Device for supplying a therapeutic gas, in particular NO or N 2 O, to a patient

Abstract

The present invention relates to a device for supplying a therapeutic gas, in particular an NO / N2 or O2 / N2O mixture, the device comprising: an internal passage (2) having a valve mechanism (5) for conveying and controlling the flow of the therapeutic gas in the internal passage (2); a control mechanism (6) for controlling the valve mechanism (5); a graphic display (7) for displaying user-selectable options (9a-9d); and a selection mechanism (8) such as a sensitive key displayed on the graphic display (7) for selecting from the selectable options (9a-9d) displayed on the graphic display (7). The control mechanism (6) is configured to count the total number (N) of patients treated by the administration of the therapeutic gas by a selection of a first given option (9a) made by the user via the selection mechanism (8), the first given option corresponding to the start of a treatment by the administration of the therapeutic gas to the relevant patient. The present invention also relates to a device for administering a gas to a patient.

Description

Technical Field

[0001] The present invention relates to a device for supplying a therapeutic gas, in particular nitric oxide (NO) or nitrous oxide (N 2 2O), and also to an apparatus for administering a gas to a patient, comprising such a therapeutic gas supply device. Background Art

[0002] Inhaled nitric oxide (NOi) is a gaseous drug which is typically used for treating patients suffering from acute pulmonary hypertension, in particular pulmonary vasoconstriction in adults or children, including neonates, as described, for example, in EP-A-560928 or EP-A-1516639.

[0003] Conventionally, a device for applying NOi treatment, commonly referred to as a NO administration device, comprises one or more gas cylinders for supplying NO / N 2 mixture to a NO-therapy administration and / or monitoring device; a medical ventilator for delivering a breathing gas such as O 2 2 / N 2 2 mixture or air, to which NO (i.e., NO / N 2 2) is added; and a patient kit which particularly comprises one or more flexible tubes and a breathing interface such as a tracheal tube.

[0004] Such NO administration devices are used in a hospital environment for NOi treatment, thereby taking care of in-patients who need to inhale NO for treating their pulmonary hypertension.

[0005] Examples of such NO administration devices are given in the documents WO-A-2012 / 094008, US-A-2015 / 320951, US-A-2015 / 273175, JP-A-H11192303, WO-A-02 / 40914 and US-A-2003 / 116159.

[0006] Now, the duration of patient treatment varies from patient to patient, i.e., from a few hours to several days. As a result, even in cases where the information on the number of patients being treated is of utmost relevance to a hospital which has to ensure the correct use of the drug and correlate the prescribed amount with its hospital activities, it is very difficult to track and record, within a hospital, the number of patients who have received NOi treatment over a given period (e.g., one month or more months, or even an entire year), which is very different from the situation with other drugs.

[0007] Similar problems exist for other therapeutic gases, in particular an equimolar mixture of oxygen and nitrous oxide (MEOPA), i.e., O 2 2 / N 2 2O mixture, and even for other medical gases.

[0008] To solve this problem, certain administration / delivery devices or gas cylinders calculate the number of hours of use of the therapeutic gas in order to deduce the number of patients being treated based on a fixed average duration of use and from that number of hours.

[0009] Now, it will be appreciated that this method is not ideal because it is based on a single average duration, while the duration of use varies widely between one patient and another. Thus, it will be readily understood that the amount of gas used by an adult is very different from that used by a newborn. Consequently, the calculated results are very inaccurate or even completely wrong.

[0010] In addition, this method also leads to errors because it relies on calculations performed by the user, and the user may make mistakes when performing these calculations.

[0011] Finally, if the gas cylinder is inadvertently opened, even if the gas being delivered is lost, the lost gas will be considered as having been used for patient care, which will make the calculation wrong again.

[0012] Thus, the problem is being able to accurately and reliably calculate the number of patients being treated with a therapeutic gas by inhalation (especially NO), which number can be consulted by the user (such as a caregiver) at any time, and the calculation of the number is automatic so as to provide useful information to the user, and this is done immediately without the user having to perform minimal calculations for themselves, especially when providing NO / N 2 in the case of a mixture to patients in need of such treatment (especially for the treatment of their pulmonary hypertension or hypo-oxygenation). Summary of the Invention

[0013] Thus, a solution according to the invention relates to a device for supplying a therapeutic gas, the device comprising:

[0014] - an internal channel for conveying a flow of therapeutic gas between (at least) a gas inlet and (at least) a gas outlet;

[0015] - a valve mechanism for controlling the flow of the therapeutic gas in the internal channel;

[0016] - a control mechanism configured to be able to control at least the valve mechanism;

[0017] - a graphical display configured to be able to (at least) display user-selectable options and possibly other information; and

[0018] - a selection mechanism configured to be able to select from the selectable options displayed on the graphical display.

[0019] According to the present invention, the control mechanism is configured to count the total number (N) of patients treated by the administration of a therapeutic gas by the selection by the user, via the selection means, of a first given option corresponding to the start of the treatment by the administration of the therapeutic gas to the relevant patient.

[0020] According to the embodiment considered, the therapeutic gas supply device of the present invention may comprise one or more of the following features:

[0021] - The control mechanism cooperates with a graphical display to display the total number (N) of patients treated as counted.

