of the activation signal, to act on the second solenoid valve to interrupt any circulation of NO/N ₂ mixture in the emergency NO line.
• it comprises a first solenoid valve, controlled by the control means, arranged on the main NO line downstream of the NO/N flow control means ₂ and on the emergency NO line of the emergency NO circuit downstream of the pneumatic valve.
• said first solenoid valve is configured to direct the NO/N ₂ mixture flow:
  • either in a downstream portion of the main NO line including the main outlet orifice,
  • either in a downstream portion of the emergency NO line connecting to the main O ₂ line.
• The first solenoid valve is a 3-way solenoid valve.
• the first solenoid valve is arranged on the downstream conduit portion of the main NO line, between the NO/N ₂ flow control means and the main outlet orifice.
• the first solenoid valve is controlled by the control means.
• the first solenoid valve is controlled by the control means to authorize or stop any passage of NO/N ₂ mixture coming from the NO/N ₂ flow control means, in particular towards the main outlet orifice or towards the junction site of the main O ₂ line and the backup NO line.
• the junction site is located downstream of the first solenoid valve.
• the emergency NO line includes a calibrated orifice device arranged downstream of the pneumatic valve.
• the emergency NO line of the emergency NO circuit is fluidly connected to the main NO line downstream of the flow control means.
• the emergency NO line of the emergency NO circuit is fluidly connected to the main NO line via the first solenoid valve, in particular a 3-way solenoid valve.
• a first pressure regulator is arranged on the emergency NO line upstream of the pneumatic valve.
• a second pressure regulator is arranged on the main O ₂ line between the second pneumatic control valve and the oxygen flow measurement means.
• a NO flow indicator device is arranged on the emergency NO line upstream of the junction site of the main O ₂ line and the emergency NO line.
• an O ₂ flow indicator device is arranged on the main O ₂ line, downstream of the O ₂ flow adjustment device or means.
• the O ₂ flow indicator device includes a ball rotameter.
• the O ₂ flow adjustment means comprise a rotating disk with calibrated orifices or the like.
• the O ₂ flow rate adjustment means are configured to adjust the flow rate of the O ₂ flow between 5 and 20 L/min.
• it comprises a flow rate selection means cooperating with the O ₂ flow rate adjustment means to select a desired O ₂ flow rate
• the flow selection means can be activated by the user.
• the flow rate selection means comprises a rotary knob or the like.
• according to another embodiment, the flow rate selection means comprises a key or the like displayed on a display screen to select the O ₂ flow rate.
• it includes data storage means, for example a computer memory or the like.
• it comprises a rigid housing, in which all or part of the elements of the NO supply device are arranged.
• the display screen is carried by the case.
• the NO content adjustment means are configured to allow the user to set or select a desired NO content of between 1 and 80 ppmv.
• the display screen is displayed in color or black and white.
• it comprises means for supplying electrical energy, i.e. supplying electric current, comprising means for electrical connection to the sector (110/220V), for example an electric cable provided with an electrical outlet or the like, and/or an electric battery, preferably rechargeable.
• a main NO line comprises at least one upstream conduit portion, preferably two upstream conduit portions arranged in parallel.
• the emergency NO circuit is supplied with NO/N ₂ by said at least one portion of conduit upstream of the main NO line, preferably the two portions of upstream conduit arranged in parallel.
• the emergency NO circuit is fluidly connected to said at least one portion of upstream conduit, preferably to the two portions of upstream conduit arranged in parallel, via at least one section of NO inlet pipe, preferably two sections of pipe NO inlet in parallel connecting fluidly to the two portions of upstream conduit.
• the emergency NO circuit is fluidly connected to the main NO line, upstream of the NO/N ₂ flow control means, in particular to said portions of upstream conduit of the main NO line, so as to be supplied in NO/N ₂ .
• the one or two NO inlet pipe sections are supplied with NO/N ₂ through the one or two NO inlet ports.

According to another aspect, the invention also relates to an installation for administering therapeutic gas containing NO, to a patient (P) comprising a device for supplying NO according to the invention, in particular as described above, powered in a NO/N ₂ mixture by at least one container of gas under pressure and in oxygen by a container of oxygen under pressure, said NO supply device providing:

• either a NO/N ₂ mixture via the main outlet orifice, to a respiratory gas circuit connected to a medical ventilator,
• either a NO/N ₂ /O ₂ mixture via the secondary orifice, to a manual or BAVU insufflator.

