No supply facility with no delivery device and anesthesia ventilator

Abstract

To provide a facility for supplying a gas mixture containing NO to a patient.SOLUTION: The equipment comprises a NO delivery apparatus, a medical ventilator 50, a NO infusion device 24, a flow measurement device 25 and a gas sampling module 61. The medical ventilator 50 is an anesthesia ventilator 150 comprising a gas outlet 151 to which the flow measuring device 25 is connected. The NO injection device 24 is arranged downstream of the flow measuring device 25, and the gas sampling module 61 is arranged at least 30cm distance D downstream of the NO injection device 24.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an apparatus for supplying an NO-based gas mixture to a patient, the apparatus comprising an NO delivery device for supplying an NO-containing gas mixture, typically an NO / N mixture, from one or more NO sources, such as pressurized gas cylinders, and an anesthesia ventilator for supplying an oxygen-based (i.e., > about 20 vol%) gas. [Background technology]

[0002] Inhalable nitric oxide (NO or iNO) is a gas preparation commonly used to treat patients suffering from acute pulmonary arterial hypertension (PPHN), particularly pulmonary vasoconstriction, in adults or children, including newborns, as described, for example, in EP-A-560928 or EP-A-1516639.

[0003] Typically, to administer inhaled NO therapy, a gas supply system, also known as an NO administration system, is used, which includes an NO delivery device and a medical ventilator, i.e., a breathing assistance device, that supplies the patient circuit.

[0004] The NO delivery device allows for the infusion of an NO-based gas mixture, typically an NO / nitrogen mixture, into a patient circuit that is also supplied with a gas flow containing oxygen (at least about 20% by volume), such as air or an oxygen / nitrogen mixture (O2 / N2), supplied by a medical ventilator. This NO infusion is accomplished using an infusion device or module located in the patient circuit.

[0005] The NO gas, typically an NO / nitrogen gas mixture, supplied to the NO delivery device generally comes from one or more pressurized gas containers, such as gas cylinders.

[0006] The patient circuit generally comprises one or more flexible conduits fluidly connected to a respiratory interface, e.g., an endotracheal intubation tube or a respiratory mask, which is used to deliver a complex therapeutic gas mixture containing NO to a treated patient in a given amount or dose, i.e., a physician-set dosage.

[0007] To regulate the amount of NO delivered, a flow sensor placed in the patient circuit upstream of the NO injection point is typically used, which measures the flow rate of the oxygen-containing gas delivered by the medical ventilator and provides this flow rate measurement to the NO delivery device.

[0008] Before being administered to the patient, the gas is typically humidified in a gas humidifier located in the patient circuit between the respiratory interface and the flow sensor.

[0009] This type of equipment is used in hospital settings to provide treatment with NO and therefore care for patients who require inhaled NO to treat their pulmonary arterial hypertension, particularly during cardiac surgery. NO delivery equipment is described in EP 3821929, EP 4209243, EP 4241817, EP 4241812, and EP 4295882.

[0010] However, when NO must be administered to a patient during a surgical procedure, for example, cardiac surgery, it may be necessary to use an anesthesia ventilator, also called an anesthesia station, that is capable of also delivering anesthetic gases such as isoflurane, desflurane, or sevoflurane, which are used to sedate / anesthetize patients during surgery.

[0011] In this case, the patient circuit used is double-branched to carry the anaesthetic gas to the patient via the inspiratory branch and then collect the exhaled gas, which is rich in CO2 and still contains the anaesthetic compounds, via the expiratory branch.

[0012] The inspiratory and expiratory branches are generally connected at a junction, also called a Y-piece, which is also connected to a respiratory interface, such as an intubation tube or a breathing mask, used to administer gas to the patient and collect exhaled gas.

[0013] The NO delivery device, and the anesthesia ventilator used in place of a conventional medical ventilator, must then be fluidly connected to the gas circuit used to administer the NO-based gas to the patient.

[0014] In particular, a flow sensor located in the inspiratory branch, which serves to measure the gas flow coming from the anesthesia ventilator to allow adjustment of the amount of NO supplied by the NO delivery device (i.e., the NO flow rate), and a gas injector device, which serves to inject NO into the inspiratory branch, must be connected to the NO delivery device, as well as a gas sampling line for monitoring the composition of the NO-based gas mixture supplied to the patient and taking gas samples from this mixture to ensure that it contains the desired proportions of NO and oxygen and, conversely, does not contain excessive amounts of toxic species such as NO.

[0015] In facilities using conventional ventilators, the NO injection module and flow sensor are generally placed in the inspiratory branch upstream of the gas humidifier, at least 30-60 cm from the ventilator outlet, and the gas sampling line is usually connected upstream of the Y-piece, typically about 15-40 cm from it.

[0016] However, these connections present a problem when the ventilator is an anesthesia ventilator rather than a conventional ventilator.