[0022] - The control mechanism comprises at least one microprocessor, preferably at least one microcontroller.

[0023] - The at least one microprocessor is arranged on an electronic board.

[0024] - The control mechanism comprises at least one microprocessor using one or more algorithms.

[0025] - The selection means comprises one or more selection keys.

[0026] - The graphical display comprises a display screen, typically a digital screen, preferably a touch screen.

[0027] - The one or more selection keys are one or more virtual keys displayed on the touch screen, i.e. one or more touch-sensitive keys.

[0028] - The graphical display is configured to display the virtual selection keys in the form of one or more selection windows.

[0029] - The graphical display comprises a display screen that is color or black and white or both color and black and white.

[0030] - The control mechanism is configured to count the total number (N) of patients treated by incrementing the value of a patient counter, in particular a counter inside the microprocessor.

[0031] - The control mechanism is configured to increment the total number (N) of patients treated by +1 in response to the user's selection of a first given option corresponding to the start of the treatment by the administration of the therapeutic gas to the relevant patient.

[0032] - The control mechanism is configured to operate the valve mechanism and start the supply of the therapeutic gas in response to the user's selection of a first given option corresponding to the start of the treatment by the administration of the therapeutic gas to the relevant patient.

[0033] - Alternatively, the control mechanism is configured to operate the valve mechanism and start supplying the treatment gas in response to the user's selection of a first given option corresponding to the start of the treatment by administering a treatment gas to a relevant patient and subsequent verification (i.e., confirmation) of the selection of the first given option. Preferably, the verification is performed by the user selecting a confirmation key, which is in particular a virtual confirmation key displayed on a graphical display.

[0034] - The control mechanism is further configured to determine, for each patient being treated, a total treatment duration corresponding to the time period elapsed between the user's selection of the following two options:

[0035] ● a first given option corresponding to the start of the treatment by administering a treatment gas to a relevant patient; and

[0036] ● a second given option corresponding to the end of the treatment by administering a treatment gas to the relevant patient.

[0037] - The control mechanism is further configured to:

[0038] ● temporarily interrupt the determination of the total treatment duration for a relevant patient after:

[0039] - the user selects a second option corresponding to the end of the treatment; or

[0040] - the user selects a third given option corresponding to the suspension of the treatment in which the administration of the treatment gas to the relevant patient is temporarily interrupted; and

[0041] ● resume / restart the determination of the total treatment duration for the relevant patient after:

[0042] - the user again selects the first given option corresponding to the start of the treatment by administering the treatment gas, i.e., makes an additional selection of the first option for the same patient; or

[0043] - the user selects a fourth given option corresponding to the resumption of the treatment by administering a treatment gas to the given patient.

[0044] - The control mechanism is further configured to prevent the value of the patient counter from increasing after the user again selects the first option corresponding to the start of the treatment for a given patient or selects the fourth option corresponding to the resumption of the treatment for a given patient. This is because the control mechanism, in particular the microprocessor, interprets / considers the re-selection of the first option or the selection of the fourth option as an indication of the resumption of the same treatment for the same patient after a temporary suspension of the treatment for that patient.

[0045] - The selection keys include:

[0046] ."Start treatment" key, which commands the start of the supply of treatment gas; and

[0047] ● "End treatment" key, which commands the stop of the supply of treatment gas.

[0048] - The "start treatment" key and the "end treatment" key are the same key that commands the start and end of the gas supply.

[0049] - The "start treatment" key and the "end treatment" key are different keys.

[0050] - The selection keys may also include:

[0051] ● "Pause treatment" key, which commands the pause of the supply of treatment gas; and / or

[0052] ● "Resume treatment" key, which commands the resumption of the supply of treatment gas (after a pause).

[0053] - The "pause treatment" key and the "resume treatment" key are the same key that commands the pause and resumption of the gas supply.

[0054] - The "pause treatment" key and the "resume treatment" key are different keys.

[0055] - According to another embodiment, the "pause treatment" key and the "end treatment" key are the same key that commands the final stop or temporary stop (i.e., pause) of the gas supply.

[0056] - According to yet another embodiment, the "start treatment" key and the "resume treatment" key are the same key that commands the start of the gas supply (i.e., initial startup or resumption after a pause).

[0057] - The control mechanism is further configured to be determined by the total number (N) of patients treated that have been counted and the total treatment duration determined for the patients treated:

[0058] ● The number (TC) of short-term treatments in which the total treatment duration is below a preset threshold duration. In other words, the number TC corresponds to the number of patients who have undergone treatments that have typically been quickly interrupted after less than three hours due to treatment ineffectiveness, the treatment having had a negative effect, or for other reasons; and / or

[0059] ● The number (TL) of long-term treatments in which the total treatment duration is above the preset threshold duration. In other words, the number TL corresponds to the number of patients who have undergone treatments of a long duration, such as possibly lasting for several days, due to treatment effectiveness.

[0060] - According to a specific embodiment, the control mechanism is further configured such that when the determined total treatment duration is below a preset minimum duration, which is below the preset threshold duration, and for example, the preset minimum duration is less than or equal to 1 hour, preferably less than or equal to 30 minutes, the total number of patients (N) to be treated is not incremented by +1 (i.e., they are not counted). This is because using the device for a short minimum duration usually corresponds to special circumstances that do not correspond to the treatment of patients, such as correcting setup errors, demonstrating for training purposes, etc. In order not to miscalculate the total number of patients (N) to be treated, such special circumstances must never be counted.