Depending on the embodiment considered, the therapeutic gas administration installation of the invention may comprise one or more of the following characteristics:

• said at least one pressurized gas container contains the NO/N ₂ mixture.
• said at least one pressurized gas container contains a NO/N ₂ 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 a NO/N ₂ mixture or medical oxygen at a pressure of at least 150 bar, or even at least 180 bar.
• the respiratory gas circuit includes an inspiratory branch and an expiratory branch.
• the inspiratory branch and the expiratory branch are fluidly connected to each other via a junction part, such as a Y-shaped part.
• the junction part is fluidly connected to a respiratory interface, such as a tracheal tube or a respiratory mask.
• the inspiratory branch and the expiratory branch include flexible pipes.
• a gas humidifier is arranged on the respiratory gas circuit, in particular on the inspiratory branch.
• the inspiratory branch comprises a flow sensor electrically connected to the NO supply device, in particular to the control means.
• the flow sensor is arranged on the inspiratory branch upstream of the NO injection site.
• the flow sensor is of the mass or pressure differential type.
• a gas sampling line fluidly connects the NO supply device to the respiratory gas circuit, preferably near the junction part, i.e. the Y-shaped part.
• the medical ventilator and the NO supply device are electrically powered by at least one electric current source.
• the emergency or secondary outlet of the NO supply device, i.e. an outlet port or orifice, is fluidly connected to a manual insufflation balloon via a connection conduit, such as a flexible pipe.

The invention will now be better understood thanks to the following detailed description, given by way of illustration but not limitation, with reference to the appended figures among which:

represents an embodiment of an installation for administering therapeutic gas to a patient P incorporating a device for supplying NO,

schematizes an embodiment of the emergency circuit of a NO supply device according to the prior art,

schematizes an embodiment of the internal architecture of an NO supply device according to the present invention, and

is a detailed diagram of the NO/N flow control means ₂ of the device .

] schematizes an embodiment of an installation 100 for administering therapeutic gas, ie a gas mixture based on NO, to a patient P incorporating a device for supplying NO 1, such as that according to the present invention.

More precisely, here it comprises two pressurized gas containers 5, arranged in parallel, each containing a gaseous mixture of NO and nitrogen (N ₂ ), ie a NO/N ₂ mixture, typically containing 250 to 1000 ppmv of NO and nitrogen (N ₂ ) for the remainder conditioned at a pressure of up to 180 bar or more, for example a NO/N ₂ mixture, containing 450 ppmv or 800 ppmv of NO. Such gas 5 containers are commonly called NO 5 cylinders.

The NO 5 bottles supply the NO/N ₂ mixture to a NO 1 supply device, such as that according to the invention, the internal architecture of which is illustrated on And . They are fluidly connected to the gas supply device 1 by NO supply lines 50, ie gas pipes, such as flexible pipes or the like. Each NO supply line 50 is connected to an NO input port 101 of the NO 1 supply device to supply a main gas circuit 200 internal to the housing 199 of the NO 1 supply device (cf. ).

The NO 1 supply device also comprises an oxygen inlet port 102 fluidly connected, via an oxygen supply line 51, such as a flexible pipe or the like, to a source of oxygen, for example a container of oxygen under pressure 52, typically an O ₂ bottle or, alternatively, the hospital network, ie an oxygen supply pipe arranged in the hospital building where patient P is treated.

The NO 5 bottles and the O ₂ bottle 52 are equipped with a gas distribution valve 55, preferably integrating gas expansion means, that is to say an RDI or integrated regulator valve, so as to be able to control the flow rate and/or pressure of the gas they deliver. The gas distribution valve 55 is preferably protected against impacts by a protective covering.

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

The medical ventilator 2 is fluidly connected to the patient P via a respiratory gas circuit 3 which here has two respiratory branches 30, 31 given that it comprises an inspiratory branch 30, that is to say a supply line in gas, used to bring the respiratory gas to patient P and an expiratory branch 31 used to recover the gas enriched in CO ₂ exhaled by patient P.

The two respiratory branches 30, 31 are typically flexible pipes made of polymer or the like. 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 part 32, typically a Y-shaped part, which is in fluid communication with a respiratory interface 4 supplying gas to patient P, such as a tracheal tube or other.

Of course, the medical ventilator 2 and the NO supply device 1 are normally electrically powered by one or more sources of electrical current, in particular their components requiring electrical energy to operate, in particular the control means 900 of the NO supply device 1 and the control system of the medical ventilator 2, i.e. electronic card with microprocessor(s), or any other component, in particular the internal motorized turbine which provides the air flow or the like, i.e. the respiratory gas. The source of electric current can be the mains (110/220V) and/or an electric battery, preferably rechargeable.

As can be seen, the NO 1 supply device makes it possible to inject the NO/N ₂ mixture into the inspiratory branch 30, via a NO injection conduit 11 opening into the inspiratory branch 30 at an injection site 8 , so as to mix the flow of NO/N ₂ and the flow of respiratory gas containing at least 21% O ₂ , ie air or an oxygen/nitrogen mixture, delivered by the medical ventilator 2.

The NO 1 supply device comprises a main outlet 210 located at the outlet of its main gas circuit 200 through which the flow of NO/N ₂ leaves the housing 199 of the NO 1 supply device and enters the conduit d NO injection 11. The NO injection conduit 11 is fluidly connected to the main outlet 210, for example via a connector or the like.