[0017] Specifically, in this case, it is not easy to interface with the NO delivery device, i.e., to connect the gas sampling line and flow sensor to the inspiratory branch. This is because facilities using anesthesia ventilators generally use more basic patient circuits, i.e., simple flexible pipes or conduits with a sealed Y-piece at the downstream outlet of the flexible pipe or conduit, without a gas humidifier since humidification is performed directly within the device using an on-board humidification and heat exchange filter. Sometimes, the expiratory branch, which is also typically made of flexible pipe, is positioned coaxially within the flexible pipe that serves as the inspiratory branch.

[0018] Other known installations for supplying gas mixtures containing NO are described in particular in US 2023 / 270960, WO 2016 / 096056 and WO 2015 / 153713.

[0019] In all cases, it will be appreciated that such a basic patient circuit does not allow for the easy insertion of a gas sampling module or injection module and flow sensor supplying a gas sampling line that must be connected to an NO delivery device without unsealing the Y-piece to insert the gas sampling module and / or cutting the flexible pipe to insert a module comprising a flow sensor and an NO injector module, as this would necessarily damage the patient circuit and / or the Y-piece and would in all cases be completely unthinkable for surgical procedures. Summary of the Invention

[0020] The present invention aims to solve the problem of connecting a gas sampling module supplying a gas sampling line and a module including a flow sensor to a basic patient circuit associated with anesthesia ventilators, particularly those used in cardiac surgery.

[0021] The solution according to the invention therefore relates to an installation for supplying a gas mixture containing NO, typically an NO / N gas mixture, to a patient, i.e. a person, comprising: - a NO delivery device configured to provide a flow of gas containing NO; - a medical ventilator for supplying a flow of breathing gas containing O2 to an inspiratory branch of a breathing circuit; - an NO infusion device, also called an infusion module, configured to inject NO-containing gas coming from an NO delivery device into a flow of respiratory gas coming from a medical ventilator; - a flow measuring device configured to measure the flow rate of a flow of breathing gas coming from a medical ventilator; a gas sampling module configured to sample a portion of the gas circulating in the intake branch downstream of the NO injection device.

[0022] Furthermore, in the installation for supplying a gas mixture containing NO according to the present invention, the medical ventilator is an anesthesia ventilator with a gas outlet, and the NO injection device is arranged downstream of the flow measuring device.

[0023] Furthermore, in the equipment for supplying a gas mixture containing NO according to the present invention, the flow measuring device is directly connected to the gas outlet of the anesthesia ventilator, and the gas sampling module is positioned downstream of the NO injection device at a distance (D) of at least 30 cm from the NO injection device.

[0024] Depending on the embodiment concerned, the installation according to the invention may also comprise one or more of the following features:

[0025] The NO injection device is disposed between the flow measurement device and the gas sampling module.

[0026] - the flow measurement device is fluidly connected to the NO infusion device by means of at least one intermediate conduit section.

[0027] - The NO infusion device is directly connected to the flow measurement device.

[0028] The infusion device (or module) is configured to mix the NO-containing gas coming from the NO delivery device with a flow of breathing gas containing O2 supplied by a medical ventilator to obtain a complex gas mixture containing NO and oxygen, typically a complex gas mixture containing NO, oxygen, and nitrogen.

[0029] Several intermediate conduit sections fluidly connect the NO injection device to the gas sampling module.

[0030] The intermediate conduit section or sections comprise a preferably bendable or flexible pipe element, for example made of a polymer.

[0031] It comprises a tubular connector for connecting, preferably by mating, one or more intermediate conduit sections.

[0032] - a tubular connector fluidly connects the at least one intermediate conduit section to a flow measurement device and an NO injection device and / or fluidly connects several intermediate conduit sections to each other.

[0033] The gas sampling module is placed downstream of the injection device (or module) at a distance of between 30 cm and 80 cm, preferably less than 60 cm, more preferably still between 30 and 50 cm.

[0034] The gas sampling module is fluidly connected (directly or indirectly) to the inspiratory branch of the breathing circuit.

[0035] - The gas sampling module is fluidly connected to the upstream end of the inspiratory branch of the breathing circuit, in other words to the inlet of the inspiratory branch of a basic breathing circuit, preferably a basic breathing circuit with a connecting piece (i.e., a Y-piece) that is sealed (i.e., non-removably attached) at the downstream end of the inspiratory branch.

[0036] - the NO infusion device is fluidly connected to the NO delivery device in such a way that the NO-containing gas is supplied by said NO delivery device.

[0037] - the flow measurement device is fluidly connected to the NO delivery device in a manner that provides a flow measurement to the NO delivery device.

[0038] The flow measurement device comprises a flow sensor.

[0039] - The flow sensor is a mass flow sensor.

[0040] the flow sensor is electrically connected to the NO delivery device, in particular to the control means of the NO delivery device.

[0041] - the gas sampling module is fluidly connected to the NO delivery device downstream of the NO injection device in such a way that it supplies the NO delivery device with gas circulating in the inspiratory branch.

[0042] The breathing circuit further comprises an expiratory branch.