[0061] - The number of long - term treatments (TL) is equal to the total number of patients (N) to be treated minus the number of short - term treatments (TC), i.e.:

[0062] TL = N – TC. Or, in other words, N = TC + TL or TC = N - TL.

[0063] - The control mechanism cooperates with a graphical display so as to also display the number of short - term treatments (TC) and / or the number of long - term treatments (TL).

[0064] - The treatment gas supply device further includes a memory storage mechanism configured to store:

[0065] ■ The total number of patients (N) to be treated;

[0066] ■ The number of short - term treatments (TC);

[0067] ■ The number of long - term treatments (TL);

[0068] ■ User - selectable options; and / or

[0069] ■ The preset threshold duration;

[0070] ■ And / or a possible preset minimum duration.

[0071] - When the treatment gas is NO, the threshold duration is less than or equal to 5 hours, typically about 3h to 4h, for example 3h.

[0072] - The minimum duration is less than or equal to 1h, for example about 30 minutes.

[0073] - The threshold duration is adjustable and / or the minimum duration is adjustable.

[0074] - The memory storage mechanism includes one or more memories for recording and storing data, such as one or more volatile or non - volatile memories, such as flash memory or some other type of memory.

[0075] - At least one memory (such as a flash memory) is located on or in the electronic board.

[0076] - The therapeutic gas supply device further includes a current supply mechanism that supplies current to the components of the device to enable them to operate, such as a display, a microprocessor, a memory, etc. The current supply mechanism may conventionally include one (or more) rechargeable or non-rechargeable batteries, a current transformer, a power cord, and a power plug that can be connected to a power network (110 / 220V), etc.

[0077] - The therapeutic gas supply device further includes a rigid housing or casing, and all or some of the components of the device, especially the control mechanism, internal channels, valve mechanism, etc., are arranged in the rigid housing or casing.

[0078] - A graphic display is arranged in the wall of the rigid housing.

[0079] - The control mechanism is configured to be able to (at least) control the valve mechanism so as to adjust the flow rate of the therapeutic gas circulating in the internal channels.

[0080] - The valve mechanism includes at least one proportional (electric) valve or a plurality of electric valves, preferably a plurality of parallel-arranged electric valves.

[0081] - The therapeutic gas supply device further includes a flow meter device arranged on the gas channel to determine (i.e., measure) the flow rate of the therapeutic gas circulating in the internal channels.

[0082] - The flow meter device is of the hot wire type or the differential pressure type.

[0083] - The flow meter device cooperates with the control mechanism.

[0084] - The therapeutic gas supply device includes a reset mechanism, such as a RESET key, etc., which allows one or more counters to be reset / zeroed.

[0085] The present invention also relates to a device for administering gas to a patient, comprising:

[0086] - At least one therapeutic gas source;

[0087] - A therapeutic gas supply device according to the present invention, which is supplied with therapeutic gas by the at least one therapeutic gas source; and

[0088] - A gas supply pipeline through which the therapeutic gas is supplied by the therapeutic gas supply device.

[0089] According to the embodiment considered, the gas administration device of the present invention may include one or more of the following features:

[0090] - It further includes a medical ventilator that is in fluid communication with the gas supply line, i.e., a respiratory assistance device.

[0091] - The medical ventilator is fluidly connected to the supply line to supply air or N 2 / O 2 mixture.

[0092] - The therapeutic gas source contains NO, especially a NO / N 2 mixture.

[0093] - The therapeutic gas source contains a NO / N 2 mixture that contains less than 2000 ppm of NO by volume, with the remainder being nitrogen, preferably less than 1000 ppm of NO by volume, with the remainder being nitrogen.

[0094] - Preferably, the therapeutic gas source contains a NO / N 2 mixture that contains 250 ppm to 900 ppm of NO by volume, with the remainder being nitrogen, such as approximately 800 ppm of NO by volume, with the remainder being nitrogen.

[0095] - Alternatively, at least one therapeutic gas source contains O 2 / N 2 O mixture, preferably an equimolar (50 / 50 mol%) mixture of oxygen and nitrous oxide, i.e., containing MEOPA.

[0096] - Alternatively, the therapeutic gas source contains oxygen and especially contains an oxygen container or an oxygen pipeline.

[0097] - Alternatively, the therapeutic gas source contains argon or an argon / oxygen mixture.

[0098] - It further includes a gas humidifier that is preferably arranged on the gas supply line downstream of the point where the therapeutic gas supply device is fluidly connected to the gas supply line to supply therapeutic gas to the gas supply line.

[0099] - It further includes a pipeline for recovering the gas exhaled by the patient.

[0100] - The gas supply line and the exhaled gas recovery line are connected to a connector, preferably a Y-shaped part, and define a patient circuit.

[0101] - The gas supply line forms the inspiratory branch of the patient circuit.

[0102] - The exhaled gas recovery line forms the expiratory branch of the patient circuit.

[0103] - The gas supply line is fluidly connected to the outlet of the medical ventilator to collect and convey the gas delivered by the medical ventilator.