The therapeutic gas mixture obtained 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 product during mixing. gas flows. Of course, unavoidable impurities may be found in the gas but they are not desired, particularly when the gas flow from fan 2 is atmospheric air rather than an O ₂ /N ₂ mixture.

Advantageously, we also provide a gas humidifier 6 arranged here on the inspiratory branch 30 downstream of the injection site 8 serving to humidify the flow of therapeutic gas, eg NO/N ₂ /O ₂ mixture, by addition of steam water, before it is inhaled by the patient P, which makes it possible to avoid or limit the drying of the respiratory tract of the patient P during his treatment by inhalation of the gas. According to another embodiment, the gas humidifier 6 could also be arranged upstream of the injection site 8. Depending on the case, the expiratory branch 31 used to collect the exhaled gases rich in CO ₂ may comprise one or more other optional components, such as for example a CO ₂ elimination device, ie a CO ₂ trap, such as a hot tank or other, making it possible to eliminate the CO ₂ present in the gases exhaled by the patient, a filter or other.

As visible on , there is also provided on the inspiratory branch 30, upstream of the injection site 8, a flow sensor 7, for example of the mass or pressure differential type, connected to the NO supply device 1, in particular to the means of control 900 of said NO 1 supply device, via a flow measurement line 71 of respiratory gas used to measure the flow of gas coming from the ventilator 2 within the inspiratory branch 30. Determining this flow rate of the ventilator (Qv) makes it possible in particular to regulate the passage of NO through the NO 1 supply device, in particular to be able to choose the flow rate of NO/N ₂ mixture to be injected as a function of the desired NO content, of the composition of the NO/N ₂ mixture coming from bottles and the gas flow (ie air or air/O ₂ ) coming from fan 2.

Furthermore, it is also possible to provide a gas sampling line 33 fluidly connecting the NO supply device 1 to the respiratory gas circuit 3, preferably near the Y-shaped part 32, for example approximately 10 to 20 cm away. upstream of the Y-piece 32, used to take gas samples and to check their conformity with the desired gas mixture to be administered to patient P.

More precisely, the NO supply device 1 comprises a main internal 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 flow control means 202 of NO/N ₂ (cf. And ), such as valves, calibrated orifices, etc., controlled by the control means 900 of the NO supply device 1, typically one (or more) microprocessors arranged on an electronic card, the operation of which is explained below. All these components are arranged in a housing 199, that is to say a rigid external carcass.

In addition, the NO supply device 1 comprises an emergency circuit 110 designed to deliver an adjustable O ₂ flow rate and a fixed NO flow rate in order to be able to ensure a supply of NO, even in the event of a breakdown, as detailed below. -After.

So, schematizes an embodiment of the secondary circuit or emergency circuit 110 of a conventional NO supply device 1. First of all, it should be noted that, on , the main gas circuit 200 of the NO 1 supply device, which conveys the NO/N ₂ mixture during normal operation of the device 1, that is to say outside of a breakdown or the like, is not shown in order to do not unnecessarily weigh down the diagram and complicate its understanding. However, this main gas circuit 200, which is arranged in the housing 199, comprises, as shown, that illustrated on Or , a main NO line 201, 203 comprising at least one portion of upstream conduit 201, namely here two portions of upstream conduit 201 arranged in parallel, since 2 bottles of NO 5 are connected to the NO 1 supply device, as illustrated on has , and furthermore at least one downstream portion 203.

As can be seen, the emergency circuit 110, 120, the operation of which can be entirely pneumatic, which is also arranged in the housing 199, comprises an emergency NO circuit 110 and an emergency O ₂ circuit 120 which include each of the pipes, passages or gas conduits making it possible to convey the different gases or gas mixtures in the box 199.

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

The inlet pipe section(s) 111-1, 111-2 are fluidly connected to the upstream conduit portions 201 (partially shown on ) downstream of a filter 115 located immediately downstream of each NO inlet port 101 in the portion(s) of upstream conduit 201, as detailed in .

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

Each portion of upstream conduit 201 further comprises a pressure measuring means 118, such as a strain gauge pressure sensor ( silicon pressure sensor in English) or the like, serving to verify that the existence of a pressure in the portion of upstream conduit 201 reflecting the presence of a connected bottle and therefore also to check the quantity of gas it contains in order to decide whether to change it (if bottle almost empty) and switch to the other bottle of gas. Said pressure measuring means 118 is located downstream of the filter 115.

Of course, according to another embodiment, the device 1 can include only a single NO inlet port 101 and therefore a single portion of upstream conduit 201 and a single section of inlet pipe 111-1. In this case, only an oxygen supply line 51, such as a flexible pipe or the like, can be fluidly connected there, which is supplied with a NO/N ₂ mixture by one or more NO 5 bottles.

