Continuous pressure ventilation device suitable for the treatment of patients with respiratory failure

Abstract

Continuous Pressure Ventilation Device Suitable for Treating Patients with Respiratory Failure. The invention relates to a non-invasive ventilation (NIV) device with continuous positive airway pressure (CPAP) comprising a gas inlet module (100), a ventilation module (200), and a gas delivery line (300) fluidically connecting the gas inlet module (100) to the ventilation module (200). Coupling means are provided to allow detachable coupling of the gas inlet module (100) to the ventilation module (200) when the device 1 is to be put into operation or when it is not in use and needs to be temporarily stored. Such a device makes it possible to treat patients suffering from respiratory difficulties or failures, in particular people infected with a coronavirus affecting their lung capacity, such as COVID-19. (Shorthand figure: Fig. 6)

Description

Title of the invention: Continuous pressure ventilation device suitable for the treatment of patients with respiratory failure

[0001] The invention relates to a non-invasive ventilation (NIV) device, in particular continuous positive pressure, with pneumatic operation for treating patients suffering from respiratory difficulties or failures, in particular people infected with a coronavirus affecting their lung capacity, for example COVID-19 or one of its variants.

[0002] Various causes can lead to respiratory system failure in some people, such as viral infections, particularly those caused by a coronavirus, such as COVID-19.

[0003] When the failure of the respiratory system leads to a decrease in the person's blood oxygen, i.e. hypoxemia, and therefore a decrease in oxygen in their tissues, the person, i.e. the patient, risks hypoxic cardiac arrest which could lead to their death.

[0004] To avoid this, a conventional treatment is based on providing supplemental oxygen to the patient. Oxygen can be provided simply via a breathing mask supplied by an oxygen source, such as a gas cylinder, or by using a mechanical ventilator (i.e. a respirator) providing oxygen to a patient respiratory interface, such as a breathing mask in simple cases or a tracheal intubation tube or a supraglottic device in more serious or even critical cases. Using a mechanical ventilator makes it possible to provide oxygen in different ventilation modes.

[0005] Sometimes it is also possible to provide oxygen by means of devices delivering gas with continuous positive airway pressure or CPAP (for Continuous Positive Airway Pressure in English). Continuous positive airway pressure, in addition to the addition of oxygen, helps to combat atelectasis of the small airways, that is to say their closure by "collapse", but also to reduce the patient's respiratory work, that is to say the effort that the latter must make to breathe, and thus greatly improves tolerance for the patient.

[0006] A CPAP-type device therefore gives better results than respiratory masks simply supplied by an oxygen source and, moreover, is generally of simpler design and operation than a mechanical ventilator, and its use requires less training for healthcare personnel. For example, the COVID-19 pandemic has highlighted a significant need to have such CPAP-type devices available to treat patients infected with this virus or one of its variants.

[0007] For this purpose, a non-invasive ventilation (NIV) device of the CPAP type may be used comprising a gas inlet module fluidly connected to a ventilation module by a flexible conduit which ensures the delivery of the respiratory gas from the gas inlet module to the ventilation module, then to the respiratory interface delivering the gas to the patient during the treatment of the patient, which is fluidly connected to the ventilation module.

[0008] However, in practice, it has been found that with this type of NIV device, a problem arises at the end of treatment, when the healthcare staff stops the treatment and disconnects the respiratory interface from the ventilation module. Indeed, the ventilation module is then at the free end of the flexible conduit which can reach 1 to 2 meters in length, and it often happens that it inadvertently hits structures, objects or even the ground, during the handling of the NIV device by the healthcare staff, which can damage it. In addition, the length of the flexible conduit increases the overall size of the entire NIV device and does not allow it to be easily stored, for example while the patient is undergoing other care or after use.

[0009] Furthermore, during a phase of non-use, such a device empties of the gas it contains, in particular the tank, and it is then essential to fill it with fresh gas each time it is used, i.e. to be able to initiate treatment, which is not very practical.

[0010] A problem is therefore to propose a non-invasive ventilation (NIV) device for patients of the CPAP type which is of simple design and which makes it possible to avoid or minimize all or part of these problems, in particular which makes it possible to simply and quickly put the device into operation and also facilitates the storage of the NIV device, in particular after use or in the event of temporary interruption of a patient's treatment.