[0043] The inspiratory and expiratory branches are fluidly connected at a connecting piece, typically a Y-piece.

[0044] The coupling part is fluidly connected to a respiratory interface, such as a breathing mask or an endotracheal intubation tube.

[0045] The expiratory branch is fluidly connected to the gas inlet of the anesthesia ventilator.

[0046] The breathing circuit comprises a flexible pipe or conduit, in particular an inspiratory branch and an expiratory branch.

[0047] It further comprises at least one NO container, typically one or more pressurized gas cylinders, containing the NO / N2 mixture.

[0048] The NO container or containers supply a flow of gas containing NO, typically a gas mixture formed of nitrogen and NO, ie an NO / N2 mixture, to the NO delivery device.

[0049] The infusion device comprises a first gas inlet to which is supplied a flow of breathing gas containing O2, i.e. breathing gas coming from a ventilator.

[0050] The infusion device also comprises a second gas inlet to which is supplied a gas containing NO coming from the NO delivery device.

[0051] The infusion device also comprises a gas outlet for supplying a complex gas mixture containing NO and oxygen obtained by mixing, within the infusion device, a gas containing NO (e.g., an NO / N2 mixture) with a flow of breathing gas containing O2 (e.g., air or an O2 / N2 mixture).

[0052] The injection device or module comprises a module body comprising an internal gas passage (ie, an internal volume or chamber) fluidly connected to a first gas inlet, a second gas inlet, and a gas outlet.

[0053] Respiratory gas coming from the ventilator enters the internal gas passage of the infusion device or module via a first gas inlet.

[0054] The NO-containing gas coming from the NO delivery device enters the internal gas passage of the infusion device or module via a second gas inlet.

[0055] The combined gas containing NO and oxygen leaves the injection device or module via the gas outlet.

[0056] The breathing circuit, in particular the inspiratory branch, is not equipped with a gas humidifier, i.e. does not have any gas humidifier.

[0057] - The flow measuring device, the NO injection device, the gas sampling module, the at least one intermediate conduit portion, and the tubular connector form an independent, detachable connection assembly for connecting an NO delivery apparatus, configured to be fluidly connected between the inspiratory branch of the patient circuit and the gas outlet of the anesthesia ventilator.

[0058] Additionally, depending on the embodiment at hand, the NO delivery device may include one or more of the following features:

[0059] - It is supplied with a gas mixture formed of nitrogen and NO.

[0060] - it comprises dose adjustment means configured to enable the user to fix or select a set NO content, i.e. a dosage, corresponding to the desired final proportion of NO in the composite gas mixture, in other words the composite gas resulting from mixing a flow of gas containing NO (i.e.) coming from the NO delivery device with a flow of breathing gas containing oxygen coming from the ventilator.

[0061] The dose adjustment means form part of the HMI (Human Machine Interface) or UGI (User Graphics Interface).

[0062] - the dose adjusting means comprises one or more touch keys that may be activated by the user and that are displayed on a digital touch screen of the HMI, preferably of the color display type;

[0063] - The set NO content is 1 to 80 ppmv, typically 5 to 40 ppmv.

[0064] - it comprises storage means comprising computer memory, for example flash memory or RAM.

[0065] - it comprises control means comprising at least one (micro)processor, for example a microcontroller;

[0066] the control means comprise one or more (micro)processors arranged on one or more electronic boards;

[0067] The control means comprise one or more (micro)processors implementing one or more algorithms, in particular one or more algorithms for operating or controlling valves, for processing flow or pressure measurements, etc.

[0068] - the storage means is arranged on the electronic board;

[0069] - It is powered by one or more current sources, typically a mains supply (110 / 220V) and / or one or more rechargeable batteries.

[0070] Furthermore, depending on the embodiment involved, the anesthesia ventilator may comprise one or more of the following features:

[0071] It incorporates one or more humidification and heat exchange filters, making it possible to humidify the respiratory gas immediately inside the ventilator, in other words upstream of the gas outlet of the anesthesia ventilator in question.

[0072] - it is configured to supply a flow of breathing gas containing O2, preferably containing at least 20 vol% oxygen, typically at least about 21 vol% oxygen.

[0073] - The O2-containing respiratory gas stream exiting the anesthesia ventilator contains water vapor, i.e., is humidified.

[0074] - Preferably, the O2-containing respiratory gas stream exiting the anesthesia ventilator has a temperature of 15-30°C.

[0075] The O2-containing breathing gas is, for example, air or an oxygen / nitrogen (O2 / N2) mixture.

[0076] - It comprises an electrically powered blower (i.e. turbine or compressor etc.) that delivers breathing gas, typically air or an oxygen / nitrogen mixture.

[0077] According to another embodiment, it comprises an internal gas circuit comprising one or more proportional valves for conveying gas and controlling its supply, in particular its flow rate, this circuit being supplied with breathing gas via one or more wall outlets, which are generally supplied with gas from a pipe network within the hospital facility or building.