The emergency NO line 111 makes it possible to convey the NO/N ₂ mixture under pressure coming, via the inlet pipe sections 111-1, 111-2, from the upstream conduit portions 201 supplied by the NO 5 bottles delivering the NO/N ₂ mixture at a pressure of the order of 3 to 6 bar relative at the outlet of the RDI 55.

We also see that the emergency NO line 111 further comprises a first pressure regulator 112, downstream of the junction site 111-3, to reduce or control the pressure of the NO/N ₂ mixture, for example to deliver a reduced pressure equal to approximately 3.2 bar relative, and a pneumatic valve 113 making it possible to control the circulation of the NO/N ₂ mixture. Which pneumatic valve 113 is located downstream of the first pressure regulator 112, considering the direction of gas circulation, knowing that the NO/N ₂ gas mixture circulates in the direction going from each gas inlet port 101 towards the regulator pressure 112.

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

Downstream of the pneumatic valve 113, the emergency NO line 111 comprises a device with a calibrated orifice 114 or the like making it possible to regulate the gas flow, ie of the NO/N ₂ mixture, and a NO flow indicator device 117 making it possible to check that the NO/N ₂ mixture flow rate is indeed equal to the expected fixed value, for example of the order of 230 mL/min.

In addition, the emergency oxygen circuit 120 comprises a main O ₂ line 121 used to transport the oxygen into the box 199, which is supplied by the O ₂ inlet port 102 to which is connected the O ₂ bottle 52, via the supply line 51 which brings the gaseous oxygen to a pressure typically between 3 and 6 bar.

The main O ₂ line 121 is connected at a junction site 130, to the emergency NO line 111, downstream of the NO flow indicator device 117 so as to mix the oxygen flow at the flow rate. adjustable, as explained below, and the flow of NO/N ₂ which has a fixed flow rate of the order of 230 mL/min for example.

As seen on , the main O ₂ line 121 also includes a filter 106, arranged immediately downstream of the O ₂ inlet port 102, as well as a first control valve 122 and a second pneumatic control valve 123. It also includes a pressure measuring means 118, such as a strain gauge pressure sensor, as explained above.

The first control valve 122, typically of the all-or-nothing type, makes it possible to control the circulation of the oxygen flow in the main O ₂ line 121. It is controlled by an actuation means 195, such as a rotary selector, a push button, a selection key or the like, operable by the user, such as a nursing staff, when he wishes to start or stop the emergency circuit 110, 120.

A first section of conduit 121-1 is fluidly connected to the main O ₂ line 121 between the O ₂ inlet port 102, in particular downstream of the filter 106, and the first control valve 122. The first section of conduit 121-1 makes it possible to pneumatically control the second pneumatic control valve 123.

As long as the first control valve 122 is closed, the gas pressure exerted in the portion of the main O ₂ 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.

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

The oxygen then continues its route in the main O ₂ line 121 passing through a second pressure regulator 124 to reduce or control the pressure of the oxygen flow, for example to obtain a pressure of 1.6 bar abs relative. The flow rate of the O ₂ flow can then be adjusted, for example between 5 and 20 L/min, by O ₂ flow rate adjustment means 125, such as a rotating disk with calibrated orifices or the like, arranged on the line main O ₂ 121 downstream of the second pressure regulator 124.

The selection of the desired O ₂ flow rate can be carried out by the user via a flow selection means 196, such as a rotary button or the like, carried by the housing 199 of the device (or according to another embodiment, a selection of an O ₂ flow rate via a key or the like displayed on a display screen 950), which flow rate selection means 196 cooperates with the O ₂ flow rate adjustment means 125.

The oxygen flow can then be checked via an O ₂ flow indicator device 126, such as a ball rotameter or the like, arranged downstream of the O ₂ flow adjustment device or means 125. The flow of oxygen obtained can then mix with the flow of NO/N ₂ from the junction site 130 where the main O ₂ line 121 connects to the backup NO line 111, as already mentioned.

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 which is fluidly connected to the main line. of O ₂ 121 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.

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

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

The first control valve 122, the second control valve 123 and the pneumatic valve 113 are for example pilot-operated pneumatic valves of the flap and spring type.

In other words, activation of the actuation means 195 by the user leads to a quasi-synchronized and/or quasi-simultaneous release of the NO/N ₂ mixture and O ₂ 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, that is to say in the common line 140 which opens at an emergency exit 141 , ie a secondary outlet, for example carried by a connection connector or the like, to which can be connected to a manual gas insufflator, that is to say a manual ventilation balloon or the like.

We understand that the operation of this emergency gas circuit 110, 120 is entirely pneumatic since it only uses gas conduits and pneumatic valves to control the gas flows.

However, as already explained, such an entirely pneumatic circuit is not ideal because the NO concentration of the gas mixture obtained (ie NO/N ₂ + O ₂ ) from the junction site 130 and therefore in the common emergency 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.