[0011] A solution according to the invention then concerns a non-invasive ventilation (NIV) device, in particular continuous positive pressure (CPAP), comprising: - a gas inlet module comprising an inlet module body (i.e. a first module body) comprising: • an internal gas passage, • an oxygen injection port in fluid communication with the internal gas passage, and • a conduit connection end piece with a gas supply port in fluid communication with the internal gas passage, said conduit connection end piece being configured to fluidly connect a flexible conduit thereto, and - a ventilation module comprising a ventilation module body (i.e. a second module body) comprising: • an upstream connection end piece with a gas inlet orifice configured to fluidly connect a flexible conduit to it, • a downstream connection tip with a gas outlet orifice configured to fluidly connect a respiratory interface, and • an internal gas circuit fluidly connecting the gas inlet orifice to the gas outlet orifice,

[0012] characterized in that the gas intake module and the ventilation module comprise coupling means allowing a user to couple, ie to fix, in a detachable, ie removable manner, the ventilation module to the gas intake module.

[0013] Depending on the embodiment considered, the non-invasive ventilation (NIV) device according to the invention may comprise one or more of the following characteristics: - the coupling means comprise a housing with a blind bottom open towards the outside arranged in the intake module body of the gas intake module cooperating with the downstream connection end of the ventilation module. - the blind bottom housing of the gas inlet module is configured to house and retain the downstream connection tip of the ventilation module. - the downstream connection end piece and the blind bottom housing form a male / female connection assembly by fitting. - the downstream connection end of the ventilation module is retained in the blind bottom housing by the internal peripheral wall of said blind bottom housing. - the downstream connection end piece has a tubular shape and the blind bottom housing has a shape complementary to the tubular shape of the downstream connection end piece, preferably a cylindrical or truncated cone shape. - the downstream connection end piece has an external section which is substantially equal to the internal section of the blind bottom housing so that the downstream connection end piece cooperates with the internal peripheral wall of the blind bottom housing, when the downstream connection end piece is inserted "by force" into the blind bottom housing, to ensure that the downstream connection end piece is held by fitting into the blind bottom housing. - when the downstream connection tip is inserted "by force" and held, i.e. fixed, in the blind bottom housing, the downstream connection tip can be subsequently extracted by a user, i.e. the attachment is temporary and is done in a detachable, i.e. removable, manner. the downstream connection end of the ventilation module is held, in a sealed manner, within the blind bottom housing. a flexible conduit having an upstream end and a downstream end, respectively, is fluidically connected to the gas inlet module and the ventilation module, respectively. the upstream and downstream ends of the flexible conduit comprise connection means configured to allow their fluid connection to a connection end piece. a flexible conduit has a length between 0.5 and 10 meters. the flexible conduit is fluidically connected, via its upstream end, which is equipped with connection means, to the conduit connection end of the gas inlet module. the flexible conduit is fluidically connected, via its downstream end, which is equipped with connection means, to the upstream connection end of the ventilation module. The flexible conduit constitutes a gas delivery line used to transport gas between the gas inlet module and the ventilation module. the connection means carried by the upstream and downstream ends of the flexible conduit are configured to allow a mechanical and fluidic connection of the flexible conduit to the gas intake module and to the ventilation module, in particular a sealed connection. the connection means carried by the upstream and downstream ends of the flexible conduit comprise tubular connectors, preferably of cylindrical or truncated cone shape, or the like. the tubular connectors carried by the upstream and downstream ends of the flexible conduit fit or are fitted, like sleeves, onto the conduit connection end of the gas inlet module and onto the upstream connection end of the ventilation module. a gas tank having an internal volume of at least 15 L is fluidically connected to the internal gas passage of the gas inlet module, preferably an internal volume of 20 to 50 L. the gas tank has an internal volume of at least 18 Liters, preferably at least 20 Liters (Liters given as water equivalent). the gas tank has an internal volume less than or equal to 50 L, preferably less than or equal to 40 L. Advantageously, the gas tank has an internal volume of between 25 and 35 L, typically of the order of 30 L. the gas tank comprises a flexible envelope, preferably formed of polymer. the gas tank is flexible, i.e. deformable and / or supple. the gas tank includes a biocompatible polymer envelope free of phthalate, or the like. the intake module body of the gas intake module is traversed by the internal gas passage. Flexible conduit is a flexible polymer pipe. the flexible conduit has a length of between 1 and 7 meters, preferably less than 5 meters, more preferably less than 3 meters, advantageously between 1 and 2 meters. The flexible conduit is used to convey the gas towards the patient, i.e. in the direction from the gas inlet module to the ventilation module. the gas tank is mechanically and fluidically connected to a tank connection nozzle of the intake module body of the gas intake module. the tank connection nozzle of the intake module body includes a connection port in fluid communication with the internal gas passage of the gas intake module. the tank connection tip may be a tubular fitting or the like. the gas intake and ventilation modules are separated from each other by being mechanically and fluidically connected to each