[0078] - it comprises control means or devices such as one or more electronic control boards. Preferably, the control means of the medical ventilator operate or control an electric blower or, depending on the situation, a proportional valve of the medical ventilator.

[0079] - It is powered by one or more current sources, typically a mains supply (110 / 220V) and / or one or more rechargeable batteries.

[0080] Finally, depending on the embodiment concerned, the NO container(s) supplying the installation of the invention may comprise one or more of the following characteristics:

[0081] The (or each) NO container(s) contains an NO / N2 mixture containing 100-2000 ppmv NO and the remainder nitrogen, preferably an NO / N2 mixture containing 100-1500 ppmv, typically 200-1000 ppmv NO.

[0082] When the NO container is full, the NO / N2 mixture therein is at a pressure of at least 150 bar (before the gas is drawn off), preferably between 10 and 250 bar.

[0083] Each NO container is or comprises one or more gas cylinders with a volume of 0.5 to 50 l (water equivalent).

[0084] - Each NO container is a pressurized gas cylinder.

[0085] Each NO container comprises a cylindrical body made of steel or aluminium alloy and fitted with a simple valve (without regulator) or a valve with an integral regulator or IRV, preferably an IRV.

[0086] - The valve fitted to the container / each container is protected by a protective cap, e.g. made of metal or polymer.

[0087] According to another aspect, the present invention also relates to a method for the therapeutic treatment of a person, i.e., a human patient (i.e., an adult, child, adolescent, or neonate), suffering from pulmonary hypertension and / or hypoxia resulting in pulmonary vasoconstriction or the like, particularly in the case of surgery involving gas anesthesia, the method comprising administering by inhalation to a person in need thereof a gas mixture comprising 1 to 80 ppmv NO and at least about 20 vol.% oxygen, preferably at least about 21 vol.% oxygen, using the above-described gas supply installation according to the present invention, the gas supply installation comprising a NO delivery device for delivering NO in such a way as to (at least partially) treat said pulmonary hypertension and / or said hypoxia, particularly pulmonary hypertension caused by cardiac surgery involving ventilatory anesthesia of the patient while the patient is placed on extracorporeal blood circulation (ECC), and an anesthesia ventilator.

[0088] [Definition] Generally, in the context of the present invention:

[0089] - "ppmv" means parts per million by volume.

[0090] - "vol%" means volume percentage.

[0091] - "NO" stands for nitric oxide.

[0092] - "NO2" refers to nitrogen dioxide.

[0093] - "N2" indicates nitrogen.

[0094] - "O2" indicates oxygen.

[0095] - Pressure is expressed in "absolute bar", abbreviated to "bar".

[0096] - The terms "concentration," "amount," "proportion," "dose," and "content" are considered equivalent and interchangeable.

[0097] - the term "means for" is considered to be fully equivalent and interchangeable with the term "device for", e.g. the term "control means" may be replaced by "control device", the term "valve means" may be replaced by "valve device", the term "storage means" may be replaced by "storage device", etc.

[0098] "Pressure measurement" is to be understood as a pressure value (e.g., a numerical value) or a signal representative of such a pressure value that reflects or corresponds to a gas pressure measured by a pressure sensor or the like.

[0099] "Flow measurement" means a flow value (e.g., a numerical value) that reflects or corresponds to a gas flow rate measured by a sensor or the like, or one or more signals (pressure or flow) that represent or allow such a flow value to be determined.

[0100] A clearer understanding of the invention will now be obtained from the following detailed description, given by way of non-limiting example with reference to the accompanying drawings, in which: FIG. [Brief explanation of the drawings]

[0101] [Figure 1] 1 illustrates a schematic diagram of one embodiment of an apparatus for administering NO to a patient being fed by a conventional medical ventilator. [Figure 2] 1 illustrates schematically one embodiment of the connection of a flow measurement device, an NO infusion device, and a gas sampling module to a gas outlet of an anesthesia ventilator according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0102] FIG. 1 shows a schematic representation of an embodiment of a gas administration installation 100 according to the present invention, comprising a nitric oxide (NO) supply device 1 for supplying a gas mixture based on NO, and a conventional medical ventilator 50 adapted to supply a gas containing at least 20 vol.% oxygen, e.g., air, i.e., a medical ventilator 50 that is not an anesthesia station or ventilator.

[0103] The installation 100 comprises an NO source 10, i.e., in this case, two pressurized gas cylinders or containers each containing an NO / N gas mixture, i.e., in this case, an NO / N gas mixture containing 100-2000 ppmv NO (remainder N), typically 100-1000 ppmv NO (remainder N), for example 450 or 800 ppmv NO (remainder N), or any other suitable concentration, the NO source 10 supplies the NO / N mixture to a device or apparatus 1 for delivering or supplying NO, and allows the supply amount of the NO / N gas mixture to be monitored and controlled.