Thus, for a NO/N ₂ gas mixture at 800 ppmv of NO (nitrogen remainder), the concentration of NO varies between 8 and 32 ppmv for an oxygen flow rate of between 5 and 20 L/min, whereas for a mixture NO/N ₂ at 450 ppmv of NO, the NO concentration varies between 4.5 and 18 ppmv for the same oxygen flow.

However, having a NO concentration which varies depending on the O ₂ flow rate chosen is not acceptable because we must be able to deliver to the patient a given dosage, that is to say a fixed quantity of NO corresponding to a concentration effective for treating his pathology, in particular in the context of ventilation of the patient by a manual ventilation bag instead of normal ventilation by the medical ventilator 2.

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

To do this, provision is made in the improved NO 1 supply device as illustrated in And which schematize an embodiment of the internal architecture of a NO 1 supply device according to the present invention.

First of all, the NO 1 supply device of includes the fully pneumatic elements of the emergency gas circuit 110, 120 of , these carry the same references and are therefore not explained again below.

Then, as visible on , the NO 1 supply device of the invention also comprises the main internal gas circuit 200 serving, during normal operation of the device 1, to supply the NO/N ₂ mixture, via the NO injection conduit 11, to the inspiratory branch 30 of the ventilation circuit 3 which is connected and supplied by the medical ventilator 2, with respiratory gas, ie air or N ₂ /O ₂ mixture, as explained above in connection with the .

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

The upstream conduit portion(s) 201 makes it possible to convey the NO/N ₂ mixture coming from the inlet pipe sections 111-1, 111-2 to NO/N flow control means ₂ 202 making it possible to control the flow rate of the NO/N ₂ mixture flow which must then be supplied to the injection conduit 11. An embodiment of the NO/N ₂ flow control means 202 is detailed in .

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

A first 3-way solenoid valve 204 is arranged on the downstream conduit portion 203 of the main NO line 201, 203 between the NO/N flow control means ₂ 202 and the main outlet orifice 210, it is that is to say that it is connected by 2 of these 3 paths to the downstream conduit portion 203 so as to control the circulation of gas in the downstream conduit portion 203. It is also connected, via its third path, 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 circulation of the gas, ie NO/N ₂ mixture, in the line of Emergency NO 111.

Furthermore, as we see on , the emergency NO line 111 comprises a second 2-way solenoid valve 150 which is normally in the open position, that is to say it allows the gas to circulate within the emergency NO line 111, and the device with calibrated orifice 114 or the like making it possible to regulate the gas flow, ie of the NO/N ₂ mixture, which on 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.

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.

According to another embodiment (not shown), 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. channels (the second solenoid valve 150 would then be removed).

Furthermore, the NO 1 supply device of the invention finally comprises oxygen flow measuring means 160 arranged on the main O ₂ line 121 between the second pressure regulator 124 and the device or means of O ₂ flow setting 125.

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), ie a pressure loss, making it possible to deduce an oxygen flow rate (Q _O2 ).

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

As can be seen, the two portions of upstream conduit 201 of the main gas circuit 200 join to form a common section 201-1 conveying the NO/N ₂ mixture. Each portion of upstream conduit 201 comprises a first control valve 700 arranged upstream of the junction site of the two portions of upstream conduit 201, which serves to authorize or stop the circulation of the flow of NO/N ₂ mixture brought by one or the other of the upstream conduit portions 201.

The common section 201-1 is then divided into two secondary sections 201-2 arranged in parallel to each other, which each include a pressure regulator device 701 and a pressure sensor 702.

The two secondary sections 201-2 are in turn divided into several sub-sections 201-3 which are also arranged in parallel to each other, namely here two sub-sections 201-3. Each sub-section 201-3 comprises a second control valve 703. Sub-sections 201-3 also include additional flow control means 704, for example calibrated orifice(s) or the like, making it possible to adjust the flow rate. at a desired flow rate value.

Of course, the NO/N flow control means ₂ 202 can include more sub-sections 201-3, each equipped with a control valve 703 and additional flow control means 704, typically a calibrated orifice, to allow a wider variety of NO flow rates to be delivered, if necessary. Preferably, the control valve(s) 703 is an all-or-nothing (TOR) type valve. The gas flow rate circulating there is fixed and depends on the pressure of the pressure regulator 701, ie a regulator, and the section of the calibrated orifice.

In fact, the control means 900 of the NO 1 supply device, 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 in the appropriate sections to obtain the desired NO dosage.

The desired NO content is chosen by the user via NO content selection means (not shown schematically) arranged on the device, for example one or more keys, cursors, selection buttons, in particular a rotary button, or the like, which make it possible to select or set a desired NO content.