other by the flexible conduit. the ventilation module body further comprises an exhaust valve in fluid communication with the internal gas circuit and, furthermore, with the atmosphere, via an exhaust port, so as to allow an escape of gas to the atmosphere, via the exhaust port, during each expiratory phase of the patient and to prevent the escape of gas to the atmosphere during each inspiratory phase of the patient. the exhaust valve comprises an internal compartment, a closure element cooperating with a valve seat, elastic means arranged in the internal compartment and acting on the closure element so as to push it towards the valve seat and an exhaust port connected finitely specifically to the atmosphere. the closing element is a valve, a flexible membrane or the like. the exhaust valve includes a PEEP adjustment system configured to allow a user to adjust a positive end expiratory pressure (PEEP) level between 0 and 30 cmH20, by modulating the elastic force that the elastic means exerts on the closure element to urge it against the valve seat. according to another embodiment, the exhaust valve comprises a non-adjustable PEEP system, i.e. configured to ensure a fixed, i.e. predefined, positive expiratory pressure (PEEP) of between 0 and 30 cmH20, for example a PEEP equal to 5 cmH20, 7.5 cmH20, 10 cmH20 or any other value up to 30 cmH20. the body of the intake module further comprises a venturi inlet configured to be fluidically connected to a venturi device, namely a venturi system in communication with the ambient atmosphere to allow an entry of additional air and / or oxygen into the internal gas passage, in particular in the event of a peak gas flow rate, in particular an air / O2 gas mixture. the venturi inlet is fluidically connected to the internal gas passage of the gas inlet module body. a venturi device is connected to the venturi inlet of the gas intake module. alternatively and preferably, the venturi inlet is configured to further form the oxygen injection orifice so as to allow fluidic (and mechanical) connection of either an oxygen source or a venturi device. In other words, the oxygen injection orifice and the venturi inlet are common and unique to allow the attachment thereto, as the case may be, of an oxygen source or a venturi device. the venturi device is permanently or detachably mounted. the venturi device comprises a venturi body comprising at least one venturi air inlet (i.e. one or more orifices or the like) allowing atmospheric air to enter the venturi device and at least one venturi oxygen inlet allowing oxygen to enter the venturi device so as to be able to produce one or more air / O2 mixtures in the venturi body. the venturi body comprising at least one venturi outlet for supplying (i.e. feeding) the air / O2 mixture to the internal gas passage of the gas intake module, via a venturi inlet arranged on the gas intake module. an oxygen source is fluidically connected to the injection orifice oxygen from the gas intake module. a gas backflow preventer is arranged in the internal gas circuit of the ventilation module. the gas anti-return device comprises a one-way valve, i.e. a valve only allowing the circulation of gas in the direction towards the patient, thus preventing any rise of gas towards the gas delivery line. the intake module body comprises connection means configured to allow an oxygen source and / or the gas tank to be connected thereto. the intake module body and the ventilation module body are formed, at least in part, of rigid material, preferably polymer. the intake module body and / or the ventilation module body is or are each formed from a single piece, in particular obtained by injection molding or any other suitable technique. the connection means include tubular or similar fittings, in particular push-fit or press-fit fittings or fittings by screwing, bayonet or any other coupling system. the valve seat of the exhaust valve cooperates with the closure element to provide a fluid seal between them. the elastic means normally pushes the sealing element against the valve seat. the sealing element is made of metal, polymer or other. the sealing element is a flexible membrane having a “bellows” or other disc shape. the elastic means comprises a spring or the like. the sealing element is fixed to the inner wall of the valve body. a respiratory interface is fluidically connected to the ventilation module, i.e. in fluid communication with the internal gas circuit of the ventilation module via the gas outlet orifice carried by the downstream connection tip of the ventilation module. the downstream connection tip of the ventilation module is configured to fluidly connect a respiratory interface by interlocking / fitting, screwing, bayonet or any other fastening system, typically by interlocking / fitting. the respiratory interface includes a respiratory mask, for example nasal or facial (i.e. oronasal), a tracheal intubation tube or a supraglottic device. - the valve body has a generally cylindrical or similar shape. - the adjustment system is carried by the valve body of the valve exhaust. - the adjustment system includes a movable part in the form of a cap which is screwed onto the valve body, i.e. the cap sits on top of the valve body. - the elastic means, i.e. spring or similar, comes to rest in the bottom of the movable part in the form of a cap. - the gas inlet module body further comprises a safety valve configured to allow air to enter the internal gas passage of the inlet module in the event of insufficient gas in the tank and / or from the oxygen source and / or the venturi device. - an oxygen source is fluidically connected to the oxygen injection port arranged on the body of the gas intake module. - another oxygen source is fluidically connected to the venturi device. - the oxygen source(s) comprises one or more pressurized oxygen cylinders or an oxygen supply pipe opening into a connection socket, typically a wall socket.

[0014] Furthermore, the non-invasive ventilation (NIV) device is configured, i.e. designed, to operate entirely and solely pneumatically, i.e. it does not include any internal micro-blower (i.e. turbine or compressor) or the like, and without electrical current, i.e. it does not include any source of electrical current.