[0104] - The exhaled gas recovery line is fluidly connected to the inlet of a medical ventilator in order to supply all or part of the gas exhaled by the patient to the medical ventilator and thus determine whether there is one or more possible gas leakage sites.

[0105] - The exhaled gas recovery line optionally (i.e., this is not mandatory) includes a CO 2 removal device that allows the removal of CO present in the exhaled gas of the patient 2 .

[0106] - The exhaled gas recovery line optionally (i.e., not mandatory) includes a filter.

[0107] - At least one therapeutic gas source includes one or more gas containers, in particular one or more pressurized gas cylinders.

[0108] - The gas container is equipped with a gas distribution valve.

[0109] - The gas distribution valve is a valve with or without a built-in regulator.

[0110] - The gas distribution valve is made of a copper alloy such as brass.

[0111] - The gas container is provided with a protective cover around the gas distribution valve.

[0112] - The protective cover is made of a polymer (i.e., plastic) material, metal, or a combination thereof.

[0113] - The fluid container is a pressurized gas cylinder that contains a gas mixture, in particular NO / N 2 .

[0114] - The fluid container has an overall cylindrical, in particular oval, shape.

[0115] According to another aspect, the present invention also relates to a treatment method that includes administering a therapeutic gas, in particular NO, such as NO / N 2 mixture, wherein the gas administration device and / or therapeutic gas supply device according to the present invention is used to supply the therapeutic gas, in particular NO, such as NO / N 2 mixture to a patient suffering from pulmonary hypertension, regardless of whether the patient is an adult, adolescent, child, or newborn, for example, the patient is a newborn suffering from persistent pulmonary hypertension of the newborn (PPHN).

[0116] Depending on the embodiment considered, before supplying the NO / N 2 mixture to the patient, the NO / N can be diluted with air or a nitrogen / oxygen mixture2 The mixture is diluted. Preferably, air or a nitrogen / oxygen mixture is supplied by a medical ventilator. BRIEF DESCRIPTION OF THE DRAWINGS

[0117] The present invention will now be better understood from the following detailed description, which is given by way of non-limiting illustration and with reference to the accompanying drawings, in which:

[0118] Figure 1 An embodiment of a therapeutic gas supply device according to the present invention is schematically shown;

[0119] Figure 2 An embodiment of a gas application device according to the present invention is schematically shown; and

[0120] Figure 3 An embodiment of a screen of a gas supply device according to the present invention is schematically shown. DETAILED DESCRIPTION OF THE INVENTION

[0121] Figure 1 An embodiment of a therapeutic gas supply device 1 according to the present invention is schematically shown, which includes a rigid housing 13 made of, for example, a polymer, in which an internal gas channel 2 for conveying a therapeutic gas flow, such as a gas conduit or a similar pipe, is arranged.

[0122] In this embodiment, taking a therapeutic gas as an example, a NO-based gas flow, that is, a mixture of nitric oxide and nitrogen or NO / N 2 .

[0123] The NO-based gas flow enters the internal gas channel 2 located between the gas outlet 4 and one (or more) gas inlets 3 and circulates in the internal gas channel 2. The gas inlet 3 and the gas outlet 4 can be carried, for example, by mechanical and fluid connection end fittings or connectors carried by the housing 13 of the device 1, and a gas pipeline for conveying gas, such as a flexible tube, is attached to the mechanical and fluid connection end fittings or connectors, as described below.

[0124] A valve mechanism 5 (i.e., one (or more) valve devices, such as a plurality of electric valves arranged in parallel) is arranged on the internal gas channel 2 and allows controlling the flow rate of the therapeutic gas circulating in the internal channel 2 in a direction extending from the gas inlet 3 to the gas outlet 4. Of course, other valve mechanisms, such as one (or more) proportional (electric) valves, can also be used.

[0125] The valve mechanism 5 is operated by a control mechanism 6 (i.e., one or more control devices) arranged in a housing 13. The control mechanism is typically an electronic board that includes one or more microprocessors, typically one or more microcontrollers, which run one or more algorithms. In particular, the control mechanism 6 enables the regulation or control of the flow rate / velocity of the gas passing through the valve mechanism 5.

[0126] In this way, the control mechanism 6 can control the valve mechanism 5 such as a plurality of electric valves arranged in parallel, that is, it can open or close all or some of these valves in order to obtain a gas flow rate (Q) determined / calculated by the microcontroller based on values adjusted / set by the user, for example, and according to the flow rate (Q') of the gas (i.e., air) delivered by the ventilator 23, as described below.

[0127] One or more flow meters (not shown) are also provided, which are arranged on the internal gas passage 2 upstream and / or downstream of the valve mechanism 5 in order to determine the flow rate (Q) of the NO-based gas. The flow meter can be differential pressure type, hot wire type, or other types. The flow meter cooperates with the control mechanism 6 in order to provide measured values to the control mechanism.

[0128] In addition, the housing 13 includes a graphic display 7, preferably a touch screen, for displaying various information or data items, in particular various options 9a - 9d that the user can select. These options can be displayed in windows or the like displayed on the touch / digital screen of the graphic display 7.