Advantageously, the NO 1 supply device of the invention is equipped with an information display screen 950, typically a digital screen, preferably a touch screen, in color or black and white, configured to display the value of the desired NO content and/or other information, such as the NO content in the NO 5 bottles or the NO or O ₂ flow values, and for example also the NO ₂ concentration, the flow delivered by the fan…

According to one embodiment, the information display screen 950 is a touch-controlled digital screen and the NO content selection means are touch-actuated selection keys, displayed on the display screen 950 touch digital. The selection or setting of the desired NO concentration is therefore done by digital pressing by the user on the touch-activated selection key(s) displayed on the display screen 950.

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

The subsections 201-3 then come together, upstream of the first 3-way solenoid valve 204, in a single line which forms the downstream conduit portion 203 of the main gas circuit 200. It may include a pressure sensor 705 or analogous, upstream of the first solenoid valve 204, in order to possibly 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.

In addition, we also see 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 connecting to the two portions of upstream conduit 201 in order to be able to carry out a gas purge of these two portions of upstream conduit 201. Each purge section 801 comprises a purge valve 803 controlled by the control means 900 so as to be able to eliminate all the 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, that is to say say is not used.

In normal operation, that is to say when the user has not actuated the actuating means 195, the NO/N ₂ mixture travels in the main gas circuit 200 of the NO 1 supply device of the invention, via the NO/N ₂ flow control means 202, from one of the gas inlet ports 101 to the main outlet port 210 which supplies the NO/N ₂ mixture to the injection conduit of NO 11 so as to then be able to inject it at the desired NO concentration, into the inspiratory branch 30 of the ventilation circuit 3 connected to the medical ventilator 2, as explained above in connection with And .

In this case, the second 2-way solenoid valve 150 is in the “normally open” position, that is to say it does not interrupt the passage of gas in the emergency NO line 111, and the first solenoid valve 204 with 3 channels is in the “normal operating” position authorizing the passage of the gas flow in the downstream conduit portion 203 up to the main outlet orifice 210.

The first solenoid valve 204 is controlled by the control means 900 to authorize or stop any passage of NO/N ₂ mixture coming from the NO flow control (ie adjustment) means 202.

In the event of a serious failure of the NO supply device 1 of the invention leading to a loss of electrical energy and/or to a cessation of operation of the control means 900 of the device 1, or even of the medical ventilator 2, in particular 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 “operating” position normal” so as to authorize circulation of the gas flow in the downstream conduit portion 203 up to the main outlet orifice 210.

This allows, after actuation by the user of the actuation means 195, a transition to entirely pneumatic type emergency mode, as explained in connection with . This therefore 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 (at 130) with the flow of oxygen at adjustable flow rate coming from the main O ₂ 121 line.

The emergency gas mixture formed of NO/N ₂ /O ₂ thus obtained can then be conveyed by the common emergency line 140 to the emergency outlet 141, ie secondary outlet, which then supplies this emergency gas mixture to a manual ventilation bag, also called manual resuscitator or BAVU. Then, the patient is then ventilated via the manual ventilation bag to ensure a supply of NO to the patient despite the severe breakdown or the like.

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 or if the nursing staff decides to ventilate the patient via a manual ventilation bag while wishing to respect the NO dosage, then the NO 1 supply device of the invention and more particularly the control means 900 and l The display screen 950 remains supplied with electrical energy by the electrical energy supply means, therefore the control means 900 remain able to operate.

In this case, the user wishing to switch the device 1 to emergency or ventilation mode by BAVU, to ensure a supply of gas to the patient via a manual ventilation balloon or BAVU, will activate, as previously, the actuation means 195 , which will then cause the first control valve 122 to open, thereby authorizing the circulation of the oxygen flow in the main O ₂ line 121 to the second control valve 123 which will then also open and allow the oxygen to pass into the downstream part of the oxygen circuit 120, located downstream of the second control valve 123, as explained above in connection with .

The oxygen flow measurement means 160 which are arranged on the main O ₂ line 121 downstream of the second pressure regulator 124 will then be able to measure the oxygen flow (Q _O2 ) and transmit this flow measurement d 'O ₂ (ie signal or value) to the control means 900 in order to calculate the flow rate of NO/N ₂ to be supplied, as explained below.

The oxygen flow can then continue its journey to the junction site 130 where the O ₂ /NO/N ₂ mixture takes place, via the O ₂ flow rate adjustment means 125 and the flow rate indicator device d 'O ₂ 126, such as a ball rotameter or the like, as already explained.

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. emergency mode (i.e. emergency activated) or normal mode (i.e. emergency not activated). This activation signal is supplied electrically to the control means 900 of the NO 1 supply device of the invention, which receive it and process it to determine whether the actuation means 195 has been actuated by the user in order to trigger the emergency mode or ventilation by BAV, in order to carry out ventilation of the patient via a manual ventilation balloon connected to the secondary outlet, i.e. the emergency outlet 141, NO 1 supply device of the invention, for example via a flexible hose.