[0015] The invention will now be better understood thanks to the following detailed description, given for illustrative but non-limiting purposes, with reference to the appended figures among which:

[0016] [Fig-1] is a block diagram of an embodiment of a VNI device according to the invention;

[0017] [Fig.2] shows schematically an embodiment of the pneumatic exhaust valve of an NIV device according to the invention, such as the device of [Fig.l];

[0018] [Fig.3] represents the gas intake module and the ventilation module of an NIV device according to the invention when they are disassembled from each other;

[0019] [Fig.4] represents the gas intake and ventilation modules of [Fig.3], when assembled together;

[0020] [Fig.5] is a sectional representation of [Fig.4]; and

[0021] [Fig.6] is a representation analogous to [Fig.4] including other elements of a NIV device according to the invention.

[0022] [Fig.l] schematizes an embodiment of a non-ventilation device 1 invasive or pneumatically operated NIV according to the invention delivering respiratory gas, preferably at continuous positive airway pressure (CPAP), to the respiratory tract of a patient P suffering from respiratory difficulties or failures, for example a person infected with a coronavirus, such as COVID-19, or resulting from any other cause or pathology, in particular for use in a hospital environment.

[0023] The NIV device 1 comprises a gas inlet module 100, a ventilation module 200 and a flexible conduit or pipe 300 acting as a gas delivery line, fluidically connecting the internal gas passage 102 of the gas inlet module 100 to the internal gas circuit 202 of the ventilation module 200 so as to be able to deliver pressurized respiratory gas, typically oxygen or an air / oxygen mixture from the gas inlet module 100 to the ventilation module 200.

[0024] The ventilation module 200 makes it possible to supply the gas to the patient P, via a patient respiratory interface 250, such as a respiratory mask, e.g. facial, or a tracheal intubation probe or a supraglottic device for example.

[0025] More precisely, the gas intake module 100 comprises an intake module body 101 or first module body, made of rigid material, for example of the polymer type, crossed by an internal gas passage 102.

[0026] The intake module body 101 of the gas intake module 100 comprises an oxygen injection port 105 carried by a tubular connector 105-1 or the like, supplied with gaseous oxygen by an oxygen source 400 and a gas supply port 106 for discharging the pressurized gas located in the internal gas passage 102 towards the flexible conduit 300 which is connected to the intake module body 101 of the gas intake module 100 by an upstream end 301.

[0027] The gas supply orifice 106 is carried by a conduit connection end piece 101-1 to which the flexible conduit 300 is mechanically and fluidically connected.

[0028] The flexible conduit 300 makes it possible to convey the gas within its lumen from the gas intake module 100 to the ventilation module 200 to which it is connected by a downstream end 302, that is to say in the direction of the patient P.

[0029] Preferably, the flexible conduit 300 is a flexible or supple gas pipe, for example made of polymer.

[0030] As illustrated in [Fig.6], the flexible conduit 300 comprises at its upstream 301 and downstream 302 ends, connection means 303, such as tubular connectors or the like allowing a mechanical and fluidic connection to the modules 100, 200, for example a connection by interlocking / fitting.

[0031] Preferably, the flexible conduit 300 has a length of between 50 cm and 5 meters, typically between 1 and 4 m, generally less than 2 m.

[0032] The oxygen source 400 comprises a pressurized oxygen cylinder, as illustrated in [Fig.l], or, according to another embodiment (not shown), an oxygen supply pipe opening at a connection socket, typically a wall socket, which may be part of a gas pipe network arranged in a hospital building or the like.

[0033] Furthermore, the internal gas passage 102 of the gas intake module 100 is also in fluid communication with a gas reservoir 107 to supply it with gas, typically oxygen, via a connecting orifice 104 arranged on a reservoir connection or fixing end piece 101-2 carried by the intake module body 101, such as a tubular connector or the like.

[0034] The gas reservoir 107 forms a reserve of gaseous oxygen, i.e. a buffer capacity, making it possible to meet the inspiratory demand of the patient P, i.e. to ensure good oxygenation of the patient, even if the latter is in high demand. The gas reservoir 107 is for example formed from a flexible polymer envelope having a capacity of at least 15 liters, advantageously at least 20 liters, typically of the order of 23 to 35 liters, for example approximately 25 to 30 liters (capacity in L in water equivalent). The size of the gas reservoir 107 is important to ensure effective ventilation of the patient P.