[0104] Each of the gas cylinders is fluidly connected to the NO supply device 1 via a gas inlet line 12, e.g., a flexible pipe or conduit equipped with connectors, which may be further equipped with devices for regulating and / or monitoring the gas pressure, e.g., a gas pressure relief valve 13, a pressure gauge, etc.

[0105] Gas inlet line 12 is fluidly connected to gas input 2 of NO delivery device 1, which feeds an internal gas circuit (not shown) used to transport gas within NO supply device 1, i.e., within the outer casing or housing of device 1. Such internal gas circuit comprises one or more conduit sections fluidly connected to NO inlet 2, which is supplied with the NO / N mixture coming from gas cylinder 10.

[0106] The gas circuit conventionally comprises solenoid valves or the like controlled by the control means of the device 1 to control the flow of gas within the internal gas circuit, and other components such as one or more pressure or flow sensors, for example MFCs (i.e. mass flow controllers).

[0107] The NO delivery device 1 further comprises an oxygen inlet 3 that is fluidly connected to an oxygen source (not shown), e.g., a pressurized oxygen cylinder or the hospital's supply network, i.e., oxygen supply piping provided in the hospital premises, via an oxygen inlet line 11, e.g., a flexible pipe, thereby allowing oxygen to be fed into the internal gas circuit 200 when required.

[0108] In FIG. 1, medical ventilator 50 is a conventional respiratory support device that delivers a flow of oxygen-based breathing gas, such as air or an oxygen / nitrogen (N2 / O2) mixture, i.e., an oxygen-based breathing gas containing at least about 20 vol% oxygen, preferably at least about 21 vol% oxygen, but is not capable of anesthetizing a patient.

[0109] The medical ventilator 50 and NO delivery device 1 of the installation 100 are in fluid communication with a breathing circuit 20, also called the patient circuit, which comprises an inspiratory branch 21 and an expiratory branch 22.

[0110] The inspiratory branch 21 serves to deliver a therapeutic gas flow, in other words a complex gas mixture containing a desired NO dose, to the respiratory interface 40 for delivery to the patient.

[0111] The complex gas mixture administered to the patient is formed by mixing an oxygen-based flow (e.g., air or an O2 / N2 mixture) coming from the ventilator 50 with an NO-containing flow, i.e., an NO / N2 gas mixture, delivered by the NO delivery device 1.

[0112] To this end, the NO delivery device 1 supplies or injects an NO / N mixture into the inspiratory branch 21 via an infusion conduit or line 23, which fluidly connects the internal gas circuit of the NO delivery device 1 to an infusion device or module 24 located in the inspiratory branch 21. The infusion device 24 is configured to mix the NO-containing gas with a flow of O-containing breathing gas coming from the ventilator 50, thereby obtaining a composite gas mixture containing NO and oxygen, i.e., the final gas mixture administered to the patient.

[0113] The infusion device 24 comprises a first gas inlet supplied with a flow of O2-containing breathing gas from the medical ventilator 50, a second gas inlet supplied with an NO-containing gas, i.e., gas coming from the NO delivery apparatus 1, and a gas outlet supplying a complex gas mixture containing NO and oxygen obtained by mixing the NO-containing gas with the O2-containing breathing gas flow in the infusion device 24. The NO / N2 flow delivered by the infusion line 23 is then mixed in an internal chamber or passage of the infusion device 24 with a flow of oxygen-based gas (>20% O2), e.g., air or an oxygen / nitrogen mixture, delivered by the ventilator 50 and carried by the inspiratory branch 21, thereby obtaining the desired complex mixture to be administered to the patient, i.e., the final NO / N2 / O2 gas mixture, essentially containing the desired dose of NO, nitrogen (N2), and oxygen (O2), as well as possibly unavoidable impurities (e.g., argon, CO2, NO2, etc.).

[0114] 1, when such an installation 100 is supplied by a conventional medical ventilator 50, the inspiratory branch 21 of the circuit 20 further comprises a gas humidifier 30 arranged downstream of the injection device 24. This makes it possible to humidify a combined gas flow, for example a NO / N2 / O2 mixture, before administering it by inhalation to the patient to be treated by means of a respiratory interface 40, for example a tracheal intubation tube or a breathing mask.

[0115] Furthermore, the patient circuit 20 additionally comprises an expiratory branch 22 for collecting gases exhaled by the patient. The inspiratory branch 21 (via downstream end 122) and the expiratory branch 22 are fluidly connected to a junction piece 41, such as a Y-piece, which is also connected to a respiratory interface 40 to ensure the exchange of gases to and from the patient's lungs.

[0116] In this conventional installation 100, the inspiratory branch 21 is fluidly connected via its upstream end 121 to an outlet port 51, such as a connector or coupling, of the medical ventilator 50 so as to collect and deliver the oxygen-based gas, typically air or an N2 / O2 mixture, supplied by the medical ventilator 50, and the expiratory branch 22 is fluidly connected to an inlet port 52, such as a connector or coupling, of the medical ventilator 50 so as to return all or part of the flow of gas exhaled by the patient (i.e., CO2-rich gas) to the medical ventilator 50.