[0129] The graphic display 7 is also configured to display one or more curves, charts, alarms, icons, etc., or any other information or data items used by the user, such as a caregiver.

[0130] A selection mechanism 8 is also provided, that is, one or more selection devices, which allows the user to select among the optional options 9a - 9d displayed on the graphic display 7, that is, to select among several options proposed and displayed on the screen, or to verify / confirm or reject an option (i.e., a selection), or to make adjustments or settings, for example, to select a value for the desired flow rate.

[0131] The selection mechanism 8 typically includes selection keys or buttons that the user can actuate. Advantageously, the selection mechanism 8 is virtual keys that are displayed on the graphic display 7 which is itself a touch screen and are operated by touch, that is, touch-sensitive keys.

[0132] According to the present invention, the control mechanism 6 is further configured to count the total number (N) of patients treated by administering a therapeutic gas by a selection of a first given option 9a made by the user via the selection mechanism 8, in particular a touch-sensitive key displayed on the graphical display 7, the first given option 9a corresponding to the start of treatment by administering a therapeutic gas to the relevant patient. For example, the start of treatment can be initiated by the user pressing a number on the "Start Treatment" key, which commands the start of the supply of the therapeutic gas.

[0133] The total number (N) of patients treated is counted by incrementing the value of a counter, such as a counter of a microprocessor or the like, by +1.

[0134] In other words, once treatment by administering a therapeutic gas (e.g., NO) to a patient is to be started, the user presses the "Start Treatment" touch-sensitive key displayed on the graphical display 7, which corresponds to the start (i.e., the start of the treatment), and increments the counter by +1, and the counter keeps count of the total number (N) of patients treated.

[0135] The total number (N) of patients treated can be displayed, for example, permanently or upon demand of the user, on the graphical display 7 after pressing a dedicated key.

[0136] As Figure 1 shown, the graphical display 7 can display a plurality of selectable options 9a - 9d, each option corresponding to a specific given action.

[0137] For example, the display 7 can display the following in the form of keys or the like:

[0138] - A first given option 9a corresponding to the start of treatment by administering a therapeutic gas to a patient, i.e., the "Start Treatment" key;

[0139] - A second given option 9b corresponding to the end of treatment of the relevant patient, i.e., the "End Treatment" key;

[0140] - A third given option 9c corresponding to a pause in treatment by temporarily interrupting the administration of the therapeutic gas to the relevant patient, i.e., pausing the treatment by selecting the "Pause Treatment" key; and

[0141] - A fourth given option 9d corresponding to resuming the treatment of a given patient by selecting the "Resume Treatment" key.

[0142] The user's selection of one of these options 9a - 9d will be sent to the microprocessor of the control mechanism 6 and the microprocessor will control the operation of the device according to the selection made, the selection of one of these options 9a - 9d being made, for example, by pressing a number on a virtual key, such as a window, of the touch screen of the display 7.

[0143] For example, the control mechanism 6 can command the valve mechanism 5 such that:

[0144] - If the pressed key corresponds to the first option 9a (i.e., corresponds to starting treatment by administering therapeutic gas to the patient, i.e., corresponds to the "Start Treatment" key), gas is allowed to circulate in the internal channel 2 in the direction towards the patient, through the flow control electric valve according to the set flow rate (Q);

[0145] - If the pressed key corresponds to the second or third option 9b or 9c and thus corresponds to terminating or temporarily stopping the treatment of the patient (i.e., corresponds to the "End Treatment" key or the "Pause Treatment" key), the circulation of gas in the internal channel 2 in the direction towards the patient is interrupted; and

[0146] - If the key pressed after pressing the third option 9c, which is synonymous with temporarily stopping treatment (i.e., temporarily pausing treatment), corresponds to the fourth option 9d, gas is allowed to circulate again in the internal channel 2 in the direction towards the patient by selecting the "Resume Treatment" key.

[0147] In Figure 1 the embodiment, these four keys 9a - 9d are separate keys each performing a specific action. However, according to other embodiments, the same key can be used to select some of these actions / options, which means the same key can be used to select multiple different options.

[0148] For example, the third option 9c and the fourth option 9d are displayed in the form of two virtual keys such as "Pause Treatment" and "Resume Treatment". However, according to another embodiment, these third and fourth options 9c, 9d can be selected by the same "Pause / Resume Treatment" virtual key.

[0149] Similarly, according to yet another embodiment, the first, third, and fourth options 9a, 9c, 9d can be selected by the same "Start / Pause / Resume Treatment" virtual key.

[0150] According to yet another embodiment, the same key can command the start of treatment and the resume of treatment after a pause, while another key can command the pause of treatment and the end of treatment.

[0151] Of course, other combinations or embodiments are also possible.

[0152] In all cases, pressing on a key or the like corresponding to the first option 9a (i.e., corresponding to starting treatment for the relevant patient, i.e., the new patient) (i.e., selected by the user) causes the number of patients being treated to increase by +1 and will not increase further by +1 until the key corresponding to the second option 9b (i.e., the key indicating the end of treatment for the relevant patient) is pressed. It must be emphasized that selecting the options 9c, 9d corresponding to pausing and / or resuming treatment does not cause any increase in the counter.