If this is the case, the control means 900 of the NO 1 supply device of the invention which remain supplied with electrical energy (ie electric current), feedback, in response to this signal, on the flow rate control means of NO/N ₂ 202 to supply the NO/N ₂ mixture at the desired flow rate and on the first 3-way solenoid valve 204 to authorize the passage of the NO/N ₂ flow from the downstream conduit portion 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 routing the flow of NO/N ₂ via the NO flow indicator device 117, to the mixing site 130 where the line meets main O ₂ 121 and the emergency NO line 111, as already explained.

Thus, the NO/N ₂ mixture being produced within the NO/N ₂ flow control means 202, it is possible to set the most suitable NO flow rate. This NO/N ₂ mixture flow rate to be supplied by the NO/N ₂ flow control means 202 can be calculated by the control means 900 of the NO 1 supply device of the invention from the NO content desired final result, the composition of the NO/N ₂ mixture in the bottles 5 and the oxygen flow measured by the oxygen flow measuring means 160 which are arranged on the main O ₂ line 121 downstream of the second pressure regulator 124. 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 numeric keys with digital actuation displayed on the The digital display screen 950 which also remains supplied with electrical current.

Being able to use a NO/N ₂ mixture produced within the NO/N ₂ flow control means 202, in the event of activation of the emergency circuit and in the absence of a complete fault of the device 1, is i.e. in case of slight failure and/or desire to carry out ventilation of the patient via a manual ventilation bag, has the advantage of guaranteeing greater precision of NO concentration of the rescue mixture supplied to the patient given that the said final NO content can be adjusted by the user via the NO content adjustment means (ie choice or selection) and that the control means 900 use this adjusted NO content value, the NO concentration in the NO/N ₂ mixture supplied by the NO 5 bottles and the O ₂ flow rate value measured to determine the NO/N ₂ flow rate to be supplied and act accordingly on the NO/N flow control means ₂ 202, in particular the first control valves 700 and the second control valves 703, to provide the adequate NO/N ₂ flow rate by controlling the passage of the gas in particular in the secondary sections 201-2, the pressure regulator device 701, the two secondary sections 201-2 and the sub-sections 201-3 comprising the additional flow control means 704, for example calibrated orifices or the like, making it possible to adjust the flow rate to a desired flow rate value.

In other words, thanks to the incorporation of the oxygen flow measurement means 160 on the main O ₂ line 121, downstream of the second pressure regulator 124, which measure the oxygen flow (Q _O2 ) and transmit this O ₂ flow measurement to the control means, the latter can calculate a flow setpoint in NO/N ₂ to be provided by the NO/N ₂ flow control means 202 while also taking into account not only the NO setpoint set by the user but also the concentration of NO in the NO/N ₂ mixture coming from the NO 5 bottles.

This leads to being able to obtain from the mixing site 130, a final mixture with a precise NO content since the NO/N ₂ mixing flow rate is no longer fixed, (eg equal to 230 mL/min) but is adjustable depending on other parameters having an influence.

However, it is then essential to prevent the flow of oxygen which passes through the second control valve 123 and which acts on the pneumatic valve 113 from being the cause of an excessive supply of NO via the NO line. emergency 111 through the second 2-way solenoid valve 150. To do this, when they receive the activation signal coming from the actuation means 195, which corresponds to a switch to emergency mode, the control means 900 of the NO 1 supply device of the invention are also configured to also act on the second 2-way solenoid valve 150, which is normally in the open position, to close it and thus prevent the NO/N ₂ mixture from being able to circulate within the emergency NO line 111 and supply the downstream part of the the emergency NO line 111 located downstream of the first solenoid valve 204.

The NO/N ₂ /O ₂ mixture thus obtained is then, as previously, conveyed via the common emergency line 140 which opens at an emergency outlet 141 to supply the emergency gas mixture formed of NO/N ₂ / O ₂ and then be able to bring it, via a flexible conduit or the like, to a manual ventilation balloon to carry out manual ventilation of the patient with the NO/N ₂ /O ₂ gas mixture having the desired dosage.

Of course, in the event of a serious failure of the device 1 with a power supply fault, no activation signal is generated by the actuation means 195 and/or is not used/processed by the control means 900, therefore in the event of activation of the emergency mode via the actuation means 195, the device 1 returns to fully pneumatic emergency mode, as explained in connection with .

The NO 1 supply device according to the invention has a higher level of safety by making it possible to adjust the NO content more precisely in the event of failure or slight breakdown, without loss of electrical power, and/or desired to carry out manual ventilation of the patient by BAVU.

Generally speaking, the NO 1 supply device according to the invention is particularly suitable for use within an installation 100 for administering therapeutic gas based on NO (< 100 ppmv), O ₂ (>21% vol) and nitrogen to a patient P, such as the installation 100 of , 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, by for example to treat PPHN in a newborn, or pulmonary hypertension in a person undergoing heart surgery.