[0035] Preferably, the gas intake module 100 may further comprise a venturi inlet 103 which can be fluidically connected to a venturi device 133 comprising (at least) a venturi air inlet 133A for atmospheric air and a venturi oxygen inlet 133B which is connected, via an oxygen line 134, to an oxygen source making it possible to produce an air / oxygen mixture which then feeds the internal gas passage 102 of the gas intake module 100. In the embodiment of [Fig.l], the oxygen injection orifice 105 and the venturi inlet 103 are two inlets distinct from each other. However, according to another embodiment (not shown), they can be formed from a single orifice or inlet, that is to say that the venturi inlet 103 can be configured to also form the oxygen injection orifice 105 so as to fluidically and mechanically connect thereto either an oxygen source or a venturi device 133.

[0036] In the embodiment of [Fig.l], the oxygen source is the same oxygen source 400, for example a pressurized oxygen cylinder, as that supplying oxygen to the internal gas passage 102 of the gas intake module 100 via the oxygen injection port 105; however, it could be another oxygen source such as a second gas cylinder, an oxygen concentrator or even a gas pipeline.

[0037] The venturi device 133 can be mounted detachably. It is not essential but can be very useful when it is desired to save oxygen. since it allows O2 / air mixtures to be made, thus diluting the oxygen with ambient air, thus using a smaller quantity.

[0038] In other words, the gas intake module 100 may also comprise a venturi device or system 133, arranged permanently or being fixed to the first module body 101, which is in communication with the ambient atmosphere via its venturi air inlet(s) 133A to allow an additional air inlet into the internal gas passage 102, in particular in the event of a gas flow peak or when it is desired to obtain an air / O2 mixture rather than using pure O2, so as to be able to increase the inspiratory flow rate at the expense of a high oxygen concentration.

[0039] The body 101 of the gas intake module 100 further comprises a safety valve 120 designed to allow ambient air to enter the internal gas passage 102 of the intake module 100 in the event of insufficient gas in the tank 107 and / or coming from the oxygen source 400, i.e. when the quantity of gas available for the patient P is insufficient, for example in the event of failure or malfunction of one or other of these components. The safety valve 120 therefore makes it possible to prevent asphyxiation of the patient P by providing him with emergency ambient air.

[0040] Furthermore, the body 201 of the ventilation module 200, i.e. the second module body 201, is crossed by an internal gas circuit 202, i.e. a conduit, passage or other, comprising a gas inlet orifice 203 supplied with gas by the flexible conduit 300, and a gas outlet orifice 204 for supplying the pressurized gas to the patient P, via the respiratory interface 250.

[0041] The body 201 of the ventilation module 200 may also be formed from a rigid material, for example of the polymer type. It is preferably formed in one piece by injection molding or the like.

[0042] The gas inlet orifice 203 and gas outlet orifice 204 are carried, respectively, by an upstream connection end piece 201-1 which is configured to fluidly connect the flexible conduit 300 thereto, and by a downstream connection end piece 201-2 which is, for its part, configured to fluidly connect the respiratory interface 250 thereto.

[0043] Preferably, the upstream and downstream connection tips 201-1, 201-2 are tubular connectors, for example cylindrical or frustoconical, onto which the flexible conduit 300 is mechanically fixed by fitting, i.e. interlocking, via its downstream end 302 provided with a downstream connector 303, and the respiratory interface 250, thus ensuring sealed fluid connections.

[0044] Furthermore, a gas anti-return device 208 arranged in the internal gas circuit 202, approximate to the gas inlet orifice 203. Preferably, the gas anti-return device 208 comprises a one-way valve allowing the passage of gas only in one direction, namely in the direction of the patient P, and therefore opposing to the rise of gases, such as gases exhaled by the patient P, towards and into the flexible conduit 300.

[0045] In order to be able to evacuate into the atmosphere the gases exhaled by the patient P, an exhaust valve 205 is provided, arranged in the body 201 of the ventilation module 200. It is designed to allow the exhaust of the exhaled gases into the atmosphere via an exhaust orifice 207 during the expiratory phases of the patient P and, conversely, to prevent the escape of gases into the atmosphere during the inspiratory phases of the patient P.

[0046] An embodiment (sectional view) of an exhaust valve 205 is shown diagrammatically in [Fig.2].

[0047] As can be seen, the pneumatic exhaust valve 205 comprises an internal compartment 206 comprising a closure element 213, such as a flap or a flexible membrane, an elastic means 207, such as a spring, arranged in the internal compartment 206 and acting on the closure element 213 so as to press on its internal face 213A and push it normally towards a valve seat 214, during the inspiratory phases. The valve seat 214 cooperates with the external face 213B of the closure element 213 to ensure a fluid seal between them, during each inspiratory phase of the patient.

[0048] In the embodiment illustrated in [Fig.2], the closure element is for example a flexible membrane 213 made of metal, plastic or another material. It has for example a general shape of a “bellows disc” and is fixed (at 216) to the internal wall 215 of the valve body 217 of the exhaust valve 205. However, according to other embodiments, the closure element may be a flap, for example rigid, or any equivalent closure means or system.