[0153] According to a variant embodiment, treatment is not started by administering treatment gas to the patient until the user verifies (i.e., confirms) the selected first option by pressing the "start treatment" key; preferably, verification is carried out by the user selecting a dedicated verification key, in particular a virtual verification key displayed on the graphical display 7, as detailed below.

[0154] In other words, the control mechanism 6 is configured to operate the valve mechanism 5 and start supplying treatment gas only after the user has selected the first given option of "start treatment" and then confirmed that option by pressing the verification key.

[0155] Furthermore, according to a more complex embodiment of the present invention, the control mechanism 6 is also configured to determine, for each patient being treated, the total treatment duration corresponding to the time period elapsed between the user selecting the first given option 9a corresponding to the start of treatment by administering treatment gas to the relevant patient and the user selecting the second given option 9b corresponding to the termination / end of treatment by administering treatment gas to the relevant patient.

[0156] As a result, the control mechanism 6 is configured to temporarily interrupt (i.e., stop) the determination of the total treatment duration for the relevant patient after the user selects the third given option 9c corresponding to pausing treatment during which the administration of treatment gas to the relevant patient is temporarily interrupted, and then resume the determination of the total treatment duration after:

[0157] - the user selects the first given option 9a corresponding to the start of treatment by administering treatment gas; or

[0158] - the user selects the fourth given option 9d corresponding to the resumption of treatment by administering treatment gas to the relevant patient.

[0159] According to yet another embodiment of the present invention, the control mechanism 6 may also be configured to determine:

[0160] - the number (TC) of short-term treatments where the total treatment duration is below a preset threshold duration, i.e., the number of patients who have undergone such short-term treatments (e.g., less than 3 hours); and / or

[0161] - The number of long-duration treatments (TL) where the total treatment duration exceeds a preset threshold duration, where TL = N – TC, where N is the total number of patients being treated, i.e., the number of patients who have undergone such long-duration treatments, which, for example, exceed 3 hours and can last up to one day to several days.

[0162] The control mechanism 6 collaborates with the graphical display 7 to display 11, 12 one or more values thus determined, namely the number of short-duration treatments (TC) and / or the number of long-duration treatments (TL).

[0163] Specifically, being able to determine and display the number of short-duration treatments (TC) and the number of long-duration treatments (TL) among the total number of patients being treated (i.e., the total number of given treatments using the relevant device) enables the differentiation of those patients who respond to the treatment (i.e., patients on whom the gas acts) and those patients on whom the gas does not act despite having been administered for the shortest duration (i.e., a duration that may reach the preset threshold duration). Such information is very useful for the nursing staff, especially for deciding whether it may be possible to change the treatment method.

[0164] For example, for iNO treatment, the threshold duration can be set to 3 hours or other "short" durations. Treatments that stop before the 3-hour mark will be considered short-duration treatments (TC) that have no significant or proven therapeutic effect on the patient, while treatments that last at least 3 hours will be considered long-duration treatments (TL) that have a beneficial effect on the patient.

[0165] Generally, the counting of patients treated with the gas administration device 1 of the present invention is processed by an algorithm run by the microprocessor of the control mechanism 6 of the device 1. This algorithm counts the total number of patients being treated (N) by incrementing the counter value. The number N is displayed on the screen 7 to provide this information to the user. It is preferably recorded in a non-volatile memory.

[0166] Advantageously, the device 1 is also capable of considering starting a completely new treatment (i.e., a new treatment for a new patient), temporarily interrupting the treatment, resuming the treatment of an unstable patient during the withdrawal phase (i.e., restarting / resuming a suspended treatment), and "short" treatments where the duration of the new treatment is less than a few hours (i.e., the preset threshold duration), which indicates that the patient does not respond to the treatment given.

[0167] The only triggering event for incrementing the counter of the total number of patients being treated (N) by +1 is the action of selecting the first option 9a corresponding to "start new treatment" displayed on the touch screen of the display 7 by pressing the virtual key, etc., corresponding to the first option 9a displayed on the screen.

[0168] When it is necessary to temporarily suspend the treatment of a given patient, the device 1 can provide an option or selection corresponding to the temporary suspension of treatment in the form of a dedicated key 9c of the "suspend treatment" type, as described above.

[0169] When resuming treatment, for example, after a long pause, the device 1 can request confirmation before increasing the counter value, for example, by verifying the option: asking the user to select an answer "yes" or "no" to a question of the type "Is this a new patient?" and providing two possible options of the answers "yes" and "no" in the form of two virtual keys displayed on the screen. The device 1 considers the answer "no" as a restart after the suspension of treatment, rather than as a new patient; thus, the counter does not increase.

[0170] The total treatment time is determined by the control mechanism 6 as the duration between the user pressing the key 9a indicating "start new treatment" and subsequently pressing another key corresponding to an option 9b of the "stop treatment" type, or even between pressing another key corresponding to a third option 9c of the "suspend treatment" type in the case where treatment is no longer resumed for the same patient subsequently, as explained above.

[0171] Advantageously, the display 7 not only shows the total number N (at 10) of patients being treated, but also shows the number TC (at 11) of short treatments and the number TL (at 12) of long treatments (i.e., complete treatments). The total number (N) of patients being treated is equal to the sum of the total number of long treatments and the total number of short treatments (i.e., N = TL + TC).