Claims (10)

NO supply device (1) comprising:

• control means (900),
• a main gas circuit (200) comprising at least one main NO line (201, 203) fluidly connecting at least one NO inlet port (101) to a main outlet port (210) to convey a NO/ mixture N ₂ of said at least one NO inlet port (101) to said main outlet orifice (210), said main NO line (201, 203) comprising controlled NO/N ₂ flow control means (202) by the control means (900),
• an emergency circuit (110, 120) comprising an emergency NO circuit (110) and an emergency O ₂ circuit (120), in which:

1. the backup NO circuit (110) includes a backup NO line (111) in fluid communication with the main NO line (201, 203), the backup NO line (111) comprising a pneumatic valve (113) making it possible to control the circulation of the NO/N ₂ mixture in the emergency NO line (111) and a second solenoid valve (150) controlled by the control means (900), and
2. the backup O ₂ circuit (120) includes a main O ₂ line (121) in fluid communication with an O ₂ inlet port (102), said main O ₂ line (121) comprising :

. a first control valve (122) controlled by actuation means (195) operable by a user to control the circulation of the oxygen flow in said main O line₂(121), said actuation means (195) being further configured to provide an activation signal to the control means (900) in response to actuation of said actuation means (195) by the user,
. a second pneumatic control valve (123) arranged downstream of the first control valve (122),
. oxygen flow measurement means (160) arranged downstream of the first control valve (122) and configured to provide at least one oxygen flow measurement to the control means (900), and
. means for adjusting the O flow rate₂(125) arranged downstream of the oxygen flow measurement means (160),
and in which:

• the main O ₂ line (121) is configured to cooperate pneumatically with the pneumatic valve (113) to allow the passage of the NO/N ₂ mixture into the backup NO line (111) in response to actuation by the user of the actuation means (195), and
• the emergency NO line (111) of the emergency NO circuit (110) and the main O ₂ line (121) of the emergency O ₂ circuit (120) are fluidly connected (130) to each other the other to form a common emergency line (140) in fluid communication with an emergency exit (141).

Device according to claim 1, characterized in that the emergency NO line (111) of the emergency NO circuit (110) and the main O ₂ line (121) of the emergency O ₂ circuit (120) are fluidly connected to each other at a junction site (130) located downstream of the O ₂ flow adjustment means (125) of the main O ₂ line (121) and downstream of the second solenoid valve (150) of the emergency NO line (111). Device according to claim 1, characterized in that the emergency NO line (111) of the emergency NO circuit (110) is fluidly connected to the main NO line (201, 203) downstream of the flow control means of NO/N ₂ (202). Device according to claim 1, characterized in that the main O ₂ line (121) is configured to cooperate pneumatically with the pneumatic valve (113) via a section of conduit (121-2) fluidly connecting the main O ₂ line (121), downstream of the second control valve (123), to said pneumatic valve (113). Device according to claim 1, characterized in that it comprises NO content adjustment means configured to allow a user to choose a desired NO content and supply said desired NO content to the control means (900). Device according to claims 1 and 5, characterized in that the control means (900) are configured to, in response to reception of the activation signal resulting from an actuation by the user of the actuation means (195) , calculate a NO/N ₂ mixture flow rate to be supplied corresponding to the desired NO content and control the NO/N ₂ flow rate control means (202) to provide said calculated NO/N ₂ mixture flow rate. Device according to claim 6, characterized in that the control means (900) are configured to calculate the NO/N ₂ mixture flow rate to be supplied from the desired NO content, the oxygen flow rate measured by the means of measurement of oxygen flow (160) and NO content in the NO/N ₂ mixture conveyed by the main NO line (201, 203). Device according to claim 1, characterized in that the control means (900) are further configured, in response to receipt of the activation signal, to act on the second solenoid valve (150) to interrupt any circulation of the NO/mixture. N ₂ in the emergency NO line (111). Device according to claims 1 and 2, characterized in that it comprises a first solenoid valve (204), controlled by the control means (900), arranged on the main NO line (201, 203) downstream of the control means NO/N flow rate₂(202) and on the emergency NO line (111) of the emergency NO circuit (110) downstream of the pneumatic valve (113), said first solenoid valve (204) being configured to direct the NO/N mixture flow₂:

• either in a downstream portion (203) of the main NO line (201, 203) comprising the main outlet orifice (210),
• either in a downstream portion of the emergency NO line (111) connecting (130) to the main O ₂ line (121).

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 NO/N mixture₂by at least one pressurized gas container (5) and oxygen by a pressurized oxygen container (52), said NO supply device (1) providing:

• either a NO/N ₂ mixture via the main outlet orifice (210), to a respiratory gas circuit (3) connected to a medical ventilator (2),
• either a NO/N ₂ /O ₂ mixture via the secondary orifice (141), to a manual or BAVU insufflator.