[0049] The closure element 213 has its internal face 213A on the side of the internal compartment 206 and its external face 213B oriented towards the internal gas circuit 202. In other words, the closure element 213 separates the internal compartment 206 from the internal gas circuit 202 by normally closing the valve inlet 230.

[0050] In the embodiment shown, the valve seat 214 is arranged around the valve inlet 230. The valve seat 214 has, for example, an annular shape and the closure element 213 acting as a valve flap may have a disc shape.

[0051] The closure element moves and / or deforms towards or away from it (direction of arrow F) depending on the inspiratory and expiratory phases of the patient and under the effect of the elastic force exerted by the elastic means 207, i.e. spring, as explained below,

[0052] In order to allow the operation of the exhaust valve 205, the internal compartment 206 also comprises a gas exhaust port 211 serving to evacuate the gas to the ambient atmosphere when the exhaust valve 205 opens, that is to say when the closure element moves or deforms away from the valve seat 214, during the expiratory phases of the patient, given that the pressure of the gas exhaled by the patient will be exerted on the internal face 213A and push it upwards on [Fig.2], that is to say towards the inside of the internal compartment 206 of the valve 205.

[0053] In other words, the pressure of the gas exhaled by the patient must be greater than the repulsion force, i.e. the stiffness, of the elastic means 207, i.e. the spring, in order to be able to obtain an opening of the exhaust valve 205, i.e. a detachment of the closure element 213 from the valve seat 214, a release of the valve inlet 230 and therefore a fluid communication of the internal gas circuit 202 with the ambient atmosphere via successively the valve inlet 230 and the gas exhaust orifice 211.

[0054] Indeed, by detaching from the valve seat 214 under the effect of the pressure of the exhaled gas, the closure element 213 frees a passage between its internal face 213A and the valve seat 214, for the pressurized gas contained in the internal gas circuit 202, which can then circulate through the valve inlet 230 and then be evacuated to the atmosphere via the gas exhaust orifice 211. It is essential that, when the patient P exhales, (almost) all of the exhaled gas rich in CO2 is evacuated to the atmosphere in order to prevent the patient from reinhaling it during the next inspiration.

[0055] This evacuation of the CO2-rich exhaled gas is done through the exhalation valve 205 which opens, during the expiratory phases, allowing the passage of gas through the gas exhaust orifice 211.

[0056] Furthermore, the non-return device 208 contributes to an efficient evacuation of the gas from the body 201 of the ventilation module 200, during the patient's expiration phases, by preventing the rise of CO2-rich gas in the flexible conduit 300.

[0057] In the embodiment of [Fig.2], the exhaust valve 205 comprises a PEP adjustment system 218 allowing the user to adjust or fix the elastic force that the elastic means 207, i.e. spring or the like, will apply to the internal surface or face 213A of the closure element 213 to push it back against the valve seat 214. The adjustment system 218 therefore makes it possible to fix a positive expiratory pressure (PEP) level of between 0 and 30 cmH20.

[0058] The PEP adjustment system 218 is carried by the valve body 217 of the exhaust valve 205 which has a generally cylindrical or similar shape. The adjustment system 218 comprises a movable part 220 in the form of a cap which is fixed by screwing 221, for example via a thread / tapping, bayonet or similar type system, to the valve body 217. The elastic means 207, i.e. spring or similar, comes to bear in the bottom 218A of the movable part 220 in the form of a cap. In other words, the elastic means 207 is sandwiched between the bottom 218A of the movable part 220 and the closing element 213 cooperating with the valve seat 214.

[0059] Thus, screwing the movable part 220 onto the valve body 217 will cause this movable part 220 to move closer to the closure element 213 and consequently a crushing or compression of the elastic means 207, typically an increase in its stiffness, and therefore also an increase in the PEP level.

[0060] Conversely, unscrewing the movable part 220 will cause the movable part 220 to move away from the closure element 213 and consequently a release or decompression of the elastic means 207, typically a reduction in its stiffness, therefore a drop in the PEP level.

[0061] However, according to another embodiment (not shown), the exhaust valve 205 may comprise a non-adjustable PEEP system, i.e. making it possible to ensure a predefined positive expiratory pressure (PEEP) between 0 and 30 cmH20, for example a PEEP equal to 5 cmH20, 7.5 cmH20, 10 cmH20 or other.