[0117] Upstream of the infusion device 24 there is a flow measurement device 25, typically a hot wire, pressure differential or other type of flow sensor, to be able to measure the flow rate of the gas delivered by the ventilator 50, such as air or N2 / O2, circulating in the inspiratory branch 21. The flow sensor 25 is connected to the NO delivery device 1 via one or more flow measurement lines 26 connected to a connection port 27 of the device 1.

[0118] Knowing the flow rate of the breathing gas allows for more efficient control or regulation of the delivery of the flow of NO (i.e., N2 / O2), and in particular the flow rate of NO, by the NO delivery device 1. This is because the flow measurements obtained by the flow sensor 25 are returned to the (micro)processor control means, typically a (micro)controller, of the NO delivery device 1, which processes these flow measurements to determine the flow of NO to be delivered as a function of the desired dose of NO and the proportion of NO in the NO / N2 flow coming from the gas cylinder 10.

[0119] Conventionally, the control means of the device 1, such as a (micro)controller (not shown as they are located inside the casing of the device 1), comprise one or more electronic boards with one (or several) (micro)processors implementing one or more algorithms, making it possible in particular to regulate or control the flow rate of the NOx-based gas by operating all or some of the (solenoid) valves, and also to perform calculations and / or to control or command all the electromechanical elements of the device 1, such as sensors, solenoid valves, displays, etc.

[0120] Typically, the NO delivery device 1 also comprises a graphical user interface (GUI) comprising a graphical display means 4, preferably a touch screen, i.e., one with a touch panel, which serves to display various information or data, icons, curves, alerts, etc., and also to display virtual selection keys and / or panes or windows, among other things, for making selections, or for inputting information such as desired values ​​(e.g., flow rates, NO doses, etc.), or any other information or data useful to the medical practitioner. The display is preferably in color, but can also be in black and white.

[0121] Power for the NO delivery device 1, in particular for components that require electrical current to operate, such as the control means, graphical display means, etc., is conventionally provided by a current source and / or power supply means (not shown), e.g., a connection to mains current (110 / 220 V) such as an electrical cord and connection socket, and / or one or more, preferably rechargeable, batteries, and / or current transformers. The power supply to the medical ventilator 50 is ensured in a similar manner, in particular by connection to mains current or by an internal battery.

[0122] The installation 100 also includes a gas sampling line 60 that fluidly connects the intake branch 21 to an inlet port 62 of the NO delivery device 1. The gas sampling line 60, e.g., a flexible pipe, is connected to a sampling module 61 inserted into the intake branch 21 between the humidifier 30 and the junction piece 41, or Y-piece, typically in the immediate vicinity of the junction piece 41. The sampling module 61 and the gas sampling line 60 allow samples of the composite gases to be taken and sent to the NO delivery device 1, where the samples are analyzed in an internal gas analyzer (not shown) that includes NO, NO, and O sensors, typically an electrochemical cell, electrically connected to a control means. This allows the gases to be monitored and checked for conformance.

[0123] In particular, it should be verified that the composition of the composite gas is compatible with the composition of the desired NO / N2 / O2 gas mixture to be administered to the patient, to ensure that the composite gas does not contain excessive amounts of toxic NO2 species, that its oxygen content is not hypoxic, that its NO2 content is not too high, and that its NO content corresponds to the desired dosage, i.e., the dose of NO to be administered by inhalation, usually selected by a medical professional, i.e., a doctor or the like. The control means of the device 1 processes the signals coming from the gas analyzer sensors and triggers an alarm if incompatible ratios are determined. The content values ​​of NO, NO2, and O2 are preferentially displayed on the graphical display means 4 of the HMI.

[0124] In such an installation 1, the NO injection module 24 and flow measurement device or flow sensor 25 are generally positioned in the inspiratory branch 21 upstream of the gas humidifier 30, at a distance of at least 30 cm to 60 cm from the outlet of the ventilator 50, and the gas sampling line 60 is connected upstream of the Y-piece 41, typically about 15 to 40 cm therefrom.

[0125] However, as mentioned above, when the ventilator 50 is an anesthesia ventilator or station 150, such as those used during surgical procedures, particularly cardiac procedures involving ECC, as shown in FIG. 2, and when the patient circuit 20 is basic, particularly having a sealed (i.e., non-removable) Y-piece 41 at the downstream end 122 of the inspiratory branch 21, it is not easy or even possible to connect the NO delivery device 1 to the inspiratory branch 21 for surgical purposes in order to supply NO to the patient and thereby prevent or minimize pulmonary hypertension, which may be caused, particularly, by ECC.

[0126] Therefore, the present invention proposes a particular design or arrangement for insertion into the patient circuit 20 , typically between the inspiratory branch 21 and the outlet 151 of the anesthesia ventilator 150 .

[0127] More specifically, as shown in FIG. 2, in accordance with the present invention, the flow measurement device or module 25 is connected directly to the gas outlet 151 of the anesthesia ventilator 150, rather than being connected more than 30 cm to 60 cm away as is the case with the conventional ventilator 50 shown schematically in FIG.