[0172] The display 10, 11, 12 of all or part of N, TL, and TC can be permanently available on the graphic display 7, or can appear on the screen only after being called by the user (e.g., by pressing a dedicated key, etc.).

[0173] Figure 2 An embodiment of a gas administration device 20 according to the present invention is schematically shown. In this case, it includes two treatment gas cylinders 21, where the treatment gas is NO / N 2 mixture. For example, the treatment gas cylinder contains 800 ppm of NO by volume (the rest is N 2 ), as Figure 1 shown and as described above, the treatment gas cylinder supplies the NO / N 2 mixture to the treatment gas supply device 1 according to the present invention.

[0174] The gas cylinder 21 is fluidly connected to the gas supply device 1 via a gas delivery pipeline 30 such as a hose. The gas delivery pipeline 30 may be equipped with gas pressure regulating and / or monitoring devices 31 such as a pressure regulator, a pressure gauge, etc. The gas delivery pipeline 30 is connected to one or more gas inlets 3 of the gas supply device 1, and the gas inlets 3 supply the internal passage 2 of the gas supply device.

[0175] It should be noted that the gas supply device 1 further includes an oxygen inlet 32, which is fluidly connected to an oxygen source, such as a hospital network, i.e., an oxygen supply pipeline running through the hospital building, via an oxygen delivery pipeline 34 such as a hose.

[0176] In addition, a medical ventilator 23, i.e., a respiratory assistance device, is provided to supply air or an oxygen / nitrogen (N 2 / O 2 ) mixture, i.e., a respiratory gas stream containing at least 21% oxygen.

[0177] The medical ventilator 23 and the gas supply device 1 are in fluid communication with a gas supply pipeline 22 for delivering a gas stream to a patient.

[0178] The gas supply device 1 delivers an NO / N mixture of, for example, 800 ppmv of NO into the gas supply pipeline 22 via an injection tube 37 so as to inject (at 37a) the stream of the NO / N 2 mixture into the stream of air or the oxygen / nitrogen mixture delivered by the medical ventilator 23. 2

[0179] The gas supply pipeline 22 further includes a gas humidifier 24, which is arranged downstream of the point (at 36) where the therapeutic gas supply device 1 is fluidly connected to the supply pipeline 22. The gas humidifier 24 allows the stream of gas (such as an NO / N 2 / air mixture) to be humidified before being inhaled by the patient via a patient breathing interface (such as a tracheal catheter, etc.). In Figure 2 , the patient / interface assembly is schematically represented as an "artificial lung" 25.

[0180] An exhaled gas recovery pipeline 27 for recovering the gas exhaled by the patient is also provided. The gas supply pipeline 22 and the exhaled gas recovery pipeline 27 are connected to a connector 28, preferably a Y-shaped part, thereby defining a patient circuit 29. The gas supply pipeline 22 forms the inhalation branch of the patient circuit 29, and the exhaled gas recovery pipeline 27 forms the exhalation branch of the patient circuit 29.

[0181] The gas supply pipeline 22 is fluidly connected to the outlet 23a of the medical ventilator so as to collect and deliver the gas delivered by the medical ventilator 23, which is usually air (or containing about 21% O 2 of N2 / O 2 The exhaled gas recovery line 27 is fluidly connected to the inlet 23b of the medical ventilator 23 so as to supply all or part of the gas flow exhaled by the patient to the medical ventilator 23.

[0182] The exhaled gas recovery line 27 may include one or more other optional components 26, such as a device for removing CO present in the gas exhaled by the patient. 2 The device for removing CO 2 i.e., the CO 2 capturer, such as a hot pot, etc., or, for example, a filter, etc. Specifically, when the gas contains N 2 O that needs to be recovered after being exhaled by the patient, the device for removing CO 2 may prove to be beneficial. In the case of "No", for example, the ventilator 23 uses the exhaled gas recovery line 27 to check for gas leakage in the circuits 22, 27.

[0183] A flow sensor 36, such as a hot-wire type or differential pressure type, is also provided upstream of the point of NO / N 2 / air connection and mixing (at 37a) within the supply line 22, which is connected to the gas supply device 1 via a flow measurement line 35 for measuring the flow rate (Q′) of a gas such as air (i.e., N 2 / O 2 ) from the ventilator 23. As explained above, this particularly allows the passage of NO to be adjusted via the electric valve 5 of the device 1.

[0184] In addition, a gas extraction line 38 that fluidly connects the gas supply device 1 to the supply line 22 may be provided near the Y-piece 28, so that gas samples can be collected and verified whether they conform to the desired mixture to be administered to the patient. When considering the direction of the gas flow circulating from the ventilator 23 to the patient, the extraction line 38 is connected to the line 22 downstream (at 38a) of the connection point 37a of the injection catheter 37.

[0185] Figure 3 An embodiment of the screen of the graphical display 7 for the gas supply device 1 according to the present invention is schematically shown, which is configured to display various information items, such as the concentrations of NO, O 2 and NO 2 in the gas. However, similarly, according to the present invention, the "Start Treatment" touch-sensitive key (i.e., window) allows the user (i.e., the caregiver) to select a first option 9a corresponding to the start of the treatment by administering NO to the patient, and incidentally, the number "N" (at 10) of patients who have been treated with this device is 1.