[0062] The effectiveness of ventilation depends on the size of the gas reservoir 107 used. In other words, the size of the oxygen reservoir (in L) directly impacts the ventilatory performance of the NIV device 1, i.e. the smaller the reservoir, the greater the pressure variations to reach the set volume. This means that a patient must make a greater respiratory effort in order to breathe properly. In other words, it is preferable to use a reservoir 107 with a larger capacity since from 15 to 20 L of capacity, a real clinical benefit for the patient appears. However, increasing the capacity of the gas reservoir 107 beyond 40 to 45 L does not allow for a further improvement in ventilation to be noted. From there, it is preferable to use a gas reservoir 107 having a capacity of between approximately 15 and 35 L, advantageously of the order of 25 to 30 L.

[0063] Generally speaking, the NIV device 1 of the invention makes it possible to ensure the maintenance of a continuous positive pressure (CPAP) during the ventilation of the patient, therefore of a good FiO2, namely the Inspired Fraction of Oxygen, which is the concentration of oxygen that the patient will ultimately receive. Thus, it is important to be able to provide the patient with an FiO2 close to 100% (i.e. close to pure oxygen) to obtain good oxygenation of his blood, thanks to ventilation, in particular in patients infected with Covid-19 or any other virus or similar negatively affecting his lung capacity.

[0064] According to the present invention, in order to solve the problems linked to the filling of the tank and the size of the NIV device 1 when it is not in use, coupling means 130, 201-2 are provided, arranged on the gas inlet module 100 and the ventilation module 200, allowing the user, such as personnel caregiver, to detachably couple the ventilation module 200 to the gas intake module 100.

[0065] Otherwise, the gas intake module 100 and the ventilation module 200 can be coupled and decoupled, that is to say assembled to one another or, conversely, disassembled from one another, by the user, thanks to the coupling means 130, 201-2, in particular after use of the NIV device 1, for example when it must be temporarily stored between two uses.

[0066] More precisely, the coupling means 130, 201-2 comprise a blind bottom housing 130, open towards the outside, arranged in the intake module body 101 of the gas intake module 100 cooperating with housing the downstream connection end piece 201-2 of the ventilation module 200.

[0067] Indeed, the blind bottom housing 130 of the gas intake module 100 is configured, i.e. sized, to house the downstream connection end piece 201-2 of the ventilation module 200 and to retain it, in a detachable manner, within the blind bottom housing 130.

[0068] Preferably, the downstream connection end piece 201-2 and the blind bottom housing 130 form a male / female assembly for connection by fitting.

[0069] For this, the downstream connection end piece 201-2 has a tubular shape, typically cylindrical or frustoconical, and the blind bottom housing 130 has a shape complementary to that of the downstream connection end piece 201-2 of the ventilation module 200, that is to say that they are substantially of the same section so that the downstream connection end piece 201-2 can be inserted “by force” into the blind bottom housing 130 and is retained there, i.e. locked in position, by the internal peripheral wall of the blind bottom housing 130.

[0070] The maintenance of the downstream connection end piece 201-2 in the blind bottom housing 130, after its insertion and fitting into said housing 130, is ensured by the friction forces or the like exerted between the external peripheral wall of the downstream connection end piece 201-2 and the internal peripheral wall of the blind bottom housing 130.

[0071] In addition, the insertion of the tip 201-2 into the blind bottom 130 makes it possible to obtain an overall seal of the NIV device 1 and thus to guarantee at all times its filling with gas given that the gas circuit is then closed, as illustrated in [Fig.6], and this, even after storage or temporary non-use. This has the advantages of avoiding gas losses and of being able to initiate a new patient treatment, without having to wait for the NIV device 1 to be completely filled given that the reservoir 107 is kept permanently entirely filled with gas, mainly O2 or air / O2 mixture.

[0072] Thus, at the start of treatment, the reservoir 107 being always full, the user has than to disconnect Injunction from the two modules 100,200 and then connect a respiratory interface 250 to the downstream connection tip 201-2 of the ventilation module 200, before starting the treatment of the patient P.

[0073] Then, at the end of treatment or between two patients, the user, i.e. a healthcare staff member, disconnects the respiratory interface 250 which is normally connected to the downstream connection tip 201-2 of the ventilation module 200, during the treatment of the patient P. The gas intake 100 and ventilation 200 modules are then as illustrated in [Fig.3], i.e. disconnected from each other, but connected to each other by the flexible conduit 300 (the flexible conduit 300 is not shown in [Fig.3]).

[0074] If the user then wishes to store the NIV device 1, he then inserts the downstream connection end piece 201-2 of the ventilation module 200 into the blind-bottomed housing 130 provided in the intake module body 101 of the gas intake module 100, and locks it in position in the housing 130, for example by “force-fitting” them into each other so that they are kept coupled due to frictional forces or the like exerted between them.

[0075] The configurations illustrated in [Fig.4] to [Fig.6] are then obtained; in [Fig.6], the flexible conduit 300 is shown. This also makes it possible to retain part of the gas contained in the reservoir 107 and incidentally in the dead volumes of the device 1, such as gas passages of the modules and conduit, thus avoiding wasting gas which would otherwise be sent to the atmosphere, and therefore saving time when starting a new treatment.