[0128] Furthermore, the gas sampling module 61 is itself positioned downstream of the flow measurement device or module 25, at a distance D of at least 30 cm from the flow measurement device or module 25, and is fluidly connected from one to the other using one or more intermediate conduit sections 45, for example, two intermediate conduit sections 45 as can be seen in Figure 2, and tubular connectors 46.

[0129] It may also be necessary or desirable to use one or more additional fluid connection elements 47, for example to connect two tubular connectors 46 together, as shown schematically in Figure 2. Such tubular connectors 46 and additional fluid connection elements 47 may be conventional and may be made, for example, of a polymer.

[0130] The intermediate conduit portion 45 preferably comprises a bendable or flexible pipe, for example made of a polymer.

[0131] Additionally, the NO injection device 24 is connected between the flow measurement device or module 25 and the gas sampling module 61 .

[0132] 2, the NO injection device 24 is attached directly to the flow measurement device or module 25, e.g., mated one to the other, such that an intermediate conduit section 45 allows the outlet of the NO injection device 24 to be connected to the inlet of the gas sampling module 61.

[0133] The gas sampling module 61, located downstream of the NO injection device 24, is located at a distance D of 30 cm to 80 cm, preferably 30 cm to 50 cm, from the NO injection device 24, allowing sufficient time for the mixture of the NO / N2 stream and the respiratory gas (e.g., air or O2 / N2) stream to be homogenized and for the gas sample taken by the gas sampling module 61 to adequately represent the proportions of NO, O2, and NO2 in the complex mixture obtained after mixing the streams.

[0134] As mentioned above, the flow measurement device 25 is connected to the NO delivery device 1, i.e., to a connection port 27 of the device 1, via a flow measurement line 26 that serves to transmit flow measurements obtained by the flow measurement device 25. The flow measurement device 25 is preferably a mass flow sensor and is electrically connected to the NO delivery device 1.

[0135] Similarly, an NO injection device 24 is connected to the outlet port 5 of the NO delivery apparatus 1 via an injection line or conduit 23 to allow the NO / N2 mixture to be delivered and then injected into the respiratory gas flow coming from the anesthesia ventilator 150.

[0136] Similarly, gas sampling module 61 is itself connected to port 62 of NO delivery device 1 via gas sampling line 60 to carry the gas sample to be tested to NO delivery device 1 .

[0137] According to one embodiment, the infusion device or module 24 comprises a module body with an internal gas passage, i.e., an internal volume or chamber, in fluid communication with a first gas inlet supplied with an O2-containing breathing gas, i.e., a flow of gas coming from the ventilator 150, a second gas inlet supplied with an NO-containing gas coming from the NO delivery device 1, and a gas outlet supplying a composite gas mixture containing NO and oxygen obtained by mixing an NO-containing gas (e.g., an NO / N2 mixture) with a flow of O2-containing breathing gas (e.g., air or an O2 / N2 mixture) within the internal gas passage of the infusion device.

[0138] According to one embodiment, flow measurement device 25 comprises a body through which an internal gas passageway passes, the body comprising an inlet port through which the flow of O2-containing breathing gas, i.e., breathing gas coming from ventilator 150, can enter the internal passageway, and an outlet port through which the flow of breathing gas exits the internal passageway. It further comprises an electronics board supported by the body and serving as a mass flow sensor in fluid communication with the internal passageway to obtain gas flow measurements within the internal passageway.

[0139] According to one embodiment, the gas sampling module 61 also comprises a body through which an internal gas passageway passes, the body comprising an inlet port through which a flow of complex gas (i.e., a NO / N2 / O2 mixture) can enter the internal passageway, and an outlet port through which the flow of complex gas leaves the internal passageway and is then carried to the patient by the inspiratory branch 21 of the patient circuit 20. It further comprises connectors or the like for fluidly connecting a gas sampling line 60 in such a way as to enable a gas sample of the complex mixture in the internal passageway to be taken, which gas sample is then carried by the gas sampling line 60 to the device 1 for analysis therein.

[0140] To facilitate their fluid connection, the flow measuring device 25, the NO injection device 24, and the gas sampling module 61 are preferably equipped with tubular end pieces, also called connectors, which allow the tubular end pieces to be mechanically and fluidly connected, in particular to the outlet 151 of the anesthesia ventilator 150, one or more intermediate conduit sections 45, and the upstream end 121 of the inspiratory branch 21, as the case may be, in particular by connection by pressure fit or mating.

[0141] For example, the first gas inlet and gas outlet of the injection device or module 24, the inlet and outlet holes of the flow measurement device 25, and the inlet and outlet holes of the gas sampling module 61 may be positioned within, i.e., supported by, such tubular end pieces.