[0186] In this embodiment, before the user has selected the first option 9a, i.e., before the window forming the touch-sensitive key on the touch screen has been pressed, one or more other options 9b-9d are not displayed.

[0187] Since the problem of recording the number of patients being treated is a widespread problem for both public and private hospitals, the device of the present invention can be used for other treatments in addition to the treatment with inhaled nitric oxide, i.e., iNO, for example, for treatment with an equimolar mixture of oxygen and nitrous oxide such as MEOPA, or for treatment with other gases such as argon.

Claims

1. An apparatus (1) for supplying a therapeutic gas, comprising: - an internal passage (2) for conveying a flow of therapeutic gas between a gas inlet (3) and a gas outlet (4); - a valve mechanism (5) for controlling the flow of therapeutic gas in the internal passage (2); - a control mechanism (6) configured to control at least the valve mechanism (5); - a graphical display (7) configured to display options (9a - 9d) that can be selected by a user; and - a selection mechanism (8) configured to select from the selectable options (9a - 9d) displayed on the graphical display (7), characterized in that the control mechanism (6) is configured to count the total number (N) of patients treated by the administration of the therapeutic gas by a selection of a first given option (9a) made by the user via the selection mechanism (8), the first given option corresponding to the start of a treatment by administering the therapeutic gas to a new patient.

2. The apparatus according to claim 1, characterized in that the control mechanism (6) cooperates with the graphical display (7) to display (10) the total count (N) of patients treated.

3. The apparatus according to claim 1 or 2, characterized in that the control mechanism (6) comprises at least one microprocessor.

4. The apparatus according to claim 1, characterized in that the selection mechanism (8) comprises selection keys, and / or the graphical display (7) comprises a touch screen.

5. The apparatus according to claim 4, characterized in that the graphical display (7) comprises a touch screen and the selection keys are virtual keys displayed on the touch screen.

6. The apparatus according to claim 1, characterized in that the control mechanism (6) is configured to count the total number (N) of patients treated by incrementing a patient counter value.

7. The apparatus according to any one of claims 1 and 6, characterized in that the control mechanism (6) is configured to increment the total number (N) of patients treated by +1 in response to the user's selection of the first given option (9a) corresponding to the start of a treatment by administering the therapeutic gas to a relevant patient.

8. The apparatus according to claim 1, characterized in that the control mechanism (6) is further configured to determine, for each patient treated, a total treatment duration corresponding to the time period elapsed between the user's selection of: - a first given option (9a) corresponding to the start of a treatment by administering the therapeutic gas to a relevant patient; and - a second given option (9b) corresponding to the end of a treatment by administering the therapeutic gas to the relevant patient.

9. The apparatus according to claim 8, characterized in that the control mechanism (6) is further configured to: a) temporarily interrupt the determination of the total treatment duration for a relevant patient after: - the user selects the second given option (9b) corresponding to the end of the treatment; or - The user selects a third given option (9c), which corresponds to a suspension of the treatment in which the administration of the treatment gas to the relevant patient is temporarily interrupted; and b) Resume the determination of the total treatment duration for the relevant patient after: - The user again selects the first given option (9a) corresponding to the start of the treatment by the administration of the treatment gas; or - The user selects a fourth given option (9d) corresponding to the resumption of the treatment by the administration of the treatment gas to the relevant patient.

10. The device according to claim 9, characterized in that the control means (6) is configured to count the total number (N) of patients treated by incrementing a patient counter value, and the control means (6) is further configured not to increment the value of the patient counter after the user again selects the first given option (9a) corresponding to the start of the treatment of a given patient or after selecting the fourth given option (9d) corresponding to the resumption of the treatment of a given patient.

11. The device according to claim 8, characterized in that the control means (6) is further configured to determine from the total number (N) of patients treated that have been counted and the total treatment duration determined for the patients treated: i) The number (TC) of short treatments in which the total treatment duration is below a preset threshold duration; and / or ii) The number (TL) of long treatments in which the total treatment duration is above the preset threshold duration.

12. The device according to claim 11, characterized in that the control means (6) cooperates with the graphical display (7) so as to also display (11; 12) the number (TC) of short treatments and / or the number (TL) of long treatments.

13. The device according to claim 3, characterized in that the at least one microprocessor is at least one microcontroller.

14. The device according to claim 6, characterized in that the patient counter is a counter within the microprocessor.

15. The device according to claim 6 or 14, characterized in that the control means (6) is further configured not to increment the value of the patient counter after the user again selects the first given option (9a) corresponding to the start of the treatment of a given patient.

16. A device (20) for administering a gas to a patient, comprising: - At least one treatment gas source (21); - A device (1) for supplying treatment gas according to any one of the preceding claims, which is supplied with treatment gas from the at least one treatment gas source (21); and - A gas supply line (22) that is supplied with treatment gas via the device (1) for supplying treatment gas.

17. The device according to claim 16, characterized in that the device further comprises a medical ventilator (23) in fluid communication with the gas supply line (22).

18. The device according to claim 16, characterized in that The at least one treatment gas source (21) comprises a NO / N 2 or O 2 / N 2 O mixture.

19. The device according to claim 18, characterized in that The at least one treatment gas source is one or more gas containers.

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