[0076] As seen in [Fig.6], when the modules 100, 200 are coupled, the flexible conduit 300 then forms a U-shaped loop 310 which can then be used to suspend the entire NIV device 1 from a hook or the like, and thus allow easy and space-saving storage.

[0077] In addition, the modules 100, 200 being coupled to each other, in a detachable / removable manner, and the flexible conduit 300 being folded into a loop, the overall size is reduced, i.e. the entire device 1 is more compact, which makes it easier to store.

[0078] Finally, the ventilation module 200 is then no longer free at the end of the flexible conduit 300, since it is coupled to the gas intake module 100, and therefore no longer risks inadvertently hitting, when it is handled, a piece of furniture or another structure likely to damage it under the effect of the impact, knowing that in general, such a ventilation module 200 is formed of a polymer, i.e. plastic, and therefore can be quite fragile and likely to break or crack in the event of an impact on a hard structure.

[0079] Furthermore, another advantage of the invention is that since the downstream connection end piece 201-2 of the ventilation module 200 is inserted, in a sealed manner, within the blind bottom housing 130, the gas flow, typically oxygen, entering through the oxygen injection port 105, as illustrated in [Fig.6], can fill (gray arrows in [Fig.6]) the entire internal volume of the device 1, in particular the internal gas passage 102, the lumen 305 of the conduit 300 and the internal gas circuit 202, and especially the reservoir 107, which makes it possible to avoid wasting gas.

Claims

1. Claims Non-invasive ventilation (NIV) device (1), in particular continuous positive airway pressure (CPAP), comprising: - a gas intake module (100) comprising an intake module body (101) comprising: • an internal gas passage (102), • an oxygen injection port (105) in fluid communication with the internal gas passage (102), and • a conduit connection end piece (101-1) with a gas supply port (106) in fluid communication with the internal gas passage (102), said conduit connection end piece (101-1) being configured to fluidly connect a flexible conduit (300) thereto, and - a ventilation module (200) comprising a ventilation module body (201) comprising: • an upstream connection end piece (201-1) with a gas inlet orifice (203) configured to fluidly connect the flexible conduit (300) thereto, • a downstream connection tip (201-2) with a gas outlet orifice (204) configured to fluidly connect a respiratory interface (250) thereto, and • an internal gas circuit (202) fluidly connecting the gas inlet port (203) to the gas outlet port (204), characterized in that the gas intake module (100) and the ventilation module (200) comprise coupling means (130, 201-2) allowing a user to detachably couple the ventilation module (200) to the gas intake module (100), said coupling means (130, 201-2) comprising a blind-bottomed housing (130) open to the outside arranged in the intake module body (101) of the gas intake module (100) cooperating with the downstream connection tip (201-2) of the ventilation module (200)

2. Device according to claim 1, characterized in that a gas reservoir (107) having an internal volume of at least 15 L is fluidically connected to the internal gas passage (102) of the gas intake module (100).

3. Device according to claim 1, characterized in that the blind bottom housing (130) of the gas intake module (100) is configured to house and retain the downstream connection end piece (201-2) of the ventilation module (200).

4. Device according to one of claims 1 or 3, characterized in that the downstream connection end piece (201-2) and the blind bottom housing (130) form a male / female connection assembly by fitting.

5. Device according to one of claims 1, 3 or 4, characterized in that the downstream connection end piece (201-2) has a tubular shape and the blind bottom housing (130) has a shape complementary to the tubular shape of the downstream connection end piece (201-2), preferably a cylindrical or frustoconical shape.

6. Device according to claim 1, characterized in that a flexible conduit (300) having a length of between 0.5 and 10 meters is fluidically connected: - via an upstream end (301) equipped with connection means (303), to the conduit connection end piece (101-1) of the gas intake module (100) and - via a downstream end (302) equipped with connection means (303), to the upstream connection end piece (201-1) of the ventilation module (200).

7. Device according to claim 2, characterized in that a gas reservoir (107) having an internal volume of 20 to 50 L is fluidically connected to the internal gas passage (102) of the gas intake module (100).

8. Device according to claim 1, characterized in that the ventilation module body (201) further comprises an exhaust valve (205) in fluid communication with the internal gas circuit (202) and, moreover, with the atmosphere.

9. Device according to claim 1, characterized in that the gas intake module (100) further comprises a venturi inlet (103) configured to be fluidically connected to a venturi device (133).

10. Device according to claim 1, characterized in that a gas non-return device (208) is arranged in the internal gas circuit (202) of the ventilation module (200), preferably the gas non-return device (208) comprises a one-way valve.

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