[0142] Generally, the flow measurement device 25, the NO injection device 24, the gas sampling module 61, the at least one intermediate conduit portion 45, and the tubular connector 46 form an independent, detachable connection assembly for connecting the NO delivery device 1, which is fluidly connected between the inspiratory branch 21 of the patient circuit 20 and the gas outlet 151 of the anesthesia ventilator 150, as shown schematically in FIG. 2, even when the patient circuit 20 is, for example, a basic one formed of a simple gas conduit and includes a Y-piece that is sealed at the downstream end of the inspiratory branch 21, in other words, is not designed to be easily disconnected or detachable from the inspiratory branch 21.

[0143] The gas administration equipment 100 according to the present invention can be used to administer nitric oxide (NO), i.e. the resulting final NO / O2 / N2 mixture, by inhalation to a person, i.e. a patient, suffering from acute pulmonary arterial hypertension, in order to treat pulmonary hypertension (PH), in particular in adult or pediatric cardiac surgery, in order to improve oxygenation by dilating pulmonary blood vessels and improving pulmonary gas exchange.

Claims

1. 1. An installation (100) for supplying a gas mixture containing NO to a patient, comprising: an NO delivery device (1) configured to provide a flow of gas containing NO; - O ２ a medical ventilator (50) for supplying a flow of breathing gas containing an NO injection device (24) configured to inject the NO-containing gas coming from the NO delivery device (1) into the flow of respiratory gas coming from the medical ventilator (50); a flow measuring device (25) configured to measure the flow rate of the flow of breathing gas coming from the medical ventilator (50), wherein the NO injection device (24) is arranged downstream of the flow measuring device (25); a gas sampling module (61) configured to sample a portion of the gas circulating in the intake branch (21), downstream of the NO injection device (24); In a facility comprising: The flow measuring device (25) is directly connected to the gas outlet (151) of the anesthesia ventilator (150), and the gas sampling module (61) is positioned downstream of the NO injection device (24) at a distance (D) of at least 30 cm from the NO injection device (24).

2. 2. The installation according to claim 1, characterized in that the NO injection device (24) is directly connected to the flow measurement device (25).

3. 3. The installation of claim 2, wherein the flow measurement device (25) is fluidly connected to the NO injection device (24) by means of at least one intermediate conduit section (45).

4. 4. The installation of claim 3, wherein several intermediate conduit sections (45) fluidly connect the NO injection device (24) to the gas sampling module (61).

5. 5. The installation according to claim 3 or 4, characterized in that a tubular connector (46) fluidly connects the at least one intermediate conduit section (45) to the flow measurement device (25) and the NO injection device (24) and / or fluidly connects several intermediate conduit sections (45) to each other.

6. 2. Installation according to claim 1, characterized in that the gas sampling module (61) is placed downstream of the NO injection device (24) at a distance (D) of 30 cm to 80 cm.

7. 2. The installation according to claim 1, characterized in that the gas sampling module (61) is fluidly connected to the inspiratory branch (21) of the breathing circuit (20).

8. 5. The installation according to claim 4, characterized in that the gas sampling module (61) is fluidly connected to the upstream end (121) of the intake branch (21).

9. 5. The installation according to claim 4, dependent on claim 1, characterized in that the breathing circuit (20) comprises a junction piece (41) sealed at the downstream end (122) of the inspiratory branch (21), preferably the junction piece (41) being a Y-piece.

10. 6. The installation according to claim 5, when dependent on claim 3, characterized in that the flow measurement device (25), the NO injection device (24), the gas sampling module (61), the at least one intermediate conduit portion (45), and the tubular connector (46) form an independent, detachable connection assembly for connecting the NO delivery device (1), configured to be fluidly connected between the inspiratory branch (21) of the breathing circuit (20) and the gas outlet (151) of the anesthesia ventilator (150).

11. 7. Installation according to claim 1 or 6, characterized in that the gas sampling module (61) is arranged downstream of the NO injection device (24) at a distance (D) of less than 60 cm.

12. 12. Installation according to claim 1, 6 or 11, characterized in that the gas sampling module (61) is arranged downstream of the NO injection device (24) at a distance (D) of 30 cm to 50 cm.

13. 2. The installation according to claim 1, characterized in that the gas sampling module (61) is fluidly connected to the inlet of the inspiratory branch (21) of the breathing circuit (20), the breathing circuit (20) being a basic circuit with a sealed junction (41) located at the downstream end of the inspiratory branch (21).

14. - the NO injection device (24) is fluidly connected to the NO delivery device (1) in such a way that the NO delivery device (1) supplies a gas containing NO; and / or - said flow measurement device (25) comprises a flow sensor fluidly connected to said NO delivery device (1) in such a way as to provide a flow measurement to said NO delivery device (1), preferably said flow sensor being a mass flow sensor; 2. The installation according to claim 1 , characterized in that

15. 2. The installation according to claim 1, characterized in that the gas sampling module (61) is fluidly connected to the NO delivery device (1) in such a way that it supplies the NO delivery device (1) with gas circulating in the intake branch (21) downstream of the NO injection device (24).

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